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EUROPEISKA KOMMISSIONEN GER GILEAD Marknadsföringstillstånd FÖR SOVALDI®▼ (SOFOSBUVIR) FÖR BEHANDLING AV KRONISK HEPATIT C-INFEKTION

Pressmeddelanden   •   2014-01-17 16:20 CET

 – Sofosbuvir godkänd för behandling av vuxna med Hepatit C (HCV) genotyper 1–6 – 
– Höga utläkningsfrekvenser och förkortad 12-veckors kombinationsbehandling av behandlingsnaiva patienter – 
– Första enbart orala behandlingsalternativet, i upp till 24 veckor, för patienter som inte kan behandlas med interferon – 
– Första behandlingen för patienter som inte kan behandlas med interferon i väntan på levertransplantation, för att förebygga HCV-recidiv- 

Foster City, Kalifornien, 17 januari, 2014 – Gilead Sciences, Inc. (Nasdaq: GILD) meddelade idag att Europeiska kommissionen gett marknadsföringstillstånd för Sovaldi®▼ (sofosbuvir, tabletter á 400 mg), en nukleotidanalog polymerashämmare för behandling av kronisk hepatit C-virusinfektion (CHC) hos vuxna, som tas en gång om dagen i kombination med andra antivirala läkemedel (ribavirin (RBV) och pegylerat interferon alfa (peg-IFN)). Dagens marknadsföringstillstånd följer på en accelererad granskning av Europeiska läkemedelsmyndigheten (EMA), något som beviljas nya läkemedel av stor betydelse för folkhälsan och möjliggör marknadsföring av sofosbuvir i samtliga av Europeiska unionens (EU) 28 länder. 

Sofosbuvir har prövats för samtliga HCV genotyper 1–6. Effekten av sofosbuvir har fastställts hos patienter med hepatit C-virus (HCV) genotyper 1 (enbart behandlingsnaiva), 2, 3 och 4, inklusive patienter som väntar på levertransplantation och de som är co-infekterade med HCV/HIV-1. De kliniska data som stödjer användning av sofosbuvir hos patienter med genotyp 5 eller 6 är begränsade. Rekommenderade behandlingar och behandlingslängd för kombinationsbehandling med sofosbuvir av patienter enbart infekterade med HCV eller co-infekterade med HCV/HIV-1: 


PatientpopulationBehandlingBehandlingslängd
Genotyp 1, 4, 5 eller 6 CHCsofosbuvir + RBV + peg-IFN12 veckor

sofosbuvir + RBV

Endast för patienter som inte är lämpade för eller inte tolererar peg-IFN

24 veckor
Genotyp 2 CHCsofosbuvir + RBV12 veckor
Genotyp 3 CHCsofosbuvir + RBV + peg-IFN
sofosbuvir + RBV
12 veckor
24 veckor
Patienter med CHC
som väntar på 
levertransplantation
 sofosbuvir + RBVfram till levertransplantation

Monoterapi rekommenderas inte. Produktresumén finns på www.ema.europa.eu. 

– Till skillnad från många andra kroniska sjukdomar kan hepatit C botas. Men av flera skäl har många HCV-patienter ännu inte blivit botade och fortskrider ofta till sista stadiet av leversjukdom eller levercancer, sade Graham Foster, MD, Professor i Hepatologi, Queen Mary University, London. 

– Med höga läkningsfrekvenser bland ett brett spektrum av patienter och en kort behandlingslängd är Sovaldi ett mycket välkommet terapeutiskt framsteg som gör att fler patienter kan behandlas och i slutänden botas. 

Ungefär nio miljoner människor i Europa har en HCV-infektion, en viktig orsak till levercancer och levertransplantation. De samhälleliga, kliniska och ekonomiska påfrestningarna av obehandlad HCV är omfattande, och de HCV-relaterade sjukvårdskostnaderna är direkt kopplade till sjukdomens svårighetsgrad. Nuvarande vårdstandard för HCV inbegriper upp till 48 veckor av en behandling med peg-IFN/RBV, vilket kan vara mindre lämpligt för vissa patientgrupper. 

Marknadsföringstillståndet för sofosbuvir är ett viktigt steg framåt i vården av hepatit C-infekterade i Europa, som gör det möjligt för många fler patienter att bli botade, sade John C Martin, PhD, ordförande och VD för Gilead Sciences. 

– Vi avser att samarbeta med nationella myndigheter och sjukvårdssystem för att så snabbt som möjligt göra sofosbuvir tillgängligt i Europa. 

Europeiska kommissionens marknadsföringstillståndet för sofosbuvir baseras primärt på data från fem fas 3-studier: NEUTRINO, FISSION, POSITRON, FUSION och VALENCE, i vilka 12 eller 16 veckors behandling med sofosbuvir befanns vara bättre eller likvärdig med nuvarande tillgängliga behandlingsalternativ med RBV/peg-IFN eller historiska kontroller, utifrån andelen patienter med varaktig virologisk respons (då HCV blir omöjlig att detektera) 12 veckor efter avslutad behandling (SVR 12). Patienter som uppnår SVR12 anses vara botade från HCV. Studiedeltagarna som behandlades med sofosbuvir uppvisade SVR12-nivåer på 50–90 procent. Se komplett information om studierna i produktresumén på www.ema.europa.eu. 

Under den europeiska regulatoriska granskningen kompletterades ansökan med data från de två fas 3-studierna VALENCE och PHOTON-1. I VALENCE-studien behandlades patienter med en HCV-infektion av genotyp 3 med sofosbuvir och RBV under 24 veckor. PHOTON-1-studien utvärderade behandling med sofosbuvir och RBV under 12 veckor hos patienter co-infekterade med HCV genotyp 2 eller 3 och HIV-1, samt under 24 veckor hos patienter co-infekterade med HCV genotyp 1 och HIV-1. Inte i någon fas 3-studie med sofosbuvir påvisades någon viral resistens mot läkemedlet bland de patienter som fick återfall efter avslutad behandling. 

Till dags datum har nästan 3 000 patienter fått minst en dos av sofosbuvir i fas 2- eller 3-studier. Sofosbuvir har tolererats väl i kliniska studier. Biverkningarna var över lag lindriga och få behandlingar avslutades på grund av dem. De vanligaste biverkningarna, som förekom hos minst 10 procent av patienterna, överensstämde med säkerhetsprofilerna för peg-IFN och RBV och omfattade trötthet, huvudvärk, illamående, sömnlöshet, yrsel, klåda och anemi. 

Sofosbuvir godkändes i USA den 6 december 2013 och i Kanada den 13 december 2013. Ansökningar behandlas för närvarande i Australien, Nya Zeeland, Schweiz och Turkiet.

Viktig säkerhetsinformation 

Kontraindikationer: Överkänslighet mot den aktiva substansen eller något av hjälpämnena. 

Särskilda varningar och försiktighetsåtgärder innan användning: Produktresuméerna för samförskrivna läkemedel bör studeras innan behandling med sofosbuvir inleds. När sofosbuvir används i kombination med RBV eller peg-IFN/RBV ska kvinnor som kan bli med barn eller deras manliga partners använda ett effektivt preventivmedel under och en tid efter behandlingen, i enlighet med rekommendationerna i ribavirins produktresumé. För ytterligare information hänvisas till ribavirins produktresumé. 

Användning tillsammans med starka inducerare av P gp: Läkemedel som är potenta inducerare av P glykoprotein (P gp) i tarmen (t.ex. rifampicin, Johannesört [Hypericum perforatum], karbamazepin och fenytoin) kan avsevärt minska plasmakoncentrationen av sofosbuvir och leda till minskad terapeutisk effekt. Sådana läkemedel bör inte användas tillsammans med sofosbuvir. 

Produktresumé finns på www.ema.europa.eu. 

Om Gilead Sciences 

Gilead Sciences är ett biofarmaceutiskt företag som upptäcker, utvecklar och marknadsför innovativa behandlingar inom områden där det finns ett icke tillgodosett medicinskt behov. Företagets åtagande är att förbättra vården för patienter över hela världen som lider av livshotande sjukdomar. Huvudkontoret ligger i Foster City i Kalifornien och Gilead har verksamhet i Nord- och Sydamerika, Europa och Stillahavsområdet. 

Framåtsyftande påståenden 

Detta pressmeddelande innehåller framåtsyftande påståenden (”forward-looking statements”) i den mening som avses i Private Securities Litigation Reform Act från 1995. Påståendena är föremål för risker, osäkerheter och andra faktorer, inklusive risken att läkare och patienter inte skulle se några fördelar hos Sovaldi jämfört med andra behandlingar och därför vara tveksamma till att förskriva läkemedlet och risken att statliga beslut om subventionering och godkännande av priser kan dröja längre än förväntat. Dessutom kanske marknadsföringsansökningar för Sovaldi som behandlas i andra länder inte godkänns enligt den nu förmodade tidsplanen, eller över huvud taget, och eventuella marknadsföringsgodkännanden kan ha betydande begränsningar avseende användning. Dessa risker, osäkerheter och övriga faktorer kan leda till att de faktiska utfallen skiljer sig avsevärt från dem som beskrivs i de framåtsyftande påståendena. Läsaren uppmanas att inte förlita sig på de framåtsyftande påståendena. Dessa och andra risker beskrivs närmare i Gileads kvartalsrapport för det kvartal som slutade den 30 september 2013, på formulär 10-Q som lämnats in till U.S. Securities and Exchange Commission. Alla framåtsyftande påståenden bygger på information som i dagsläget finns tillgänglig för Gilead, och Gilead påtar sig inget ansvar för att uppdatera några sådana framåtsyftande påståenden. 

Sovaldi är ett registrerat varumärke som tillhör Gilead Sciences, Inc. eller dess associerade företag. 

För mer information om Gilead Sciences, besök företagets webbplats på www.gilead.com, följ Gilead på Twitter (@GileadSciences) eller ring Gilead Public Affairs på 001 650 574 3000.


KONTAKTPERSONER: 
Patrick O’Brien (Investerare i USA)
001 (650) 522 1936 

Cara Miller (Media i USA)
001 (650) 522 1616 

Arran Attridge (Media i Europa)
0044 208 587 2477 

Gilead är ett biomedicinskt företag med inriktning på forskning, utveckling och marknadsföring av innovativa behandlingar inom områden där adekvat vård saknas. Gilead har bland annat utvecklat nya läkemedel mot HIV och hepatit som väsentligt förbättrat livssituationen för patienter världen över. Gileads huvudkontor ligger i Kalifornien och företaget bedriver verksamhet i Nordamerika, Europa och Australien. Det nordiska huvudkontoret ligger i Stockholm, Sverige, och startades upp 2008. Gilead grundades 1987 och har på bara tjugo år blivit ett av världens största biomedicinska företag med en snabbt växande produktportfölj. Läs mer på www.gilead.com

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STRIBILD® – EN NY ENTABLETTSBEHANDLING MOT HIV – FINNS NU I SVERIGE

Pressmeddelanden   •   2013-06-08 08:46 CEST

Solna Gate, Sverige, 8 juni 2013 – Gilead Sciences, Inc. (Nasdaq: GILD) meddelade i dag att Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabin 200 mg/tenofovirdisoproxilfumarat 245 mg), som är en ny entablettsbehandling mot hiv-1-infektion, nu finns tillgänglig i Sverige. Stribild är godkänd för vuxna patienter som inte tidigare fått antiretroviral behandling eller som bär på hiv-1-virus utan kända mutationer förenade med resistens mot någon av de tre antiretrovirala substanserna i Stribild. Europeiska kommissionen utfärdade den 24 maj 2013 försäljningstillstånd för Stribild® i Europeiska unionen.

”Stribild är ett nytt behandlingsalternativ mot hiv som ger oss läkare ökade möjligheter att hitta en behandling som passar den enskilda patienten”, säger Anders Blaxhult som är läkare och docent vid Venhälsan i Stockholm.

Fler än 6 000 personer lever med hiv i Sverige i dag och 2012 rapporterades 441 nya personer med hiv-infektion.

Stribild är den tredje av Gileads hiv-behandlingar som bygger på en enda tablett som blir tillgänglig i Europa. Den första, Atripla® (efavirenz 600 mg/emtricitabin 200 mg/tenofovirdisoproxilfumarat 245 mg), godkändes 2007 och marknadsförs av Gilead i samarbete med Bristol-Myers Squibb och Merck & Co. Den andra, Eviplera®▼ (emtricitabin 200 mg/rilpivirin 25 mg/tenofovirdisoproxilfumarat 245 mg), marknadsförs av Gilead och Janssen R&D Irland och beviljades försäljningstillstånd i EU i november 2011.

Om Stribild

Stribild består av fyra Gilead-substanser som kombinerats i en tablett som tas en gång per dag: elvitegravir 150 mg, cobicistat 150 mg, emtricitabin 200 mg och tenofovirdisoproxilfumarat 245 mg.

Elvitegravir hör till den grupp antiretrovirala substanser som kallas integrashämmare. Integrashämmare påverkar replikationen av hiv genom att hämma virusets förmåga att ta sig in i det genetiska materialet i de mänskliga cellerna. I mars 2005 ingick Gilead ett licensavtal rörande elvitegravir med Japan Tobacco Inc. (JT). Enligt detta avtal har Gilead ensamrätt att utveckla och saluföra elvitegravir i alla länder utom Japan, där JT behåller rättigheterna.

Cobicistat är Gileads egen potenta mekanismbaserade hämmare av enzymet cytokrom P450 3A (CYP3A) som metaboliserar läkemedel i kroppen.

Elvitegravir och cobicistat som fristående läkemedel är fortfarande under prövning och deras säkerhet och effekt har ännu inte kunnat fastställas.

Viktig produktinformation om Stribild för EU

Laktatacidos, oftast i förening med leversteatos, har rapporterats vid användning av nukleosidanaloger. Laktatacidos är förenat med hög dödlighet och patienter med ökad risk bör övervakas noggrant.

Stribild bör inte tas tillsammans med några av följande substanser på grund av risken för allvarliga och/eller livshotande biverkningar, förlust av virologisk respons och resistensutveckling mot Stribild:

·  alfa-1-adrenoreceptorantagonister: alfuzosin

·  antiarytmika: amiodaron, kinidin

·  antikonvulsiva medel: karbamazepin, fenobarbital, fenytoin

·  antimykobakteriella medel: rifampicin

·  ergotderivat: dihydroergotamin, ergometrin, ergotamin

·  tarmreglerande medel: cisaprid

·  växtbaserade läkemedel: johannesört (Hypericum perforatum)

·  HMG-CoA-reduktashämmare: lovastatin, simvastatin

·  neuroleptika: pimozid

·  PDE-5-hämmare: sildenafil för behandling av pulmonell arteriell hypertension

·  sedativa/hypnotika: oralt administrerat midazolam, triazolam

Stribild som kombinationsläkemedel bör inte administreras samtidigt med andra läkemedel innehållande tenofovirdisoproxilfumarat, lamivudin eller adefovirdipivoxil för behandling av hepatit B-virusinfektion.

Emtricitabin och tenofovir utsöndras huvudsakligen via njurarna genom en kombination av glomerulär filtration och aktiv tubulär sekretion. Njursvikt, nedsatt njurfunktion, förhöjt kreatinin, hypofosfatemi och proximal tubulopati (inklusive Fanconis syndrom) har rapporterats vid användning av tenofovirdisoproxilfumarat.

Patienter som tidigare avslutat en behandling med tenofovirdisoproxilfumarat på grund av njurtoxicitet bör inte behandlas med Stribild.

Kreatininclearance bör beräknas och uringlukos och urinprotein kontrolleras innan behandling med Stribild sätts in.

Behandling med Stribild bör inte sättas in om patientens kreatininclearance < 70 ml/min. Behandling med Stribild bör enligt rekommendationen inte heller inledas om patientens kreatininclearance < 90 ml/min, om inte Stribild efter genomgång av tillgängliga behandlingsalternativ bedöms vara det mest lämpliga alternativet för den enskilda patienten.

Kreatininclearance, serumfosfat, uringlukos och urinprotein bör kontrolleras var fjärde vecka under det första året och därefter var tredje månad. Mer frekvent övervakning av njurfunktionen bör övervägas om patienten löper ökad risk för att drabbas av njurskada.

Kobicistat hämmar den tubulära sekretionen av kreatinin och kan ge upphov till en lätt ökning av serumkreatinin och en lätt minskning av kreatininclearance. Patienter vars serumkreatinin ökar med mer än 26,5 μmol/l (0,3 mg/dl) från utgångsvärdet bör övervakas noggrant med avseende på njurfunktion.

Njurfunktionen bör kontrolleras på nytt inom en vecka om serumfosfat < 0,48 mmol/l (1,5 mg/dl) eller om kreatininclearance sjunker till < 70 ml/min under pågående behandling med Stribild.

Om kreatininclearance < 50 ml/min eller serumfostat sjunker till < 0,32 mmol/l (1,0 mg/dl) bör behandlingen med Stribild avbrytas.

I nuläget föreligger inte tillräckliga data för att det ska kunna fastställas om samadministrering av tenofovirdisoproxilfumarat och kobicistat medför ökad risk för skadliga reaktioner på njurarna jämfört med behandlingar med tenofovirdisoproxilfumarat utan kobicistat.

Stribild bör undvikas vid samtidig eller nyligen avslutad behandling med nefrotoxiska läkemedel på grund av ökad risk för skadliga reaktioner på njurarna (med TDF-komponenten i Stribild).

Skelettabnormaliteter (som i sällsynta fall kan leda till frakturer) kan uppträda i samband med proximal renal tubulopati och vid misstanke härom bör lämpliga åtgärder vidtas i samråd med läkare.

Stribild har inte studerats hos patienter med gravt nedsatt leverfunktion (CPT grad C).

Hos patienter som är infekterade med både hiv och hepatit B-virus (HBV) kan en avbruten behandling med Stribild leda till en allvarlig akut försämring av hepatitsjukdomen. Patienter som är infekterade med både hiv och HBV och som avslutar behandlingen med Stribild bör övervakas noggrant med såväl klinisk uppföljning som laboratorieuppföljning under minst flera månader efter behandlingens slut. Om lämpligt bör eventuell tidigare behandling mot hepatit B återupptas. Patienter med avancerad leversjukdom eller cirros rekommenderas inte att avbryta behandlingen, eftersom hepatitsjukdomen kan förvärras med leverdekompensation som följd.

Immunreaktiveringssyndrom har rapporterats hos patienter som behandlats med kombinationsterapi som innefattar de substanser som ingår i Stribild.

Omfördelning av kroppsfett (lipodystrofi) har noterats i samband med kombinationsterapi hos hiv-patienter. De långsiktiga konsekvenserna av dessa biverkningar är ännu inte kända.

Kontaktpersoner

Dick Sundh, General Manager, +46-70-3161268

Göran Skoglund, Medical Director, +46-70-8734464

Stephen Head, Media (EU), +44-208-587-2359 

Om Gilead Sciences

Gilead är ett biomedicinskt företag med inriktning på forskning, utveckling och marknadsföring av innovativa behandlingar inom områden där adekvat vård saknas. Gilead har bland annat utvecklat nya läkemedel mot HIV och hepatit som väsentligt förbättrat livssituationen för patienter världen över. Gileads huvudkontor ligger i Kalifornien och företaget bedriver verksamhet i Nordamerika, Europa och Australien. Det nordiska huvudkontoret ligger i Stockholm, Sverige, och startades upp 2008. Gilead grundades 1987 och har på bara tjugo år blivit ett av världens största biomedicinska företag med en snabbt växande produktportfölj. Läs mer på www.gilead.com

Framåtsyftande påståenden

Detta pressmeddelande innehåller framåtsyftande påståenden (”forward-looking statements”) i den mening som avses i Private Securities Litigation Reform Act från 1995. Påståendena är föremål för risker, osäkerheter och andra faktorer, inklusive risken för att läkare inte ser någon fördel med Stribild jämfört med andra hiv-behandlingar och därför är tveksamma till att förskriva läkemedlet. Dessa risker, osäkerheter och övriga faktorer kan leda till att de faktiska resultaten skiljer sig avsevärt från dem som beskrivs i de framåtsyftande påståendena. Läsaren uppmanas att inte förlita sig på de framåtsyftande påståendena. Dessa och andra risker beskrivs närmare i Gileads kvartalsrapport för det kvartal som avslutades den 31 mars 2013 på formulär 10-Q som lämnats in till U.S. Securities and Exchange Commission. Alla framåtsyftande påståenden bygger på information som i dagsläget finns tillgänglig för Gilead, och Gilead påtar sig inget ansvar för att uppdatera några sådana framåtsyftande påståenden.

Stribild förenklar hiv-terapin eftersom en komplett behandling kan erhållas med bara en tablett per dag.

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International AIDS Candlelight Memorial Day 30 år – Jonas Gardell och Barbro Westerholm tog emot utmärkelse

Pressmeddelanden   •   2013-05-24 11:45 CEST

Med start i San Francisco 1983 arrangeras i år Candlelight Memorial Day för 30:e gången, bland annat i Sverige. Rörelsen bakom International AIDS Candlelight Memorial Day är global och har sedan starten arbetat för att HIV-positiva ska få leva ett hälsosamt och värdigt liv.

-  Rörelsen arbetar hela tiden med att synliggöra människor som lever med HIV. Det är viktigt att folk känner till att hiv inte innebär samma sak idag som på 80- och 90-talen. Kunskaper och förståelse måste alltså öka om vi ska kunna minska stigmatiseringen och diskrimineringen, säger Peter Månehall, Ombudsman HIV-Sverige.

Candlelight Memorial Day uppmärksammas också av HIV-Sverige som delade ut Heders Red Ribbon till personer som gjort något betydelsefullt för hivpositivas livssituation under året som gått. 2013 års utmärkelse gavs till Jonas Gardell och Barbro Westerholm.

Ny bok om HIV-liv

I samband med 30-årsdagen utkommer en ny bok som handlar om att leva med HIV idag. Boken är framtagen av det biomedicinska företaget Gilead och är en påminnelse om att alla slags människor kan bära på viruset. Men framför allt handlar den om hopp och att HIV är annorlunda i idag i jämförelse med 1983.

- Candlelight Memorial Day är en dag då vi minns det förgångna. Vi minns de människor som inte längre finns bland oss och de framsteg som gjorts. Som kvinna, HIV-positiv och mamma väljer jag att hedra de båda, säger Ophelia Haanyama, Senior Advisor på Noaks Ark.

Gilead är ett biomedicinskt företag med inriktning på forskning, utveckling och marknadsföring av innovativa behandlingar inom områden där adekvat vård saknas. Gilead har bland annat utvecklat nya läkemedel mot HIV och hepatit som väsentligt förbättrat livssituationen för patienter världen över. Gileads huvudkontor ligger i Kalifornien och företaget bedriver verksamhet i Nordamerika, Europa och Australien. Det nordiska huvudkontoret ligger i Stockholm, Sverige, och startades upp 2008. Gilead grundades 1987 och har på bara tjugo år blivit ett av världens största biomedicinska företag med en snabbt växande produktportfölj. Läs mer på www.gilead.com

International AIDS Candlelight Memorial Day ägde rum för 30:e året i rad. I samband med detta delade HIV-Sverige ut Heders Red Ribbon till Jonas Gardell och Barbro Westerholm vid. Samtidigt publicerades en ny svensk bok som visar hur livet med HIV ser ut idag. Bokens utgångspunkt är att HIV är som vilken kronisk sjukdom som helst, men att skräck och oro i onödan dikterar livet för HIV-positiva.

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European Commission Approves Viread ® for HIV-1 Infection in Children and Adolescents and for Chronic Hepatitis B in Adolescents

Pressmeddelanden   •   2012-11-29 15:03 CET

-- New Oral Granule Formulation and Lower-Strength Tablets Available for New Indications --


Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for two new indications for once-daily Viread® (tenofovir disoproxil fumarate). The first new indication permits the use of Viread in combination with other antiretroviral agents for the treatment of HIV-1 infected pediatric patients aged 2 to less than 18 years with nucleoside reverse transcriptase inhibitor (NRTI) resistance or toxicities precluding the use of first line pediatric agents. Additionally, Viread is now approved for the treatment of chronic hepatitis B virus (HBV) infection in adolescent patients aged 12 to less than 18 years with compensated liver disease and evidence of immune active disease. Today’s authorization covers all 27 countries of the European Union (EU). Viread was approved for use in combination with other antiretroviral agents as a treatment for HIV-1 infection in adults and for chronic HBV in 2002 and 2008, respectively, and is the most-prescribed molecule for these diseases in major European countries.

Today’s decision includes marketing authorization for a new oral granule formulation of Viread for HIV-1 infected children aged 2 to less than 6 years, and for HIV-1 infected children above 6 years of age for whom a solid dosage form is not appropriate. The agency also approved three new reduced-strength Viread tablets in doses of 123 mg, 163 mg and 204 mg for HIV-1 infected children aged 6 to less than 12 years. The use of the lower-strength tablets and the oral granule formulation are based on the patient’s age and weight.

The existing, full-strength 245 mg Viread tablet formulation is now available for use by adolescents aged 12 to less than 18 years to treat both HIV-1 infection and chronic HBV infection in those with compensated liver disease. For adolescents and adults for whom the 245 mg tablets are not appropriate, the oral granule formulation may be used.

“We are pleased to provide new therapeutic options for younger patients living with HIV and chronic hepatitis B and will work to make these pediatric formulations available as quickly as possible,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences.

The new indications are supported by clinical data from three studies examining the use of Viread among children and adolescents with HIV and among adolescents with chronic HBV. The safety and efficacy of Viread has not been established in children less than 2 years of age for HIV treatment, or in children less than 12 years of age for the treatment of chronic HBV.

In an effort to accelerate the availability of pediatric formulations in low-income countries, where the majority of children with HIV live, Gilead has established incentives to encourage its Indian generic manufacturing partners to develop pediatric formulations of its HIV treatments. Through these partnerships, Gilead already makes Viread available at significantly reduced cost for adults living with HIV and chronic HBV in low-income countries.

EU Important Safety Product Information About Viread, Including Boxed Warnings

·  Lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues, including tenofovir disoproxil fumarate. Lactic acidosis has a high mortality and patients at increased risk should be followed closely.

·  A multidisciplinary approach is recommended for the management of children and adolescents to weigh on a case-by-case basis the benefit-risk balance of treatment.

·  Rare events of renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil fumarate.

·  It is recommended that creatinine clearance is calculated in all adult patients prior to initiation therapy with Viread and renal function (creatinine clearance and serum phosphate) is also monitored every four weeks during the first year and the very three months. In patients at risk for renal impairment, more frequent monitoring should be considered. In children and adolescents, renal function (creatinine clearance and serum phosphate) should be evaluated prior to treatment and monitored during treatment as in adults.

·  If renal abnormalities are detected or suspected in children and adolescents, consultation with a nephrologist should be obtained to consider interruption of Viread treatment.

·  Use of Viread should be avoided with concurrent or recent use of nephrotoxic medications. If concomitant use of Viread and nephrotoxic agents is unavoidable, renal function must be monitored weekly.

·  Dose interval adjustment is recommended in adult patients with moderate renal impairment (creatinine clearance 30-49 mL/min).

·  Viread is not recommended in adult patients with severe renal impairment (creatinine clearance < 30 mL/min). If no alternative treatment is available, prolonged dose intervals may be used.

·  Viread is not recommended for use in children and adolescents with renal impairment.

·  Bone abnormalities (infrequently leading to fractures) may be associated with proximal renal tubulopathy and appropriate consultation should be obtained if suspected.

·  Viread may cause a reduction in bone mineral density (BMD) and the effects of Viread associated changes in BMD on long term bone health and future fracture risk are currently unknown in children and adolescents. If bone abnormalities are detected or suspected in children and adolescents, consultation with an endocrinologist and /or nephrologist should be obtained.

·  Immune reconstitution syndrome has been reported in patients treated with combination therapy, including Viread.

·  Redistribution and/or accumulation of body fat have been observed in patients taking anti-HIV medicines. The cause and long-term effect of these conditions are unknown.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk that healthcare providers may not see advantages of Viread for HIV-infected children and HBV-infected adolescents over other formulations and may therefore be reluctant to prescribe the product. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

EU Summary of Product Characteristics for Viread is available at http://www.ema.europa.eu/ema/index.jsp?curl=/pages/home/Home_Page.jsp

Viread is a registered trademark of Gilead Sciences, Inc.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Source: Gilead Sciences, Inc.

Gilead Sciences, Inc.
Patrick O’Brien, +1 650-522-1936 (Investors)
Stephen Head, +44 (208) 587-2359 (Media, Europe)
Cara Miller, +1 650-522-1616 (Media, U.S.)


-- New Oral Granule Formulation and Lower-Strength Tablets Available for New Indications --

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Gilead Announces Sustained Virologic Response Rate of 78% From Phase 3 Study of Sofosbuvir for Genotype 2/3 Hepatitis C Infected Patients

Pressmeddelanden   •   2012-11-29 09:59 CET

-- POSITRON Demonstrates Efficacy of a 12-Week All-Oral Regimen of Sofosbuvir Plus Ribavirin for Chronic Hepatitis C Patients who are Unable or Unwilling to Take Interferon --


Gilead Sciences (Nasdaq:GILD) today announced topline results from the Phase 3 POSITRON study examining a 12-week course of once-daily sofosbuvir plus ribavirin (RBV) in patients with genotype 2 or 3 chronic hepatitis C virus (HCV) infection who are not candidates to take interferon (IFN). The study found that 78 percent of patients (n=161/207) remained HCV RNA undetectable 12 weeks after completing therapy (SVR12). The safety profile of sofosbuvir was similar to that observed in previous studies, and there were few treatment discontinuations due to adverse events.

POSITRON is the first of three Phase 3 studies to be completed that are evaluating sofosbuvir therapy in HCV genotype 2 or 3 infected patient populations.

“Achieving a sustained virologic response in three quarters of patients is an impressive result for a sofosbuvir-based, all-oral treatment in a group of individuals for which no suitable alternative therapy exists. These patients by definition had previously declined interferon-based therapy, were ineligible to receive interferon, or were interferon intolerant,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer, Gilead Sciences. “We look forward to sharing data from additional Phase 3 studies in early 2013, and expect to submit our first regulatory filings for sofosbuvir by mid-2013.”

In POSITRON, HCV genotype 2 or 3 patients who were interferon intolerant, interferon ineligible or unwilling to take interferon were randomized (3:1) to receive 12 weeks of either sofosbuvir 400 mg once daily plus weight-based RBV twice daily (n=207) or matching placebo (n=71). Of the 207 patients randomized to the sofosbuvir/RBV arm, 15 percent had compensated cirrhosis (more advanced liver disease) and 53 percent were infected with genotype 2. SVR12 rates were 93 percent in genotype 2 and 61 percent in genotype 3. In the small percentage of patients with cirrhosis at baseline who received sofosbuvir/RBV, 61 percent achieved SVR12. All patients receiving sofosbuvir/RBV became HCV RNA negative on treatment and relapse accounted for all virologic failures. No patient in the placebo group achieved an SVR12. The most common adverse events reported in greater than 10 percent of patients in the study were fatigue, nausea, headache, insomnia, pruritis and anemia.

Full data from the study will be submitted for presentation at a future scientific conference.

The Phase 3 clinical trial program for sofosbuvir includes two additional studies evaluating 12 and 16 weeks of therapy with sofosbuvir plus RBV in HCV genotype 2 and 3 infected patients. A fourth Phase 3 clinical trial is evaluating sofosbuvir combined with RBV and peg-IFN among patients with HCV genotypes 1, 4, 5 and 6. Pending the results, these studies will support initial regulatory filings in mid-2013 for an all-oral therapy with sofosbuvir plus RBV among genotype 2/3 treatment-naïve, treatment-experienced and interferon-intolerant patients, and for sofosbuvir in combination with RBV and peg-IFN among treatment-naïve patients with HCV genotypes 1, 4, 5 and 6.

About Sofosbuvir

Sofosbuvir (formerly referred to as GS-7977) is a once-daily nucleotide analog polymerase inhibitor for the treatment of HCV infection. Sofosbuvir is being evaluated as part of multiple therapeutic regimens, including the programs outlined above in combination with RBV and peg-IFN. Additionally, sofosbuvir is being studied as a once-daily fixed-dose combination containing sofosbuvir and the NS5A inhibitor GS-5885, with the added goal of creating a potent, tolerable and convenient all-oral treatment for genotype 1 infected HCV patients that may eliminate the need for interferon and/or RBV.

Sofosbuvir and GS-5885 are investigational products and their safety and efficacy have not yet been established.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility that the proportion of patients who maintain a sustained virologic response with longer follow up will not be as favorable as the sustained virologic response rates reported in this press release and the possibility of unfavorable results from additional clinical trials involving sofosbuvir and the fixed-dose combination of sofosbuvir and GS-5885. As a result, sofosbuvir and GS-5885 as single agents or as a fixed-dose combination may never be successfully commercialized. Further, Gilead may make a strategic decision to discontinue development of the compounds or the fixed-dose combination regimen if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Source: Gilead Sciences

Gilead Sciences
Patrick O’Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)



-- POSITRON Demonstrates Efficacy of a 12-Week All-Oral Regimen of Sofosbuvir Plus Ribavirin for Chronic Hepatitis C Patients who are Unable or Unwilling to Take Interferon --

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Ny undersökning: Många söker mer kunskap om hiv

Pressmeddelanden   •   2012-11-23 08:59 CET

I oktober 2012 genomfördes en webbaserad enkät med syfte att kartlägga kunskapen och attityder om hiv bland allmänheten. Bland annat visar den att omkring 40 procent av dem som svarade hade gjort något för att få mer kunskaper om hiv de senaste åren. Den viktigaste källan till information var Internet. Även Jonas Gardells roman och tv-serie ”Torka aldrig tårar utan handskar” har bidragit till ökad kunskap.

903 personer valde att besvara frågorna i enkäten; 788 personer avslutade hela enkäten. Bland dessa var det endast 25 personer (3%) som uppgav att de hade hiv, trots att man på olika sätt uppmanat denna grupp att delta. Bland hivpositiva uppgav två av tre att deras diagnos har en negativ inverkan på livskvaliteten och 1/3 upplever att man blir diskriminerad på grund av sin hivstatus.

– Enkätsvaren bekräftar att hiv, trots de framsteg som gjorts inom behandlingsforskningen, alltjämt är en sjukdom med långtgående konsekvenser för den som förvärvat infektionen. Behovet av psykosociala stödinsatser kvarstår. Svaren visar också att det finns ett fortsatt behov av informationsinsatser, säger Jukka Aminoff, kanslichef på Riksförbundet Noaks Ark.

En av tre har aldrig hivtestat sig

Sex procent uppgav att de kände sig oroliga för att vara hivsmittade och hälften av dem menade att denna oro påverkade sexuallivet negativt. Bland dem som svarade på enkäten var det en tredjedel som inte hade hivtestat sig någon gång. Majoriteten av dem som inte testat sig menade att de inte utsatt sig för något man ansåg vara en risk. Endast 3 procent angav att de undvikit att hivtesta sig antingen av rädsla för registrering eller för den omdebatterade svenska smittskyddslagstiftningen.

Kunskapen om hur hiv smittar är hög vad gäller oskyddade samlag, delande av injektionssprutor och överföring via blod, blodprodukter och transplanterade organ. Däremot råder det bland respondenterna stor osäkerhet om hur smittsamt hiv är vid oralsex.

Flera personer har velat testa sig men blivit nekade

Fem procent svarade ”Ja” på frågan om man någon gång velat hivtesta sig men hade av sjukvården nekats eller övertalats av avstå. I Socialstyrelsens meddelandeblad till sjukvården april 2012 framhålls att det är av stor vikt att testning för hiv och sexuellt överförbara infektioner är lätt tillgänglig och att hälso- och sjukvården har en generös inställning till möjligheten att få testa sig.

– Det finns en mängd goda argument för att göra hivtestning mera lättillgänglig, och inga hållbara argument emot. Vi behöver både större tillgänglighet, alternativa former för testning och flera aktörer som utför hivtestning, uppger Jukka Aminoff.

Undersökningen initierades och genomfördes av Riksförbundet Noaks Ark i samarbete med Gilead Sciences, med Netdoktor som källa.

FÖR YTTERLIGARE INFORMATION:

Riksförbundet Noaks Ark: Jukka Aminoff, kanslichef. 08-700 46 00. jukka.aminoff@noaksark.org

Gilead Sciences: Marie Ohrlander, Senior Product Manager HIV, Nordics. 0709-788 117. marie.ohrlander@gilead.com

Noaks Ark blev Sveriges första organisation för att förebygga hiv och att stödja smittade, sjuka och deras närmaste. Till Noaks Arks lokalföreningar är människor som har hiv, är närstående eller har behov av att prata om hiv välkomna för att få stöd, vara med i gemenskapen och delta i olika aktiviteter som utflykter, föreläsningar och middagar.

Gilead är ett biomedicinskt företag med inriktning på forskning, utveckling och marknadsföring av innovativa behandlingar inom områden där adekvat vård saknas. Gilead har bland annat utvecklat nya läkemedel mot hiv och hepatit som väsentligt förbättrat livssituationen för patienter världen över.



I oktober 2012 genomfördes en webbaserad enkät med syfte att kartlägga kunskapen och attityder om hiv bland allmänheten. Bland annat visar den att omkring 40 procent av dem som svarade hade gjort något för att få mer kunskaper om hiv de senaste åren. Den viktigaste källan till information var Internet.

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Gilead ’s Once-Daily Single Tablet Regimen Stribild™ Maintains High Viral Suppression Through Two Years of Therapy Among Treatment-Naïve HIV Patients

Pressmeddelanden   •   2012-11-16 09:57 CET

-- Pivotal Data from Two Phase 3 Studies Highlight Stribild’s Sustained Efficacy, Safety and Tolerability Profile --

GLASGOW, England--(BUSINESS WIRE)--Nov. 15, 2012-- Gilead Sciences (Nasdaq:GILD) today announced two-year (96-week) results from two pivotal Phase 3 studies (Studies 102 and 103) evaluating the company’s newest single tablet HIV regimen, StribildTM (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), among treatment-naïve patients with HIV-1 infection. Data show that Stribild was non-inferior after two years of treatment to two standard of care HIV regimens, Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in Study 102 and a protease-based regimen of ritonavir-boosted atazanavir plus Truvada® (emtricitabine and tenofovir disoproxil fumarate) in Study 103. These results were presented today in an oral session at the 11th International Congress on Drug Therapy in HIV Infection (HIV11) in Glasgow, United Kingdom.

“In these studies, Stribild demonstrated a robust clinical profile, including sustained efficacy, safety and resistance results over two years of treatment,” said Jürgen Rockstroh, MD, Professor of Medicine, University of Bonn, Germany and a lead investigator for Study 103. “Stribild was also associated with a lower incidence of certain central nervous system side effects compared to Atripla, and had a favorable triglycerides profile versus the atazanavir-based regimen.”

Stribild combines four compounds in one daily tablet: elvitegravir, an integrase inhibitor; cobicistat, a pharmacoenhancing agent; emtricitabine and tenofovir disoproxil fumarate. The regimen was approved by the U.S. Food and Drug Administration (FDA) on August 27, 2012 for use by treatment-naïve HIV-positive adults based on 48-week results from Studies 102 and 103. A marketing application for Stribild is currently under review in the European Union.

Study 102 found that at 96 weeks of treatment, 84 percent of Stribild patients (n=293/348) and 82 percent of Atripla patients (n=287/352) achieved HIV RNA (viral load) < 50 copies/mL, based on the FDA snapshot algorithm (95 percent CI for the difference: -2.9 to +8.3 percent for Stribild vs. Atripla; predefined criterion for non-inferiority was a lower bound of a two sided 95 percent CI of -12 percent).

Similarly, results from Study 103 show that 83 percent of Stribild patients (n=294/353) and 82 percent of patients receiving the atazanavir-based regimen (n=292/355) achieved HIV RNA < 50 copies/mL, based on the FDA snapshot algorithm (95 percent CI for the difference: -4.5 to +6.7 percent for Stribild vs. the atazanavir-based regimen; predefined criterion for non-inferiority was a lower bound of a two sided 95 percent CI of -12 percent).

In both Studies 102 and 103, rates of discontinuation due to adverse events were similar across all treatment groups (5 percent for Stribild in each study, 7 percent for Atripla and 6 percent for the atazanavir-based regimen). The most common adverse events occurring in at least 10 percent of Stribild patients in Study 102 were diarrhea, nausea, upper respiratory infection, headache, abnormal dreams, fatigue, depression and insomnia; in Study 103, they were diarrhea, nausea, upper respiratory infection, headache, nasopharyngitis, depression, back pain and fatigue. In Study 102, there were consistently higher reports at each study visit through 96 weeks of abnormal dreams and dizziness in the Atripla arm, with 14 percent and 4 percent of patients experiencing abnormal dreams and dizziness, respectively, on the Atripla arm vs. 8 percent and 1 percent, respectively on the Stribild arm at 96 weeks. Similarly, in Study 103, reports of diarrhea were consistently higher through 96 weeks of treatment on the atazanavir-based arm compared to Stribild, with 4 percent of Stribild patients vs. 9 percent of patients on an atazanavir-based regimen experiencing this problem at 96 weeks.

The frequency of Grade 3-4 adverse events and laboratory abnormalities was also comparable between study regimens. However, in Study 102, patients taking Stribild experienced lower rates of neuropsychiatric side effects (Grades 1-4) through 96 weeks compared to Atripla patients, including abnormal dreams (15 percent for Stribild vs. 28 percent for Atripla), dizziness (8 percent vs. 25 percent) and insomnia (11 percent vs. 16 percent). Patients taking Stribild also experienced lower increases in total cholesterol and LDL (low-density lipoprotein or “bad” cholesterol) compared to Atripla, and in Study 103, experienced significantly smaller increases in triglycerides compared to those taking the atazanavir-based regimen. Additionally, through week 96, reports of Grade 3-4 hyperbilirubinemia were lower in the Stribild arm compared to the atazanavir-based arm (0.6 percent vs. 65 percent).

In September 2012, Stribild was added to U.S. Department of Health and Human Services (DHHS) guidelines as an “alternative” treatment regimen for patients new to HIV therapy. Atripla and ritonavir-boosted atazanavir plus Truvada are both listed as “preferred” first-line regimens in the guidelines.Stribild has a Boxed Warning of lactic acidosis/severe hepatomegaly with steatosis and post treatment acute exacerbation of hepatitis B; see below for important safety information.

Gilead recently initiated WAVES, a Phase 3b study evaluating Stribild compared to ritonavir-boosted atazanavir plus Truvadaamong more than 500 HIV-positive treatment-naïve women. Additional studies examining the efficacy and safety of switching treatment-experienced virologically suppressed patients to Stribild are also underway.

Study 102

Study 102 is a randomized (1:1), double-blind Phase 3 clinical trial comparing the efficacy, safety and tolerability of Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) (n=348) versus Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) (n=352) among HIV-infected treatment-naïve adults with HIV RNA levels greater than or equal to 5,000 copies/mL. The primary endpoint of the study is the proportion of patients achieving HIV RNA levels < 50 copies/mL at 48 weeks of treatment, per the FDA snapshot algorithm. Secondary objectives will evaluate the efficacy, safety and tolerability of the treatment regimens through 192 weeks of treatment.

At baseline, patients in the Stribild arm had a median HIV RNA of 4.75 log10 copies/mL and mean CD4 cell count of 391 cells/mm3. Patients in the Atripla arm had a median HIV RNA of 4.78 log10 copies/mL and mean CD4 cell count of 382 cells/mm3. Across both arms, 33 percent of patients had HIV RNA > 100,000 copies/mL, and 13 percent of patients had CD4 counts ≤ 200 cells/mm3.

At 96 weeks, mean increases in CD4 cell counts were 295 cells/mm3 for Stribild patients and 273 cells/mm3 for Atripla patients (p=0.19). Virologic failure rates were 6 percent for Stribild compared to 8 percent for Atripla.

Five percent of Stribild patients and 7 percent of Atripla patients discontinued treatment due to adverse events. The most common adverse events leading to treatment discontinuation among patients taking Stribild were renal events, depression and fatigue. Between 48 and 96 weeks of treatment, two Stribild patients discontinued due to serum creatinine increase without features of proximal renal tubulopathy, and both patients improved after treatment discontinuation.

Median changes from baseline in total cholesterol, HDL (high-density lipoprotein or “good” cholesterol) and LDL at 96 weeks were, respectively, +9, +6 and +9 mg/dL for Stribild and +18, +8 and +16 mg/dL for Atripla (total cholesterol, p<0.001; HDL, p=0.008; LDL, p=0.011). The median change in triglycerides was +4 mg/dL for Stribild and +8 mg/dL for Atripla (p=0.41).

Study 103

Study 103 is a randomized (1:1), double-blind Phase 3 clinical trial comparing the efficacy, safety and tolerability of Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) (n=353) versus atazanavir 300 mg boosted by ritonavir 100 mg plus Truvada (emtricitabine and tenofovir disoproxil fumarate) (n=355) among HIV-infected treatment-naïve adults with baseline HIV RNA levels > 5,000 copies/mL. The primary endpoint of the study is the proportion of patients achieving HIV RNA levels < 50 copies/mL at 48 weeks of treatment, per the FDA snapshot algorithm. Secondary objectives will evaluate the efficacy, safety and tolerability of the treatment regimens through 192 weeks of treatment.

At baseline, patients in the Stribild arm had a median HIV RNA of 4.88 log10 copies/mL and mean CD4 cell count of 364 cells/mm3. Patients in the atazanavir-based arm had a median HIV RNA of 4.86 log10 copies/mL and mean CD4 cell count of 375 cells/mm3. Across both arms, 41 percent of patients had HIV RNA > 100,000 copies/mL and 13 percent had CD4 counts ≤ to 200 cells/mm3.

At 96 weeks, patients in both arms experienced similar increases in CD4 cell counts (mean increase of 256 cells/mm3 for Stribild and 261 cells/ mm3 for the atazanavir-based regimen). The virologic failure rate was 7 percent for both treatment regimens. Five percent of Stribild patients and 6 percent of patients on the atazanavir-based regimen discontinued treatment due to adverse events. The most common adverse events leading to treatment discontinuation among patients taking Stribild were renal events, diarrhea, pyrexia, nausea, vomiting and fatigue. Between 48 and 96 weeks of treatment, one Stribild patient and one patient in the atazanavir-based regimen discontinued due to serum creatinine increase without features of proximal renal tubulopathy, and both patients improved after treatment discontinuation.

Ocular icterus (associated with elevated bilirubin levels) was less common among Stribild patients (less than 1 percent) compared to patients taking the atazanavir-based regimen (14 percent).

Median changes from baseline in total cholesterol, HDL and LDL at 96 weeks, were, respectively, +14, +6 and +14 mg/dL for Stribild, and +8, +5 and +11 mg/dL for the atazanavir-based regimen (total cholesterol, p=0.046; HDL, p=0.24; LDL, p=0.32). The median change in triglycerides was +5 mg/dL for Stribild and +16 mg/dL for the atazanavir-based regimen (p=0.012).

Studies 102 and 103 are ongoing in a blinded fashion. After week 192, patients will continue to take their blinded study drug until treatment assignments have been unblinded, at which point all subjects will be given the option to participate in an open-label rollover extension and receive Stribild. Additional information about the study can be found at www.clinicaltrials.gov.

About Stribild

Stribild contains four Gilead compounds in a complete once-daily, single tablet regimen: elvitegravir 150 mg; cobicistat 150 mg; emtricitabine 200 mg; and tenofovir disoproxil fumarate 300 mg. Stribild is indicated in the United States as a complete regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naïve. A Marketing Authorisation Application (MAA) for the regimen was validated for review by the European Medicines Agency (EMA) on December 20, 2011. Stribild does not cure HIV-1 infection.

Elvitegravir is a member of the integrase inhibitor class of antiretroviral compounds. Integrase inhibitors interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells. Elvitegravir was licensed by Gilead from Japan Tobacco Inc. (JT) in March 2005. Under the terms of Gilead’s agreement with JT, Gilead has exclusive rights to develop and commercialize elvitegravir in all countries of the world, excluding Japan, where JT retains rights. Gilead submitted a New Drug Application (NDA) to FDA for elvitegravir as a standalone agent on June 27, 2012, and the agency has set a target action date under the Prescription Drug User Fee Act (PDUFA) of April 27, 2013. An MAA for elvitegravir in the EU was validated for review by EMA on June 18, 2012.

Cobicistat is Gilead’s proprietary potent mechanism-based inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body. Unlike ritonavir, cobicistat acts only as a pharmacoenhancing or “boosting” agent and has no antiviral activity. Gilead submitted an NDA to FDA for cobicistat as a standalone agent on June 28, 2012, and a PDUFA date of April 28, 2013 has been set. An MAA for cobicistat in the EU was validated for review by EMA on May 22, 2012.

Elvitegravir and cobicistat as standalone agents are investigational products and their safety and efficacy have not yet been established.

Important Safety Information about Stribild

BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

·  Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (“tenofovir DF”), a component of Stribild, in combination with other antiretrovirals.

·  Stribild is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Stribild have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Emtriva or Viread, which are components of Stribild. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Stribild. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Contraindications

·  Coadministration: Do not use with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. Do not use with drugs that strongly induce CYP3A as this may lead to a loss of virologic response and possible resistance to Stribild. Use with the following drugs is contraindicated: alfuzosin, rifampin, dihydroergotamine, ergotamine, methylergonovine, cisapride, lovastatin, simvastatin, pimozide, sildenafil for pulmonary arterial hypertension, triazolam, oral midazolam, and St. John’s wort.

Warnings and Precautions

·  New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir DF and Stribild. Monitor estimated creatinine clearance (CrCl), urine glucose, and urine protein in all patients prior to initiating and during therapy; additionally monitor serum phosphorus in patients with or at risk for renal impairment. Cobicistat may cause modest increases in serum creatinine and modest declines in CrCl without affecting renal glomerular function; patients with an increase in serum creatinine greater than 0.4 mg/dL from baseline should be closely monitored for renal safety. Do not initiate Stribild in patients with CrCl below 70 mL/min. Discontinue Stribild if CrCl declines below 50 mL/min. Avoid concurrent or recent use with a nephrotoxic agent.

·  Use with other antiretroviral products: Stribild is a complete regimen for the treatment of HIV-1 infection. Do not coadminister with other antiretroviral products, including products containing any of the same active components; products containing lamivudine; products containing ritonavir; or with adefovir dipivoxil.

·  Decreases in bone mineral density (BMD) and cases of osteomalacia have been seen in patients treated with tenofovir DF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss.

·  Fat redistribution and accumulation have been observed in patients receiving antiretroviral therapy.

·  Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.

Adverse Reactions

·  Common adverse drug reactions in clinical studies (incidence greater than or equal to 5%; all grades) were nausea (16%), diarrhea (12%), abnormal dreams (9%), headache (7%), and fatigue (5%)

Drug Interactions

·  CYP3A substrates: Stribild can alter the concentration of drugs metabolized by CYP3A or CYP2D6. Do not use with drugs highly dependent on these factors for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening adverse events.

·  CYP3A inducers: Drugs that induce CYP3A can decrease the concentrations of components of Stribild. Do not use with drugs that strongly induce CYP3A as this may lead to loss of virologic response and possible resistance to Stribild.

·  Antacids: Separate Stribild and antacid administration by at least 2 hours.

·  Prescribing information: Consult the full prescribing information for Stribild for more information on potentially significant drug interactions, including clinical comments.

Dosage and Administration

·  Adult dosage: One tablet taken orally once daily with food.

·  Renal impairment: Do not initiate in patients with CrCl below 70 mL/min. Discontinue in patients with CrCl below 50 mL/min.

·  Hepatic impairment: Not recommended in patients with severe hepatic impairment.

Pregnancy and Breastfeeding

·  Pregnancy Category B: There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry has been established.

·  Breastfeeding: Emtricitabine and tenofovir have been detected in human milk. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that healthcare providers may not recognize the benefits of starting patients new to therapy on Stribild. As Stribild is used over longer periods of time by many patients with underlying health problems taking numerous other medicines, Gilead may find new issues such as safety, resistance or drug interaction issues, which may require it to provide additional warnings or contraindications on the label or narrow Stribild’s approved indication, each of which could reduce the market acceptance of Stribild. In addition, regulatory authorities including the European Medicines Agency may not approve marketing applications for Stribild, elvitegravir and/or cobicistat in the timelines anticipated or at all. Further, even if marketing approval is granted for any of these products, there may be significant limitations on their use. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

U.S. full prescribing information for Stribild is available at www.Stribild.com.
U.S. full prescribing information for Atripla is available at www.Atripla.com.
U.S. full prescribing information for Truvada is available at www.Truvada.com.
EU Summary of Product Characteristics for Atripla and Truvada is available at www.ema.europa.eu

Stribild is a trademark of Gilead Sciences, Inc.
Truvada is a registered trademark of Gilead Sciences, Inc.
Atripla is a registered trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.



-- Pivotal Data from Two Phase 3 Studies Highlight Stribild’s Sustained Efficacy, Safety and Tolerability Profile --

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Gilead ’s Complera® Non-Inferior to Atripla® Among Treatment-Naïve HIV Patients

Pressmeddelanden   •   2012-11-16 09:55 CET

-- STaR Study Findings Support Complera as an Important Single Tablet Regimen Option --

GLASGOW, England--(BUSINESS WIRE)--Nov. 15, 2012-- Gilead Sciences (Nasdaq:GILD) today announced Phase 3b clinical trial results from STaR (Single Tablet Regimen), the first head-to-head study comparing the single tablet regimens Complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) and Atripla® (efavirenz/emtricitabine/tenofovir disoproxil fumarate) in treatment-naïve adults with HIV infection. Data demonstrated that Complera, which is marketed as Eviplera® in the European Union, is non-inferior to Atripla based on the proportion of patients with HIV RNA levels (viral load) < 50 copies/mL at 48 weeks.

Complera demonstrated a statistically significant difference in efficacy compared to Atripla among patients with low baseline viral load (≤ 100,000 copies/mL), and was non-inferior to Atripla among patients with high baseline viral load (> 100,000 copies/mL). Notably, the virologic failure rate was low and comparable between Complera and Atripla, including among patients with baseline viral load up to 500,000 copies/mL. In addition, Complera was well-tolerated with fewer adverse events across all grades and fewer discontinuations due to adverse events (3 percent versus 9 percent; p<0.001) in the Complera and Atripla arms, respectively. These results were presented today in an oral session at the 11th International Congress on Drug Therapy in HIV Infection (HIV11) in Glasgow, United Kingdom.

“Since its U.S. approval in 2006, Atripla has become a standard of HIV care, so the rate of viral suppression demonstrated by Complera in this study is impressive,” said Calvin J. Cohen, MD, M.Sc., Director of Research, Community Research Initiative of New England and principal investigator of the STaR study. “Further, these data reinforce the tolerability profile of Complera and support its role as an important single tablet treatment option for many HIV patients new to therapy.”

At week 48, 86 percent of patients taking Complera (n=338/394) compared to 82 percent of patients taking Atripla (n=320/392) achieved HIV RNA levels < 50 copies/mL based on the U.S. Food and Drug Administration (FDA) snapshot algorithm (95 percent CI for the difference: -1.1 percent to +9.2 percent; predefined criterion for non-inferiority was the lower bound of a two-sided 95 percent CI of -12 percent). Among patients with baseline viral load ≤ 100,000 copies/mL, 89 percent of Complera patients (n=231/260) compared to 82 percent of Atripla patients (n=204/250) achieved viral suppression to < 50 copies/mL (95 percent CI for the difference: 1.1 percent to 13.4 percent). Among patients with baseline viral load > 100,000 copies/mL, 80 percent of Complera patients (n=107/134) and 82 percent of Atripla patients (n=116/142) achieved viral suppression to < 50 copies/mL (95 percent CI for the difference: -11.1 percent to 7.5 percent).

Virologic failure per snapshot algorithm was defined as patients failing to achieve viral load < 50 copies/mL at week 48, or discontinuing study drug prior to this time point due to lack of efficacy, or discontinuing study drug for other reasons and with last available viral load showing ≥ 50 copies/mL. Virologic failure rates for Complera and Atripla were, respectively, 5 percent and 3 percent for patients with viral load ≤ 100,000 copies/mL; 10 percent and 9 percent for patients with viral load > 100,000 to 500,000 copies/mL; and 25 percent and 16 percent for patients with viral load > 500,000 copies/mL.

Complera was approved in the United States in August 2011 and is indicated for use as a complete regimen for treatment-naïve adults with HIV-1 infection. Complera combines Gilead’s Truvada® (emtricitabine and tenofovir disoproxil fumarate) with Janssen R&D Ireland’s rilpivirine (marketed as Edurant®). In previous studies, more rilpivirine-treated patients with viral load > 100,000 copies/mL at the start of therapy experienced virologic failure compared to those with viral load < 100,000 copies/mL.Complera has Boxed Warnings of lactic acidosis/severe hepatomegaly with steatosis and post treatment acute exacerbation of hepatitis B; see below for important safety information.

Complera received marketing authorization from the European Commission as Eviplera in November 2011, becoming the first single tablet regimen approved for patients new to HIV therapy in Europe. In November 2012, Eviplera was added to European AIDS Clinical Society (EACS) treatment guidelines as a recommended regimen for treatment-naïve HIV patients.

About STaR

STaR (Study 110) is an ongoing, randomized (1:1), open-label Phase 3b study evaluating the efficacy and safety of Complera (n=394 treated) compared to Atripla (n=392 treated) among treatment-naïve HIV-positive adults with baseline HIV RNA levels ≥ 2,500 copies/mL. The primary objective of the study is to evaluate the non-inferiority, at a 12 percent margin, of Complera compared to Atripla in achieving HIV RNA levels < 50 copies/mL through 48 weeks of therapy, based on the FDA snapshot algorithm. Secondary endpoints include safety and efficacy of change from baseline in CD4 cell count at weeks 48 and 96 of therapy, and development of genotypic and phenotypic resistance at the time of virologic failure. Randomization was stratified by baseline HIV RNA levels (≤ or > 100,000 copies/mL).

Baseline mean CD4 cell counts were 396 cells/mm3 for Complera patients and 385 cells/mm3 for Atripla patients, and baseline HIV RNA levels were 4.8 log10 copies/mL in both treatment arms. In the Complera and Atripla arms, respectively, at baseline, 66 and 64 percent of patients had HIV RNA levels of ≤ 100,000 copies/mL, 25 percent and 30 percent had HIV-1 RNA levels between 300,000 and 500,000 copies/mL, and 9 percent and 6 percent had HIV-1 RNA levels > than 500,000 copies/mL.

At week 48, changes in CD4 cell counts were +200 cells/mm3 for patients taking Complera and +191 cells/mm3 for patients taking Atripla (p=0.34). The overall virologic failure rate per snapshot algorithm was similar in both treatment arms (8 percent for Complera and 6 percent for Atripla).

Seven percent (n=29) and 14 percent (n=54) of patients in the Complera and Atripla arms, respectively, experienced a Grade 3 or 4 adverse event. The most common treatment-related adverse events occurring in more than 5 percent of Complera patients were headache, insomnia, dizziness, depression, abnormal dreams, anxiety and somnolence.

Laboratory abnormalities (Grade 3-4) occurring in at least one percent of patients in either treatment arm included neutrophils, ALT, AST, GGT, amylase, creatine kinase, hyperglycemia, total cholesterol, glycosuria and hematuria. Only creatine kinase occurred in more than 5 percent of patients (5.1 percent in both arms).

Complera patients experienced lower mean increases compared to Atripla patients in fasting total cholesterol (1 vs. 22 mg/dL) and LDL (1 vs. 14 mg/dL) (p<0.001 for both tests). HDL increased by an average of 2 mg/dL in the Complera arm vs. 8 mg/dL in the Atripla arm (p<0.001). Triglycerides decreased by an average of 8 mg/dL among Complera patients and increased by 8 mg/dL among Atripla patients at 48 weeks (p<0.001). The ratio of total cholesterol to HDL declined by an average of 0.2 in both treatment arms.

The mean change in estimated glomerular filtration rate (GFR) by Cockcroft-Gault at week 48 was -5.4 mL/min for the Complera arm and +4.6 mL/min for the Atripla arm (p<0.001). Resistance mutations were observed in 4 percent of patients taking Complera and 1 percent of patients taking Atripla.

Complera Important Product Safety Information and Indication

WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of Complera, in combination with other antiretrovirals.

Complera is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Complera have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Emtriva or Viread, which are components of Complera. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Complera. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

CONTRAINDICATIONS

Complera should not be co-administered with the following drugs, as significant decreases in rilpivirine plasma concentrations may occur due to CYP3A enzyme induction or gastric pH increase, which may result in loss of virologic response and possible resistance to Complera or to the class of NNRTIs:

·  the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin

·  the antimycobacterials rifabutin, rifampin, rifapentine

·  proton pump inhibitors, such as esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole

·  the glucocorticoid systemic dexamethasone (more than a single dose)

·  St John’s wort (Hypericum perforatum)

WARNINGS AND PRECAUTIONS

·  New onset or worsening renal impairment
Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of tenofovir disoproxil fumarate. Assess creatinine clearance (CrCl) before initiating treatment with Complera. Monitor CrCl and serum phosphorus in patients at risk for renal impairment, including patients who have previously experienced renal events while receiving Hepsera® (adefovir dipivoxil). Avoid administering Complera with concurrent or recent use of nephrotoxic drugs. Patients with CrCl below 50 mL per minute should not receive Complera.

·  Drug Interactions
Complera should be used with caution when given with drugs that may reduce the exposure of rilpivirine.

Complera should be used with caution when co-administered with a drug with a known risk of Torsade de Pointes.

·  Depressive Disorders
The adverse reaction depressive disorders (depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, suicidal ideation) has been reported with rilpivirine. During the Phase 3 trials (N = 1,368), the incidence of depressive disorders (regardless of causality, severity) reported among rilpivirine (N = 686) or efavirenz (N = 682) was 8% and 6%, respectively. Most events were mild or moderate in severity. The incidence of Grade 3 and 4 depressive disorders (regardless of causality) was 1% for both rilpivirine and efavirenz. The incidence of discontinuation due to depressive disorders among rilpivirine or efavirenz was 1% in each arm. Suicide attempt was reported in 2 subjects in the rilpivirine arm while suicide ideation was reported in 1 subject in the rilpivirine arm and in 3 subjects in the efavirenz arm. Patients with severe depressive symptoms should seek immediate medical evaluation to assess the possibility that the symptoms are related to Complera, and if so, to determine whether the risks of continued therapy outweigh the benefits.

·  Decreases in bone mineral density
Bone mineral density (BMD) monitoring should be considered for patients who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss. Cases of osteomalacia (associated with proximal renal tubulopathy and which may contribute to fractures) have been reported in association with the use of tenofovir disoproxil fumarate.

·  Co-administration with other products
Complera should not be administered concurrently with other medicinal products containing any of the same active components, emtricitabine, rilpivirine, or tenofovir disoproxil fumarate (Emtriva, Edurant, Viread, Truvada, Atripla), with medicinal products containing lamivudine (Epivir, Epivir-HBV, Epzicom, Combivir, Trizivir), or with adefovir dipivoxil (Hepsera).

·  Fat redistribution
Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy.

·  Immune reconstitution syndrome
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including the components of Complera. Further evaluation and treatment may be necessary. Autoimmune disorders may occur in the setting of immune reconstitution.

ADVERSE REACTIONS

The most common adverse drug reactions to rilpivirine (incidence greater than or equal to 2%, Grades 2-4) were insomnia and headache.

The most common adverse drug reactions to emtricitabine and tenofovir disoproxil fumarate (incidence ≥ 10%) were diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.

DRUG INTERACTIONS

·  Complera should not be used with drugs where significant decreases in rilpivirine plasma concentrations may occur (See CONTRAINDICATIONS).

·  Complera is a complete regimen for the treatment of HIV-1 infection; therefore Complera should not be administered with other antiretroviral medications for the treatment of HIV-1 infection.

·  Drugs inducing or inhibiting CYP3A enzymes: Rilpivirine is primarily metabolized by cytochrome P450 (CYP) 3A, and drugs that induce or inhibit CYP3A may thus affect the clearance of rilpivirine. Coadministration of rilpivirine and drugs that induce CYP3A may result in decreased plasma concentrations of rilpivirine and loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs. Coadministration of rilpivirine and drugs that inhibit CYP3A may result in increased plasma concentrations of rilpivirine.

·  Drugs increasing gastric PH: Coadministration of rilpivirine with drugs that increase gastric pH may decrease plasma concentrations of rilpivirine and loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs.

·  Drugs affecting renal function: Since emtricitabine and tenofovir are primarily eliminated by the kidneys, coadministration of Complera with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of emtricitabine, tenofovir, and/or other renally eliminated drugs. Some examples include, but are not limited to, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir and valganciclovir.

·  QT prolonging drugs: There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and drugs that prolong the QTc interval of the electrocardiogram. In a study of healthy subjects, supratherapeutic doses of rilpivirine (75 mg once daily and 300 mg once daily) have been shown to prolong the QTc interval of the electrocardiogram. Complera should be used with caution when coadministered with a drug with a known risk of Torsade de Pointes.

DOSAGE AND ADMINISTRATION

Adults: The recommended dose of Complera is one tablet taken orally once daily with a meal.

Renal Impairment: Because Complera is a fixed-dose combination, it should not be prescribed for patients requiring dose adjustment such as those with moderate or severe renal impairment (creatinine clearance below 50 mL per minute).

INDICATION

Complera is indicated for use as a complete regimen for the treatment of HIV-1 infection in antiretroviral treatment-naïve adults. This indication is based on Week 48 safety and efficacy analyses from 2 randomized, double-blind, active controlled, Phase 3 trials in treatment-naïve subjects comparing rilpivirine to efavirenz.

The following points should be considered when initiating therapy with Complera:

·  More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure compared to subjects with HIV-1 RNA less than 100,000 copies/mL at the start of therapy

·  The observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the NNRTI class compared to efavirenz

·  More subjects treated with rilpivirine developed lamivudine/emtricitabine associated resistance compared to efavirenz

Complera is not recommended for patients less than 18 years of age.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that healthcare providers may not recognize the benefits of starting HIV patients new to therapy on Complera. In addition, as Complera is used over longer periods of time by many patients with underlying health problems taking numerous other medicines, Gilead may find new issues such as safety, resistance or drug interaction issues, which may require it to provide additional warnings or contraindications on the label or narrow Complera’s approved indication, each of which could reduce the market acceptance of Complera. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

U.S. full prescribing information for Complera is available at www.Complera.com
U.S. full prescribing information for Atripla is available at www.Atripla.com
U.S. full prescribing information for Truvada is available at www.Truvada.com

EU Summary of Product Characteristics for Atripla, Eviplera and Truvada are available at www.ema.europa.eu

Complera, Eviplera and Truvada are registered trademarks of Gilead Sciences, Inc.

Atripla is a registered trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.

Edurant is a registered trademark of Janssen R&D Ireland.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.



-- STaR Study Findings Support Complera as an Important Single Tablet Regimen Option --

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Gilead ’s Once-Daily Novel Prodrug for the Treatment of HIV Meets 24-Week Primary Objective in Phase 2 Study

Pressmeddelanden   •   2012-11-01 14:19 CET

-- Data Support Tenofovir Alafenamide Fumarate as Component of Future Single Tablet HIV Regimens --

 Gilead Sciences, Inc. (Nasdaq: GILD) today announced that a Phase 2 clinical trial evaluating tenofovir alafenamide fumarate (TAF; formerly referred to as GS-7340), an investigational novel prodrug of tenofovir for the treatment of HIV-1 infection, met its primary objective. The ongoing study compares a once-daily single tablet regimen containing TAF 10 mg/elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg with StribildTM (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) among treatment-naïve adults. The TAF-based regimen achieved a similar virologic response to Stribild based on the proportion of patients with HIV RNA levels (viral load) of less than 50 copies/mL at 24 weeks of therapy (87 percent versus 90 percent, respectively).

Compared to Stribild, the TAF-based regimen demonstrated statistically significantly smaller reductions from baseline to week 24 in bone mineral density at the lumbar spine and hip (p<0.005). In addition, small, statistically significant differences were seen in serum creatinine and in calculated creatinine clearance between the two arms in favor of the TAF-containing regimen (p<0.02). No patient discontinued study drug for renal adverse events. There were no statistically significant differences in the frequency of laboratory abnormalities and the frequency and nature of adverse events were generally similar between the two arms. Both regimens were generally well tolerated. Gilead plans to submit these data for presentation at a scientific conference next year.

“These interim findings are encouraging and warrant advancing this TAF-containing single tablet regimen into Phase 3 development,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences.

TAF is also being studied in a second ongoing Phase 2 trial evaluating a single tablet regimen containing TAF, Janssen R&D Ireland’s protease inhibitor Prezista® (darunavir), cobicistat and emtricitabine compared to Truvada® (emtricitabine and tenofovir disoproxil fumarate) plus Prezista and cobicistat, dosed as individual components. The study is fully enrolled and 24-week results will be available in the first half of 2013.

About the Study

The Phase 2 study is a randomized, double-blind 48-week clinical trial among HIV-1 infected adults with HIV RNA levels (viral load) greater than or equal to 5,000 copies/mL and CD4 cell counts greater than 50 cells/mm3. A total of 170 patients were randomized (2:1) to receive a once-daily tablet containing TAF 10 mg/elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg (n=112) or Stribild (n=58). Bone mineral density was assessed in all patients by DEXA scans at baseline and at week 24.

The study is ongoing. Secondary endpoints will include the proportion of patients who achieve viral load of less than 50 copies/mL at 48 weeks of therapy, and changes in HIV-1 RNA and in CD4 cell count from baseline to Weeks 24 and 48. After week 48, patients will continue to take their blinded study drug until treatment assignments have been unblinded, at which point all will be given the option to participate in an open-label rollover extension and receive the TAF-based single tablet regimen.

Additional information about the study can be found at www.clinicaltrials.gov.

About Tenofovir Alafenamide Fumarate

Tenofovir alafenamide fumarate (TAF) is a nucleotide reverse transcriptase inhibitor and a novel prodrug of tenofovir, the active agent in Viread® (tenofovir disoproxil fumarate). Phase 1b dose-ranging studies identified a dose of TAF that is ten times lower than Viread and provides greater antiviral efficacy. The smaller milligram size of TAF may enable the development of new fixed-dose combinations and single tablet regimens for HIV therapy that are not feasible with Viread.

About Elvitegravir

As an integrase inhibitor, elvitegravir interferes with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells. Elvitegravir was licensed by Gilead from Japan Tobacco Inc. (JT) in March 2005. Under the terms of Gilead’s agreement with JT, Gilead has exclusive rights to develop and commercialize elvitegravir in all countries of the world, excluding Japan, where JT retains rights. Gilead submitted a New Drug Application (NDA) to FDA for elvitegravir on June 27, 2012, and the agency has set a target action date under the Prescription Drug User Fee Act (PDUFA) of April 27, 2013.

About Cobicistat

Cobicistat is Gilead’s proprietary potent mechanism-based inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body. Unlike ritonavir, cobicistat acts only as a pharmacoenhancing or “boosting” agent and has no antiviral activity. Gilead submitted an NDA to FDA for cobicistat on June 28, 2012, and a PDUFA date of April 28, 2013 has been set.

TAF, elvitegravir and cobicistat are investigational products and their safety and efficacy have not yet been established.

Important Safety Information about Stribild

Stribild contains four Gilead compounds in a complete once-daily, single tablet regimen: elvitegravir 150 mg; cobicistat 150 mg; emtricitabine 200 mg; and tenofovir disoproxil fumarate 300 mg. Stribild is indicated as a complete regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naïve. Stribild does not cure HIV-1 infection.

BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

·  Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (“tenofovir DF”), a component of Stribild, in combination with other antiretrovirals.

·  Stribild is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Stribild have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Emtriva or Viread, which are components of Stribild. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Stribild. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Contraindications

·  Coadministration: Do not use with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. Do not use with drugs that strongly induce CYP3A as this may lead to a loss of virologic response and possible resistance to Stribild. Use with the following drugs is contraindicated: alfuzosin, rifampin, dihydroergotamine, ergotamine, methylergonovine, cisapride, lovastatin, simvastatin, pimozide, sildenafil for pulmonary arterial hypertension, triazolam, oral midazolam, and St. John’s wort.

Warnings and Precautions

·  New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir DF and Stribild. Monitor estimated creatinine clearance (CrCl), urine glucose, and urine protein in all patients prior to initiating and during therapy; additionally monitor serum phosphorus in patients with or at risk for renal impairment. Cobicistat may cause modest increases in serum creatinine and modest declines in CrCl without affecting renal glomerular function; patients with an increase in serum creatinine greater than 0.4 mg/dL from baseline should be closely monitored for renal safety. Do not initiate Stribild in patients with CrCl below 70 mL/min. Discontinue Stribild if CrCl declines below 50 mL/min. Avoid concurrent or recent use with a nephrotoxic agent.

·  Use with other antiretroviral products: Stribild should not be coadministered with products containing any of the same active components; with products containing lamivudine; with adefovir dipivoxil; or with products containing ritonavir.

·  Decreases in bone mineral density (BMD) and cases of osteomalacia have been seen in patients treated with tenofovir DF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss.

·  Fat redistribution and accumulation have been observed in patients receiving antiretroviral therapy.

·  Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.

Adverse Reactions

·  Common adverse drug reactions in clinical studies (incidence greater than or equal to 5%; all grades) were nausea, diarrhea, abnormal dreams, headache and fatigue.

Drug Interactions

·  CYP3A substrates: Stribild can alter the concentration of drugs metabolized by CYP3A or CYP2D6.

Do not use with drugs highly dependent on these factors for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening adverse events.

·  CYP3A inducers: Drugs that induce CYP3A can decrease the concentrations of components of Stribild. Do not use with drugs that strongly induce CYP3A as this may lead to loss of virologic response and possible resistance to Stribild.

·  Antacids: Separate Stribild and antacid administration by at least 2 hours.

·  Prescribing information: Consult the full prescribing information for Stribild for more information on potentially significant drug interactions, including clinical comments.

Dosage and Administration

·  Adult dosage: One tablet taken orally once daily with food.

·  Renal impairment: Do not initiate in patients with CrCl below 70 mL/min. Discontinue in patients with CrCl below 50 mL/min.

·  Hepatic impairment: Not recommended in patients with severe hepatic impairment.

Pregnancy and Breastfeeding

·  Pregnancy Category B: There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry has been established.

·  Breastfeeding: Emtricitabine and tenofovir have been detected in human milk. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including risks related to the possibility of unfavorable 48-week results from this or other clinical trials involving TAF, including the trial evaluating the single tablet regimen of TAF, darunavir, cobicistat and emtricitabine. Further, Gilead may be unable to obtain clinical trial results in the timelines currently anticipated and may need to modify or delay the clinical trials or to perform additional trials. Further, Gilead may make a strategic decision to discontinue development of TAF if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. There is also risk of failing to obtain approvals from regulatory authorities for TAF, alone or in combination with other products, and the New Drug Applications for elvitegravir and cobicistat may not be approved by the U.S. Food and Drug Administration or other regulatory agencies in the timelines anticipated or at all. As a result, these product candidates as standalone agents or as part of single tablet regimens may never be successfully commercialized. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2012, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

U.S. full prescribing information for Stribild is available at www.Stribild.com.

U.S. full prescribing information for Truvada is available at www.Truvada.com.

Stribild, Truvada and Viread are trademarks or registered trademarks of Gilead Sciences, Inc.
Prezista is a registered trademark of Janssen R&D Ireland

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Source: Gilead Sciences, Inc.

Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)


Gilead är ett biomedicinskt företag med inriktning på forskning, utveckling och marknadsföring av innovativa behandlingar inom områden där adekvat vård saknas. Gilead har bland annat utvecklat nya läkemedel mot HIV och hepatit som väsentligt förbättrat livssituationen för patienter världen över. Gileads huvudkontor ligger i Kalifornien och företaget bedriver verksamhet i Nordamerika, Europa och Australien. Det nordiska huvudkontoret ligger i Stockholm, Sverige, och startades upp 2008. Gilead grundades 1987 och har på bara tjugo år blivit ett av världens största biomedicinska företag med en snabbt växande produktportfölj. Läs mer på www.gilead.com

-- Data Support Tenofovir Alafenamide Fumarate as Component of Future Single Tablet HIV Regimens --

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U.S. FDA Approves Gilead's Stribild™, a Complete Once-Daily Single Tablet Regimen for Treatment-Naïve Adults with HIV-1 Infection

Pressmeddelanden   •   2012-08-28 10:13 CEST

– Stribild is Gilead’s Third Single Tablet Regimen for the Treatment of HIV and the First to Contain an Integrase Inhibitor –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 27, 2012-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved StribildTM (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults. Stribild, referred to as “Quad” prior to FDA approval, combines four compounds in one daily tablet: elvitegravir, an integrase inhibitor; cobicistat, a pharmacoenhancing agent; emtricitabine and tenofovir disoproxil fumarate.

“Over the past decade, co-formulated HIV medicines have simplified therapy for many patients and have become standard of care,” said Paul Sax, MD, Clinical Director of the Division of Infectious Diseases at Brigham and Women’s Hospital, Boston, Professor of Medicine at Harvard Medical School, and principal investigator of one of the Stribild pivotal studies. “Today’s approval of Stribild will provide physicians and their patients an effective new single tablet treatment option for individuals starting HIV therapy for the first time.”

The approval of Stribild is supported by 48-week data from two pivotal Phase 3 studies in which the single tablet regimen met its primary objective of non-inferiority compared to Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) (Study 102) and to a regimen containing ritonavir-boosted atazanavir plus Truvada® (emtricitabine/tenofovir disoproxil fumarate) (Study 103). Today’s approval is also supported by Chemistry, Manufacturing and Controls (CMC) information on the individual components of Stribild and the co-formulated single tablet regimen.

“For much of the company’s 25-year history, Gilead has focused on the development of improved treatments and simplified regimens for HIV,” said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. “Therapies that address the individual needs of patients are critical to enhancing adherence and increasing the potential for treatment success, and we are proud to introduce a new single tablet regimen for the healthcare and patient communities.”

Stribild is the third single tablet HIV regimen developed by Gilead. The first, Atripla, was approved in 2006 and is marketed by Gilead and Bristol-Myers Squibb in the United States. The second single tablet regimen, Complera® (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), which combines Gilead’s Truvada and Janssen R&D Ireland’s rilpivirine, was approved in 2011.

In all studies of Stribild, most adverse events were mild to moderate. Stribild has Boxed Warnings of lactic acidosis/severe hepatomegaly with steatosis and post treatment acute exacerbation of hepatitis B; see below for important safety information.

Applications for marketing approval of Stribild are also pending in Australia, Canada and the European Union. In the developing world, Gilead has granted multiple Indian manufacturing partners and the Medicines Patent Pool the right to develop generic versions of Stribild and distribute them to 100 developing countries. These agreements include a complete technology transfer of the manufacturing process for the single tablet regimen.

Patient Assistance Programs

Gilead’s U.S. Advancing Access® program provides assistance to patients in the United States who do not have insurance or who need financial assistance to pay for their medications, including Stribild. Patients may contact Advancing Access at 1-800-226-2056 between 9:00 a.m. and 8:00 p.m. (Eastern Time) to see if they are eligible for the program.

For patients with private insurance, Gilead’s co-pay coupon program provides assistance with out-of-pocket expenses for Gilead’s HIV medications, including Stribild, starting at the first dollar. Additionally, Gilead is working closely with the ADAP Crisis Task Force, as the company has done for each of its other HIV medications, to provide discounts to state AIDS Drug Assistance Programs (ADAPs) that will help ensure access to Stribild for patients who receive medications through these programs.

About Stribild

Stribild contains four Gilead compounds in a complete once-daily, single tablet regimen: elvitegravir 150 mg; cobicistat 150 mg; emtricitabine 200 mg; and tenofovir disoproxil fumarate 300 mg. Stribild is indicated as a complete regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naïve. Stribild does not cure HIV-1 infection.

Elvitegravir is a member of the integrase inhibitor class of antiretroviral compounds. Integrase inhibitors interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells. Elvitegravir was licensed by Gilead from Japan Tobacco Inc. (JT) in March 2005. Under the terms of Gilead’s agreement with JT, Gilead has exclusive rights to develop and commercialize elvitegravir in all countries of the world, excluding Japan, where JT retains rights. Gilead submitted a New Drug Application (NDA) to FDA for elvitegravir on June 27, 2012.

Cobicistat is a pharmacoenhancing or “boosting” agent that enables elvitegravir once-daily dosing. It is a potent mechanism-based inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body. Cobicistat acts only as a pharmacoenhancer and has no antiviral activity. Gilead submitted an NDA to FDA for cobicistat on June 28, 2012.

Elvitegravir and cobicistat as standalone agents are investigational products and their safety and efficacy have not yet been established.

Important Safety Information about Stribild

BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (“tenofovir DF”), a component of Stribild, in combination with other antiretrovirals.
  • Stribild is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Stribild have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Emtriva or Viread, which are components of Stribild. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Stribild. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Contraindications

  • Coadministration: Do not use with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. Do not use with drugs that strongly induce CYP3A as this may lead to a loss of virologic response and possible resistance to Stribild. Use with the following drugs is contraindicated: alfuzosin, rifampin, dihydroergotamine, ergotamine, methylergonovine, cisapride, lovastatin, simvastatin, pimozide, sildenafil for pulmonary arterial hypertension, triazolam, oral midazolam, and St. John’s wort.

Warnings and Precautions

  • New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir DF and Stribild. Monitor estimated creatinine clearance (CrCl), urine glucose, and urine protein in all patients prior to initiating and during therapy; additionally monitor serum phosphorus in patients with or at risk for renal impairment. Cobicistat may cause modest increases in serum creatinine and modest declines in CrCl without affecting renal glomerular function; patients with an increase in serum creatinine greater than 0.4 mg/dL from baseline should be closely monitored for renal safety. Do not initiate Stribild in patients with CrCl below 70 mL/min. Discontinue Stribild if CrCl declines below 50 mL/min. Avoid concurrent or recent use with a nephrotoxic agent.
  • Use with other antiretroviral products: Stribild should not be coadministered with products containing any of the same active components; with products containing lamivudine; with adefovir dipivoxil; or with products containing ritonavir.
  • Decreases in bone mineral density (BMD) and cases of osteomalacia have been seen in patients treated with tenofovir DF. Consider monitoring BMD in patients with a history of pathologic fracture or risk factors for bone loss.
  • Fat redistribution and accumulation have been observed in patients receiving antiretroviral therapy.
  • Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.

Adverse Reactions

  • Common adverse drug reactions in clinical studies (incidence greater than or equal to 5%; all grades) were nausea, diarrhea, abnormal dreams, headache and fatigue.

Drug Interactions

  • CYP3A substrates: Stribild can alter the concentration of drugs metabolized by CYP3A or CYP2D6. Do not use with drugs highly dependent on these factors for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening adverse events.
  • CYP3A inducers: Drugs that induce CYP3A can decrease the concentrations of components of Stribild. Do not use with drugs that strongly induce CYP3A as this may lead to loss of virologic response and possible resistance to Stribild.
  • Antacids: Separate Stribild and antacid administration by at least 2 hours.
  • Prescribing information: Consult the full prescribing information for Stribild for more information on potentially significant drug interactions, including clinical comments.

Dosage and Administration

  • Adult dosage: One tablet taken orally once daily with food.
  • Renal impairment: Do not initiate in patients with CrCl below 70 mL/min. Discontinue in patients with CrCl below 50 mL/min.
  • Hepatic impairment: Not recommended in patients with severe hepatic impairment.

Pregnancy and Breastfeeding

  • Pregnancy Category B: There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk. An Antiretroviral Pregnancy Registry has been established.
  • Breastfeeding: Emtricitabine and tenofovir have been detected in human milk. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors, including the risk that physicians and patients may not see advantages of Stribild over other therapies and may therefore be reluctant to prescribe the product, and the risk that public payers may be reluctant to approve or provide reimbursement for the product. In addition, pending marketing applications for Stribild, including in the European Union, and for elvitegravir and cobicistat as standalone agents may not be approved or approval may be delayed, and marketing approvals, if granted, may have significant limitations on their use. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2012, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

U.S. full prescribing information for Stribild is available at www.Gilead.com.

U.S. full prescribing information for Atripla is available at www.Atripla.com.

U.S. full prescribing information for Complera is available at www.Complera.com.

U.S. full prescribing information for Truvada is available at www.Truvada.com.

Advancing Access, Complera, Stribild and Truvada are trademarks or registered trademarks of Gilead Sciences, Inc., or its related companies.

Atripla is a registered trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.

For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Source: Gilead Sciences, Inc.

Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Erin Rau, 650-522-5635 (Media)

 

Gilead är ett biomedicinskt företag med inriktning på forskning, utveckling och marknadsföring av innovativa behandlingar inom områden där adekvat vård saknas. Gilead har bland annat utvecklat nya läkemedel mot HIV och hepatit som väsentligt förbättrat livssituationen för patienter världen över. Gileads huvudkontor ligger i Kalifornien och företaget bedriver verksamhet i Nordamerika, Europa och Australien. Det nordiska huvudkontoret ligger i Stockholm, Sverige, och startades upp 2008. Gilead grundades 1987 och har på bara tjugo år blivit ett av världens största biomedicinska företag med en snabbt växande produktportfölj. Läs mer på www.gilead.com

– Stribild is Gilead’s Third Single Tablet Regimen for the Treatment of HIV and the First to Contain an Integrase Inhibitor –

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Om Gilead Science

Om Gilead Science:

Gilead är ett biomedicinskt företag med inriktning på forskning, utveckling och marknadsföring av innovativa behandlingar inom områden där adekvat vård saknas. Gilead har bland annat utvecklat nya läkemedel mot HIV och hepatit som väsentligt förbättrat livssituationen för patienter världen över. Gileads huvudkontor ligger i Kalifornien och företaget bedriver verksamhet i Nordamerika, Europa och Australien. Det nordiska huvudkontoret ligger i Stockholm, Sverige, och startades upp 2008. Gilead grundades 1987 och har på bara tjugo år blivit ett av världens största biomedicinska företag med en snabbt växande produktportfölj. Läs mer på www.gilead.com

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