AbbVie’s MAVIRET® (glecaprevir/pibrentasvir) accepted for use within NHS Scotland

MAIDENHEAD, UK, Nov. 15, 2017 – AbbVie, a global research and development based biopharmaceutical company, today announced that its pan-genotypic hepatitis C regimen, Maviret®, has been accepted for use within NHS Scotland, following an assessment by the Scottish Medicines Consortium (SMC)1 . 

Maviret® is accepted for use for the treatment of chronic hepatitis C virus (HCV) infection in adults. Chronic hepatitis C is a silent, progressive disease that can lead to liver damage, scarring of the liver (cirrhosis), liver cancer and death2 . It is estimated that in Scotland 50,000 people are living with chronic hepatitis C 3. 

Charles Gore, Chief Executive of The Hepatitis C Trust said: “New treatments, such as Maviret®, offer patients with all the major genotypes of hepatitis C a chance of clearing the virus with as little as 8 weeks of treatment. This is good news for patients who now have a number of treatment choices that can benefit their quality of life and health. Treatment is cost effective and can also make a positive impact on overall public health as the pool of disease is reduced through treatment. It will also help Scotland achieve targets in relation to the World Health Organization’s (WHO) elimination agenda. We now need to see England follow suit quickly if we are to achieve the WHO goal of eliminating hepatitis C as a public health threat by 2030.” 

About Maviret® 

Maviret® is a once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A inhibitor and pibrentasvir (40mg), an NS5A inhibitor (glecaprevir/pibrentasvir), for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. Full summary of product characteristics is available at www.medicines.org.uk/emc 

Important EU Safety Information Contraindications: 

Maviret® is contraindicated in patients with severe hepatic impairment (Child-Pugh C). Concomitant use with atazanavir containing products, atorvastatin, simvastatin, dabigatran etexilate, ethinyl oestradiol-containing products, strong P-gp and CYP3A inducers, such as rifampicin, carbamazepine, St. John’s wort, phenobarbital, phenytoin, and primidone.

Special warnings and precautions for use: 

Hepatitis B virus reactivation 

Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents. HBV screening should be performed in all patients before initiation of treatment. Hepatic impairment Maviret® is not recommended in patients with moderate hepatic impairment (Child-Pugh B). 

Patients who failed a prior regimen containing an NS5A- and/or an NS3/4A-inhibitor 

Maviret® is not recommended for the re-treatment of patients with prior exposure to NS3A/4A and/or NS5Ainhibitors. 

Adverse Reactions 

Most common (≥10%) adverse reactions for Maviret® were headache and fatigue. ▼ Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie UK Ltd. Please contact ukadverseevents@abbvie.com. With biological medicines, healthcare professionals should report adverse reactions by brand name and batch number.

-ENDS-

References 

1 SMC Advice No. 1278/17 https://www.scottishmedicines.org.uk/files/advice/glecaprevir_pibrentasvir_Maviret_FINAL_Oct_2017_amended_3 0.10.17_for_website.pdf (accessed November 2017) 

2 Harris, R. J. et al. 2016. New treatments for hepatitis C virus (HCV): scope for preventing liver disease and HCV transmission in England. J Viral Hepat, 23: 631–643 

3 Health Protection Scotland, http://www.hps.scot.nhs.uk/bbvsti/hepatitisc.aspx (accessed, November 2017)

4 MAVIRET® tablets (glecaprevir/pibrentasvir) Summary of product characteristics. Maidenhead, UK. AbbVie, Ltd. Full summary of product characteristics is available at www.medicines.org.uk/emc

AXHCV171644 Date of preparation: November 2017