The Lancet Infectious Diseases publishes Phase 3 data showing 99 percent of adults with chronic hepatitis C infection and compensated cirrhosis achieved virologic cure with AbbVie’s glecaprevir/pibrentasvir

Maidenhead, UK, 16 August 2017 – AbbVie, a global biopharmaceutical company, today announced The Lancet Infectious Diseases has published results from the Phase 3, single arm, open label, multicentre EXPEDITION-1 trial evaluating glecaprevir/pibrentasvir in chronic hepatitis C infected adult patients with genotypes 1, 2, 4, 5 or 6 and compensated cirrhosis. The data demonstrate a 99 percent (n=145/146) virologic cure* rate was achieved with 12 weeks of treatment¹.

"While the hepatitis C treatment landscape has transformed over recent years, there have been limited options for patients with specific treatment challenges, including in certain patients with compensated cirrhosis,” said Xavier Forns, M.D., head of hepatitis unit, Hospital Clinic de Barcelona, Spain and lead author of The Lancet Infectious Disease paper. “These data reinforce the important role glecaprevir/pibrentasvir could play as a new treatment option for adult patients and one that could help simplify treatment algorithms and reduce treatment burden.”

The data demonstrate glecaprevir/pibrentasvir achieved an overall sustained virologic response rate of 99 percent (n=145/146), regardless of baseline RNA values, treatment history, presence of baseline NS3 or NS5A polymorphisms, or any other baseline factor¹.

In July 2017, AbbVie announced that the European Commission had granted marketing authorisation for Maviret, 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). AbbVie’s treatment is now licensed for use in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.

“We are delighted that EXPEDITION-1 data have been published in The Lancet Infectious Diseases and, given the recent marketing authorisation for Maviret, we are now committed to ensuring as wide as possible access to this highly effective treatment for eligible patients,” said Dr Alice Butler, Medical Director, AbbVie UK.

About EXPEDITION-1

EXPEDITION-1 is a single arm, multicentre, open-label study evaluating the efficacy and safety of 12 weeks of glecaprevir/pibrentasvir in adults with GT1, 2, 4, 5 or 6 chronic HCV infection and compensated cirrhosis (Child-Pugh A). The study enrolled 146 patients, including those new to treatment or who had prior treatment experience with IFN-based treatments (IFN/pegIFN ± RBV, or sofosbuvir + RBV ± pegIFN). The primary endpoint was the percentage of patients achieving SVR12. SVR12 was achieved by 145/146 (99 percent) patients, with one GT1a-infected patient experiencing relapse. No patients experienced ALT elevations equal to or above Grade 3. Of the 11 patients (7.5 percent) who experienced serious AEs, none were considered treatment-related.

In the EXPEDITION-1 study, the majority of adverse events (AEs) were mild and no patients discontinued treatment due to an AE. The most common AEs (≥10 percent) were fatigue and headache.

Detailed product information can be found at www.medicines.org.uk.

▼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.

References

¹ The Lancet Infectious Diseases, 14 August 2017 (online). Available at http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(17)30496-6/fulltext (accessed 16 August 2017)

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Date of preparation: August 2017