CHMP Backs 8-Week HCV Treatment Option With Viekirax + Exviera

Troy Brown, RN

February 28, 2017

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has voted to recommend a shorter, 8-week treatment with ombitasvir/paritaprevir/ritonavir (Viekirax, AbbVie) tablets plus dasabuvir (Exviera, AbbVie) tablets for some adult patients with previously untreated chronic infection with genotype 1b (GT1b) hepatitis C virus (HCV) and minimal to moderate fibrosis.

The medication combination is currently approved in the European Union as a 12-week treatment for patients with GT1b chronic HCV infection without cirrhosis or with compensated cirrhosis.

"AbbVie continuously strives to expand the utility of our HCV treatments, including investigating a shorter path to virologic cure for people living with HCV," Michael Severino, MD, executive vice president, research and development and chief scientific officer, AbbVie, said in a news release. "With this positive CHMP opinion, we will bring an [8-week] treatment option for the many HCV patients with GT1b."

Some 160 million people globally have HCV infection, and GT1b is the most common subtype worldwide. In Europe, 47% of the 9 million patients with chronic HCV are infected with this subtype.

The recommendation follows a discussion of data from the dedicated phase 3b GARNET study. The study found that after 8 weeks of treatment with the drug combination, 98% (n = 160 of 163) of previously untreated patients with chronic GT1b HCV infection without cirrhosis had sustained virologic response at 12 weeks after treatment. The most frequently reported adverse events, which occurred at a rate of 5% or greater, were headache (21%), fatigue (17%), nasopharyngitis (8%), pruritus (8%), nausea (6%), and asthenia (5%).

"Nearly half of the people living with chronic hepatitis C in Europe are infected with genotype 1b," Tania Mara Welzel, MD, MHSc, study author and medical lead of the Clinical Study Center at the Department of Medicine at J.W. Goethe University in Frankfurt, Germany, said in the news release. "Viekirax + Exviera has demonstrated high cure rates with only eight weeks of treatment in GT1b patients with minimal to moderate fibrosis."

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