Dive Brief:
- AbbVie reported on Friday a combination of its cirrhosis drugs Viekirax (ombitasvir/paritaprevir/ritonavir) and Exviera (dasbuvir) tablets led to overwhelmingly positive response rates in a Phase 3b study of patients with genotype 1b chronic hepatitis C.
- The study showed 98% of patients infected with untreated chronic hepatitis C without cirrhosis achieved sustained virologic response rates at 12 weeks post-treatment, according to data presented at a conference in Paris.
- AbbVie is competing with Gilead and Merck in an increasingly tight hepatitis C market, which has been transformed over the past several years by the entry of highly effective direct-acting antiviral treatments.
Dive Insight:
As the rate of hepatitis C increases worldwide, with 130 to 160 million people infected with the virus, drug development and competition has intensified. At the same time, more effective treatments have "cured" many of the most easily reached patients in the U.S., making growth in that market more difficult.
Genotyple 1b (GT1b) is the most common type of hepatitis c virus (HCV) in the world, impacting an estimated 83 million people, according to AbbVie. In Europe, GT1b is the most predominant of six major HCV subtypes, accounting for 47% of the estimated people infected with chronic HCV in Europe. In the U.S., an estimated 23% have GT1b.
For several years, Gilead has dominated the Hepatitis C market, but saw sharp declines this summer in sales of its market-leading drug Harvoni. Merck and AbbVie have been fighting to chip away at Gilead's market share, aiming to compete on price and other measures of efficacy.
AbbVie has already received approvals in the European Union for Viekirax and Exviera as treatment for GT1b patients without cirrhosis or with compensated cirrhosis for 12 weeks.
“Viekirax + Exviera has already achieved high cure rates wth 12 weeks of treatment,” said Stefan Zeuzem, study author and chief of the Department of Medicine at the JW Goethe University Hospital in Frankfurt, Germany. “These results now show the potential for cure in just eight weeks with Viekirax and Exviera in HCV genotype 1b infected patients without liver cirrhosis.”
In the study, the most commonly reported adverse events were headache (21%); fatigue (17%), nasopharyngitis (8 %), pruritus (8 %), nausea (6%) and asthenia (5%). These adverse events were mostly mild, with one patient discontinuing treatment due to adverse events.