Enanta Pharma (ENTA) Announces New Data from VIEKIRAX + EXVIERA Phase 3 in Genotype 1b HCV

September 23, 2016 6:19 AM EDT

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Enanta Pharmaceuticals, Inc., (Nasdaq: ENTA) announced new data showing high response rates with just eight weeks of VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets) treatment. VIEKIRAX + EXVIERA is currently approved in the European Union for GT1b patients without cirrhosis or with compensated cirrhosis for 12 weeks.

In AbbVie’s Phase 3b GARNET study, 98 percent (n=160/163) of previously untreated patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection without cirrhosis achieved sustained virologic response rates at 12 weeks post-treatment (SVR12).1 These data were presented today at the 2016 EASL Special Conference: New Perspectives in Hepatitis C Virus Infection – The Roadmap for Cure, in Paris, France and included in the newly published ‘EASL Recommendations on Treatment of Hepatitis C.’

Paritaprevir is Enanta’s lead protease inhibitor identified within the ongoing Enanta-AbbVie collaboration and is one of the direct-acting antivirals in AbbVie’s VIEKIRAX + EXVIERA treatment regimen for chronic hepatitis C virus (HCV).

In 2016, the World Health Organization has estimated that 130-150 million people worldwide are infected with HCV.5 In Europe, GT1b is the predominant genotype, accounting for approximately 47 percent of the estimated nine million Europeans infected with chronic HCV.3,4,6

In the GARNET study, the most commonly reported adverse events (≥5 percent) were headache (21 percent), fatigue (17 percent), nasopharyngitis (8 percent), pruritus (8 percent), nausea (6 percent) and asthenia (5 percent). These adverse events were mostly mild, with one patient discontinuing treatment due to adverse events.1

About the GARNET Study

The Phase 3b GARNET study is a multicenter, open-label, single-arm study, investigating the safety and efficacy of eight weeks of treatment with VIEKIRAX + EXVIERA without ribavirin in treatment-naïve patients with GT1b chronic HCV infection without cirrhosis.1 The study enrolled 166 patients across 20 sites around the world. Of the 166 patients enrolled, 163 patients had GT1b chronic HCV infection without cirrhosis and three patients with other HCV genotypes were excluded from the efficacy analysis. The primary endpoint is the percentage of patients who achieved a sustained virologic response 12 weeks after treatment (SVR12).

Two patients experienced post-treatment relapse and one subject discontinued due to noncompliance. Less than one percent of patients experienced serious adverse events or clinically significant (Grade ≥3) laboratory abnormalities. One patient discontinued treatment on Day 45 due to an adverse event but achieved SVR12.

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

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