Abstract
Background and purpose Peginterferon Lambda was being developed as an alternative to alfa interferon for the treatment of chronic hepatitis C virus (HCV) infection. We compared peginterferon Lambda-1a plus ribavirin (Lambda/RBV) and Lambda/RBV plus daclatasvir (DCV; pangenotypic NS5A inhibitor) with peginterferon alfa-2a plus RBV (alfa/RBV) in treatment-naive patients with HCV genotype 2 or 3 infection.Methods In this multicenter, double-blind, phase 3 randomized controlled trial, patients were assigned 2:2:1 to receive 24 weeks of Lambda/RBV, 12 weeks of Lambda/RBV + DCV, or 24 weeks of alfa/RBV. The primary outcome measure was sustained virologic response at post-treatment Week 12 (SVR12).Results Overall, 874 patients were treated: Lambda/RBV, n = 353; Lambda/RBV + DCV, n = 349; alfa/RBV, n = 172. Patients were 65 % white and 33 % Asian, 57 % male, with a mean age of 47 years; 52 % were infected with genotype 2 (6 % cirrhotic) and 48 % with genotype 3 (9 % cirrhotic). In the Lambda/RBV + DCV group, 83 % (95 % confidence interval [CI] 78.5, 86.5) achieved SVR12 (90 % genotype 2, 75 % genotype 3) whereas SVR12 was achieved by 68 % (95 % CI 63.1, 72.9) with Lambda/RBV (72 % genotype 2, 64 % genotype 3) and 73 % (95 % CI 66.6, 79.9) with peginterferon alfa/RBV (74 % genotype 2, 73 % genotype 3). Lambda/RBV + DCV was associated with lower incidences of flu-like symptoms, hematological abnormalities, and discontinuations due to adverse events compared with alfa/RBV.ConclusionThe 12-week regimen of Lambda/RBV + DCV was superior to peginterferon alfa/RBV in the combined population of treatment-naive patients with genotype 2 or 3 infection, with an improved tolerability and safety profile compared with alfa/RBV.Electronic supplementary materialThe online version of this article (doi:10.1186/s40064-016-2920-z) contains supplementary material, which is available to authorized users.
Highlights
Background and purposePeginterferon Lambda was being developed as an alternative to alfa interferon for the treatment of chronic hepatitis C virus (HCV) infection
Genotype 3 infection has been associated with poorer outcomes than genotype 2, including a higher incidence of steatosis (Matos et al 2006), accelerated fibrosis (Bochud et al 2009; Probst et al 2011), increased risk of hepatocellular cancer, and lower sustained virologic response (SVR) rates following treatment with alfa/RBV or oral direct-acting antiviral (DAA)-based regimens (Zeuzem et al 2004; Andriulli et al 2008)
We report the results of a phase 3 study of Lambda/RBV, with and without DCV, versus alfa/RBV in previously untreated patients with genotype 2 or 3 infection
Summary
Peginterferon Lambda was being developed as an alternative to alfa interferon for the treatment of chronic hepatitis C virus (HCV) infection. Chronic hepatitis C virus (HCV) infection affects up to 170 million people worldwide based on serologic data (Lavanchy 2009), resulting in approximately 500,000 deaths each year (World Health Organization 2012). HCV genotype 2 or 3 infection was treated primarily with 24 weeks of peginterferon alfa-2a plus ribavirin (alfa/RBV). Genotype 3 infection has been associated with poorer outcomes than genotype 2, including a higher incidence of steatosis (Matos et al 2006), accelerated fibrosis (Bochud et al 2009; Probst et al 2011), increased risk of hepatocellular cancer, and lower sustained virologic response (SVR) rates following treatment with alfa/RBV or oral direct-acting antiviral (DAA)-based regimens (Zeuzem et al 2004; Andriulli et al 2008)
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