Vertex announced new data from an interim analysis of the exploratory global Phase 3b CONCISE study evaluating the potential to shorten total treatment with telaprevir combination therapy to 12 weeks in certain people with genotype 1 chronic hepatitis C virus (HCV) infection who have the IL28B CC genotype. Incivek (telaprevir) tablet is an oral medicine that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication.
CONCISE is a randomized, placebo-controlled, global, multi-center study designed to evaluate the safety and efficacy of a 12-week regimen of telaprevir tablets in combination with pegylated-interferon and ribavirin in patients with genotype 1 chronic HCV infection who have the IL28B CC genotype. In this study, telaprevir was dosed as three 375mg tablets twice daily. The study includes 239 people with hepatitis C who are new to treatment as well as those who relapsed after at least one prior course of treatment with pegylated-interferon and ribavirin alone. All study participants were assigned to receive telaprevir in combination with pegylated-interferon and ribavirin for 12 weeks. Patients who continued all study drugs for 12 weeks and achieved a rapid viral response to treatment (measured as undetectable HCV RNA at week 4) were randomized 2:1 to receive no further treatment or an additional 12 weeks of pegylated-interferon and ribavirin alone. People who did not achieve a rapid viral response or who did not continue all study drugs for 12 weeks were assigned a total pegylated-interferon and ribavirin treatment duration of 24 or 48 weeks based on virologic response. The primary endpoint of the study is the proportion of randomized people who achieve a sustained viral response (HCV RNA < lower limit of quantification) 12 weeks after the last planned dose of study drug (SVR12).
Of the 239 people in the study, 159 people completed 12 weeks of telaprevir combination treatment and had undetectable hepatitis C virus at week four of treatment (rapid viral response) and were eligible to be randomized. In the 12-week total treatment group, of the 85 people with data available at the time of the interim analysis, 87% (74/85) had undetectable hepatitis C virus 12 weeks after the end of treatment (SVR12). In the 24-week treatment group, of the 30 people with data available at the time of the interim analysis, 97% (29/30) achieved SVR12.
Incivek (telaprevir) is already indicated to be used in combination with peginterferon alfa and ribavirin to treat chronic hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment. Safety and efficacy in children under 18 years of age is unknown.
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