Combination Treatment with Daclatasvir Produces Good Results in Patients with Genotype 4 Hepatitis C

SVR12 rates significantly higher in patients treated with daclatasvir/peginterferon alfa/ribavirin combination.

With limited and unsatisfactory treatment options currently available for patients with genotype 4 hepatitis C virus (HCV), the results from the COMMAND-4 study presented at IDWeek 2014 offer some promise for these hard-to-treat patients.

In the study, 82 patients with genotype 4 HCV were treated with 60 mg once daily of the NS5A inhibitor daclatasvir in combination with peginterferon alfa 180 µg once weekly and weight-based ribavirin (1000-1200 mg/day) twice daily. In the study’s other arm, 42 patients received placebo plus peginterferon alfa and ribavirin.

Researchers evaluated the safety and efficacy of this combination in treatment-naïve patients with genotype 4 HCV, including patients with cirrhosis. The primary endpoint of the study was sustained virologic response at 12 weeks (SVR12).

Patients treated with the daclatasvir combination who had undetectable HCV RNA at weeks 4 and 12 (extended rapid virologic response, or eRVR) received 24 weeks of treatment with the daclatasvir/peginterferon alfa/ribavirin combination. Patients who did not have an eRVR received an additional 24 weeks of treatment with peginterferon alfa/ribavirin. All patients in the placebo group received 48 weeks of treatment with peginterferon alfa/ribavirin.

The median age of patients in the daclatasvir group was 48.5 years, and the median age in the placebo group was 50. Seventy-three percent of patients in the daclatasvir group were white, 22% were black, and 5% were identified as “other.”

In the placebo group, 86% of patients were white, with 12% black and 2% other. The authors noted that 75% of study participants were IL28B non-CC and 11% had cirrhosis. There was a “diverse representation of GT 4 subtypes, with GT 4A, 4C, or 4D being the most common (57%).”

The authors reported that SVR12 rates documented on or after post-treatment Week12 were “significantly higher” in the group treated with the daclatasvir/peginterferon alfa/ribavirin combination than in the group that received placebo plus peginterferon alfa/ribavirin (82% vs. 43%, respectively).

Click here to continue reading on HCP Live.