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Daclatasvir with PEG-IFN a-2a/ribavirin reduced treatment time for HCV
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In a phase 2b clinical trial, a regimen of daclatasvir combined with pegylated interferon alfa-2a and ribavirin was safe and generally well tolerated among patients with hepatitis C virus genotype 2 and 3 infections, as well as reduced the duration of treatment, according to study data.
Researchers randomly assigned 151 patients with HCV genotype 2 (n=71) or 3 (n=80) infection to 60 mg daclatasvir (Bristol-Myers Squibb) for 12 or 16 weeks or placebo for 24 weeks, both combined with PEG-IFN a-2a and ribavirin. Fifty patients were in the 12-week group, 50 were in the 16-week group and 51 received placebo. Treatment duration was extended to 24 weeks if patients did not achieve an early virologic response.
Of the patients with HCV genotype 2, 83% of those in the 12-week group, 83% of the 16-week group and 63% of patients taking placebo achieved a sustained virologic response at 24 weeks. In the HCV genotype 3 group, 69% of those in the 12-week group, 67% of the 16-week group and 59% of patients taking placebo achieved SVR at 24 weeks.
More patients with HCV genotype 3 relapsed after treatment compared with HCV genotype 2 patients (12 vs. 3), according to the research.
Common adverse events that were observed in at least 5% of all patients included fatigue, insomnia, asthenia, rash and others. No deaths occurred. However, seven patients who received daclatasvir and two patients who received placebo discontinued treatment due to an adverse event.
“Twelve or 16 weeks of treatment with daclatasvir, in combination with peginterferon alfa-2a and ribavirin, is a well-tolerated and effected therapy for patients with HCV genotype 2 or 3 infections,” the researchers concluded. “Daclatasvir-containing regimens could reduce the duration of therapy for these patients.”
Disclosure: The study was funded in part by Bristol-Myers Squibb. Dore reports various financial ties with AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Janssen, Merck, Roche and Vertex. See the study for a full list of the other researchers’ financial disclosures.