Daclatasvir inhibits the HCV nonstructural protein NS5A. Recent research suggests that it targets two steps of the viral replication process, enabling rapid decline of HCV RNA.
Daclatasvir has been tested in combination regimens with pegylated interferon and ribavirin, as well as with other direct-acting antiviral agents including asunaprevir and sofosbuvir. It is on the World Health Organization’s List of Essential Medicines, a list of the most important medications needed in a basic health system.
Twenty-four or 48 weeks of daclatasvir plus interferon and ribavirin cured 82 percent of people with genotype 4 of hepatitis C virus (HCV), including those with cirrhosis, in a recent trial, HCP Live reports. Researchers in the COMMAND-4 study conducted a placebo-controlled trial of people with genotype 4 of the virus, including 82 participants who received the NS5A inhibitor daclatasvir plus interferon and ribavirin, and 42 participants who received a placebo plus interferon and ribavirin. The findings were announced at IDWeek 2014 in Philadelphia.
At weeks 4 and 12, 79 percent of participants taking daclatasvir had an undetectable HCV viral load, known as an extended rapid virologic response (eRVR). They spent 24 weeks on the three-drug regimen. Those in the daclatasvir arm who did not achieve an eRVR took an additional 24 weeks of just interferon and ribavirin. All of those in the placebo arm were treated for 48 weeks. Of this group, just 12 percent achieved an eRVR Eighty-two percent of the participants taking daclatasvir achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), compared with 43 percent taking the placebo. Cure rates in the daclatasvir arm were not affected by IL28B genotype, age, race, gender, cirrhosis status or baseline viral load. A total of 9.8 percent of those in the daclatasvir group experienced severe adverse side effects, compared with 4.8 percent of the placebo group. However, 7.1 percent of those in the placebo group experienced adverse side effects that led to discontinuation of treatment, compared with 4.9 percent of those in the daclatasvir arm.
Combination Treatment with Daclatasvir Produces Good Results in Patients with Genotype 4 Hepatitis C.
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.
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