NS5A inhibitor daclatasvir taken daily in combination with NSHB inhibitor GS-7977 may treat patients with various genotypes of hepatitis C, according to interim results presented at the International Liver Congress in Barcelona, Spain.
In the phase 2 study, researchers randomly assigned 44 patients with HCV genotype 1 and 44 patients with HCV genotypes 2/3, all noncirrhotic, into three groups. Participants received either 400 mg GS-7977 daily for seven days, then 60 mg daclatasvir (DCV) along with GS-7977 daily for 23 weeks; DCV and GS-7977 in combination for 24 weeks; or DCV, GS-7977 and ribavirin for 24 weeks. Participants’ HCV RNA levels were reported at the meeting following 12 weeks of treatment; follow-up will continue until 12 weeks after conclusion of the regimen to determine how many participants retain undetectable RNA levels.
After four weeks of treatment, all participants across all groups had HCV RNA below LLOQ. By 12 weeks, one patient with genotype 3 in the seven-day GS-7977 group experienced virologic breakthrough, while all remaining evaluable patients maintained RNA levels below LLOQ, with undetectable RNA in all participants excluding one in the ribavirin group. The addition of ribavirin was not found to impact virologic response to treatment.
Two participants stopped treatment because of unrelated adverse events. More than 25% of patients experienced events including headache, fatigue and nausea.
“Interim results … show that the once-daily combination of DCV and GS-7977 was generally well-tolerated and achieved high rates of early virologic suppression in treatment-naïve patients infected with HCV genotypes 1a, 1b, 2 or 3,” the researchers wrote.
For more information:
Sulkowski M. Abstract #1422. Presented at: The International Liver Congress, April 18-22, Barcelona, Spain.