Dual therapy of daclatasvir and asunaprevir produces SVR12 in phase 3 trial

LONDON — Hepatitis C virus genotype 1b-infected patients given a dual therapy of daclatasvir and asunaprevir for 12 or 24 weeks achieved a sustained virologic response, according to research from a phase 3 trial presented at the International Liver Congress.

Researchers analyzed 643 patients who received both 60 mg of daclatasvir (DVC) QD and 100 mg of asunaprevir (ASV) BID. Treatment naive patients (n=203) received the dual therapy or matching placebos (102) for 12 weeks, whereas null/partial responders (n=205) and ineligible/intolerant of peginterferon/ribavirin (n=235) received dual therapy for 24 weeks. The DVC and ASV treatment naive group continued treatment through 24 weeks, whereas the placebos entered a different study after 12 weeks. Seventy-one percent of patients were IL28B non-CC; 30% were cirrhotic. The primary endpoint was sustainable virologic response at 12 weeks (SVR12).

Overall SVR12 among DSV and ASV-treated patients were 90% in the treatment naive (182/203) and 82% in null/partial (168/205) and 82% among ineligible/intolerant (192/235). SVR12 rates were similar between the cirrhotic (n=437) and non-cirrhotic (n=206) patients, whereas no differences were observed based on age, gender, race or IL28B genotype. Six percent of patients experienced serious adverse events, resulting in two-percent discontinuing treatment. Ten-percent of treatment-naive patients, 18% of prior null/partial response and 18% of ineligible/intolerant did not achieve SVR12.

The dual therapy was generally well-tolerated in patients with hepatitis C virus genotype 1b infection, according to researchers.

For more information:

Manns M. #O165: All-Oral Dual Therapy with Daclatasvir and Asunaprevir in Patients with HCV Genotype 1B Infection: Phase 3 Study Results. Presented at: The International Liver Congress 2014; April 9-13, London.

Disclosure: Relevant financial disclosures were not provided by researchers.