Bristol-Myers Squibb announced results from its HALLMARK-Dual Phase 3 study of all-oral, interferon- and ribavirin-free regimen of daclatasvir (DCV), a NS5A inhibitor and asunaprevir (ASV), a NS3 inhibitor in patients with genotype 1b hepatitis C virus infection (HCV).
In the HALLMARK-Dual multinational clinical trial, treatment-naïve patients (n=205) received DCV 60mg once daily plus ASV 100mg twice daily for 12 weeks, and 102 patients received matching placebo for 12 weeks. The DCV+ASV treatment-naïve group continued treatment through week 24 while placebo recipients entered another DCV+ASV study. The peginterferon/ribavirin-ineligible/intolerant (n=235) and non-responder patients (n=205) received the same doses of DCV and ASV for 24 weeks. The primary endpoint was the percentage of patients with a sustained virologic response at 12 weeks after the end of treatment (SVR12).
Results demonstrated that 90% of treatment-naïve patients, 82% of prior null or partial response to peginterferon/ribavirin (non-responders), and 82% of peginterferon/ribavirin ineligible/intolerant patients achieved SVR12. Among peginterferon/ribavirin ineligible/intolerant patients, SVR12 was achieved by patients with anemia/neutropenia (91%); depression (80%) and compensated advanced fibrosis/cirrhosis with thrombocytopenia (73%). At baseline, 33 treatment-naïve, 63 non-responders, and 111 ineligible/intolerant patients had cirrhosis. SVR rates were similar in cirrhotic (84%) and non-cirrhotic (85%) patients treated with DCV + ASV.
Recently Bristol-Myers Squibb has submitted a New Drug Application (NDA) to the FDA for the use of daclatasvir in combination with other agents for the treatment of adults with HCV with compensated liver disease including genotypes 1, 2, 3, and 4.
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