Study: Hepatitis C Combo Therapy Cures Up to 90%
Data reinforce potential of daclatasvir-based regimens
Positive phase III results have been reported from the global HALLMARK–Dual study investigating the all-oral, interferon- and ribavirin-free regimen of daclatasvir (DCV), an NS5A inhibitor, and asunaprevir (ASV), an NS3 inhibitor, in patients infected with genotype 1b hepatitis C virus (HCV).
The results showed that the 24-week regimen achieved an overall sustained virologic response (i.e., a functional cure) 12 weeks after the end of treatment in 90% of treatment-naïve patients; in 82% of peginterferon (peg-IFN)/ribavirin non-responders; and in 82% of peg-IFN/ribavirin ineligible/intolerant patients, including cirrhotic and non-cirrhotic patients (84% and 85%, respectively).
The new data will be presented at the 49th annual meeting of the European Association for the Study of the Liver (EASL), held April 9–13 in London.
This phase III multinational clinical trial involved 18 countries, including countries with a high prevalence of genotype 1b, such as Korea and Taiwan. In the study, treatment-naïve patients (n = 205) received DCV 60 mg once daily plus ASV 100 mg 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; placebo recipients entered another DCV + ASV study. The peg-IFN/ribavirin-ineligible/intolerant patients (n = 235) and the non-responder patients (n = 205) received the same doses of DCV and ASV for 24 weeks. The trial’s primary endpoint was the percentage of patients with a sustained virologic response at 12 weeks after the end of treatment.
DCV is an investigational NS5A replication complex inhibitor that has been studied in more than 5,500 patients as part of multiple direct-acting antiviral (DAA)-based combination therapies. It is being evaluated in combination with sofosbuvir (Sovaldi, Gilead) in patients with a high unmet need, such as pre- and post-transplant patients, HIV/HCV co-infected patients, and patients with genotype 3, as part of the ongoing phase III ALLY program.
Source: Bristol-Myers Squibb; April 10, 2014.