April 30, 2013
Treatment-naive patients with chronic hepatitis C experienced high rates of sustained virologic response from a combination of three direct-acting antivirals in a study presented at the International Liver Congress in Amsterdam.
In an open-label phase 2 study, researchers randomly assigned 32 treatment-naive patients with chronic HCV genotype 1 to 60 mg NS5A inhibitor daclatasvir (DCV) once daily, 200 mg protease inhibitor asunaprevir (ASV) twice daily and 75 mg non-nucleoside NS5B inhibitor BMS-791325 twice a day for 24 or 12 weeks (n=16 each). A second cohort was later assigned DCV, ASV and 150 mg BMS-791325 (Bristol-Myers Squibb) for 24 (n=16) or 12 weeks (n=18).
Nearly all patients had HCV RNA levels below 25 IU/mL after 4 weeks, excluding two participants from the 12-week, 150-mg group. No significant differences in virologic response were observed, with 92% of all evaluable patients experiencing SVR at 4 weeks. SVR12 and SVR24 were achieved by 94% of the first two groups, and all evaluable patients in this cohort experienced either or both SVR24 and SVR36, according to a press release.
In the second cohort, three treatment failures occurred, including virologic breakthroughs in the 12- and 24-week groups and one relapse in the 12-week group.
The most commonly reported adverse event was headache (27.3% of cases). Single cases of renal calculus and cerebral vasoconstriction unrelated to the study were considered serious adverse events, but no patients died or discontinued therapy because of treatment-related effects.
“The diversity of the hepatitis C patient population requires multiple treatment options that can enable a personalized approach,” Brian Daniels, MD, senior vice president of Global Development and Medical Affairs for Bristol-Myers Squibb, said in the release. “These data, which demonstrate comparable efficacy among the 12- and 24-week triple-DAA treatment groups, support the rapid phase 3 development of this investigational triple-DAA regimen and provide further data on daclatasvir as an important component of DAA-based therapy.”
For more information:
Everson GT. #1423: Interim Analysis of an Interferon (IFN)- and Ribavirin (RBV)-Free Regimen of Daclatasvir (DCV), Asunaprevir (ASV), and BMS-791325 in Treatment-Naive, Hepatitis C Virus Genotype 1-Infected Patients. Presented at: The International Liver Congress 2013; April 24-28, Amsterdam.
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