October 8, 2013
SAN FRANCISCO – A regimen of daclatasvir, asunaprevir, and a non-nucleoside NS5B inhibitor yielded high sustained virologic response rates among patients with hepatitis C genotype 1 in a study presented at ID Week 2013.
Gregory T. Everson, MD, University of Colorado Denver in Aurora, Colo., and colleagues randomly assigned 32 noncirrhotic, treatment-naive patients with hepatitis C genotype 1 to 60 mg NS5A inhibitor daclatasvir (DCV) once daily and 200 mg protease inhibitor asunaprevir (ASV) and 75 mg non-nucleoside NS5B inhibitor BMS-791325 twice daily for 24 (group 1; n=16) or 12 weeks (group 2; n=16). An additional 34 patients then were randomly assigned 60 mg DCV once daily and 200 mg ASV and 150 mg BMS-791325 twice daily for 24 (group 3; n=16) or 12 weeks (group 4; n=18).
Across the groups, all but two patients achieved HCV RNA below 25 IU/mL at 4 weeks of treatment, with 92% of evaluable patients achieving sustained virologic response at 4 weeks and 94% at 12 and 24 weeks. Rate of virologic response did not differ significantly between those who received 12 or 24 weeks of therapy.
The most commonly observed adverse events, occurring in more than 10% of patients, included asthenia, gastrointestinal issues and headache. No patients experienced hepatotoxicity or ALT, AST or bilirubin elevations of grade 3 or higher. Two serious events occurred, neither of which was considered treatment related, and no patients discontinued therapy because of treatment-related adverse events.
“DCV+ASV+BMS-791325 achieved high rates of SVR4, SVR12 and SVR24 in treatment-naive GT1 patients, characterized by GT1a and IL28B non-CC,” the researchers wrote. “This regimen was well tolerated with no apparent safety signals. Expansion of the current study is under way to better define the efficacy and safety of this regimen.”