A Next Step for Genotype 1 HCV Regimens: Eliminating Ribavirin

As described in recent reviews, interferon-free regimens will soon likely be approved to treat genotype 1 hepatitis C virus (HCV) infection in the near future (NEJM JW Gastroenterol Jan 15 2014, NEJM JW Gastroenterol Nov 15 2013). In previous regimens, most adverse effects were related to interferon; however, ribavirin also has significant adverse effects, namely anemia.

The purpose of the current phase IIA, open-label study was to examine the efficacy and safety of an interferon- and ribavirin-free regimen for treatment of genotype 1 HCV infection. Sixty-six treatment-naive patients without cirrhosis were randomly assigned to receive either a 12-week or 24-week regimen comprising daclatasvir (an NS5A replication complex inhibitor; 60 mg daily), asunaprevir (an NS3 protease inhibitor; 200 mg twice daily), and BMS-791325 (a non-nucleoside NS5B inhibitor; 75 mg or 150 mg twice daily). The primary endpoint was sustained virologic response at 12 weeks after treatment (SVR12).

Sixty-one of 66 patients (92%) achieved SVR12. Similar response rates were achieved in genotypes 1a and 1b (94% and 88%), in IL28B host genotypes CC and non-CC (100% and 89%), with 75-mg and 150-mg doses of BMS-791325 (94% and 91%), and with durations of 12 and 24 weeks (94% and 91%). During treatment, two patients experienced virologic breakthrough, and one patient relapsed. There were no adverse events leading to discontinuation.