This article is more than 5 years old. Information may no longer be current.

Patients with HCV who failed prior therapy benefited from vaniprevir/peginterferon/ribavirin

The addition of vaniprevir to pegylated interferon and ribavirin significantly improved sustained virologic response among patients with chronic hepatitis C in a recent study.

In an international, phase 2b, double blind study, researchers randomly assigned 211 noncirrhotic patients who had failed previous interferon-based therapy for chronic HCV genotype 1 (GT 1) to receive one of the following regimens:

• 24 weeks of 600 mg vaniprevir (MK-7009) twice daily with 180 mcg weekly peginterferon and 1,000 to 1,200 mg daily ribavirin (PR) (n=42, completed by 35 patients)
• 24 weeks of 600 mg MK-7009 twice daily with PR, followed by 24 weeks of PR with placebo (n=44, completed by 32)
• 48 weeks of 300 mg MK-7009 twice daily with PR (n=41, completed by 30)
• 48 weeks of 600 mg MK-7009 twice daily with PR (n=42, completed by 34)
• 48 weeks of PR with placebo (n=42, completed by 18)

All treated groups experienced sustained virologic response (SVR) at 24 weeks more frequently than placebo patients (19% of cases; P<.001 for all comparisons). The highest SVR rate occurred in the group that received 24 weeks of vaniprevir and 24 weeks of placebo (84.2% of cases).Among patients who received 600 mg vaniprevir, 71.1% of the 24-week group and 78% of the 48-week group achieved SVR, while 66.7% experienced SVR in the 300-mg group.

Adverse events occurred in nearly all participants, including 83.3% of placebo recipients and between 90% and 97.8% of treated patients. GI-related events, including diarrhea, nausea and vomiting, occurred more frequently among treated patients than controls.

“Patients treated with MK-7009 plus PR experienced significant improvement in SVR compared to PR control in a population of GT 1 experienced patients,” the researchers concluded. “Results show that MK-7009 compares favorably with other first-generation protease inhibitors. MK-7009 was generally well tolerated and most adverse experiences were mild to moderate in severity. Based on these findings, the development of MK-7009 has advanced to phase 3 in Japan.”

Disclosure: See the study for a full list of relevant disclosures.