Combination Treatment Effective in Patients With HCV Who Failed Prior Therapy

A recent study found that combination treatment glecaprevir and pibrentasvir is both effective and well tolerated in patients with chronic hepatitis C who have failed previous therapies.

The results of the study, presented at The Liver Meeting hosted by the American Association for the Study of Liver Diseases, demonstrated that the combination treatment was particularly effective in patients who were previously treated with a sofosburvir/NS5A inhibitor.

Researchers conducted a multicenter, randomized, controlled trial of a fixed-dose combination of once-daily 300 mg of glecaprevir and 120 mg of pibrentsvir. In total, 117 patients participated in the study which evaluated the combination treatment for 16 weeks in compensated cirrhotic and noncirrhotic patients with hepatitis C genotype 1 (GT1)-infection.

Patients without cirrhosis were randomly assigned to receive the combination for either 12 or 16 weeks in a 2:1 ratio, and patients with cirrhosis were randomly assigned to receive the combination plus ribavirin for 12 weeks, or the combination alone for 16 weeks at a 1:1 ratio.

“The [glecaprevir/pibrentsvir] regimen given for 16 weeks was approved by the [FDA] for retreatment of [hepatitis C] GT1-infected patients who failed a prior NS5Ai-containing regimen without prior exposure to a protease inhibitor,” said Mark Sulkowski, MD.

Overall, the study demonstrated that the combination treatment was well tolerated among participants. Adverse events such as fatigue, headache, and nausea were reported in 17%, 19%, and 9% of patients, respectively. The addition of ribavirin was also associated with more adverse events. In all, 11 serious adverse events were observed among 9 participants in the study, including 1 death due to hepatocellular carcinoma; none were classified as treatment-related.