HCV Treatment Combination Safe, Effective

The once-daily, ribavirin-free, direct-acting antiviral treatment combination glecaprevir plus pibrentasvir is a safe and effective treatment for patients with hepatitis C virus (HCV) genotypes 1, 2, 4, 5, or 6 infection with compensated cirrhosis, according to a recent study.

For their study, the researchers evaluated 146 adult patients with HCV infection genotypes 1, 2, 4, 5, or 6 and compensated cirrhosis at 40 sites from 6 countries from December 7, 2015, to May 4, 2016. A total of 48 (33%) had genotype 1a infection, 39 (27%) had genotype 1b infection, 34 (23%) had genotype 2 infection, 16 (11%) had genotype 4 infection, 2 (1%) had genotype 5 infection, and 7 (5%) had genotype 6 infection.
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All patients enrolled in the study were either naïve to HCV treatment or were refractory to treatment with interferon or pegylated interferon with or without ribavirin, or sofosbuvir plus ribavirin with or without pegylated interferon.

During the study, patients received 300 mg oral glecaprevir coformulated with 120 mg pibrentasvir once daily for 12 weeks. The researchers defined the primary outcome as sustained virological response (HCV RNA less than 15 IU/mL) at 12 weeks post-treatment.

Results indicated that 145 (99%) patients had achieved sustained virological response within 12 weeks post-treatment, with 1 (1%) relapse at 8 weeks post-treatment. The researchers noted 101 adverse events, of which 65 (64%) were mild. The most commonly reported adverse events were fatigue (19%) and headache (14%). A total of 11 (8%) patients had experienced serious adverse events, none of which were related to the study drugs.

“Our results show that 99% of patients treated with once-daily glecaprevir plus pibrentasvir achieved a sustained virological response at 12 weeks,” the researchers concluded.

“Furthermore, this drug regimen had a favorable safety profile in previously treated or untreated patients with chronic HCV genotype 1, 2, 4, 5, or 6 infection and compensated cirrhosis. These findings could help simplify treatment algorithms and reduce treatment burden.”

—Christina Vogt

Reference:

Forns X, Lee SS, Valdes J, et al. Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial [Published online August 14, 2017]. Lancet Infect Dis. doi:10.1016/S1473-3099(17)30496-6.