Once-Daily Treatment Regime for Hepatitis C With Compensated Cirrhosis
Patients enrolled in the study were required to have a plasma HCV RNA concentration of 10000 IU/mL or more at the time of screening.
A once-daily coformulated regimen of glecaprevir with pibrentasvir leads to sustained virologic response in 99% of people with compensated cirrhosis and hepatitis C genotypes 1, 2, 4, 5, or 6, according to recent research published in The Lancet Infectious Diseases.
In this phase 3 study, researchers enrolled 146 patients with compensated cirrhosis and hepatitis C genotypes 1, 2, 4, 5, or 6. Participants were untreated or were previously nonresponsive to treatment with interferon with or without ribavirin or sofosbuvir plus ribavirin with or without interferon. For 12 weeks, participants received oral glecaprevir 300 mg with pibrentasvir 120 mg once daily.
At 12 weeks post-treatment, 145 participants (99%; 95% CI, 98-100) had sustained virologic response, which was the primary efficacy end point of the study.
The patient who did not achieve 12-week sustained virologic response had a relapse at 8 weeks post-treatment and had a history of nonresponse to pegylated interferon and ribavirin.
Adverse events were mostly mild and occurred in 69% (n=101) of participants. The most frequently reported adverse events were fatigue (19%, n=28) and headache (14%, n=20). No treatment-related serious adverse events were reported. Moreover, alanine aminotransferase levels were not significantly elevated from baseline in any patient.
The study authors concluded that “all-oral, once-daily glecaprevir coformulated with pibrentasvir is an efficacious treatment option for most patients with HCV infection and compensated cirrhosis.”
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.