Once-Daily Glecaprevir/Pibrentasvir Effective for Hepatitis C
Discontinuation of treatment because of adverse events occurred in approximately 1% of individuals in any treatment group.
According to the results of a study published in the New England Journal of Medicine, once-daily glecaprevir-pibrentasvir for 8 or 12 weeks achieved high rates of sustained virologic response at 12 weeks posttreatment for patients with hepatitis C virus (HCV) infection who did not have cirrhosis.
To evaluate the efficacy and safety of glecaprevir 300 mg plus pibrentasvir 120 mg in patients with HCV infection, researchers conducted 2 open-label phase 3 trials. A total of 1208 patients with HCV infection and no cirrhosis were enrolled. In the first trial, patients with genotype 1 infection were randomly assigned to receive glecaprevir-pibrentasvir for either 8 or 12 weeks. In the second trial, patients with genotype 3 infections were randomly assigned to receive glecaprevir-pibrentasvir or sofosbuvir-daclatasvir for 12 weeks. A second cohort of patients were recruited and nonrandomly assigned to receive glecaprevir-pibrentasvir for 8 weeks. The rate of sustained virologic response at 12 weeks after treatment completion was evaluated for the treatment groups.
Among the 703 patients with genotype 1, the sustained virologic response rate at 12 weeks was 99.1% for the 8-week group and 99.7% for the 12-week group. In a per protocol analysis, the sustained virologic response rate was 100% in both groups. Moreover, 8-week treatment with glecaprevir-pibrentasvir was shown to be noninferior to 12-week treatment for patients with genotype 1.
The 12-week rate of sustained virologic response for patient with genotype 3 who received glecaprevir-pibrentasvir for 12 weeks was 95%, which was noninferior to the sustained virologic response rate for sofosbuvir-daclatasvir (97%). Patients with genotype 3 who were treated with glecaprevir-pibrentasvir for 8 weeks also had a sustained virologic response rate of 95%.
Common adverse events included headache and fatigue. No serious adverse events were considered to be related to the trial drugs.
The study investigators concluded that "treatment with glecaprevir–pibrentasvir for 8 weeks yielded rates of sustained virologic response at 12 weeks of 99% and 95% in patients without cirrhosis who had HCV genotype 1 infection or genotype 3 infection, respectively, which indicated that 8 weeks of treatment with glecaprevir–pibrentasvir is an efficacious treatment option for HCV genotype 1 or 3 infection."
Zeuzem S, Foster GR, Wang S, et al. Glecaprevir-pibrentasvir for 8 or 12 weeks in HCV genotype 1 or 3 infection. N Engl J Med. 2018;378:354-369.