Treatment options for patients with chronic HCV continue to evolve, and effective agents with shorter treatment duration are needed to decrease morbidity. The coformulation of the nonstructural (NS) 3/4A protease inhibitor glecaprevir and NS5A inhibitor pibrentasvir was approved for the treatment of patients with HCV genotypes 1-6 without cirrhosis has demonstrated pangenotypic efficacy, a favorable safety profile, high barrier to resistance, and synergistic antiviral activity.
Data also suggests suitable efficacy of the drug combination with both 8 and 12-week regimens. This reports the findings of two open-label, randomized trials (ENDURANCE 1 and 3) evaluating glecaprevir-pibrentasvir for patients with HCV genotype 1 or 3, and compare the efficacy of glecaprevir-pibrentasvir to sofosbuvir-daclatasvir for HCV genotype 3.
The results demonstrated a high rate of sustained virologic response at 12 weeks (primary end point) in patients with HCV genotype 1 or 3 treated with glecaprevir-pibrentasvir. Noninferiority was shown in glecaprevir-pibrentasvir treatment for 8 versus 12 weeks in patients with either genotype, and between glecaprevir-pibrentasvir and sofobusvir-daclatasvir for patients with HCV genotype 3. Among secondary end points, there was no statistical difference in virologic relapse or failure after 8 weeks or 12 weeks of glecaprevir-pibrentasvir in patients with either genotype. The safety profile of glecaprevir-pibrentasvir was similar with 8 or 12-week treatment and associated with few serious adverse events or laboratory abnormalities.