Patients with chronic hepatitis C virus (HCV) genotype 5 or 6 achieve high rates of sustained virologic response when treated with glecaprevir/pibrentasvir, according to study results published in The Lancet Gastroenterology & Hepatology.
The study included adults with chronic HCV genotype 5 or 6 who were previously untreated or treatment-experienced from 24 hospitals and clinics in Europe, Oceania, North America, South Africa, and Southeast Asia. Participants without cirrhosis received once-daily oral glecaprevir/pibrentasvir (300 mg/120 mg) for 8 weeks or 12 weeks for participants with compensated cirrhosis. The study’s primary end point was sustained virologic response (HCV RNA <15 IU/ml) at 12 weeks after treatment.
Of 84 enrolled participants, 23 had genotype 5 infection and 61 had genotype 6 infection. Overall, 97.6% (n=82) of participants achieved sustained virologic response at 12 weeks after treatment, including 95.7% (n=22) of participants with genotype 5 and 98.4% (n=60) of participants with genotype 6.
In participants with genotype 6, one with genotype 6f infection and cirrhosis had on-treatment virologic failure at week 12. Another participant with genotype 5a without cirrhosis had achieved sustained virologic response at post-treatment week 4 but relapsed at post-treatment week 12.
Of all participants, 6% (n=5) experienced serious adverse events but none were deemed related to glecaprevir/pibrentasvir or led to discontinuation of treatment.
The only adverse events that occurred in ≥10% of participants were fatigue (13%, n=11) and headache (13%, n=11).
There were no reports of post-baseline grade 3 or higher increases in aminotransferase concentrations.
“The additional data in patients infected with these less prevalent genotypes support the indication of glecaprevir/ pibrentasvir as a truly pangenotypic regimen for HCV infection,” the researchers concluded.
This study was funded by AbbVie.
Asselah T, Lee SS, Yao BB, et al. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic hepatitis C virus genotype 5 or 6 infection (ENDURANCE-5, 6): an open-label, multicentre, phase 3b trial [published online November 1, 2018]. Lancet Gastroenterol Hepatol. doi:10.1016/S2468-1253(18)30341-8.