Asselah T, et al. - In this study, the researchers assessed the effectiveness and safety of glecaprevir/pibrentasvir particularly in subjects infected with chronic hepatitis C virus (HCV) genotype 5 or 6 in adults. It was observed that glecaprevir/pibrentasvir scored high SVR12 values (ie, HCV RNA <15 IU/mL at 12 weeks post-treatment) and was well endured in participants with HCV genotype 5 or 6 infections with compensated liver disease.

Methods

• In Europe, Oceania, North America, South Africa, and southeast Asia, ENDURANCE-5,6, a phase 3b, single-arm, open-label, multicentre trial was performed in 24 hospitals or clinics.
• Adult participants with chronic HCV genotype 5 or 6 infection who were previously untreated or treatment-experienced were involved.
• For 8 weeks (for patients without cirrhosis) or 12 weeks (for patients with compensated cirrhosis), glecaprevir/pibrentasvir (300 mg/120 mg) was given orally once daily.
• They assessed within each HCV genotype, and analyzed in the intention-to-treat population and the primary efficiency endpoint was SVR12 (ie, HCV RNA <15 IU/mL at 12 weeks post-treatment).

Results

• They involved 84 patients : 23 with genotype 5 infection and 61 with genotype 6 infection from Feb 9, 2017 to Aug 28, 2018.
• Out of the 84 candidates, 82 (97·6%, 95% CI 94·4–100·0) achieved SVR12.
• Twenty-two (95·7%, 95% CI 87·3–100·0) of 23 participants with genotype 5 infection reached SVR12, as did 60 (98·4%, CI 95·2–100·0) of 61 with genotype 6 infection.
• One patient with HCV genotype 5a without cirrhosis who had achieved SVR at post-treatment week 4 was found relapsed at post-treatment week 12 and one patient with an HCV genotype 6f infection and cirrhosis was observed on-treatment virological failure at treatment week 12.
• They notified 5 (6%) cases with serious adverse events, none of which were deemed related to glecaprevir/pibrentsavir or led to discontinuation.
• The only unfavorable events appeared in 10% or more of patients were fatigue (11 [13%] patients) and headache (11 [13%]).
• The investigators did not report any post-baseline grade 3 or higher increases in aminotransferase concentrations.