Integrated analysis of 8-week glecaprevir/pibrentasvir in Japanese and overseas patients without cirrhosis and with hepatitis C virus genotype 1 or 2 infection. Journal of gastroenterology Naganuma, A., Chayama, K., Notsumata, K., Gane, E., Foster, G. R., Wyles, D., Kwo, P., Crown, E., Bhagat, A., Mensa, F. J., Otani, T., Larsen, L., Burroughs, M., Kumada, H. 2019


BACKGROUND: Chronic hepatitis C virus (HCV) infection with genotypes (GT) 1 and 2 accounts for over 50% of HCV infections globally, including over 97% of all HCV infections in Japan. Here, we report an integrated analysis of efficacy and safety of 8-week treatment with the all-oral, fixed-dose combination of the direct acting antivirals (DAA), glecaprevir and pibrentasvir (G/P), in DAA-naive Japanese and overseas patients without cirrhosis and with HCV GT1 or GT2 infection.METHODS: Data from 899 DAA-naive patients without cirrhosis and with HCV GT1 or GT2 infection treated with G/P (300/120mg) for 8weeks in the six Phase 2 or 3 overseas or Japan-only clinical trials were included. All patients who received =1 dose of G/P were included in an intent-to-treat (ITT) analysis. The objectives were to evaluate rate of sustained virologic response 12weeks post-treatment (SVR12) and safety of the 8-week regimen in the ITT population.RESULTS: Overall, SVR12 was achieved by 98.9% (889/899) of DAA-naive patients without cirrhosis, including 99.2% (597/602) of GT1-infected and 98.3% (292/297) of GT2-infected patients.Less than1% (2/899) of patients overall and no Japanese patients experienced virologic failure. SVR12 rate was >97% for patients regardless of baseline characteristics, and common comorbidities or co-medications. Overall, <1% (2/899) discontinued G/P due to an adverse event (AE) and 1.6% (14/899) of patients experienced a serious AE.CONCLUSIONS: 8-week G/P treatment is safe and efficacious in DAA-naive patients without cirrhosis and with HCV GT1 or GT2 infection, demonstrating high SVR12 rates regardless of baseline patient and disease characteristics. CLINICALTRIALS.GOV IDENTIFIERS: The trials discussed in this paper were registered with as follows: NCT02707952 (CERTAIN-1), NCT02723084 (CERTAIN-2), NCT02243280 (SURVEYOR-I), NCT02243293 (SURVEYOR-II), NCT02604017 (ENDURANCE-1), NCT02738138 (EXPEDITION-2).

View details for PubMedID 30868245