Abstract

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 ClinicalTrials.gov as follows: NCT02707952 (CERTAIN-1), NCT02723084 (CERTAIN-2), NCT02243280 (SURVEYOR-I), NCT02243293 (SURVEYOR-II), NCT02604017 (ENDURANCE-1), NCT02738138 (EXPEDITION-2).

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