Theme: Clinical Research Year: 2025
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Background: Reinfection is a major obstacle to Hepatitis C virus (HCV) elimination, HCV reinfection rates among PWIDs (people who inject drugs) and MSMs (men who have sex with men) range from 4-30/100 person years and 7.3-15.2/100 person yrs respectively. This analysis aims to confirm the efficacy and safety of G/P in persons with acute HCV and a history of prior HCV infection. Methods: A secondary analysis of safety and efficacy of G/P was carried out in a subset of subjects from the phase 3 study (NCT04903626) of adults with acute HCV infection who were treatment-naive for current infection and had ≥1 prior HCV infections. Results: Among 286 subjects with acute HCV infection, 52 (18.2%) had ≥1 prior HCV infections. A majority of subjects with prior infections had HCV/HIV-1 co-infection (92.3%) and were MSMs (78.8%), and 28.8% were PWIDs (on-going or history of illicit injection drug use). Treatment for prior HCV infections included IFN/ PEG-IFN/RBV, G/P, SOF/VEL or SOF-based regimens, and other regimens. Sustained virologic response at 12-weeks post-treatment (SVR12) rates in subjects with one or more prior infections were 98.1% (ITT) and 100% (mITT; ITT excluding subjects who failed to achieve SVR12 due to reasons other than virologic failure). Safety demonstrated by treatment related (TR) adverse events (AEs) was similar between subjects that had ≥1 and no prior infections. No subjects reported serious TR-AEs or TR-AEs leading to G/P discontinuation or died. No subject with ≥1 prior HCV infections experienced an alanine aminotransferase ≥ Grade 2 or a total bilirubin ≥ Grade 3 during treatment that had worsened from their baseline grade. Conclusion: G/P is highly safe and effective in acute HCV subjects who have a history of ≥1 prior HCV infections. |