2966 A Sub-Analysis of Puerto Rican Hepatitis C Infected Patients Enrolled in the Phase 2 and 3 Glecaprevir-Pibrentasvir Clinical Program

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INTRODUCTION: Chronic hepatitis C virus (HCV) infection is a leading cause of cirrhosis and advanced liver disease, and viral clearance is associated with reduced risk of developing cirrhosis, hepatic decompensation, and death. Glecaprevir (NS3/4A protease inhibitor) and pibrentasvir (NS5A inhibitor) are direct-acting antivirals (DAAs) co-formulated as a once-daily, fixed-dose combination regimen (G/P) to treat genotype (GT) 1‒6 HCV infection. G/P has been licensed in the United States and Europe, supported by a phase 2/3 global clinical trial program demonstrating high efficacy with a favorable safety profile. The objective of this study was to describe the clinical characteristics and virologic response to G/P in Puerto Rican (PR) patients included in the G/P clinical program. METHODS: Data were pooled from 14 phase 2, 3, and 3b clinical trials conducted in 32 countries and representing 3,233 treatment-naive and treatment-experienced patients with chronic HCV GT1–6 infection who received G/P once-daily for 8, 12, or 16 weeks. The primary endpoints were percentage of patients with sustained virologic response 12 weeks after treatment (SVR12) and percentage with treatment-emergent adverse events (AEs). RESULTS: From the 3,233 patients included in the G/P clinical program, this sub-analysis included 79 (2%) patients from sites in Puerto Rico. Overall, 52 (66%) were male, 64 (81%) were white race and the median age was 56 years (range: 29–78). Most patients were infected with HCV GT1 (n = 69; 87%), of whom 71% (49/69) had GT1a infection, and overall, 63 (80%) were treatment-naïve. Additionally, 39 (53%) patients had baseline fibrosis stage F0–F1, while 25 (34%) had stage F4. The overall SVR12 rate was 97.5% (77/79), with two patients not achieving SVR12 due to non-virologic reasons (both missing SVR12 data). AEs occurred in 38 (48%) patients, with none leading to discontinuation. Serious AEs occurred in 4 (5%) patients but none were deemed by investigators to be related to DAAs. There were 4 (5%) grade ≥3 laboratory abnormalities, and none were deemed clinically meaningful. CONCLUSION: G/P achieved high SVR12 rates and was well-tolerated in Puerto Rican patients enrolled in the G/P clinical trial program. The efficacy and safety profile of G/P in Puerto Rican patients was comparable to the overall patient population in the G/P registrational trial program, and SVR12 rates were comparable to real-world studies of G/P.