IDDF2019-ABS-0212 Real-world effectiveness and safety of glecaprevir/pibrentasvir in adults with chronic hepatitis C virus infection: a meta-analysis

Abstract

Background Glecaprevir/pibrentasvir (G/P) is approved for adults infected with hepatitis C virus (HCV) genotypes 1–6. In clinical trials, G/P was associated with high rates of sustained virologic response at post-treatment Week 12 (SVR12) and was well tolerated. Currently, real-world evidence (RWE) regarding G/P use is being collected. A systematic review and meta-analysis of RWE reporting the effectiveness and safety of G/P were undertaken. Methods Biosis, Derwent Drug File, Embase®, International Pharmaceutical Abstracts, Medline®, and SciSearch databases were searched using pre-defined terms for ‘G/P’ and ‘RWE’ to identify real-world prospective/retrospective studies (1 January 2017–15 October 2018) that reported SVR12 and/or safety parameters in HCV-infected adults (N≥20) treated with G/P. Congress presentations up to 12 November 2018 were included. Random effects meta-analysis was used to determine SVR12 and naive pooling for adverse event (AE) rates. Intention-to-treat (ITT) SVR12 analyses included all patients dosed with G/P; modified ITT (mITT) excluded those who had non-virologic failure. Results 10,048 adults treated with G/P in 16 studies were included; ITT SVR12 rates were reported in 14 studies and mITT SVR12 rates in 11 studies. SVR12 rates overall and by subgroups based on ITT and mITT populations are shown (table 1). AEs were summarised in 6 studies and reported in 12.7% (724/5685) of patients. Treatment discontinuations due to AEs were summarised in 5 studies and reported in 0.5% (24/4508) of patients. The most frequent AEs were pruritus (4.7%; 126/2698), fatigue (4.4%; 146/3305), and headache (2.7%; 102/3759). SVR12 and safety data will be updated in the final presentation. Conclusions Consistent with results observed in clinical trials, RWE indicates that G/P is a well-tolerated and highly effective pangenotypic treatment option for a broad range of HCV-infected patients (table 1).