Efficacy and Safety of Glecaprevir/Pibrentasvir for Chronic Hepatitis C Patients: A Systematic Review and Meta-analysis

Abstract

Background and Aims: Glecaprevir/pibrentasvir is a pangenotypic regimen recently approved for the treatment of chronic hepatitis C virus (HCV) infection. The objective of the present review was to summarize the findings from clinical trials to understand how patient-related factors influence glecaprevir/pibrentasvir efficacy (sustained virologic response rates at 12 weeks' after treatment [referred to as SVR12]) and safety. Methods: Data from 21 phase III clinical trials were analyzed. Results: The integrated efficacy analysis included 4,817 patients. Findings showed 97.5% of all included patients with chronic HCV achieved SVR12 in the intention-to-treat population. SVR12 rate was >95% across subgroups of interest. The integrated safety analysis included 4,015 patients. Findings showed that 64.1% of patients reported an adverse event, and <0.1% of patients reported a serious adverse event related to glecaprevir/pibrentasvir. Conclusions: These results indicate that the 8-or 12-week glecaprevir/pibrentasvir treatment is effective for patients infected with HCV genotypes 1-6 without or with compensated cirrhosis, with good safety profiles, irrespective of treatmentexperience. Glecaprevir/pibrentasvir is a good option for patients with human immunodeficiency virus/HCV coinfection and comorbid HCV and severe renal impairment.

Glecaprevir-pibrentasvir for chronic hepatitis C – a clinical review

“…These results were confirmed in another systematic review and meta-analysis of 21 phase 3 clinical trials including 4817 patients with HCV genotype 1-6, which found an SVR12 rate of 97%. 82 Moreover, real-world data from Italy, [83][84][85][86] Germany, 87 Scotland, 88 Austria, 86 Belgium, 86 France, 86 Greece, 86 Poland, 86 Portugal, 86 Switzerland, 86 Israel, 86 Taiwan, 89,90 Japan, [91][92][93][94][95][96][97][98][99][100] and the U.S. 88,101 confirm the efficacy and safety of GLE/PIB in patients with chronic HCV genotype 1-6, including those on hemodialysis 90,92,97,98 and recipients of liver transplantation. 93 Although there have been a few case reports of acute liver injury, including a case of elevated liver enzymes in a non-cirrhotic patient, 102 a case report of severe hyperbilirubinemia and jaundice in a patient with compensated cirrhosis, 103 and a case of jaundice and fatigue, 104 it is difficult to attribute these to GLE/ PIB treatment given the pathology of HCV infection itself.…”