Glecaprevir/pibrentasvir in patients with chronic HCV and recent drug use: An integrated analysis of 7 phase III studies

Real‐life glecaprevir/pibrentasvir in a large cohort of patients with hepatitis C virus infection: The MISTRAL study

“…Both GLE and PIB have a high barrier to resistance, potent pan‐genotypic antiviral activity, primarily biliary metabolism and clearance, and negligible renal excretion. GLE/PIB demonstrated a 98% rate of SVR at post‐treatment week 12 (SVR12) in over 2200 patients in phase II and III clinical trials across all six major HCV genotypes, including patients without cirrhosis or with compensated cirrhosis, prior HCV treatment experience and severe renal impairment …”

“…Since their introduction in 2011 and subsequent endorsement as standard of care in 2015, DAAs have changed considerably the HCV management scenario thus providing a mounting clinical evidence of their efficacy in large trials and more recently in real‐life settings . Given the detrimental consequences of HCV infection, mostly cirrhosis, HCC and higher risk of undergoing liver transplantation, the increased SVR rates above 95% as documented in specific patient subgroups, hold promise in facilitating treatment access to previously underserved populations such as PWID, patients with compensated cirrhosis and those harbouring the difficult‐to‐treat HCV3 genotype.…”

Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases–Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection

“…Eight weeks of the daily fixed‐dose combination of glecaprevir (300 mg)/pibrentasvir (120 mg) gained FDA approval for use in treatment‐naive or interferon‐experienced adolescents aged ≥ 12 years or weighing ≥ 45 kg with any HCV genotype infection, without cirrhosis or with compensated cirrhosis (Child‐Pugh A). Although the registration trial included only adolescents with genotype 1‐4, glecaprevir/pibrentasvir garnered FDA approval for all genotypes based on the safety and efficacy of the regimen demonstrated in adults . The recommendations for use of glecaprevir/pibrentasvir in treatment‐experienced adolescents are also based on clinical trial data from adults .…”

“…Several well-designed, robust clinical trials have demonstrated the safety (147) and high curative efficacy of glecaprevir/pibrentasvir (148)(149)(150)(151)(152)(153)(154)(155)(156)(157)(158) and sofosbuvir/ velpatasvir (159)(160)(161)(162)(163)(164) among treatment-naive persons without cirrhosis regardless of HCV genotype. These findings have been confirmed in real-world cohort studies for both glecaprevir/pibrentasvir (165)(166)(167) and sofosbuvir/velpatasvir.…”

“…Although the registration trial included only adolescents with genotype 1-4, (276) glecaprevir/pibrentasvir garnered FDA approval for all genotypes based on the safety and efficacy of the regimen demonstrated in adults. (148)(149)(150)(152)(153)(154)(155)(156)(157)(165)(166)(167)277) The recommendations for use of glecaprevir/pibrentasvir in treatmentexperienced adolescents are also based on clinical trial data from adults. (154,156,176,(278)(279)(280) Given its pangenotypic activity and safety and efficacy records in adults, the HCV guidance panel recommends glecaprevir/pibrentasvir as the first choice for adolescent HCV treatment.…”