Reau N.Kwo P.Y.Rhee S.Brown R.S.Jr.Agarwal K.Angus P.Gane E.JIA-HORNG KAOMantry P.S.Mutimer D.Reddy K.R.Tran T.T.Hu Y.B.Gulati A.Krishnan P.Dumas E.O.Porcalla A.Shulman N.S.Liu W.Samanta S.Trinh R.Forns X.2021-09-042021-09-0420180270-9139https://www.scopus.com/inward/record.uri?eid=2-s2.0-85054321603&doi=10.1002%2fhep.30046&partnerID=40&md5=0e3e62c4fd806e26349e36a652a0f13ahttps://scholars.lib.ntu.edu.tw/handle/123456789/581830Well-tolerated, ribavirin-free, pangenotypic hepatitis C virus (HCV) treatments for transplant recipients remain a high priority. Once-daily glecaprevir/pibrentasvir demonstrates high rates of sustained virologic response at 12 weeks posttreatment (SVR12) across all major HCV genotypes (GTs). This trial evaluated the safety and efficacy of glecaprevir/pibrentasvir for patients with chronic HCV GT1-6 infection who had received a liver or kidney transplant. MAGELLAN-2 was a phase 3, open-label trial conducted in patients who were ?3 months posttransplant. Patients without cirrhosis who were HCV treatment-naive (GT1-6) or treatment-experienced (GT1, 2, 4-6; with interferon-based therapy with or without sofosbuvir, or sofosbuvir plus ribavirin) received glecaprevir/pibrentasvir (300/120 mg) once daily for 12 weeks. The primary endpoint compared the percentage of patients receiving glecaprevir/pibrentasvir with SVR12 to a historic SVR12 rate based on the standard of care. Safety of glecaprevir/pibrentasvir was assessed. In total, 80 liver transplant and 20 kidney transplant patients participated in the trial. Most patients had no or minimal fibrosis (80% had fibrosis scores F0-F1) and were infected with HCV GT1 (57%) or GT3 (24%). The overall SVR12 was 98% (n/N = 98/100; 95% confidence interval, 95.3%–100%), which exceeded the prespecified historic standard-of-care SVR12 threshold of 94%. One patient experienced virologic failure. One patient discontinued because of an adverse event considered to be unrelated to treatment; this patient achieved SVR12. Adverse events were mostly mild in severity, and laboratory abnormalities were infrequent. Conclusion: Once-daily glecaprevir/pibrentasvir for 12 weeks is a well-tolerated and efficacious, ribavirin-free treatment for patients with chronic HCV GT1-6 infection who have received a liver or kidney transplant. (ClinicalTrials.gov NCT02692703.) (Hepatology 2018; 00:000-000). ? 2018 The Authors. Hepatology published by Wiley Periodicals, Inc. on behalf of American Association for the Study of Liver Diseases.[SDGs]SDG3alanine aminotransferase; amino acid; bilirubin; clarithromycin; creatinine; cyclosporine; everolimus; glecaprevir plus pibrentasvir; peginterferon; rapamycin; ribavirin; sofosbuvir; tacrolimus; virus RNA; ABT-493; benzimidazole derivative; pibrentasvir; quinoxaline derivative; sulfonamide; adult; aged; alanine aminotransferase blood level; anticoagulant therapy; antiviral therapy; Article; bilirubin blood level; cerebrovascular accident; chronic hepatitis C; combination drug therapy; creatinine blood level; creatinine clearance; diarrhea; disease severity; drug efficacy; drug safety; estimated glomerular filtration rate; fatigue; female; headache; health care quality; Hepatitis C virus genotype 1; Hepatitis C virus genotype 2; Hepatitis C virus genotype 3; Hepatitis C virus genotype 4; Hepatitis C virus genotype 5; Hepatitis C virus genotype 6; human; immunosuppressive treatment; immunotherapy; international normalized ratio; kidney graft; kidney graft rejection; liver graft; liver graft rejection; major clinical study; male; medication compliance; multicenter study; nausea; open study; patient compliance; phase 3 clinical trial; priority journal; pruritus; relapse; side effect; sustained virologic response; urinary tract infection; chronic hepatitis C; clinical trial; dose response; drug administration; graft recipient; graft rejection; graft survival; international cooperation; kidney transplantation; liver transplantation; middle aged; prognosis; risk assessment; treatment outcome; Adult; Aged; Benzimidazoles; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Female; Graft Rejection; Graft Survival; Hepatitis C, Chronic; Humans; Internationality; Kidney Transplantation; Liver Transplantation; Male; Middle Aged; Prognosis; Quinoxalines; Risk Assessment; Sulfonamides; Transplant Recipients; Treatment Outcomejournal article10.1002/hep.30046296728912-s2.0-85054321603