A168 Use of Ledipasvir/Sofosbuvir (Ldv/Sof) With or Without Ribavirin (Rbv) in Genotype 1 (Gt 1) HCV-Infected Patients Post Liver Transplant (Lt): Evaluation of Several Real-World Datasets (Rwd)

Bourlière, Marc; Charlton, Michael; Manns, Michael P.; Prieto, M.; Fernandez, I.; Londoño, María Carlota; Kwok, Ryan M.; Smith, Coleman I.; Ngo, Hien Chi; Lee, S; Zhang, J; Arterburn, Sarah; Copans, Amanda; Rosarro, L; Curry, Michael P.; Flamm, S.

doi:10.1093/jcag/gwy008.169

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“…Ledipasvir/sofosbuvir has been approved for the treatment of HCV genotypes 1, 4, 5, and 6 across many countries globally, and its efficacy and safety in these genotypes have been reported in both clinical and real‐world studies. The SVR12 of LDV/SOF in HCV genotype 1 ranges from 95% to 98% in global clinical trials and 94% to 100% in real‐world cohorts; 13 in Asian patients with HCV genotype 1 infection, LDV/SOF has even higher SVR12 rates, with up to 97–100% in clinical trials and real‐world experience 14–17 . In HCV genotypes 4, 5, and 6, LDV/SOF has been shown to have SVR12 rates of 93–95% 18,19 …”

Section: Discussionmentioning

confidence: 99%

Twelve weeks of ledipasvir/sofosbuvir all‐oral regimen for patients with chronic hepatitis C genotype 2 infection: Integrated analysis of three clinical trials

Asahina

Liu

Gane

et al. 2020

Hepatology Research

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The combination of ledipasvir and sofosbuvir (LDV/SOF) has been approved for the treatment of various hepatitis C virus (HCV) genotypes across many countries. This article presents an integrated analysis of three prospective phase II/III trials in the Asia Pacific region to evaluate the efficacy and safety of 12 weeks of LDV/SOF in HCV genotype 2 patients without cirrhosis or with compensated cirrhosis. Methods: A total of 200 patients were included in the integrated analysis. The primary end point was the rate of sustained virologic response for 12 weeks after the end of therapy (SVR12), analyzed by fibrosis stage, treatment history, HCV genotype subtype, and presence of baseline resistance associated substitutions (RAS). Safety was evaluated by adverse events and laboratory abnormalities.

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Section: Discussionmentioning

confidence: 99%