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Observational Study
. 2016 Jan;22(1):24-33.
doi: 10.1002/lt.24366.

Interferon-free Therapy for Genotype 1 Hepatitis C in Liver Transplant Recipients: Real-world Experience From the Hepatitis C Therapeutic Registry and Research Network

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Free PMC article
Observational Study

Interferon-free Therapy for Genotype 1 Hepatitis C in Liver Transplant Recipients: Real-world Experience From the Hepatitis C Therapeutic Registry and Research Network

Robert S Brown Jr et al. Liver Transpl. .
Free PMC article

Abstract

Recurrent infection with the hepatitis C virus (HCV) after liver transplantation (LT) is associated with decreased graft and patient survival. Achieving sustained virological response (SVR) with antiviral therapy improves survival. Because interferon (IFN)-based therapy has limited efficacy and is poorly tolerated, there has been rapid transition to IFN-free direct-acting antiviral (DAA) regimens. This article describes the experience with DAAs in the treatment of posttransplant genotype (GT) 1 HCV from a consortium of community and academic centers (Hepatitis C Therapeutic Registry and Research Network [HCV-TARGET]). Twenty-one of the 54 centers contributing to the HCV-TARGET consortium participated in this study. Enrollment criteria included positive posttransplant HCV RNA before treatment, HCV GT 1, and documentation of use of a simeprevir (SMV)/sofosbuvir (SOF) containing DAA regimen. Safety and efficacy were assessed. SVR was defined as undetectable HCV RNA 64 days or later after cessation of treatment. A total of 162 patients enrolled in HCV-TARGET started treatment with SMV+SOF with or without ribavirin (RBV) following LT. The study population included 151 patients treated with these regimens for whom outcomes and safety data were available. The majority of the 151 patients were treated with SOF and SMV alone (n = 119; 79%) or with RBV (n = 32; 21%), The duration of therapy was 12 weeks for most patients, although 15 patients received 24 weeks of treatment. Of all patients receiving SOF/SMV with or without RBV, 133/151 (88%) achieved sustained virological response at 12 weeks after therapy and 11 relapsed (7%). One patient had virological breakthrough (n = 1), and 6 patients were lost to posttreatment follow-up. Serious adverse events occurred in 11.9%; 3 patients (all cirrhotic) died due to aspiration pneumonia, suicide, and multiorgan failure. One experienced LT rejection. IFN-free DAA treatment represents a major improvement over prior IFN-based therapy. Broader application of these and other emerging DAA regimens in the treatment of posttransplant hepatitis C is warranted.

Conflict of interest statement

Robert S. Brown, Jr., M.D., M.P.H.: Consulting, grant support from Gilead, Abbvie, Janssen Jacqueline G. O’Leary M.D. M. P.H: Gilead, Abbvie, Jansen, Novartis, Astellas K. Rajender Reddy M.D: Ad-Hoc Advisory Board and Grant Support: Gilead, Abbvie, BMS, Merck, Janssen, Vertex Alexander Kuo, M.D.: Gilead grant funding Giuseppe (Joseph) Morelli, M.D.: Grant funding from AbbVie, BMS, Gilead, Merck, Janssen, Vertex, Idenix, Conatus, and Salix James R. Burton, Jr. M.D.: Research grant support with AbbVie, Gilead, and Janssen. R. Todd Stravitz, M.D.: Gilead grant funding Christine Durand, M.D.: Consultant and grant funding from Gilead Adrian M. Di Bisceglie, M.D.: Grant funding from Gilead, AbbVie, Janssen, consultant funds from Gilead and AbbVie outside the submitted work. Paul Kwo, M.D.: Reports consultant work from Advisory Board, AbbVie, BMS, Gilead, Merck, Janssen, grant funding from AbbVie, BMS, Gilead, Merck, Janssen, Conatus. Catherine T. Frenette, M.D.: Gilead employment and stockholder Thomas G. Stewart, PhD: Reports no disclosures during the conduct of the study. David R. Nelson, M.D.: Reports grant funding from AbbVie, Gilead, BMS, Janssen, Merck, Vertex, and GSK during the conduct of the study. Michael W. Fried, M.D.: Reports grant funding from AbbVie, Bristol-Myers Squibb, Gilead, Glaxo, Merck, Vertex, Genentech/Roche and consultant funding from Genentech/Roche, Tibotec/Janssen, Vertex, Merck, Glaxo, Novartis, AbbVie, Gilead, Bristol-Myers Squibb during the conduct of the study along with funding from the NIH for research. Norah Terrault, MD: Grants: Gilead, AbbVie; Advisory board: Janssen, Merck, BMS, Achillion

Figures

Figure 1
Figure 1
Odds Ratio Estimates of SVR12 Controlling for Regimen Choice. (Excludes non-virological failures.) Odds ratios are calculated from conditional logistic regression models stratified on regimen. Each line represents an estimate from a distinct model in which SVR is the outcome, the predictor is the covariate, and regimen is the stratum.
Figure 2
Figure 2
Relative Risk of SVR12 (SOF+SMV+RBV reference). (Excludes non-virological failures.) Relative risks are Mantel-Haenszel estimates stratified on previous treatment (experienced v. naive). Previous treatment is a predictor of regimen choice (SOF+SMV v. SOF+SMV+RBV) among patients which completed treatment or discontinued due to virological reasons. (Relative risk estimates for Tx experienced and Tx Naive are not stratified.)

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