PMID- 25825070 OWN - NLM STAT- MEDLINE DCOM- 20160318 LR - 20231013 IS - 1527-6473 (Electronic) IS - 1527-6465 (Print) IS - 1527-6465 (Linking) VI - 21 IP - 6 DP - 2015 Jun TI - Sofosbuvir and simeprevir for treatment of hepatitis C virus infection in liver transplant recipients. PG - 823-30 LID - 10.1002/lt.24126 [doi] AB - Recurrent hepatitis C virus (HCV) infection occurs universally in the allograft in the absence of effective antiviral therapy before liver transplantation (LT). Antiviral therapy with sofosbuvir and simeprevir has proven to be highly effective and well tolerated in the nontransplant setting for treatment of HCV genotype 1 infection; therefore, we sought to evaluate the efficacy and safety of this regimen in LT recipients with recurrent HCV infection. This was a retrospective analysis of a single-center treatment protocol of patients with HCV genotype 1 infection who received a 12-week combination regimen of sofosbuvir and simeprevir. Sixty-one patients (35 with genotype 1a and 26 with genotype 1b) completed treatment with simeprevir and sofosbuvir. Three patients received additional ribavirin. Laboratory data and clinical assessments performed at the baseline, on treatment, at the end of treatment, and 12 weeks after the completion of antiviral therapy [sustained virological response at 12 weeks (SVR12)] were analyzed. The median time after LT was 5.4 years [interquartile range (IQR), 1.9-8.4 years], and tacrolimus was the most commonly used immunosuppressive agent (80.3%). Overall, SVR12 was achieved in 93.4% [95% confidence interval (CI), 84%-97%] of LT recipients treated with 12 weeks of sofosbuvir and simeprevir. When they were analyzed according to the HCV subtype, LT recipients with genotype 1b had a 100% SVR12 rate (95% CI, 87%-100%), whereas SVR12 was 89% (95% CI, 74%-95%) for those with genotype 1a. Advanced fibrosis (METAVIR F3-F4) was associated with diminished antiviral efficacy in LT recipients with genotype 1a [SVR12, 67% (95% CI, 39%-86%); P = 0.01]. Overall, the incidence of adverse events (AEs) was low, and no severe AEs occurred during treatment. In conclusion, treatment with a 12-week regimen of sofosbuvir and simeprevir was well tolerated and resulted in a high SVR12 rate for LT recipients with recurrent HCV genotype 1 infection. Genotype 1a patients with advanced fibrosis of the allograft were more likely to relapse. CI - (c) 2015 American Association for the Study of Liver Diseases. FAU - Gutierrez, Julio A AU - Gutierrez JA AD - Division of Hepatology, Miller School of Medicine, University of Miami, Miami, FL. AD - Texas Liver Institute, Health Science Center, University of Texas, San Antonio, TX. FAU - Carrion, Andres F AU - Carrion AF AD - Division of Hepatology, Miller School of Medicine, University of Miami, Miami, FL. FAU - Avalos, Danny AU - Avalos D AD - Division of Hepatology, Miller School of Medicine, University of Miami, Miami, FL. FAU - O'Brien, Christopher AU - O'Brien C AD - Division of Hepatology, Miller School of Medicine, University of Miami, Miami, FL. FAU - Martin, Paul AU - Martin P AD - Division of Hepatology, Miller School of Medicine, University of Miami, Miami, FL. FAU - Bhamidimarri, Kalyan Ram AU - Bhamidimarri KR AD - Division of Hepatology, Miller School of Medicine, University of Miami, Miami, FL. FAU - Peyton, Adam AU - Peyton A AD - Division of Hepatology, Miller School of Medicine, University of Miami, Miami, FL. LA - eng GR - T32 DK007202/DK/NIDDK NIH HHS/United States PT - Journal Article PT - Research Support, Non-U.S. Gov't PL - United States TA - Liver Transpl JT - Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society JID - 100909185 RN - 0 (Antiviral Agents) RN - 9WS5RD66HZ (Simeprevir) RN - WJ6CA3ZU8B (Sofosbuvir) SB - IM CIN - Liver Transpl. 2015 Oct;21(10):1327-9. PMID: 26123079 CIN - Liver Transpl. 2015 Oct;21(10):1330. PMID: 26271051 MH - Aged MH - Allografts/pathology MH - Antiviral Agents/*therapeutic use MH - Drug Therapy, Combination MH - Female MH - Fibrosis MH - Genotype MH - Hepacivirus/genetics MH - Hepatitis C/*drug therapy/virology MH - Humans MH - Liver/pathology MH - Liver Transplantation MH - Male MH - Middle Aged MH - Postoperative Complications/*drug therapy MH - Recurrence MH - Retrospective Studies MH - Simeprevir/*therapeutic use MH - Sofosbuvir/*therapeutic use PMC - PMC6658191 MID - NIHMS1041287 COIS- Conflicts of interest: Andres F. Carrion and Danny Avalos have no relevant conflicts of interest. Julio A. Gutierrez serves on scientific advisory boards or has received research grants from Gilead and AbbVie. He is a speaker for Janssen Therapeutics and AbbVie. Christopher O'Brien serves on scientific advisory boards and has received research grants from Gilead, Janssen Therapeutics, Bristol-Myers Squibb, and AbbVie. Paul Martin has received consulting fees and grant support from Gilead and Janssen Therapeutics. Kalyan Ram Bhamidimarri has received grant support from Bristol Myers-Squibb, AbbVie, Vital Therapies, Biotest Pharma, Ocera, Salix, and Synageva and serves on scientific advisory boards for Janssen Therapeutics, Gilead Sciences, Genentech, and AbbVie. Adam Peyton serves on scientific advisory boards for Janssen Therapeutics, Gilead Sciences, Bristol Myers-Squibb, Genentech, and AbbVie. EDAT- 2015/04/01 06:00 MHDA- 2016/03/19 06:00 PMCR- 2019/07/25 CRDT- 2015/04/01 06:00 PHST- 2014/12/18 00:00 [received] PHST- 2015/02/15 00:00 [revised] PHST- 2015/03/14 00:00 [accepted] PHST- 2015/04/01 06:00 [entrez] PHST- 2015/04/01 06:00 [pubmed] PHST- 2016/03/19 06:00 [medline] PHST- 2019/07/25 00:00 [pmc-release] AID - 10.1002/lt.24126 [doi] PST - ppublish SO - Liver Transpl. 2015 Jun;21(6):823-30. doi: 10.1002/lt.24126.