PMID- 27943544 OWN - NLM STAT- MEDLINE DCOM- 20170807 LR - 20170807 IS - 1399-3062 (Electronic) IS - 1398-2273 (Linking) VI - 19 IP - 1 DP - 2017 Feb TI - Treatment of hepatitis C virus recurrence after transplantation with sofosbuvir/ledipasvir: The role of ribavirin. LID - 10.1111/tid.12647 [doi] AB - BACKGROUND: Hepatitis C virus (HCV) recurrence after liver transplantation (LT) used to be a serious problem in the era of interferon-based treatment. Since the introduction of modern directly acting antivirals, treatment has become easier and shorter. According to published data, in the natural course of hepatitis C infection the duration of antiviral treatment with sofosbuvir (SOF) and ledipasvir (LDV) may be shortened to 12 instead of 24 weeks, using ribavirin (RBV) in addition. Furthermore, the question of whether or not RBV is really necessary, in a 12-week SOF/LDV treatment in the post-transplant setting, is still unanswered. PATIENTS AND METHODS: At our institution, 100 liver transplant patients with HCV recurrence underwent interferon-free SOF-based treatment. A total of 51 patients received SOF/LDV with or without RBV. Twenty-nine HCV genotype 1 or 4 patients with histologically proven stage 0-2 fibrosis were treated with SOF/LDV for 12 weeks; another 22 patients with advanced fibrosis (stage 3-4) either received SOF/LDV plus weight-adjusted RBV or prolonged treatment for 24 weeks. RESULTS: End of treatment response and sustained virological response (SVR) were achieved in 100% of the 51 patients, irrespective of the treatment group. Patients with prolonged treatment duration or with RBV developed significantly more adverse events (AEs) compared to the SOF/LDV group: 19 (86.4%) vs 8 (27.6%), P<.001. One of the predominant and most relevant AEs was the development of anemia in 43.1% of 10 patients receiving RBV, which was a significant result (P<.001). RBV co-medication had to be reduced in 11 (55%) patients and then stopped in 8 (40%) patients because of AEs. No significant difference was observed among the groups regarding kidney function. CONCLUSION: The SOF/LDV combination is a reliable therapy of recurrent HCV infection after LT. It is easy to administer and to achieve SVR in immunocompromised patients without interactions with immunosuppressive medications. Considering the high rate of AEs, frequent discontinuation of RBV treatment, and the 100% SVR, the use of RBV as co-medication in a 12-week SOF/LDV regimen does not seem to be justified after LT. CI - (c) 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. FAU - Globke, Brigitta AU - Globke B AD - General, Visceral and Transplant Surgery, Charite Campus Virchow, Berlin, Germany. FAU - Raschzok, Nathanael AU - Raschzok N AD - General, Visceral and Transplant Surgery, Charite Campus Virchow, Berlin, Germany. FAU - Teegen, Eva-Maria AU - Teegen EM AD - General, Visceral and Transplant Surgery, Charite Campus Virchow, Berlin, Germany. FAU - Pratschke, Johann AU - Pratschke J AD - General, Visceral and Transplant Surgery, Charite Campus Virchow, Berlin, Germany. AD - General, Visceral, Thoracic and Vascular Surgery, Charite Campus Mitte, Berlin, Germany. FAU - Schott, Eckart AU - Schott E AD - Gastroenterology and Hepatology, Charite Campus Virchow, Berlin, Germany. FAU - Eurich, Dennis AU - Eurich D AD - General, Visceral and Transplant Surgery, Charite Campus Virchow, Berlin, Germany. LA - eng PT - Comparative Study PT - Journal Article DEP - 20170111 PL - Denmark TA - Transpl Infect Dis JT - Transplant infectious disease : an official journal of the Transplantation Society JID - 100883688 RN - 0 (Antiviral Agents) RN - 0 (Benzimidazoles) RN - 0 (Fluorenes) RN - 0 (Immunosuppressive Agents) RN - 013TE6E4WV (ledipasvir) RN - 49717AWG6K (Ribavirin) RN - WJ6CA3ZU8B (Sofosbuvir) SB - IM MH - Aged MH - Antiviral Agents/pharmacology/*therapeutic use MH - Benzimidazoles/pharmacology/*therapeutic use MH - Drug Interactions MH - Drug Therapy, Combination MH - Female MH - Fluorenes/pharmacology/*therapeutic use MH - Hepacivirus/*drug effects/isolation & purification MH - Hepatitis C, Chronic/*drug therapy MH - Humans MH - Immunocompromised Host MH - Immunosuppressive Agents/pharmacology/therapeutic use MH - Liver Transplantation/*adverse effects MH - Male MH - Middle Aged MH - Recurrence MH - Retrospective Studies MH - Ribavirin/pharmacology/*therapeutic use MH - Sofosbuvir/pharmacology/*therapeutic use OTO - NOTNLM OT - DAAs OT - HCV recurrence OT - ledipasvir OT - liver transplantation OT - sofosbuvir EDAT- 2016/12/13 06:00 MHDA- 2017/08/08 06:00 CRDT- 2016/12/13 06:00 PHST- 2016/07/09 00:00 [received] PHST- 2016/08/27 00:00 [revised] PHST- 2016/09/12 00:00 [accepted] PHST- 2016/12/13 06:00 [pubmed] PHST- 2017/08/08 06:00 [medline] PHST- 2016/12/13 06:00 [entrez] AID - 10.1111/tid.12647 [doi] PST - ppublish SO - Transpl Infect Dis. 2017 Feb;19(1). doi: 10.1111/tid.12647. Epub 2017 Jan 11.