Hepatic decompensation/serious adverse events in post-liver transplantation recipients on sofosbuvir for recurrent hepatitis C virus

Neal Patel, Kian Bichoupan, Lawrence Ku, Rachana Yalamanchili, Alyson Harty, Donald Gardenier, Michel Ng, David Motamed, Viktoriya Khaitova, Nancy Bach, Charissa Chang, Priya Grewal, Meena Bansal, Ritu Agarwal, Lawrence Liu, Gene Im, Jennifer Leong, Leona Kim-Schluger, Joseph Odin, Jawad AhmadScott Friedman, Douglas DIeterich, Thomas Schiano, Ponni Perumalswami, Andrea Branch

Research output: Contribution to journalArticlepeer-review

4 Scopus citations


AIM: To determine the safety profile of new hepatitis C virus (HCV) treatments in liver transplant (LT) recipients with recurrent HCV infection. METHODS: Forty-two patients were identified with recurrent HCV infection that underwent LT at least 12 mo prior to initiating treatment with a Sofosbuvir-based regimen during December 2013-June 2014. Cases were patients who experienced hepatic decompensation and/or serious adverse events (SAE) during or within one month of completing treatment. Controls had no evidence of hepatic decompensation and/or SAE. HIVinfected patients were excluded. Cumulative incidence of decompensation/SAE was calculated using the Kaplan Meier method. Exact logistic regression analysis was used to identify factors associated with the composite outcome. RESULTS: Median age of the 42 patients was 60 years [Interquartile Range (IQR): 56-65 years], 33% (14/42) were female, 21% (9/42) were Hispanic, and 9% (4/42) were Black. The median time from transplant to treatment initiation was 5.4 years (IQR: 2.1-8.8 years). Thirteen patients experienced one or more episodes of hepatic decompensation and/or SAE. Anemia requiring transfusion, the most common event, occurred in 62% (8/13) patients, while 54% (7/13) decompensated. The cumulative incidence of hepatic decompensation/SAE was 31% (95%CI: 16%-41%). Risk factors for decompensation/SAE included lower pre-treatment hemoglobin (OR = 0.61 per g/dL, 95%CI: 0.40-0.88, P < 0.01), estimated glomerular filtration rate (OR = 0.95 per mL/min per 1.73 m2, 95%CI: 0.90-0.99, P = 0.01), and higher baseline serum total bilirubin (OR = 2.43 per mg/dL, 95%CI: 1.17-8.65, P < 0.01). The sustained virological response rate for the cohort of 42 patients was 45%, while it was 31% for cases. CONCLUSION: Sofosbuvir/ribavirin will continue to be used in the post-transplant population, incluDing those with HCV genotypes 2 and 3. Management of anemia remains an important clinical challenge.

Original languageEnglish
Pages (from-to)2844-2854
Number of pages11
JournalWorld Journal of Gastroenterology
Issue number9
StatePublished - 7 Mar 2016


  • Anemia
  • Hepatic decompensation
  • Hepatitis C virus
  • Liver transplant
  • Ribavirin
  • Serious adverse event
  • Sofosbuvir


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