Multicenter experience using Ledipasvir/Sofosbuvir ± RBV to treat HCV GT 1 relapsers after simeprevir and sofosbuvir treatment

Bashar Aqel, Michael Leise, Hugo E. Vargas, Kymberly D. Watt, Andrew P. Keaveny, Nan Zhang, Surakit Pungpapong

Research output: Contribution to journalArticlepeer-review

2 Scopus citations


Introduction and aim. Approximately 10%-15% of patients with hepatitis C genotype 1 (HCV GT1) experience virological relapse after all-oral antiviral regimen using simeprevir (SMV) and sofosbuvir (SOF). The efficacy and safety of treating such relapsers using ledipasvir/sofosbuvir (LDV/SOF) with/without ribavirin (RBV) has been limited. Objective. Report the virological response and safety of LDV/SOF with/without RBV for 12-24 weeks in treating HCV GT1 relapsers after SMV + SOF. Material and methods. Patients treated with standardized clinical protocol utilizing LDV/SOF with/without RBV at three transplant centers were retrospectively reviewed. Results. Forty-five patients (29% post-LT, 82% male, 13% non-white, 73% subtype 1a, 86% IL28B CT/ TT, 78% F3-4) started LDV/SOF with/without RBV at a median of 22 weeks (range 7-55 weeks) after the last dose of SMV+SOF treatment. Thirty-seven patients received LDV/SOF for 24 weeks (24/37 patients with RBV) and eight patients received LDV/SOF for 12 weeks (5/8 patients with RBV). RBV dose was adjusted for renal function. Sixteen patients who were RBV-ineligible received LDV/SOF without RBV for 12 or 24 weeks. SVR 12 was achieved in 96% (43/45) of patients. Baseline viral load, RBV use, or GT1 subtype did not impact SVR 12. Minimal adverse events were reported in those without RBV; 45% of patients who received RBV developed significant anemia requiring RBV dose reduction and/or discontinuation. In LT recipients, minimal immunosuppression dose adjustments were required and no biopsy-proven acute rejection occurred. Conclusions. Treatment with LDV/SOF with/without RBV for 12-24 weeks was very well tolerated and resulted in high SVR 12 rates (96%) in HCV GT1 relapsers to SMV + SOF treatment.

Original languageEnglish (US)
Pages (from-to)815-821
Number of pages7
JournalAnnals of hepatology
Issue number5
StatePublished - Sep 1 2018


  • Direct acting antiviral agents (DAA)
  • Hepatitis C
  • Ledipasvir
  • Relapser
  • Simeprevir
  • Sofosbuvir

ASJC Scopus subject areas

  • Hepatology


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