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Effectiveness of Ledipasvir/Sofosbuvir with/without Ribavarin in Liver Transplant Recipients with Hepatitis C
Sammy Saab1,2, Justin Rheem3, Melissa A Jimenez2
1Departments of Medicine at the University of California at Los Angeles, Los Angeles, California, USA.
Insights
Ledipasvir/sofosbuvir is an effective, interferon-free treatment for recurrent hepatitis C virus (HCV) infection post-liver transplant (LT). This therapy, with or without ribavirin, achieved a 94% sustained viral response, though anemia was noted with ribavirin use.
Area of Science:
- Hepatology
- Transplant Surgery
- Virology
Background:
- Recurrent hepatitis C virus (HCV) infection is a common complication after liver transplantation (LT), leading to significant patient morbidity and mortality.
- Effective and safe treatment options are crucial for managing post-LT HCV recurrence.
Purpose of the Study:
- To evaluate the safety and efficacy of ledipasvir/sofosbuvir, with or without ribavirin, for treating recurrent genotype 1 HCV in liver transplant recipients.
- To assess treatment outcomes, including viral suppression and sustained virologic response.
Main Methods:
- Retrospective evaluation of 85 liver transplant recipients treated for recurrent HCV genotype 1.
- Treatment regimens included ledipasvir/sofosbuvir for 12 or 24 weeks, with or without ribavirin.
- Safety assessed by drug cessation rates; efficacy measured by viral load and sustained virologic response (SVR).
Main Results:
- High rates of viral suppression were observed, with 81% achieving undetectable viral levels at 4 weeks and 100% by end of therapy.
- A 94% sustained virologic response (SVR) at 12 weeks post-therapy was achieved.
- No patients discontinued ledipasvir/sofosbuvir; 5 of 43 (11.6%) on ribavirin ceased treatment due to side effects, primarily anemia.
Conclusions:
- Ledipasvir/sofosbuvir, with or without ribavirin, represents an effective and well-tolerated interferon-free treatment for recurrent HCV post-liver transplant.
- Anemia is a notable side effect in liver transplant recipients treated with ribavirin.
- This regimen offers a promising therapeutic strategy for a challenging clinical scenario.
Abstract:
Recurrent infection of hepatitis C virus (HCV) in liver transplant (LT) recipients is universal and associated with significant morbidity and mortality. We retrospectively evaluated the safety and efficacy of ledipasvir/sofosbuvir with and without ribavirin in LT recipients with recurrent genotype 1 hepatitis C. Eighty-five LT recipients were treated for recurrent HCV with ledipasvir/sofosbuvirwith and without ribavirin for 12 or 24 weeks. The mean (± standard deviation [SD]) time from LT to treatment initiation was 68 (±71) months. The mean (± SD) age of the cohort was 63 (±8.6) years old. Most recipients were male (70%). Baseline alanine transaminase, total bilirubin, and HCV ribonucleic acid (RNA) values (± SD) were 76.8 (±126) mg/dL, 0.8 (±1.3) U/L, and 8,010,421.9 (±12,420,985) IU/mL, respectively. Five of 43 recipients who were treated with ribavirin required drug cessation due to side effects, with 4 of those being anemia complications. No recipient discontinued the ledipasvir/sofosbuvir. Eighty-one percent of recipients had undetectable viral levels at 4 weeks after starting therapy, and all recipients had complete viral suppression at the end of therapy. The sustained viral response at 12 weeks after completion of therapy was 94%. : Ledipasvir and sofosbuvir with and without ribavirin therapy is an effective and well-tolerated interferon-free treatment for recurrent HCV infection after LT. Anemia is not uncommon in LT recipients receiving ribavirin.
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