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Sofosbuvir plus simeprevir treatment of recurrent genotype 1 hepatitis C after liver transplant
Carmi Santos Punzalan1, Curtis Barry1, Isabel Zacharias1
1Division of Gastroenterology, Department of Medicine, University of Massachusetts Medical Center, Worcester, MA, USA.
Insights
Sofosbuvir and simeprevir offer a safe and effective oral treatment for recurrent hepatitis C (HCV) genotype 1 infection in liver transplant patients, achieving high sustained virologic response rates.
Area of Science:
- Hepatology
- Virology
- Transplant Medicine
Background:
- Recurrent hepatitis C (HCV) post-liver transplant presents treatment challenges.
- Previous studies showed sofosbuvir/simeprevir efficacy in non-transplant HCV genotype 1.
- This study evaluated this regimen in post-transplant HCV genotype 1.
Purpose of the Study:
- To assess the efficacy and tolerability of sofosbuvir plus simeprevir in liver transplant recipients with recurrent HCV genotype 1.
- To determine the sustained virologic response rate 12 weeks post-treatment.
Main Methods:
- Prospective, observational study design.
- 12-week daily regimen of sofosbuvir (400 mg) and simeprevir (150 mg) without ribavirin.
- Primary endpoint: sustained virologic response at 12 weeks post-therapy.
Main Results:
- 95% of patients achieved undetectable hepatitis C 12 weeks after treatment completion.
- 100% viral undetectability at the end of the 12-week treatment course.
- The regimen was well-tolerated, with 26% starting treatment within 6 months post-transplant and 19% having cirrhosis.
Conclusions:
- Sofosbuvir plus simeprevir is an effective oral treatment for genotype 1 HCV post-liver transplant.
- The regimen demonstrates good tolerability in this patient population.
- This combination offers a valuable therapeutic option for recurrent HCV in liver transplant recipients.
Background:
Patients with recurrent hepatitis C (HCV) infection post-liver transplant can be difficult to treat safely and effectively. A prior (COSMOS) study in patients with non-transplant HCV, using sofosbuvir plus simeprevir, had high efficacy and tolerability in treating patients with HCV genotype 1, even prior non-responders to interferon therapy and those with cirrhosis. Our aim was to evaluate the efficacy of sofosbuvir and simeprevir in patients with genotype 1 HCV post-liver transplant.
Methods:
In this prospective, observational study, patients received sofosbuvir 400 mg plus simeprevir 150 mg daily for 12 wk without ribavirin. The primary end point was a sustained virologic response 12 wk after the end of therapy.
Results:
Forty-two patients completed the treatment. Twenty-six percent started the treatment ≤ 6 months post-liver transplant. Nineteen percent of the included patients had cirrhosis, 14% with decompensation. At week 4 on the treatment, 21% of patients had detectable virus but at the end of the treatment, 100% were undetectable. Twelve weeks after the end of the treatment, 95% of the patients had undetectable hepatitis C. The regimen was generally well tolerated.
Conclusion:
The oral regimen of sofosbuvir plus simeprevir without ribavirin is efficacious and well tolerated in the treatment of patients with genotype 1 hepatitis C post-liver transplant.
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