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.
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.
Authors: Sammy Saab; Justin Rheem; Melissa A Jimenez; Tiffany M Fong; Michelle H Mai; Caterina A Kachadoorian; Negin L Esmailzadeh; Sherona N Bau; Susan Kang; Samantha D Ramirez; Jonathan Grotts; Gina Choi; Francisco A Durazo; Mohammed M El-Kabany; Steven-Huy B Han; Ronald W Busuttil Journal: J Clin Transl Hepatol Date: 2017-05-14