An Interferon-Free HCV Regimen in Patients Needing Liver Transplantation

Atif Zaman, MD, MPH reviewing Curry MP et al. Gastroenterology 2015 Jan. Charlton M et al. Gastroenterology 2015 Jan. Aghemo A and Donato MF. Gastroenterology 2015 Jan.

A regimen of sofosbuvir and ribavirin was effective and safe in companion pilot studies involving patients with well-compensated cirrhosis.

In two recent industry-funded studies, investigators evaluated the safety and efficacy of sofosbuvir (400 mg daily) and ribavirin (1000–1200 mg daily) for treating hepatitis C virus (HCV) infection in patients needing liver transplantation.

In a phase II, open-label study, 61 patients with Child-Pugh scores ≤7 and hepatocellular carcinoma received up to 48 weeks of the sofosbuvir-ribavirin regimen before liver transplantation. The primary endpoint was HCV RNA <25 IU/mL at 12 weeks after liver transplantation (SVR12). Of the 43 patients who underwent liver transplantation and had HCV RNA <25 IU/mL at that time, 70% achieved SVR12. The likelihood of achieving SVR12 was higher in patients with HCV RNA <25 IU/mL for ≥30 days versus <30 days pretransplantation (95% vs. 36%), as calculated by editorialists.

In an open-label study of 40 patients (83% with HCV genotype 1, 40% with cirrhosis, 88% treatment-experienced) with compensated recurrent HCV infection post–liver transplantation, all patients received the sofosbuvir-ribavirin regimen for 24 weeks. Sustained virologic response at 12 weeks after treatment (primary endpoint) was achieved in 28 of 40 patients (70%). All treatment failure was due to relapse. The regimen was safe; the most common adverse events were fatigue, headache, and anemia.

Between both studies, four patients discontinued therapy prematurely (unrelated to the study drug), no drug interactions with immunosuppressant agents occurred, and no resistance was detected.

Citation(s):

Curry MP et al. Sofosbuvir and ribavirin prevent recurrence of HCV infection after liver transplantation: An open-label study. Gastroenterology 2015 Jan; 148:100.

Charlton M et al. Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation. Gastroenterology 2015 Jan; 148:108. 

Aghemo A and Donato MF.Sofosbuvir treatment in the pre and post liver transplantation phase: The sooner, the better. Gastroenterology 2015 Jan; 148:13.