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Sofosbuvir, ribavirin prevented HCV recurrence after transplantation

In a prospective, open-label pilot study, a sofosbuvir and ribavirin regimen was safe and effective in treating recurrent hepatitis C virus infection after liver transplantation.

“A well-tolerated and effective treatment protocol for recurrence of HCV infection following liver transplantation is an important unmet clinical need,” researcher Michael R. Charlton, MD, of the Mayo Foundation in Rochester, Minn., said in a press release. “Our study demonstrates that patients with characteristics that have historically been difficult to cure with interferon-based regimens, including those with advanced disease, may benefit from this all-oral interferon-free therapy.”

Michael R. Charlton

Charlton and colleagues enrolled 40 patients with compensated recurrent HCV infection and dosed them with 400 mg sofosbuvir (Sovaldi, Gilead Sciences) and 400 mg ribavirin per day for 24 weeks. Ribavirin doses were adjusted during the 24 weeks based on creatinine clearance and hemoglobin values, according to the research. Of all the patients, 78% were men, 85% were white, 83% had HCV genotype 1, 88% were previously treated with interferon and 40% had cirrhosis proven by liver biopsy.

Twenty-eight patients achieved a sustained virologic response after 12 weeks of therapy. Twelve patients experienced relapse after the end of therapy. Overall, viral resistance during or after therapy was not detectable in any of the patients. All 40 patients had HCV RNA plasma concentration levels below the lower limit of quantification (LLOQ) at 4 weeks of therapy; all patients who achieved SVR12 maintained HCV RNA concentrations below the LLOQ after 24 weeks of therapy.

Common adverse events were fatigue (30%), diarrhea (28%), headache (25%) and anemia (20%). Two patients discontinued therapy due to adverse events. However, no deaths, graft losses or rejection occurred, according to the research. Six patients experienced serious adverse events, such as pneumonia and hepatocellular carcinoma, but were unrelated to the therapy.

“Treatment with the all-oral regimen of sofosbuvir and ribavirin for 24 weeks resulted in a SVR rate of 70% among patients who experienced recurrence of HCV infection after liver transplantation,” the researchers concluded. “This population, which included a high proportion of patients with characteristics that have historically been difficult to cure with interferon-based regimens — HCV genotype 1, prior treatment experience, advanced fibrosis and cirrhosis and concurrent immunosuppression — may benefit from this all-oral therapy.”        

Disclosure: The trial was funded by Gilead Sciences. Charlton reports receiving grant and research support from Gilead, Janssen, Merck and Novartis, and he is a consultant for AbbVie, Bristol-Myers Squibb, Gilead, Janssen and Sanofi-Aventis. See the study for a full list of relevant financial disclosures of the other researchers.