The first study1, a Phase 2, open-label study, found that combination therapy with sofosbuvir and ribavirin for up to 48 weeks before liver transplantation can prevent recurrence of HCV infection post-transplantation in 70 percent of patients. This study provides proof of concept that successful interferon-free treatment prior to liver removal can eliminate the disease in most patients.
“Patients with hepatitis C virus at the time of liver transplantation universally experience recurrent HCV infection,” said lead study author Michael P. Curry, MD, from Beth Israel Deaconess Medical Center, Boston, MA. “Recurrent HCV infection follows an aggressive course. Given the burden of disease — the increased morbidity, mortality and costs — and the lack of a safe and broadly effective treatment to prevent recurrence of HCV infection, these results provide hope for patients in need.”
The second study2 was a prospective, multi-center, open-label pilot study, consisting of patients with recurrent HCV infection after a primary or secondary liver transplant. Patients received an all-oral regimen of sofosbuvir and ribavirin for 24 weeks, which resulted in sustained virologic response, with no detectable virus, in 70 percent of patients. This rate is similar to that achieved in clinical trials using the same dose and duration of sofosbuvir and ribavirin in the nontransplant setting.
“A well tolerated and effective treatment protocol for recurrence of HCV infection following liver transplantation is an important unmet clinical need,” said lead study author Michael R. Charlton, MD, Mayo Foundation, Rochester, MN. “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.”
In both studies, the rate of discontinuation due to adverse events was low.
Liver disease secondary to HCV infection is, by far, the most common indication for liver transplantation in the U.S. and is also the most common reason for transplanted livers to fail. Learn more about HCV in the AGA patient brochure.
Both trials were funded by Gilead Sciences, Inc.
1 Curry, M.P., et al. Sofosbuvir and Ribavirin Prevent Recurrence of HCV Infection after Liver Transplantation: An Open-Label Study, Gastroenterology, Volume 148(1): 100-107.e1
2 Charlton, M.R., et al., Sofosbuvir and Ribavirin for Treatment of Recurrent Hepatitis C Virus Infection After Liver Transplantation, Gastroenterology, Volume 148(1): 108-117
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