AIDSMAP , (05.16.2013)
Researchers, including Elizabeth Verna of Columbia University and others from the Consortium to Study Health Outcomes in Hepatitis C Virus (HCV) Liver Transplant Recipients (CRUSH-C) study evaluated triple therapy in liver transplant recipients at six US centers. The researchers reported on their study results at the 48th International Liver Congress in Amsterdam, the Netherlands, on April 24–28, 2013.
The research included 112 patients with HCV genotype 1 (55 percent with harder-to-treat subtype 1a). Of these, 80 percent were men, the majority were white, their median age was 58 years, and 26 percent had the favorable IL28B CC gene variant. Half of the patients had been treated previously with interferon-based therapy post-transplant, 25 percent were relapsers, 27 percent were partial responders, and 48 percent were null responders. Most had moderate-to severe fibrosis and all participants were being treated with immunosuppressive drugs to prevent organ rejection.
Triple therapy for HCV consisted of pegylated interferon, ribavirin, and either telaprevir or boceprevir. Median time from liver transplantation to the start of therapy was 3.7 years. At week 4 of treatment, 66 percent of patients had undetectable HCV RNA, which increased to 84 percent of patients at week 12. Altogether, 64 percent of patients had extended rapid virological response (eRVR). Of the 43 patients who completed therapy with at least 4 weeks of post treatment follow-up, 65 percent achieved sustained virological response (SVR) 4. Among those with eRVR, the SVR4 rate rose to 93 percent of patients. For patients with advanced disease, 44 percent achieved SVR4 compared with 71 percent without advanced disease. Adverse events were common and 11 percent discontinued treatment. One in five experienced serious adverse events requiring hospitalization, 4 percent experienced liver graft rejection, and 6 percent died during follow-up.
The researchers concluded that high eRVR rates can be achieved with triple therapy, exceeding previous rates with pegylated interferon/ribavirin alone, even with hard-to-treat patients. They acknowledged that SVR4 rates may be lower in patients with advanced disease, and that the results must be balanced against high rates of adverse events. They also noted that improving tolerability and identifying predictors of SVR are critical to optimizing the risks-benefits of post liver transplant triple therapy.
The full report, “ A Multicenter Study of Protease Inhibitor-Triple Therapy in HCV-Infected Liver Transplant Recipients; Report from the CRUSH-C Group,” was published online in the Journal of Hepatology (2013; doi:10.1016/S0168-8278(13)60025-2).