The Institute for Clinical and Economic Review developed an evidence report, including a systematic review of the literature, a cost-effectiveness model, and a budget impact assessment, to support a public meeting of the California Technology Assessment Forum (CTAF) on December 18, 2014, on interferon-free therapy for chronic hepatitis C virus (HCV) infection.1
Fewer than 10% of the 3 to 4 million Americans infected with HCV have been treated because of the adverse effects and low response rate of therapy based on interferon and ribavirin.2,3 In late 2014, the Food and Drug Administration (FDA) approved the first 3 interferon-free combinations of direct-acting antiviral (DAA) agents for patients infected with HCV genotype 1. These included simeprevir plus sofosbuvir, ledipasvir plus sofosbuvir, and the combination of 3 DAAs: paritaprevir with ritonavir, ombitasvir, and dasabuvir. A fourth combination is currently approved in Europe but not in the United States: daclatasvir plus sofosbuvir. Sustained virologic response at 12 weeks (SVR12), defined as the absence of detectable HCV RNA 12 weeks following the completion of therapy, was the primary outcome in the pivotal clinical trials. There are no long-term data on the durability of response to the new therapies, but data from earlier treatments suggest that less than 1% to 2% of patients experience relapse following SVR24.4 In addition, SVR24 is associated with a reduction in fibrosis, progression to cirrhosis or hepatocellular carcinoma, and death from liver disease.4