Benefit-risk assessment of new and emerging treatments for hepatitis C: focus on simeprevir and sofosbuvir.

Greater understanding of the hepatitis C virus (HCV) genome and life cycle of the HCV virion allows for new targets for therapy that directly act on the viral machinery to inhibit replication. Numerous direct-acting antivirals are in development, and four have been brought to market. Simeprevir, a second-generation protease inhibitor, has been approved for HCV genotype 1 patients in combination with pegylated interferon-α and ribavirin. Sofosbuvir, a novel nucleotide analog, has pangenotypic coverage and has been approved for HCV genotype 1 patients with ribavirin and pegylated interferon-α. For HCV genotypes 2 and 3, an all-oral regimen of sofosbuvir with ribavirin has become the new gold standard for treatment. The efficacy and safety for these two novel therapies among various subpopulations of those infected with chronic hepatitis C are discussed in the following review. In addition, off-label and future therapeutic regimens are addressed, as well as the concerns about cost of current and future therapies.