Table 1. Comparison of FDA-approved indications for hepatitis C antiviral agents1,16–18.
Sofosbuvir | Boceprevir | Simeprevir | Telaprevir | |
Brand name | Sovaldi | Victrelis | Olysio | Incivek |
Manufacturer | Gilead Sciences | Merck | Janssen | Vertex Pharmaceuticals |
Approval date | December 6, 2013 | May 13, 2011 | November 22, 2013 | May 23, 2011 |
Indication | Treatment of chronic hepatitis C as a component of a combination antiviral treatment regimen; efficacy established in subjects with HCV genotype 1, 2, 3, or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 coinfection | Chronic HCV genotype 1 infection in adult patients with compensated liver disease, including cirrhosis, who are treatment naive or who have failed previous therapy with interferon and ribavirin, including prior null responders, partial responders, and relapsers | Chronic HCV genotype 1 infection in adult patients with compensated liver disease, including cirrhosisa | Chronic HCV genotype 1 infection in adult patients with compensated liver disease, including cirrhosis, who are treatment naive or who have failed previous therapy with interferon-based treatment, including prior null responders, partial responders, and relapsers |
Note: HCV = hepatitis C virus; HIV = human immunodeficiency virus.
Simeprevir has been studied in treatment-naive patients and patients who have failed previous therapy with peginterferon and ribavirin, and the US Food and Drug Administration (FDA)-approved labeling contains dosing recommendations for patients who are treatment naive or who have failed previous therapy with interferon and ribavirin, including prior null responders, partial responders, and relapsers, although these populations are not specified in the indication.