FDA Approves New Treatment for Chronic Hepatitis C

The FDA has announced in a news release that it has approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection.

Describing simeprevir as “a protease inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate” that is to be used as “a component of a combination antiviral treatment regimen,” along with peginterferon-alfa and ribavirin.

Simeprevir was reviewed under the FDA’s priority review program, which evaluated safety and efficacy data for the drug, including “five clinical studies of 2,026 treatment-naive and treatment-experienced participants” who were randomly assigned to receive a combination of simeprevir plus peginterferon-alfa and ribavirin or placebo plus peginterferon-alfa and ribavirin.

The studies “were designed to measure whether a participant’s hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response), suggesting a participant’s infection had been cured.”

In the studies, “80 percent of treatment-naive participants given Olysio plus peginterferon-alfa and ribavirin achieved sustained virologic response, compared to 50 percent of participants receiving peginterferon-alfa and ribavirin alone.”

The studies also showed that simeprevir was effective in improving response rates in treatment-experienced patients whose hepatitis C infection had returned (referred to as “prior relapsers”) and in treatment-experienced patients “who partially responded to prior therapy (partial responders) and those who did not respond to prior therapy (null responders).”

In the FDA news release, Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said simeprevir “is the third FDA-approved protease inhibitor to treat chronic hepatitis C virus infection, and provides health professionals and patients with a new, effective treatment for this serious disease.”

In a news release announcing the approval of simeprevir, Janssen Therapeutics, Division of Janssen Products, LP, noted the drug is to be used as part of combination antiretroviral therapy for the treatment of chronic hepatitis C “in genotype 1 infected adults with compensated liver disease, including cirrhosis.”

In clinical trials, simeprevir was found to be less effective in patients infected with the genotype 1a hepatitis C virus with an NS3 Q80K polymorphism. The FDA said that the simeprevir label will include “a recommendation to screen for the presence of the strain prior to beginning therapy and to consider alternative therapy if the strain is detected.”

In the Janssen news release, Douglas Dieterich, MD, Professor of Medicine in the Division of Liver Diseases, Mount Sinai School of Medicine, and an investigator in the clinical trials of simeprevir, said this medication “was studied in a number of different patient populations, including individuals who have relapsed or failed to respond to previous treatments,” and that its approval by the FDA “is an important milestone for people living with chronic hepatitis C as it means that patients have a new treatment option with the potential to cure this challenging disease.”

Based on these clinical trial results, treatment-naïve and prior-relapser patients are recommended to be treated with a fixed treatment regimen of 12 weeks of simeprevir, combined with 24 weeks of pegylated interferon and ribavirin. For prior partial- and null-responder patients, a treatment regimen of 12 weeks of simeprevir combined with 48 weeks of pegylated interferon and ribavirin is recommended.