Hepatitis C-A third agent that acts directly against the virus has been approved

New HCV Drug Approved

Published: Nov 25, 2013

By Michael Smith, North American Correspondent, MedPage Today

 

A third agent that acts directly against hepatitis C (HCV) has been approved, according to the company that makes the drug.

But simeprevir (Olysio) -- an NS3/4A protease inhibitor intended to be used in combination with two standard HCV medications, pegylated interferon, and ribavirin -- is the first such agent that can be taken once a day, Janssen Therapeutics said in a release.

The other two protease inhibitors to win approval -- telaprevir (Incivek) and boceprevir (Victrelis) -- got the nod in 2011.

Simeprevir is approved for genotype 1 infected adults with compensated liver disease, including cirrhosis, the company release said. The move was expected, after an advisory board in October voted unanimously in favor of approval. The FDA usually follows such advice, although it is not obliged to do so.

The three protease inhibitors are the leading edge of a wave of so-called direct-acting agents, or DAAs, that target aspects of HCV replication. In contrast, ribavirin is a general anti-viral agent and interferon works by boosting the immune system.

Simeprevir, combined with interferon and ribavirin, yielded solid results in various patient groups, where cure was defined as undetectable virus 12 or 24 weeks after the end of therapy (SVR₁₂ or SVR₂₄):

• Among treatment-naive patients, 80% of those getting simeprevir, along with interferon and ribavirin, achieved SVR12, compared with 50% of those getting interferon and ribavirin plus a placebo.
• Among those who had relapsed after previous treatment with interferon and ribavirin, SVR₁₂ rates were 79% in the simeprevir group and 37% in the placebo group.
• Among patients who had only partly responded to previous therapy with interferon and ribavirin, simeprevir-based treatment led to undetectable virus 24 weeks after the end of treatment (SVR₂₄) in 65%, compared with 9% in the placebo group.
• And among patients who had not responded at all to previous treatment with interferon and ribavirin, 53% reached SVR₂₄ on simeprevir-based therapy, compared with 19% in the placebo group.

For both treatment-naive patients and those who had relapsed, the drug is recommended to be used for 12 weeks, combined with 24 weeks of interferon and ribavirin.

For those whose previous response was partial or null, a treatment regimen of 12 weeks, combined with 48 weeks of interferon and ribavirin, is recommended.

The efficacy of the drug is "greatly decreased" in patients whose virus has the so-called Q80K polymorphism in the protease gene, the company noted, urging that patients discuss the issue of testing for the variant with their doctors and choose a different therapy if Q80K is present.

Despite that limitation, the approval is "an important milestone," according to Douglas Dieterich, MD, of Mount Sinai School of Medicine in New York City, who was involved in the simeprevir clinical trials.

"It means that patients have a new treatment option with the potential to cure this challenging disease," he said in the release.

http://www.medpagetoday.com/Gastroenterology/Hepatitis/43101