FDA Approve Telaprevir (Incivek) to Treat Hepatitis C

On 23 May 2011, the FDA approved telaprevir (Incivek) to be used in combination with peginterferon alfa and ribavirin to treat hepatitis C genotype 1. Telaprevir is the second direct acting antiviral drug against the hepatitis C virus to be approved.

Telaprevir is indicated in adult patients with compensated liver disease, including cirrhosis, who are treatment-naive (patients who have not received interferon-based drug therapy for their infection) or who have previously been treated with interferon-based treatment and not responded adequately, including prior null responders, partial responders, and relapsers.

The approval of telaprevir is based on safety and efficacy data in approximately 2250 adult subjects who were previously untreated (ADVANCE and ILLUMINATE) or who had failed previous peginterferon alfa and ribavirin therapy (REALIZE) in clinical studies.

The following points should be considered when initiating treatment with telaprevir:

• Telaprevir must not be administered as monotherapy and must only be prescribed with both peginterferon alfa and ribavirin.
• A high proportion of previous null responders (particularly those with cirrhosis) did not achieve a Sustained Virologic Response (SVR) and had telaprevir resistance-associated substitutions emerge on treatment with telaprevir combination treatment.
• Telaprevir efficacy has not been established for patients who have previously failed therapy with a treatment regimen that includes telaprevir or other HCV NS3/4A protease inhibitors

Source: FDA listserve (23 May 2011).

For full prescribing details se the product lable at:

www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf (PDF download)

Links to external websites are current at time of posting but not maintained.