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Telaprevir (Incivek) Approved for Hepatitis C

SUMMARY
On May 23 the U.S. FDA approved Vertex's HCV protease inhibitor telaprevir (brand name Incivek), the second direct-acting hepatitis C drug launched this month.

By Liz Highleyman

INCIVEK (750 mg) is given as two 375-mg tablets three times daily for 12 weeks.

The advent of direct-acting antiviral agents that target different steps of the hepatitis C virus (HCV) lifecycle will revolutionize hepatitis C treatment. Current standard therapy -- pegylated interferon plus ribavirin -- works by stimulating the immune response rather than directly attacking the virus.

In late April both telaprevir and Merck's boceprevir were unanimously recommended for approval by the Food and Drug Administration's Antiviral Drugs Advisory Committee.

Telaprevir was approved for use by adult chronic hepatitis C patients with HCV genotype 1 and compensated liver disease; the indication includes both treatment-naive individuals and prior non-responders or relapsers. It has not yet been approved for HIV positive people, though recently reported data show that it improves response rates in HIV/HCV coinfected patients.

The standard oral dose is 750 mg 3-times-daily with food. Telaprevir should be taken for the first 12 weeks in combination with pegylated interferon (Pegasys or PegIntron) plus ribavirin; telaprevir is then stopped while pegylated interferon/ribavirin are continued. Most people with good early response to the triple combination can stop all treatment at week 24, while others continue pegylated interferon/ribavirin through week 48.

The pivotal ADVANCE, ILLUMINATE, and REALIZE trials showed that adding telaprevir produced higher sustained virological response (SVR) rates than standard therapy alone. People who achieve SVR -- generally considered a cure -- reduce their risk of developing liver cirrhosis and hepatocellular carcinoma.

For treatment-naive genotype 1 patients, SVR rates approached 80% with telaprevir triple therapy, compared with less than 50% for initial standard therapy; furthermore, most were able to shorten treatment from 48 to 24 weeks.

In the REALIZE trial, the likelihood of SVR for genotype 1 non-responders ranged from 86% for prior relapsers (versus 22% with a second course of standard therapy alone) to 32% for prior "null responders" who experienced no significant reduction in HCV viral load with previous therapy.

Telaprevir was generally well-tolerated in studies to date, but about half of patients developed skin rash or itching, including a small number with severe skin reactions such as Stevens-Johnson Syndrome. Adding telaprevir to standard therapy also increases the risk of developing anemia.

"With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition," said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research. "The availability of new therapies that significantly increase responses while potentially decreasing the overall duration of treatment is a major step forward in the battle against chronic hepatitis C infection."

Vertex is expected to begin shipping telaprevir by the end of the month. The company has put in place a financial assistance and patient support program to help people with limited resources gain access to telaprevir.

"Hepatitis C can lead to liver failure, cancer and the need for a transplant, and for the past decade, the best we could offer patients was a year of difficult treatment that resulted in a viral cure for fewer than half of them," said Phase 3 principal investigator Ira Jacobson, MD, from Weill Cornell Medical College in a press release issued by Vertex. "With Incivek, 79 percent of people new to treatment achieved a viral cure."

Vertex's news release, including findings from Phase 3 trials, important safety information, and patient assistance information, is available online at http://investors.vrtx.com/releasedetail.cfm?ReleaseID=580154.

Full Incivek Prescribing Information is available at http://www.incivek.com.

Incivek label information is also available from the FDA at http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201917lbl.pdf.

5/24/11

Sources

U.S. Food and Drug Administration. FDA Approves Incivek for Hepatitis C. Press release. May 23, 2011.

R Klein and K Struble (FDA). Approval of Incivek (telaprevir), a direct acting antiviral drug to treat hepatitis C virus (HCV). FDA Hepatitis Update. May 23, 2011.

Vertex. FDA Approves Incivek (telaprevir) for People with Hepatitis C. Press release. May 23, 2011.




 




 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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