Black Patients Fare Well on Vertex Hepatitis C Drug

In a Phase III study, Vertex Pharmaceutical Inc.'s experimental hepatitis C drug telaprevir boosted sustained viral response rates among black patients, suggest data presented to the 61st annual meeting of the American Association for the Study of Liver Diseases in Boston.

Among black patients taking telaprevir with standard treatment, 62 percent achieved a sustained viral response (SVR), compared with just 25 percent for those taking pegylated interferon and ribavirin alone. As previously reported, the SVR rate was 75 percent for all patients receiving telaprevir in combination with pegylated interferon and ribavirin, compared with 44 percent for those on standard treatment alone. The new data are important because of higher hepatitis C prevalence and lower SVR rates among African Americans.

"If you look at that treatment difference and then you look at the difference in the overall population, in fact the benefit relatively speaking is even greater," said Robert Kauffmann, Vertex's chief medical officer. "African Americans bear a large proportion of the burden of hepatitis C in the United States, compared with Caucasians and the overall population."

In a subgroup analysis, 62 percent of patients with advanced liver fibrosis or cirrhosis taking telaprevir achieved SVR, compared with 33 percent on standard therapy.

Another study showed 58 percent of telaprevir patients met criteria for a 24-week treatment. Criteria were undetectable viral levels in the blood at weeks four and 12. Another study showed no benefit from extending therapy to 48 weeks once these criteria were met.

Telaprevir and a similar treatment candidate being developed by Merck & Co. are generating excitement due to their comparatively better SVR rates in a shorter time than standard therapy alone. It is believed that thousands of people with hepatitis C are awaiting approval of these drugs before they initiate treatment.

Vertex plans to complete its application for telaprevir for Food and Drug Administration review this year. Many expect FDA approval to be granted in 2011.

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