FDA approves Gilead's HIV drug combo

FOSTER CITY, Calif., March 8 (UPI) -- Gilead Sciences said Wednesday it has been approved to market once-daily HIV drugs Truvada and Viread.

The company said the Food and Drug Administration has approved its once-daily anti-retroviral Viread and its fixed-dose drug Truvada, which are actually a combination of the company's already-marketed anti-retrovirals Emtriva and Viread in a single daily tablet.


"In the United States, Truvada is now the most-prescribed antiretroviral of its class and its use is quickly growing in the European Union, where it was more recently made available," said Kevin Young, Gilead's executive vice president of commercial operations.

"We look forward to continuing to generate and share important data from ongoing clinical studies to help further define the profile of our products for the medical community," he said.

The approval was based on the FDA's review of Gilead's 48-week "Study 934" of Viread, in which a combination of Viread and Emtriva was compared to Combivir.

The FDA's approval of the two treatments includes prescribing information reflecting data from Study 934 showing that 84 percent of patients in the Viread/Emtriva group achieved HIV RNA fewer than 400 copies/mL through week 48, compared to 73 percent of patients on Combivir.


But the apparent difference in effectiveness was due mainly to a higher number of discontinuations in the Combivir group due to adverse events -- 9 percent vs. 4 percent in the Viread/Emtriva group -- and other factors such as patient withdrawal and non-compliance, Gilead said.

The FDA approved Viread in October 2001, while Truvada was cleared in August 2004.

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