FDA approves Emtriva

By Advocate.com Editors

Originally published on Advocate.com July 03 2003 12:00 AM ET

The Food and Drug Administration on Wednesday approved Emtriva (emtricitabine), formerly known as FTC, a new once-daily HIV nucleoside reverse transcriptase inhibitor developed by Gilead Sciences. The drug was approved for use in combination HIV antiretroviral therapy. The FDA based its approval on data from two 48-week clinical trials showing that the drug, when used as part of combination therapy, lowered blood-based viral levels and raised T-cell counts in both treatment-naive and treatment-experienced HIV-positive adults. Emtriva is indicated for adults ages 18 and older. Safety and effectiveness in pediatric patients have not been determined.

The recommended dose of the drug is one 200-milligram capsule daily, taken with or without food. Common side effects of the medication include headache, diarrhea, nausea, rash, and skin discoloration on the palms of the hands and soles of the feet. It is recommended that all patients with HIV be tested for hepatitis B infection before beginning Emtriva because some clinical trial participants coinfected with HIV and hepatitis B reported hepatitis flare-ups after discontinuing the medication.

Gilead officials say the drug will be available and shipped to wholesalers next week. The U.S. wholesale price of the medication is $252.83 for a one-month supply. Gilead officials say the company is now working to develop a single pill that combines Emtriva with its other once-a-day anti-HIV drug, the nucleotide reverse transcriptase inhibitor Viread, which received FDA approval in October 2001.