August 4, 2003

FDA approves anit-HIV drug invented by Emory researchers

By Holly Korschun

A one-capsule, once-daily medication discovered at Emory for the treatment of HIV has been approved by the U. S. Food and Drug Administration (FDA) for commercial use.

Emtriva (emtricitabine), as the medication will be known, is in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs). It inhibits reverse transcriptase, the enzyme that copies HIV RNA into new viral DNA. By interfering with this process, which is a key to the replication of HIV, Emtriva can help to lower the amount of HIV, or “viral load,” in a patient’s body and increase the number of immune system cells called T-cells or CD4 cells. These immune-system effects are associated with improved health and decreased likelihood of AIDS-related illnesses.

Emtriva was invented by Emory scientists Raymond Schinazi, professor of pediatrics and senior research scientist at the VA Medical Center; Dennis Liotta, professor of chemistry, and Woo-Baeg Choi, president of FOB Synthesis, a drug discovery company located at the Emtech Center on the Briarcliff campus.

“We are extremely proud of our scientists and their many years of research dedicated to developing effective therapies for patients with HIV,” said Frank Stout, vice president for research. “The approval of Emtriva marks an exciting and positive development for thousands of patients.”

Unlike many other anti-HIV drugs, Emtriva is taken only once a day as a 200 mg capsule. It is indicated for the treatment of HIV in adults in combination with other antiretroviral drugs, and its once-a-day dosing could make it easier for patients to keep up with complex multidrug regimens.

Emtriva was evaluated in Phase I, II and III clinical trials in more than 2,000 patients who have been treated with other HIV drugs as well as patients who have not yet been treated, and was shown to effectively suppress HIV replication when used in combination with other antiretroviral medications.

Emory scientists have been at the forefront of research in HIV and AIDS and pioneering drug discovery for nearly 20 years. Emory scientists are responsible for the discovery of a number of drugs now commonly used to treat HIV.

The Emory Center for AIDS Research includes more than 100 scientists throughout the University studying HIV prevention and treatment, and the Emory Vaccine Center is home to one of the largest university vaccine centers in the world and a renowned program in HIV vaccine research.

The drug will be marketed and distributed by Gilead Sciences. Emtriva was originally licensed from Emory in 1996 by Triangle Pharmaceuticals, which was later acquired by Gilead.