Washington Blade - July 18, 2003
Ryan Lee

"I think its biggest attributes are its dosing and the side effects of this drug are very, very mild compared to almost anything else out there," said Emory scientist Dennis Liotta, who developed Emtriva along with Raymond Schinazi and Woo-Baeg Choi. "For the vast majority of patients, this is a very well tolerated drug."

Emtriva is a nucleoside reverse transcriptase inhibitor drug, meaning it prevents HIV from replicating itself inside infected cells. If untreated, HIV can reproduce itself inside cells to the point that it releases the virus to infect other parts of the body.

"By interfering with this process ... 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)," according to a press release from Gilead.

Long, bumpy road

When the U.S. Food & Drug Administration announced July 2 that it had approved Emtriva, it marked the pinnacle of a sometimes-difficult journey for the drug.

Liotta said he, Choi and Schinazi first began developing the drug around 1989, and began shopping Emtriva to different drug companies, hoping to take their new drug from their laboratory into clinical trials, and eventually into pharmacies.

In the middle of the 1990s, the pharmaceutical company Burroughs Wellcome tested Emtriva and eventually licensed it. As Burroughs began conducting clinical trials to determine the new drug's safety levels, the company was acquired by another drug company, Glaxo, in 1995.

At the time, Glaxo was already developing its own reverse transcriptase inhibitor, Epivir, and was not interested in continuing Emtriva's development, Liotta said. A group of former Burroughs virologists were dissatisfied after the merger with Glaxo, and decided to leave the company in favor of Triangle Pharmaceuticals, an upstart drug company headquartered in North Carolina.

In 1996, Triangle licensed Emtriva, filed a fresh investigational new drug application with the FDA and restarted clinical trials, Liotta said. After years of testing, Triangle applied for Emtriva's FDA approval last September, but was acquired by Gilead in the middle of January.

Gilead, based in Foster City, Calif., assumed responsibility for the remaining clinical trials, and received FDA approval July 2.

Convenience highlighted

Emtriva is being billed by Gilead and Liotta as an attractive alternative to current HIV-treatment regiments that require multiple drugs to be taken, multiple times per day.

"One of the biggest issues in combination therapies is compliance," Liotta said. "Patients on some triple or quadruple therapies can have huge pill burdens - eight, 10, 15 pills a day, some before you eat, some after you eat."

But Emtriva isn't a magic bullet for HIV, according to Mark Milano, an AIDS activist with ACT UP-New York.

"Emtriva is the ultimate me-too drug in that it is very similar to Epivir, and the people who have developed a resistance to Epivir won't be able to take it," he said.

Milano also said Emtriva may leave tell-tale marks on non-white users, including skin discoloration on hand palms and feet soles.

And although Emtriva is described as a once-daily, one-capsule treatment against HIV, it must be taken in combination with other drugs, otherwise the virus would mutate and develop a resistance to the medication.

To further reduce the number of pills HIV patients must take, Gilead is working to combine Emtriva with its other anti-HIV drug, Viread, to create a once-daily combination pill, Liotta said.

Gilead has set its wholesale price for Emtriva at $252.83 for a month's supply, which matches the price of a month's supply of Epivir to the penny. Spokespeople for both companies said the retail price for the two drugs varies greatly, and depends on where they are purchased.

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