Once A Day AIDS Drug Approved

Sat. July 5, 2003 12:00 AM by 365gay.com

Los Angeles, California - AIDS drug Emtriva Wednesday was approved by the US Food and Drug Administration. The drug, developed by a small California pharmaceutical company, will be available next week when the firm begins shipping it to suppliers across the country.

The once a day capsule is similar to GlaxoSmithKline's Epivir or 3TC, now one of the mainstays in the treatment of HIV. Both medications are used in combination with other drugs in so-called cocktails that have turned HIV infection into a more manageable disease for many of the estimated 1 million Americans now infected.

Emtriva will not be cheap. Gilead Sciences, which developed the new drug said it will charge wholesalers about $253 for 30 pills -- or close to $3,100 for a year's supply. That's somewhat less than the $3,700 list price for a year's supply of Epivir from GlaxoSmithKline.

The drug has been tested on more than 2,000 patients -- some for up to four years. Like other AIDS medications, side effects include headache, diarrhea, nausea and rash.

The FDA has required a warning that the drug, like others in its class, could cause severe, even fatal blood and liver disorders. And some patients had flare-ups of hepatitis B infections when they stopped taking Emtriva.

Nevertheless, one man who participated in the trials, Kevin Roland, a 35-year-old computer networks analyst from Seattle hailed the simplicity of the regimen and the relatively few side effects.

Roland says that when the study ended, two years ago, he was forced onto another drug regimen. He has done well: the virus can't be detected in his blood, and his immune system is back to healthy levels. Still, he intends to switch back to Emtriva.

He said that after the first three weeks of treatment that included Emtriva, side effects like nausea and fatigue seemed to vanish. And he liked the convenience.

"Compliance is the key to keeping the virus suppressed," he said. "The more times a day you have to take a drug, the more you're apt to miss a dose."

Gilead Sciences says it is now developing an even simpler medication, that would combine Emtriva with its best-selling AIDS drug, Viread. The combination drug could reach the market by early 2005 and compete with a twice-a-day pill from GlaxoSmithKline called Combivir.

by Mary Ellen Peterson
365Gay.com Newscenter
Los Angeles Bureau
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This article originally appeared on 365gay.com. Republished with permission.