FDA approves HIV drug combo

Streamlines regimen for patients

By Michele Dula Baum
CNN.com Health and Food Writer

(CNN) -- Diagnosed as HIV-positive in 1997, Allen Schorejs of Houston, Texas, delayed treatment for two years because he feared the toxic side effects of many anti-retroviral drugs.

"Oh -- the horror stories that I heard from people I had known," he remembered. "I didn't want to take any pills."

Although Schorejs finally overcame his fear and began a two-drug regimen in the fall of 1999, the U.S. Food and Drug Administration made his road a bit easier Wednesday with the approval of a new therapy combining three well-known medications into one tablet.

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"It's just phenomenal," he said. "I just have to take a minute out of the day. I don't even have to think about it now."

Made by Glaxo Wellcome, the new therapy is being marketed as Trizivir. It combines the drugs abacavir, zidovudine and lamivudine, which are classed as nucleoside reverse transcriptase inhibitors. The three have already been approved by the FDA and have been in use for some years.

"Having people being able to combine all their medications into one pill twice a day is a huge step forward," said Dr. Peter Ruane, an infectious disease specialist in Los Angeles, California.

Some patients may be daunted by the prospect of taking a fistful of pills with varying requirements -- take with food, take with water only, take on an empty stomach, for instance. Others may find it financially prohibitive, the physician said. Using Trizivir reduces not only the amount of medication, but also diminishes the cost to one insurance co-payment a month.

The necessity of taking fewer pills also increases the chance that patients will comply with their drug regimen, Ruane said.

Cost is estimated at $26.60 a day, the same as the three drugs separately, according to Glaxo. Trizivir will be available next month by prescription.

Still, there are dangers associated with Trizivir. About 5 percent of people who try abacavir, marketed as Ziagen, suffer serious, sometimes fatal complications. Since Trizivir contains abacavir, people who try the combination will risk the same complications.

Fatigue, nausea, vomiting, labored breathing, fever and skin rash indicate hypersensitivity reaction to the drug, which can be life threatening. Any such symptoms should be reported to and monitored closely by a physician.

"Every drug used on HIV has got major, major problems associated with it, of a kind," said Ruane. "That's why, increasingly, HIV is becoming a specialist area."

While the Trizivir combination is the newest FDA-approved, anti-HIV medication, it is just one of a catalog of drugs now available. A new protease inhibitor -- the most-recommended class of new HIV drugs -- called Kaletra received accelerated approval from the FDA in September.

Kaletra is a combination of the protease inhibitors lopinavir and ritonavir. It is given twice daily as well, and has been deemed appropriate for use in children as young as 6 months.

Trizivir is only recommended for adults and teen-agers weighing more than 88 pounds (40 kilograms) because it is a fixed-dose drug.

"What the best strategy is varies from doctor to doctor and patient to patient," said Ruane. "For people who are in long-term (anti-HIV treatment), it makes a huge difference" to be able to take just two pills a day.

"A lot of people have a lot of shame," the physician continued. "They hide their pills from their co-workers and families. This makes it much easier to hide, and much easier to take."

Schorejs said his only difficulties after enrolling in a study on Trizivir this past June were two weeks of recurrent nausea, which eventually stopped.

"Now, my viral load has stayed undetectable and my T-cells have increased. My physician is amazed at how well it's doing for me," Schorejs said.

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Glaxo Wellcome Homepage
Journal of the American Medical Association: HIV/AIDS information
AIDS Internet Information Gateway
U.S. Food and Drug Administration

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