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New HIV Drug Leads the Pack

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WebMD Health News

Dec. 15, 1999 (Atlanta) -- A new drug for HIV disease is changing HIV treatment.

Until now, the most effective of the so-called drug cocktails designed to keep HIV in check have contained a class of drugs called protease inhibitors. But now a member of a new class of drugs -- the non-nucleoside reverse-transcriptase inhibitors, or NNRTIs -- appears to work better and be easier to take.

The new NNRTI is Sustiva, also known as efavirenz. The first of two studies published in TheNew England Journal of Medicine showed that the drug works better than the protease inhibitor Crixivan (indinavir) when used in combination with two established HIV drugs (AZT [zidovudine] and 3TC [lamivudine]).

The second study shows that children as young as 4 years old respond very well to a cocktail of Sustiva, the protease inhibitor Viracept (nelfinavir), and at least one drug in the same class as AZT.

"We are really very pleased with the long-term viral suppression," Stuart E. Starr, MD, lead author of the pediatric study, tells WebMD. "The take-home lesson is that this is a very potent combination of antiretroviral agents."

These findings mean that drug combinations including Sustiva are likely to become the first-line standard of care for both adult and pediatric patients with early HIV infection.

The published findings show that the Sustiva combinations maintain their effect for 48 weeks. But in interviews with WebMD, co-authors of both studies say that among study participants whose HIV viral loads became undetectable while on combination therapy including Sustiva -- 63% of children and 70% of adults -- virtually all maintained undetectable viral loads for up to 88 weeks.

Both studies enrolled patients with relatively early HIV disease with limited previous exposure to medications. The adults had never received any NNRTI, any protease inhibitor, or 3TC. Children had never received an NNRTI or protease inhibitor.

Long-term therapy with protease inhibitors is known to cause problems with fat metabolism -- often leading to changes in physical appearance -- and symptoms such as nausea and diarrhea.

Douglas Manion, MD, medical director of DuPont Pharmaceuticals and co-author of the adult study, was even more enthusiastic about the results. DuPont manufactures Sustiva. The firm wholly funded the adult study and partially funded the pediatric study (conducted with the National Institutes of Health).

"Efavirenz in adults has surpassed the current standard of care with protease inhibitors by 50% and the current standard in children by 100%," Manion says. "Anyone who has responded through one year succeeded through the second year. There are basically no [treatment] failures through the second year."

Jeffrey Lennox, MD, agrees. "I've seen the study results presented," he tells WebMD. "I think people feel the study was well done." He and his colleagues already are using Sustiva as a first-line therapy for appropriate patients. "Generally, efavirenz is a good choice for most patients, but you have to individualize treatment based on their own needs and treatment history," says Lennox, who is the medical director of the Emory University infectious disease program at Atlanta's Grady Memorial Hospital. "We've started quite a few of our children on efavirenz, and one of the main reasons is it comes in a liquid formulation that children find tolerable. [The protease inhibitor] ritonavir has a liquid formulation that's very potent, but you can't get kids to take it."

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