Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
The Associated Press; Friday, September 18, 1998
Lauran Neergaard, AP Medical Writer
DuPont Pharmaceuticals' Sustiva appears about as effective as protease inhibitors, the landmark medicines that have helped thousands of HIV patients rebound from their disease.
But it still must be taken as part of the so-called AIDS cocktail, in combination with a protease inhibitor or, in patients who have failed protease inhibitors or can't tolerate their side effects, together with older AIDS medicines, the FDA cautioned.
Sustiva, known chemically as efavirenz, is not a new class of AIDS drugs. Its advance is that it has to be taken just once a day and seems to have milder side effects.
Until now, people taking AIDS cocktails had to swallow 20 to 40 pills on a precise schedule throughout the day, timing them carefully to take some with meals and some without. Missing even a few pills allowed the HIV virus to mutate and become more difficult to treat.
Substituting Sustiva into the AIDS cocktail could significantly cut the number of pills patients must swallow every day, to as low as five pills a day in some people.
The FDA approved Sustiva for both adults and children, important because child patients don't have as many therapy options as adults.
Sustiva's main side effects are dizziness, insomnia, impaired concentration, abnormal dreams and drowsiness. Therefore, patients should consider taking Sustiva at bedtime, the FDA said, and definitely avoid driving or operating machinery if they suffer the side effects. Unlike most AIDS drugs, these side effects usually disappear over time, the FDA said.
But occasionally, people can suffer delusions or severe depression, symptoms mostly seen in patients with a history of mental illness or substance abuse, and those patients should stop taking Sustiva, the agency said. The drug also can cause birth defects, so women must use effective contraception.
In one study, 450 HIV patients were given either Sustiva or the popular protease inhibitor Crixivan in addition to AZT and 3TC. After 24 weeks, 69 percent of the Sustiva patients had virus levels undetectable in lab tests, compared with 52 percent of Crixivan patients.
"Initial HIV therapy with Sustiva in a regimen that does not include a protease inhibitor, but achieves a high level of efficacy, provides a promising new option," said Dr. Paul Friedman, president of DuPont Pharmaceuticals Research Laboratories.
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