Now patients have a new alternative. Assistant Professor of Medicine Karen Tashima recently led clinical trials of a new drug, Sustiva, that requires fewer doses, seems to have less-severe side effects, and actually works better than previous drugs. “We were surprised, and we were thrilled for the patients,” says Tashima, one author of a December New England Journal of Medicine article on the new drug
Sustiva works by blocking the enzyme HIV needs to reproduce. Tashima studied Sustiva when taken with two other drugs to form a so-called AIDS cocktail. Among the patients taking Sustiva, the virus fell to undetectable levels in 70 percent of patients compared to 48 percent of those on a protease inhibitor. Only 27 percent of Sustiva patients stopped treatment because of side effects, compared to 43 percent of others. A study conducted by other researchers suggests that Sustiva is also more effective in children.
The “huge advantage” of the new drug, Carpenter says, is its easy dosage regimen. In Tashima’s study, patients took three Sustiva capsules at bedtime and the rest of a seven-pill cocktail the next morning. Other patients took six to ten protease inhibitors in two or three doses, in addition to the rest of their medications.
Sustiva can cause dizziness, insomnia, and nightmares, but usually for no longer than a few weeks. Side effects of other drugs can last longer and take a greater toll; one of the most upsetting, Carpenter says, is a distortion in body-fat distribution that can leave patients with potbellies and legs on which the fat has wasted away.
New drugs like Sustiva are emerging from the lab so quickly that treatment guidelines are constantly in danger of lagging behind. When the International AIDS Society-USA guidelines panel that Carpenter chairs issued recommendations in 1998, it did not include Sustiva or other drugs that have emerged within the last year. In order to keep up, the panel was reconvened last year to draft new guidelines, which were published in the Journal of the American Medical Association in January.
The recommendations address new information on all kinds of AIDS therapies. Time has shown, for example, that while drugs can keep the virus in check, they cannot eradicate it. Since becoming virus-free is no longer the goal of these treatments, Carpenter says, patients’ care will not suffer if they move to less-potent treatments.
Doctors also now know that drugs can reverse HIV damage to the immune system. As a result, it’s sometimes acceptable to defer treatment until later in the progression of the disease. If a patient does not have any AIDS symptoms and is planning to be married, for instance, Carpenter says it is reasonable to wait until after the wedding to begin a Sustiva regimen.
The new guidelines suggest that doctors individualize HIV treatment. “If a patient does not feel part of the decision,” says Carpenter, “he becomes less likely to take the medications.” Carpenter treated a young electrician, for example, who opted against Sustiva because he was worried about being dizzy on the job. He instead chose a regimen of protease inhibitors, which can cause diarrhea.
The panel also concluded that doctors must keep a close eye on patients. “Even patients who take [the treatments] regularly for a while tend to trail off,” Carpenter says. “If people can stick to their regimens carefully, they can live very useful and reasonable lives.”