PROVIDENCE, R.I. - Protease inhibitors - the backbone ingredient of the potent triple therapy drug regimen - may not be performing as well in practice as they did in clinical trials, and some patients who could benefit from them may not be receiving them, according to three studies about access, adherence and tolerance of the potent drugs in 254 patients being treated at five urban sites in Boston and Rhode Island.
In one study, about 40 percent of 151 patients who tried one or more of the four available protease inhibitors eventually discontinued the drug. The most common reason patients gave was gastrointestinal and systemic side effects, followed by treatment failure, says lead author Valerie Stone, M.D., director of the Hope Center for HIV Care at Memorial Hospital in Pawtucket, R.I., and an assistant professor of medicine at Brown University.
"Patients can only benefit from protease inhibitors while they are taking the pills," Stone says. "If it turns out that regular patients in clinical practice aren't able to stick with the medications, they can't derive the benefits, such as increased survival and improved quality of life, that we've been led to expect." The take-home lesson is to optimize treatment regimens for individual patients and to closely manage side effects and toxicity, Stone says.
Despite the side effects and complex daily drug doses, most patients successfully adhere to their protease inhibitor therapy, except for those patients who have active substance abuse or alcohol problems, says another study Stone will present Wednesday, July 1.
Although they can stick to treatment, women, minorities and patients with less education are less likely to be offered potent drug cocktails containing protease inhibitors, according to another paper by Stone and colleagues to be given Thursday, July 2. "While combination regimens containing protease inhibitors can dramatically improve outcomes, not all patients who can benefit are receiving them even when clearly indicated," Stone says.
Media Contacts:
Valerie Stone M.D., (401) 729-2395, valerie_stone@mhri.org