July 15, 2004 (Bangkok, Thailand) -- It's the weekend and you're off to the beach. You're leaving your work behind and now researchers say HIV-infected people may be able to leave their drugs behind as well.
"We wanted to give patients a break on the weekend, with the benefits of lowering fatigue, toxicity, and costs," says co-investigator Sandy Sheble-Hall, RN, a clinical research nurse at the Community Research Initiative of New England in Boston.
"And in this pilot program, it worked," Sheble-Hall tells WebMD. "Patients took their medication for five days and then stopped it for two days, while maintaining control of the virus."
Speaking here at the XV International AIDS Conference, Sheble-Hall says that the idea for the study grew out of several previous trials of "drug holidays" among patients with HIV infection. "Some worked, with patients maintaining undetectable levels of HIV in their bodies, while some didn't," he says.
More Studies Needed
"We hypothesized that those studies -- in which patient would be on the drugs for seven days and then have seven days off might have been pushing the envelope too far. We thought a five-day on, two-day off schedule might be more feasible."
Which proved to be the case, he tells WebMD.
The study included 30 patients on antiviral drugs to treat HIV. And 28 of them responded as well as they would have had they been taking the drug every day of the week, he says.
"We don't really know why two of the patients rebounded," Sheble-Hall says. "But when we took these patients off the intermittent therapy and put them back on seven-day regimens, their viral loads again became undetectable."
Sheble-Hall says no serious adverse events were observed in any of the patients.
Also, on a 10-point quality of life questionnaire, in which 10 corresponded to best quality of life, the median score was 10, he says. "Everyone preferred the five-days on, two-days off schedule. It relieved the burden of taking pills every day and gave them a break on the very days Westerners are used to taking off."
"Some patients were scared at first, but willing -- and then glad -- they took the risk," he says. The patients are now being followed out to 48 weeks, with the next step being a larger, longer study.
Pierre Giguere, MSC, BPharm, an AIDS specialist in Ottawa, Canada, says he was impressed by the originality of the study. "Giving weekend breaks is an audacious idea, it needs courage," he tells WebMD.
"From a patient perspective, it is really a great break from the usual seven-day schedule," he says.
Like the researchers, he explains that he needs to see longer data before he would recommend it to his patients. "This is a great first step. Now we need longer, larger studies."