Encouraging compliance among HIV patients

Disease management could make big impact

Nearly half of HIV patients admitted to not taking their medications as prescribed in a study published recently by physicians at the Johns Hopkins University School of Medicine in Baltimore. Physicians surveyed in the same study estimated that more than half of their patients skip doses or fail to refill their prescriptions.

Besides compromising their current health, patients who don't comply dramatically reduce the future effectiveness of drug cocktails and may unwittingly make themselves resistant to other HIV medications. That's one of the reasons HIV is perfect for a disease management focus, says David Block, MD, MBA, one of the study's authors and a staff physician at Johns Hopkins' Moore Clinic. There's lots of room for a team approach to education that could motivate patients to comply and could result in tremendous cost savings.

"Because of the way HIV is treated, adherence is more important than in any other disease I can think of," says Block, who is also vice president of product planning and acquisition at the Wilmington, DE-based DuPont Merck Pharma-ceutical Company, which sponsored the study. "It's not like high blood pressure or diabetes where if you stop your medication, your numbers go up but starting it again will make them go down. If you miss your HIV medications even once, the virus can become resistant forever. And the resistance applies to other drugs in the class. You only have one chance to do it right with HIV."

Block says the study, published in the May issue of the Journal of the International Association of Physicians in AIDS Care, surveyed 665 patients and 100 physicians and was designed to highlight the importance of patient compliance in HIV treatment. Researchers knew adherence was a problem, but they were surprised the rates were so high because physicians spend so much time on counseling, and 93% of the patients said they understood that taking anti-HIV drugs properly would prolong their lives. Still, the study showed:

o 43% of patients admitted to not adhering to their regimen within the last week prior to the survey.

o 26% admitted to not adhering within the previous day.

o 54% said they knew other people who aren't adhering either.

The majority of physicians (89%) said they considered nonadherence to the drug regimen to be a serious problem, and they estimated that 50% or more of their patients skip doses.

Patients and physicians also were asked why adherence was a problem. Their answers included complexity of the schedule, food requirements, number of doses per day, and side effects. Thirty-two percent of patients said they either forgot or slept through a dose, and the same number reported taking doses at the wrong time. When asked what could be done to fix this problem, patients and physicians in the study gave answers including once-daily dosing, fewer pills per dose, and medications without food restrictions.

"The challenges are immense," Block says. "We need drugs that are simpler to take and that are more forgiving. Physicians also need to focus on coming up with a regimen patients can live with, and make sure they understand they only have one good chance to fight HIV. They just can't blow it."

Joel Gallant, MD, MPH, associate professor of medicine at Johns Hopkins and director of the Moore Clinic, says drug regimens should be tailored to the individual patient's lifestyle. Before prescribing the first medication, physicians should ask patients how they will work the drugs into their lives. "Most HIV experts are aware of this problem, but the patients are becoming aware of it too late," he says.

Physicians also should expand their prescribing options and not rely on the drugs they've historically used if certain patients will have difficulty complying. "Assessment of compliance is poor," Gallant says. "Physicians tend to discuss it at the beginning, but if the patient is doing well they might not mention it again. Or they ask the question in such a way that the patient fears admitting they've failed. A good way to approach it is to say at every visit:'Just about everybody misses doses of HIV medications. How often would you say you've missed since the last time I saw you?"

The study found that the better the patient is doing, the more likely he or she will stop complying with medications. Drug holidays - periods in which a patient stopped taking the drug regimen completely - increased from an average duration of 6.2 days for patients who had been treated between two and 12 months to an average of 14.4 days for those treated more than 25 months.

"When people are out for a while with good results, they get relaxed," Block says. "They don't want to be reminded two or three times a day that they have HIV. They just want to be normal."

Drug companies are working to develop new HIV drugs with once-daily dosing. DuPont Merck recently filed a new drug application with the U.S. Food and Drug Administration for Sustiva, which, if approved, would be the first once-daily HIV drug on the market.

For more information, contact:

· David Block, MD, MBA, vice president of product planning and acquisition, DuPont Merck Pharmaceutical Company, DuPont Merck Plaza, P.O. Box 80705, Wilmington, DE 19880-0705. Telephone: (302) 992-4545.

· Joel Gallant, MD, MPH, director of the Moore Clinic, The Johns Hopkins University School of Medicine, 1830 E. Monument St., 463-A, Baltimore, MD 21287-0003.