UB Study Proves that Medication Adherence "Coaching" Significantly Impacts Health Status of AIDS Patients

BUFFALO, N.Y. -- Taking steps to tailor medication regimens for patients being treated for the first time for HIV infection and to assure that they adhere to those regimens can pay off with improved virologic results nearly a year following initiation of treatment, according to a study by University at Buffalo researchers.

Forty-eight weeks into treatment, 94 percent of the patients participating in an outpatient HIV Medication Adherence Clinic had viral loads below detection, compared with 63 percent of those in a control group who did not receive the intensive adherence intervention.

According to the UB researchers, this is the first time that an adherence program in an outpatient setting has been shown to affect viral load for such a prolonged period in HIV patients. Failure rates for initial treatment regimens for HIV patients traditionally have been as high as 50 percent.

The results were presented Monday (July 8, 2002) in a poster session at the 14th International AIDS Conference in Barcelona, Spain.

"AIDS is an epidemic, but the health-care system deals with the disease in the same way that it deals with conditions like high blood pressure," explained Gene Morse, Pharm.D., UB professor and chair of the Department of Pharmacy Practice in the UB School of Pharmacy and Pharmaceutical Sciences and a co-author of the study.

"The current standard of care goes like this: the physician writes a prescription, the patient goes to the pharmacy, gets the medications and tries to do the best he or she can," he explained.

"The need for an alternative model for managing HIV patients and their medications has been supported by the data in this study."

It is particularly important, he added, because the initial treatment regimen for HIV-infected patients has the greatest chance of suppressing the patient's viral load and determining disease outcome.

The UB study involved outpatients in the HIV Medication Adherence Clinic operated by the UB School of Pharmacy and Pharmaceutical Sciences and based in the Immunodeficiency Services Clinic in the Erie County Medical Center. Since opening its doors in September 1997, the clinic, the first of its kind in the world, has counseled hundreds of HIV patients.

Lori Esch, Pharm.D., a co-author of the study who is director of the clinic and a UB clinical assistant professor of pharmacy practice, said the study included 25 patients seen in the clinic who participated in the adherence program and 38 controls who received standard care, but did not participate in the program.

Patients participated in a three-part educational program focusing on basic understanding of HIV infection, psychosocial factors and proper medication-administration instructions.

Esch explained that a pharmacist is intimately involved in decision-making about what medications are prescribed for patients seen in the clinic so that therapy is individualized based on a patient's medical history, lifestyle and concurrent medications. Potential adherence barriers, anticipated toxicities, pill burdens, dosing intervals and regimen preferences were discussed in detail with each patient, evaluated, reported to their health-care providers and used to select an individualized treatment regimen.

"Although many drug combinations are capable of suppressing viral load, not all combinations are suitable for every patient," Esch explained. "These study results support the philosophy that it isn't necessarily the specific drugs used that is as important as how well they are tailored to the patient."

The pharmacist works intensively with the patient for as long as a month before the patient takes his or her first pill and is involved in intensive coaching during the first four months of treatment. Patients are provided tools such as pillboxes, dose cards, a daily dosing schedule and beepers, if needed. If questions or problems arise, the patient can contact a pharmacist through a telephone hotline operated by the clinic.

"Our clinic gives patients a jumpstart for sticking to their regimens that the system, as it exists now, is not set up to provide," said Esch.

That jumpstart is critical, the UB researchers explained, because when patients interrupt therapy for any reason, the virus has a chance to develop resistance.

"When you're dealing with a disease like hypertension, the patient can stop taking medication and then start up again, and the drugs will work," explained Morse. "But with AIDS, when you take your medications incorrectly, resistance will develop, so the adherence program becomes an integral part of the overall HIV pharmacology program."

Other researchers involved in the study, all of UB, were Katherine I. Klem, Pharm.D.; Lori Kuhman, Pharm.D., and Ross G. Hewitt, M.D.

The UB program is being adapted for use in Zimbabwe through a visiting professorship at UB, funded by a grant from the National Institute for Allergy and Infectious Diseases.

UB pharmacy students, post-doctoral residents and practicing pharmacists from across the U.S. participate in training programs in the adherence clinic.