IHV Develops New Medication Model For HIV/AIDS Patients

May 7, 2003

Patients have coaches & partners to help them maintain rigorous schedule

(BALTIMORE, MD) - The Institute of Human Virology has launched a national pilot program, called the JACQUES Initiative, that utilizes support elements like DOT (direct observation therapy) to help improve the long-term treatment success rates for patients infected with HIV/AIDS. The model, similar to one successfully used to improve treatment outcomes for tuberculosis, also partners patients with medical care providers, friends, family or fellow patients who provide regular support as they embark a rigid regimen of antiretroviral therapy.

HIV/AIDS patients have long had the daunting challenge of juggling multiple prescription drugs on a very rigorous schedule with little margin for error. A few missed doses could irreversibly lead to the failure of a patient's treatment plan and a subsequent decline in health.

"There's a tremendous amount of pressure on these patients to perform a task that requires much diligence, just ask anyone taking birth control or high blood pressure medication. We've tried to recognize the inherent pitfalls and develop a system that provides peer support, motivation and encouragement," says Dr. Robert Redfield, director of the Clinical Care and Research Division of the Institute of Human Virology, a part of the University of Maryland Biotechnology Institute that's led by internationally renowned Dr. Robert Gallo.

The IHV treats more than 3,000 patients annually and sees firsthand the success -- and failures -- of HIV/AIDS patients trying to maintain a life of normalcy while attending to the rigorous needs of both their disease and their medication schedules.

"Many patients do very well on therapy, yet for others it became evident that the current method provides dismal results," explains Redfield. Physicians in Baltimore, San Francisco and Cleveland are seeing a more than 50 percent failure rate in less than two years. "Most see that as a failure on the part of the patient," Redfield adds, "but I believe it represents both challenges and opportunities for providers."

Clinicians at the Institute of Human Virology have developed a new strategy, being tested now as part of a national pilot program funded by the Abell Foundation and the Maryland AIDS Administration.

"The concept," says Derek Spencer, C.R.N.P., JACQUES Initiative Executive Director, "places much greater emphasis on the inclusion of family and friends as a support element, someone this person already knows and trusts or someone trained by the Institute to give guidance, support and mentorship to those struggling to make their treatment plan a success."

This peer might be someone who successfully managed the disease on their own and can speak from practical experience or might simply be a loved one who's available for feedback, motivation and support.

These individuals are known as coaches, partners or friends and provide the backbone of an alternative treatment delivery system that may make it easier for a patient with HIV/AIDS to adhere to their treatment schedule -- simply by reinforcement, gentle reminders and words of encouragement.

The approach - which might be viewed as "soft" in the world of hard science - is especially critical now that HIV/AIDS has been rated the worst epidemic and deadliest disease in medical history. Some 23 million have died worldwide and another 42 million are infected. Some countries are unable to afford drugs to even keep the disease at bay; others that have treatment options available continue to see patients develop resistance to the drugs.

AIDS clinicians have seen marked advances on the treatment front, especially since the introduction of what is known as protease inhibitors and highly-active antiretroviral therapy. But again, these often require numerous prescriptions taken multiple times a day - and at very precise times.

"We recognize it's difficult and we've developed a system to try to make it easier," Redfield explains. "The tools we have right now are impressive," he adds, "but they have limitations." For instance, if you have a 95 percent adherence rate, there's a 20 percent failure rate. If you have a 90 percent adherence rate, there's a 50 percent failure rate.

If a person fails therapy once, the likelihood is even greater that a second regiment will have even shorter durability.

"We must design clinical systems that match the standards and treatment outcomes we desire for our patients," Spencer adds. "If we want our patients to take their medicine excellently, we must function at that same level of excellence."

Redfield is hopeful that results from the pilot program, which also incorporates monthly workshops for HIV patients and family members, will translate to better health for the HIV/AIDS patients he sees each day.

"We know that with the current treatment approach, we need a 99 percent adherence rate to be effective. I'm convinced that if we let you do this on your own, no matter how good you are, a majority of patients will fail, but it doesn't have to be that way," says Redfield.

Note to Reporters: More than 100 patients signed up to participate in this program immediately after its launch.

The Institute of Human Virology (IHV) is a center of the University of Maryland Biotechnology Institute and affiliated with University of Maryland Medicine. It was established to create and develop a world-class center of excellence focusing on chronic viral diseases and virally linked cancers. The IHV is dedicated to discovery, research, treatment, and prevention of these diseases and cancers. Its unique structure seeks to connect cohesive, multidisciplinary research and clinical programs so that new treatments are streamlined from discovery to patient. The IHV serves patients locally and the scientific community globally. The Institute of Human Virology was formed in 1996 as a partnership between the State of Maryland, the City of Baltimore, the University System of Maryland, and the University of Maryland Medical System.