Fran Lowry

June 10, 2012

June 10, 2012 (Miami Beach, Florida) — Patients with HIV who received problem-solving counseling to help them overcome barriers that might prevent them from taking their medication as prescribed were more adherent and had better virologic suppression at the end of a year than those who received usual care.

The finding was presented here by Robert Gross, MD, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, at the 7th International Conference on HIV Treatment and Prevention Adherence, which was jointly sponsored by the International Association of Physicians in AIDS Care, the National Institute of Mental Health, and the Post Graduate Institute for Medicine.

"This intervention is flexible and when tailored to the individual's adherence barriers, it results in improved adherence to the degree that it produces a clinically significant difference in virologic suppression," Dr. Gross told Medscape Medical News.

There are many reasons why people do not take their medicines as recommended by their healthcare provider, he said.

"We all know the case of Magic Johnson — one of the most public people to announce that he has HIV infection — who got started on therapy and then decided that the virus had been suppressed and he wasn't going to take his meds anymore. When he did, as expected, he had a massive rebound," Dr. Gross said. "So deciding on your own that you're not going to do what your doctor says and make your own decisions about whether you will take your meds or not is one type of nonadherence.

"Other common reasons include forgetting, bothersome side effects, lives that become too chaotic, depression, lack of motivation," he continued. "There can be as many reasons for being noncompliant as there are people with HIV. So the issue of nonadherence is actually quite complex and not a simple phenomenon at all."

That variability is why tailoring an intervention to an individual is so important, he emphasized.

In the current study, Dr. Gross and his colleagues randomly assigned 91 patients with HIV to managed problem-solving (MAPS), a 5-step behavioral intervention, and 89 patients to usual care. All patients were older than 18 years (median age, 42 years) and were just beginning their antiretroviral therapy or were starting a new regimen after their current antiretroviral therapy had failed, with HIV RNA > 1000 copies/mL.

Sixty-one percent of the patients were male and 85% were black. The median baseline viral load was 2000 copies/mL, and median CD4 cell counts were 250 cells/mm3.

Each patient in the MAPS group met 4 times during a 3-month period with a behavioral interventionist who had been trained in problem-solving. At each visit, patients were encouraged to brainstorm solutions to problems they were encountering regarding taking their medicines.

Patients in the MAPS group also received 9 phone calls during the 3 months and monthly telephone "booster sessions" thereafter for 1 year.

HIV viral load was assessed every 3 months and HIV copy-years were compared between the 2 groups.

"HIV copy-years is a metric of success but doesn't say if the patient has HIV detectable in their blood. It gives a more nuanced answer, telling how much of the time over the past year they had HIV in their blood and also how much HIV they had in their blood at that time," Dr. Gross explained. "That metric has been shown to be associated with survival, and the lower it is the more likely you are to survive with HIV."

High Dropout Rate Typical in HIV Adherence Studies

A large number of patients in both groups dropped out of the study; 33 from the MAPS group and 23 from the usual care group were lost to follow-up.

"When you are studying a very challenging population of people who have had trouble adhering, dropping out of care is very common," Dr. Gross noted.

"The number of patients who dropped out in this study is distressing but it is the reality of working with a very challenging HIV population. If you want to tackle a difficult problem like adherence, you have to accept the fact that adhering to even coming into the study or staying in care can be difficult," he said.

To perform an intention-to-treat (ITT) analysis, the researchers replaced missing HIV viral loads with baseline viral load values. They also performed an as-treated (AT) analysis, with the last observation carried forward. HIV copy-years was calculated as average log10 viral load over each quarter multiplied by 3 and summed over the year.

The study found that in both ITT and AT analyses, patients in the MAPS intervention group had lower HIV copy-years (ITT — MAPS: 1.54 log copy-years vs usual care: 2.02 log copy-years, P = .046; AT — MAPS: 1.36 log copy-years vs usual care: 1.87 log copy-years, P = 0.027).

"MAPS improves HIV copy-years outcome and should be used where resources are available," Dr. Gross said.

Conference co-chair José M. Zuniga, PhD, MPH, from the International Association of Physicians in AIDS Care, Washington, DC, noted that the study authors did not define what constituted usual care.

"But since the sites involve academic centers [Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, the Philadephia Veterans Affairs Hospital] one might question how this compares to community or rural health centers," Dr. Zuniga told Medscape Medical News.

"Still, the study showed that the intervention subjects were more likely to achieve and maintain undetectable HIV viral loads, though perhaps curiously the intervention appeared to increase the drop-out rate in the study," Dr. Zuniga, who was not part of the study, said. "Indeed, as the authors point out, the disproportionate drop-out rate actually attenuated the intervention's measured viral load effect. It would be important, especially for resource-limited environments, to determine if the MAPS strategy would have similar outcomes using expensive MEMS cap adherence monitors."

Dr. Gross and Dr. Zuniga have disclosed no relevant financial relationships.

7th International Conference on HIV Treatments and Prevention Adherence. Abstract # 79967. Presented June 5, 2012.


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