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Entitled, "Guidelines In Action: Applying the HHS 'Guidelines for the Use of Antiretroviral Agents in HIV-Infected Adults and Adolescents' to Clinical Practice," the symposium was held just before the start of the 37th annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and was sponsored by the Brown University School of Medicine and the Brown University AIDS Program.

"The Department of Health and Human Services issued the most comprehensive treatment guidelines for HIV disease to date and we are now seeing them put into practice," stated Charles C.J. Carpenter, M.D., professor of medicine at Brown University School of Medicine. Dr. Carpenter is chair of the National Institutes of Health Panel to Define the Principles of Therapy of HIV Infection, which developed the principles upon which the guidelines are based. "The Panel agreed that given the complexities of antiretroviral therapies, treatment should be directed by an experienced physician wherever possible. 'Guidelines in Action' is designed to bring practicing clinicians together to examine emerging and existing data and to explore the challenges of making critical treatment decisions."

The guidelines recommend combining two nucleoside analogues with a protease inhibitor as the standard of care in HIV. At the symposium, researcher Joseph J. Eron, M.D., presented preliminary data from the first direct head-to-head comparison of such triple combination regimens. "Prior to this time, triple combination regimens have only been compared to two-drug combinations or to monotherapy," said Dr. Eron. Initial data from this study showed equal effectiveness of the combinations AZT/3TC/indinavir, d4T/3TC/indinavir, and d4T/ddI/indinavir. Each combination was well tolerated, with slightly more minor adverse events in the AZT-containing arm. "These studies provide important insights as we begin to adopt new standards of care for people living with HIV/AIDS," stated Dr. Eron, who is assistant professor in the Department of Medicine at the University of North Carolina.

Richard D'Aquila, M.D., presented current data on drug resistance patterns, the process by which HIV mutates into strains that develop resistance to antiretroviral agents. Dr. D'Aquila noted that resistance has profound implications for the sequencing of combination therapies for long- term clinical benefit. "We need to understand the biology of resistant viruses and be able to measure antiretroviral resistance to optimize treatment choices. For example, laboratory data suggest that if you start a patient on ddI and then switch to 3TC, you still get the full benefit of both agents. But if you start with 3TC, you may diminish the subsequent effectiveness of ddI," observed Dr. D'Aquila, who is assistant professor of medicine, Harvard Medical School.

"The current triple-drug regimens have been very impressive in driving HIV below detectable levels, but the failure rate hovers at at least 10-20% for patients without extensive prior treatment," observed Calvin J. Cohen, M.D., research director, Community Research Initiative of New England. "Therefore, a 'Plan B' is essential. In selecting initial and subsequent therapies, the clinician must consider such factors as resistance and the patient's ability to take the medication as prescribed, as the sequencing of antiretroviral therapy can preserve or limit future therapeutic options.

"We must not simply 'Hit hard, hit early' -- we must 'hit wisely'," Dr. Cohen concluded.

Audience members had the opportunity to make treatment decisions on the spot. Through electronic polling, the audience answered questions in response to specific case studies. In one case study of a 25-year-old, HIV-positive male who had not received any prior antiretroviral treatment (ART), 77% of the respondents recommended ART for this patient. While 31% selected AZT + 3TC + a highly active protease inhibitor (PI), 68% chose different combinations: 26% chose d4T + 3TC + PI; 17% selected d4T + ddI + PI; and 25% selected a non- specified ART regimen.

In another case involving a 20-year-old, HIV-positive mother of two children, the two factors that most influenced the audience to recommend ART were viral burden and the likelihood of adherence to therapy. More than half of the audience (51%) recommended using d4T + ddI + a highly active PI, whereas 20% chose AZT + 3TC + PI, 17% selected d4T + 3TC + PI, 10% said they would use the double-protease combination of ritonavir + saquinavir, and 3% indicated ritonavir + saquinavir + two nucleoside analogues.

"Clearly, as we weigh treatment options, we have to consider high levels of resistance, the ability of the patient to adhere to the regimen, and the significant anti-HIV activity of the combinations," summarized Dr. Cohen. "Symposia such as these are of great value as we all try to understand the emerging data to make the right treatment decisions with and for our patients."

An audio/visual presentation of the entire symposium will be available on the Internet within a week of its presentation at ICAAC by visiting http://www.healthcg.com.

The "Guidelines in Action" symposium was supported by an unrestricted educational grant from Bristol-Myers Squibb Immunology.

SOURCE Brown University School of Medicine

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