New Treatment Guidelines for HIV Released: Presented at AIDS 2006, Toronto SYDNEY

TORONTO, CANADA -- August 22, 2006 -- Treatment guidelines for chronic HIV infection have been revised by the International AIDS Society-USA and released here at the 16th International AIDS Conference (AIDS 2006).

Also published in the August16th special issue of the Journal of the American Medical Association (JAMA), the guidelines focus on 4 specific themes: when to start antiretroviral therapy (ART), what drugs to use at the start of therapy, when to switch regimens, and what drugs to use when changing regimens.

The new guidelines were presented during a news conference organized by JAMA to highlight the journal's special edition to coincide with the conference.

The impetus to updating the guidelines comes with new research developments since 2004, when International AIDS Society -- USA Panel (ISA-USA) issued its last set of treatment guidelines. A 16-member panel reviewed 181 scientific citations, dating to May 2006, in drafting its most current set of guidelines.

The panel's guidelines, which recommend that initial antiretroviral therapy (ART) begin when CD4 cell counts drop below 350 cells/mm3 and before falling below 200 cells/mm3 in asymptomatic patients. According to the panel, ART is not warranted in patients whose CD4 cell counts are above 350 cells/mm3.

The guidelines confirm that the mainstay of ART is to administer 2 nucleoside reverse transcriptase inhibitors (NRTIs) along with a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI) boosted with low-dose ritonavir.

Patients on ART need to be monitored every 4 to 8 weeks, until plasma HIV-1 RNA levels become undetectable or below 50 copies/mL, the guidelines state. Initial and longer-term adherence to ART is necessary for treatment success, the panel said in its recommendations.

The panel suggested that switching therapies is an option if viral suppression has been achieved and that switching is warranted when treatment failure has been recorded. "This offers evidence for starting ART at certain points in time as well as what drugs to start," said Magda Sobieszczyk, MD, Instructor, division of infectious diseases, Columbia University, New York, New York, and co-investigator with panel chair Scott Hammer, MD, Harold C. Neu professor of medicine, professor of public health (epidemiology) and chief, division of infectious diseases, Columbia Presbyterian Medical Center, New York, New York.

"We wanted to summarize recent developments in clinical trials and to discuss red flags on when to change regimens if patients are failing therapy," Dr. Sobieszczyk said.

Factors such as viral hepatitis co-infection, genotypic drug resistance, metabolic disturbances and reproductive status enter into choices of ART, noted the panel.

"Someone may be more worried about pill burden or metabolic toxicities, which are more commonly seen with the use of protease inhibitors," she said. "If pregnancy is an issue, then the use of a drug like efavirenz, which can be teratogenic, would be of concern. The therapy should be individualized based on the patient's profile."

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