IAC: HIV Care Guidelines Expand Treatment Eligibility

By Michael Smith
MEXICO CITY, 04 aug 2008 - About 100,000 additional HIV-positive patients in the U.S. would be eligible for initiation of antiretroviral therapy under new treatment guidelines issued here.
The 2008 recommendations of the International AIDS Society-USA Panel support initiating therapy even in patients whose immune system remains relatively robust, according to Scott Hammer, M.D., of Columbia.
The guidelines remove the previous upper limit of 500 CD4-positive T cell per microliter of plasma, above which therapy was not recommended, Dr. Hammer said.
He said the changes "substantially increase the eligible group" of HIV-positive people in the U.S., although he was unable to give more than a "ballpark" figure of about 100,000.
The guidelines appear in the Aug. 6 issue of the Journal of the American Medical Association and were released in conjunction with the 17th International AIDS Conference.
The guidelines are intended to guide HIV care in the developed world, Dr. Hammer said, but in the long run, the 14-member panel that developed them hopes they will also guide care in developing countries.
Previously, antiretroviral therapy was recommended if a patient's CD4 cell count fell below 200 cells per microliter of plasma and was recommended for consideration when the count was between 200 and 350.
Therapy was not recommended for patients whose CD4 cell count remained above 350.
In the new guidelines, therapy should begin at 350, and in any case before the count reaches 200, Dr. Hammer said.
Above 350, therapy should be considered on an individual basis, based on co-morbidities, risk factors for progression to AIDS and other diseases, and patient readiness for treatment, he said.
For 2008, the panel also removed the upper limit of 500 cells, suggesting that - depending on the other factors - treatment could begin at any CD4 level, Dr. Hammer said.
The changes came as a result of several factors, he said, including more antiretroviral drugs, a better understanding of the adverse effects of delaying treatment, and more insight into the role of HIV in non-AIDS conditions such as cardiovascular and renal disease.
Currently, Dr. Hammer said, there are 25 individual drugs in seven classes, approved for HIV therapy in the U.S. and - in what he called a sign of "maturation" for the field -- two others have gone out of production.
The range of available drugs has alleviated fears that early therapy would leave patients without options if and when resistance or toxicity developed, he said.
And mounting evidence suggests that a high viral load - regardless of CD4 cell count - is linked to increased morbidity and mortality, he said.
Also, trials of treatment interruptions have suggested that HIV has a role in cardiovascular disease, non-AIDS malignancies, renal disease, and liver disease, he said.
All those factors "support moving forward to earlier initiation of treatment," he said.
The guidelines continue to recommend that initial treatment be based either on a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a ritonavir-boosted protease inhibitor (PI), combined with two nucleoside or nucleotide reverse transcriptase inhibitors (nRTI).
The preferred NNRTI is efavirenz (Sustiva), but several PIs are suggested, including lopinavir (Kaletra), atazanavir (Reyataz), fosamprenavir (Lexiva), darunavir (Prezista), and saquinavir (Fortovase, Invirase).
The suggested nRTI combinations are tenofovir/emtricitabine (Viread/Emtriva) and abacavir/lamivudine (Ziagen/3TC).
If abacavir is being considered, the guidelines suggested that patient monitoring should include testing for the immune marker HLA-B*5701, which is associated with abacavir hypersensitivity reactions.
The guidelines also suggest that, before the CCR5 antagonist maraviroc (Selzentry) is used, patients be tested for so-called viral tropism, the type of virus causing their infection.
For all patients, including those experienced with HIV medications, Dr. Hammer said, the goal remains to drive the viral load below the level of 50 copies of viral RNA per milliliter of blood, which is the lower limit of detection for the most sensitive assays.
Primary source: Journal of the American Medical AssociationSource reference:Hammer SM et al. "Antiretroviral Treatment of Adult HIV Infection: 2008 Recommendations of the International AIDS Society-USA Panel." JAMA. 2008;300(5):555-570