HIV Therapy: Early Treatment Extends Life

A study led by Dr. Bruce Schackman of Weill Cornell Medical College shows that early antiretroviral therapy for HIV-positive patients may significantly increase life expectancy -- even after accounting for side effects like heightened cholesterol levels. And though early therapy is still being denied to many patients because of cost, it was found to be cost-effective.

In the study's computer simulation model, the projected life expectancy of a 37-year-old patient receiving early highly active antiretroviral therapy was nearly three years longer than that of a patient receiving delayed therapy (16.54 years vs. 13.73 years), even assuming increased cholesterol levels, a side effect associated with the therapy. This benefit is attributable to HAART's effectiveness in reducing HIV viral levels, which improves CD4 cell count and leads to a reduction in the likelihood of opportunistic infections. The study also compared life expectancy for early vs. delayed therapy assuming no cholesterol side effects, and the results were similar (16.66 years vs. 13.80 years).

The timing of HAART initiation has been the subject of controversy because of the drugs' side effects, including elevated cholesterol and fat redistribution (a condition that may have a negative effect on the patient's quality of life but is not life-threatening). Last year the U.S. Department of Health and Human Services changed its recommendation for initial HAART use: It suggested offering HAART only to those patients with somewhat more advanced disease (viral loads of greater than 30,000 copies/mL or CD4 cell count less than 350/(micro)L.

The current study's findings suggest that HIV patients who choose early treatment offered according to current guidelines will benefit. "Changes in cholesterol levels or quality of life associated with HAART should not be used by government or private payers to justify placing limitations on access to early HIV treatment," said Schackman, an assistant professor of public health. "We know that access is being denied due to budget limitations among AIDS Drug Assistance Programs, which frequently pay for early treatment for HIV patients who are too healthy to qualify for Medicaid. [ADAPs] in 10 states have one or more program restrictions, including capped enrollment, limited drug coverage, or expenditure caps. Early treatment is cost-effective, so enrollment caps that delay access until the patient's HIV disease becomes more advanced are an inefficient reallocation of resources."

Early HAART is more expensive than delayed treatment. However, its cost-effectiveness ratio -- a measure of "value for money" -- is well below the median for all medical interventions nationwide. Early HAART's cost-effectiveness ratio was shown to be $13,000 per quality-adjusted life year, with or without the consideration of increased risk of heart disease. Even after adjusting for the decline in quality of life that may be associated with fat redistribution, early HAART's cost-effectiveness ratio was $17,000-$24,000 per quality-adjusted life year. This ratio is less than half that for cholesterol-lowering drugs used to prevent coronary heart disease in men without HIV.

The full report, "Cost-effectiveness Implications of the Timing of Antiretroviral Therapy in HIV-Infected Adults," was published in the Archives of Internal Medicine (2002;162:2478-2486).

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