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A new study by a research scientist at Weill Cornell Medical College has shown that early antiretroviral therapy for individuals with HIV may significantly increase life expectancy, even when accounting for side effects like heightened cholesterol levels. Additionally, early therapy was found to be cost effective, yet it is still being denied to many patients because of cost.

The study, recently published in the Archives of Internal Medicine, and led by Dr. Bruce Schackman of Weill Cornell's Department of Public Health, employed a computer simulation model to determine how the therapy and its side effects affected life expectancy, cost, and quality of life.

The projected life expectancy for a 37-year-old patient receiving early treatment of highly active antiretroviral therapy (HAART) was nearly three years longer than for a patient receiving delayed therapy (16.54 years versus 13.73 years), even assuming increased cholesterol levels, a side effect associated with the therapy. This life-expectancy benefit is attributable to the treatment's effectiveness in reducing levels of HIV virus, or viral load, which improves CD4 cell count (a marker for immune system health) 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; results were similar (16.66 years versus 13.80 years).

"Early HAART prevents or delays expensive and significant HIV-related complications and dramatically prolongs life," said Dr. Bruce Schackman, Assistant Professor of Public Health at Weill Cornell Medical College and the study's lead author.

Since its introduction six years ago, HAART has saved the lives of thousands of individuals with HIV. Recently, the appropriate timing to initiate treatment has been the subject of controversy because new side effects have been identified, including elevated cholesterol and fat redistribution (a condition that may have a negative effect on patients' quality of life but is not life-threatening). Last year the U.S. Department of Health and Human Services (HHS) changed its recommendation for initial use of HAART, suggesting offering the therapy to only those patients with somewhat more advanced disease, with a presence of HIV viral loads greater than 30,000 copies/mL or a CD4 cell count of less than 350/µL.

The study's findings suggest that HIV patients who choose early treatment when it is offered according to the 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 Dr. Schackman. "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. AIDS Drug Assistance Programs in 10 states have one or more program restrictions, including capped enrollment, limited drug coverage, or expenditure caps. Early therapy 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, but its cost-effectiveness ratio (a measure of "value for money") is well below the median for all medical interventions nationwide. The cost-effectiveness ratio of early HAART was shown to be $13,000 per quality-adjusted life year, with or without the consideration of increased heart disease risk. Even after adjusting for the decline in quality of life that may be associated with fat redistribution, early HAART's cost-effectiveness ratio was between $17,000 and $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 non-HIV infected men.

"Decisions about initiating antiretroviral therapy must clearly take into account factors such as an individual patient's readiness to adhere to potentially complex treatment regimens, cardiovascular disease history and risk factors, and potential psychological vulnerability to symptoms such as fat redistribution," said Dr. Schackman.

"But as long as the reduction in quality of life was 70 percent or less, early treatment afforded a higher quality-adjusted life expectancy compared with deferred treatment," Dr. Schackman added.

Added Dr. Marshall J. Glesby, Assistant Professor of Medicine and Public Health at Weill Cornell Medical College, Assistant Attending Physician at NewYork-Presbyterian Hospital Weill Cornell Medical Center, and Co-Director of the Cornell Clinical Trials Unit, a leading center for HIV clinical trials: "The potential for antiretroviral-induced cholesterol elevations to increase cardiovascular risk over the long-term is a concern, but these elevations can usually be managed with appropriate lipid-lowering drugs. This study is important because it reminds us that the powerful benefits of HAART cannot be overlooked, even as we search for new ways to avoid or treat side effects."

Cost-effectiveness analyses were conducted using the Cost-Effectiveness of Preventing AIDS Complications model that was developed by collaborators at the Massachusetts General Hospital and the Harvard School of Public Health, and data were collected from clinical trials, cohort studies, and other published literature. The study assumed a hypothetical population of one-million HIV-infected adults with viral loads of 10,000 to 30,000 copies/mL and a CD4 cell count of 350/µL, comparing a strategy of initiating antiretroviral therapy immediately at a CD4 count of 350/µL (early therapy) with a CD4 cell count of 200/µL (late therapy).