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Early HIV Therapy Yields Better Outcomes and Fewer Toxicities
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By Deborah Mitchell
DENVER (Reuters Health) Feb 08 - HIV-infected patients may need to start highly active antiretroviral therapy (HAART) earlier than current US treatment guidelines suggest.
Treatment guidelines currently recommend delaying HAART until patients reach CD4 cell counts lower than 250 cells per microliter to avoid treatment toxicities. However, the results of a large study reported at the 13th annual Conference on Retroviruses and Opportunistic Infections found that patients who start treatment earlier and do not interrupt treatment actually have fewer toxicities and better outcomes.
"The intuitive thinking is the longer you are on a drug, the more the exposure to the drug, the greater the risk of developing toxicity will be," lead investigator Dr. Kenneth Lichtenstein of the University of Colorado Health Center, Denver told Reuters Health.
"What we have found is that it's the exact opposite. If you're going to develop toxicity, you develop it early, and it usually is associated with more advanced disease. If you don't develop it in the first year, your risk of developing it in the second year is lower and the risk continues to go down over time."
Dr. Liechtenstein and colleagues at the Centers for Disease Control and Prevention in Atlanta and Cerner Corp in Vienna, Virginia, evaluated 2222 patients in the HIV Outpatient study cohort who were seen at least twice between 1996 and 2005.
The subjects were stratified by pretreatment CD4 cell count, time of HAART initiation, and the development of three major toxicities.
Overall, 113 patients developed renal insufficiency, 301 developed peripheral neuropathy and 176 had lipoatrophy.
Compared with patients who started HAART when CD4 counts were 200 cells per microliter or lower, patients with CD4 counts higher than 350 cells per microliter when they began treatment were at least 60% less likely to develop renal insufficiency. They were also at least 60% less likely to develop lipoatrophy and 30% less likely to develop peripheral neuropathy.
Adherence to treatment also affected outcomes. CD4 counts were higher over an 8-year period in patients who took HAART 95% of the time or more than patients who took their drugs less frequently -- regardless of pre-HAART CD4 level. Similarly, compared with less compliant patients, more patients who took HAART at least 95% of the time had viral loads below 50 copies/mL (57% vs 36%; p < 0.01).
Patients who stayed on treatment 95% of the time or more had a lower incidence of HIV-related mortality and morbidity and appeared to have a lower risk of developing some toxicities, compared with patients who were less compliant, regardless of when HAART began. Less consistent use of therapy was also associated with an increased risk of renal insufficiency and peripheral neuropathy, but the risk of lipoatrophy was decreased.
Dr. Lichtenstein believes the committee that advises Health and Human Services on HIV treatment guidelines should consider the results of this study, along with those of other studies with similar findings.
"I wouldn't change the guidelines based on this study alone," he said. He also stressed that this was an epidemiological study, not a randomized, controlled trial. However, "a lot of the same kinds of things were seen in large structured treatment interruption studies that were randomized, controlled trials."
As a clinician, Dr. Lichtenstein starts his patients on HAART early. "I have very few patients hospitalized and very few complications. Although this is anecdotal," he commented, "it's consistent with the data."
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