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Start with Four Drugs to Combat HIV: Presented at CROI

By Roberta Friedman, PhD

SAN FRANCISCO, CA -- February 11, 2004 -- HIV infected patients do better if they start out taking 4 antiretroviral agents, according to findings presented here February 9^th at the 11^th Conference on Retroviruses and Opportunistic Infections.

The FORTE trial showed that three quarters of patients who were previously untreated achieved low viral loads with induction using 4 drugs, compared to two thirds of patients taking the standard regimen of 3 drugs.

Study investigator David Asboe, MD, Chelsea and Westminster Hospital in London, said that patients in the induction/maintenance arm had significantly better response to treatment on most of the virologic criteria measured in the trial.

The trial tested 6 months of 4-drug therapy with a switch to 3 drugs thereafter. Dr. Asboe said it was difficult to recruit patients because the fourth drug is a protease inhibitor, and "there was a lot of resistance to that" as the adverse effects of these agents were just becoming known. The 62 induction/maintenance, 60 standard treatment were followed for a median of 81 weeks.

Standard treatment was 2 nucleoside reverse transcriptase inhibitors (didanosine and stavudine, or zidovudine and lamivudine), and a non-nucleoside reverse transcriptase inhibitors. The induction/maintenance regimen started with the addition of a protease inhibitor for 24 to 32 weeks until the viral load was <50 copies/mL.

At 24 weeks, fewer patients on the 4-drug regimen (31%) had failed to achieve the virologic goal compared to 48% taking the standard 3-drug regimen (P < .06). At 32 weeks, the failure rates were 18% and 43%, respectively (P < .002). CD4 cell counts did not differ at 48 weeks.

No differences appeared for the 2 regimens with respect to adverse events or time to progression to AIDS or death.

"It is unlikely that people will change their practice based on 1 study," said Dr. Asboe, "but the results are provocative."


[Study title: A Virological Benefit From an Induction/Maintenance Strategy Compared With a Standard 3-drug Regimen in Antiretroviral Naïve Patients: the FORTE Trial. Abstract 564]

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