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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 9th at the 11th 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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