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FDA Approves New Labeling for BMS’ Sustiva Describing Long-Term Durability in Treatment-Naive Patients
FDA on Thursday approved new labeling for Bristol Myers Squibb's antiretroviral drug Sustiva that describes data from a recent clinical trial showing that the drug is effective at suppressing HIV in people who have taken a Sustiva-containing regimen for three years, the Associated Press reports. In the three-and-a-half year study -- which included 1,266 treatment-naïve, HIV-positive people -- subjects were randomized into three groups: the first group took Sustiva, zidovudine and lamivudine; the second took Sustiva, indinavir and lamivudine; and the third took indinavir, zidovudine and lamivudine. At the end of the study, 48% of patients in the first group had an HIV-1 RNA viral load below 400 copies per milliliter, compared with 40% in the second group and 29% in the third group. The study also found that 43% of patients in the first group had a viral load below 50 copies per milliliter, compared with 31% in the second group and 23% in the third (Associated Press, 8/26). "With this new labeling, health care professionals now have additional information to draw on when creating a durable antiretroviral regimen for their treatment-naïve patients," Anthony Hooper, BMS president of U.S. pharmaceuticals, said (BMS release, 8/26).
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