FDA approves new label information for Sustiva
August 31 2004 12:00 AM ET
The Food and Drug Administration on Thursday approved new label information for Bristol-Myers Squibb's HIV nonnucleoside reverse transcriptase inhibitor Sustiva that includes data from a recent clinical trial showing that a Sustiva-based regimen is effective in suppressing HIV replication for at least three years. The clinical trial studied 1,266 previously treatment-naive HIV-positive adults who began a regimen containing Sustiva and various combinations of two other anti-HIV drugs. About 48% of patients taking Sustiva, AZT, and 3TC maintained HIV viral loads under 400 copies per milliliter of blood during the 3-1/2-year study; 43% had viral loads under 50 copies. This compares to 40% of those taking Sustiva, Crixivan, and 3TC who had viral loads under 400 copies; and 29% of those taking Crixivan, AZT, and 3TC who had viral loads under 400 copies. "With this new labeling, health care professionals now have additional information to draw on when creating a durable antiretroviral regimen for their treatment-naive patients," said Anthony Hooper, president of U.S. pharmaceuticals for BMS.