A phase 3 trial shows efficacy of this first-in-class investigational drug. Although persons with HIV (PWH) that have multidrug-resistant HIV-1 are not as prevalent as before, their treatment options continue to be limited. Investigators now report 48-week results of the ongoing industry-funded phase 3 BRIGHTE trial of fostemsavir, an investigational (not FDA-approved) prodrug that is converted to temsavir, a first-in-class attachment inhibitor that binds to gp120, preventing attachment and entry of the virus into T-cells. The drug inhibits both CCR5- and CXCR4-tropic viruses. Patients with virologic failure and documented resistance to at least four of six antiretroviral classes were assigned to either a randomized or a nonrandom-ized cohort. Those with at least one but no more than two active drugs available were randomized 3:1 to blinded fostem-savir (600 mg twice daily) or placebo. Nonrandomized patients were thought to have no active agents available and thus received open-label fostemsavir (600 mg twice daily). The primary end-point was the mean change in log_10 HIV-1 RNA from day 1 to day 8. After week 24, virologic failure was defined as an HIV-1 viral load >400 copies/mL after suppression.
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