Enfuvirtide: The first fusion inhibitor for the treatment of patients with HIV-1 infection (PDF)

Enfuvirtide (Fuzeon, Roche/Trimeris) is the first member of a unique class of antiretrovirals known as the fusion inhibitors to gain FDA approval for the treatment of human immunodeficiency virus type-1 (HIV-1) infection. Enfuvirtide is indicated for use in combination with other antiretroviral agents in the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. Phase 3 trials demonstrated that adding enfuvirtide 90 mg twice daily to an optimized background regimen chosen with genotypic and phenotypic resistance testing improved the surrogate end points of HIV ribonucleic acid (RNA) levels, CD4 cell counts, and the proportion of patients reaching clinically undetectable HIV RNA levels (<400 and <50 copies/mL) through 24 weeks. Enfuvirtide?s efficacy in treatment-experienced patients when added to an optimized background regimen makes it a promising choice for salvage therapy. Further studies will be required to support enfuvirtide?s use in treatment-naïve patients.