title: Enfuvirtide (T-20) cross-reactive glycoprotein 41 antibody does not impair the efficacy or safety of enfuvirtide.
abstract: The present study investigated the effect of enfuvirtide cross-reactive glycoprotein 41 (gp41) antibody on the efficacy or safety of enfuvirtide in patients participating in 1 of 2 24-week phase 3 clinical trials (T-20 vs. optimized regimen only [TORO] 1 and TORO 2). Serum samples from human immunodeficiency virus-infected patients receiving enfuvirtide plus optimized background (OB) and from patients receiving OB only were evaluated for enfuvirtide cross-reactive gp41 antibodies. Most patients had detectable levels of antibody at baseline; 78% of patients treated with enfuvirtide plus OB had a > or =30% decrease in level of antibody, compared with 43% of patients treated with OB only. Baseline antibody status did not influence virological responses to enfuvirtide-containing treatment. Favorable virological responses were more common among patients who experienced a > or =30% decrease from baseline than among those who experienced either an increase or a lesser decrease. A decrease in virus load correlated with a decrease in level of antibody. Safety was unaffected by the presence of positive antibody at any time point or change in level of antibody. There was no evidence that enfuvirtide cross-reactive gp41 antibody affects the efficacy or safety of enfuvirtide.
authors.affiliation: University of Toronto, Toronto, Ontario, Canada. sharon.walmsley@uhn.on.ca
authors.forename: Sharon
authors.initials: S
authors.lastname: Walmsley
authors.forename: Keith
authors.initials: K
authors.lastname: Henry
authors.forename: Christine
authors.initials: C
authors.lastname: Katlama
authors.forename: Mark
authors.initials: M
authors.lastname: Nelson
authors.forename: Antonella
authors.initials: A
authors.lastname: Castagna
authors.forename: Jacques
authors.initials: J
authors.lastname: Reynes
authors.forename: Bonaventura
authors.initials: B
authors.lastname: Clotet
authors.forename: James
authors.initials: J
authors.lastname: Hui
authors.forename: Miklos
authors.initials: M
authors.lastname: Salgo
authors.forename: Ralph
authors.initials: R
authors.lastname: DeMasi
authors.forename: John
authors.initials: J
authors.lastname: Delehanty
mesh_terms: D000293:Adolescent; D000328:Adult; D003429:Cross Reactions; D004342:Drug Hypersensitivity / Q000276:immunology; D000077560:Enfuvirtide; D015483:HIV Antibodies / Q000097:blood*; D015700:HIV Envelope Protein gp41 / Q000009:adverse effects / Q000276:immunology* / Q000627:therapeutic use*; D023581:HIV Fusion Inhibitors / Q000627:therapeutic use*; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy*; D015497:HIV-1 / Q000276:immunology* / Q000302:isolation & purification; D006801:Humans; D007279:Injections, Subcutaneous; D010146:Pain / Q000276:immunology; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D012867:Skin / Q000276:immunology; D019562:Viral Load
chemical_list: D015483:HIV Antibodies; D015700:HIV Envelope Protein gp41; D023581:HIV Fusion Inhibitors; D010446:Peptide Fragments; D012367:RNA, Viral; D000077560:Enfuvirtide