title: Lack of benefit of 3-month intensification with enfuvirtide plus optimized background regimen (OBR) versus OBR alone in patients with multiple therapeutic failures: the INNOVE study.
abstract: The objective of the present study was to evaluate the virological efficacy of a 3-month short-course intensification with enfuvirtide (ENF) associated with an optimized background regimen (OBR) in treatment-experienced patients infected with HIV-1 with multiple therapeutic failures. This was a prospective, randomized, open-label multicenter trial including patients infected with HIV-1 and harboring a multi-resistant virus that was still susceptible to at least 2 active compounds. Patients were randomized (1:1) to receive OBR + ENF or OBR alone. ENF was discontinued at Week 12. The primary endpoint was the proportion of patients with plasma viral load <50 copies/ml at Week 24. Fifteen patients were randomized into the OBR group and 14 into the OBR + ENF group with a median viral load of 4.1 log(10)  copies/ml and a median CD4+ cell count of 346 cells/mm(3) . The primary endpoint was achieved in 93% (14/15) and 79% (11/14) of patients, respectively. Eighty-seven percent (13/15) of patients had a viral load <50 copies/ml as soon as Week 12 in the OBR group and 79% (11/14) in the OBR + ENF group. At Week 12, the median CD4+ cell count was 327 in the OBR and 437 in the OBR + ENF groups and at Week 24 they were comparable. Intensification with ENF had no significant impact on PBMCs HIV-DNA levels. A 3-month short-course intensified treatment with ENF did not improve Week-24 virological response in treatment-experienced patients infected with HIV-1 harboring resistant viruses that were still susceptible to two antiretroviral drugs.
authors.affiliation: Laboratory of Virology, AP-HP, CHU Saint-Antoine, UPMC University Paris 06, INSERM U943, Paris, France.
authors.forename: Laurence
authors.initials: L
authors.lastname: Morand-Joubert
authors.forename: Jade
authors.initials: J
authors.lastname: Ghosn
authors.forename: Constance
authors.initials: C
authors.lastname: Delaugerre
authors.forename: Boniface
authors.initials: B
authors.lastname: Giffo
authors.forename: Caroline
authors.initials: C
authors.lastname: Solas
authors.forename: Assia
authors.initials: A
authors.lastname: Samri
authors.forename: Alexandrina
authors.initials: A
authors.lastname: Pinta
authors.forename: Aurore
authors.initials: A
authors.lastname: Triglia
authors.forename: François
authors.initials: F
authors.lastname: Raffi
mesh_terms: D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D023241:Antiretroviral Therapy, Highly Active / Q000379:methods*; D000077560:Enfuvirtide; D005260:Female; D015700:HIV Envelope Protein gp41 / Q000008:administration & dosage*; D015658:HIV Infections / Q000188:drug therapy*; D015497:HIV-1 / Q000302:isolation & purification; D006801:Humans; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000008:administration & dosage*; D011446:Prospective Studies; D016879:Salvage Therapy / Q000379:methods*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D015700:HIV Envelope Protein gp41; D010446:Peptide Fragments; D000077560:Enfuvirtide