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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
Author(s) -
MorandJoubert Laurence,
Ghosn Jade,
Delaugerre Constance,
Giffo Boniface,
Solas Caroline,
Samri Assia,
Pinta Alexandrina,
Triglia Aurore,
Raffi François
Publication year - 2012
Publication title -
journal of medical virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.782
H-Index - 121
eISSN - 1096-9071
pISSN - 0146-6615
DOI - 10.1002/jmv.23388
Subject(s) - enfuvirtide , medicine , regimen , clinical endpoint , viral load , randomized controlled trial , gastroenterology , surgery , human immunodeficiency virus (hiv) , virology , immunology , gp41 , antigen , epitope
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. J. Med. Virol. 84:1710–1718, 2012. © 2012 Wiley Periodicals, Inc.