Impact on health-related quality of life of a switch from enfuvirtide to raltegravir among multidrug-resistant HIV-1-infected patients: a randomized open-label trial (EASIER-ANRS 138).

Abstract

BACKGROUND:

among multidrug-resistant HIV-1-infected patients, enfuvirtide has demonstrated sustained efficacy, but long-term use is inconvenient due to twice-daily subcutaneous injections which often induce injection-site reactions. We investigated whether a switch from enfuvirtide to raltegravir, an orally available HIV-integrase inhibitor, may improve health-related quality of life (HRQoL).

METHODS:

170 multidrug-resistant HIV-1-infected patients who were receiving enfuvirtide-based regimens were randomised to the maintenance of enfuvirtide or the switch to raltegravir at day 0. At week 24, all patients received raltegravir up to week 48. HRQoL was assessed at baseline and weeks 24 and 48 using a self-report MOS-HIV questionnaire. HRQoL scores were compared between arms using analysis of covariance (ANCOVA) models.

RESULTS:

at week 24, least-squares means changes from baseline for the maintenance and the substitution arms were -5.3 and +5.8 (P = .001) for the pain score, -4.7 and +4.8 (P = .02) for the social functioning score, and -1.3 and +2.0 (P = .003) for the physical summary score, respectively.

CONCLUSION:

among multidrug-resistant HIV-1-infected patients, a switch from enfuvirtide to raltegravir resulted in statistically significant improvements in multiple HRQoL dimensions over 24 weeks in comparison to the maintenance under enfuvirtide.

• Authors: Thomas Boulet, Juliette Pavie, Isabelle Charreau, Joséphine Braun, Jacques Reynes, Philippe Morlat, Lionel Piroth, Bruno Spire, Jean-Michel Molina, Jean-Pierre Aboulker, Easier-Anrs 138 Study Group
• Journal: HIV clinical trials (HIV Clin Trials) 2010 Sep-Oct Vol. 11 Issue 5 Pg. 283-93 ISSN: 1528-4336 [Print] England
• PMID: 21126958 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• HIV Envelope Protein gp41
• HIV Fusion Inhibitors
• HIV Integrase Inhibitors
• Peptide Fragments
• Pyrrolidinones
• RNA, Viral
• Enfuvirtide
• Raltegravir Potassium

Topics

• Administration, Oral
• Adult
• Chi-Square Distribution
• Enfuvirtide
• Female
• HIV Envelope Protein gp41 (administration & dosage)
• HIV Fusion Inhibitors (administration & dosage)
• HIV Infections (blood, drug therapy, immunology, psychology)
• HIV Integrase Inhibitors (administration & dosage)
• HIV-1
• Humans
• Injections, Subcutaneous
• Male
• Middle Aged
• Peptide Fragments (administration & dosage)
• Prospective Studies
• Pyrrolidinones (administration & dosage)
• Quality of Life (psychology)
• RNA, Viral (blood)
• Raltegravir Potassium
• Surveys and Questionnaires