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Health-Related Quality of Life With Enfuvirtide (ENF; T-20) in Combination With an Optimized Background Regimen

Cohen, Calvin J MD, MSC*; Clumeck, Nathan MD, PhD; Molina, Jean-Michel MD; Thompson, Melanie MD§; Patel, Kavita PHARMD, MBA; Wintfeld, Neil PhD; Green, Jesse PhD

JAIDS Journal of Acquired Immune Deficiency Syndromes: September 1st, 2004 - Volume 37 - Issue 1 - p 1140-1146
doi: 10.1097/01.qai.0000133054.43198.dc
Clinical Science

Summary This study assessed the impact of enfuvirtide on health-related quality of life (HRQoL). Patients enrolled in 2 phase 3 trials T-20 versus Optimized Regimen Only (TORO 1 and 2) completed the Medical Outcomes Study (MOS)-HIV questionnaire at baseline and at 4, 8, 16, and 24 weeks. A total of 995 treatment-experienced HIV-1–infected individuals received either self-administered enfuvirtide (90 mg twice daily) + optimized background (OB) or OB alone and had at least 1 follow-up visit. Data from the 2 clinical trials were pooled. Analysis of covariance was used to evaluate changes in the 10 MOS-HIV scale scores and 2 summary scores. Least-squares means for these changes were calculated and used to test for between-group differences. There were no significant between-group differences in any HRQoL measure at baseline. Most MOS-HIV scores showed improvement in the enfuvirtide arm compared with OB alone, although only some of these were significant. Improvements in the general health scale were significantly higher in the enfuvirtide arm compared with OB alone at all post-baseline time points. No scale or summary score for the OB arm showed a significantly greater improvement in score from baseline compared with the enfuvirtide arm, at any time point. The mental health summary score at 24 weeks was significantly higher in the enfuvirtide arm compared with OB alone. Enfuvirtide in addition to an OB regimen does not adversely affect and may improve HRQoL when self-administered for up to 24 weeks by treatment-experienced, HIV-1–infected individuals.

From *Community Research Initiative of New England, Boston, MA; †Centre Hospitalier Universitaire Saint-Pierre, Brussels, Belgium; ‡Saint-Louis Hospital, Paris, France; §AIDS Research Consortium of Atlanta, GA; and ¶Roche, Nutley, NJ.

Received January 7, 2004;

accepted for publication May 7, 2004.

Funded by Roche Pharmaceuticals and Trimeris, Durham, NC.

Calvin J. Cohen has received research support from Roche Pharmaceuticals and has received honoraria and acted as a consultant for Roche. Dr. Cohen reports having received consulting fees, lecture fees, or grant support from Roche, Bristol-Myers Squibb, Abbott, Gilead, Boehringer Ingelheim, GlaxoSmithKline, and Trimeris. Nathan Clumeck reports no conflict of interest. Jean-Michel Molina has received honoraria and acted as a consultant for Roche, Bristol-Myers Squibb, Abbott, Gilead, GlaxoSmithKline, and Triangle. Melanie Thompson has received research support from the following: Abbott Laboratories, Agouron/Pfizer Pharmaceuticals, Boehringer-Ingelheim, Bristol-Myers Squibb, Centers for Disease Control, Adult Spectrum of Disease Project, Chiron Corp., Glaxo SmithKline, Gilead Sciences, Merck Research Laboratories, National Institutes of Allergy and Infectious Diseases, Community Programs for Clinical Research on AIDS, Acute Infection and Early Disease Research Program, Oxo-Chemie, Roche Laboratories, Serono, Theratechnoliges, Triangle Pharmaceuticals, and Trimeris. Melanie Thompson has received honoraria or support for advisory committees, lectures, and CME programs from the following: Abbott Laboratories, Agouron/Pfizer Pharmaceuticals, Bristol-Myers Squibb, Glaxo SmithKline, Gilead Sciences, Merck Research Laboratories, Serono, Triangle Pharmaceuticals, and Virologics, Inc. Kavita Patel, Neil Wintfeld, and Jesse Green are full-time employees of Hoffmann-LaRoche, Inc.

Reprints: Calvin J. Cohen, Community Research Initiative of New England, 23 Miner Street, Boston, MA 02215 (e-mail: ccohen@crine.org).

© 2004 Lippincott Williams & Wilkins, Inc.