enfuvirtide and HIV-Associated-Lipodystrophy-Syndrome

The aim of the study was to compare the metabolic and morphological effects of enfuvirtide plus an optimized background (OB) regimen vs. OB alone (control group) in treatment-experienced patients in the T-20 vs. Optimized Regimen Only (TORO) studies.. Body composition and metabolic changes were investigated in patients over 48 weeks, based on fasting chemistries, body weight, and other anthropometric measurements. Dual-energy X-ray absorptiometry (DEXA) and computed tomography (CT) scans were performed in a patient subgroup (n=155) at baseline and at weeks 24 and 48.. At week 48, mean changes from baseline were similar between treatment groups for glucose, insulin, C-peptide, total cholesterol, low-density lipoprotein (LDL) cholesterol, very low density lipoprotein (VLDL) cholesterol, high-density lipoprotein (HDL) cholesterol and triglyceride levels. The enfuvirtide group experienced a significant increase in body weight [mean change from baseline +0.99 kg; 95% confidence interval (CI) +0.54, +1.44] and, in those who had body scans, there was a significant increase in truncal fat (by DEXA: median change +419.4 g; 95% CI+71.3, +767.5) and total fat [visceral adipose tissue (VAT)+subcutaneous adipose tissue (SAT) by single-slice abdominal CT scan: median change +25.5 cm(2) ; 95% CI+8.9, +42.0] over 48 weeks; significant increases in these parameters were not seen in the control group. There was no significant change in truncal:peripheral fat ratio in either the enfuvirtide or the control group.. The addition of enfuvirtide to an OB regimen does not appear to have unfavourable effects on fat distribution or metabolic parameters.

Topics: Absorptiometry, Photon; Adolescent; Adult; Aged; Aged, 80 and over; Antiretroviral Therapy, Highly Active; Body Composition; Body Weight; Dyslipidemias; Enfuvirtide; Female; HIV Envelope Protein gp41; HIV Fusion Inhibitors; HIV Infections; HIV-Associated Lipodystrophy Syndrome; Humans; Male; Middle Aged; Peptide Fragments; Tomography, X-Ray Computed; Waist Circumference; Waist-Hip Ratio; Young Adult

Topics: Acquired Immunodeficiency Syndrome; Administration, Cutaneous; Anesthetics, Local; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Argentina; Asia; Attitude to Health; Awareness; Child; Child Health Services; Congresses as Topic; Developing Countries; Disease Outbreaks; Enfuvirtide; Female; Health Services; HIV Envelope Protein gp41; HIV-Associated Lipodystrophy Syndrome; Homosexuality, Male; Humans; Lidocaine; Male; Peptide Fragments