Improved measures of quality of life, lipid profile, and lipoatrophy after treatment interruption in HIV-infected patients with immune preservation: results of ACTG 5170.

Background: Antiretroviral treatment interruption (TI) occurs frequently in routine clinical practice. The consequences of TI on quality of life (QOL), body habitus, and lipid parameters have not been studied.

Methods: We assessed QOL, symptoms, lipid measurements, and body circumference changes in patients who underwent prolonged TI (up to 96 weeks) in AIDS Clinical Trials Group 5170, a multicenter, prospective study. Major entry criteria were pre-antiretroviral therapy (ART) and entry CD4 count > 350 cells/mm3, entry HIV RNA < 55,000 copies/mL, and on ART for > 6 months. QOL was assessed at baseline and subsequent time points (to week 96) by patient self-report (0-100 scale), by patient-reported Symptoms Distress Module, and by the Multidimensional Health Status tool. Fasting total, high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol, and triglycerides were measured at baseline and subsequent time points to week 24. Neck, arm, mid-thigh, waist, and hip circumferences were measured through week 96. Paired t tests, Wilcoxon signed rank tests, and the generalized estimating equation approach were used in the data analysis.

Results: A total of 167 subjects enrolled with median baseline and nadir CD4 count of 833 and 436 cells/mm3, respectively, and median time on ART 4.5 years. One hundred forty-nine subjects were receiving a thymidine analog-containing regimen (zidovudine or stavudine before TI). Self-reported QOL score on ART started high (mean 83.4 at baseline) and remained so after TI (83.0 at week 96, P = 0.49). Mean number of symptoms decreased from 8.2 at baseline to 7.0 at week 96, P = 0.016. The overall symptom summary score decreased from baseline to week 96, P = 0.01. The symptoms most frequently reported during TI were fatigue, feeling sad, nervousness, insomnia, myalgias, and changes in body appearance. There were no significant changes from baseline in the Multidimensional Health Status mental or physical domain scores. After TI, lipids (total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides) decreased at weeks 12 and 24. Lipid changes were similar in patients stopping a nonnucleoside reverse transcriptase inhibitor vs a protease inhibitor regimen, except for HDL, which showed greater decreases in those interrupting an nonnucleoside reverse transcriptase inhibitor. Body circumference measurements of arm, waist, hip, and mid-thigh increased after TI.

Conclusions: In a cohort of individuals with high QOL and preserved immune function, QOL did not change during a prolonged TI. Modest decreases in total cholesterol, LDL and HDL cholesterol, and triglycerides and a modest increase in limb fat were observed.