1st International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV 26–28 June 1999 - San Diego, CA, USA

THE SALSA (SELF-ASCERTAINED LIPODYSTROPHY SYNDROME ASSESSMENT) COHORT: ABNORMALITIES IN CASES COMPARED TO CONTROLS

Antiviral Therapy 1999; 4(Suppl. 2):44 (abstract no. 22)

N Muurahainen¹, J Falutz², G Santos³, R Pettit¹, M Kleintop¹, M Glesby⁴, D Kotler¹ and the SALSA Investigators Group
¹Serono Laboratories, Norwell Massachusetts, USA; ²Montreal General Hospital, Montreal, Canada; ³Betances, New York, New York, USA; and ⁴The Community Research Initiative on AIDS, New York, New York, USA

INTRODUCTION: In some HIV surveys low percentages (often <10%) of patients display pronounced fat redistribution. The SALSA cohort focuses on HIV patients with abnormal body shape and/or metabolism and compares them to demographically matched controls. Presently the cohort includes over 430 patients from 48 clinical centres. To help establish a lipodystrophy (LD) case definition, abnormalities reported by 'cases' diagnosed by their clinicians with altered body habitus and/or metabolic pathology are compared to those reported by HIV-positive and healthy controls not diagnosed by their clinicians as cases.

DESIGN/SUBJECTS: Sites provide patient/physician SALSA questionnaires which inquire in detail about body shape and laboratory abnormalities. Frequencies of self-reported LD, fat accumulation (FA) and physician-reported laboratory abnormalities are compared by Fischer's exact test. This analysis includes the first 270 patients. Cases (n=210, 24% female) were aged 25 to 69 years, with CD4 counts of 4 to 1456 cells/mm³, 98% receiving combination antiretroviral therapy including a PI, and 51 having undetectable viral loads (VL) <500 copies/ml. HIV-positive controls (n=36, 25% female) were 30 to 69 years, with CD4 counts of 54 to 1338 cells/mm³, 86% on PI and 55% with undetectable VL. Healthy controls (n=24, 10 female) were 29 to 64 years.

RESULTS: Male cases (n=160) reported significantly (P<0.05) more belly FA (with frequencies of 76%, 66%, 42% in the cases, HIV-positive and healthy controls, respectively) limb LD (68%, 33%, 36%), buttock LD (59%, 26%, 14%), facial LD (57%, 22%, 14%) and buffalo hump (19%, 0%, 0%). Male cases also displayed more hypertriglyceridaemia (84%, 14%, 0%), hypercholesterolaemia (53%, 15%, 0%) and hypertension (20%, 0%, 7%) than gender-matched controls. Female cases (n=50) reported significantly (P<0.05) more belly FA (98%, 44%, 40%), breast FA (74%, 22%, 10%), limb LD (54%, 11 %, 10%), buttock LD (44%, 0%, 10%) and had more hypertriglyceridaemia (32%, 0%, 0%) and hypercholesterolaemia (29%, 0%, 0%) than gender-matched controls.

CONCLUSIONS: Although HIV-positive 'cases' report more abnormalities than gender-matched HIV-positive and healthy controls, controls also report abnormalities. Additional multivariate analyses and studies employing more objective measures of fat distribution (ongoing) are needed to more fully elucidate a case definition for LD syndrome(s).

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