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

LACK OF CLINICAL LIPODYSTROPHY IN PATIENTS RECEIVING EFAVIRENZ PLUS NRTIs IN STUDY 006

Antiviral Therapy 1999; 4(Suppl. 2):55(abstract no. 39)

R Stryker¹, D Skiest², K Tashima³, S Staszewski⁴, SA Villano⁵, DF Labriola⁵, NM Ruiz⁵ and the Study 006 Investigator Team^5
1Pacific Oaks Research, Beverly Hills, California; ²Southwestern Medical School, Dallas, Texas; ³The Miriam Hospital, Providence, New Jersey,USA; ⁴Klinikum der JW Goethe-Universitat, Frankfurt, Germany; and ⁵DuPont Pharmaceuticals Company, Wilmington, Delaware, USA

BACKGROUND: Lipodystrophy is a poorly defined syndrome of fat redistribution which has been linked to antiretroviral therapy, most notably the use of PIs. We examined the cohorts of Study 006 for clinical signs consistent with lipodystrophy. In Study 006, lamivudine-, NNRTI- and PI-naïve patients were randomized in open-label fashion to efavirenz/ lamivudine/zidovudine or efavirenz/indinavir or indinavir/lamivudine/zidovudine.

METHODS: Of 1266 patients enrolled, 1223 were followed for 24 weeks, 378 for 48 weeks and 132 for 72 weeks. The longest time on study was 88 weeks. In the absence of a universally accepted definition of lipodystrophy, we probed the database for reports of the following: increased fat tissue, buffalo hump, breast enlargement, abdomen enlarged, wasting, lipodystrophy, lipoma or lipidosis. We divided the cases as being probable lipodystrophy (term used in database: lipodystrophy, crix belly, buffalo hump, fat mass due to PI) or possible lipodystrophy (above plus lipoma, breast enlargement, wasting, obesity).

RESULTS: No cases of probable lipodystrophy were noted in the efavirenz plus NRTIs arm compared to 2.1 % and 1.7% for the efavirenz plus indinavir and indinavir plus NRTIs arms, respectively. When considering all possible cases, the incidence of lipodystrophy was 0.2%, 2.3% and 2.9% for efavirenz plus NRTIs, efavirenz plus indinavir and indinavir plus NRTIs, respectively.

CONCLUSIONS: No cases of probable clinical lipodystrophy were observed in the efavirenz plus NRTIs arm of study 006.

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