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Cumulative Time-Dependent Probability of Developing Fat Tissue Alterations in Female Patients Treated with Combined Antiretroviral Therapy M. GALLI*, A. L. RIDOLFO, L. RAVASIO, C. GERVASONI, L. CORSICO, F. ADORNI1, S. SANTAMBROGIO, A. D’ARMINIO MONFORTE, and M. MORONI1.
Inst. Infectious Diseases & Tropical Med., Univ. Milano, 1ITBA-CNR, Milano, Italy Background: Fat tissue alterations (FTA), including fat accumulation (FA), fat redistribution (FR) and lipodystrophy (LD), are frequently observed in patients (pts) treated with antiretroviral therapy (ART). Moreover, some evidences suggest a higher incidence of FR in females.
Methods: We performed a observational study in a cohort of female pts consecutively recruited since November 1997 analyzing the time-dependent cumulative probability of developing FTA according to the drug combination administered .
Results: At enrollment, FTA was present in 39/321 pts (12.1%). FR was the most common alteration (36/39, 92.3%) while LD was observed in only 2 cases. By April 1999, 107/309 pts (34.6%) still in follow up presented with FTA: 53 FR, 25 FA and 28 LD. A remission of FR and its evolution in localized FA was observed in 7 and 2 cases, respectively, after treatment withdrawal (n=2) or after changing one or more drugs (n=7); in 4 cases FR evolved in LD under initial treatment(n=2) or after changing one or more drugs (n=2).
The cumulative probability of developing FTA in PI-treated pts (considering also the pre-study period of treatment) was 29.8% after 1 year of follow up and 44.4% after two years, while the probability of developing LD was 7.1% after 1 year and increased to 10% after 2 years. Intention to treat analysis in pts treated with 2 NRTIs at enrollment did not evidence a significantly different cumulative probability of developing FTA after 1 year of follow up in pts treated with ZDV containing- and d4T-containing-regimens (21% vs 28%). The probability of developing LD in the two groups was 5.5% and 8.5%, respectively.
Conclusions: FTA is a frequent untoward effect of ART in females. FR, including breast enlargement in the majority of cases, is the earliest manifestation and frequently occurs also in pts not receiving PIs. LD generally needs longer period of treatment to develop and may be observed also PI-naive pts treated with NRTI combinations.
Key Words: fat redistribution, HAART, lipodystrophy
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