[20] INCIDENCE OF FAT TISSUE ABNORMALITIES IN PROTEASE INHIBITOR-NAÏVE PATIENTS TREATED WITH NRTI COMBINATIONS

1st International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV

26–28 June 1999 - San Diego, CA, USA

INCIDENCE OF FAT TISSUE ABNORMALITIES IN PROTEASE INHIBITOR-NAÏVE PATIENTS TREATED WITH NRTI COMBINATIONS

Antiviral Therapy 1999; 4(Suppl. 2):43 (abstract no. 20)

M Galli¹, AL Ridolfo¹, C Gervasoni¹, L Ravasio¹, F Adorni² and M Moroni¹
¹Institute of Infectious Diseases and Tropical Medicine, University of Milan; and ²National Research Council, ITBA, Milan, Italy

BACKGROUND: Alterations of fat tissue distribution (AFTD) and lipid metabolism have been recently described also in PI-naïve patients on NRTI treatment.

OBJECTIVES: To assess the incidence of AFTD in patients on stable treatment with two NRTIs.

DESIGN: Prospective study started in March 1998 on PI-naïve subjects on treatment with or entering in a double NRTI therapy. The analysis was performed on patients who remained on double NRTI treatment, without adding PI or NNRTI. Prevalent cases of AFTD at March 1998 were excluded. We considered as AFTD the following conditions: abdominal (AA), dorsocervical (BA) and breast (BA) fat accumulation; wasting of the fat tissue in the arms (WA), legs (WL) and face (WF); fat redistribution (FR) defined as fat accumulation in the upper part of the body with wasting in the lower part.

RESULTS: The analysis involved 188 patients (92 male, 96 female). The risk of developing AFTD was significantly higher in women (OR 5.05; 95% CI 1.96-13.00). Males remained on treatment with NRTI combinations for 205 and females for 215 person years. One or more AFTD were detected in 25 females (26%) and six males (6.5%). The incidence rate per 1000 person-years was 116.2 (95% CI 48.0-184.4) in females and 29.2 (95% CI 0-64.2) in males. FR with breast enlargement was observed in 11 women. AFTD were observed in 7/72 (9.7%) patients treated with zidovudine/lamivudine, 1/10 with zidovudine/ zalcitabine, 2/24 (8.3%) with zidovudine/didanosine, 19/70 (27.1%) with stavudine/lamivudine, 1/3 with stavudine/Zalcitabine and 1/9 with stavudine/didanosine.

CONCLUSIONS: Incidence of AFTD is high also in PI-naïve subjects treated with double NRTI combinations. The risk of developing AFTD is higher in women.

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