16th International AIDS Conference Toronto, Canada - August 13 - 18, 2006

GLOMERULAR DYSFUNCTION AND ASSOCIATED RISK FACTORS FOLLOWING INITIATION OF ART IN ADULTS WITH HIV INFECTION IN AFRICA

Int Conf AIDS. 2006 Aug 13-18;16 Abstract No. ThAb0105

Reid A.¹, Stöhr W.², Walker S.², Ssali F.³, Munderi P.⁴, Gilks C.⁵, on behalf of the DART Trial
¹ University of Zimbabwe, Harare, Zimbabwe, ² MRC Clinical Trials Unit, London, United Kingdom, ³ Joint Clinical Research Centre, Kampala, Uganda, ⁴ MRC/UVRI Programme on AIDS, Entebbe, Uganda, ⁵ Imperial College, London, United Kingdom

BACKGROUND: Nephropathy is a complication of HIV infection, but may also be a drug side-effect.

METHODS: DART is a randomised trial of management strategies in symptomatic ART-naïve adults with CD4<200 cells/mm³ in 3 sites initiating therapy with Combivir plus tenofovir, nevirapine or abacavir (only drugs randomised were abacavir and some nevirapine: NORA substudy). Biochemistry was performed at baseline, weeks 4 and 12, then 12-weekly. We estimated GFR using Cockcroft-Gault, adjusted for body surface area. We analysed incidence of severe GFR reduction (≥grade 3: <30 ml/min/1.73m²) and GFR changes within three periods (baseline to week 4, 4 – 48, 48 – 72) where follow-up was >50% complete in each ART group, considering demographics, regimen and baseline biochemistry/hematology as predictors using random effects models.

RESULTS: Data to 12/05 on 3313 patients (65% women; median age 37 years; baseline CD4 86 cells/mm³, weight 57 kg, GFR 89 ml/min/1.73m₂) are included. By 72 weeks, 43 (1.3%) patients developed severe GFR reduction, with similar rates for tenofovir (33/2467,1.3%) compared to nevirapine (3/247,1.2%), nevirapine-NORA (4/299,1.3%) or abacavir (3/300,1.0%) (p=1.0). However, GFR changes did vary with first-line regimen: Adjusted means at baseline, and changes to weeks 4, 48, and 72 were 95, -1, -2, and -5 ml/min/1.73m² with tenofovir; 96, +1, +1, and +6 with nevirapine; 88, +5, +8, and +4 with nevirapine-NORA; and 86, +1, +7, and +4 ml/min/1.73m² with abacavir-NORA (p<0.001, <0.001 and 0.004 between regimens, in the three periods). Lower weight, lower haemoglobin, and lower GFR at baseline were all associated with greater GFR increase post-baseline (all p<0.001).

CONCLUSIONS: Severe GFR impairments were infrequent on all regimens, and patients with baseline renal impairment showed greatest improvements, suggesting that renal benefits outweigh risks over the short-to-mid-term. Differences between regimens in changes from baseline were small, statistically significant but clinically insignificant. Investigating the potential for longer-term nephrotoxicity requires further follow-up.

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2006-08-13
ThAb0105

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