Eighth International Congress on Drug Therapy in HIV Infection Glasgow, UK - 12-16 November 2006

Int Cong Drug Therapy HIV 2006 Nov 12-16;8:Abstract No. PL13.2

M Harris, R Joy, N Zalunardo, R Werb, B Yip, R Hogg, J Montaner
AIDS Research Program, St. Paul’s Hospital, Vancouver, BC, Canada; BC Centre for Excellence in HIV/AIDS, Vancouver, BC, Canada; Division of Nephrology, University of BC, Vancouver, BC, Canada

PURPOSE OF THE STUDY: TDF use in the EAP was associated with clinically significant Cr increases, seen earlier in patients with lower CD4. Since approval, TDF use is not restricted by previous ARV, CD4, renal function or concomitant medications. We examined factors associated with Cr increase and TDF discontinuations (d/c) using a database including ARV history and lab values.

METHODS: HIV+ adults starting TDF 01/01/03 to 31/05/05 and with ≥1 Cr within 6 mo of TDF start and ≥1 Cr while still on TDF were included. Endpoints were Cr ≥1.3x pre-TDF baseline (BL) or TDF d/c for any reason. Logistic regression was used to calculate unadjusted and adjusted odds ratios (OR). Event-free subjects were right censored at the last Cr test up to 31/10/05.

SUMMARY OF RESULTS: Analysis includes 1182 patients: 1000 male (85%), 188 ARV naïve (16%), 265 with AIDS (22%), median age 42 yrs, previous ARV 34 mo, CD4 220/mm³, VL 24,500 c/mL, Cr 83 µmol/L, GFR 92 mL/min/1.73m². Concomitant ARV included ddI in 406 (34%) and boosted PIs in 967 (82%). Median time on TDF was 12.2 mo. Five % (62/826) developed Cr ≥1.3x BL and 20% (236/1182) d/ced TDF, including 66 (6%) who died. In multivariate analysis, factors associated with Cr ≥1.3x BL were concomitant ddI (OR 2.14; p=0.015), BL CD4 (OR 1.59/ 100 cell decrement; p<0.0001), and female gender (OR 2.33; p=0.029). Factors associated with TDF d/c were concomitant ddI (OR 2.21; p<0.0001), BL CD4 (OR 1.22/ 100 cell decrement; p<0.0001), and previous ARV exposure (OR 0.89/ 12 mo; p<0.0001).

CONCLUSIONS: Among patients taking TDF, Cr elevation and TDF discontinuation are associated with concomitant use of ddI (but not boosted PIs), and with lower CD4, as previously shown.

Plenary Session: Hot Topics and Late Breakers

2006-11-12
PL13.2

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