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13th Annual Conference of the British HIV Association29 March–1 April 2007, Brighton, UK |
EFFICACY AND SAFETY OF TENOFOVIR DF (TDF)-CONTAINING VERSUS NON-TDF-CONTAINING REGIMENS IN BLACK ANTIRETROVIRAL-NAÏVE PATIENTS
HIV Med 2007; 8(Suppl. 1):10 (abstract no. P1)
Anton Pozniak1, Shan-shan Chen2, Andrew Cheng2 and Jeffrey Enejosa2
1Chelsea and Westminster Hospital, London, UK, 2Gilead Sciences, Foster City, CA, USA
AIM/OBJECTIVE: Limited studies have been conducted to evaluate antiretroviral therapy in HIV-infected patients from distinct ethnic backgrounds. We analysed the outcomes of antiretroviral therapy in two Phase III, prospective randomized clinical trials that had enrolled 20–25% Black patients.
METHODS: We evaluated the 96-week safety and efficacy of a TDF-containing versus a non-TDF-containing regimen (Control) among Black antiretroviral naïve patients who enrolled in Studies 903 and 934. These studies compared TDF versus d4T or AZT in combination with efavirenz and 3TC or FTC and included patients with HIV-1 RNA >5000 (Study 903) or >10,000 c/mL (Study 934) and any CD4 count at screening.
RESULTS: 228 [TDF: n=125; Control: n=103 (903: n=53; 934: n=50)] Black patients were enrolled. Baseline (BL) characteristics: TDF: 36% female, median age 35, HIV-1 RNA 4.95 log10 c/mL, CD4 195 cells/mm3; Control: 35% female, median age 33, HIV-1 RNA 4.73 log10 c/mL CD4 227. 5% in the TDF arm versus 13% in the Control arm discontinued study regimen by Week 96 due to adverse events. No patient in the TDF arm discontinued due to renal adverse events. At Week 96, significantly more patients in the TDF arm achieved HIV RNA <400 c/mL compared to Control (65% versus 48%, P=0.006, TLOVR). Similar increases in CD4 counts were seen through 96 weeks (TDF: +267, Control: +233). Patients on TDF had significantly lower elevations in fasting cholesterol and triglycerides versus Control. Estimated GFR by Cockcroft-Gault was similar between arms and remained unchanged through 96 weeks. A trend toward higher limb fat was seen in the TDF arm at Week 96.
CONCLUSION/DISCUSSION: TDF-based therapy demonstrated significantly greater virological suppression compared to thymidine analogue-based therapy in Black antiretroviral-naïve patients through 96 weeks. Patients in the TDF arm had significantly lower elevations in fasting total cholesterol and triglycerides. Renal function was similar between arms and unchanged through 96 weeks.
2007-03-29
P1
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