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Title: Tenofovir DF- and Thymidine Analog-Containing Regimens Display Similar Efficacies in Antiretroviral-Naive Women: Presented at HIV-DART

"Tenofovir DF- and Thymidine Analog-Containing Regimens Display Similar Efficacies in Antiretroviral-Naive Women: Presented at HIV-DART"

By Marjan Hezareh, PhD CANCUN, MEXICO -- December 14, 2006 -- Antiretroviral-naive women who are treated with antiretroviral regimens that contain tenofovir or a thymidine analog achieve similar treatment responses after 96 weeks, according to an analysis of data from 2 phase 3 studies. Jeffrey Enejosa, MD, Gilead Sciences, Foster city, California, presented the data here at HIV-DART 2006, the Frontiers in Drug Development for Antiretroviral Therapies meeting. Dr. Enejosa and colleagues evaluated the safety and efficacy of regimens containing tenofovir (TDF) or a thymidine analog (stavudine; azidothymidine, AZT) in combination with efavirenz and lamivudine (Epivir, 3TC) or emtricitabine (Emtriva). The antiretroviral naive women in the analysis were enrolled in 2 prospective, randomized studies (study 903 and 934). Study 903 enrolled 600 patients with HIV viral load > 5000 copies/mL, and Study 934 enrolled 511 patients with viral loads >10,000 copies/mL. All were treatment naive. The overall results from Study 903 (25% women) showed that, at week 144, a TDF-containing regimen had comparable efficacy to a stavudine-containing regimen. The results of Study 934 (13% women) showed that at week 96 the proportion of patients who achieved an HIV-1 viral load below 400 copies/mL was higher in the TDF-containing regimen as compared to AZT-containing regimen. Baseline viral load in the 113 women in TDF arm was 4.76 log[₁₀ copies/mL and 4.79 log₁₀ copies/mL in the 109 women in the thymidine analog arm. Median CD4 counts were 265 and 262 cells/mm³ in TDF and control arm, respectively.

At week 96, the proportion of women with a viral load below 400 (62% in TDF and 62% in control) and 50 copies/mL (60% in TDF and 56% in control) was similar in both the TDF and control arm (thymidine-analog containing regimen).

Women in TDF arm displayed significantly higher limb fat (mean total limb fat (kg) 13 vs. 9.3, P < .001) and lower elevations in fasting total cholesterol, LDL, and triglycerides at week 96 (23 vs 50, P < .001; 6 vs 23, P < .001; -12 vs. 49, P < .001, respectively) as compared with the control groups (n = 109)

Renal function as measured by serum creatinine, phosphorous, Cockcroft-Gault (GFR), and GFR by Modification of Diet in Renal Disease was similar between both arms and was minimally changed at week 96 as compared to baseline.

In the TDF arm the mean change of CD4 cell count from baseline to week 96 was +283 cells/mm³ versus +289 cells/mm³ in the control arm (P = .80).

[Presentation title: Efficacy and Safety of Tenofovir DF (TDF)-Containing Versus Thymidine Analog-Containing Regimens in Antiretroviral-Naive HIV-1-Infected Women. Abstract 63]

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