Background:  Studies evaluating the relationship between race and ART have shown that therapeutic response and side effects vary in HIV-infected patients from distinct ethnic backgrounds. We analyzed the outcomes in 2 phase III, prospective randomized clinical trials 20 to 25% of whose enrolled patients were black.

Methods:  We evaluated the 96-week safety and efficacy of a tenofovir DF (TDF)-containing vs a non-TDF-containing regimen (control) among black ART-naive patients who enrolled in Studies 903 and 934. These studies compared TDF vs stavudine (d4T) or zidovudine (AZT) in combination with efavirenz (EFV) and lamivudine (3TC) or emtricitabine (FTC) and included patients with HIV-1 RNA >5000 (Study 903) or >10,000 copies/mL (Study 934) and any CD4 count at screening.  

Results:  We enrolled 228 (TDF n = 125; control n = 103) black patients. Baseline characteristics were for TDF:  36% female, median age 35, HIV-1 RNA 4.95 log₁₀ copies/mL, CD4 195 cells/mm³; control:  35% female, median age 33, HIV-1 RNA 4.73 log₁₀ copies/mL, CD4 227.  By week 96, 5% in the TDF arm vs 13% in the control arm had discontinued the study regimen because of adverse events. No patient in the TDF arm discontinued because of renal adverse events.

Conclusions:  TDF-based therapy demonstrated significantly greater virologic suppression than thymidine analog-based therapy in black ART-naïve patients through 96 weeks. Patients in TDF arm had significantly lower elevations in fasting total cholesterol and triglycerides. A trend toward higher limb fat was seen in the TDF arm at week 96.  Renal function was similar between arms and unchanged through 96 weeks.