Tenofovir DF is as safe and effective in combination therapy as stavudine in people infected with HIV who have never taken antiretrovirals

Question Is tenofovir DF as safe and effective as stavudine, in combination with lamivudine and efavirenz, for people infected with HIV who have never taken antiretroviral drugs? Study design Double blind randomised controlled equivalence trial. Main results At 48 weeks, HIV RNA levels were less than 400 copies/ml in 80% of people receiving the tenofovir DF combination compared with 84% of people receiving the stavudine combination (see Results table 1). As the lower level of equivalence was set at −10%, the two regimens were not equivalent. However, at 48, 96 and 144 weeks, the proportion of people with HIV RNA less than 50 copies/ml was equivalent for the two groups. There were no significant differences between groups in frequency of adverse abnormal events and abnormalities in laboratory test results. Tenofovir DF combination significantly lowered the mean increase in fasting triglyceride levels, total cholesterol and LDL-cholesterol, and significantly raised the mean increase in HDL-cholesterol compared with the stavudine combination (see Results table 2). Lipodystrophy was less common with tenofovir DF combination compared with stavudine combination (tenofovir DF ν stavudine: 3% ν 19%, p < 0.01 ). Authors’ conclusions Tenofovir DF is as safe and effective as stavudine, in combination with lamivudine and efavirenz, for people infected with HIV who have not previously used antiretrovirals. The tenofovir DF combination reduces the incidence of lipodystrophy and produces more favourable lipid profiles than the stavudine combination.