[Use study of tenofovir DF in highly active anti-retroviral therapy]. / Estudio de utilización de Tenofovir DF en el tratamiento antirretroviral de gran actividad.

ABSTRACT

OBJECTIVE: Describe the efficacy and safety of tenofovir. METHODS: Observational, descriptive study. Data were analyzed for the intention-to-treat sample. The primary efficacy end-point included the proportion of patients with HIV-1 RNA level of 50 copies/ml or less. Secondary efficacy end points was the increase of the CD4 cell count at week 48. The primary safety end-point was the number of patients with abnormalities (clinical adverse events and laboratory toxicities). The causality of the adverse effects was measured by the Naranjo algorithm. RESULTS: 154 subjects were enrolled; 12 were excluded from all analyses. Efficacy end points Plasma HIV-1 RNA response -1.29 +/- 0.97 log10 copies/ml; Patients with HIV-1 RNA levels of 50 copies/ml or less 28.16%; CD4 cell count response 40.27 +/- 141.50 cel/mm3. Safety profile was similar to showed at prescribing information, 3 Fanconi Syndrome were detected. CONCLUSION: Tenofovir supposes an antiretroviral of high effectiveness in our hospital, with an optimum safety profile.