1. [Use study of tenofovir DF in highly active anti-retroviral therapy].
- Author
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Fernández Lisón LC, Vázquez Domínguez B, Rodríguez Gómez FJ, Hevia Alonso A, and Pujol de la Llave E
- Subjects
- Adenine therapeutic use, Adult, Aged, Female, Humans, Male, Middle Aged, Tenofovir, Acquired Immunodeficiency Syndrome drug therapy, Adenine analogs & derivatives, Anti-HIV Agents therapeutic use, Antiretroviral Therapy, Highly Active, Organophosphonates therapeutic use
- 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.
- Published
- 2006
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