[Use study of tenofovir DF in highly active anti-retroviral therapy].
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.


CONCLUSIONS
Tenofovir supposes an antiretroviral of high effectiveness in our hospital, with an optimum safety profile.
Fernández Lisón
L C
LC
Farmacia Hospitalaria, Hospital Don Benito-Villanueva, Badajoz. luis.fernandezl@ses.juntaex.es
Vázquez Domínguez
B
B
Rodríguez Gómez
F J
FJ
Hevia Alonso
A
A
Pujol de la Llave
E
E
D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy*; D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000627:therapeutic use*; D000068698:Tenofovir
D019380:Anti-HIV Agents; D063065:Organophosphonates; D000068698:Tenofovir; D000225:Adenine