Use study of tenofovir DF in highly active anti-retroviral therapy
Describe the efficacy and safety of tenofovir. 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 th...
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Published in | Anales de medicina interna (Madrid, Spain : 1984) Vol. 23; no. 12; p. 573 |
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Main Authors | , , , , |
Format | Journal Article |
Language | Spanish |
Published |
Spain
01.12.2006
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Subjects | |
Online Access | Get full text |
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Summary: | Describe the efficacy and safety of tenofovir.
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.
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.
Tenofovir supposes an antiretroviral of high effectiveness in our hospital, with an optimum safety profile. |
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ISSN: | 0212-7199 |