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Tenofovir failed to meet study endpoints in adolescents with HIV-1
Negra MD. Pediatr Infect Dis J. 2012;doi:10.1097/INF.0b013e31824bf239.
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Tenofovir disoproxil fumarate was safe in adolescents, but it did not reduce HIV levels to expected levels when combined with an optimized background regimen, according to study results from the Instituto de Infectologia Emílio Ribas in São Paulo, Brazil.
Marinella Della Negra, MD, and colleagues examined data from two randomly assigned groups of HIV-1-positive adolescents; 45 adolescents received 300 mg of tenofovir (Viread, Gilead Sciences) and 42 received a placebo for 48 weeks. Patients were then checked for time-weighted plasma change of HIV-1 RNA from baseline at week 24.
Although tenofovir was considered safe, the researchers said it did not decrease viral levels when compared with placebo. When adolescents were evaluated for HIV-1 RNA of less than 400 copies/mL, there was little difference in the tenofovir group (40.9%) and the placebo group (41.5%).
The researchers said patients in both groups also had baseline genotypic resistance to tenofovir (48.9% of the tenofovir group and 33.3% of the placebo group), which may have influenced the outcomes. They found no significant differences in bone mineral density or renal function between the two groups.
“This study of [tenofovir] in combination with an optimized background regimen in antiviral-experienced adolescents did not meet its primary or secondary efficacy endpoints,” the researchers concluded.
Disclosure: Gilead Sciences funded the study.
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