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|Type:||Artigo de periódico|
|Title:||Long-term Efficacy And Safety Of Tenofovir Disoproxil Fumarate In Hiv-1 Infected Adolescents Failing Antiretroviral Therapy: The Final Results Of Study Gs-us-104-0321|
de Carvalho A.P.
de Aquino M.Z.
da Silva M.T.N.
|Abstract:||BACKGROUND:: Reports of long-term tenofovir disoproxil fumarate (TDF) treatment in HIV-infected adolescents are limited. We present final results from the open-label (OL) TDF extension following the randomized, placebo-controlled, double-blind phase of GS-US-104-0321(Study 321).METHODS:: HIV-infected 12-17 year-olds failing antiretrovirals who received TDF 300 mg or placebo (PBO) with an optimized background regimen (OBR) for 24-48 weeks received OL TDF plus OBR in a single arm study extension. HIV-1 RNA and safety, including bone mineral density (BMD), was assessed in all TDF recipients.RESULTS:: 81 subjects received TDF (median duration 96 weeks). No subject died or discontinued OL TDF for safety/tolerability. At Week 144, proportions with HIV-1 RNA <50 copies/mL were 30.4% (7/23 subjects with baseline HIV-1 RNA>1000 c/mL initially randomized to TDF), 41.7% (5/12 subjects with HIV-1 RNA < 1000 c/mL who switched PBO to TDF), and 0% (0/2 subjects failed randomized PBO plus OBR with HIV-1 RNA>1000 c/mL and switched PBO to TDF). Viral resistance to TDF occurred in 1 subject. At Week 144, median decrease in estimated GFR (eGFR) was 38.1 mL/min/1.73 m2 (n=25). Increases in median spine (+12.70%, n=26) and total body less head (TBLH) BMD (+4.32%, n=26) and height-age adjusted Z-scores (n=21; +0.457 for spine, +0.152 for TBLH) were observed at Week 144. Five of 81 subjects (6%) had persistent >4% BMD decreases from baseline.CONCLUSIONS:: Despite suboptimal adherence, some subjects had virologic responses to TDF plus OBR, and TDF resistance was rare. TDF was well-tolerated and can be considered for treatment of HIV-infected adolescents.|
|Editor:||Lippincott Williams and Wilkins|
|Appears in Collections:||Unicamp - Artigos e Outros Documentos|
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