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.
| Autor: | Della Negra M; From the *Instituto de Infectologia Emílio Ribas, São Paulo, Brazil; †Hospital Infantil Joana de Gusmão, Hospital DIA - Agronômica, Florianópolis, Brazil; ‡Instituto da Criança do Hospital das Clínicas da FMUSP, São Paulo, Brazil; §Faculdade de Medicina, UFMG, Belo Horizonte, Brazil; ¶Universidade Estadual de Campinas-UNICAMP, Campinas, Brazil; ‖Gilead Sciences, Foster City, California; and **Gilead Sciences, Cambridge, United Kingdom., De Carvalho AP, De Aquino MZ, Pinto JA, Da Silva MT, Andreatta KN, Graham B, Liu YP, Quirk EK |
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| Jazyk: | angličtina |
| Zdroj: | The Pediatric infectious disease journal [Pediatr Infect Dis J] 2015 Apr; Vol. 34 (4), pp. 398-405. |
| DOI: | 10.1097/INF.0000000000000649 |
| Abstrakt: | 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 (PBO)-controlled, double-blind phase of GS-US-104-0321 (Study 321). Methods: HIV-infected 12- to 17-year-olds treated with TDF 300 mg or PBO with an optimized background regimen (OBR) for 24-48 weeks subsequently 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: Eighty-one 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 of 23 subjects with baseline HIV-1 RNA >1000 c/mL initially randomized to TDF), 41.7% (5 of 12 subjects with HIV-1 RNA <1000 c/mL who switched PBO to TDF) and 0% (0 of 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 glomerular filtration rate was 38.1 mL/min/1.73 m (n = 25). Increases in median spine (+12.70%, n = 26) and total body less head BMD (+4.32%, n = 26) and height-age adjusted Z-scores (n = 21; +0.457 for spine, +0.152 for total body less head) were observed at week 144. Five of 81 subjects (6%) had persistent >4% BMD decreases from baseline. Conclusions: 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. |
| Databáze: | MEDLINE |
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