Efficacy and Safety of Darunavir/Ritonavir at 48 Weeks in Treatment-naive, HIV-1-infected Adolescents Results From a Phase 2 Open-label Trial (DIONE)
Background: Twice-daily darunavir/ritonavir is indicated in treatment-experienced children (>= 3 years). This study assessed once-daily administration in treatment-naive adolescents. Methods: Phase 2, 48-week, open-label, single-arm study evaluating pharmacokinetics, safety and efficacy of once-d...
| Autores: | , , , , , , , , , |
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| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2014 |
| País: | España |
| Institución: | Fundació Sant Joan de Déu |
| Repositorio: | r-FSJD. Repositorio Institucional de Producción Científica de la Fundació Sant Joan de Déu |
| OAI Identifier: | oai:fsjd.fundanetsuite.com:p6922 |
| Acceso en línea: | https://fsjd.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=6922 |
| Access Level: | acceso abierto |
| Palabra clave: | adolescents darunavir HIV-1 ritonavir treatment-naive |
| Sumario: | Background: Twice-daily darunavir/ritonavir is indicated in treatment-experienced children (>= 3 years). This study assessed once-daily administration in treatment-naive adolescents. Methods: Phase 2, 48-week, open-label, single-arm study evaluating pharmacokinetics, safety and efficacy of once-daily darunavir/ritonavir 800/100 mg in treatment-naive, HIV-1-infected adolescents (>= 12 to < 18 years, >= 40 kg) with zidovudine/lamivudine or abacavir/lamivudine. Results: Twelve patients (67% female; median 14.4 years) were enrolled. After 24 and 48 weeks, respectively, 11 of 12 (92%) and 10 of 12 (83%) patients achieved viral load <50 copies/mL (intent-to-treat time-to-loss of virologic response); all had >= 1 log(10) drop in viral load versus baseline. Median CD4(+) cell count increased by 175 and 221 cells/mm(3) (intent-to-treat-noncompleter -failure) after 24 and 48 weeks, respectively. Eighty-three percent of patients were adherent to darunavir/ritonavir. One patient was never suppressed and 1 patient rebounded. No patients developed darunavir resistance-associated mutations or lost phenotypic susceptibility to any commercially available protease inhibitor or any background nucleoside reverse transcriptase inhibitor. Eleven patients (92%) reported >= 1 adverse event (AE), considered in 2 patients to be at least possibly related to darunavir (gastrointestinal-related events and dizziness). Four patients had >= 1 serious AE. Three patients reported >= 1 grade 3/4 AE; no serious or grade 3/4 AEs were considered darunavir related. No patients discontinued because of AEs. Conclusions: Over 48 weeks, once-daily darunavir/ritonavir 800/100 mg plus NRTIs was effective and well-tolerated for treatment of HIV-1-infected, antiretroviral-naive adolescents (>= 12 to <18 years). These findings support use of once-daily darunavir/ritonavir 800/100 mg in this population. |
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