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)
Por:
Flynn P, Komar S, Blanche S, Giaquinto C, Noguera-Julian A, Welch S, Lathouwers E, Van de Casteele T, Kakuda TN and Opsomer M
Publicada:
1 sep 2014
Resumen:
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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