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SAFETY AND EFFICACY OF DARUNAVIR/RITONAVIR IN TREATMENT-EXPERIENCED PEDIATRIC PATIENTS: WEEK 48 RESULTS OF THE ARIEL TRIAL
Autor
Afiliación
University of the Witwatersrand. Faculty of Health Sciences. Perinatal HIV Research Unit. Johannesburg, South Africa.
Helios Salud. Buenos Aires, Argentina.
Gaitonade Center for AIDS Research and Education (YRG CARE). VHS, Chennai, India.
Hospital Geral de Nova Iguaçu. Departamento de Doenças Infecciosas. Nov Iguaçu, RJ, Brasil / Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de AIDS e Imunologia Molecular. Rio de Janeiro, RJ, Brasil.
Janssen Infectious Diseases BVBA. Beerse, Belgium.
Janssen Research & Development LLC., Titusville, New Jersey, USA.
Janssen Infectious Diseases BVBA. Beerse, Belgium.
Janssen Infectious Diseases BVBA. Beerse, Belgium.
Janssen Infectious Diseases BVBA. Beerse, Belgium.
Janssen Research & Development LLC., Titusville, New Jersey, USA.
Helios Salud. Buenos Aires, Argentina.
Gaitonade Center for AIDS Research and Education (YRG CARE). VHS, Chennai, India.
Hospital Geral de Nova Iguaçu. Departamento de Doenças Infecciosas. Nov Iguaçu, RJ, Brasil / Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de AIDS e Imunologia Molecular. Rio de Janeiro, RJ, Brasil.
Janssen Infectious Diseases BVBA. Beerse, Belgium.
Janssen Research & Development LLC., Titusville, New Jersey, USA.
Janssen Infectious Diseases BVBA. Beerse, Belgium.
Janssen Infectious Diseases BVBA. Beerse, Belgium.
Janssen Infectious Diseases BVBA. Beerse, Belgium.
Janssen Research & Development LLC., Titusville, New Jersey, USA.
Resumen en portugues
Background: ARIEL (Darunavir in treatment-experienced pediatric population)
was a phase II, open-label study assessing safety and antiviral activity
of darunavir/ritonavir twice daily with an optimized background regimen
(OBR) in treatment-experienced, HIV-1-infected pediatric patients (3
to <6 years, weighing 10 to <20 kg).
Methods: The study consisted of an initial 4-week screening period, 48
weeks of treatment and a 4-week follow-up period. Patients initially
received darunavir/ritonavir 20/3 mg/kg twice-daily for 2 weeks. Following
review of pharmacokinetic, safety and antiviral data, the doses of darunavir/
ritonavir were adjusted to 25/3 mg/kg twice-daily for patients <15 kg, and
375/50 mg twice-daily for patients 15 to <20 kg.
Results: Of the 34 patients screened, 21 were treated (median treatment
duration 48.6 weeks). Darunavir plus an OBR was well tolerated over 48
weeks, with no new safety concerns, and a comparable safety profile to that
seen in older children and adults. All treatment-emergent lipid-related and
glucose-related laboratory abnormalities were grade 1 or 2. At week 48, 17
of 21 patients (81.0%) had a confirmed virologic response (intent-to-treat,
time-to-loss of virologic response). Improvements in height and weight
were seen during the study.
Conclusions: No new safety concerns were observed over a 48 week
period. These results led to lowering the age to 3 years at which darunavir/
ritonavir is indicated for use in treatment-experienced pediatric patients.
This study also established doses of darunavir to use in treatment-experienced,
HIV-1-infected patients aged 3 to <6 years. A high virologic response
was observed with this dose. No development of resistance was observed in
patients who experienced virologic failure.
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