The DIANA Study: Continued Access to Darunavir/Ritonavir (DRV/r) and Long-Term Safety Follow-Up in HIV-1-Infected Pediatric Patients Aged 3 to < 18 Years.
Journal
Drug safety
ISSN: 1179-1942
Titre abrégé: Drug Saf
Pays: New Zealand
ID NLM: 9002928
Informations de publication
Date de publication:
04 2021
04 2021
Historique:
accepted:
05
12
2020
pubmed:
29
12
2020
medline:
21
4
2022
entrez:
28
12
2020
Statut:
ppublish
Résumé
Darunavir is a human immunodeficiency virus type 1 (HIV-1) protease inhibitor boosted with ritonavir (DRV/r) or cobicistat. This study provided continued access to DRV/r and assessed long-term safety in patients aged 3 to < 18 years. Patients who had completed treatment in the DELPHI (TMC114-C212), DIONE (TMC114-TiDP29-C230), or ARIEL (TMC114-TiDP29-C228) studies were eligible to participate if they derived benefit from using DRV/r in countries where it was not available to them. DRV/r dosing was continued based on original study protocols. Only safety data were collected. Reportable adverse events (AEs) included AEs considered at least possibly related to treatment with DRV/r, AEs leading to discontinuation or treatment interruption, and serious AEs (SAEs). Forty-six patients rolled over to this study and received at least one dose of DRV/r. Median duration of DRV/r intake was 4.2 years. Overall, 15/46 patients experienced one or more reportable AEs, 10/46 patients experienced one or more grade 3 or 4 AEs, and 12/46 patients experienced one or more SAEs. The most common grade 3 or 4 and SAEs were pneumonia (3/46) and asthma (2/46). Only one AE (grade 1 lipoatrophy) was considered probably related to DRV/r (DIONE, n = 1). Overall, 3/46 patients experienced an HIV-related AE (grade 3 pneumonia SAE; grade 2 tuberculosis SAE, and grade 2 lipoatrophy AE), none of which were considered related to DRV/r or led to study discontinuation. Two AEs leading to discontinuation were pregnancies. These long-term safety results continue to support DRV/r as a valuable therapeutic option for the treatment of HIV-1 infection in pediatric patients aged ≥ 3 years. ClinicalTrials.gov: NCT01138605/EudraCT number: 2009-017013-29; first submitted 8 April 2010.
Identifiants
pubmed: 33367975
doi: 10.1007/s40264-020-01032-0
pii: 10.1007/s40264-020-01032-0
doi:
Substances chimiques
HIV Protease Inhibitors
0
Ritonavir
O3J8G9O825
Darunavir
YO603Y8113
Banques de données
ClinicalTrials.gov
['NCT01138605']
EudraCT
['2009-017013-29']
Types de publication
Clinical Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
439-446Références
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