PMID- 33367975
OWN - NLM
STAT- MEDLINE
DCOM- 20220420
LR  - 20220531
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Linking)
VI  - 44
IP  - 4
DP  - 2021 Apr
TI  - 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.
PG  - 439-446
LID - 10.1007/s40264-020-01032-0 [doi]
AB  - INTRODUCTION: Darunavir is a human immunodeficiency virus type 1 (HIV-1) protease 
      inhibitor boosted with ritonavir (DRV/r) or cobicistat. OBJECTIVE: This study 
      provided continued access to DRV/r and assessed long-term safety in patients aged 
      3 to < 18 years. METHODS: 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). RESULTS: 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. CONCLUSION: 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. TRIAL 
      REGISTRATION: ClinicalTrials.gov: NCT01138605/EudraCT number: 2009-017013-29; 
      first submitted 8 April 2010.
FAU - Violari, Avy
AU  - Violari A
AUID- ORCID: 0000-0002-9437-776X
AD  - Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, University of the 
      Witwatersrand, Johannesburg, South Africa. violari@mweb.co.za.
FAU - Masenya, Maysseb
AU  - Masenya M
AD  - Shandukani Research Centre, Wits RHI, Johannesburg, South Africa.
FAU - Blanche, Stephane
AU  - Blanche S
AD  - Pediatric Immunology-Hematology Unit, Hopital Necker-Enfants Malades, Assistance 
      Publique-Hopitaux de Paris (AP-HP) and Faculte de Medecine Paris Descartes, 
      Paris, France.
FAU - Vanveggel, Simon
AU  - Vanveggel S
AD  - Janssen Pharmaceutica NV, Beerse, Belgium.
FAU - Hufkens, Veerle
AU  - Hufkens V
AD  - Janssen Pharmaceutica NV, Beerse, Belgium.
FAU - Chetty, Polan
AU  - Chetty P
AD  - Janssen Research and Development, High Wycombe, UK.
FAU - Opsomer, Magda
AU  - Opsomer M
AD  - Janssen Pharmaceutica NV, Beerse, Belgium.
LA  - eng
SI  - ClinicalTrials.gov/NCT01138605
SI  - EudraCT/2009-017013-29
PT  - Clinical Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20201224
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
RN  - 0 (HIV Protease Inhibitors)
RN  - O3J8G9O825 (Ritonavir)
RN  - YO603Y8113 (Darunavir)
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Child, Preschool
MH  - *Darunavir/adverse effects
MH  - Follow-Up Studies
MH  - *HIV Infections/drug therapy
MH  - HIV Protease Inhibitors/adverse effects
MH  - *HIV-1
MH  - Health Services Accessibility
MH  - Humans
MH  - *Ritonavir/adverse effects
EDAT- 2020/12/29 06:00
MHDA- 2022/04/21 06:00
CRDT- 2020/12/28 12:20
PHST- 2020/12/05 00:00 [accepted]
PHST- 2020/12/29 06:00 [pubmed]
PHST- 2022/04/21 06:00 [medline]
PHST- 2020/12/28 12:20 [entrez]
AID - 10.1007/s40264-020-01032-0 [pii]
AID - 10.1007/s40264-020-01032-0 [doi]
PST - ppublish
SO  - Drug Saf. 2021 Apr;44(4):439-446. doi: 10.1007/s40264-020-01032-0. Epub 2020 Dec 
      24.