PMID- 34180785
OWN - NLM
STAT- MEDLINE
DCOM- 20211025
LR  - 20211025
IS  - 2578-7470 (Electronic)
IS  - 2578-7470 (Linking)
VI  - 22
IP  - 2
DP  - 2021 Apr
TI  - Dolutegravir-based regimens in treatment-naive and treatment-experienced aging 
      populations: analyses of 6 phase III clinical trials.
PG  - 46-54
LID - 10.1080/25787489.2021.1941672 [doi]
AB  - Background: Older adults living with HIV (OALWH) are a growing population facing 
      unique challenges to successful antiretroviral therapy.Objective: To assess 
      efficacy and safety profiles of antiretroviral regimens, including those 
      containing dolutegravir, in OALWH.Methods: Combined data from 6 phase III/IIIb 
      trials in treatment-naive (ARIA, FLAMINGO, SINGLE, SPRING-2; N = 2634) and 
      treatment-experienced (DAWNING, SAILING; N = 1339) participants receiving 
      dolutegravir- or non-dolutegravir-based regimens were analyzed by age (<50, >/=50 
      to <65, and >/=65 years). Baseline data included comorbidities and numbers of 
      concomitant medications. Week 48 efficacy outcomes included virologic response 
      (HIV-1 RNA <50 copies/mL) and CD4+ cell count change from baseline. Safety 
      outcomes included incidence of adverse events (AEs), serious AEs, and AE-related 
      withdrawals.Results: Use of >/=5 concomitant medications was more frequently 
      reported among treatment-naive and treatment-experienced participants aged >/=50 to 
      <65 (30% [90/296] and 25% [57/227], respectively) and >/=65 years (43% [10/23] and 
      29% [4/14]) than among those aged <50 years (13% [310/2315] and 11% [118/1098]). 
      Comorbidities were more prevalent in the older age groups. For dolutegravir-based 
      regimens, Week 48 rates of virologic response and change in CD4+ cell count were 
      similar across age groups (treatment naive, 80-87% and 234-251 cells/mm(3); 
      treatment experienced, 70-100% and 105-156 cells/mm(3), respectively). There were 
      no major differences in safety outcomes in each age group.Conclusions: In these 
      analyses of combined phase III/IIIb trial data, efficacy and safety of 
      dolutegravir-based regimens were generally similar across age groups in 
      treatment-naive or treatment-experienced participants. Polypharmacy and 
      comorbidities were more common among OALWH than those aged <50 years.
FAU - Spinelli, Frank
AU  - Spinelli F
AD  - ViiV Healthcare, Research Triangle Park, NC, USA.
FAU - Prakash, Manyu
AU  - Prakash M
AD  - ViiV Healthcare, Brentford, UK.
FAU - Slater, Jill
AU  - Slater J
AD  - ViiV Healthcare, Research Triangle Park, NC, USA.
FAU - van der Kolk, Mike
AU  - van der Kolk M
AD  - ViiV Healthcare, Amersfoort, Netherlands.
FAU - Bassani, Niccolo
AU  - Bassani N
AD  - Quanticate, Hitchin, UK.
FAU - Grove, Richard
AU  - Grove R
AD  - GlaxoSmithKline, Uxbridge, UK.
FAU - Wynne, Brian
AU  - Wynne B
AD  - ViiV Healthcare, Research Triangle Park, NC, USA.
FAU - van Wyk, Jean
AU  - van Wyk J
AD  - ViiV Healthcare, Brentford, UK.
FAU - Clark, Andrew
AU  - Clark A
AD  - ViiV Healthcare, Brentford, UK.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20210628
PL  - England
TA  - HIV Res Clin Pract
JT  - HIV research & clinical practice
JID - 101738312
RN  - 0 (Heterocyclic Compounds, 3-Ring)
RN  - 0 (Oxazines)
RN  - 0 (Piperazines)
RN  - 0 (Pyridones)
RN  - DKO1W9H7M1 (dolutegravir)
SB  - IM
MH  - Aged
MH  - Aging
MH  - *HIV Infections/drug therapy
MH  - *HIV-1
MH  - Heterocyclic Compounds, 3-Ring
MH  - Humans
MH  - Oxazines
MH  - Piperazines
MH  - Pyridones
OTO - NOTNLM
OT  - antiretroviral therapy
OT  - comorbidities
OT  - integrase strand transfer inhibitor
OT  - older adults living with HIV
OT  - polypharmacy
OT  - virologic suppression
EDAT- 2021/06/29 06:00
MHDA- 2021/10/26 06:00
CRDT- 2021/06/28 12:17
PHST- 2021/06/29 06:00 [pubmed]
PHST- 2021/10/26 06:00 [medline]
PHST- 2021/06/28 12:17 [entrez]
AID - 10.1080/25787489.2021.1941672 [doi]
PST - ppublish
SO  - HIV Res Clin Pract. 2021 Apr;22(2):46-54. doi: 10.1080/25787489.2021.1941672. 
      Epub 2021 Jun 28.