PMID- 33686573
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20210515
IS  - 2193-8229 (Print)
IS  - 2193-6382 (Electronic)
IS  - 2193-6382 (Linking)
VI  - 10
IP  - 2
DP  - 2021 Jun
TI  - Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed 
      People with HIV Aged >/= 65 Years: Week 48 Results of a Phase 3b, Open-Label Trial.
PG  - 775-788
LID - 10.1007/s40121-021-00419-5 [doi]
AB  - INTRODUCTION: We report the 48-week results of an ongoing study to assess the 
      efficacy and safety of switching older people with HIV to 
      bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF). METHODS: This was a 
      96-week, phase 3b, open-label, single-arm study (GS-US-380-4449; NCT03405935). 
      Virologically suppressed individuals aged >/= 65 years receiving 
      elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or a tenofovir 
      disoproxil fumarate-based regimen were switched to B/F/TAF. Primary endpoint was 
      the percentage of participants with HIV-1 RNA < 50 copies/ml at week 24. RESULTS: 
      Eighty-six participants (median age 69 [range 65-80] years; 87% male; 95% white) 
      were enrolled and treated in five European countries. Rates of virologic 
      suppression were 97.7% at week 24 and 90.7% at week 48; none had HIV-1 RNA >/= 50 
      copies/ml, and 100% had virologic suppression by missing = excluded analysis at 
      both time points. No treatment-emergent resistance was observed. There were no 
      grade 3-4 study drug-related adverse events (AEs) or study drug-related serious 
      AEs or deaths. Three AEs led to premature discontinuation; one (moderate 
      abdominal discomfort) was attributed to the study drug by the investigator. At 
      week 48, median changes from baseline in weight and estimated glomerular 
      filtration rate were + 0.1 kg (interquartile range [IQR] - 1.0, 2.3) 
      and - 6.0 ml/min (IQR - 10.2, 0.0), respectively. There were no clinically 
      relevant changes from baseline to week 48 in fasting lipid parameters. Treatment 
      satisfaction improved, and health-related quality of life was maintained from 
      baseline through week 48. Median adherence to the study drug was 98.6% (IQR 96.0, 
      100). CONCLUSIONS: Switching to B/F/TAF was effective and well tolerated through 
      48 weeks in virologically suppressed adults aged >/= 65 years. TRIAL REGISTRATION: 
      ClinicalTrials.gov identifier, NCT03405935.
FAU - Maggiolo, Franco
AU  - Maggiolo F
AD  - Division of Infectious Diseases, ASST Papa Giovanni XXIII, Bergamo, Italy.
FAU - Rizzardini, Giuliano
AU  - Rizzardini G
AD  - Division of Infectious Diseases, Luigi Sacco Hospital, ASST Fatebenefratelli 
      Sacco, Milan, Italy.
AD  - School of Clinical Medicine, Faculty of Health Science, University of the 
      Witwatersrand, Johannesburg, South Africa.
FAU - Molina, Jean-Michel
AU  - Molina JM
AD  - Department of Infectious Diseases, Saint Louis Hospital, University Paris 
      Diderot, Paris, France.
FAU - Pulido, Federico
AU  - Pulido F
AD  - Unidad VIH, Hospital Universitario 12 de Octubre, imas12, UCM, Madrid, Spain.
FAU - De Wit, Stephane
AU  - De Wit S
AD  - St Pierre University Hospital, Universite Libre de Bruxelles, Brussels, Belgium.
FAU - Vandekerckhove, Linos
AU  - Vandekerckhove L
AD  - University Hospital Ghent, Ghent, Belgium.
FAU - Berenguer, Juan
AU  - Berenguer J
AD  - Infectious Diseases, Hospital General Universitario Gregorio Maranon (IiSGM), 
      Madrid, Spain.
FAU - D'Antoni, Michelle L
AU  - D'Antoni ML
AD  - Gilead Sciences, Foster City, CA, USA.
FAU - Blair, Christiana
AU  - Blair C
AD  - Gilead Sciences, Foster City, CA, USA.
FAU - Chuck, Susan K
AU  - Chuck SK
AD  - Gilead Sciences, Foster City, CA, USA.
FAU - Piontkowsky, David
AU  - Piontkowsky D
AD  - Gilead Sciences, Foster City, CA, USA.
FAU - Martin, Hal
AU  - Martin H
AD  - Gilead Sciences, Foster City, CA, USA.
FAU - Haubrich, Richard
AU  - Haubrich R
AD  - Gilead Sciences, Foster City, CA, USA.
FAU - McNicholl, Ian R
AU  - McNicholl IR
AD  - Gilead Sciences, Foster City, CA, USA.
FAU - Gallant, Joel
AU  - Gallant J
AUID- ORCID: 0000-0002-7144-1642
AD  - Gilead Sciences, Foster City, CA, USA. joel.gallant@gilead.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT03405935
PT  - Journal Article
DEP - 20210309
PL  - New Zealand
TA  - Infect Dis Ther
JT  - Infectious diseases and therapy
JID - 101634499
PMC - PMC8116430
OTO - NOTNLM
OT  - Age
OT  - Bictegravir
OT  - Clinical trial
OT  - Emtricitabine
OT  - HIV
OT  - Older
OT  - Safety
OT  - Tenofovir alafenamide
EDAT- 2021/03/10 06:00
MHDA- 2021/03/10 06:01
PMCR- 2021/03/09
CRDT- 2021/03/09 06:15
PHST- 2021/01/12 00:00 [received]
PHST- 2021/02/19 00:00 [accepted]
PHST- 2021/03/10 06:00 [pubmed]
PHST- 2021/03/10 06:01 [medline]
PHST- 2021/03/09 06:15 [entrez]
PHST- 2021/03/09 00:00 [pmc-release]
AID - 10.1007/s40121-021-00419-5 [pii]
AID - 419 [pii]
AID - 10.1007/s40121-021-00419-5 [doi]
PST - ppublish
SO  - Infect Dis Ther. 2021 Jun;10(2):775-788. doi: 10.1007/s40121-021-00419-5. Epub 
      2021 Mar 9.