PMID- 36912172
OWN - NLM
STAT- MEDLINE
DCOM- 20230314
LR  - 20230925
IS  - 1468-1293 (Electronic)
IS  - 1464-2662 (Linking)
VI  - 24
IP  - 3
DP  - 2023 Mar
TI  - Efficacy and safety of switching to bictegravir, emtricitabine, and tenofovir 
      alafenamide in virologically suppressed Asian adults living with HIV: A pooled 
      analysis from three international phase III randomized trials.
PG  - 290-300
LID - 10.1111/hiv.13386 [doi]
AB  - OBJECTIVES: Data on switching to bictegravir, emtricitabine, and tenofovir 
      alafenamide (B/F/TAF) in virologically suppressed Asian people living with HIV 
      are limited. We performed a pooled analysis of virologically suppressed Asian 
      participants from three international phase III trials to evaluate the efficacy 
      and safety of switching to B/F/TAF. METHODS: Virologically suppressed people 
      living with HIV were randomized to switch to B/F/TAF or to stay on baseline 
      regimens. The primary endpoint was the proportion of participants with plasma 
      HIV-1 RNA >/=50 copies/ml at week 48. We analysed the incidence of adverse events 
      (AEs), laboratory abnormalities, and changes in relevant tolerability parameters 
      through 48 weeks. RESULTS: Overall, 136 Asian participants were included. The 
      proportions of participants with plasma HIV-1 RNA >/=50 copies/ml at week 48 were 
      low in both arms (0% for B/F/TAF vs 1.4% for those who stayed on baseline 
      regimens). Those who switched to B/F/TAF had virological suppression rates 
      similar to those who stayed on baseline regimens (100% vs 95.9%, p = 0.2485), 
      with no treatment-emergent resistance. Drug-related AEs occurred in three 
      participants in each arm; none were serious. No participants discontinued the 
      study drug because of AEs, and no deaths were observed. No significant 
      differences were observed between the arms in the median changes in estimated 
      glomerular filtration rate, body weight, and most lipid parameters. Switching 
      from tenofovir disoproxil fumarate-containing regimens to B/F/TAF resulted in a 
      significant decrease in tubular proteinuria compared with those who stayed on 
      baseline regimens (p < 0.01). CONCLUSIONS: Virologically suppressed Asian people 
      living with HIV who switched to B/F/TAF maintained 100% virological suppression 
      at week 48, with no treatment-emergent drug resistance and safety profiles 
      comparable to those seen in people who stayed on baseline regimens. CLINICAL 
      TRIAL NUMBER: ClinicalTrials.gov (NCT02603120, NCT02652624, and NCT02603107).
CI  - (c) 2022 The Authors. HIV Medicine published by John Wiley & Sons Ltd on behalf of 
      British HIV Association.
FAU - Avihingsanon, Anchalee
AU  - Avihingsanon A
AUID- ORCID: 0000-0003-3222-9611
AD  - HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.
AD  - Centre of Excellence in Tuberculosis, Faculty of Medicine, Chulalongkorn 
      University, Bangkok, Thailand.
FAU - Chetchotisakd, Ploenchan
AU  - Chetchotisakd P
AD  - Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
FAU - Kiertiburanakul, Sasisopin
AU  - Kiertiburanakul S
AUID- ORCID: 0000-0003-4379-4704
AD  - Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
FAU - Ratanasuwan, Winai
AU  - Ratanasuwan W
AD  - Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
FAU - Siripassorn, Krittaecho
AU  - Siripassorn K
AD  - Bamrasnaradura Infectious Diseases Institute, Nonthaburi, Thailand.
FAU - Supparatpinyo, Khuanchai
AU  - Supparatpinyo K
AD  - Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
FAU - Martin, Hal
AU  - Martin H
AD  - Gilead Sciences, Foster City, California, USA.
FAU - Wang, Hui
AU  - Wang H
AD  - Gilead Sciences, Foster City, California, USA.
FAU - Wong, TinHung
AU  - Wong T
AD  - Gilead Sciences, Hong Kong.
FAU - Wang, Hsiu Yin
AU  - Wang HY
AD  - Gilead Sciences, Taipei, Taiwan.
LA  - eng
SI  - ClinicalTrials.gov/NCT02603120
SI  - ClinicalTrials.gov/NCT02603107
SI  - ClinicalTrials.gov/NCT02652624
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20220817
PL  - England
TA  - HIV Med
JT  - HIV medicine
JID - 100897392
RN  - G70B4ETF4S (Emtricitabine)
RN  - 8GB79LOJ07 (bictegravir)
RN  - 0 (Anti-HIV Agents)
RN  - JAC85A2161 (Adenine)
RN  - 0 (Heterocyclic Compounds, 4 or More Rings)
RN  - 63231-63-0 (RNA)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Emtricitabine/therapeutic use
MH  - *HIV Infections/drug therapy
MH  - *Anti-HIV Agents/therapeutic use
MH  - Randomized Controlled Trials as Topic
MH  - Adenine/adverse effects
MH  - Heterocyclic Compounds, 4 or More Rings/adverse effects
MH  - RNA/therapeutic use
OTO - NOTNLM
OT  - Asian
OT  - Bictegravir
OT  - HIV
OT  - regimen switch
OT  - safety
OT  - virologically suppressed
EDAT- 2023/03/14 06:00
MHDA- 2023/03/15 06:00
CRDT- 2023/03/13 06:12
PHST- 2022/01/27 00:00 [received]
PHST- 2022/07/27 00:00 [accepted]
PHST- 2023/03/13 06:12 [entrez]
PHST- 2023/03/14 06:00 [pubmed]
PHST- 2023/03/15 06:00 [medline]
AID - 10.1111/hiv.13386 [doi]
PST - ppublish
SO  - HIV Med. 2023 Mar;24(3):290-300. doi: 10.1111/hiv.13386. Epub 2022 Aug 17.