PMID- 36896821
OWN - NLM
STAT- MEDLINE
DCOM- 20230313
LR  - 20230428
IS  - 2040-2058 (Electronic)
IS  - 1359-6535 (Linking)
VI  - 28
IP  - 2
DP  - 2023 Feb
TI  - Treatment-related early discontinuations and adverse events among newly diagnosed 
      people living with HIV initiating integrase inhibitors in a real-world setting.
PG  - 13596535231163703
LID - 10.1177/13596535231163703 [doi]
AB  - BACKGROUND: Cohort studies suggest higher discontinuation rates with integrase 
      strand transfer inhibitors (INSTIs) than are seen in clinical trials. We assessed 
      discontinuations and adverse events (AEs) that were considered related to the 
      initial INSTI in the first year following initiation among treatment-naive people 
      living with HIV (PLWH). METHODS: Newly diagnosed PLWH initiating raltegravir, 
      elvitegravir/cobicistat, dolutegravir or bictegravir in combination with 
      emtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil 
      fumarate between 10/2007 and 1/2020 at the Orlando Immunology Center were 
      included. Unadjusted incidence rates (IRs) and incidence rate ratios (IRRs) were 
      calculated for treatment-related discontinuations and AEs associated with the 
      initial INSTI in the first year following initiation. RESULTS: Of 331 enrolled, 
      26 (8%) initiated raltegravir, 151 (46%) initiated elvitegravir/cobicistat, 74 
      (22%) initiated dolutegravir and 80 (24%) initiated bictegravir. Within the first 
      year, treatment-related discontinuations occurred in 3 on elvitegravir/cobicistat 
      (IR 0.02 per person-years (PPY)) and 5 on dolutegravir (IR 0.08 PPY); no 
      treatment-related discontinuations occurred among those initiating raltegravir or 
      bictegravir. Eleven treatment-related AEs occurred in 7 on raltegravir (IR 0.46 
      PPY), 100 treatment-related AEs occurred in 63 on elvitegravir/cobicistat (IR 
      0.72 PPY), 66 treatment-related AEs occurred in 37 on dolutegravir (IR 0.97 PPY) 
      and 65 treatment-related AEs occurred in 34 on bictegravir (IR 0.88 PPY). 
      Unadjusted IRRs did not reveal any significant difference between INSTIs in terms 
      of early treatment-related discontinuations or AEs. CONCLUSIONS: In our cohort, 
      treatment-related AEs occurred in 43% initiating INSTIs but were responsible for 
      early discontinuation in only 2% with no treatment-related discontinuations 
      observed among those initiating RAL or BIC.
FAU - Rolle, Charlotte-Paige
AU  - Rolle CP
AUID- ORCID: 0000-0002-6444-2225
AD  - Orlando Immunology Center, Orlando, FL, USA.
AD  - Department of Global Health, Emory University Rollins School of Public Health, 
      Atlanta, GA, USA.
FAU - Castano, Jamie
AU  - Castano J
AD  - Orlando Immunology Center, Orlando, FL, USA.
FAU - Nguyen, Vu
AU  - Nguyen V
AD  - Orlando Immunology Center, Orlando, FL, USA.
FAU - Patel, Kiran
AU  - Patel K
AD  - 2158Gilead Sciences, Foster City, CA, USA.
FAU - Hinestrosa, Federico
AU  - Hinestrosa F
AD  - Orlando Immunology Center, Orlando, FL, USA.
AD  - 124506University of Central Florida College of Medicine, Orlando, FL, USA.
FAU - DeJesus, Edwin
AU  - DeJesus E
AD  - Orlando Immunology Center, Orlando, FL, USA.
AD  - 124506University of Central Florida College of Medicine, Orlando, FL, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Antivir Ther
JT  - Antiviral therapy
JID - 9815705
RN  - 8GB79LOJ07 (bictegravir)
RN  - 43Y000U234 (Raltegravir Potassium)
RN  - 0 (Integrase Inhibitors)
RN  - 0 (Heterocyclic Compounds, 3-Ring)
RN  - 0 (Pyridones)
RN  - 0 (Anti-HIV Agents)
RN  - G70B4ETF4S (Emtricitabine)
RN  - LW2E03M5PG (Cobicistat)
RN  - 0 (HIV Integrase Inhibitors)
SB  - IM
MH  - Humans
MH  - *HIV Infections/drug therapy/diagnosis
MH  - Raltegravir Potassium/adverse effects
MH  - Integrase Inhibitors/therapeutic use
MH  - Heterocyclic Compounds, 3-Ring/adverse effects
MH  - Pyridones/adverse effects
MH  - *Anti-HIV Agents/adverse effects
MH  - Emtricitabine/therapeutic use
MH  - Cobicistat/adverse effects
MH  - *HIV Integrase Inhibitors/adverse effects
OTO - NOTNLM
OT  - INSTI discontinuations
OT  - adverse events
OT  - real-world
OT  - safety
OT  - tolerability
EDAT- 2023/03/11 06:00
MHDA- 2023/03/14 06:00
CRDT- 2023/03/10 06:03
PHST- 2023/03/10 06:03 [entrez]
PHST- 2023/03/11 06:00 [pubmed]
PHST- 2023/03/14 06:00 [medline]
AID - 10.1177/13596535231163703 [doi]
PST - ppublish
SO  - Antivir Ther. 2023 Feb;28(2):13596535231163703. doi: 10.1177/13596535231163703.