PMID- 37815035
OWN - NLM
STAT- MEDLINE
DCOM- 20231226
LR  - 20240319
IS  - 2048-7207 (Electronic)
IS  - 2048-7193 (Linking)
VI  - 12
IP  - 12
DP  - 2023 Dec 16
TI  - Efficacy, Safety, and Tolerability of Doravirine/Lamivudine/Tenofovir Disoproxil 
      Fumarate Fixed-Dose Combination Tablets in Adolescents Living With HIV: Results 
      Through Week 96 from IMPAACT 2014.
PG  - 602-609
LID - 10.1093/jpids/piad078 [doi]
AB  - BACKGROUND: IMPAACT 2014 study is a phase I/II, multicenter, open-label, 
      nonrandomized study of doravirine (DOR) co-formulated with lamivudine (3TC) and 
      tenofovir disoproxil fumarate (TDF) as fixed-dose combination (DOR FDC) in 
      adolescents with HIV-1. We report the efficacy, safety, and tolerability of DOR 
      FDC through 96 weeks. METHODS: Participants were adolescents aged 12 to <18 years 
      who weighed at least 45 kg and who were either antiretroviral (ARV)-naive or 
      virologically suppressed without documented resistance mutations to DOR/3TC/TDF. 
      The efficacy endpoint was the proportion of participants with HIV-1 RNA <40 
      copies/mL assessed at weeks 48 and 96 using the observed failure approach. Safety 
      and tolerability outcomes were incidence of adverse events (AEs) and treatment 
      discontinuations. RESULTS: A total of 45 adolescents, median age 15 (range, 
      12-17) years, 58% females, were enrolled and 2 (4.4%) participants were ARV 
      naive. Of the 45 participants, 42 (93.3%) completed the study and 41 (91.1%) 
      completed the study treatment. At week 48, 41/42 (97.6%; 95% confidence interval 
      [CI], 87.4-99.9) and week 96, 37/40 (92.5%; 95% CI, 79.6-98.4) participants had 
      achieved or maintained HIV-1 RNA <40 copies/mL. There were no treatment-related 
      discontinuations due to AEs and no drug-related AEs >/=grade 3 or deaths. 
      CONCLUSIONS: We found once-daily dosing of DOR FDC to be safe and well tolerated 
      for maintaining viral suppression through 96 weeks in adolescents living with 
      HIV-1.
CI  - (c) The Author(s) 2023. Published by Oxford University Press on behalf of The 
      Journal of the Pediatric Infectious Diseases Society. All rights reserved. For 
      permissions, please e-mail: journals.permissions@oup.com.
FAU - Rungmaitree, Supattra
AU  - Rungmaitree S
AD  - Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol 
      University, Bangkok, Thailand.
FAU - Aurpibul, Linda
AU  - Aurpibul L
AUID- ORCID: 0000-0003-0246-8187
AD  - Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, 
      Thailand.
FAU - Best, Brookie M
AU  - Best BM
AD  - Skaggs School of Pharmacy and Pharmaceutical Sciences and Pediatrics Department, 
      School of Medicine-Rady Children's Hospital San Diego, University of California 
      San Diego, San Diego, California, USA.
FAU - Li, Xiang
AU  - Li X
AD  - Frontier Science Technology and Research Foundation, Madison, Wisconsin, USA.
FAU - Warshaw, Meredith G
AU  - Warshaw MG
AD  - Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public 
      Health, Boston, Massachusetts, USA.
FAU - Wan, Hong
AU  - Wan H
AD  - Merck & Co., Inc., Rahway, New Jersey, USA.
FAU - Tobin, Nicole H
AU  - Tobin NH
AD  - Department of Pediatrics, Division of Pediatric Infectious Diseases, David Geffen 
      School of Medicine, University of California, Los Angeles, California, USA.
FAU - Jumes, Patricia
AU  - Jumes P
AD  - Merck & Co., Inc., Rahway, New Jersey, USA.
FAU - Leavitt, Randi
AU  - Leavitt R
AD  - Merck & Co., Inc., Rahway, New Jersey, USA.
FAU - McCarthy, Katie
AU  - McCarthy K
AD  - FHI 360, Durham, North Carolina, USA.
FAU - Scheckter, Rachel
AU  - Scheckter R
AD  - FHI 360, Durham, North Carolina, USA.
FAU - Ounchanum, Pradthana
AU  - Ounchanum P
AD  - Chiangrai Prachanukroh Hospital PHPT, Chiang Rai, Thailand.
FAU - Violari, Avy
AU  - Violari A
AD  - Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South 
      Africa.
FAU - Teppler, Hedy
AU  - Teppler H
AD  - Merck & Co., Inc., Rahway, New Jersey, USA.
FAU - Campbell, Havilland
AU  - Campbell H
AD  - Merck & Co., Inc., Rahway, New Jersey, USA.
FAU - Krotje, Chelsea
AU  - Krotje C
AD  - Frontier Science, Amherst, New York, USA.
FAU - Townley, Ellen
AU  - Townley E
AD  - DAIDS/NIAID/NIH, Rockville, Maryland, USA.
FAU - Moye, Jack
AU  - Moye J
AD  - NICHD/NIH, Bethesda, Maryland, USA.
FAU - Melvin, Ann J
AU  - Melvin AJ
AD  - Department of Pediatrics, Division of Pediatric Infectious Disease, University of 
      Washington and Seattle Children's Research Institute, Seattle, Washington, USA.
CN  - IMPAACT 2014 study team
LA  - eng
GR  - UM1 AI068616/AI/NIAID NIH HHS/United States
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PL  - England
TA  - J Pediatric Infect Dis Soc
JT  - Journal of the Pediatric Infectious Diseases Society
JID - 101586049
RN  - 0 (Anti-HIV Agents)
RN  - 0 (Anti-Retroviral Agents)
RN  - 913P6LK81M (doravirine)
RN  - 2T8Q726O95 (Lamivudine)
RN  - 63231-63-0 (RNA)
RN  - 99YXE507IL (Tenofovir)
SB  - IM
MH  - Adolescent
MH  - Female
MH  - Humans
MH  - Male
MH  - *Anti-HIV Agents/adverse effects
MH  - Anti-Retroviral Agents/therapeutic use
MH  - *HIV Infections/drug therapy
MH  - *HIV Seropositivity
MH  - Lamivudine/adverse effects
MH  - RNA/therapeutic use
MH  - Tenofovir/adverse effects
MH  - Treatment Outcome
OTO - NOTNLM
OT  - HIV-1
OT  - MK-1439A
OT  - adolescents
OT  - doravirine
FIR - Beck, Justine
IR  - Beck J
FIR - Sise, Thucuma
IR  - Sise T
FIR - Kapogiannis, Bill G
IR  - Kapogiannis BG
FIR - George, Kathleen
IR  - George K
FIR - Morgan, Patricia
IR  - Morgan P
FIR - Woolwine-Cunningham, Yvonne
IR  - Woolwine-Cunningham Y
FIR - Leblanc, Rebecca
IR  - Leblanc R
FIR - Trabert, Kathleen
IR  - Trabert K
FIR - Mendell, Jeanne
IR  - Mendell J
FIR - Alvero, Carmelita
IR  - Alvero C
FIR - Farhad, Mona
IR  - Farhad M
FIR - Pasyar, Sarah
IR  - Pasyar S
FIR - Muresan, Petronella
IR  - Muresan P
FIR - Patel, Nehali
IR  - Patel N
FIR - English, Adrienne
IR  - English A
FIR - Heince, Ryan
IR  - Heince R
FIR - Jones, Sandra
IR  - Jones S
FIR - Cooper, Ellen
IR  - Cooper E
FIR - McLaud, Debra
IR  - McLaud D
FIR - McFarland, Elizabeth
IR  - McFarland E
FIR - Hays, Shane Curran
IR  - Hays SC
FIR - Dunn, Jennifer
IR  - Dunn J
FIR - Navarro, Kacey
IR  - Navarro K
FIR - Robson, Amanda
IR  - Robson A
FIR - Ndiwani, Hilda
IR  - Ndiwani H
FIR - Mathiba, Ruth
IR  - Mathiba R
FIR - Violari, Avy
IR  - Violari A
FIR - Ramsagar, Nastassja
IR  - Ramsagar N
FIR - Chotirosniramit, Nuntisa
IR  - Chotirosniramit N
FIR - Khamrong, Chintana
IR  - Khamrong C
FIR - Chantong, Jiraporn
IR  - Chantong J
FIR - Srita, Angkana
IR  - Srita A
FIR - Cressey, Tim R
IR  - Cressey TR
FIR - Sukrakanchana, Praornsuda
IR  - Sukrakanchana P
FIR - Kaewmamuang, Kanyanee
IR  - Kaewmamuang K
FIR - Thaweesombat, Yupawan
IR  - Thaweesombat Y
FIR - Vanprapar, Nirun
IR  - Vanprapar N
FIR - Chokephaibulkit, Kulkanya
IR  - Chokephaibulkit K
FIR - Kongstan, Nantaka
IR  - Kongstan N
FIR - Lermankul, Watcharee
IR  - Lermankul W
EDAT- 2023/10/10 12:43
MHDA- 2023/12/18 06:42
CRDT- 2023/10/10 06:53
PHST- 2023/05/24 00:00 [received]
PHST- 2023/09/27 00:00 [accepted]
PHST- 2023/12/18 06:42 [medline]
PHST- 2023/10/10 12:43 [pubmed]
PHST- 2023/10/10 06:53 [entrez]
AID - 7303744 [pii]
AID - 10.1093/jpids/piad078 [doi]
PST - ppublish
SO  - J Pediatric Infect Dis Soc. 2023 Dec 16;12(12):602-609. doi: 
      10.1093/jpids/piad078.