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 Article Swipe
Supattra Rungmaitree
,
Linda Aurpibul
,
Brookie M. Best
,
Xiang Li
,
Meredith G. Warshaw
,
Hong Wan
,
Nicole H. Tobin
,
Patricia Jumes
,
Randi Y. Leavitt
,
Katie McCarthy
,
Rachel Scheckter
,
Pradthana Ounchanum
,
Avy Violari
,
Hedy Teppler
,
Havilland Campbell
,
Chelsea Krotje
,
Ellen Townley
,
Jack Moye
,
Ann J. Melvin
,
Justine Beck
,
Thucuma Sise
,
Bill G. Kapogiannis
,
Kathleen George
,
Patricia Morgan
,
Yvonne Woolwine-Cunningham
,
Rebecca Leblanc
,
Kathleen Trabert
,
Jeanne Mendell
,
Carmelita Alvero
,
Mona Farhad
,
Sarah Pasyar
,
Petronella Muresan
,
Nehali Patel
,
Adrienne English
,
Ryan Heince
,
Sandra Gracia Jones
,
Ellen Cooper
,
Debra McLaud
,
Elizabeth J. McFarland
,
Shane Curran Hays
,
Jennifer Dunn
,
Kacey Navarro
,
Amanda Robson
,
Hilda Ndiwani
,
Ruth Mathiba
,
Avy Violari
,
Nastassja Ramsagar
,
Nuntisa Chotirosniramit
,
Chintana Khamrong
,
Jiraporn Chantong
,
Angkana Srita
,
Tim R. Cressey
,
Pra-ornsuda Sukrakanchana
,
Kanyanee Kaewmamuang
,
Yupawan Thaweesombat
,
Nirun Vanprapar
,
Kulkanya Chokephaibulkit
,
Nantaka Kongstan
,
Watcharee Lermankul
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1093/jpids/piad078
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1093/jpids/piad078
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)-naïve 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 naïve. 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.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1093/jpids/piad078
- OA Status
- green
- Cited By
- 2
- References
- 31
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4387472368
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4387472368Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1093/jpids/piad078Digital Object Identifier
- Title
-
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 2014Work title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2023Year of publication
- Publication date
-
2023-10-10Full publication date if available
- Authors
-
Supattra Rungmaitree, Linda Aurpibul, Brookie M. Best, Xiang Li, Meredith G. Warshaw, Hong Wan, Nicole H. Tobin, Patricia Jumes, Randi Y. Leavitt, Katie McCarthy, Rachel Scheckter, Pradthana Ounchanum, Avy Violari, Hedy Teppler, Havilland Campbell, Chelsea Krotje, Ellen Townley, Jack Moye, Ann J. Melvin, Justine Beck, Thucuma Sise, Bill G. Kapogiannis, Kathleen George, Patricia Morgan, Yvonne Woolwine-Cunningham, Rebecca Leblanc, Kathleen Trabert, Jeanne Mendell, Carmelita Alvero, Mona Farhad, Sarah Pasyar, Petronella Muresan, Nehali Patel, Adrienne English, Ryan Heince, Sandra Gracia Jones, Ellen Cooper, Debra McLaud, Elizabeth J. McFarland, Shane Curran Hays, Jennifer Dunn, Kacey Navarro, Amanda Robson, Hilda Ndiwani, Ruth Mathiba, Avy Violari, Nastassja Ramsagar, Nuntisa Chotirosniramit, Chintana Khamrong, Jiraporn Chantong, Angkana Srita, Tim R. Cressey, Pra-ornsuda Sukrakanchana, Kanyanee Kaewmamuang, Yupawan Thaweesombat, Nirun Vanprapar, Kulkanya Chokephaibulkit, Nantaka Kongstan, Watcharee LermankulList of authors in order
- Landing page
-
https://doi.org/10.1093/jpids/piad078Publisher landing page
- Open access
-
YesWhether a free full text is available
- OA status
-
greenOpen access status per OpenAlex
- OA URL
-
https://www.ncbi.nlm.nih.gov/pmc/articles/11494224Direct OA link when available
- Concepts
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Medicine, Tolerability, Lamivudine, Adverse effect, Dosing, Fixed-dose combination, Internal medicine, Tenofovir, Confidence interval, Clinical endpoint, Human immunodeficiency virus (HIV), Gastroenterology, Randomized controlled trial, Virology, Virus, Hepatitis B virusTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
2Total citation count in OpenAlex
- Citations by year (recent)
-
2025: 1, 2024: 1Per-year citation counts (last 5 years)
- References (count)
-
31Number of works referenced by this work
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.(TDF) | 24 |
| abstract_inverted_index.37/40 | 166 |
| abstract_inverted_index.41/42 | 156 |
| abstract_inverted_index.HIV-1 | 86, 176 |
| abstract_inverted_index.I/II, | 8 |
| abstract_inverted_index.There | 180 |
| abstract_inverted_index.[CI], | 161 |
| abstract_inverted_index.found | 198 |
| abstract_inverted_index.least | 59 |
| abstract_inverted_index.phase | 7 |
| abstract_inverted_index.study | 4, 12, 145, 151 |
| abstract_inverted_index.total | 116 |
| abstract_inverted_index.using | 96 |
| abstract_inverted_index.viral | 212 |
| abstract_inverted_index.weeks | 92, 216 |
| abstract_inverted_index.years | 55 |
| abstract_inverted_index.(4.4%) | 132 |
| abstract_inverted_index.HIV-1. | 33, 221 |
| abstract_inverted_index.Safety | 101 |
| abstract_inverted_index.dosing | 200 |
| abstract_inverted_index.either | 65 |
| abstract_inverted_index.events | 109 |
| abstract_inverted_index.living | 219 |
| abstract_inverted_index.median | 120 |
| abstract_inverted_index.report | 35 |
| abstract_inverted_index.weeks. | 46 |
| abstract_inverted_index.years, | 125 |
| abstract_inverted_index.(91.1%) | 148 |
| abstract_inverted_index.(92.5%; | 167 |
| abstract_inverted_index.(93.3%) | 142 |
| abstract_inverted_index.(97.6%; | 157 |
| abstract_inverted_index.(range, | 123 |
| abstract_inverted_index.IMPAACT | 2 |
| abstract_inverted_index.Methods | 47 |
| abstract_inverted_index.Results | 114 |
| abstract_inverted_index.adverse | 108 |
| abstract_inverted_index.deaths. | 195 |
| abstract_inverted_index.failure | 99 |
| abstract_inverted_index.naïve. | 136 |
| abstract_inverted_index.safety, | 38 |
| abstract_inverted_index.through | 44, 214 |
| abstract_inverted_index.weighed | 57 |
| abstract_inverted_index.without | 71 |
| abstract_inverted_index.12–17) | 124 |
| abstract_inverted_index.Abstract | 0 |
| abstract_inverted_index.achieved | 173 |
| abstract_inverted_index.assessed | 90 |
| abstract_inverted_index.efficacy | 78 |
| abstract_inverted_index.endpoint | 79 |
| abstract_inverted_index.enrolled | 129 |
| abstract_inverted_index.females, | 127 |
| abstract_inverted_index.fumarate | 23 |
| abstract_inverted_index.interval | 160 |
| abstract_inverted_index.observed | 98 |
| abstract_inverted_index.outcomes | 104 |
| abstract_inverted_index.≥grade | 192 |
| abstract_inverted_index.approach. | 100 |
| abstract_inverted_index.completed | 143, 149 |
| abstract_inverted_index.copies/mL | 89 |
| abstract_inverted_index.efficacy, | 37 |
| abstract_inverted_index.incidence | 106 |
| abstract_inverted_index.mutations | 74 |
| abstract_inverted_index.tenofovir | 21 |
| abstract_inverted_index.tolerated | 209 |
| abstract_inverted_index.treatment | 112 |
| abstract_inverted_index.&lt;18 | 54 |
| abstract_inverted_index.&lt;40 | 88, 178 |
| abstract_inverted_index.Background | 1 |
| abstract_inverted_index.confidence | 159 |
| abstract_inverted_index.copies/mL. | 179 |
| abstract_inverted_index.disoproxil | 22 |
| abstract_inverted_index.documented | 72 |
| abstract_inverted_index.doravirine | 14 |
| abstract_inverted_index.fixed-dose | 26 |
| abstract_inverted_index.lamivudine | 18 |
| abstract_inverted_index.maintained | 175 |
| abstract_inverted_index.once-daily | 199 |
| abstract_inverted_index.proportion | 82 |
| abstract_inverted_index.resistance | 73 |
| abstract_inverted_index.suppressed | 70 |
| abstract_inverted_index.treatment. | 152 |
| abstract_inverted_index.Conclusions | 196 |
| abstract_inverted_index.adolescents | 31, 50, 218 |
| abstract_inverted_index.combination | 27 |
| abstract_inverted_index.maintaining | 211 |
| abstract_inverted_index.open-label, | 10 |
| abstract_inverted_index.suppression | 213 |
| abstract_inverted_index.(ARV)-naïve | 67 |
| abstract_inverted_index.79.6–98.4) | 170 |
| abstract_inverted_index.87.4–99.9) | 162 |
| abstract_inverted_index.DOR/3TC/TDF. | 76 |
| abstract_inverted_index.Participants | 48 |
| abstract_inverted_index.adolescents, | 119 |
| abstract_inverted_index.drug-related | 190 |
| abstract_inverted_index.multicenter, | 9 |
| abstract_inverted_index.participants | 84, 133, 171 |
| abstract_inverted_index.tolerability | 40, 103 |
| abstract_inverted_index.co-formulated | 16 |
| abstract_inverted_index.nonrandomized | 11 |
| abstract_inverted_index.participants, | 140 |
| abstract_inverted_index.virologically | 69 |
| abstract_inverted_index.antiretroviral | 66 |
| abstract_inverted_index.discontinuations | 184 |
| abstract_inverted_index.discontinuations. | 113 |
| abstract_inverted_index.treatment-related | 183 |
| cited_by_percentile_year.max | 95 |
| cited_by_percentile_year.min | 90 |
| corresponding_author_ids | https://openalex.org/A5081328251 |
| countries_distinct_count | 3 |
| institutions_distinct_count | 59 |
| corresponding_institution_ids | https://openalex.org/I48076826 |
| sustainable_development_goals[0].id | https://metadata.un.org/sdg/3 |
| sustainable_development_goals[0].score | 0.8700000047683716 |
| sustainable_development_goals[0].display_name | Good health and well-being |
| citation_normalized_percentile.value | 0.63634371 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | False |