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
Issued Date
2023-12-01
Resource Type
ISSN
20487193
eISSN
20487207
Scopus ID
2-s2.0-85180270961
Pubmed ID
37815035
Journal Title
Journal of the Pediatric Infectious Diseases Society
Volume
12
Issue
12
Start Page
602
End Page
609
Rights Holder(s)
SCOPUS
Bibliographic Citation
Journal of the Pediatric Infectious Diseases Society Vol.12 No.12 (2023) , 602-609
Suggested Citation
Rungmaitree S., Aurpibul L., Best B.M., Li X., Warshaw M.G., Wan H., Tobin N.H., Jumes P., Leavitt R., McCarthy K., Scheckter R., Ounchanum P., Violari A., Teppler H., Campbell H., Krotje C., Townley E., Moye J., Melvin A.J. 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. Journal of the Pediatric Infectious Diseases Society Vol.12 No.12 (2023) , 602-609. 609. doi:10.1093/jpids/piad078 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/95639
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 2014
Author's Affiliation
Siriraj Hospital
Skaggs School of Pharmacy & Pharmaceutical Sciences
FHI 360
Frontier Science & Technology Research Foundation, Inc.
National Institute of Child Health and Human Development (NICHD)
National Institute of Allergy and Infectious Diseases (NIAID)
University of the Witwatersrand, Johannesburg
University of Washington
Merck & Co., Inc.
Center for Biostatistics in AIDS Research
David Geffen School of Medicine at UCLA
Chiang Mai University
Chiangrai Prachanukroh Hospital
Frontier Science and Technology Research Foundation
Skaggs School of Pharmacy & Pharmaceutical Sciences
FHI 360
Frontier Science & Technology Research Foundation, Inc.
National Institute of Child Health and Human Development (NICHD)
National Institute of Allergy and Infectious Diseases (NIAID)
University of the Witwatersrand, Johannesburg
University of Washington
Merck & Co., Inc.
Center for Biostatistics in AIDS Research
David Geffen School of Medicine at UCLA
Chiang Mai University
Chiangrai Prachanukroh Hospital
Frontier Science and Technology Research Foundation
Corresponding Author(s)
Other Contributor(s)
Abstract
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.