Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2023 Dec 16;12(12):602-609.
doi: 10.1093/jpids/piad078.

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

Supattra Rungmaitree  1 , Linda Aurpibul  2 , Brookie M Best  3 , Xiang Li  4 , Meredith G Warshaw  5 , Hong Wan  6 , Nicole H Tobin  7 , Patricia Jumes  6 , Randi Leavitt  6 , Katie McCarthy  8 , Rachel Scheckter  8 , Pradthana Ounchanum  9 , Avy Violari  10 , Hedy Teppler  6 , Havilland Campbell  6 , Chelsea Krotje  11 , Ellen Townley  12 , Jack Moye  13 , Ann J Melvin  14 ; IMPAACT 2014 study team
Collaborators, Affiliations
Clinical Trial

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

Supattra Rungmaitree et al. J Pediatric Infect Dis Soc. .

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.

Keywords: HIV-1; MK-1439A; adolescents; doravirine.

PubMed Disclaimer

References

    1. Flynn PM, Abrams EJ. Growing up with perinatal HIV. AIDS 2019; 33:597–603. - PubMed
    1. Kibalama Ssemambo P, Nalubega-Mboowa MG, Owora A, et al. . Virologic response of treatment experienced HIV-infected Ugandan children and adolescents on NNRTI based first-line regimen, previously monitored without viral load. BMC Pediatr 2021; 21:139. - PMC - PubMed
    1. Salou M, Dagnra AY, Butel C, et al. . High rates of virological failure and drug resistance in perinatally HIV-1-infected children and adolescents receiving lifelong antiretroviral therapy in routine clinics in Togo. J Int AIDS Soc 2016; 19:20683. - PMC - PubMed
    1. Frange P, Blanche S, Veber F, Avettand-Fenoel V. Dolutegravir in the long term in children and adolescents: frequent virological failure but rare acquired genotypic resistance. HIV Med 2021; 22:958–64. - PubMed
    1. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV 2021. Accessed June 3, 2021. https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult...

Publication types