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
. 2025 Jun 1;99(2):202-210.
doi: 10.1097/QAI.0000000000003655.

Efficacy and Safety of the Two-Drug Regimen Dolutegravir-Lamivudine in Adolescents Living With HIV-1 Naive to Antiretroviral Therapy at 48 Weeks (DANCE): A Single-Arm, Open-Label, Phase 3b Trial

Thanyawee Puthanakit  1 , Linda Aurpibul  2 , Monica Lopez  3 , Marcia Wang  4 , Marika Ciuffa  5 , Gilda Bontempo  6 , S Y Amy Cheung  4   7 , Isabelle Deprez  4   7 , Ann M Buchanan  3 , Cindy Vavro  3 , Michael McKenna  5 , Sherene Min  3 , Lionel K Tan  8
Affiliations
Clinical Trial

Efficacy and Safety of the Two-Drug Regimen Dolutegravir-Lamivudine in Adolescents Living With HIV-1 Naive to Antiretroviral Therapy at 48 Weeks (DANCE): A Single-Arm, Open-Label, Phase 3b Trial

Thanyawee Puthanakit et al. J Acquir Immune Defic Syndr. .

Abstract

Background: Dolutegravir-lamivudine is recommended for initial antiretroviral therapy (ART) in adults living with HIV-1; however, no clinical trials have assessed this regimen in adolescents, a potentially more challenging population to treat. We evaluated efficacy, safety, and pharmacokinetics of dolutegravir-lamivudine as initial ART in adolescents living with HIV-1.

Setting: Nine centers in Thailand, Kenya, and South Africa.

Methods: In the single-arm, open-label, phase 3b DANCE study (NCT03682848), adolescents naive to ART aged ≥12 to <18 years, weighing ≥25 kg, with plasma HIV-1 RNA 1000 to ≤500,000 copies/mL received single once-daily dolutegravir-lamivudine fixed-dose combination tablet orally for 48 weeks (treatment phase). The primary endpoint was proportion of participants with HIV-1 RNA <50 copies/mL at Week 48 [Snapshot; intention-to-treat-exposed (ITT-E) population]. Safety outcomes were evaluated in the safety population. Both the ITT-E and safety populations consisted of participants who received ≥1 dose of dolutegravir-lamivudine (N = 32). A sensitivity analysis was performed using data from all but 2 participants who were withdrawn before Week 48 because of site closure (n = 30).

Results: At Week 48, 26 of 32 (81%; 95% CI: 64 to 93) participants had HIV-1 RNA <50 copies/mL; in sensitivity analyses, 26 of 30 (87%; 95% CI: 69 to 96) participants achieved virologic suppression. No confirmed virologic withdrawals or deaths were reported. One drug-related adverse event was reported (grade 3 decreased glomerular filtration rate) and was the only adverse event leading to study withdrawal at data cut. Pharmacokinetic parameters were comparable with adult systemic exposure ranges.

Conclusions: Dolutegravir-lamivudine demonstrated efficacy and safety as initial ART in adolescents with HIV-1 through 48 weeks.

Keywords: 2-drug regimen; adolescents; antiretroviral therapy; dolutegravir; lamivudine; pharmacokinetics.

PubMed Disclaimer

References

    1. Gandhi RT, Bedimo R, Hoy JF, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2022 recommendations of the International Antiviral Society-USA Panel. JAMA. 2023;329:63–84.
    1. World Health Organization. Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery and Monitoring: Recommendations for a Public Health Approach. World Health Organization; 2021. Available at: https://www.who.int/publications/i/item/9789240031593 . Accessed May 7, 2024.
    1. European AIDS Clinical Society. Guidelines Version 12.0. European AIDS Clinical Society; 2023. Available at: https://www.eacsociety.org/media/guidelines-12.0.pdf . Accessed May 7, 2024.
    1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services, February 27, 2024. Available at: https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/ad... . Accessed May 7, 2024.
    1. Cahn P, Sierra Madero J, Arribas JR, et al. Three-year durable efficacy of dolutegravir plus lamivudine in antiretroviral therapy-naive adults with HIV-1 infection. AIDS. 2022;36:39–48.

Publication types

MeSH terms

Associated data

Grants and funding