Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023
First Pharmacokinetic Data of Tenofovir Alafenamide Fumarate and Tenofovir With Dolutegravir or Boosted Protease Inhibitors in African Children: A Substudy of the CHAPAS-4 Trial.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
10 citing papers in PubMed, 13 citations in OpenAlex.
- Second-Line Antiretroviral Therapy for Children Living with HIV in Africa.The New England journal of medicine · 2025Trial
- Pharmacokinetics of once-daily darunavir/ritonavir in second-line treatment in African children with HIV.The Journal of antimicrobial chemotherapy · 2024Trial
- Population pharmacokinetics of ritonavir-boosted atazanavir in subsequent-line treatment in African children with HIV.Antimicrobial agents and chemotherapy · 2026Observational
- Pharmacokinetics of Twice-daily Tenofovir Alafenamide in Adults With HIV-associated Tuberculosis on Bictegravir/Emtricitabine/Tenofovir Alafenamide and Rifampicin.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- Pharmacokinetics of lopinavir/ritonavir in second-line treatment of children with HIV in the CHAPAS-4 trial.AIDS (London, England) · 2025Article
- Growing Up with HIV: A Comprehensive Review of Treatment and Care in Low- and Middle-Income Countries.Current HIV/AIDS reports · 2025Review
- CROI 2025: The Challenges of Sustaining Viral Suppression, Addressing Advanced HIV Disease, and Ending the HIV Epidemic Targets.Topics in antiviral medicine · 2025Review
- The Management of Chronic Hepatitis B: 2025 Guidelines Update from the Canadian Association for the Study of the Liver and Association of Medical Microbiology and Infectious Disease Canada.Canadian liver journal · 2025Article
- Optimising Paediatric HIV Treatment: Recent Developments and Future Directions.Paediatric drugs · 2024Review
- Comprehensive analysis of the potential biological significance of CCL5 in pan-cancer prognosis and immunotherapy.Scientific reports · 2024Article
Corrections and comments
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Authors and funding
21 authors at 8 institutions in 6 countries.
Funding
Abstract
backgroundWe evaluated the pharmacokinetics of tenofovir alafenamide fumarate (TAF) and tenofovir in a subset of African children enrolled in the CHAPAS-4 trial.
methodsChildren aged 3-15 years with human immunodeficiency virus infection failing first-line antiretroviral therapy were randomized to emtricitabine/TAF versus standard-of-care nucleoside reverse transcriptase inhibitor combination, plus dolutegravir, atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir. Daily emtricitabine/TAF was dosed according to World Health Organization (WHO)-recommended weight bands: 120/15 mg in children weighing 14 to <25 kg and 200/25 mg in those weighing ≥25 kg. At steady state, 8-9 blood samples were taken to construct pharmacokinetic curves. Geometric mean (GM) area under the concentration-time curve (AUC) and the maximum concentration (Cmax) were calculated for TAF and tenofovir and compared to reference exposures in adults.
resultsPharmacokinetic results from 104 children taking TAF were analyzed. GM (coefficient of variation [CV%]) TAF AUClast when combined with dolutegravir (n = 18), darunavir/ritonavir (n = 34), or lopinavir/ritonavir (n = 20) were 284.5 (79), 232.0 (61), and 210.2 (98) ng*hour/mL, respectively, and were comparable to adult reference values. When combined with atazanavir/ritonavir (n = 32), TAF AUClast increased to 511.4 (68) ng*hour/mL. For each combination, tenofovir GM (CV%) AUCtau and Cmax remained below reference values in adults taking 25 mg TAF with a boosted protease inhibitors.
conclusionsIn children, TAF combined with boosted PIs or dolutegravir and dosed according to WHO-recommended weight bands provides TAF and tenofovir concentrations previously demonstrated to be well tolerated and effective in adults. These data provide the first evidence for use of these combinations in African children. CLINICAL TRIALS REGISTRATION: ISRCTN22964075.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.