Cited by 723HIV/AIDS drug development and treatmentHIV/AIDS Research and InterventionsHIV Research and Treatment

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Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV

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Venter, Willem D.F., Moorhouse, Michelle, Sokhela, Simiso, Fairlie, Lee, Mashabane, Nkuli, Masenya, Masebole, Serenata, Celicia, Akpomiemie, Godspower, Qavi, Ambar, Chandiwana, Nomathemba, Norris, Shane, Chersich, Matthew, Clayden, Polly, Abrams, Elaine, Arulappan, Natasha, Vos, Alinda, McCann, Kaitlyn, Simmons, Bryony, Hill, Andrew·2019·New England Journal of Medicine

DOI 10.1056/nejmoa1902824

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Abstract

BACKGROUND: Two drugs under consideration for inclusion in antiretroviral therapy (ART) regimens for human immunodeficiency virus (HIV) infection are dolutegravir (DTG) and tenofovir alafenamide fumarate (TAF). There are limited data on their use in low- and middle-income countries. METHODS: We conducted a 96-week, phase 3, investigator-led, open-label, randomized trial in South Africa, in which we compared a triple-therapy combination of emtricitabine (FTC) and DTG plus either of two tenofovir prodrugs - TAF (TAF-based group) or tenofovir disoproxil fumarate (TDF) (TDF-based group) - against the local standard-of-care regimen of TDF-FTC-efavirenz (standard-care group). Inclusion criteria included an age of 12 years or older, no receipt of ART in the previous 6 months, a creatinine clearance of more than 60 ml per minute (>80 ml per minute in patients younger than 19 years of age), and an HIV type 1 (HIV-1) RNA level of 500 copies or more per milliliter. The primary end point was the percentage of patients with a 48-week HIV-1 RNA level of less than 50 copies per milliliter (as determined with the Snapshot algorithm from the Food and Drug Administration; noninferiority margin, -10 percentage points). We report the primary (48-week) efficacy and safety data. RESULTS: A total of 1053 patients underwent randomization from February 2017 through May 2018. More than 99% of the patients were black, and 59% were female. The mean age was 32 years, and the mean CD4 count was 337 cells per cubic millimeter. At week 48, the percentage of patients with an HIV-1 RNA level of less than 50 copies per milliliter was 84% in the TAF-based group, 85% in the TDF-based group, and 79% in the standard-care group, findings that indicate that the DTG-containing regimens were noninferior to the standard-care regimen. The number of patients who discontinued the trial regimen was higher in the standard-care group than in the other two groups. In the per-protocol population, the standard-care regimen had equivalent potency to the other two regimens. The TAF-based regimen had less effect on bone density and renal function than the other regimens. Weight increase (both lean and fat mass) was greatest in the TAF-based group and among female patients (mean increase, 6.4 kg in the TAF-based group, 3.2 kg in the TDF-based group, and 1.7 kg in the standard-care group). No resistance to integrase inhibitors was identified in patients receiving the DTG-containing regimens. CONCLUSIONS: Treatment with DTG combined with either of two tenofovir prodrugs (TAF and TDF) showed noninferior efficacy to treatment with the standard-care regimen. There was significantly more weight gain with the DTG-containing regimens, especially in combination with TAF, than with the standard-care regimen. (ADVANCE ClinicalTrials.gov number, NCT03122262.).

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Authors: Venter, W. D. F., Moorhouse, M., Sokhela, S., Fairlie, L., Mashabane, N., Masenya, M., Serenata, C., Akpomiemie, G., Qavi, A., Chandiwana, N., Norris, S., Chersich, M., Clayden, P., Abrams, E., Arulappan, N., Vos, A., McCann, K., Simmons, B., & Hill, A.
Affiliations: From Ezintsha (W.D.F.V., M. Moorhouse, S.S., N.M., C.S., G.A., N.C., N.A., A.V.), Wits Reproductive Health and HIV Institute, Faculty of Health Sciences (W.D.F.V., M. Moorhouse, S.S., L.F., N.M., M. Masenya, C.S., G.A., N.C., M.C., N.A., A.V.), and the South African Medical Research Council Developmental Pathways for Health Research Unit, Department of Pediatrics, School of Clinical Medicine, Faculty of Health Sciences (S.N.), University of the Witwatersrand, Johannesburg; the Faculty of Medicine,...
South African Medical Research Council (ZA)
ORCID: Venter, Willem D.F.
Moorhouse, Michelle
Sokhela, Simiso
Fairlie, Lee
Mashabane, Nkuli
Masenya, Masebole
Serenata, Celicia
Akpomiemie, Godspower
Qavi, Ambar
Chandiwana, Nomathemba
Norris, Shane
Chersich, Matthew
Clayden, Polly
Abrams, Elaine
Arulappan, Natasha
Vos, Alinda
McCann, Kaitlyn
Simmons, Bryony
Hill, Andrew
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2019-08-29
Volume: 381
Issue: 9
Pages: 803-815
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1902824
OpenAlex: W2962964639
Cited by: 723
References: 31
Citations by year: 2026: 65 · 2025: 84 · 2024: 117 · 2023: 110 · 2022: 90 · 2021: 112 · 2020: 120 · 2019: 25
FWCI: 66.47
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
ePrints Soton (University of Southampton) (submittedVersion)
Spiral (Imperial College London) (submittedVersion)
Utrecht University Repository (Utrecht University) (submittedVersion)
Funders: UNITAID (2016-07-Wits RHI)
U.S. Agency for International Development (AID-OAA-A-15-00069)
South African Medical Research Council
Topics: Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
Life Sciences › Immunology and Microbiology › Virology › HIV Research and Treatment
Keywords: dolutegravir, tenofovir alafenamide, tenofovir disoproxil fumarate, HIV-1 infection, antiretroviral therapy, triple therapy, emtricitabine, efavirenz, non-inferiority, viral suppression, treatment discontinuation, low- and middle-income countries, South Africa
MeSH terms: Dolutegravir, Adenine, Adolescent, Adult, Drug Therapy, Combination, Female, Heterocyclic Compounds, 3-Ring, Humans, Male, Middle Aged, Oxazines, Phosphorous Acids, Piperazines, Pregnancy, Pregnancy Complications, Infectious, Prodrugs, Pyridones, RNA, Viral, Uracil, HIV-1, Bone Density, HIV Infections, CD4 Lymphocyte Count, HIV Integrase Inhibitors, Viral Load, Anti-Retroviral Agents, Young Adult, Intention to Treat Analysis

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Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV

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