Final 192-week efficacy and safety results of the ADVANCE Trial, comparing 3 first-line antiretroviral regimens

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dc.contributor.authorNorris, Shane
dc.contributor.authorSokhela, Simiso
dc.contributor.authorVenter, Willem D. F.
dc.contributor.authorBosch, Bronwyn
dc.contributor.authorWoods, Joana
dc.contributor.authorMcCann, Kaitlyn
dc.contributor.authorAkpomiemie, Godspower
dc.contributor.authorChandiwana, Nomathemba
dc.contributor.authorMashabane, Nkuli
dc.contributor.authorTembo, Angela
dc.contributor.authorSimmons, Bryony
dc.contributor.authorLalla-Edward, Samanta
dc.contributor.authorSiedner, Mark J.
dc.contributor.authorSinxadi, Phumla
dc.contributor.authorHermans, Lucas
dc.contributor.authorFairlie, Lee
dc.contributor.authorVos, Alinda
dc.contributor.authorAbrams, Elaine
dc.contributor.authorManne-Goehler, Jennifer M.
dc.contributor.authorMoorhouse, Michelle
dc.contributor.authorClayden, Polly
dc.contributor.authorQavi, Ambar
dc.contributor.authorChersich, Matthew
dc.contributor.authorMasenya, Masebole
dc.contributor.authorArulappan, Natasha
dc.contributor.authorHill, Andrew
dc.date.accessioned2024-08-16T11:22:52Z
dc.date.available2024-08-16T11:22:52Z
dc.date.issued2024-01
dc.description.abstractBackground: ADVANCE compared 3 World Health Organization–recommended first-line regimens in participants with HIV who were antiretroviral naive. Methods: This randomized, open-label, noninferiority trial enrolled participants living with HIV with no antiretroviral exposure in the previous 6 months to 1 of the following arms: tenofovir alafenamide (TAF) / emtreicitabine (FTC) + dolutegravir (DTG) (2 tablets), tenofovir disoproxil fumarate (TDF) / FTC + DTG (2 tablets), or a fixed-dose combination of TDF / FTC / efavirenz (EFV) (1 tablet). We report the final safety and efficacy data up to 192 weeks. Results: Repeat consent from the original 351 participants randomized to each arm was obtained from 230 participants (66%) in the TAF/FTC + DTG arm, 209 (60%) in the TDF/FTC + DTG arm, and 183 (52%) in the TDF/FTC/EFV arm. At 192 weeks, 213 (61%) of the original 351 participants in the TAF/FTC + DTG arm, 195 (56%) in the TDF/FTC + DTG arm, and 172 (49%) in the TDF/FTC/EFV arm had confirmed RNA <50 copies/mL, with low virologic failure in all groups and no significant integrase inhibitor mutations in any arm. Mean weight gain was 8.9 kg (SD, 7.1) in the TAF/FTC + DTG arm, 5.9 kg (SD, 7.1) in the TDF/FTC + DTG arm, and 3.2 kg (SD, 8.1) in the TDF/FTC/EFV arm at 192 weeks from baseline and was greatest among women, those taking TAF, and those with lower baseline CD4 counts. The weight trajectory slowed after week 96. There were few clinical events and minor laboratory changes and differences among arms after 96 weeks. There were no significant differences in treatment-emergent hypertension or pregnancy outcomes by arm. Conclusions: High viral suppression was seen across arms, with no resistance to DTG. Weight gain continued but slowed after 96 weeks, with few clinical events or laboratory changes.
dc.description.sponsorshipUnitaid.
dc.description.sponsorshipUSAID.
dc.description.sponsorshipSouth African Medical Research Council.
dc.description.sponsorshipViiV Healthcare.
dc.description.sponsorshipGilead Sciences.
dc.description.submitterPM2024
dc.facultyFaculty of Health Sciences
dc.identifier0000-0001-7124-3788
dc.identifier.citationSokhela S, Venter WDF, Bosch B, et al. Final 192-Week Efficacy and Safety Results of the ADVANCE Trial, Comparing 3 First-line Antiretroviral Regimens. Open Forum Infect Dis. 2024;11(3):ofae007. Published 2024 Jan 24. doi:10.1093/ofid/ofae007
dc.identifier.issn2328-8957 (online)
dc.identifier.other10.1093/ofid/ofae007
dc.identifier.urihttps://hdl.handle.net/10539/40159
dc.journal.linkhttps://academic.oup.com/ofid
dc.journal.titleOpen Forum Infectious Diseases
dc.language.isoen
dc.publisherOxford University Press
dc.rights© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence
dc.schoolSchool of Clinical Medicine
dc.subjectDolutegravir
dc.subjectTenofovir
dc.subjectObesity
dc.subjectSuppression
dc.subjectResistance
dc.subject.otherSDG-3: Good health and well-being
dc.titleFinal 192-week efficacy and safety results of the ADVANCE Trial, comparing 3 first-line antiretroviral regimens
dc.typeArticle
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