Final 192-week ffficacy and safety results of the ADVANCE trial, comparing 3 first-line antiretroviral regimens
Final 192-week ffficacy and safety results of the ADVANCE trial, comparing 3 first-line antiretroviral regimens
Background: 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) / emtricitabine (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.
dolutegravir, obesity, resistance, suppression, tenofovir
Sokhela, Simiso
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Venter, Willem D.F.
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Bosch, Bronwyn
24dc6f4c-bea7-42c1-8d34-1fb95429da73
Woods, Joana
923b671e-1eb9-427f-a1f1-52bbdc16277f
al, et
df099e87-31d7-4ccf-a9fa-b92a380537f9
Norris, Shane A.
1d346f1b-6d5f-4bca-ac87-7589851b75a4
24 January 2024
Sokhela, Simiso
1b102d5d-7249-4bc1-8bac-f41d9ca8be3a
Venter, Willem D.F.
6ea54f2f-3a31-47fd-92ce-a74b47bea990
Bosch, Bronwyn
24dc6f4c-bea7-42c1-8d34-1fb95429da73
Woods, Joana
923b671e-1eb9-427f-a1f1-52bbdc16277f
al, et
df099e87-31d7-4ccf-a9fa-b92a380537f9
Norris, Shane A.
1d346f1b-6d5f-4bca-ac87-7589851b75a4
Sokhela, Simiso, Venter, Willem D.F., Bosch, Bronwyn, Woods, Joana, al, et and Norris, Shane A.
(2024)
Final 192-week ffficacy and safety results of the ADVANCE trial, comparing 3 first-line antiretroviral regimens.
Open Forum Infectious Diseases, 11 (3).
(doi:10.1093/ofid/ofae007).
Abstract
Background: 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) / emtricitabine (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.
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ofae007
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Accepted/In Press date: 23 January 2024
Published date: 24 January 2024
Keywords:
dolutegravir, obesity, resistance, suppression, tenofovir
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Local EPrints ID: 504090
URI: http://eprints.soton.ac.uk/id/eprint/504090
ISSN: 2328-8957
PURE UUID: 54e6e2ff-925e-4f59-bc5c-7e2f48500820
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Date deposited: 22 Aug 2025 17:02
Last modified: 23 Aug 2025 02:16
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Author:
Simiso Sokhela
Author:
Willem D.F. Venter
Author:
Bronwyn Bosch
Author:
Joana Woods
Author:
et al
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