TY - JOUR
T1 - Dolutegravir/Lamivudine Is Noninferior to Continuing Dolutegravir- and Non-Dolutegravir-Based Triple-Drug Antiretroviral Therapy in Virologically Suppressed People With Human Immunodeficiency Virus
T2 - DUALING Prospective Nationwide Matched Cohort Study
AU - Vasylyev, Marta
AU - Wit, Ferdinand W N M
AU - Jordans, Carlijn C E
AU - Soetekouw, Robin
AU - van Lelyveld, Steven F L
AU - Kootstra, Gert-Jan
AU - Delsing, Corine E
AU - Ammerlaan, Heidi S M
AU - van Kasteren, Marjo E E
AU - Brouwer, Annemarie E
AU - Leyten, Eliane M S
AU - Claassen, Mark A A
AU - Hassing, Robert-Jan
AU - den Hollander, Jan G
AU - van den Berge, Marcel
AU - Roukens, Anna H E
AU - Bierman, Wouter F W
AU - Groeneveld, Paul H P
AU - Lowe, Selwyn H
AU - van Welzen, Berend J
AU - Richel, Olivier
AU - Nellen, Jeannine F
AU - van den Berk, Guido E L
AU - van der Valk, Marc
AU - Rijnders, Bart J A
AU - Rokx, Casper
N1 - © The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
PY - 2024/4
Y1 - 2024/4
N2 - BACKGROUND: Confirming the efficacy of dolutegravir/lamivudine in clinical practice solidifies recommendations on its use.METHODS: Prospective cohort study (DUALING) in 24 human immunodeficiency virus (HIV) treatment centers in the Netherlands. HIV RNA-suppressed cases were on triple-drug antiretroviral regimens without prior virological failure or resistance and started dolutegravir/lamivudine. Cases were 1:2 matched to controls on triple-drug antiretroviral regimens by the use of dolutegravir-based regimens, age, sex, transmission route, CD4
+ T-cell nadir, and HIV RNA zenith. The primary endpoint was the treatment failure rate in cases versus controls at 1 year by intention-to-treat and on-treatment analyses with 5% noninferiority margin.
RESULTS: The 2040 participants were 680 cases and 1380 controls. Treatment failure in the 390 dolutegravir-based cases versus controls occurred in 8.72% and 12.50% (difference: -3.78% [95% confidence interval {CI}, -7.49% to .08%]) by intention-to-treat and 1.39% and 0.80% (difference: 0.59% [95% CI, -.80% to 1.98%]) by on-treatment analyses. The treatment failure risk in 290 non-dolutegravir-based cases was also noninferior to controls. Antiretroviral regimen modifications unrelated to virological failure explained the higher treatment failure rate by intention-to-treat. A shorter time on triple-drug antiretroviral therapy and being of non-Western origin was associated with treatment failure. Treatment failure, defined as 2 consecutive HIV RNA >50 copies/mL, occurred in 4 cases and 5 controls but without genotypic resistance detected. Viral blips occured comparable in cases and controls but cases gained more weight, especially when tenofovir-based regimens were discontinued.CONCLUSIONS: In routine care, dolutegravir/lamivudine was noninferior to continuing triple-drug antiretroviral regimens after 1 year, supporting the use of dolutegravir/lamivudine in clinical practice.CLINICAL TRIALS REGISTRATION: NCT04707326.
AB - BACKGROUND: Confirming the efficacy of dolutegravir/lamivudine in clinical practice solidifies recommendations on its use.METHODS: Prospective cohort study (DUALING) in 24 human immunodeficiency virus (HIV) treatment centers in the Netherlands. HIV RNA-suppressed cases were on triple-drug antiretroviral regimens without prior virological failure or resistance and started dolutegravir/lamivudine. Cases were 1:2 matched to controls on triple-drug antiretroviral regimens by the use of dolutegravir-based regimens, age, sex, transmission route, CD4
+ T-cell nadir, and HIV RNA zenith. The primary endpoint was the treatment failure rate in cases versus controls at 1 year by intention-to-treat and on-treatment analyses with 5% noninferiority margin.
RESULTS: The 2040 participants were 680 cases and 1380 controls. Treatment failure in the 390 dolutegravir-based cases versus controls occurred in 8.72% and 12.50% (difference: -3.78% [95% confidence interval {CI}, -7.49% to .08%]) by intention-to-treat and 1.39% and 0.80% (difference: 0.59% [95% CI, -.80% to 1.98%]) by on-treatment analyses. The treatment failure risk in 290 non-dolutegravir-based cases was also noninferior to controls. Antiretroviral regimen modifications unrelated to virological failure explained the higher treatment failure rate by intention-to-treat. A shorter time on triple-drug antiretroviral therapy and being of non-Western origin was associated with treatment failure. Treatment failure, defined as 2 consecutive HIV RNA >50 copies/mL, occurred in 4 cases and 5 controls but without genotypic resistance detected. Viral blips occured comparable in cases and controls but cases gained more weight, especially when tenofovir-based regimens were discontinued.CONCLUSIONS: In routine care, dolutegravir/lamivudine was noninferior to continuing triple-drug antiretroviral regimens after 1 year, supporting the use of dolutegravir/lamivudine in clinical practice.CLINICAL TRIALS REGISTRATION: NCT04707326.
U2 - 10.1093/ofid/ofae160
DO - 10.1093/ofid/ofae160
M3 - Article
C2 - 38567196
SN - 2328-8957
VL - 11
JO - Open Forum Infectious Diseases
JF - Open Forum Infectious Diseases
IS - 4
M1 - ofae160
ER -