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1023. Suppressed Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide vs. Dolutegravir/Lamivudine: Virologic Failure and Durability

BACKGROUND: In the US, two common single-tablet regimens for HIV treatment are bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) and dolutegravir/lamivudine (DTG/3TC). We sought to compare B/F/TAF and DTG/3TC in virologically suppressed, treatment-experienced people with HIV in the OPERA(®)...

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Autores principales: Pierone, Gerald, Fusco, Jennifer S, Brunet, Laurence, Sension, Michael, Dunbar, Megan, Gruber, Joshua, Dieterich, Douglas, Fusco, Gregory P
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10677299/
http://dx.doi.org/10.1093/ofid/ofad500.054
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author Pierone, Gerald
Fusco, Jennifer S
Brunet, Laurence
Sension, Michael
Dunbar, Megan
Gruber, Joshua
Dieterich, Douglas
Fusco, Gregory P
author_facet Pierone, Gerald
Fusco, Jennifer S
Brunet, Laurence
Sension, Michael
Dunbar, Megan
Gruber, Joshua
Dieterich, Douglas
Fusco, Gregory P
author_sort Pierone, Gerald
collection PubMed
description BACKGROUND: In the US, two common single-tablet regimens for HIV treatment are bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) and dolutegravir/lamivudine (DTG/3TC). We sought to compare B/F/TAF and DTG/3TC in virologically suppressed, treatment-experienced people with HIV in the OPERA(®) cohort. METHODS: All treatment-experienced adults with HIV switching to B/F/TAF or DTG/3TC (01Aug2020-30Jun2022) with a viral load (VL) < 200 copies/mL at switch and ≥1 follow-up VL were included. Confirmed virologic failure (VF) was defined as 2 consecutive VL ≥200 copies/mL or regimen discontinuation following a VL ≥200 copies/mL; VL ≥50 copies/mL was used in a sensitivity analysis. Discontinuation was defined as any regimen modification or a treatment gap >45 days. Incidence rates (Poisson regression) and hazard ratios (Cox proportional hazard models) were estimated with inverse probability of treatment weights (IPTW) to adjust for race, payer, CD4 count and eGFR at baseline. Covariate balance was assessed with standardized mean differences; values ≤0.10 indicated adequate balance. RESULTS: On B/F/TAF, 3713 individuals were followed for a median of 16 months (interquartile range: 11, 22). On DTG/3TC, 2327 individuals were followed for a median of 15 months (10, 21). The distribution of key characteristics differed between groups; balance was achieved with IPTW (Table 1). VF(≥200) incidence rates per 100 person years were low (B/F/TAF: 1.7; DTG/3TC: 2.1); risk with B/F/TAF was not statistically different than with DTG/3TC (HR(≥200): 0.84 [95% CI: 0.59, 1.18]). VF(≥50) incidence rates were higher, but risk did not differ between groups (HR(≥50): 1.04 [0.86, 1.26]; Fig 1). All-cause regimen discontinuation was less likely with B/F/TAF than DTG/3TC (HR: 0.83; 95% CI: 0.73, 0.94; Fig 2). Treatment-related discontinuation (i.e., last VL ≥200 copies/mL, adverse diagnosis, side effect, lab abnormality) was identified in 6% of B/F/TAF and 9% of DTG/3TC discontinuers. [Figure: see text] [Figure: see text] [Figure: see text] CONCLUSION: In this real-world US cohort, virologically suppressed individuals switching to B/F/TAF were less likely to discontinue their regimen than those switching to DTG/3TC. VF was infrequent and no statistical difference was observed in the risk of VF between regimens over the study duration. DISCLOSURES: Jennifer S. Fusco, BS, Epividian, Inc.: Salary|Epividian, Inc.: Ownership Interest|Epividian, Inc.: Stocks/Bonds Laurence Brunet, PhD, Epividian, Inc.: Salary|Epividian, Inc.: Stocks/Bonds Michael Sension, MD, Gilead: Advisor/Consultant|Gilead: Honoraria|Viiv: Advisor/Consultant|Viiv: Grant/Research Support|Viiv: Honoraria Megan Dunbar, PhD, Gilead: Employment Joshua Gruber, PhD, Gilead Sciences, Inc: Employee|Gilead Sciences, Inc: Stocks/Bonds Douglas Dieterich, MD, Abbvie: Advisor/Consultant|Abbvie: Honoraria|Gilead: Advisor/Consultant|Gilead: Honoraria|Merck: Advisor/Consultant|Merck: Honoraria Gregory P. Fusco, MD, MPH, Epividian, Inc.: Board Member|Epividian, Inc.: Ownership Interest|Epividian, Inc.: Stocks/Bonds
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spelling pubmed-106772992023-11-27 1023. Suppressed Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide vs. Dolutegravir/Lamivudine: Virologic Failure and Durability Pierone, Gerald Fusco, Jennifer S Brunet, Laurence Sension, Michael Dunbar, Megan Gruber, Joshua Dieterich, Douglas Fusco, Gregory P Open Forum Infect Dis Abstract BACKGROUND: In the US, two common single-tablet regimens for HIV treatment are bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) and dolutegravir/lamivudine (DTG/3TC). We sought to compare B/F/TAF and DTG/3TC in virologically suppressed, treatment-experienced people with HIV in the OPERA(®) cohort. METHODS: All treatment-experienced adults with HIV switching to B/F/TAF or DTG/3TC (01Aug2020-30Jun2022) with a viral load (VL) < 200 copies/mL at switch and ≥1 follow-up VL were included. Confirmed virologic failure (VF) was defined as 2 consecutive VL ≥200 copies/mL or regimen discontinuation following a VL ≥200 copies/mL; VL ≥50 copies/mL was used in a sensitivity analysis. Discontinuation was defined as any regimen modification or a treatment gap >45 days. Incidence rates (Poisson regression) and hazard ratios (Cox proportional hazard models) were estimated with inverse probability of treatment weights (IPTW) to adjust for race, payer, CD4 count and eGFR at baseline. Covariate balance was assessed with standardized mean differences; values ≤0.10 indicated adequate balance. RESULTS: On B/F/TAF, 3713 individuals were followed for a median of 16 months (interquartile range: 11, 22). On DTG/3TC, 2327 individuals were followed for a median of 15 months (10, 21). The distribution of key characteristics differed between groups; balance was achieved with IPTW (Table 1). VF(≥200) incidence rates per 100 person years were low (B/F/TAF: 1.7; DTG/3TC: 2.1); risk with B/F/TAF was not statistically different than with DTG/3TC (HR(≥200): 0.84 [95% CI: 0.59, 1.18]). VF(≥50) incidence rates were higher, but risk did not differ between groups (HR(≥50): 1.04 [0.86, 1.26]; Fig 1). All-cause regimen discontinuation was less likely with B/F/TAF than DTG/3TC (HR: 0.83; 95% CI: 0.73, 0.94; Fig 2). Treatment-related discontinuation (i.e., last VL ≥200 copies/mL, adverse diagnosis, side effect, lab abnormality) was identified in 6% of B/F/TAF and 9% of DTG/3TC discontinuers. [Figure: see text] [Figure: see text] [Figure: see text] CONCLUSION: In this real-world US cohort, virologically suppressed individuals switching to B/F/TAF were less likely to discontinue their regimen than those switching to DTG/3TC. VF was infrequent and no statistical difference was observed in the risk of VF between regimens over the study duration. DISCLOSURES: Jennifer S. Fusco, BS, Epividian, Inc.: Salary|Epividian, Inc.: Ownership Interest|Epividian, Inc.: Stocks/Bonds Laurence Brunet, PhD, Epividian, Inc.: Salary|Epividian, Inc.: Stocks/Bonds Michael Sension, MD, Gilead: Advisor/Consultant|Gilead: Honoraria|Viiv: Advisor/Consultant|Viiv: Grant/Research Support|Viiv: Honoraria Megan Dunbar, PhD, Gilead: Employment Joshua Gruber, PhD, Gilead Sciences, Inc: Employee|Gilead Sciences, Inc: Stocks/Bonds Douglas Dieterich, MD, Abbvie: Advisor/Consultant|Abbvie: Honoraria|Gilead: Advisor/Consultant|Gilead: Honoraria|Merck: Advisor/Consultant|Merck: Honoraria Gregory P. Fusco, MD, MPH, Epividian, Inc.: Board Member|Epividian, Inc.: Ownership Interest|Epividian, Inc.: Stocks/Bonds Oxford University Press 2023-11-27 /pmc/articles/PMC10677299/ http://dx.doi.org/10.1093/ofid/ofad500.054 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Abstract
Pierone, Gerald
Fusco, Jennifer S
Brunet, Laurence
Sension, Michael
Dunbar, Megan
Gruber, Joshua
Dieterich, Douglas
Fusco, Gregory P
1023. Suppressed Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide vs. Dolutegravir/Lamivudine: Virologic Failure and Durability
title 1023. Suppressed Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide vs. Dolutegravir/Lamivudine: Virologic Failure and Durability
title_full 1023. Suppressed Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide vs. Dolutegravir/Lamivudine: Virologic Failure and Durability
title_fullStr 1023. Suppressed Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide vs. Dolutegravir/Lamivudine: Virologic Failure and Durability
title_full_unstemmed 1023. Suppressed Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide vs. Dolutegravir/Lamivudine: Virologic Failure and Durability
title_short 1023. Suppressed Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide vs. Dolutegravir/Lamivudine: Virologic Failure and Durability
title_sort 1023. suppressed switch to bictegravir/emtricitabine/tenofovir alafenamide vs. dolutegravir/lamivudine: virologic failure and durability
topic Abstract
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10677299/
http://dx.doi.org/10.1093/ofid/ofad500.054
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