Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Assessing the Risk Factors of Detectable Viral Loads after Switching to Dolutegravir and Lamivudine or Bictegravir, Emtricitabine and Tenofovir Alafenamide Fumarate in a Real-World Cohort of Treatment-Experienced Adults Living with HIV

Version 1 : Received: 29 December 2023 / Approved: 3 January 2024 / Online: 3 January 2024 (10:25:58 CET)

How to cite: Lee, S.; Lin, Y.; Chen, C.; Cheng, S.; Chang, S.; Ku, S.; Cheng, C. Assessing the Risk Factors of Detectable Viral Loads after Switching to Dolutegravir and Lamivudine or Bictegravir, Emtricitabine and Tenofovir Alafenamide Fumarate in a Real-World Cohort of Treatment-Experienced Adults Living with HIV. Preprints 2024, 2024010100. https://doi.org/10.20944/preprints202401.0100.v1 Lee, S.; Lin, Y.; Chen, C.; Cheng, S.; Chang, S.; Ku, S.; Cheng, C. Assessing the Risk Factors of Detectable Viral Loads after Switching to Dolutegravir and Lamivudine or Bictegravir, Emtricitabine and Tenofovir Alafenamide Fumarate in a Real-World Cohort of Treatment-Experienced Adults Living with HIV. Preprints 2024, 2024010100. https://doi.org/10.20944/preprints202401.0100.v1

Abstract

In the TANGO study, the long-term noninferior efficacy of switching to dolutegravir/lamivudine (DTG/3TC) compared to continuing tenofovir alafenamide–based regimens was demonstrated in treatment-experienced adults with HIV. However, there is limited real-world data comparing the effectiveness and safety of bictegravir/emtricitabine/tenofovir alafenamide fumarate (BIC/FTC/TAF) and DTG/3TC in Asia. This retrospective observational study, conducted at a designated HIV-care hospital from March 2019 to January 2023, aimed to address this gap. Demographic, clinical, and laboratory data, including HIV viral loads and lipid profiles, were collected and analyzed. The primary outcome was the proportion of patients with HIV RNA <50 copies/mL at week 48 in both groups, utilizing a snapshot, per-protocol–exposed population. A total of 1086 patients were included, with 511 in the DTG/3TC group and 575 in the BIC/FTC/TAF group. At week 48, 98% of patients in the DTG/3TC group and 94% in the BIC/FTC/TAF group achieved HIV RNA <50 copies/mL (p <0.01). Logistic regression analysis identified risk factors for detectable viral loads at week 48, including HIV RNA >100,000 copies/mL (AOR 5.13, 95% CI 1.42–18.53), low-level viremia (AOR 3.91, 95% CI 1.07–14.25), and record of virologic failure ≥2 times (AOR 4.21, 95% CI 1.64–10.85) before the switch. Furthermore, no significant difference was found between the DTG/3TC and BIC/FTC/TAF regimens (AOR: 1.51, 95% CI 0.70–3.24). In conclusion, the study demonstrates that the effectiveness and safety profiles of DTG/3TC and BIC/FTC/TAF were comparable in treatment-experienced adults with HIV, particularly among those with undetectable viral loads at baseline.

Keywords

dolutegravir/lamivudine (DTG/3TC); bictegravir/emtricitabine/tenofovir alafenamide fumarate (BIC/FTC/TAF); effectiveness; treatment-experienced adults living with HIV; real-world

Subject

Medicine and Pharmacology, Epidemiology and Infectious Diseases

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