Search Results (2)

Background: Demonstrating durable viral suppression after switching to dolutegravir/lamivudine in clinical practice solidifies its use. Methods: This was a prospective cohort (DUALING) study conducted in 24 Dutch HIV treatment centers. HIV-RNA-suppressed cases undergoing triple-drug antiretroviral therapy without prior virological failure or resistance who switched to dolutegravir/lamivudine (cases) were 1:2 matched to controls, who remained on triple-drug antiretroviral therapy. Matching was stratified by dolutegravir use in the triple-drug antiretroviral therapy, and further by age, sex, HIV acquisition route, CD4⁺T-cell nadir, and HIV-RNA zenith. The primary endpoint was the treatment failure rate at 2 years, determined using intention-to-treat and on-treatment analyses with a 5% noninferiority margin. Results: The 2040 mostly male (84.3%) participants included 390 cases of dolutegravir-based triple-drug regimens with 680 controls, and 290 cases of non-dolutegravir-based triple-drug regimens with 580 controls. In the dolutegravir-based cases and controls, treatment failure occurred in 12.6% and 23.3% of patients in the intention-to-treat analysis (difference: −10.7%, 95%CI: −15.3% to −6.1%) and 2.6% and 2.4% of patients in the on-treatment analysis (difference: +0.2%, 95%CI −1.9% to +2.3%). The treatment failure risk in non-dolutegravir-based cases and controls was 15.2% and 19.9% in the intention-to-treat analysis (difference: −4.7, 95%CI: −10.0% to +0.6%) and 1.2% and 1.9% in the on-treatment analysis (difference +0.7%, 95%CI −2.6% to +1.1%). Therapy modifications unrelated to virological failure explained the higher treatment failure rate in the intention-to-treat analysis. In dolutegravir/lamivudine cases, a shorter time of prior triple-drug antiretroviral therapy, age < 50 years, and non-Western origin were associated with treatment failure in the multivariable analysis. Viral blips occurred in 6.8% of cases and 5.1% of controls. In the post hoc analysis, discontinuing tenofovir disoproxil fumarate-based triple-drug antiretroviral therapy led to weight gain in people with (+2.7 kg) and without (+2.3 kg) prior dolutegravir use. Conclusions: In this nationwide clinical practice study, switching to dolutegravir/lamivudine was noninferior to continuing triple-drug antiretroviral therapy after 2 years of follow-up. Full article

Switching to bictegravir, emtricitabine, and tenofovir alafenamide (BIC/FTC/TAF) from other antiretroviral regimens is safe and effective for virologically suppressed people living with HIV (PLWH). The term virological suppression includes both low but detectable HIV viremia and undetectable HIV viremia, and the latter is possibly associated with a lower immune activation state. Herein, we describe a 24-month follow-up of experienced PLWH with plasma HIV RNA undetectable or detectable < 50 copies/ml switching to BIC/FTC/TAF. A previous 12-month monitoring was available, and the factors correlated with treatment efficacy. This retrospective multicenter study included PLWH who switched to BIC/FTC/TAF in the period of 2019–2022, and who were HBsAg and HCV RNA negative. The follow-up study times were 6 (T6), 12 (T12), 18 (T18), and 24 (T24) months after the switch (T0). Survival analysis with multiple-failure-per-subject design, Kaplan–Meier survival estimates, multivariate analysis of variance, multilevel linear regression, and a hierarchical ordered logistic model were applied. A total of 329 PLWH had plasma HIV RNA which was either undetectable or detectable at <50 copies/mL at T0, and 197 responded to all inclusion criteria: M/F 140/57; the median CD4+ cell count was 677 cells/mm³; and HIV RNA at T0 was undetectable in 108 patients. Most of the 197 patients (122, 61.9%) were on a previous INSTI-based regimen. HIV RNA undetectability was more frequent at each follow-up point in patients with HIV RNA that was undetectable at T0, and it showed a higher frequency throughout the follow-up period in patients with always-undetectable HIV RNA in the 12 months before the switch. A higher nadir CD4 cell count had a predictive role, and HBcAb positivity had no influence. In conclusion, the switch could be programmed and possibly delayed on a case-by-case basis in order to achieve persistent plasma HIV RNA undetectability. Undiagnosed loss of HBcAb has no detrimental consequences on the response to BIC/FTC/TAF. Full article