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Introduction: Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and dolutegravir plus lamivudine (DTG + 3TC) are well tolerated and effective in clinical trials. This study aimed to evaluate the safety and efficacy of these two schemes in a real-world setting and to obtain the first dataset for switching to BIC/FTC/TAF and DTG + 3TC in a Chinese population. Methods: This retrospective single-center cohort study in China included participants who switched to DTG + 3TC or BIC/FTC/TAF between January 2020 and February 2023. The main endpoint was the proportion of participants with HIV-1 RNA levels of ≥ 50 copies/mL. Safety, tolerance, and the incidence of low-level viremia (LLV) were evaluated. Results: A total of 525 participants were included, 454 of whom were included in the PP analysis. At week 48, the proportions of participants with HIV-1 RNA ≥ 50 copies/mL were 4.4% (10/225) for DTG + 3TC and 6.1% (14/229) for BIC/FTC/TAF; virological efficacy did not differ significantly between the two groups. Consistent results were obtained in an intent-to-treat (ITT) analysis. The incidences of LLV were 3.6% (7/193) and 4.9% (10/206), respectively. During the study, none of the participants stopped taking drugs because of a lack of efficacy or adverse reactions. Conclusions: Both regimens are well tolerated and effective for switching HIV-1 infection therapy. However, the detection of genotypic drug resistance should be considered when baseline virological non-suppression is observed. [ABSTRACT FROM AUTHOR]

Introduction: Ainuovirine/lamivudine/tenofovir is a novel antiretroviral therapy regimen used to treat human immunodeficiency virus-1 (HIV-1) infection. This study aimed to compare the pharmacokinetics of ainuovirine/lamivudine/tenofovir in HIV-1-infected patients aged ≥ 65 (elderly patients) and ≤ 40 years (young patients). Methods: This prospective, open-label, parallel controlled clinical study included 15 young and 15 elderly patients. Blood (1 mL) was collected 30 min before dosing and at 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, and 24 h after dosing, to measure the plasma concentrations of ainuovirine/lamivudine/tenofovir. Safety was assessed by monitoring the adverse events, physical examinations, and clinical laboratory tests. Results: Plasma concentrations of each ainuovirine/lamivudine/tenofovir component reached peak levels 1–4 h after dosing and gradually decreased during the remaining observation period. Compared with the young group, ainuovirine had significantly higher T1/2Ke, AUC0–24, and AUC0–inf (all P < 0.05) in the elderly group, whereas Ke (P = 0.002) was significantly lower. However, the Cmax and Tmax of ainuovirine did not differ significantly. Lamivudine and tenofovir also had a significantly higher Cmax (p = 0.004 and p = 0.008, respectively) and AUC0–inf (P = 0.014 and P = 0.006, respectively) in the elderly group, whereas there was no significant difference in Tmax, Ke, and T1/2Ke. Ainuovirine/lamivudine/tenofovir was well tolerated in both the young and elderly groups. Conclusion: This study suggests that the ainuovirine/lamivudine/tenofovir regimen might be an effective and safe treatment regimen for HIV-1-infected patients aged ≥ 65 years and ≤ 40 years. Further studies are needed to confirm these results and develop optimal dosing regimens for elderly HIV-1-infected patients. [ABSTRACT FROM AUTHOR]