Safety and adherence of bictegravir/emtricitabine/tenofovir alafenamide for HIV post-exposure prophylaxis among adults in Guiyang China: a prospective cohort study.

BACKGROUND: The effectiveness of post-exposure prophylaxis (PEP) depends on participants adherence, making it crucial to assess and compare regimen options to enhance human immunodeficiency virus (HIV) prophylaxis strategies. However, no prospective study in China has shown that the completion rate and adherence of single-tablet regimens in HIV PEP are higher than those of multi-tablet preparations. Therefore, this study aimed to assess the completion rate and adherence of two HIV PEP regimens. METHODS: In this single-center, prospective, open-label cohort study, we included 179 participants from May 2022 to March 2023 and analyzed the differences in the 28-day medication completion rate, adherence, safety, tolerance, and effectiveness of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and tenofovir disoproxil fumarate, emtricitabine, and dolutegravir (TDF/FTC + DTG). RESULTS: The PEP completion rate and adherence were higher in the BIC/FTC/TAF group than in the TDF/FTC + DTG group (completion rate: 97.8% vs. 82.6%, P = 0.009; adherence: 99.6 ± 2.82% vs. 90.2 ± 25.29%, P = 0.003). The incidence of adverse reactions in the BIC/FTC/TAF and TDF/FTC + DTG groups was 15.2% and 10.3% (P = 0.33), respectively. In the TDF/FTC + DTG group, one participant stopped PEP owing to adverse reactions (1.1%). No other participants stopped PEP due to adverse events. CONCLUSIONS: BIC/FTC/TAF and TDF/FTC + DTG have good safety and tolerance as PEP regimens. BIC/FTC/TAF has a higher completion rate and increased adherence, thus, is recommended as a PEP regimen. These findings emphasize the importance of regimen choice in optimizing PEP outcomes. TRIAL REGISTRATION: The study was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR2200059994(2022-05-14), https://www.chictr.org.cn/bin/project/edit?pid=167391 ).

Efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide fumarate for adult patients with human immunodeficiency virus-1 in China: a retrospective real-world cohort study.

BACKGROUND: This study aimed to evaluate the therapeutic effect and tolerance of bictegravir/emtricitabine/tenofovir alafenamide fumarate (BIC/FTC/TAF) use for 24 weeks in anti-retroviral therapy (ART)-naïve patients in China. METHODS: This single-center retrospective cohort study included ART-naïve patients who received BIC/FTC/TAF from July 2021 to April 2022. The proportion of patients with HIV RNA < 50 copies/mL at the end point of 24 weeks (virological suppression rate) was the primary outcome, and the changes in CD4 cell count, CD4/CD8 ratio, weight, blood lipid, and safety were secondary outcomes. RESULTS: A total of 80 ART-naïve patients were enrolled. The virological suppression rate was 86.3% at 24 weeks. The median CD4 cell count increased from 212 cells/µL (interquartile range [IQR]: 90.3-398.3) at baseline to 348 cells/µL (IQR: 219.8-541.0) at 24 weeks. The median CD4/CD8 ratio increased from 0.25 (IQR: 0.13-0.37) at baseline to 0.40 (IQR: 0.26-0.66) at 24 weeks. During the follow-up of 80 ART-naïve patients using BIC/FTC/TAF, 16 participants had adverse events; however, these events did not lead to drug withdrawal. CONCLUSION: This real-world cohort study showed that BIC/FTC/TAF could achieve good immunological and virological responses in ART-naïve patients. In addition, this study also shows good safety.

Comparison of dolutegravir+Lamivudine and bictegravir/emtricitabine/tenofovir alafenamide in antiretroviral therapy-naïve patients infected with HIV: preliminary results from clinical practice.

BACKGROUND: The efficacy and safety of dolutegravir+lamivudine (DTG +3TC) and bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) have been demonstrated in clinical trials of treatment-naïve therapy. However, real-life data are lacking. We investigated and compared the virological outcomes and safety of DTG + 3TC with BIC/FTC/TAF in an adult cohort of people living with HIV (PLWH). RESEARCH DESIGN AND METHODS: We performed a retrospective cohort analysis of PLWH who were naïve to antiretroviral therapy and initiated the antiretroviral regimen of DTG + 3TC or BIC/FTC/TAF from January 2020 to March 2022. Treatment effectiveness, defined as the capability of treatment to achieve viral suppression (viral load < 50 copies/mL), was analyzed. Changes in immunology, metabolism, liver and renal function after 48 weeks of treatment were evaluated. RESULTS: At 48 weeks, both groups showed high viral suppression, with 82.4% (108/131) and 89% (129/145) of the patients in the BIC/FTC/TAF and DTG + 3TC groups, respectively, having viral suppression (OR = 0.58, 95% CI: 0.29-1.15, P = 0.3). No differences existed in immunology, metabolism, liver and renal function; however, BIC/FTC/TAF led to greater weight gain. CONCLUSIONS: Both optimization strategies showed high tolerability in antiretroviral therapy-naïve patients, with no differences in virological efficacy; however, BIC/FTC/TAF may be related to the risk of weight gain risk. Further research is required to evaluate this problem.

Pharmacokinetics and Safety of Ainuovirine/Lamivudine/Tenofovir Combination Tablets in Young and Elderly Patients with Human Immunodeficiency Virus-1 Infection.

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.

Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir Plus Lamivudine for Switch Therapy in Patients with HIV-1 Infection: A Real-World Cohort Study.

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.

Real-world implementation of dolutegravir plus lamivudine in people living with HIV in Southwest China.

BACKGROUND: Long-term outcome data from real-world studies on the implementation of a two-drug dolutegravir plus lamivudine (DTG+3TC) regimen for the treatment of human immunodeficiency virus (HIV) infection remain limited. This study evaluated the real-world effectiveness and safety of DTG+3TC in people living with HIV (PLHIV) in Southwestern China. METHODS: This was an observational, single-center, retrospective study that enrolled antiretroviral therapy (ART)-naïve (n = 36) and ART-experienced patients with HIV (n = 86) between January 2019 and April 2021. The virological response to therapy and adverse events were documented. The primary endpoint was an HIV viral load (VL) <50 copies/mL at week 48. RESULTS: The proportion of treatment-naïve and ART-experienced PLHIV with a VL <50 copies/mL at 48 weeks was 97.2% and 97.7%, respectively. The CD4 count increased significantly by 80.2 cells/µL (P = 0.012) and 79.0 cells/µL (P = 0.021) in the ART-naïve and ART-experienced patients, respectively. No patients discontinued DTG+3TC by week 48 due to adverse events. CONCLUSION: Virologic suppression may be achieved with DTG+3TC, in ART-naïve patients with a high VL, and in ART-experienced patients with residual viremia. This study also demonstrated a low prevalence of drug-related side effects.