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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.

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 )., (© 2024. The Author(s).)

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.

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.