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Purpose: This study aimed to assess the immunological efficacy and the impact on weight of dolutegravir (DTG)-based antiretroviral therapy (ART) regimen in ART-naive people living with HIV (PLWH). Methods: A prospective study was conducted on ART-naïve PLWH who treated with DTG-based or efavirenz (EFV)-based regimens in The Second Hospital of Nanjing. Based on previous studies, the sample size was 332 patients calculated by PASS software. Considering a 20% dropout rate, the expected sample size was 416 patients, which were 208 patients in the DTG and EFV groups, respectively. Results: Among 416 enrolled participants, the median age was 30.0 years (25.0– 43.0), 388 (93.3%) males. At baseline, patients in the DTG group had worse pre-treatment immune level, but with no significant difference in weight compared to the EFV group. After 12 months of follow-up, the CD4+ T-cell counts increased greater in the DTG group (P=0.036), while the CD4+/CD8+ T-cell ratio increased greater in the EFV group (P=0.014). There was no significant difference in the normalization of various immune indicators between the two groups. The weight gain of patients in the DTG group at different follow-up points was all significantly higher than that in the EFV group (P< 0.05). Multivariate logistic regression analysis showed that DTG-based regimens (OR=4.524, 95% CI: 2.371– 8.634, P< 0.001), baseline VL ≥ 10^5 copies/mL (OR=2.563, 95% CI: 1.411– 4.657, P=0.002), and baseline CD4+ T-cell counts < 200 cells/μL (OR=2.595, 95% CI: 1.430– 4.709, P=0.002) were risk factors for weight gain ≥ 5 kg during the 12-month follow-up period. Conclusion: After 12 months of follow-up, the increase in CD4+ T-cell counts was higher in the DTG group than in the EFV group, but the overall immunological efficacy was similar in both groups. However, attention should be paid to patients' weight, especially in patients with high baseline viral load and low CD4+ T-cell counts who were treated with the DTG-based regimen. [ABSTRACT FROM AUTHOR]

Background: Results from both clinical trials and real-world observational studies suggest that lamivudine plus dolutegravir (3TC + DTG) dual therapy has excellent virological efficacy and safety in HIV-1-infected patients. However, there is still no relevant study related to this dual therapy reported in China., Methods: In this multicenter, retrospective, observational study that included HIV-1-infected patients in China, baseline and follow-up data were collected to analyze the virological suppression rate, immune restoration, and adverse events during follow-up in HIV-1-infected patients who switched to the 3TC + DTG dual therapy., Results: This study recruited 112 HIV-1-infected patients, including 101 men (90.2%), with a median age of 44.0 years (IQR: 33.00-57.75) and median CD4+ T-cell count of 432.13 cells/μL (IQR: 237.75-578.50). The overall virological suppression rate was 94.5% at the 24-week follow-up. However, the virological suppression rates of men who have sex with men patients and patients with CD4+ T-cell count of <350 cells/μL were higher than the baseline value (P < 0.05) at week 24. The results of Cox regression analysis showed that the baseline CD4+ T-cell count was an independent determinant of immune restoration in patients, and patients with baseline CD4+ T-cell count of 350-500 cells/μL outperformed patients with baseline CD4+ T-cell count of <350 cells/μL in immune restoration (hazard ratio: 4.469, 95% confidence interval: 1.801 to 11.091, P = 0.001). Adverse events were reported in 5 patients (incidence rate of 4.5%); among them, 3 patients developed neuropsychiatric symptoms. Results from the laboratory data analysis showed that patients with grade 1 and 2 adverse events had elevated levels of low-density lipoprotein cholesterol and total bilirubin. Furthermore, grade 3 and 4 adverse events were associated with the elevation of blood glucose level in 4 patients., Conclusions: Thus, the 3TC + DTG dual therapy displayed an excellent virological efficacy against HIV-1 infections and had an acceptable safety profile, with predominantly mild adverse events in HIV-1-infected patients in China., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)