Immunological Efficacy and the Impact on Weight of Dolutegravir-Based Regimen in Antiretroviral Therapy (ART)-Naïve Patients with HIV Infection.

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.