Document resource
Background To date, there is no a direct comparison about changes in body weight, metabolic parameters and inflammatory markers across antiretroviral therapy-naïve people living with HIV (PWH) starting bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF), dolutegravir/lamivudine (DOL/3TC) or doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF).Methods We performed a prospective, observational, cohort study on adult PWH who started as initial ART the single tablet regimen BIC/F/TAF, DOL/3TC or DOR/3TC/TDF. Physical and laboratory parameters were evaluated during a 12-month follow-up. Patients with baseline HIV RNA >500,000 copies/mL or genotype resistance testing showing reduced sensitivity to >1 of the prescribed antiretroviral drugs were excluded.Results Study inclusion criteria were met by 120 patients who were enrolled into the study: 40 subjects started DOR/3TC/TDF, 40 BIC/F/TAF, and 40 DOL/3TC. Median age was 45.2 years and 91 patients (75.8%) were males. The median baseline log10 HIV RNA was 5.18 copies/mL, median baseline CD4+ lymphocyte count was 363 cells/mm3, and 29 patients (24.2%) had one or more comorbidities. Baseline characteristics of study patients exhibited a general homogeneity across all groups. Twelve months after the initiation of ART, a significantly higher increase in median value of body weight was observed in the BIC/F/TAF group (+2.66 Kg) and in DOL/3TC group (+2.41 Kg) compared to DOR/3TC/TDF one (+1.17 Kg) (p=0.017 and 0.033, respectively). Moreover, the increase in median value of waist circumference was significantly greater in the BIC/F/TAF group (+2.11 cm) and in DOL/3TC group (+1.92 cm) compared to DOR/3TC/TDF one (+0.56 cm) (p<0.001). At month 12, changes in median values of all evaluated inflammatory and coagulation markers were comparable across all groups and no significant variations for each marker were reported in comparison with respective baseline values. During the 12-month follow-up, a significantly greater elevation in median concentrations of total cholesterol was reported in the BIC/F/TAF group (+34 mg/dL) than in the DOR/3TC/TDF (+6 mg/dL; p<0.001) and 3TC/DOL (+13 mg/dL; p=0.042) groups. After 12 months, the proportion of patients with HIV RNA <50 copies/mL was comparable in all groups: 90% (36/40) in the DOR/3TC/TDF group, 87.5% (35/40) in the BIC/F/TAF group, and 85% (34/40) in the DOL/3TC group. Treatment discontinuations were very uncommon and the incidence of adverse events was very low and comparable in subjects treated with DOR/3TC/TDF, BIC/F/TAF, or DOL/3TC.Conclusions In our study, initial antiretroviral regimen with DOR/3TC/TDF led to a significantly lower increase in body weight in comparison with BIC/F/TAF and DOL/3TC after a 12-month follow-up, and to a significantly lower elevation in total cholesterol in comparison with BIC/F/TAF, while no significant differences were reported with regard to other metabolic parameters and serum inflammation markers.