Clinical efficacy and safety of bictegravir/emtricitabine/tenofovir alafenamide and lamivudine/dolutegravir in the treatment-naive patients with acquired immunodeficiency syndrome
Objective To analyze the efficacy and safety of integrase inhibitor-based single-tablet regimens bictegravir/emtricitabine/tenofovir alafenamide(B/F/TAF)and lamivudine/dolutegravir(3TC/DTG)in the treatment-naïve patients with acquired immunodeficiency syndrome(AIDS).Methods This study was a retrospective cohort study.The clinical data of treatment-naïve AIDS patients initiating anti-retroviral therapy(ART)with B/F/TAF or 3TC/DTG and on ART for greater than or equal to 24 weeks from October 2020 to July 2023 in Shanghai Public Health Clinical Center,Fudan University were collected.The baseline human immunodeficiency virus(HIV)-1 RNA,CD4+T lymphocyte counts at baseline and 12 weeks of treatment,and the rates of virological suppression and virological failure at 24 weeks of treatment,and levels of total cholesterol,serum creatinine,uric acid before and after treatment were compared between the B/F/TAF group and 3TC/DTG group.Independent sample t test,corrected t test,Mann-Whitney U test,Wilcoxon signed rank test,chi-square test were used for statistical analysis.Results Among 189 treatment-naïve AIDS patients,141 cases were in B/F/TAF group and 48 cases in 3TC/DTG group.The HIV-1 RNA level at baseline was 1.77(0.78,4.52)x 105 copies/mL in the B/F/TAF group and 0.97(0.24,2.20)x 105 copies/mL in the 3TC/DTG group.There was a statistically significant difference between the two groups(U=2 221.00,P=0.006).There were 77.3％(109/141)patients on B/F/TAF achieved complete virological suppression with no virological failure at week 24,and 85.4％(41/48)on 3TC/DTG achieved complete virological suppression with one(2.1％)virological failure at week 24.At 12 weeks of treatment,92.2％(130/141)of the patients in the B/F/TAF group and 85.4％(41/48)of the patients in the 3TC/DTG group had an increase in CD4+T lymphocyte count by more than 30％compared with baseline.The proportion of CD4+T lymphocyte count increased by more than 100/μL from baseline in the B/F/TAF group was 67.4％(95/141),and that in the 3TC/DTG group was 52.1％(25/48).There were no significant differences between the two groups(x2=1.91 and 3.61,respectively,P=0.167 and 0.733).The levels of total cholesterol(W=2 036.00,t=-5.42,respectively),serum creatinine(W=1 098.00,234.00,respectively),uric acid(W=2 188.00,299.00,respectively)and the proportion of patients with mild to moderate renal insufficiency(x2=22.29,8.22,respectively)in the B/F/TAF group and 3TC/DTG group after 24 weeks of treatment were significantly higher than those before treatment(all P＜0.01).Conclusions Both B/F/TAF and 3TC/DTG are effective in terms of virological suppression and immunological recovery and have good safety profiles in treatment-naïve patients with AIDS.
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