Background:Dual regimen dolutegravir(DTG)plus lamivudine(3TC)has demonstrated non-inferior efficacy compared to DTG-based three-drug regimens(3DRs),yet directly comparative data regarding the efficacy and safety of DT...Background:Dual regimen dolutegravir(DTG)plus lamivudine(3TC)has demonstrated non-inferior efficacy compared to DTG-based three-drug regimens(3DRs),yet directly comparative data regarding the efficacy and safety of DTG+3TC and bictegravir/emtricitabine/tenofovir alafenamide(B/F/TAF)for therapy-naïve people with human immunodeficiency virus(HIV)-1(PWH)are still limited.We aimed to assess the antiviral potency and safety profiles of DTG+3TC vs.B/F/TAF based on antiretroviral therapy(ART)-naïve PWH in China.Methods:This retrospective multicenter study enrolled PWH initiating ART with DTG+3TC or B/F/TAF from 2020 to 2022 in Guangdong and Guangxi.We analyzed response rates based on target not detected(TND)status using intention-to-treat(ITT)analysis.Subgroups were formed based on baseline viral load(VL)(<100,000 vs.≥100,000 copies/mL)and CD4^(+)cell count(<200 vs.≥200 cell/µL).Median time to TND VL was assessed by Kaplan-Meier method.We also measured changes from baseline in CD4^(+)cell counts,CD4/CD8 ratio,lipid parameters,weight,creatinine(Cr),estimated glomerular filtration rate(eGFR),and drug-related adverse effects(DRAEs).Results:We enrolled 280 participants,including 137(48.9%)on DTG+3TC and 143(51.1%)on B/F/TAF.At week 48,96.4%(132/137)on DTG+3TC and 100%(143/143)on B/F/TAF achieved TND(P=0.064).At week 12,TND responses were higher with B/F/TAF(78.3%[112/143])than DTG+3TC(30.7%[42/137])(P<0.001).This trend held across subgroups.B/F/TAF achieved TND faster(12 weeks)than DTG+3TC(24 weeks)(P<0.001).No differences were seen in CD4^(+)cell count and CD4/CD8 ratio,except in the high-VL subgroup,where B/F/TAF showed better recovery.DRAEs were significantly lower with B/F/TAF(4.9%[7/143])than with DTG+3TC(13.1%[18/137])(P=0.016).Lipid parameters,body weight,and Cr increased in both groups over 48 weeks,with DTG+3TC showing a more favorable effect on triglycerides,high-density lipoprotein(HDL)cholesterol,and weight gain.Conclusions:In this real-life study,B/F/TAF led to a faster viral decline and fewer DRAEs compared to DTG+3TC.No significant difference was observed in the TND rate at week 48,regardless of baseline VL and CD4^(+)cell count.CD4^(+)recovery was superior for B/F/TAF in participants with high VL.The DTG+3TC regimen had less impact on metabolic changes than B/F/TAF.展开更多
文摘Background:Dual regimen dolutegravir(DTG)plus lamivudine(3TC)has demonstrated non-inferior efficacy compared to DTG-based three-drug regimens(3DRs),yet directly comparative data regarding the efficacy and safety of DTG+3TC and bictegravir/emtricitabine/tenofovir alafenamide(B/F/TAF)for therapy-naïve people with human immunodeficiency virus(HIV)-1(PWH)are still limited.We aimed to assess the antiviral potency and safety profiles of DTG+3TC vs.B/F/TAF based on antiretroviral therapy(ART)-naïve PWH in China.Methods:This retrospective multicenter study enrolled PWH initiating ART with DTG+3TC or B/F/TAF from 2020 to 2022 in Guangdong and Guangxi.We analyzed response rates based on target not detected(TND)status using intention-to-treat(ITT)analysis.Subgroups were formed based on baseline viral load(VL)(<100,000 vs.≥100,000 copies/mL)and CD4^(+)cell count(<200 vs.≥200 cell/µL).Median time to TND VL was assessed by Kaplan-Meier method.We also measured changes from baseline in CD4^(+)cell counts,CD4/CD8 ratio,lipid parameters,weight,creatinine(Cr),estimated glomerular filtration rate(eGFR),and drug-related adverse effects(DRAEs).Results:We enrolled 280 participants,including 137(48.9%)on DTG+3TC and 143(51.1%)on B/F/TAF.At week 48,96.4%(132/137)on DTG+3TC and 100%(143/143)on B/F/TAF achieved TND(P=0.064).At week 12,TND responses were higher with B/F/TAF(78.3%[112/143])than DTG+3TC(30.7%[42/137])(P<0.001).This trend held across subgroups.B/F/TAF achieved TND faster(12 weeks)than DTG+3TC(24 weeks)(P<0.001).No differences were seen in CD4^(+)cell count and CD4/CD8 ratio,except in the high-VL subgroup,where B/F/TAF showed better recovery.DRAEs were significantly lower with B/F/TAF(4.9%[7/143])than with DTG+3TC(13.1%[18/137])(P=0.016).Lipid parameters,body weight,and Cr increased in both groups over 48 weeks,with DTG+3TC showing a more favorable effect on triglycerides,high-density lipoprotein(HDL)cholesterol,and weight gain.Conclusions:In this real-life study,B/F/TAF led to a faster viral decline and fewer DRAEs compared to DTG+3TC.No significant difference was observed in the TND rate at week 48,regardless of baseline VL and CD4^(+)cell count.CD4^(+)recovery was superior for B/F/TAF in participants with high VL.The DTG+3TC regimen had less impact on metabolic changes than B/F/TAF.
