The efficacy and safety of Biktarvy in Treatment-Naïve Late Presenters with HIV-1 Infection
HIV epidemic is still severe in China, the estimated number if PLWH in HIV is around 1.25 million all of China with an increasing trend of new cases. Late presenters with low CD4 T cells and/or with hight viral load should be paid more attention for better treatment and care. As a new combined antiretroviral regimen of integrase inhibitor, B/F/TAF was recently approved in US and European and also in China which needs more real world data in China. Non-inferiority or advantage of B/F/TAF comparing with the first line TDF/3TC/EFV for later presenters in China needs to be explored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
202
randomized, multicentered, open-lable RCT, one arm with B/F/TAF and one arm with TDF/3TC/EFV
TDF/3TC/EFV
The Guangxi Zhuang Autonomous Region Longtan Hospital
Liuzhou, Guangxi, China
Lanzhou Feike Hospital
Lanzhou, Guansu, China
The Second Hospital of Nanjing
Najing, Jiangsu, China
China Liaoning Dalian Public Health Clinical Center
Dalian, Liaoning, China
Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 12
Proportion of participants with HIV-1 RNA \< 50 copies/mL at Weeks 12
Time frame: Weeks 12
Proportion of participants with HIV-1 RNA < 50 copies/mL at Weeks 4,24,48
Proportion of participants with HIV-1 RNA \< 50 copies/mL at Weeks 4,24,48
Time frame: Weeks 4,24,48
The Change in CD4 T cell count from baseline at Weeks 12,24,48
The Change in CD4 T cell count from baseline at Weeks 12,24,48
Time frame: Weeks 12,24,48
Change in CD4/CD8 ratio from baseline at Weeks 12,24,48
Change in CD4/CD8 ratio from baseline at Weeks 12,24,48
Time frame: Weeks 12,24,48
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Tianjin Second People's Hospital
Tianjin, China