Abstract
BackgroundConcerns regarding potential toxicity and drug-drug interactions during long-term treatment with three-drug active antiretroviral therapy (ART) regimens have been attracting increasing attention. We aimed to evaluate the efficacy and safety of dolutegravir (DTG) plus lamivudine (3TC) in ART-naive adults in China.MethodsThis prospective observational cohort study enrolled HIV-naive inpatients treated with DTG + 3TC (2DR arm) or efavirenz (EFV) plus tenofovir disoproxil fumarate (TDF) and 3TC (3DR arm). There were no limits on baseline viral load. Inflammatory biomarkers were also investigated in the 2DR arm.ResultsBetween September 2019 and January 2020, 27 patients treated with DTG + 3TC and 28 patients treated with EFV + TDF + 3TC were enrolled in the study. At week 12, the proportion of patients with viral loads < 50 copies/mL in the 2DR arm was 81.5% (22/27) compared with 53.6% (15/28) in the 3DR arm (p < 0.01). At week 24, the proportion of patients with viral loads < 50 copies/mL in the 2DR arm was 100% (26/26) compared with 83.3% (20/24) in the 3DR arm (p < 0.05). Mean changes in CD4 cell counts from baseline at week 12 were 125.46 cells/µL in the 2DR arm and 41.20 cells/µL in the 3DR arm (p < 0.05). Mean changes in CD4 cell counts from baseline at week 24 were 209.68 cells/µL in the 2DR arm and 73.28 cells/µL in the 3DR arm (p < 0.05).ConclusionsDTG + 3TC achieved virologic suppression more rapidly than EFV + TDF + 3TC after 12 and 24 weeks. DTG + 3TC could represent an optimal regimen for advanced patients.Clinical Trial Registration ChiCTR1900027640 (22/November/2019).
Highlights
There has been a sustained decrease in the mortality and morbidity of patients with human immunodeficiency virus type 1 (HIV-1) infection since the introduction of highly active antiretroviral therapy (HAART) [1, 2]
Levels of inflammatory markers including interleukin (IL)-6, D-dimer, soluble tumor necrosis factor receptor-1, high-sensitivity C reactive protein are independently predictive of mortality in individuals with treated HIV-1 infection with a history of AIDS [18]. In this prospective cohort study, we aimed to evaluate the efficacy and safety of DTG + 3TC compared with a first line three-drug regimen (3DR) (EFV + tenofovir disoproxil fumarate (TDF) + 3TC) for treatment of HIV-1 infection in ART-naive adults in China with no limitations on baseline viral load
Genotypic tests were performed by the Chinese Center for Disease Control prior to HAART administration; none of the participants harbored viruses bearing mutations conferring resistance to integrase strand transfer inhibitor (INSTI) or NRTIs
Summary
There has been a sustained decrease in the mortality and morbidity of patients with human immunodeficiency virus type 1 (HIV-1) infection since the introduction of highly active antiretroviral therapy (HAART) [1, 2]. Concerns related to the safety profiles of these medicines administered throughout the life course have attracted increasing attention. Two-drug regimens (2DRs) have been investigated as a means to improve the quality of life of patients with HIV-1 by reducing adverse drug reactions, saving costs, and improving HAART compliance [5,6,7]. Dolutegravir (DTG), a second-generation integrase strand transfer inhibitor (INSTI), is attractive as a component of 2DRs because of its high antiviral potency and resistance barriers [8,9,10]. Lamivudine (3TC) is an effective component of 2DRs with a well-documented safety profile and a high barrier to resistance [11]. Concerns regarding potential toxicity and drug-drug interactions during long-term treatment with three-drug active antiretroviral therapy (ART) regimens have been attracting increasing attention. We aimed to evaluate the efficacy and safety of dolutegravir (DTG) plus lamivudine (3TC) in ART-naive adults in China
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