BACKGROUND: Limited data inform evidence-based co-administration of DTG/TDF/3TC (TLD) with daily isoniazid (H) and rifapentine (P) for 1 month (1HP) or weekly HP for 3 months (3HP) for tuberculosis preventive therapy (TPT) in people living with HIV (PWH), particularly from Asia.
METHODS: A randomized control trial of 1 HP or 3 HP for TPT among PWH in 15 HIV clinics in Thailand is ongoing study from 2019 to present. At the beginning, only EFV/TDF/FTC was allowed. After the A5372 study demonstrated high DTG plasma concentrations among Thai PWH, TLD once daily was initiated from March 2022 onward. We reported the 24 weeks efficacy and safety of TLD and EFV/TDF/FTC with either 1 HP or 3HP.
RESULTS: Of 1070 participants analysed (59% male, median body weight 62.6 kg) , 804 (75%) took EFV/TDF/FTC and 266 (25%) received TLD; 546 (51%) participants received 1HP. Median ART duration prior to TPT was 1.2 (IQR:0.6-7.2) years; the majority of participants started TPT within 3 months of TLD or EFV/TDF/FTC initiation (66%), especially in the TLD group (84%). At week 24, viral suppression (HIV VL =50 copies/mL) was high in both EFV/TDF/FTC (92.2% 1HP and 91% 3HP) and TLD (92.8% 1HP and 94.7% 3HP) (Figure1). Hepatotoxicity >grade 2, that was mainly asymptomatic and self-limited, developed in 8.8% of 1 HP and 6.4% 3HP groups. Only 0.4% and 0.2% of 1070 participants prematurely discontinued 1 HP and 3 HP, respectively, due to hepatotoxicity or hypersensitivity reactions. Only 0.8% TLD group participants prematurely discontinued TPT.
Figure. 1A-C represent median CD4 change, HIV VL suppression and grading of hepatotoxicity in each treatment group