Landman R, de Truchis P, Assoumou L, et. al. ANRS 170 QUATUOR study group. A 4-days-on and 3-days-off maintenance treatment strategy for adults with HIV-1 (ANRS 170 QUATUOR): a randomised, open-label, multicentre, parallel, non-inferiority trial. Lancet HIV. 2022 Feb; 9(2): e79-e90. doi: 10.1016/S2352-3018(21)00300-3. PMID: 35120640
This randomized, open-label, non-inferiority trial examined 48-week efficacy, safety, and participant experience after switching to a 4-days-on, 3-days-off treatment strategy compared to standard daily continuous treatment using commonly prescribed ART combinations (INSTI, NNRTI, and PI-based regimens which included a 2 NRTI backbone). 636 participants were followed from 2018-2020 at multiple French hospitals: they were mostly male (85%) and had received ART for a median 6+ years, with a median 5.8 years of viral suppression < 50 copies/mL. At week 48, in the mITT population, 96% in the intermittent treatment group and 97% in the continuous treatment group maintained plasma VL < 50 copies/mL with no treatment strategy modification, demonstrating non-inferiority [with the predefined margin of -5%]. Of 10 participants who experienced virologic failure, 3/6 in the intermittent group and 1/4 in the continuous treatment group developed new drug resistance mutations. Grade 3-4 adverse events were reported in 9% vs. 12% of the intermittent and continuous treatment groups, respectively. Daily life satisfaction improved in 59% of participants in the intermittent group vs. 7% of the continuous treatment group.