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Background: Initiating same-day ART for newly HIV-diagnosed individuals reduces secondary HIV transmissions and the risk of them being lost to follow-up between diagnosis and initiation of ART., Methods: The FAST study was a national, prospective, single-arm study assessing the efficacy, safety and feasibility of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in a same-day initiation model. ART had to be started on the first medical appointment, before any laboratory results were available. Participants completed a self-administered questionnaire at each visit including a HIV anxiety 5-point Likert scale. The primary outcome was the proportion of participants in the ITT population with plasma HIV RNA (pVL) < 50 copies/mL at Week (W) 24 using the FDA Snapshot algorithm., Results: Overall, 112 participants were included in the ITT population. During follow-up, seven participants discontinued the study drug but remained on the study, and seven others discontinued follow-up. According to FDA Snapshot analysis, at W24 and W48, 90/112, (80.4%; 95% CI: 71.8-87.3) and 95/112 (84.8%; 95% CI: 76.8-90.9) of participants achieved pVL < 50 copies/mL, respectively. The protocol-defined virological failure (PDVF, 2 consecutive pVL ≥ 50 copies/mL as of W24) was observed in 11/112 (9.8%) at W24 and 14/112 (12.5%) at W48. No emergent resistance-associated mutation was detected in those with PDVF at W24 and W48. BIC/FTC/TAF was well tolerated through to W48, with a low incidence of grade 3-4 adverse events (15/100 person-years). Patient opinion of same-day treatment initiation and continuing BIC/FTC/TAF was very favourable., Conclusions: These results suggest that BIC/FTC/TAF is safe, effective and well accepted for same-day initiation., (© The Author(s) 2023. Published by Oxford University Press on behalf of British Society for Antimicrobial Chemotherapy. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Sparing of antiretroviral drug classes could reduce the toxicity and cost of maintenance treatment for HIV infection., Objectives: To evaluate the non-inferiority of efficacy and the safety of lopinavir/ritonavir (r) monotherapy versus a single-tablet regimen of efavirenz, emtricitabine and tenofovir (EFV/FTC/TDF) over 2 years., Methods: Adults on stable ART with plasma HIV-1 RNA viral load <50 copies/mL for the past 12 months and no documented treatment failure were randomized to receive either lopinavir/r or EFV/FTC/TDF for 2 years. The primary endpoint was the proportion of patients without treatment failure at week 96 (viral load <50 copies/mL at week 96, confirmed at week 98), without study treatment discontinuation, a new AIDS-defining illness, or death., Results: In the ITT analysis, the primary endpoint was reached by, respectively, 64% and 71% of patients in the lopinavir/r (n = 98) and EFV/FTC/TDF arms (n = 97), yielding a difference of -6.8% (lower limit of the 95% two-sided CI: -19.9%). Sanger and UltraDeep sequencing showed the occurrence of PI mutations in the lopinavir/r arm (n = 4) and of NNRTI and/or NRTI mutations in the EFV/FTC/TDF arm (n = 2). No unexpected serious clinical events occurred., Conclusions: Lopinavir/r monotherapy cannot be considered non-inferior to EFV/FTC/TDF. PI resistance rarely emerged in the lopinavir/r arm and did not undermine future PI options. Two years of lopinavir/r monotherapy had no deleterious clinical impact when compared with EFV/FTC/TDF.

Objectives: The aim of this study was to identify factors associated with non-adherence over a 10 year follow-up of the APROCO-COPILOTE cohort during the maintenance phase of highly active antiretroviral therapy (HAART)., Methods: Overall, 1010 patients participated in this analysis, each having had at least 12 months of follow-up after HAART initiation and at least one self-reported adherence measure available during the follow-up period (month 12-month 120). Data collection was based on clinical records and self-administered questionnaires that gathered patients' psychosocial characteristics and experience with HIV disease and treatment. First, a generalized estimating equations (GEE) model was used to identify non-adherence predictors. Secondly, a Heckman two-stage approach was used in order to account for missing data bias and to measure the extent to which this could affect the results of the first model., Results: Non-adherent behaviour was reported by 747 patients (2070 visits). After correcting for the bias due to missing data, non-adherence was independently associated with side effects, having a three times or more daily dosing regimen, experience of being at clinical stage B/C and being diagnosed as HIV-positive for <6 months. Non-adherence was more likely among patients who were younger, had children, were born in the European Union, had depressive symptoms, consumed alcohol daily and declared a lack of support from their main partner. Adjusting for missing outcome data changed the pattern of predictors., Conclusions: Reasons for non-adherence depended on both psychosocial conditions and treatment-related characteristics. To improve long-term patient outcomes for those at risk of adherence failure, tailor-made patient-specific psychosocial interventions and regimen-based strategies with improved tolerance need to be implemented.