Predictors for choosing doravirine-based versus INSTI-based regimen in ART-naïve and ART-experienced people with HIV in real-world setting: Data from the Icona cohort

RATIONALE: Doravirine (DOR) is an attractive new option both for ART-naïve people with HIV (PWH) and those with suppressed HIV-RNA who seek treatment simplification. We used real-world data to examine the pattern of use of DOR-containing regimens in these settings. METHODS: All PWH enrolled in the Icona cohort after January 2020 who initiated a three-drug regimen (3-DR) with DOR or an integrase inhibitor (INSTI)-based regimen as first antiretroviral therapy (ART) or when switching ART, with HIV-RNA ≤50 copies/mL, were included. We used univariate and multivariable logistic regression models to identify demographic factors, immuno-virological and laboratory markers associated with the prescription of 3-DR DOR instead of INSTI-based regimens. RESULTS: A total of 5803 PWH were included; 1958 were in the first regimen (80 DOR, 1,878 INSTI) and 3854 (387 DOR, 3,458 INSTI) were ART-experienced virologically suppressed. In the first line, 3-DR DOR was more frequently started in people who inject drugs, and its use was also associated with higher body mass index, higher low-density lipoprotein levels, and less advanced HIV disease compared with PWH initiating an INSTI-based regimen. In the switch setting, older age, Italian origin, higher estimated glomerular filtration rate and aspartate aminotransferase levels were all strongly associated with 3-DR DOR use, as well as higher a CD4/CD8 ratio (only vs. 3-DR INSTI), while the association with lipid abnormalities was attenuated. CONCLUSIONS: Our analysis shows that among PWH in care in Italy, those with less advanced HIV disease but with other fragilities and potential risk factors for comorbidities are more likely to use DOR- than INSTI-based regimens, regardless of prior treatment history.