Time spent with HIV-RNA ≤ 200 copies/ml in a cohort of people with HIV during the U=U era

Objective: Zero risk of linked HIV transmission in sero-discordant couples when the HIV-infected partner had viral load (VL) <200 copies/mL (‘U status’) was found in observational studies. We aimed at estimating the proportion of time in which ‘U status’ was maintained and identifying factors associated with the risk of losing it. / Design: Observational cohort study. / Methods: We included participants in the ICONA cohort who had reached an established ‘U status’ (VL≤200 copies/mL for >6 months) as of December 2010. The outcome was the number of person-days of follow up (PDFU) above a VL>200 copies/ml, relative to the total number of PDFU observed. A logistic regression model was used to identify factors independently associated with the risk of losing ‘U status’. / Results: 8,241 persons living with HIV were included in the analysis who contributed 12,670,888 PDFU. Of these, 1,648 (20%) were female, 768 (9%) were people who inject drugs (PWID), and 2,066 (25%) were foreing-born. The median of VL measurements was 9 (IQR: 4–15). Overall, only 3.1% of PDFU were observed when VL was >200 copies/mL. The proportion of PDFU with VL>200 cp/ml was higher than average in females (5.3%), unemployed (5.4%), PWID (4.7%), and in people with>3 previous virologic failures (6.3%). These variables were significant predictors of losing ‘U status’ in the multivariable logistic regression. / Conclusions: Our results reinforce the validity of the U=U message in real-world setting. However, we identified subsets of our study population at higher risk of losing the ‘U status’ for whom additional efforts are needed