We performed a retrospective, observational study in which we enrolled treatment-experienced, virologically suppressed PLWHIV from 9 Italian clinical centers. Criteria for eligibility were patient's informed consent to data collection, being at least 18 year old, being on stable (ie, at least 6 months) antiretroviral therapy (ARV) with viral suppression (HIV-RNA<50 copies/mL) at the moment of switch to lamivudine plus dolutegravir (baseline), and being HBsAg negative.
The primary study objective was to evaluate time to virological failure (VF, defined by a single HIV-1 RNA ≥1000 copies/mL or by 2 consecutive HIV-1 RNA ≥ 50 copies/mL) and the time to treatment discontinuation (TD, defined as the interruption of either 3TC or DTG) for any cause. Survival analysis was used to determine the time to VF and TD, and the respective predictors were analyzed by Cox regression. The study was performed according to the principles of the Declaration of Helsinki and received the approval by each independent local ethics committee (study coordination site protocol number 5284/15). Data were analyzed by using SPSS Statistics for Windows, Version 23.0 (IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp).
J Acquir Immune Defic Syndr. 2021;88(3):234-237. © 2021 Lippincott Williams & Wilkins