Cohort profile: The Observational cohort for the study of DOlutegravir in Antiretroviral Combination REgimens (ODOACRE).

The Observational cohort for the study of DOlutegravir in Antiretroviral Combination REgimens (ODOACRE) cohort was established in Italy in 2016 to evaluate the overall efficacy and tolerability of dolutegravir (DTG)-based antiretroviral (ARV) regimens in clinical practice. The ODOACRE cohort enrols all adult HIV-1-infected patients, both treatment-naïve and treatment-experienced, starting a DTG-based ARV regimen, in 11 clinical centres in Italy from 2014. In recent years, various works by the ODOACRE cohort have been produced, demonstrating the high efficacy and tolerability of DTG-based ARV regimens in clinical practice, both in ART-naïve (in the setting of acute HIV-1 infection and late presenters patient) and experienced patients. We confirmed the virological efficacy of DTG-based regimens and we evaluated predictors of virological failure. We investigated cause of discontinuation and evaluated tolerability and metabolic profile of the regimens. Within these investigations, we explored particularly the use of DTG in simplification in two-drug regimen with either rilpivirine or lamivudine. We also compared DTG-based regimens with other integrase inhibitors in clinical practice. To continue to study long-term efficacy and tolerability of DTG-based regimens is the purpose of the ODOACRE cohort.

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Competing interests: GB received travel grant from Gilead. ACa has received a personal grant from AB, Gilead and ViiV. GS has received funds for speaking by Gilead, Merk, Janssen, Abbvie, ViiV. AL received personal fees from BMS, Gilead, Merck, ViiV, AbbVie and Janssen and grants from BMS, Gilead, ViiV and Janssen. GM is in an ongoing relation as board member for ViiV Healthcare, Gilead Sciences and Jannsen. BR received travel grants from Jannsen, ViiV, Gilead MSD and received grants for consultancy from Abbvie, MSD, Viiv. AG received speaker fees from Mylan. AB has received non-financial support from Bristol-Myers Squibb and ViiV Healthcare, and personal fees from Gilead Sciences. CM has participated in advisory boards, received study grants and/or speaker honoraria from Abbvie, Gilead, Viiv, Janssen, Angelini, BMS and MSD. SR received research grants to his Institution from ViiV Heathcare, Gilead Sciences and Jannsen, outside the submitted work; he was also a paid consultant for ViiV Heathcare, Gilead Sciences, Merck Sharp and Dohme, Bristol-Myers Squibb, Janssen and Mylan. SDG was a paid consultant or member of advisory boards for Gilead, ViiV Healthcare, Janssen-Cilag, Merck Sharp & Dohme and Bristol-Myers Squibb.