Clinical outcomes of Dolutegravir treatment in people living with HIV in Brazil: Protocol for the CODE Cohort

The Clinical Outcomes of Dolutegravir Treatment in People Living with HIV in Brazil (CODE) cohort study is a multicenter, prospective, observational study designed to evaluate the safety and efficacy of Dolutegravir (DTG)-based antiretroviral therapy (ART) among people living with HIV across diverse settings in Brazil. With the recent global shift towards DTG as a preferred option for first-line ART, particularly in low- and middle-income countries, there is vital need for comprehensive real-world data to inform its widespread use. CODE aims to fill this knowledge gap by assessing the clinical outcomes of both ART-naïve and ART-experienced patients initiating DTG-based regimens, as well as those who have switched from non-DTG-based ART. The primary objective of this study is to determine the proportion of patients who discontinue DTG due to any adverse events, specifically focusing on metabolic and psychiatric outcomes. Secondary objectives include evaluating the rates of virological suppression, the occurrence of immune reconstitution inflammatory syndrome (IRIS), changes in body mass index (BMI), and the development of HIV drug resistance. The CODE cohort will enroll approximately 5000 participants from multiple clinical sites across Brazil, including 2500 ART-naïve individuals, 1000 patients switching to DTG-based regimens for various reasons, and a comparator group of 1500 individuals who initiated non-DTG-based ART between 2013 and 2016, before DTG was available in the country. Participants will be followed for up to 36 months, with data collection points at baseline, 6, 12, 24, and 36 months. This study is expected to generate critical insights into the long-term outcomes associated with DTG-based ART, particularly in real-world settings that reflect the complexities of routine clinical care. By providing robust data on the effectiveness and safety of DTG in a diverse patient population, the CODE study aims to contribute to the optimization of HIV treatment strategies both in Brazil and globally.