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Dolutegravir

New Research on Dolutegravir Treatment in HIV Patients Showcases Promise in Brazil

Strategic Insights

— 2 min read

A team of investigators from Federal University Bahia conducted a comprehensive study on the clinical outcomes of dolutegravir (DTG) treatment in people living with HIV in Brazil. The research, known as the Clinical Outcomes of Dolutegravir Treatment in People Living with HIV in Brazil (CODE) cohort study, aims to assess the safety and efficacy of DTG-based antiretroviral therapy (ART) among diverse patient populations in Brazil.

As the world shifts towards DTG as a preferred option for first-line ART, especially in low- and middle-income countries, there is a growing need for real-world data to inform its widespread use. The CODE study aims to fill this knowledge gap by evaluating the clinical outcomes of both ART-naive and ART-experienced patients initiating DTG-based regimens, as well as those who have switched from non-DTG-based ART.

The study expects to enroll approximately 5000 participants from multiple clinical sites across Brazil, including 2500 ART-naive individuals, 1000 patients switching to DTG-based regimens, and a comparator group of 1500 individuals who initiated non-DTG-based ART between 2013 and 2016. Participants will be followed for up to 36 months, with data collection points at baseline, 6, 12, 24, and 36 months.

Key Takeaways:

  • The CODE cohort study aims to evaluate the clinical outcomes of dolutegravir treatment in people living with HIV in Brazil, particularly in real-world settings that reflect the complexities of routine clinical care.
  • The study will assess the proportion of patients who discontinue DTG due to adverse events, specifically focusing on metabolic and psychiatric outcomes.
  • The study will also evaluate 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 research is expected to provide critical insights into the long-term outcomes associated with DTG-based ART, particularly in a diverse patient population.
  • The CODE study aims to contribute to the optimization of HIV treatment strategies both in Brazil and globally.

Statistics:

  • The study expects to enroll approximately 5000 participants from multiple clinical sites across Brazil.
  • The study will follow participants for up to 36 months.
  • The research will assess the proportion of patients who discontinue DTG due to adverse events, specifically focusing on metabolic and psychiatric outcomes.
  • The study will evaluate 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 study aims to provide critical insights into the long-term outcomes associated with DTG-based ART, particularly in a diverse patient population.

Sources:

  • NewsRx. Report Summarizes HIV/AIDS Study Findings from Federal University Bahia (Clinical outcomes of dolutegravir treatment in people living with HIV in Brazil: protocol for the CODE cohort). AIDS Weekly. October 20, 2025; p 142.
  • Clinical outcomes of dolutegravir treatment in people living with HIV in Brazil: protocol for the CODE cohort. BMC Infectious Diseases, 2025;25(1):1248.

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