Risks of metabolic syndrome in the ADVANCE and NAMSAL trials

Area of Science:

• Clinical Medicine
• Pharmacology
• Public Health

Background:

• Substantial clinical obesity rates were observed in the ADVANCE and NAMSAL trials evaluating antiretroviral drugs.
• Rising obesity prevalence is a significant risk factor for metabolic syndrome, potentially increasing its incidence.

Purpose of the Study:

• To evaluate the risk of developing metabolic syndrome in participants of the ADVANCE and NAMSAL trials.
• To investigate the association between specific antiretroviral drug regimens and the incidence of metabolic syndrome.

Main Methods:

• Metabolic syndrome was defined by central obesity plus two or more of: raised triglycerides, reduced HDL-cholesterol, raised blood pressure, or raised fasting glucose.
• Prevalence was assessed at baseline and week 192, with differences between treatment arms analyzed using the chi-squared test.

Main Results:

• In ADVANCE, treatment-emergent metabolic syndrome incidence was 15% (TAF/FTC+DTG), 10% (TDF/FTC+DTG), and 7% (TDF/FTC/EFV), with significantly higher rates in DTG-containing arms.
• In NAMSAL, incidence was 14% (TDF/3TC+DTG) versus 5% (TDF/3TC+EFV), with significantly higher rates in the TDF/3TC+DTG arm.

Conclusions:

• Treatment-emergent metabolic syndrome is associated with dolutegravir-based antiretroviral therapy, likely linked to obesity.
• Clinicians should counsel patients on INSTI-based ART about lifestyle modifications to prevent metabolic complications.