30 July 2022 | Statements

Pooled data analysis from three large-scale clinical trials reveal long-term effects of dolutegravir-based treatment regimens on people living with HIV

Montreal, 30 July 2022 – Joint analysis from three HIV clinical research studies investigating the long-term effects of dolutegravir-based antiretroviral treatment regimens at 192 weeks’ follow-up showed it to remain safe and better tolerated than the previously recommended first-line drug efavirenz, with higher rates of viral suppression and lower risks of drug resistance.

These results are based on pooled data from the ADVANCE, DolPHIN2, and NAMSAL-ANRS-12313 clinical trials that evaluated the long-term risk-benefits of antiretroviral medicines in first-line HIV treatments.

In addition, a combined analysis of more than 1000 pregnant women living with HIV across five randomized trials, including ADVANCE,  DolPHIN-2, and  NAMSAL, showed no significant difference between dolutegravir and efavirenz in the risk of neonatal deaths, stillbirths, or mother to child HIV transmission. These findings also support the World Health Organization’s recommendation of the use of dolutegravir as the preferred HIV treatment for all populations.

However, though most patients who were started on dolutegravir-based regimens did well and were happy with the medication, the three trials revealed varying levels of weight gain experienced by certain populations of people living with HIV that did not seem to halt even beyond four years of treatment.

This was observed mostly among Africans, and more commonly among African women than men. This warrants urgent additional research to understand the causes and potential treatment responses to new concerns related to obesity, metabolic syndrome, and risk of cardiovascular disease in addition to physical and emotional discomfort. This should include potential ways to control weight while maintaining dolutegravir-based regimens, including the use of other medications and measures to diminish the undesirable effects.

This work highlights the critical importance of early inclusion of diverse populations in clinical trials to ensure all people have access to the best treatments possible. It is because of the joint and broad analysis conducted through these three trials that this issue was able to be identified and it is hoped that this will encourage further research to quickly develop adequate solutions.

The results are based on data from ADVANCE, DolPHIN2, and NAMSAL, led by Ezintsha, University of Liverpool, and University of Montpellier-IBB-ANRS, respectively, with funding support from Unitaid.


About Unitaid

Unitaid is a global health agency engaged in finding innovative solutions to prevent, diagnose, and treat diseases more quickly, affordably, and effectively, in low- and middle-income countries. Its work includes funding initiatives to address major diseases such as HIV, malaria, and tuberculosis, as well as HIV co-infections and co-morbidities including advanced HIV disease, cervical cancer, and hepatitis C, and cross-cutting areas, such as fever management. Unitaid is now applying its expertise to address challenges in advancing new therapies and diagnostics for the COVID-19 pandemic, serving as a key member of the Access to COVID-19 Tools (ACT) Accelerator, co-leading with Wellcome the Therapeutics Pillar and participating in the Diagnostics Pillar. Unitaid is hosted by the World Health Organization.

Media contacts:


Thalia Bayle
Communications officer
M: +41 79 660 56 37

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