Young people living with HIV should take their HIV medicines daily, according to the BREATHER+ trial

08 Apr 2026

Taking HIV medicines every day without taking breaks remains the best way to keep the virus under control in young people living with HIV who are taking the most widely used combination of HIV medicines. This is according to new results from the BREATHER+ trial, published yesterday in The Lancet HIV.

The BREATHER+ trial involved 470 young people aged 12-19 from Uganda, South Africa, Zimbabwe, and Kenya. It looked at whether young people living with HIV, who were taking dolutegravir/tenofovir-based triple antiretroviral therapy, could safely take weekends off their HIV medicines.

The trial tested a short cycle therapy, where people took HIV medicines for five days and then had two days off treatment each week. This was compared to standard continuous therapy, where people took their HIV medicines every day. The aim of the trial was to test if the short-cycle therapy was as safe and as effective at keeping the virus under control as the continuous therapy.

To take part in the trial, young people needed to already be on dolutegravir-based antiretroviral therapy and have an undetectable HIV viral load. Participants were followed up for at least 96 weeks after they joined the trial.

The accepted threshold to detect the HIV virus in blood is 50 copies/mL. Any measurement below that shows that the virus is suppressed and the treatment is working. Any measurement equal to or above 50 copies/mL suggests that the treatment is not working as well as it could.

BREATHER+ found that short-cycle therapy was not as effective as continuous therapy in keeping HIV virus suppressed. The proportion of young people with two consecutive tests with ≥50 copies/mL of HIV virus was 10% in the short-cycle therapy, compared to 5% of those in the continuous therapy group.

These results reinforce that taking HIV medicines every day is the best way to keep the virus under control. Therefore, young people living with HIV should continue to take their medicines every day without taking any breaks.

The findings from BREATHER+ were different from previous trials on short-cycle therapy. Those studies found that short-cycle therapy was as good as continuous therapy when used in adults or young people, using the same or different combination of drugs, and when participants had their viral load checked every 12 weeks. In BREATHER+, we followed standard monitoring practices, checking viral loads every 6 to 12 months. More frequent tests might have helped detect early signs of viral activity (or “blips”) sooner, allowing timely support with medication adherence and helping participants bring the virus back under control without needing to switch to daily treatment. However, this is unlikely to be feasible in many places.

Although unexpected, the results from BREATHER+ were very clear. We are continuing to explore new ways to support young people living with HIV in managing their treatment more easily. One of the studies we are working on is the LATA trial, which is looking at whether long-acting injectable HIV medicines can be just as effective as HIV medicines in keeping the virus under control. We expect to see results from LATA in 2026.

BREATHER+ was funded by the European and Developing Countries Clinical Trials Partnership [RIA2017MC2005] supported by the European Union. The BREATHER+ trial was coordinated by the MRC Clinical Trials Unit at UCL (now known as the Innovative Clinical Trials Unit). The Sponsor was UCL. It was run at five sites in four countries in Sub-Saharan Africa:

Baylor College of Medicine Children's Foundation, Uganda
Joint Clinical Research Centre (JCRC), Uganda
University of Zimbabwe Clinical Research Centre (UZCRC), Zimbabwe
Moi University Clinical Research Centre, Kenya
Durban International Clinical Research Site - Enhancing Care Foundation, South Africa

The social science sub-study was led by the London School of Hygiene and Tropical Medicine. Penta coordinated youth involvement through the Youth Trial Boards. Health economics work was led by the Centre for Health Economics at the University of York.

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