BREATHER Plus

What was this study about?

The goal of HIV treatment is to make sure the amount of HIV virus in the blood remains very low. This is called having an undetectable viral load. If this goal is achieved and sustained life-long, then people living with HIV can live a healthy life, with a normal life expectancy. However, it is challenging to take medication every single day for life. This may be an even bigger challenge for teenagers living with HIV.

In BREATHER Plus we compared two different ways of taking HIV medicines that include the HIV medicine dolutegravir. We wanted to see if a similar proportion of young people in the Short Cycle Therapy group had low HIV virus as in the Continuous Treatment group and whether they found other benefits to having two days off treatment each week:

• Short Cycle Therapy: where people taking part took all their HIV medicines during the week but stopped taking them at weekends (either Friday and Saturday or Saturday and Sunday)
• Continuous Treatment: where people taking part took all their HIV medicines every day without any interruptions

 People joining BREATHER Plus had an equal chance of being randomised to one of the two groups.

 

 

What difference did this study make?

After at least two years of follow-up, BREATHER+ found that short-cycle therapy was not as good as continuous therapy in terms of keeping the HIV virus suppressed. The proportion of young people with two consecutive tests with viral loads ≥50 copies/mL was 10% in the short-cycle therapy, compared to 5% of those in the continuous therapy group.

These results reinforce that the current treatment, which involves 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 tablets every day without breaks.

The results from BREATHER+ differ from previous trials of short-cycle therapy, which have found that short-cycle therapy is as good as continuous therapy when used in adults or young people on a different combination of drugs, all of whom had frequent viral load monitoring. This may have helped reduce the risk of confirmed viral load rebound through identifying blips earlier and using adherence counselling to help participants resuppress the virus quickly without returning to continuous therapy.

Although disappointing, BREATHER+ findings were very clear. We are continuing to work on new trials to help young people living with HIV manage their treatment more easily. For example, our LATA trial is investigating whether long-acting injectable HIV medicines work as well as HIV medicines to keep the virus under control. We expect to find out the results from LATA in 2026.

Please click here to read the published BREATHER Plus article.

 

Type of study

Randomised trial

Contact details

mrcctu.bplata@ucl.ac.uk

Who funded the study?

This project was part of the EDCTP2 Programme (grant code: RIA2017MC-2005) supported by the European Union.

The European and Developing Countries Clinical Trials Partnership (EDCTP2) is a collaboration between countries in Europe and sub-Saharan Africa supported by the European Union, to improve the health of Africans by doing important research trials.