HIV therapy has changed dramatically over the last 10 years. Modern HIV therapy offers many choices that allow customized treatments for individual patients. While new HIV treatments are better at controlling the virus and have fewer side effects, many people are unable to take their treatments in a way that leads to an undetectable viral load. In the real world, as many as 30% of people living with HIV infection do not consistently have undetectable HIV levels due to a very rigid regimen of HIV therapy that often is difficult to follow.
Many features of HIV treatments themselves can help people take medications consistently (also called adherence). An ideal treatment should be simple, well tolerated and combine well with treatment for other illnesses. Treatment should also be easy to fit into daily life where many other considerations such as work, financial and food insecurity may make it hard to take medications regularly. Once-a-day HIV therapies and single tablet regimens (STR) are likely to help support adherence and increase the chance of having an undetectable viral load.
While studies have suggested use of STR can lead to significant improvements in adherence, it is still not known if they will result in better HIV control and improved health. This will be the first randomized controlled trial that will directly compare if switching to an STR called Triumeq will improve adherence rates and HIV control.
Patients will be randomized in a 1:1 fashion to the experimental arm: Immediate switch to dolutegravir 50mg /abacavir 600mg/3TC 300mg once daily administered as fixed dose combination tablet Triumeq combined with adherence support or to the control arm: Continued on currently prescribed cART regimen with adherence support followed by delayed switch to dolutegravir 50mg /abacavir 600mg/3TC 300mg once daily administered as a fixed dose combination tablet Triumeq combined with continued adherence support at 24 weeks in all subjects with HIV RNA >50 copies/ml or if they chose to.
This trial is being led by Dr. Marina Klein of the McGill University Health Centre, and is supported by CTN and ViiV Healthcare.