CTN 286: TriiAdd Study

About The Study

CTN 286 sought to address the challenge some people living with HIV face in controlling their viral load, especially people from higher-risk populations. The study aimed to determine, in addition to adherence support, whether switching to a single-tablet treatment (Triumeq) is more effective in achieving HIV viral suppression than continuing with multi-tablet combination medications (cART) for people who have difficulty with medication adherence.

About The Disease

Modern HIV therapy offers many choices and allows for customized treatments for individual patients. For many people, these new therapies have led to undetectable HIV levels. While new HIV treatments are better at controlling the virus and have fewer side effects, many people are still unable to take their medications in the prescribed way and thus have been unable to achieve undetectable viral loads. As many as 30% of people living with HIV infection do not consistently have undetectable HIV levels and remain at risk for HIV-related illnesses, development of resistance and may transmit HIV infection to others. An ideal treatment should be simple, well tolerated, and combine well with treatments for other illnesses. The treatment should also easily fit into daily life where other considerations such as work, finances, and food insecurity can make it difficult to take medications regularly. Once-a-day HIV therapies and single-tablet regimens are likely to increase adherence and therefore increase the chance of suppressing the virus.

Study Approach

This was the first randomized, controlled trial that directly evaluated if switching to a single tablet regimen (Triumeq) improves adherence rates and HIV control. Researchers recruited 27 participants from 11 CTN-affiliate sites across Canada. Participants were randomly assigned to one of two groups. The first group immediately switched to Triumeq and received adherence support counselling. The second group continued to take their current medication and received adherence support for 24 weeks, after which they were given the choice to switch to Triumeq. Both groups were followed for up to 72 weeks (1.5 years). Adherence and HIV viral control were assessed at each study visit.

Results

In total, 50 people were screened and 27 were randomized from 11 sites across Canada. The trial was stopped early due to difficulties with recruitment of participants. Participants were predominantly from African, Caribbean, and Black communities, Indigenous people, or had a history of injection drug use. Six participants dropped out or stopped treatment.

The proportion of participants who achieved viral suppression at week 24 was 4/12 (33%) in the current medication arm vs. 7/13 (54%) in the Triumeq arm. All seven participants achieving viral suppression at week 24 in the Triumeq arm continued in study and maintained suppression through week 72. Of the six remaining participants in current medication arm who switched to Triumeq at week 24, three achieved viral suppression at weeks 48 and 72.

Forgetfulness, competing demands, substance use, negative treatment experiences, economic barriers/lack of insurance, and insufficient support were the most frequently reported barriers to adherence.

Conclusion

While switching to the single tablet Triumeq appeared to improve control of HIV, the trial encountered many challenges and was stopped early due to slow recruitment. It was difficult to find participants without prior drug resistance. Despite intensive support, participants continued to face adherence barriers and many dropped out of the study.