Jill Lau
Pausing the pills: attitudes to treatment interruption
Participants in HIV cure trials will increasingly need to consider stopping antiretroviral treatment. This will be the only sure way to know if a cure strategy really works. In the U=U era, when HIV treatment is increasingly effective and easy to take, treatment interruption needs to be thoughtfully approached.
An analytical treatment interruption, or ATI for short, is the practice of stopping ART during a clinical study. Recommendations for how studies incorporating ATI should be performed were recently published. This consensus document is an important development. Little is known, however, about what positive people and their doctors think about how these studies are done. It is really important to ask specific questions about when ATI might be acceptable, and how the risks of stopping treatment can be managed.
A group of researchers from the Alfred Hospital, the Doherty Institute, the Australian Research Centre for Sex Health and Society, along with representatives from Living Positive Victoria and the National Association of People with HIV Australia designed two surveys to explore attitudes to ATI. The surveys were hosted on this website in 2018, asking people living with HIV and their doctors what they thought about ATI. The findings of the surveys have now been published, so let’s look at what they’ve told us.
Who did the surveys?
442 people living with HIV and 144 doctors completed the surveys. Respondents were mostly living in high-income countries such as Australia, the United States of America and Western Europe. Most survey respondents living with HIV identified as gay men who had sex with men, mirroring the picture of HIV in these countries.
What were the survey findings?
Few doctors and even fewer people living with HIV (PLHIV) surveyed had previous experience with HIV cure studies. This is despite general interest in HIV cure research. Doctors were generally supportive of their patients entering HIV cure studies. Mainly altruistic reasons motivated PLHIV to participate in these studies.
The surveys highlighted a difference between what HIV positive people expect from HIV cure focused studies, and what is currently happening in the real world. PLHIV preferred monthly viral load checks, but the recent recommendations are suggesting studies should perform weekly blood tests. Many PLHIV were uncomfortable with the prospect of having a detectable viral load during ATI. A detectable viral load is, however, very common for participants in these types of studies. Discussions about ATI in HIV cure research are taking off at the same time as the rallying call of U=U, or undetectable=untransmittable. Fear of having a detectable virus level, and the risk of passing on HIV to sexual partners was a serious concern for both PLHIV and doctors.
Several factors were identified that improved the willingness of people to enter ATI studies. These included the options of home-based viral load testing, home visits by nurses, and the provision of PrEP to HIV negative partners of study participants.
Compared to doctors, more people living with HIV thought an HIV cure would be achieved in the next decade. The practice of ATI, however, was more familiar to doctors than people living with HIV.
What can we do with these findings?
The discussion about managing ATI will need to evolve as HIV cure-focused research progresses. The published surveys represent the views of a relatively small group of people in high-income countries. Attitudes elsewhere, and in other groups of people living with HIV, may well be different.
The surveys clearly show a gap between what PLHIV and their doctors understand and expect from HIV cure-focused studies, and what is actually happening. Involving people living with HIV in the design of studies requiring ATI will be critical. Clear and comprehensive education about the ins and outs of ATIs must be developed and shared with the HIV community. Strategies such as videos and infographics, and peer educators may help successfully spread this information. Researchers need to tread carefully to manage the mixed messages of U=U and the power of ATI in HIV cure research.
The full report of the survey findings can be found here. (Please note that there is a paywall. If you can’t access the article, email us and we’ll send you a copy)
Recommendations and considerations for future ATI trials resulting from the surveys
- Focus on improving stakeholder engagement and involvement in early stages of clinical trial design
- Prioritise research into home-based HIV viral load testing
- Include PrEP counselling and provision into future treatment interruption trial protocols
- Develop educational material for both people living with HIV and their doctors on HIV cure science
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