Do ATIs in HIV cure-related studies cause anxiety?

Many studies linked to finding a cure for HIV involve asking participants to take an analytic treatment interruption (ATI). This requires stopping HIV treatment (ART) for several weeks or months to see the impact on viral load.

While an ATI is generally thought to be safe in the short-term and context of a carefully monitored study, there are very limited data on the long-term impact. In the absence of surrogate markers for viral rebound, ATIs are also the only way to test the impact of cure-related interventions.

However, because stopping treatment is not recommended in treatment guidelines and viral rebound also affects the risk of transmitting HIV, taking an ATI could easily increase anxiety and affect the participants’ lives in other ways.

A new study by John Sauceda from University of California and colleagues monitored anxiety levels using questionnaires that were self-completed before and during an ATI in two small studies. The results showed different patterns of anxiety in each study.

One study showed high levels of anxiety two weeks before the ATI, which then significantly dropped from roughly 9.5 on a general anxiety score to roughly 6.5 during the study. It then only increased slightly in absolute terms.

In the second study, anxiety levels were low before the ATI and increased from approximately 2 to 7, at which it remained, roughly.

In a pooled analysis, the mean anxiety scores did increase during the studies and this was highly statistically significant (p=0.0008). However, although the authors didn’t comment on the clinical significance, the absolute increases were less than 0.5 on the same scale which seems minor, and there were no individual reports of acute high levels of anxiety.

Neither study reported anxiety levels after the ATI or whether these returned to baseline.

This perhaps shows concerns about the baseline levels in each study and it is not clear whether participants were asked about any experiences unrelated to the research that might have affected the results.

The researchers also noted that as with many cure-related studies these were small studies (n=15 and n=10, respectively) with limited demographic diversity and they suggest their approach should be routinely included in larger studies in the future.

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This careful study highlighted an aspect of cure-related research that is often overlooked. The results show the importance of including surveys relating to the quality of life of participants and that this can easily be done.

ATI studies involve significant changes to someone’s life if they have previously been on stable ART, and they often include an intensive schedule of study visits.

It is also reassuring that anxiety levels appeared minimal in this paper. Anecdotally, participants in cure-related studies often feel a positive connection from being able to help in this research.