Many people living with HIV unwilling to interrupt treatment for prolonged periods during HIV cure trials

A study assessing the opinions of people living with HIV and their healthcare providers about analytical treatment interruptions (ATIs) has found that patients had limited understanding of how ATIs are usually conducted in HIV cure studies. These findings are reported by Dr Jillian Lau and colleagues in AIDS Research and Retroviruses.

Treatment interruptions pose potential risks, and both people living with HIV and their clinicians expressed concerns about HIV transmission during ATIs.

Antiretroviral therapy is essential for the health of people living with HIV. However, during an ATI, HIV-positive people temporarily stop their treatment, while being closely monitored as part of clinical research towards an HIV cure. Short-term treatment interruptions for these purposes are considered safer than prolonged interruptions, which increase the risk of opportunistic infections, drug resistance and other harms.

Glossary

cure

To eliminate a disease or a condition in an individual, or to fully restore health. A cure for HIV infection is one of the ultimate long-term goals of research today. It refers to a strategy or strategies that would eliminate HIV from a person’s body, or permanently control the virus and render it unable to cause disease. A ‘sterilising’ cure would completely eliminate the virus. A ‘functional’ cure would suppress HIV viral load, keeping it below the level of detection without the use of ART. The virus would not be eliminated from the body but would be effectively controlled and prevented from causing any illness. 

detectable viral load

When viral load is detectable, this indicates that HIV is replicating in the body. If the person is taking HIV treatment but their viral load is detectable, the treatment is not working properly. There may still be a risk of HIV transmission to sexual partners.

analytical treatment interruption (ATI)

As part of a research study, when study participants are requested to interrupt their antiretroviral therapy (ART) and be closely monitored. Most of these studies are in the field that aims to eventually achieve ‘ART-free remission’ or ‘HIV cure’. They usually look at the time it takes for the viral load to rebound after the interruption, following which ART is restarted.

viraemia

The presence of virus in the blood.

 

opportunistic infection (OI)

An infection that occurs more frequently or is more severe in people with weakened immune systems, such as people with low CD4 counts, than in people with healthy immune systems. Opportunistic infections common in people with advanced HIV disease include Pneumocystis jiroveci pneumonia; Kaposi sarcoma; cryptosporidiosis; histoplasmosis; other parasitic, viral, and fungal infections; and some types of cancer. 

The majority of the 442 people living with HIV who completed the survey were from middle- and high-income countries; 22% identified as female, 64% as gay/homosexual/lesbian, and 39% were over 50 years old. Ninety-five per cent were on treatment, of whom 83% reported an undetectable viral load.

When asked about the frequency of clinical monitoring during an ATI, around a third of people with HIV preferred monthly CD4 counts and viral load tests. This does not align with current cure research where viral load is being monitored weekly.

In response to how long they would be willing to have a detectable viral load, 35% of respondents preferred viral load to remain undetectable during treatment interruptions and would not accept any sustained periods of viremia. However, a rise in viral load is an inevitable outcome of an ATI. In contrast, 27% would accept a viral load rise of up to 1000 copies/ml.

Of the healthcare providers surveyed, 18% were uncomfortable with their patients having a detectable viral load and would prefer treatment to resume once their viral load became detectable. In contrast, a third of healthcare providers were not concerned about viremia or their patients being off treatment for prolonged periods, as long as they showed no signs of illness.  

Both groups preferred CD4 count to remain above 350 during trials.

Asked about potential risks of treatment interruptions, both groups were “very concerned” about HIV transmission. The researchers suggest that these perceptions may be linked to increased awareness of U=U. They recommend that PrEP is provided for participants’ seronegative partners during ATIs.

People with HIV were also concerned about a decline in general health, the risk of opportunistic infections and the development of resistant virus.

The results showed that nearly 60% of people living with HIV would be more willing to participate in HIV cure trials if home-based viral load testing was available, with 51% indicating they would be more willing if nurses could perform home visits. Others said they would participate if there was some financial compensation. Over half the participants said they would be more willing if PrEP was offered to HIV-negative partners.

In conclusion, the authors note that, although there is an “interest in HIV cure research and optimism towards a cure being achievable, there is a clear disconnect between what people living with HIV expect from cure focused clinical trials, and what is currently being practiced”. They recommend that “clear education messages and careful consent processes need to be developed in relation to analytical treatment interruptions in HIV cure research”.