More detailed findings came from a survey completed by 400
Americans living with HIV, 77% of whom were male. Whereas 65% were white, 17% were
black, 12% Hispanic, 4% mixed and 2% Asian. Alongside the survey, interviews
were conducted with 36 people living with HIV, clinicians, researchers, bioethicists
and regulators. Results were reported in a series of posters.
Whereas the Australian data came from a general survey of HIV-positive
people (HIV Futures 8) that covered a range of issues, the American
participants were connected to HIV cure research networks and were recruited to
a survey about an HIV cure. They could be expected to be better informed about cure
issues and more interested in taking part in a cure study.
Despite this, 8% thought a cure for HIV was already in
existence. A further 27% thought a cure would probably be available within five
years and 33% thought it would only take ten years.
Asked about the potential benefits of taking part in cure-related
research, benefits to the wider society ranked highly. Helping find a cure for
HIV (95%), helping others with HIV in the future (90%) and contributing to
scientific knowledge (88%) were among the most cited reasons.
Such social benefits could have an emotional impact – ‘feeling
good about contributing to HIV cure research’ was an important personal benefit
(80%). Respondents also hoped to gain knowledge about their own health or HIV
(78%) and new treatment options (77%). Getting better access to medical care was cited by a number of participants, but relatively few were motivated by financial compensation.
In terms of clinical benefits, many respondents hoped that
they might increase their immune system’s ability to fight HIV (92%), reduce the
reservoir of HIV in their body (85%), control viral load in the absence of
treatment (84%) or reduce the risk of transmitting the virus to a sexual
partner (79%). However the researchers comment, “Early phase research does not
confer projected direct clinical benefits and there is the possibility of harm
while advancing medical knowledge.”
The survey showed participants to be less aware of risks
than of benefits. Asked which potential risks would discourage them from participating
in an HIV cure-related study, respondents indicated a number of possible harms,
but in lower numbers.
In terms of clinical risks, increased cancer risk (49%),
developing resistance to antiretrovirals (37%), side-effects (30%) and the known
risks of stopping HIV medications (30%) could discourage participation.
Study procedures presenting the greatest barriers were
lumbar punctures (26%), bone marrow biopsies (22%), lymph node biopsies (13%)
and rectal biopsies (13%). Specific side-effects such as hair loss (32%) and
vomiting (23%) would be off-putting. Practical problems like trouble parking at
the clinic (20%) or getting transport to it (17%) could also discourage trial
participation.
A smaller group of people living with HIV were interviewed
and asked what might be ‘too much risk’ for them to take part. Some of their
responses were:
“Trying an approach
never tested on humans.”
“Gene manipulations
that result in cancers probably would be the most frightening and unbearable.”
“If I were to become
resistant to the drugs that are saving my life at present.”
“A risk that would
have me end up in irreversibly poorer health than I am now.”
“Greater than 1% risk
of death.”
Clinicians and researchers who were interviewed also had
views on what would constitute ‘too much risk’. Most said that stem cell
transplants in otherwise healthy, cancer-free participants who are stable and
suppressed on antiretroviral therapy would be too risky. Others mentioned
anti-programmed cell death protein 1 that has shown significant toxicities in animal
studies.
Likewise, regulators who were interviewed said that some
studies were too risky to go ahead. If there was either insufficient
information to assess risk or insufficient potential benefits to outweigh the
risks, approval would not be given. A poorly designed study would be unlikely
to bring us closer to a cure, while exposing participants to risk.
One particular study procedure that could expose participants to harm is an analytical treatment interruption. Antiretroviral
treatment would need to be stopped, in order to assess time to viral rebound or
predictors of rebound. Of the survey respondents, 26% indicated they were very
willing and 42% somewhat willing to interrupt their treatment.
During interviews, motivations for agreeing to stop included
a desire to help find a cure (“Knowing that
you are a part of something that may help a lot of people in the future”), past
experiences with treatment interruptions (“They
took me off the medications for three years; and for three years, my CD4 count
never dropped below 550.”) and financial benefits (“It would be less expensive not having to take meds for 6 months”).
But other participants saw a treatment interruption as
something that would be ‘too much risk’. They were concerned that they might
experience a rise in viral load, could transmit HIV, could develop resistance
or could have opportunistic infections.