If people who need HIV drugs aren’t getting them now, why should the prevention benefit of treatment be the reason that the drugs become available?

Roger Pebody
Published: 15 June 2012

The issue of ‘treatment as prevention’ raises a number of ethical issues, Richard Ashcroft, professor of bioethics at Queen Mary University of London told the IAPAC Controlling the HIV epidemic with antiretrovirals evidence summit in London this week.

He reminded the audience that it is rare for a doctor to give a patient a medicine that will primarily benefit a third party. He went on to highlight situations in which, at present, antiretroviral treatment is not universally available to all people who need it for their own health. In such circumstances, why should treatment’s prevention benefit be “the clincher” that convinces funders and policy makers to make the drugs more widely available?

At the same meeting, Kevin Fisher of AVAC noted that the ethical concerns tended to differ in different parts of the world. In settings where there is already good access to HIV treatment, the concerns are often related to individuals experiencing external pressure or compulsion to take treatment. In resource-limited settings, the concerns focused more on the cost of and access to treatment.

“Prevention is a consequence of treating those in need.” Stefano Vella

Stefano Vella of the Istituto Superiore di Sanità in Italy said that, in resource-limited settings, working towards universal access to antiretrovirals was the way to take treatment as prevention forward. “Prevention is a consequence of treating those in need,” he said.

But there’s also the question of the quality of the antiretroviral regimens that are commonly used in poorer countries. “We cannot curb the epidemic with sub-optimal therapies,” he said, pointing to drugs such as d4T, which are cheaper but have significant side-effects, as well as to people kept on failing first-line regimens.

In a number of richer countries, the concerns centre more often on the treatment choices that an individual makes, and how the balance is struck between the benefits to individual health and those to public health.

This issue is likely to remain unsettled as long as there is no consensus or clear evidence on whether there is a benefit or harm to the individual in starting HIV treatment with a CD4 cell count above 350. Secondary data from the HPTN 052 trial, which will be presented at July’s International AIDS Conference in Washington, may shed light on this. But the START trial, which was designed to definitively answer the question, is still recruiting participants and will not provide results for another four years.

Gus Cairns of NAM reminded the audience that patient choice is an issue in any treatment decision, with doctors always needing to take it into account alongside their professional duty to care for the patient. Even if the CD4 cell count is 10 cells/mm3 and the doctor very strongly recommends treatment, the patient can still make the choice to refuse treatment.

Robert Carroll of the Association of Nurses in AIDS Care pointed out that if there is a massive expansion in the number of people taking treatment, there will need to be a corresponding rise in the number of healthcare workers. Will these new workers be sufficiently trained and have the skills to support patient autonomy, avoid coercion and understand the impact of stigma? These are likely to be particular concerns as treatment approaches become ever more simplified and standardised.

“This discussion is a theoretical one – the reality is exactly the opposite.” Jorge Saavedra

Equally, Ceri Evans, a sexual health adviser at London’s Chelsea and Westminster Hospital, commented on the skills and staff time needed when supporting individuals who are considering personal decisions about treatment as prevention. For example, when individuals in a serodiscordant couple are considering stopping using condoms, there may be power imbalances within the couple that need to be addressed.

Eric Fleutelot of Sidaction said that there were risks of creating new categories of ‘bad’ people with HIV – those who choose not to take treatment, or those who don’t adhere to their medication. In places where the law criminalises HIV exposure (exposing someone to the risk of HIV transmission, even if transmission doesn’t take place) the law may evolve to recognise the negligible risk of transmission when a person is on effective treatment. While this would generally be welcomed, it will add to the social pressure to take treatment.

But some participants felt that some of these anxieties and debates did not engage with the realities on the ground. Jorge Saavedra of the AIDS Healthcare Foundation reminded the audience that access to treatment remains a real problem in the United States. Being denied treatment was a far more significant problem than being pressurised to take it, he suggested. “This discussion is a theoretical one – the reality is exactly the opposite,” he said.

In fact, almost every speaker presented a diagram on the ‘treatment cascade’ – showing how, at every stage, patients are not retained in the healthcare system or are unable to access the medical care they need. For example, Kevin Fisher highlighted a US study (illustrated below) which showed that, of the estimated 1,178,350 people with HIV infection, only 80% are diagnosed. Of those who are diagnosed, just 51% are linked with a care provider and stay in care. Of those in care, 89% take HIV treatment, and of this group, 77% achieve a suppressed viral load, the aim of antiretroviral treatment.

Thus, the bar at far right of the cascade diagram shows that just 28% of those living with HIV in the United States (328,475 people) have a suppressed viral load. This means that treatment can only have a limited impact on the American epidemic. Moreover, it also raises ethical questions about the inequalities in access to healthcare in the US, with individuals from poor and marginalised populations being particularly likely to be excluded.

While the equivalent diagram for the UK is more encouraging, it is still only 53% of those with HIV who have an undetectable viral load. This is largely due to problems with undiagnosed infection – an area where there are important inequalities, with black people and heterosexual men being especially likely to have their infection undiagnosed.