Has Motsoaledi stopped consulting civil society?

In his budget vote speech in July, Health Minister Aaron Motsoaledi announced that the HIV treatment initiation threshold in South Africa will be pushed up to 500 CD4 cells/mm3.

He also said, ‘Our next step is to increase coverage in the manner proposed by the 90 percent approach. This means testing most, if not all, of the population annually, initiating everyone who is positive on treatment regardless of CD4, and supporting all those that are on treatment.’ These announcements came as a surprise to me and my colleagues at the Treatment Action Campaign (TAC) – the largest membership-based HIV organisation in South Africa. They were not discussed with the TAC, nor were they discussed through the relevant structures in the South African National AIDS Council (SANAC). The last we heard from discussions at SANAC was that South Africa would be sticking to an initiation threshold of 350 CD4 cells/mm3.

The decision to raise the treatment eligibility threshold to 500 cells/mm3 is an important one, with implications for the already overstrained healthcare system and many people living with HIV. For Minister Motsoaledi to have taken this decision without consulting local patient groups and experts is very disappointing.

A complex debate
Whether or not to initiate at 500 or 350 is a complex debate. The World Health Organisation guidelines both recommend starting at 500. The WHO guidelines, however, make it clear that the evidence for starting at 350 is ‘strong’ while the evidence for starting at 500 is only ‘moderate’. Part of the reason for disagreement has to do with the evidence gap when it comes to starting treatment at 500. While some observational data has been interpreted to support earlier initiation, the same data is considered by others to be inconclusive. The randomised control trial that should answer this question (the START trial) is ongoing.

In favour of a 500 initiation threshold, it is argued that there are operational benefits to starting patients earlier since some patients are lost to care in the time between testing positive and starting treatment. It is also possible that having in viral replication in the blood and an ongoing viral response, even if it is still at very low levels, could be harmful. We don’t really know yet, but there is a case for providing patients who are worried about their health with treatment at 500 rather than 350. Most notably, though, there are strong indications that earlier treatment reduces the risk of onward transmission and is therefore an important part of HIV prevention. (It should be noted, though, that the trial showing this benefit randomised patients to immediate treatment or treatment at 250 – and therefore has limited relevance to the 350 v 500 debate.) It is also worth noting that the 500 threshold is arbitrary and not based on any evidence. It could just as well have been 472 or 528.
The most important counter argument is that starting people at 500 may expose some people to avoidable harm. For example, to put an otherwise healthy person at risk of efavirenz-related psychological side effects (even if the risk is small) should not be done without very careful consideration and informed consent. It is a concern that in South Africa’s overstretched healthcare system, informed consent will often not be obtained and patients will simply be started on treatment. In addition, earlier treatment will, with the current ARVs, contribute to increased drug resistance over time, although we do not know how serious a problem that will be. It is also plausible that people who start on treatment at higher CD4 counts may be more likely to default. Finally, while the South African healthcare system is already buckling under the current demand, increasing demand in this way may be counterproductive. It could be argued that we should first come to terms with our retention in care problem before increasing the pool of eligible patients.

It is a shame that the Minister has not engaged in this debate with us before making his decision.

Test and treat, whether we like it or not
The Minister’s remarks quoted above were made shortly after the recent AIDS conference in Melbourne. In his budget vote speech he specifically refers to the three 90s. The three 90s are new targets set by UNAIDS that state:
1) 90 percent of HIV-positive people must know there status by 2030; 2) 90 percent of these must be started on treatment, and 3) 90 percent of these must be virally suppressed.

The second of these UNAIDS targets goes beyond the current WHO guidelines by recommending ‘test and treat’ (an approach whereby everyone who tests HIV-positive is placed on treatment irrespective of CD4 count). Minister Motsoaledi expressly endorsed ‘test and treat’ in his budget vote speech. Again, he has not engaged with South African civil society on this decision.

Similarly, UNAIDS did not engage with the TAC prior to launching the 90s in Melbourne. They have since given the TAC an opportunity to comment, but our comments have not resulted in any changes to the targets. For example, our argument that the second 90 should only refer to treatment-eligible patients, rather than all HIV-positive people, was not accepted. While all such requests can obviously not be taken on board, UNAIDS must explain more clearly its decisions to reject such recommendations.

The UNAIDS treatment targets document provides neither sufficient motivation for the chosen targets, nor adequate consideration of counter arguments. It is, for example, simply assumed that the next step after initiation at 500 will be ‘test and treat’ – even though this approach is not currently recommended in any major guidelines (except, arguably, the US guidelines, which allow for treatment above 500, although informed choice is stressed). The UNAIDS document ignores the possibility that the START trial may find no benefit at initiating above 350.

It is also puzzling that the HPTN052 trial is used to argue that individual patients will benefit from earlier treatment. As noted before, this trial randomised to immediate treatment and treatment at 250 or below, and should not be overinterpreted in arguing for treatment above 350. In addition, hardly any attention is given in the document, to the potential harm from earlier treatment and the essential role that informed consent must play.
While human rights and the rejection of coercion are paid lip-service, a true human rights approach would place much more focus on informed patient choice on whether to start treatment or not.

The UNAIDS treatment targets document provides neither sufficient motivation for the chosen targets, nor adequate consideration of counter arguments.

The Patient Choice alternative?
There remain many unanswered questions about both treatment at 500 and ‘test and treat’. A third approach worth considering is that of informing patients properly and letting them make the decision on when to start. In such a ‘patient choice’ system, all patients will be offered treatment irrespective of CD4 count, but patients will not be pressured to start at CD4 counts above 350. While it would be made clear to patients that treatment at 350 or below is strongly recommended, the pros and cons of earlier treatment will be properly explained to a patient should he or she want to start earlier. It is likely that such an informed patient choice-focused model would also lead to improved retention in care.

A ‘patient choice’ model takes into account the rights and interests of patients in a way that the UNAIDS ‘test and treat’ approach and UNAIDS’s second 90 does not. As currently framed, UNAIDS’s target of treating 90 percent of HIV-positive people will create an incentive for health systems to place people on treatment without allowing those people to make an informed choice to delay treatment initiation.

Ambitious targets are needed to bring an end to the AIDS epidemic, but those targets should not undermine patient choice. An equally ambitious, but more acceptable target, would be for all people who are HIV-positive to have been accurately counselled on the pros and cons of earlier treatment by 2030, and for all those who choose to start treatment, to have access to it. Such targets might not fit neatly into the schema of three 90s, but then, why should they?