In his budget vote speech in July, Health Minister Aaron Motsoaledi announced that the initiation threshold for HIV treatment will be increased from 350 to 500 CD4 cells/mm3.
A CD4 count is a measure of the strength of someone’s immune system – the higher the count, the stronger the immune system.
He also said: “Our next step is to increase coverage in the manner proposed by the 90% 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 surprised the Treatment Action Campaign (TAC), the largest membership-based HIV organisation in South Africa. They were not discussed with the TAC or the relevant structures of the South African National Aids Council.
The last we heard was that South Africa would be sticking to an initiation threshold of 350.
Too much strain on health system
The decision to raise the treatment eligibility threshold is important and has serious implications for the already overstrained healthcare system and many people living with HIV.
Raising the threshold is a complicated issue.
The World Health Organisation (WHO) guidelines recommend starting at 500. But they make it clear that the evidence for starting at 350 is “strong” and the evidence for starting at 500 is only “moderate”.
Part of the reason for disagreement has to do with the lack of evidence. Some observational data has been interpreted to support earlier initiation at 500.
But some people consider it to be inconclusive, and the randomised control trial (the strategic timing of antiretroviral treatment trial known as Start) that should answer this question is ongoing.
Advantages and drawbacks
It is argued that there are operational benefits to starting patients earlier, since some are lost to care in the time between testing positive and starting treatment. There is also a case to be made for providing patients who are worried about their health to begin 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 is 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 counterargument is that starting people at 500 may expose some 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 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 antiretrovirals, 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.
Counterproductive to gains made
Finally, the healthcare system is already buckling under the current demand and 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.
The minister’s remarks were made shortly after the International Aids conference in Melbourne in July. In his budget vote speech, he refers to the three 90s, new targets set by the Joint United Nations Programme on HIV and Aids (UNAids) that state: 90% of HIV-positive people must know their status by 2020; 90% of these must be started on treatment; and 90% of these must be virally suppressed.
The second of these UNAids targets goes beyond the current WHO guidelines by recommending “test and treat”, which places everyone who tests HIV positive on treatment, irrespective of CD4 count.
Motsoaledi endorsed “test and treat” in his budget vote speech without discussing it with civil society.
TAC not considered
Similarly, UNAids did not consult the TAC before launching the 90s in Melbourne. The agency has 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.
The UNAids treatment targets document provides neither sufficient reason for the chosen targets nor adequately considers counter arguments. It is, for example, assumed that the next step after initiation at 500 will be “test and treat”, even though this approach is not recommended in any of the major guidelines (except, arguably, those of the United States, which allow for treatment above 500, although informed choice is stressed).
UNAids ignores the possibility that the Start trial may find no benefit at initiating treatment above 350.
Patient choice approach
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 would be offered treatment irrespective of their CD4 count, but they would not have pressure put on them to start at CD4 counts above 350.
Although it would be made clear to patients that treatment at 350 or below is strongly recommended, the pros and cons of earlier treatment would be properly explained should he or she want to start earlier.
It is likely that an informed patient-choice 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 the “second 90” do not.
Ambitious targets and neat schemes
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 2020, and for all those who choose to start treatment to have access to it.
These targets might not fit neatly into the scheme of three 90s but then, why should they?
Marcus Low is the head of the policy, research and communications department of the Treatment Action Campaign. This piece was originally published in the latest NSP Review, a quarterly publication jointly published by the TAC and Section27