START changes everything

START changes everything

results in from the landmark START trial, all dials are aligning on how to beat back the HIV epidemic. Everything is set, but will there be lift-off?

In July findings from the landmark START trial were presented at the International AIDS Society Conference held in Vancouver, Canada, and simultaneously published in the New England Journal of Medicine (NEJM). Data from another important trial called TEMPRANO were also published in the NEJM.

Together these two trials provide a conclusive answer on one of the most debated questions relating to HIV treatment in recent years. We have previously written in the NSP Review about what we considered to be a lack of evidence in support of treatment at CD4 counts above 350 cells/mm3. We argued that a definitive answer would only come from the START trial. With these findings in, the debate on when to start treatment in HIV-positive people is now over.

START is an ongoing randomised controlled trial that examined early versus delayed treatment for people with HIV. HIV-positive trial participants who started ART early experienced significantly fewer serious AIDS events than people who delayed starting ART until their CD4 counts dropped to 350 cells/mm3 or had an AIDS-defining illness.
The early treatment arm had 14 cases of cancer compared to 39 in the delayed treatment arm. In addition, the early treatment arm had six cases of tuberculosis as opposed to 20 in the delayed arm. The overall AIDS-related events rate in the early arm was 1.8 percent compared to 4.1 percent in the delayed arm – which amounts to a relative risk reduction of 57 percent. There were a total of 12 deaths in the early arm compared to 21 in the delayed arm, although this last finding was not statistically significant.
These are much more compelling findings than we had anticipated. In essence, START provides convincing evidence that many serious AIDS-related events like cancer and TB can be prevented by early treatment.

In light of these findings it was clear to us at the Treatment Action Campaign (TAC) that antiretroviral therapy must now be recommended and provided to all HIV-positive people in South Africa. We changed our position accordingly. As START shows, providing treatment at CD4 counts above the current eligibility threshold of 500 cells/mm3 would prevent significant numbers of cancer and TB cases in South Africa – and by extension among our members. We thus urge government to update the national treatment guidelines to allow for treatment for all HIV-positive people irrespective of CD4 count. Broadly speaking, it appears that the lower your CD4 count falls, the more urgent becomes the need to start taking ART. We thus recommend that where legitimate resource constraints limit capacity to start people on ART, people with lower CD4 counts should be prioritised.

Previous research has shown that people on ART with suppressed viral loads are unlikely to transmit HIV (in particular the HPTN052 trial). That earlier treatment also benefits the health of individuals means that the interests of individual people living with HIV are now aligned with the public health objective of preventing transmission by putting people on to treatment earlier. Our previous criticism of the second “90” (90 percent of people who test HIV-positive on treatment) in the UNAIDS “90-90-90” targets thus also now falls away.
We can now fully support the target of 90 percent of HIV-positive people knowing their status by 2020, 90 percent of these to be on antiretroviral treatment by 2020, and 90 percent of these people to be virally suppressed by 2020.

Will there be lift-off?
While START together with HPTN052 points toward “test and treat” and to “90-90-90” as the way forward, we are concerned that the AIDS response in South Africa may be faltering at the very moment when we need lift-off. As reported elsewhere in this issue of NSP Review, HIV testing rates appear to be declining in South Africa. This decline, together with widespread stock-outs of essential medicines and worryingly low rates of retention in care, are raising serious red lights for us. At the recent SA AIDS conference in Durban, we argued that our public health-care system is at code red. Nothing has changed.

We find it unlikely that South Africa would reach the “90-90-90” targets without a radical political intervention. In provinces with dysfunctional health-care systems, such as Mpumalanga, the Free State, the Eastern Cape, Limpopo, to some extent Gauteng, and increasingly North West, there seems to be little accountability required of failing MECs for Health or failing heads of health departments or failing district managers. As TAC General Secretary Anele Yawa argued at SA AIDS, the elephant in the room is politics. The problem everyone is tiptoeing around is that key positions in our health-care system are increasingly filled with loyal cadres of the African National Congress (ANC) rather than with qualified people committed to fixing the public healthcare system. In a shockingly dysfunctional province like Mpumalanga the underlying problem is clearly political. Similarly, in Limpopo the TAC has had to deal with five different MECs for health in as many years.

It is hard to see a sustainable improvement in our public healthcare system while people like Free State MEC for Health Benny Malakoane remains in place. Malakoane is facing multiple charges of fraud and corruption and has consistently been in denial about the state of healthcare in his province. (You can read about the situation in the Free State on page X.) Unfortunately, the lack of accountability that we see in the Free State is emblematic of a wider lack of accountability throughout government and the public service. It is not a stretch to argue that the biggest obstacle in South Africa’s way to reaching the “90-90-90” targets is the ANC’s explicit policy of cadre deployment.

The road to reach “90-90-90”
While the core obstacles in our view are political, there are also a number of more practical and technical issues that need to be addressed if we are to reach the 90-90-90 targets. It is essential that the South African National AIDS Council, the Department of Health, treasury and civil society get together to figure out the nitty gritty of reaching these ambitious targets by 2020.

As explained on page X, we need to ensure that HIV testing rates in South Africa increase rather than decrease if we are to reach the first “90”. Increased testing will require significant human and financial resources. It would also be essential to ensure that testing, and then treatment, is accompanied with quality counselling services. We are concerned that HIV counselling services have not increased in line with the increasing numbers of people on ART. In some areas where we work there has, in fact, been a decrease in the availability of HIV counselling services. We suspect that as people start treatment at higher CD4 counts, and while they are still healthy, good counselling will become an even more important part of ensuring good treatment adherence. The Department of Health must urgently provide clarity in relation to the role of various levels of counsellors and treasury should make sure the money is available to employ the army of counsellors that we desperately need.

The way forward will also require a shift of emphasis from CD4 count tests toward viral load counts. While an initial CD4 count may be useful, a viral load test becomes the more important test once someone is on treatment. Viral load tests show whether the replication of HIV in the body is successfully being suppressed by ART – and as such it provides a good indication of when people may need to switch to an alternative ART regimen. Both South African and World Health Organisation HIV treatment guidelines recommend at least one viral load test per year. We have, however, seen widely varying estimates of what percentage of people on ART in South Africa actually receive these tests. It is imperative that all HIV-positive people on ART should be given this test at least annually and that they should be provided with their test results.

To better understand the state of our AIDS response it is important that we do not look only at the numbers of people who have started ART, but also at whether patients remain in care and healthy. Viral load coverage rates are a good indicator of the number of people who are receiving care, while viral suppression rates are a very useful indicator of the health of those people. As per the third “90”, the Department of Health and SANAC must make viral load monitoring a cornerstone of how we measure our AIDS response.
Better and more open reporting of viral load data could also play an important part in increasing accountability in the healthcare system. We see no reason why patients should not have access to the viral coverage and viral suppression rates for their clinic, their district and their province. If the Department of Health shares more of this data more regularly, it would help civil society to hold healthcare facilities, districts, and provinces to account more effectively.

Six steps toward 90-90-90:

  1. All HIV-positive people in South Africa should be recommended antiretroviral therapy (ART)
  2. All people starting ART should receive thorough and accurate counselling about the benefits of taking ART.
  3. Where congestion or resource limitations make it impossible to offer ART to all HIV-positive people, people with CD4 counts below 350 cells/mm3 should be prioritised.
  4. All people on ART should receive at least one viral load test per year.
  5. The Department of Health should regularly report retention in care, viral load coverage and viral load suppression rates for all facilities in the public healthcare system in South Africa.
  6. Political obstacles to health system strengthening must be addressed.