Findings from the landmark START trial were presented at the International AIDS Society Conference held in Vancouver, Canada, and published in the New England Journal of Medicine (NEJM). Data from another important trial called TEMPRANO was also published in the NEJM. In light of the compelling findings from these two trials the Treatment Action Campaign (TAC) is updating its position on HIV treatment in South Africa.
1. All HIV positive people in South Africa should be RECOMMENDED antiretroviral therapy (ART)
START is a randomized controlled trial that examined early versus delayed treatment for people with HIV. It has provided clear evidence that early treatment benefits the health of HIV-positive people. HIV positive 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 6 cases of tuberculosis as opposed to 20 in the delayed arm. The overall AIDS-related events rate in the early arm was 1.8% compared to 4.1% in the delayed arm – which amounts to a relative risk reduction of 57%. 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.
START provides compelling evidence that serious AIDS-related events like cancer and TB can be prevented by early treatment. In the light of this, all HIV positive people in South Africa should be recommended ART irrespective of CD4 count. Current treatment guidelines in South Africa recommend ART only once a person’s CD4 count drops to 500 cells/mm3.
Previous research has shown that people on ART with suppressed viral loads are unlikely to transmit HIV. That early treatment benefits the individual patients is thus also good news for HIV prevention.
2. All people starting ART should receive thorough and accurate counselling about the benefits of taking ART
Effective pre and post-test counselling remains an essential part of the HIV treatment programme. Any expansion in treatment provision must be accompanied with a corresponding expansion of human resource capacity to ensure that effective counselling and treatment support services can be provided. Just like people have a right to access treatment, people also have a right to be accurately informed about all the risks and benefits of starting ART. It is also worth noting that many people who will start ART at high CD4 counts may never have experienced any severe symptoms or illness related to HIV. We foresee that effective counselling will be essential to ensuring good treatment adherence in this group of people.
We are however 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.
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
It is clear from the START trial that people who delay treatment are at significantly higher risk of serious AIDS-related events such as cancer and tuberculosis. 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.
4. All people on ART should receive at least one viral load test per year
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.
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.
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. Publicly reporting such figures will create greater accountability in the healthcare system and help flag underperforming districts or health facilities. At the moment much of this data is not publicly available – making it harder to hold underperforming health facilities and districts accountable.
Retention in care, viral load coverage and viral load suppression rates must be published regularly for all health facilities, all districts, and all provinces.
6. Political obstacles to health system strengthening must be addressed
The public healthcare system in South Africa is plagued by stockouts of essential medicines, staff shortages, poor infrastructure, and severe management short-comings. A key contributing factor to this dysfunction is that many people appear to be employed or appointed for political reasons rather than for their competence or ability and commitment to effectively serve the public. A lack of willingness to address these political problems is undermining the South African public healthcare system – and by extension the country’s AIDS response, and needs to be addressed.
While ambitious targets like the UNAIDS 90/90/90 are needed (and now supported by more robust evidence), we consider the lack of focus given to the dysfunction in the healthcare systems that are supposed to deliver these targets to be a serious oversight. We call on all activists, health agencies, and policy-makers not to ignore our warnings of health system dysfunction and to work with us in fighting this dysfunction.
The way forward:
The combined results of the START and TEMPRANO trials present a significant turning point in our struggle against HIV. The new evidence unequivocally clarifies what needs to be done. It will however require extraordinary political-will to scale up the provision of quality HIV testing, prevention, treatment and support services in the way that we now know we must.
– We thus call for an urgent meeting of the South African National AIDS Council (SANAC) to consider the implications of the new evidence and how to ensure that access to ART and related support services are scaled up quickly and efficiently.
– We call for an urgent meeting and ongoing interaction between SANAC, the Department of Health and treasury to cost the scale-up of ART and accompanying support services like counselling. They must also model the costs-effectiveness and potential savings of recommending ART to all HIV positive people in South Africa as a matter of urgency. All such costing and modelling should include the cost of revitalising and scaling up South Africa’s HIV Councilling and Testing programme.
– We also require a massive and sustained public programme of HIV prevention and treatment literacy. Such a programme will be crucial to ensuring that more people get tested for HIV and that people on treatment are better retained on treatment. TAC is committed to revitalising its treatment literacy programme, but we will need the help of healthcare workers, SANAC, the Department of Health and donors if such a programme is to reach the required scale.
TAC thanks the participants, investigators, doctors and nurses in the START trial. START shows the value to society and medicine of running large, predominantly publicly-funded, clinical trials that set out to answer clear questions.