Let women decide whether they want to take dolutegravir

By Maureen Milanga and Lotti Rutter

An important new antiretroviral medicine called dolutegravir will soon become available to people living with HIV in various Sub-Saharan African countries, including South Africa. Unfortunately, many women might be denied access to this new drug due to an inability of regulators and health departments to see potential risks associated with the drug in the proper context. (See this article for more on the benefits of dolutegravir over current treatments.)

In May this year, preliminary findings from an observational study in Botswana raised a potential concern about the use of dolutegravir for women. Dolutegravir was in the process of being recommended in national HIV guidelines in almost 70 low- and middle-income countries, following the medicine’s earlier introduction in wealthier countries.

The concern relates to an ongoing observational study in Botswana (the Tsepamo study) that found a potential risk relating to the use of dolutegravir at the time a woman conceives. Preliminary analysis from the study showed that four women out of 426 who conceived while taking the medicine gave birth to infants who had neural tube defects. This worked out to a rate of 0.9%, higher than the average of 0.1% of women in the rest of the population. Updated data since shows an additional 170 births, with no additional neural tube defects reported (thus bringing the rate down to 0.67%). At the time of writing, the number of conceptions in the study are over 800, and no more babies have been born with neural tube defects.

Neural tube defects can be caused by a number of factors, such as a woman having insufficient folic acid at conception, or diabetes. The cause of these four cases is not conclusive and we do not know if dolutegravir causes birth defects when taken during conception. In fact, while an increase in neural tube defects was observed in Botswana, it has not been observed in any other countries conducting similar studies. In summary, it all may be by chance, or it may be a real danger. We need more time to be sure. The final outcomes of Tsepamo are expected in April 2019.

What the guidelines say

The WHO issued guidelines recommending dolutegravir as an alternative option for first line treatment of HIV in 2016. After the preliminary Tsepamo findings were released, the WHO issued updated guidelines in July 2018 outlining how countries should proceed in rolling out dolutegravir. The guidelines stated:

“Adolescent girls and women of childbearing potential who do not currently want to become pregnant can receive dolutegravir together with consistent and reliable contraception.”

And that;

“Woman-centred health services involve an approach to health care that consciously adopts the perspectives of women and their families and communities. This means that health services see women as active participants in and beneficiaries of trusted health systems that respond to women’s needs, rights and preferences in humane and holistic ways. Care is provided in ways that respect women’s autonomy in decision-making about their health, and services must provide information and options to enable women to make informed choices. The needs and perspectives of women, their families and communities are central to providing care and to designing and implementing programmes and services. A woman-centred approach is underpinned by two guiding principles: promoting human rights and promoting gender equality”.

Following the WHO caution regarding the use of dolutegravir many countries have taken a conservative approach on women’s access to this medicine, and in some cases slowed or stalled progress altogether. We understand a guidelines committee meeting in South Africa is scheduled for 30 November.
The conservative stance being taken in a number of countries restricting women’s ability to choose dolutegravir echoes other age-old struggles for women to be able to make choices about their own health. In this instance, some policy makers are changing treatment guidelines to recommend that dolutegravir be reserved only for men and for women above 50 years of age. In doing so they are taking away women’s right to make an informed choice over their own bodies and health needs.

Women of childbearing age have the right to make an informed decision on whether they want to use dolutegravir or not – and alongside that they have the right to be provided with access to a range of contraceptive options and termination of pregnancy services. The Tsepamo data is as yet not conclusive, and is one study from a single country. We do not know if dolutegravir causes birth defects when taken during conception. On the other hand, dolutegravir’s side effect profile of decreased risk of development of drug resistance, decreased costs, and superior ability to suppress high viral loads late in pregnancy, make it an important option for use in South Africa and the region.

This is an edited extract from a new dolutegravir briefing developed by Health GAP. To download the colourful and informative briefing click here.

Lotti Rutter and Maureen Milanga are Associate Directors of International Policy & Advocacy at Health GAP based in South Africa and Kenya respectively.

AIDS2018: Reduction in price of bedaquiline welcome, but is it enough?

This week the price of bedaquiline in the public sector in South Africa was cut in half. What does this mean for the increased uptake of this critically important TB drug across the world?

This week at the International AIDS Conference South Africa’s Minister of Health Dr Aaron Motsoaledi announced that the South African government had negotiated a much-reduced price for the multi-drug resistant tuberculosis (MDR-TB) drug bedaquiline.

Bedaquiline is something of a break-through drug being one of only two new TB drugs approved in the last half-a-century. The South African government recently announced that bedaquiline will replace kanamycin injections in the country’s standard treatment for MDR-TB. This decision has been widely welcomed given the serious side-effects, such as irreversible hearing-loss, related to the painful injections. It is expected that the World Health Organization and other high-TB-burden countries will follow South Africa’s lead.

The new price announced by Minister Motsoaledi is $400 (around R5400) for a six-month treatment course. This is down from a price of $750 according to Motsoaledi. The figure quoted to Spotlight by the Department of Health last month was $820. Either way, the South African government has managed to negotiate a price drop of around 50%. For this they deserve credit.

More good news is that the new price will also be available to countries purchasing bedaquiline through the Global Drug Facility and to countries that benefited from the soon-to-end bedaquiline donation programme. It is now up to these countries to update their MDR-TB treatment guidelines and to ensure that all people who can benefit from the drug has access to it. So far, uptake of bedaquiline outside of South Africa has been depressingly poor and many people are still being exposed to hearing-loss causing injections of doubtful efficacy.

And yet, even the $400 price is far from ideal. Researchers from the University of Liverpool have estimated that bedaquline could be produced and sold at a profit for under $100. The researchers did however assume much larger volumes than current demand – so that price might not be realistic right away. It is with this in mind that activists recently demanded that bedaquiline should be priced no higher than $200 for a six-month course. Whether this demand played a role in the price-cut is not known.

For some perspective, a year’s supply of first line antiretrovirals costs the South African government about $100. Six months of drug susceptible TB treatment (a full course) costs less than $30. It should also be kept in mind that bedaquiline is just one of multiple drugs used for MDR-TB and the entire MDR-TB drug regimen will thus cost much more than $400.

It seems likely that for bedaquline to become available to all people who need it across the world the price will have to be dropped further. Then said, this week’s price-cuts is a firm step in the right direction. It is now up to countries to start scaling up use of this drug and over time to negotiate further price cuts.

Low is both an editor of Spotlight and a member of the Global TB Community Advisory Board, one of the organisations that demanded a reduction in the price of bedaquiline. The views expressed in this article are his own.

AIDS2018: Time to make AIDS political again

By Anele Yawa

Two years ago, we welcomed the world to the International AIDS Conference

Anele Yawa at the Durban2016 march

in Durban, South Africa. At a march of ten thousand people we held up banners proclaiming that 20 million people still need treatment. At that conference we said to the world that AIDS is not over – and indeed, the misguided rhetoric about the end of AIDS have now given way to more sober, more realistic assessments. The reality is that we are still in the thick of it.

In South Africa, as in many other countries, the first phase of the global AIDS response was a fight for policy. It was a fight for the idea that governments have a responsibility to do whatever they need to do to get HIV treatment to the people who need it. In our country it involved various court cases and a fight against AIDS denialism. Around the world it required a massive effort by activists, researchers, diplomats, progressive business persons and willing governments. Our shared success is something to be celebrated.

That said, the victories of this first phase of our struggle against HIV has to be won again and again. We cannot take the recognition of the human rights of all people for granted nor can we take the affordability of medicines for granted. As we hear reports of plans to shut down UNAIDS without any public consultation, we can’t take even United Nations support for granted. As we know too well, we can’t take continued political will or funding from our governments for the AIDS response for granted either. All this work from the first phase of the AIDS response must continue and we must support each other in it.

Almost everyone agrees today that we need to provide prevention, treatment and care to all who need it. The wide adoption of the 90-90-90 targets are testimony to that consensus. We have reached a point in the AIDS response where the question is not so much what to do, but rather how to actually get it done given the state of our healthcare systems.

We now know that policy victories and innovative technical interventions can only take us so far. In South Africa, and in many other countries, the AIDS response has come up against a wall. This wall is the widespread dysfunction in our healthcare systems. It doesn’t matter how good our donor-written policies are if they are never implemented. It is no use if we have medicines in depots, but the medicines never reach the people in the clinics. Beautiful guidelines for treatment and care mean little if we refuse to employ healthcare workers to actually provide the treatment and care.

As TAC we we are very clear: Our struggle against HIV is now in a new phase, a phase where our fundamental struggle is against dysfunction, mismanagement and corruption in our public healthcare system.

This new phase of our struggle is, in its way, much harder than the struggles against AIDS denialism and profiteering pharmaceutical companies. There are fewer victories to be had in laws or in policies. The problems we face are much more diffuse and harder to influence. Meetings in board rooms in Geneva, New York or Amsterdam matter less in this phase of our struggle, while community meetings in Lusikisiki and Khayelitsha matter more and more.

As TAC we have in recent years attempted to create accountability across the public healthcare system in South Africa. Our 200 branches spread across the country have each adopted a clinic – where our members, all users of the public healthcare system, both monitor and provide support where possible. Where issues persist, we escalate them to district or provincial level, and if needs be to the National Department of Health. Let me be clear, the more we monitor, and the more systematically we monitor, the more disturbed we get about the near collapse of our public healthcare system.

Our recent monitoring reports on seven of South Africa’s nine provinces paint a very bleak picture. In these and in our previous reports, it has become clear that TB infection control measures are grossly deficient in many facilities – turning many clinic waiting areas into likely transmission areas. Our diagnosis of widespread dysfunction in public sector facilities is confirmed by devastating reports from the Office of Health Standards Compliance (a statutory health inspection body that reports to parliament).

The crisis in many of our public facilities does not come from nowhere. Over the last decade, on the watch of former President Jacob Zuma, corruption has flourished in South Africa and the public service has been systematically hollowed out. This has directly impacted the healthcare system and the AIDS response.

It is worth recounting some details. Recently in emerged that millions ear-marked for HIV in the North West province was looted to pay overinflated prices to a controversial ambulance company that is now the subject of police investigations. This is while over 200 000 HIV treatment eligible people in that province are not yet on treatment.

In the same province strikes resulted in the shutdown of the public healthcare system, a shutdown that meant medicines distribution had stopped completely for weeks on end. Some shared treatment with others, others paid high prices in private pharmacies, many simply defaulted. These strikes, and a similarly disruptive strike at a Gauteng hospital, suggest that more healthcare workers are now prepared to strike in ways that place patients at risk. It tells us that the ethos of public service has dangerously eroded.

Of course, there are still many good people trying to do their best within a failing system. The tragedy though is that there is so little help for them. While some politicians come when there is a strike or a protest, they generally show little interest in fixing the underlying problems plaguing the system. Indeed, many officials in provincial departments of health have been appointed for political reasons or with corrupt motives and have neither the inclination or the ability to start turning the system around. And even with Jacob Zuma gone, the balance of powers in the ANC is such that many corrupt and underperforming persons remain firmly in place.

Part of why Cyril Ramaphosa is now President of South Africa is a deal he made with David Mabuza, the former Premier of Mpumalanga province and now Deputy President of South Africa. Mabuza has generally been associated with some of the more unsavoury characters in the ruling party and on his watch Mpumlanga politics was mired in alleged corruption. As Deputy President Mabuza is also now the new head of the South African National AIDS Council, a body already ridden in controversy over the way it removed its former CEO and its failure to deal decisively with conflicts of interest. While Premier in Mpumlanga and chairing that province’s provincial AIDS council, Mabuza failed completely to address that province’s severe HIV crisis, not to mention the general corruption of that province’s government.

That Mabuza is now making some of the right noises on HIV and TB is of course welcome and we will hold him to his words. That our government has finally approved a progressive new policy on patents and medicines 17 years after the Doha Declaration is also welcome. That our Department of Health has shown urgency in introducing new medicines such as bedaquiline for MDR-TB and dolutegravir for HIV is to be applauded.

But, as Minister Aaron Motsoaledi recently admitted, South Africa’s healthcare system is in crisis. From our national department he has tried to stop the crisis, but in South Africa the healthcare system is run by provinces and Motsoaledi has been powerless to get the provinces into line. The underlying reality is that inside the borders of South Africa, our internationally popular Minister is severely hamstrung by his lack of political power.

Ultimately, as with all the issues we faced in the first phase of our struggle, the second phase is also fundamentally political. And as we have to address the patronage networks within our ruling party in South Africa, we call on our international allies to address the distorted values of the current United States administration and to seek out again the international solidarity that made our movement as successful as it once was.

As the world gathers in Amsterdam for the 22nd International AIDS Conference, my appeal to you is to once again make AIDS political. Just like the gag rule and Global Fund withdrawal is political, the failure in my country to act against corrupt individuals is political. The potential shutdown of UNAIDS and the mishandling of sexual harassment at the agency is political. In recent years we have too often played nice with our elected leaders and as a result they have come to believe that AIDS is almost over. We must once again take the gloves off and make AIDS political. We have elected our leaders, we demand that they deliver the AIDS response and the healthcare systems we need.

Anele Yawa is the General Secretary of the Treatment Action Campaign. The TAC is a South African membership-based organisation that advocates for the rights and interests of people living with and affected by HIV and TB.

NHI Bill: Welcome but flawed

By David Sanders & Louis Reynolds, People’s Health Movement South Africa

The People’s Health Movement South Africa (PHM-SA) welcomes the National Health Insurance (NHI) Bill in that it confirms Universal Health Coverage (UHC) through a single payer system as the platform for the delivery of health care. The goal of UHC is to realise the right to comprehensive health care of good quality for everyone on the basis of need, while ensuring that no one experiences financial hardship in accessing the care they need.  Comprehensive care includes promotive, preventative, curative, rehabilitative and palliative health services regardless of people’s socio-economic or health status.  The NHI should be funded through a solidarity mechanism where there is a cross-subsidy from the rich to the poor via taxation.

Although we are supportive of the principles that underpin the NHI, PHM has several reservations about whether the Bill can deliver UHC. More broadly, we remain deeply concerned about government’s ability to steer this ambitious project in the context of South Africa’s deep-seated and multi-pronged health crisis.

Administration of the NHI Fund

The Bill makes clear that the NHI Fund will be overseen by a Board of ten persons appointed or approved by the Minister. It will be the only purchaser of health services from accredited providers – public and private – and will ensure equity and efficiency in health care. A unitary system with the National Health Insurance Fund (NHIF) as the single purchaser of services allows for strategic purchasing of those services that are necessary to reach defined health goals. .

A justifiable concern, expressed by a number of analysts and based on experience of state-owned enterprises, is the potential that exists for this enormous fund to be looted.

Services free at the point of use will be provided to permanent residents while documented refugees and asylum seekers will be eligible for free emergency services, care for conditions of public health importance (presumably TB, HIV and other infectious diseases) and services for paediatric and maternal conditions.

Services not reimbursed by the fund (i.e. not part of the defined ‘package’) can be paid for through medical schemes or out-of-pocket. All users are required to be registered with a primary care provider (presumably a clinic, health centre or general practitioner) and will have to attend such a provider before being eligible for specialist care.

Services provided under NHI

The details of what services are to be funded (the benefit package) are not provided. It is hoped that the benefits package will be identical for all users of NHI-funded providers. However, the Government Gazette of July 2017 titled ‘NHI Implementation: Institutions, bodies and commissions that must be established’ describes the proposed funding arrangements for five different groups: the unemployed, the informal sector (such as taxi industry; hawkers, domestic workers), those in formal sector employment (bigger business), those in formal sector employment (small and medium size business), civil servants (including SOEs, Intelligence Agencies, Defence, Police Service). This is a concern, since it implies that there will be different packages for different groups. Although this arrangement is said to be ‘transitional’, experience from other countries shows that it is very difficult to change such benefits packages once they have been in place for any length of time. It is likely that the poorest and sickest in our country will receive the most limited package of services. If this occurs it will increase already existing inequality.

A ‘Benefits Advisory Committee’ will decide what the content of these packages will be. This important body has representation from all medical schools, provinces, private hospitals, medical schemes and the World Health Organisation (WHO) but none from civil society or labour. This will be supported by a Health Benefits Pricing Committee which also has only technocrats.

There is no room in these committees for meaningful public participation. This will bias their work and decisions towards hospital-centred specialist care and a narrow biomedical approach. It is essential to include civil society and labour on these committees.

Their proceedings should also be open and transparent, and accountable to the Minister and Parliament. In particular, they must be accountable for the reasonableness of their choices of the benefits they include in the package. The reasoning behind their choices should be open to public scrutiny, including the evidence upon which they are based and how they apply in local contexts.

Only the Stakeholder Advisory Committee, a large body that merely advises the Minister, has representation from indigenous practitioners, NGOs and civil society, although they are greatly outnumbered by representatives from professional and statutory bodies.

How will NHI purchase services?

Purchasing of services is intended to be devolved to provincial and district level hospitals and at sub-district level to contracting units for primary health care. District Health Management Offices are intended to play a coordinating role.

Justifiable concern has been expressed about whether these sub-district and district entities will have the capacity to undertake such detailed and complex activities. The mechanisms for payment of accredited service providers are vague in the Bill and it is strongly rumoured that medical schemes may be enrolled to perform this function. PHM-SA is concerned that the greater likelihood of urban and private providers being accredited than public and (especially) rural providers, holds the danger of aggravating already existing urban/rural inequity. For example, the great majority of medical specialists and therapists of various kinds are overwhelmingly located in large metros, especially in Gauteng and Western Cape. This effectively means that public tax money will be used to fund a service that will likely cater preferentially for the better-off living in urban areas.

Transitional arrangements

The Bill specifies transitional arrangements that consist of three phases extending to 2026. The current second phase will focus on establishing institutions that will form the basis for the Fund, as well as on interim purchasing of personal health care services. Phase 3, from 2022 to 2026, will establish the necessary structures and be guided by two committees – the National Tertiary Health Services Committee and the National Governing Body on Training and Development. These will be responsible for a Human Resources for Health (HRH) development plan.

PHM has two concerns about these arrangements: Firstly, an HRH plan is required urgently to ensure the development of a robust public health sector, especially at district level and below, so that the NHI can operate effectively and efficiently in formerly underserved areas. Secondly, given their unimpressive record to date in transforming health sciences education and training, it is unlikely that these structures, whose composition has been proposed to include mainly hospital-based clinicians and educators, will implement an appropriate HRH plan.

The Ministerial Advisory Committee on Health Care Benefits will be a precursor to the Benefits Advisory Committee which will advise the Minister on priority setting. Although the composition of this structure is not specified in the Bill, the 2017 gazette discussed above proposed a composition in which senior government officials and medical scheme representatives predominated. This structure too creates a concern that the emphasis will be on facility-based clinical medicine and that primary and community-level care will be marginalized, as will prevention activities.

The context: the national health crisis

While the crisis in the public health sector is front-line news today, the private sector is in a crisis of its own — a crisis of growing medical scheme unaffordability,  shrinking benefits and static or declining  membership.

The roots of the crisis lie in the systematic underdevelopment and structural inequality enforced by apartheid. Its more immediate cause is the neoliberal Growth, Employment and Redistribution (GEAR) macroeconomic policy adopted by the ANC-led government in 1996.  GEAR follows the free market fundamentalist mantra of public sector austerity, privatisation of public services and goods, trade deregulation and low corporate tax. It is failing in all 3 of its components: growth is poor, unemployment rampant, and we remain one of the most unequal countries in the world.

More than 2 decades of austerity, combined with a deepening culture of corruption, have aggravated both facets of the national health crisis. Firstly, the state has failed to address inequity in access to the social determinants of health (SDH) such as sufficient quality food, water, sanitation etc through poor service delivery and growing unemployment and income inequality, thus aggravating the burden of disease. Secondly, the tight financial constraints imposed on the public health sector by austerity, together with a growing and increasingly pervasive culture of corruption, has led to loss of posts and skills, deteriorating infrastructure, and demoralisation of staff at all levels of the system. The fact that rigid austerity was forced on the public sector in the face of the burgeoning and badly-managed HIV-AIDS pandemic of the 1990s made it all the more devastating.

Strengthening the public health sector

Before the public health sector can participate in the NHI it will need to be strengthened substantially, especially in terms of its physical infrastructure, human resource base and their skills, especially in leadership and governance. These imperatives will require strong political will and significant funds. Government has little option but to provide such funding, since the current health crisis is untenable. Although the upfront financial commitment will be large, the returns on investment are potentially even greater – as a result of savings on long-term health care, improved economic productivity of a healthier workforce, and the multiplier effect in the economy of having a larger number of employed people, especially rural women.

Financing the NHI

The Bill says very little about possible sources of funding for the NHIF, but there are no real options other than through taxation and an end to austerity budgets. PHMSA believes that progressive income tax — a surcharge added to the normal income tax at an increasing percentage — would be the best option. The principle that those who can afford it pay more, while those who need more health care receive more care, also builds social solidarity. The retrogressive recent increase in VAT adds to the tax burden of poor and working class people and exacerbates inequity in access to the social determinants of health through increased prices on some essential commodities.

There is no doubt that increases in revenue from tax are necessary to strengthen the public sector and finance the NHI. This may be difficult politically, but we believe there is room for such increases. Forslund notes that, because tax brackets have increased faster than inflation, the tax burden on the middle class and the rich has decreased substantially over the past decades. He points out that if the government had merely kept personal income tax stable since 2005/06 – by raising tax brackets strictly at the rate of inflation – personal income tax would have added more than R150 billion to the present budget. This would have made financing the NHI easier even before raising additional tax.

The alternative to tax is to borrow, which means eventually paying more and more government income towards debt servicing and away from delivering services.

Corruption

It is also essential to root out corruption. Corruption weakens the state, delegitimises taxation, destroys public services, and ruins the social fabric. Corruption thrives in dark spaces where the public and private sectors meet. Forslund argues that “as long as the public sector isn’t strong enough to provide basic services, but relies on “partnerships” and tenders, corruption will remain rampant”.

Conclusion

There have been many responses to the NHI Bill, most of them negative, many containing uncomfortable truths about the state of the health system and the extreme difficulty of fixing it. But this strengthens the case for the NHI and an equitable health system based on UHC and the principles of Primary Health Care. The state, at present, does not have the capacity to deliver it. Nor can the corporate private sector, as is shown by abundant empirical evidence in the public health literature. This places a major responsibility on civil society to give the state critical support and mobilise the public around health. It underpins PHMSA’s campaign for a “People’s NHI”.

The People’s Health Movement South Africa calls upon all citizens of South Africa and civil society to unite behind a People’s NHI to ensure that the principles of the Right to Health, Universality and Social Solidarity are adhered to throughout the implementation process. 

To join the People’s NHI Campaign, please do one of the following:

  • Dial *134*1994*333# (it’s free)
  • SMS ‘NHI’ to 31660 (standard cost SMS)
  • Visit http://bit.ly/2r22Tnl
  • Or send a PCM to 066 040 9017

Contact Person: AnneleenDeKeukelaere@secretariat@phm-sa.org

 

 

8 key findings from new district health report

The Health Systems Trust last week published the latest edition of the District Health Barometer (DHB). The DHB provides a wealth of district, provincial and national level data on a wide variety of indicators. Below we have picked out eight interesting national-level findings. You can access the DHB 2016/2017 report and an associated data file by clicking here.

1. In 2016 only an estimated 72.8% of people in South Africa with diagnosed TB were started on TB treatment. The rate was slightly lower at 68% for people with TB resistant to rifampicin (one of the standard first line medicines to treat TB). The fact that around 27% of people with diagnosed TB do not start treatment timeously puts the health of these people at risk and makes it more likely that they will transmit TB in their communities.

2. According to current treatment guidelines almost all patients with both HIV and TB should be receiving antiretroviral therapy (ART). According to the DHB only 28% of people in this group received ART in 2011 (partly due to different treatment guidelines at the time). This number climbed rapidly to 90.8% in 2015 and then dropped to 88.3% in 2016. We do not know whether this drop from 2015 to 2016 is real or whether it is due to a statistical or reporting error.

3. According to the DHB the annual death rate for people with drug-resistant TB (DR-TB) is around 23%. The rate of loss to follow up is around 17% and only around 50.5% of people with DR-TB are successfully treated.

4. There has been a steady rise in the number of male condoms distributed in recent years – growing from 15.7 per male over 15 in 2011 to 47.5 in 2016.

5. The percentage of total life years lost due to non-communicable diseases (NCDs) in South Africa has risen over the last four years from 34.5% to 38.2%. This provides further evidence of the growing threat of NCDs to people living in South Africa and to the country’s healthcare system and economy.

6. In 2016/2017 only 82.3% of infants received all the required immunisations in the first year of life. This was a substantial drop from the previous two years – something the report ascribes to both vaccine shortages and poor distribution.

“During 2016/17, immunisation coverage nationally was 82.3%, almost 10 percentage points lower than the national target of  92.0%. This  was a 6.9 percentage  point  reduction  from  the  immunisation  coverage  of  89.2%  reported  in   2015/16 and lowest during the last five years. Between 2012/13 and 2014/15 there has been a general upward trend, with  immunisation  coverage  increasing  from 83.6% in 2012/13 to 89.8% in 2014/15.  The  rate  then declined slightly between 2014/15 and 2015/16 but showed a huge drop in 2016/17. The main reasons that contributed to this decline were: the global  shortage of Hexavalent that lasted approximately nine months and was resolved at a national level in October 2016; in some  provinces and/or districts the available stock was distributed equally to different areas without considering the demands  and population targets, thus painting an extremely heterogeneous picture of coverage.” – DHB

7. In 2016 there was 18 119 stillbirths in South Africa. While there is a downward trend over the last three years, the DHB also reports a downward trend in live births – which suggests that the decrease in still births is at least in part due to a reduction in the overall birth rate.

8. According to the DHB the period from 2014/2015 to 2016/2017 has seen steady reductions in the following three child-health-related indicators: Diarrhoea deaths under five years (1 514 to 886), pneumonia deaths under five years (1 411 to 1 003), and severe acute malnutrition death under five years (1 851 to 1 188). While the trend is encouraging, it is nevertheless unacceptable that over a thousand children in South Africa died of severe acute malnutrition in 2016/2017.

Steps to consider when proving PrEP in higher-education institutions

By Thuthukile Mbatha, SECTION27

1 October is set to become a memorable day in some higher-education institutions. It marks the day in 2017 that Pre-Exposure Prophylaxis (PrEP) was first rolled out at select campus health clinics as a new, highly effective HIV-prevention method. PrEP is an ARV drug combination taken to prevent infection by HIV-negative people who are at a greater risk of acquiring HIV. The two drugs in the only registered PrEP pill in South Africa are tenofovir and emptricitabine – also known under the brandname Truvada.

The provision of PrEP in South Africa occurs through various sites, these include the national health system, demonstration projects, large scale implementation initiatives (i.e. Dreams project) and the private sector. The Department of Health (NDoH) has identified seven higher education institutions that will form part of the above sites in rolling out PrEP to young people.

These institutions are the University of Free State, the University of Venda, Rhodes University, Nelson Mandela University, the University of Zululand, the University of Limpopo and Vaal University. Not all of them began rolling out PrEP on the set date; however, all these institutions were selected because they met the criteria set by the National Department of Health to assess their state of readiness to provide primary healthcare services to students.

A number of factors must be considered when determining whether an institution is fit for PrEP roll-out. These include staffing, qualification of nurses, dispensing licences and adequate storage, to name a few. The seven institutions currently providing PrEP are already dispensing antiretroviral treatment (ART) to students living with HIV, as well as other primary healthcare services, which was another prerequisite for PrEP provision. Many institutions do not offer this service for the reasons listed above, among others.

It is important for professional nurses to have a primary healthcare qualification, and also to acquire a dispensing licence. This enables them to deliver primary healthcare services, including ART and PrEP initiation. The provision of such services is usually supported by the District Department of Health office. Only the institutions that pass the assessment are considered as PrEP roll-out sites. In the institutions listed above, extensive training of clinic health personnel and peer educators was done to ensure readiness for PrEP provision and demand creation in these institutions. However, students have not yet been properly engaged, as the roll-out was introduced at what was a very busy time for students, who were preparing for exams. These institutions aim to intensify their demand-creation campaigns in the new year.

Most institutions fund the operation of their own campus health clinics; however, the Department of Health supplies them with family-planning and STI medicines. “We had to sign a memorandum of understanding with the Department of Health in order for them to supply us with PrEP,” said a health professional at one of the institutions.

“We do not have a set target number of students to provide PrEP to – every student who comes to our clinic and requests it is given it, after doing an HIV test and establishing that the student is HIV-negative,” she added.

The seven higher-education institutions that have started rolling out PrEP are an addition to the 17 demonstration sites providing PrEP that were established from June 2016. These demonstration sites include clinics for sex workers and for men who have sex with men (MSM). South Africa’s approach to PrEP roll out is focusing on targeting these ‘key population’ groups. For groups of people considered to be key populations, see www.avert.org/professionals/hiv-social-issues/key-affected-populations

Truvada (or any other tenofovir-based regimen) as PrEP is still not included in the South African Essential Drugs List (EDL). Its inclusion in the EDL would bring down the costs of PrEP, which would make it cheaper for the National Department of Health to provide sustainably to people who need it.

It is also important to note that the state of readiness for PrEP varies from institution to institution. Institutions such as the Technical and Vocational Education Training (TVET) colleges do not have campus health clinics, therefore they rely on off-campus clinics for sexual and reproductive healthcare services. The future roll-out plans should also consider such cases. A proper audit of all campus and off-campus clinics is required, so that all the issues may be addressed before the scale-up of PrEP roll-out.

Moreover, for PrEP roll-out to be effective, the inclusion of Student Representative Councils is very important, because of the power of influence they possess. It is critical to have student involvement in the entire process, to ensure a more positive uptake.

The state of PrEP access in SA

By Thuthukile Mbatha, SECTION27

Young women between the ages of 15 and 24 years are among the key population groups with the highest risk of contracting HIV. It is estimated that about 2 000 HIV infections occur weekly in South Africa among this group. A number of HIV-prevention campaigns have been targeting the youth out of school. Young women between the ages of 15 and 24 years in higher education institutions are usually the last ones to find out about such initiatives. The assumption that young women in higher education institutions are more knowledgeable about HIV prevention – and therefore more responsible – is false. They are as vulnerable as the young women out of school.

South Africa has a number of HIV-prevention interventions that were introduced to try and curb the increasing number of HIV infections in the country. These include female and male condoms, medical male circumcision, treatment as prevention, Post-Exposure Prophylaxis (PEP), and recently, Pre-Exposure Prophylaxis (PrEP).

PrEP is not yet widely accessible in the public sector South Africa. It can only be accessed through demonstration sites, clinical research institutes, and the private sector. A month’s supply of a daily dose of PrEP costs between R300 and R550 from the private sector. However, not all medical aids will cover the costs.

PrEP is only given to HIV-negative people who self-identify as being at substantial risk of acquiring HIV. The demonstration sites have seen a very low uptake of PrEP by the key population groups. This has raised concerns about providing it to young women, as they too may have a hard time adhering to the dosage regime; in other words, they may not take it as prescribed.

Any introduction of a new prevention product or intervention meets a lot of scepticism from the targeted population to begin with. Many clinical trials have been done that have shown that a lot of interventions work; however, they all experience a low uptake at first. The female condom, for instance, has been around for several years, but has been under-used. There have been many campaigns and initiatives highlighting the importance of medical male circumcision, shown to decrease the chances of contracting HIV among men by 60 per cent; however, we are still seeing only a relatively slow increase in the number of young men being circumcised.

What have we learnt from past experiences? Are we still employing the same strategies that we applied in previous interventions? The US is one of the first countries to roll out PrEP; they also saw a low uptake at first, but it has been improving gradually.

The scepticism seen is fuelled by the failure of PrEP in some clinical trials, such as those for FEM PrEP and VOICE – both of which involved women. These studies were testing the effectiveness of oral PrEP among women at higher risk of contracting HIV. They had to be stopped early when it became clear that the studies would not be able to show whether or not the pill prevented HIV acquisition (due to low treatment adherence in the trials).

However, the main reason for this was found to be low adherence. The women in these two studies were not taking the PrEP as prescribed. This conclusion was supported by evidence of very low drug levels in their systems; another reason is that they did not perceive themselves as being at greater risk of contracting HIV. According to the World Health Organisation (WHO), a person must take the PrEP pill daily for at least seven consecutive days before they are fully protected, and then continue taking it daily.

However, subsequent trials showed that in fact, PrEP does reduce risk in women. The Partners demonstration project was done using serodiscordant heterosexual couples as subjects, and proved effective. These are couples in which one partner is HIV-positive and on treatment, and the other is HIV-negative.

Some people are concerned that providing PrEP to young women will lead to promiscuity. However, there is no evidence of this among those taking PrEP. Furthermore, PrEP itself reduces the risk of HIV very effectively, so sex on PrEP should not be seen as ‘unprotected’. Sex on PrEP is ‘barrier-free’, perhaps, but certainly not unprotected or unsafe.

There’s a need here for a paradigm shift when discussing what is and isn’t ‘safer’ sex. Unlike condoms, which protect the user from pregnancy, STIs and HIV infection, PrEP only protects against contracting HIV. Someone taking PrEP would still need to use a condom or some other form of contraception as part of a combination prevention method.

As women, we value choice. For example, the decision to use Depo-Provera over an Intra-Uterine Device (IUD) as a family planning method lies solely with the individual. Young women in higher education institutions are no exception. They too need to be afforded the opportunity to choose which HIV-prevention option is best for them.

Studies have confirmed that PrEP works if you take it. So why are we not rolling it out to all young women at substantial risk of acquiring HIV? The alarming pregnancy rates in higher education institutions indicates low use of condoms and other family planning methods.

Providing PrEP to only a select group of people is not getting us anywhere. The country continues to see rising HIV infections among young women aged between 15 and 24 years. How many more infections do we have to see before we scale it up? Let’s equip young women with access to the best HIV prevention, and with the knowledge that will enable them to make informed decisions. The inclusion of PrEP into a comprehensive sexual and reproductive health package is the first step. PrEP campaigns should go hand in hand with campaigns to promote HIV testing and other available HIV-prevention tools.

Professor Quarraisha Abdool

One in five people with HIV – or who have newly acquired HIV – lives in South Africa, despite it being home to less than 1% of the global population. The use of phylogenetics to understand the infection of HIV highlights that about 24% of young women under 25 years of age do not know their HIV status; and about 60% are acquiring HIV from male partners who are on average eight or more years older than them, i.e. in the 25 to 40 age group. The majority of men of 25 to 40 years old are unaware of their HIV status and have high viral loads, suggesting recently acquired infection and hence higher transmission rates.

Young men are acquiring HIV from already infected women 25 to 35 years of age; on average, the age difference in these cases is about a year. About 40% of men 25 to 40 years old are having sex with women younger than 25 and women older than 25 concurrently, thus perpetuating these cycles of transmission. Preventing HIV infection in young women under 25 years will require a multi-pronged approach that includes Sexual and Reproductive Health Rights services to young women; finding the missing men (who do not access health services); and treatment of women older than 25.

Preventing HIV infection in adolescent girls and young women could change the course of the epidemic in Africa, and reverse the current poor global progress in HIV prevention. Oral tenofovir, alone or in combination with emtricitabine (PrEP), is the only woman-initiated prevention technology that does not require partner knowledge or co-operation. We cannot afford not to make this prevention option available to young women.

What is PrEP?

PrEP – in full, Pre-Exposure Prophylaxis – is ARV drugs taken by HIV-negative people to protect themselves from getting HIV. The only drug combination registered as PrEP in South Africa is tenofovir and emtricitabine – widely known under the brandname Truvada.

 

Glossary of terms

Adherancerefers to taking any form of treatment as prescribed, without missing a dose

Clinical trialsrefers to research studies involving human subjects

Demonstration sites serve two purposes: 1. They enable the country to learn enough about implementation issues related to PrEP so that the transition is more feasible between research (including demonstration project research) and the wider expansion and institutionalisation entailed in scaling up implementation. 2. They enable the World Health Organisation (WHO) to extract generalisable information for the eventual development of guidelines for PrEP delivery.

Serodiscordant couplesintimate partners, regardless of gender, such that one is living with HIV and the other is HIV-negative

Substantial risk – anyone who engages in regular condom-less sex with persons of unknown HIV status or who are HIV-positive is at greater risk of contracting HIV.

 


Why I take PrEP

Nomnotho Ntsele (20) is a second-year student at the Durban University of Technology. She also volunteers as a peer educator.

When I first heard about PrEP, I thought it was meant for promiscuous people – I did not think it was for me at all. The fact that it was only available to sex workers supported my assumptions. I did not understand that anyone could be at substantial risk of contracting HIV, especially young women my age. My opinion changed when I attended the Youth Dialogue in Prevention at SECTION27 in September, where I learnt a lot more about the science of PrEP, and realized that even I am at risk of contracting HIV.

I then started reading more about it, and incorporated the information I learnt in my peer-education work. I started telling other students in my institution about this other option for HIV prevention. Following my residence visits and talks, I was approached by students in serodiscordant relationships (where one partner is HIV-positive and the other HIV-negative) asking about where to access PrEP. I remembered that at the Youth Dialogue, we were told that the Centre for the AIDS Programme of Research in South Africa (CAPRISA) and the Wits Reproductive Health & HIV Institute are currently offering it to young women who are not part of clinical trials. I therefore referred them to CAPRISA.

As I myself am in a long-distance relationship, I realised that I am also at risk of contracting HIV. Moreover, I was curious to know how this PrEP pill works. I wanted to be able to address students’ concerns about side effects and other related questions. And maybe PrEP was for me too?

My decision to take PrEP almost broke my relationship with my boyfriend. He works in the north of KwaZulu-Natal, and we do not see each other often. He felt that my decision to take PrEP was motivated by a lack of trust in him. He wanted to leave me, and also accused me of cheating on him, saying that was the reason I’d decided to take the pill. After several arguments trying to explain to him why I’d decided to take PrEP, he went to a pharmacy to do blood tests, including an HIV test. He told me that he was ‘clean’. I continued to take PrEP.

I must say, it wasn’t easy in the beginning. Taking a pill when you are not sick is not child’s play. It doesn’t help that I suffered mild side effects – nausea, and a bit of dizziness – but they all subsided within a few days. I started taking PrEP during my exam preparations, so I used to take it every day at 21h00. Now that I have finished writing, 21h00 is no longer convenient for me. I take it earlier now.

A lot of my peers at university would benefit from PrEP. Most of them are dating celebrities, or guys who have money. I imagine some of them think they are ‘exclusive’, but this would be a lie. Though if CAPRISA didn’t provide PrEP through its study clinic, and I had to pay for it, I wouldn’t have considered it. I already have competing needs – buying PrEP with my financial aid money would be the last thing on my mind. The government should provide PrEP to everyone who needs it.

 

Mental health and pill-taking: Getting beyond HIV

By Professor Francois Venter

Recently, I took part in a chat show on Radio 702 to discuss how to disclose one’s HIV status to one’s sex partners. Hosted by Eusebius McKaiser, the show was vibrant, entertaining and challenging – made more so by the other guest, Thula Mkhize. Thula is an HIV-positive, heterosexual man in a discordant relationship (his wife is HIV-negative). Thula speaks openly and passionately about his sex life, and we chatted about the ethics of disclosing on the first or second or third date, among other things.

Dating when HIV-positive can be very tricky. When do you disclose your status to a new sex partner? How do antiretrovirals impact on your sex life? Why do we sometimes take risks that don’t seem rational? Relationships are hard, but can be so much harder when you have a background condition that is sexually transmitted.

The show went well; but I found some of the callers talking about their experience of disclosure surprisingly moving and upsetting. People were calling in, talking about the enormous impact of HIV on their sex lives, and of partners slowly pushing them away due to their status. This was not the violent, ignorant stigma that we easily identify and loudly denounce, but a more subtle, much more personal rejection. It reminded me of a good friend who is HIV-positive, who when she is about to engage in sex with a guy, says he often behaves as if he were doing her a huge favour, despite her being completely non-infectious on treatment. These little and not-so-little indignities can be devastating, and can prick holes in your self-esteem. Getting reliable support after disclosure is far from guaranteed.

A few weeks ago we lost Prudence Mbele, a beloved long-time activist living openly with HIV, who died of TB. Prudence was famous for her ‘pill holidays’ – a big no-no in HIV-land, as it leads to further immune damage. The idea of someone stopping their life-saving tablets – even temporarily – boggles the minds of most health providers. Her death triggered an intense media and Facebook/Twitter reaction, filled both with criticism at her choices as well as empathy, as people shared their own hard stories about taking antiretrovirals. Yet this notion of ‘pill fatigue’ affects lots of people in the HIV field and beyond, and generates a lot of chatter on social media.

Pill fatigue is a difficult concept to swallow, as a health professional. The daily tablet we use for HIV is small and getting smaller, has very few side effects, and is becoming safer all the time. Public health guidelines in South Africa recommend that a huge proportion of our population need tablets for diabetes, hypertension and cholesterol, among other ailments, especially as people get older. Pills are a part of normal life for everyone as they get older – so why should HIV-positive people complain of pill fatigue?

Some of those reasons relate to anxiety and depression and stigma, now strongly linked to delayed presentation for treatment, as well as adherence to their meds. Sadly, mental health issues are more associated with medical hot air than with any content; very few resources are allocated specifically to this area in either the public or the private sector, despite tons of data suggesting they are important. We have some very spirited and smart mental health professionals trying to change this, but there is in inertia in the current health system. This is also coupled with harsh societal views around mental health – depressed people are told to pull themselves together, think positive thoughts, be grateful – which are less than helpful to people experiencing sometimes devastating physical symptoms as a result of mental ill health. The truth is that mental ill health is probably just as stigmatised as HIV.

What does all of this mean, for someone with HIV? There are no magic bullets; but this is the best advice I can offer:

Identify your mental health symptoms

It’s a good idea to pay attention to your mental health, as well as your physical health. The first step is noticing whether you are feeling different – do you have feelings of hopelessness, persistent sadness, a lack of energy to get through your normal routine, or disrupted sleep or eating patterns? If so, and if these persist for more than a couple of weeks, you may be becoming depressed.

Do you have persistent and repetitive thoughts, worrying about your life or other problems? Do you notice physical symptoms such as shortness of breath, churning stomach or nausea, dizziness or rapid heartbeat, fear of new situations or people? If so, and these persist for more than a couple of weeks, you may be experiencing anxiety.

Get support

The best thing you can do is ask for support. It is sometimes very hard to reach out, especially when you may be afraid of people’s reactions. My experience though is that families and friends can be remarkably compassionate; and studies have shown that people who are open about their HIV status tend to get more support, have fewer issues with adherence, and generally appear to be happier. In one study, people with HIV who had good social support mechanisms reported the same quality of life, once they were on successful antiretrovirals, as people without HIV. Disclosing your HIV status can be scary, but it can also keep you healthy. Similarly, if you notice your mental health is wobbling, disclosing this to your friends and family can help keep you healthy.

Of course, this does not hold true for everyone. The world can be brutal and violent, families may use stigmatising diseases to play out internal politics, and not every spouse is going to be supportive. Use common sense, and choose your support network carefully. Equally, this does not mean you need to rush out and disclose to everyone the moment you get your diagnosis – I’ve seen quite a lot of people treating this period as a kind of confessional. Learning you are HIV-positive can be a huge shock; give yourself time to think it through, and decide when and who you want to disclose to.

American sex therapist Dan Savage famously says that disclosure on a date (or in any other situation) tells the other person only a small thing about you; whereas their reaction tells you everything you need to know about them. While it can be a shock to hear from a friend or loved one that they have HIV, or depression, or any other scary condition, there is no excuse for casually offensive opinions or hurtful comments. You do not have to stand for it, and you can be clear in deciding whether to continue a relationship with an individual who is rejecting or judgemental about your physical or mental health.

You can often find support groups through local churches, NGOs and community organisations. These don’t work for everyone, but can be of huge benefit. You might find that sharing your experiences and finding out more about HIV will be empowering, and this will help keep you both physically and mentally well. Also, you could talk about your mood; and if you are feeling low or anxious, it can be enormously helpful just to tell someone about it.

So pay attention to your friendship circle, family and community; and invest time and energy in these relationships.

Speak to your health professional

It is likely that you will receive very little clinical help concerning your mental health. Many health professionals are woefully under-trained around mental health, and you might find yourself brushed off if you try to talk to your doctor, nurse or even counsellor about this. If you feel strong enough, you can ask questions and insist that your health worker answer them; or if they can’t, that they do their own research and come back to you.

You have a right to mental health care, even though the reality is that South Africa is very under-resourced in this field. Your raising it could be helpful in transforming your own health worker’s understanding, too, and could contribute towards changes in broader mental health policy for everyone, over time. Also, challenge people on social media and in public, when they post trite messaging on mental health issues (the most annoying I have seen is a meme saying that people with depression don’t need tablets – just a pair of running shoes and a forest). They will be more careful next time.

Take your medication

Taking tablets every day for ‘conditions’ when you’re healthy is fast becoming a fact of life for everyone, for everything from high blood pressure to diabetes. Getting onto antiretrovirals, developing habits around swallowing tablets and staying on treatment, and finding the easiest system possible for getting your tablets, will move this aspect to ‘habit’ rather than being a constant reminder of the virus. If you acknowledge to yourself that pill fatigue might actually be systems fatigue – weariness around a health system that remains largely inefficient and unfriendly, and wastes so much of your time – this might help you to address your own negative thought patterns about taking your meds, and help you to stick to the regime. If you can, try to find a clinic that has good systems and helpful, competent staff. This will help you stay mentally healthy too.

If you are persistently depressed, it might also be possible to obtain anti-depressant medications on prescription. Primary healthcare clinics have access to anti-depressant drugs, and these can be a valuable addition to other counselling support. If you have the means, shop around for a professional you relate to – one who is sympathetic to mental health issues.

There are many similarities between taking anti-depressants and taking antiretrovirals. You need to take your meds consistently, without interruption, in order to achieve the best results. You may experience some side effects; but these can often be mitigated by changing the dose slightly, or just waiting for your body to get used to them. Many people take anti-depressants for months or years in order to keep their mood stable and enhance their mental health. There is nothing to fear from these drugs.

Get activated

Use activism to get behind organisations advocating for better health services, for both HIV and mental health. In a recent study we did on truck drivers (most of whom were HIV-negative), rates of anxiety and depression were very high; we see similar prevalence among carers, low-income families living in poor housing, and inner-city dwellers. If you can, donate money to help them campaign, and to hire good staff. Become a vocal supporter of better mental health initiatives, wherever they exist. Challenge your health provider to take mental health seriously, and be bold about opening conversations with your friends and family about mental health. The World Health Organisation estimates that one out of every four people suffers mental illness at some point in their lives, so you are not alone.

You might find useful mental health information and support through one of the smartphone apps or personalised telephonic support lines that are becoming increasingly available. These may involve a cost, but there have been enough studies to show that they can be valuable. Watch this space to learn more about which ones are reliably effective.

What should HIV-negative people and healthcare workers be doing? I guess trying to avoid the trite ‘support’ statements – from ‘Well, at least you’re alive’, to the hideous ‘We will all die one day’ – would be a start. I have been at dinners in white, middle-class suburbia where someone is loudly opining about morality and its connection with HIV, not knowing that the couple across from me are my patients. The same holds for mental health issues – think before saying some stupid, stigmatising thing. There needs to be much more community awareness about the importance of unconditional acceptance and support of people on any kind of chronic medication.

If you’re a health professional, the best thing you can do is to educate yourself around mental health – and learn, firstly, how to accurately diagnose someone with depression or anxiety; and secondly, how best to work out a treatment plan. Mental ill health is rarely healed only through drugs, but more usually involves a comprehensive strategy encompassing talking therapies, good lifestyle interventions, removing stress, treating other health conditions, and prescription medications. Compassion, empathy and the ability to ask the patient questions about their unique experience of living in their own body are crucial. The last thing you should be doing is adding to stigma by putting your foot in your mouth. It is not a moral failing to suffer mental ill health, just as it is not a moral failing to be HIV-positive, or have any sexually transmitted infection.

As South Africans, there are many things that grind us down: corrupt politics; lack of jobs; increasing living costs; high rates of violent crime; poverty and poor service delivery; alcohol abuse; and family and relationship break-ups. If you also take into account the reality that too many of us experienced trauma because of the brutalising effects of apartheid, it is no wonder that mental ill health is so prevalent in our society. Sadly, we have been slow to acknowledge this and implement adequate policies to help mitigate mental illness.

Just as with HIV, every single one of us knows another person who is experiencing mental ill health. However, this may be hidden – due to stigma, shame, lack of understanding, and lack of adequate treatment. As a country, we achieved a lot when we started taking HIV seriously: through activism, scientific research, transformed health delivery systems and a lot of hard work at all levels, we managed to turn the epidemic around and make HIV a manageable condition. We can do the same with mental health, if we are motivated to do so.

Professor Francois Venter is a medical doctor who has been involved in HIV patient care, as well as guideline development and studies on new HIV treatments, for many years. He had lots of support from work colleagues and friends in editing this article.

For more information and resources on mental health, go to:

* This article was first published in a special print edition of Spotlight published ahead of the Treatment Action Campaign’s 6th National Congress held in August 2017. A PDF of that print publication can be downloaded here.

Modernising ART

By Dr Michelle Moorhouse

South Africa, like many lower and middle-income countries, follows the World Health Organization (WHO) recommended public health approach, using standardised drug regimens to treat HIV. This along with task shifting from doctors to NIMART (Nurse initiation and management of antiretroviral therapy) trained nurses has enabled more than 3.9 million people living with HIV (PLWH) to access life-saving antiretroviral therapy (ART) since 2003. ART is undeniably one of the biggest successes of modern medicine, along with vaccines and antibiotics

While we have some pretty great treatments already, there is still room for

improvement. Current first-line ART is a big pill to swallow, it has some unpleasant side effects, resulting in poor adherence and virological failure, and resistance develops quite easily; it will not get any cheaper over time. From the more logistical aspect, the high dose of the drugs that make up first-line ART means they use more ingredients meaning they cost more, and is the reason the pill is so big, which in turn means the packaging is big, and takes up more space in the pharmacy. Clearly, we need treatments which are easier to take in terms of size and are cheaper. And if you compare first-line ART in lower middle income countries (LMIC), some of the drugs being used are no longer recommended in better resourced settings.

Current first line ART

So, let’s look a little more closely at our current first-line ART. According to our

ART is undeniably one of the biggest successes of modern medicine, along with vaccines and antibiotics

national guidelines, most people living with HIV (PLWH) will receive a combination of efavirenz (EFV), tenofovir (TDF) and emtricitabine (FTC) or lamivudine (3TC) as first-line ART. FTC/3TC, which are structurally almost identical, really contribute very little in the way of toxicity generally and are usually continued through subsequent lines of therapy so I am not going to say much more about them here, and going to confine my deliberations to EFV and TDF.

What is great about this combination is that millions of PLWH around the world have been treated with it for years so there is a wealth of experience with it – a bit like that comfortable T-shirt we like to sleep in, for us as prescribers, but perhaps not so much for PLWH. The regimen has proven virological efficacy, is generally well tolerated, is simple to take as it is dosed once daily and is co-formulated into a single tablet fixed-dose combination (FDC).

What are the problems with EFV? It comes with some unpleasant side effects (abnormal dreams, nightmares, hallucinations even and other neuropsychiatric type symptoms mainly; occasionally rash); has a very low resistance barrier; and requires a high dose. Its safety in pregnancy has been established despite a bumpy start in early development and it plays relatively well with most other drugs, including TB drugs (but not all, for example some contraceptives such as implantables). EFV is an example of one of the first-line drugs which has disappeared from first-line treatment in many wealthier countries.

Alternatives to EFV

So how do we improve on EFV? There are a number of alternatives to EFV to consider which are currently available in South Africa. Rilpivirine (RPV) is one option, from the same class of ARVs as EFV, and is dosed at 25 mg (compared to 600 mg of EFV which contributes significantly to the size of the FDC). RPV is much better tolerated than EFV and is incredibly cheap, which is always good news in a drug which could be potentially be used to treat millions of people. The downside is that it is not yet available in any FDCs in South Africa, can’t be used with rifampicin-based TB treatment or in anyone with a high viral load when starting treatment, and in the public sector we don’t do viral loads at treatment initiation, so it too has its warts. However, it is being studied in some interesting new combinations so let’s not completely set it aside just yet. Certainly as a switch option RPV is a very good choice in patients who don’t tolerate EFV, and there are studies which support this.

Dolutegravir (DTG) is another option already available in South Africa. Again, another low dose drug at 50 mg. In registrational first-line studies no one with virological failure developed any DTG resistance which means this drug is incredibly robust. DTG was also the first drug to ever beat EFV in a head-to-head study, where pretty much all others had previously tried and failed, and this was probably a lot to do with the fact that DTG is more tolerable than EFV. And as the saying goes, if it sounds too good to be true… In fact, there are emerging data suggesting there may be some side effects which include dizziness and anxiety. But this is coming mainly from European cohorts, which do not have the same genetic diversity of African populations. Currently a massive study called ADVANCE that compares DTG to EFV is underway in South Africa and includes screening for these types of symptoms. DTG is also available already co-formulated in SA with abacavir (ABC) and 3TC, but it is not practical to roll out this particular FDC programmatically as ABC is very expensive.

But as DTG requires only a 50 mg dose, if it were to be introduced into the public sector programme, produced by a generic manufacturer with South Africa’s buying power as the largest consumer of generic ART in the world, DTG would be an affordable option for first-line ART, and is currently an alternative option in the WHO guidelines. With regard to DTG and TB drugs there is an interaction, which can be overcome by adjusting the dosing of the DTG, but this might not be necessary – some studies are underway to look into this. One of the current challenges with DTG is at this stage we don’t know a lot about DTG in pregnant women. Botswana made the bold move of introducing DTG into their HIV treatment programme in June 2016, including for pregnant women and it is anticipated that they will present data on the first pregnancies at the IAS conference in Paris in July 2017 which will start to fill this gap. So, we have a very robust drug that is well tolerated and can be co-formulated into a small inexpensive pill – looks promising.

Then there are also other future third-drug options which are not available in South Africa (or indeed anywhere else) as yet. These include doravirine and bictegravir. Doravirine is from the same class of drugs as EFV and RPV. It is still in phase 3 of development (registrational studies) and whether or not it will ever hit our shores is unknown. Bictegravir, also in phase 3, is a drug which is very similar to DTG and is co-formulated with tenofovir alafenamide fumarate (TAF), which I will discuss a little more below, and FTC.

An alternative to TDF

So, moving on to TDF. The problems with TDF are in some ways similar to those with EFV. The high dose means a high active pharmaceutical ingredient requirement which drives the pill size and the cost. And it also has some toxicity associated with it. Currently, we do not have any alternatives available in South Africa  that are any better but there is one which should be available soon, namely TAF (tenofovir alafenamide fumarate). TAF, like the TDF in current first-line ART is a pro-drug of tenofovir. TAF is given at a much lower dose (approximately 10-fold lower) than TDF. TAF is associated with much less kidney and bone toxicity than TDF. The ADVANCE study will also compare TAF and TDF, as most studies of DTG used ABC as the backbone, and also would not have included many African participants. TAF has not been studied with TB drugs or in pregnant women as yet, but these studies are underway. Once we have a better understanding of this, on account of the better safety profile and the lower dose which will result in significant reductions in cost, TAF is set to be a favourable option to replace TDF.

And in fact, if DTG, FTC and TAF are co-formulated potentially we are looking at a future first-line regimen, to quote Prof Francois Venter, “smaller than an aspirin” which is incredibly potent, incredibly robust, incredibly well tolerated, all while being incredibly cheap – incredible isn’t it?

ART does not exist in a vacuum

All of this is very important, while we have such tough targets to chase – the famous 90-90-90. And to achieve that third 90 we need to modernise treatments so that PLWH can adhere to them. When there are so many other challenges to overcome within a healthcare system, optimising ART to be as simple, safe, efficacious and robust as possible facilitates safer task shifting to other cadres of staff which may help alleviate some of the human resource shortages faced within healthcare facilities.

But no matter how good the drugs are, ART does not exist in a vacuum, and ART alone will not achieve the three 90s. ART will not fix the healthcare system. ART will not address stigma. ART will not help us achieve that first 90 – 90% of PLWH knowing their status. ART will not find the missing in action to test them – the men, the key populations, the adolescents, girls and young women – and then link them to care to achieve the second 90. ART will not then retain them in care, and measure their viral load so we can see if we are reaching that third 90.

Massive investment in infrastructure and development of systems backed by political will is critical. Civil society must remain engaged and all of this must be backed by a National Strategic Plan (NSP) that is realistic, detailed, and embodies the principles of equity and access. There is a massive amount of work to be done to conquer HIV in South Africa, but optimised ART is certainly a great step in the right direction.

Dr Michelle Moorhouse – Wits Reproductive Health and HIV Institute and Southern African HIV Clinicians Society

HIV docs win quack HIV gel case

By Lauren Jankelowitz, CEO SA HIV Clinicians Society

The South Gauteng High Court this week ruled in favour of the SA HIV Clinicians Society in its legal battle with a doctor who promoted a product marketed as Dr Hugh’s Dermo Blue Pre-sex Protection Gel, which claimed to prevent HIV infection.

The Society previously informed clinicians and patients that the gel was untested and not proven to work, and explained the steps it had taken to ensure that the product was withdrawn from the market. This ultimately led to the doctor suing the Society for defamation.

The Society has an evidence-based approach to all its work and this is what was used when we considered the product in question. Part of the work of the Southern African HIV Clinicians Society includes constant efforts to debunk non-proven HIV “cures” and emphasise the importance of offering patients therapies that have been tested according to rigorous standards.

We are relieved and satisfied with the outcome. Part of the Society’s mandate is to provide doctors with the evidence that they need to give patients the best possible quality of care. Part of safeguarding patients is preventing the sale and use of untested products.

Such products, whether they are marketed as HIV cures or ways of preventing HIV infection, could encourage people to feel safe under false pretenses and thus put them at risk, and even cause harmful side effects. The Society reiterates the importance of taking HIV medication or using HIV prevention methods that have been thoroughly evaluated according to the highest scientific standards. This is the only way to ensure that those who seek medical care are protected.

“People who feel that they are at risk or fear for their health can be very vulnerable and thus fall prey to those selling quick-fixes or untested remedies. The Society plays a crucial role in ensuring that these patients aren’t taken advantage of and receive the best care possible,” says Society board member Professor Yunus Moosa.

Society President Dr Francesca Conradie agrees: “The Society aims to advance evidence-based interventions, whether for prevention or treatment. We will continue to work as advocates for those affected by HIV. This ruling is fantastic news for us.”