Keiskamma Trust, an Eastern Cape based health organisation, praised around
the world for its incredible community work which has saved thousands of lives, is in danger after funding cuts. Ntsiki Mpulo spent time with a community worker to give us a glimpse into the important work they do in a province where the health system is unable to deliver.
“The magnitude of the HIV/Aids challenge facing the country calls for a concerted, co-ordinated and co-operative national effort in which government in each of its three spheres and the panoply of resources and skills of civil society are marshalled, inspired and led.”
This was the rallying call of the judgment in Minister of Health vs Treatment Action Campaign, in 2002. Following years of AIDS denialism, the court upheld the constitutional right of all HIV-positive pregnant women to access healthcare services to prevent mother-to-child transmission of HIV (PMTCT).
Dr Carol Hofmeyer, a medical doctor who had settled in the Eastern Cape town of Hamburg, heeded the call, and began administering lifesaving ART (anti-retroviral therapy) to the people surrounding the village. The programme started with a handful of community health workers supporting the AIDS hospice. They now have 80 community health workers who serve 47 villages and 13 clinics in the Amathole District area surrounding Hamburg, including Peddie and Nier Village.
Nontobeko Twane, a community health worker based in Mgababa village, started as a volunteer at Keiskamma Trust in 2006. She received training as a community health worker, and was then employed on a permanent basis. She hasn’t worked elsewhere, and the stipend she receives is her only source of income.
She tested positive for HIV in February 2008, and was initiated on treatment in May 2008. She has steadfastly taken treatment since that day, and continues to do so today. She understands the challenges related to taking chronic medication for the rest of her life, and is thus able to provide the support that her patients need.
She is based largely at Keiskamma Trust, which is the temporary home of Hamburg Clinic. The Trust stepped in and offered its premises as a temporary measure when the 30-year-old Hamburg Clinic building collapsed in 2012. Through this collaboration, the Keiskamma Trust community health workers have developed a close working relationship with the clinic sisters.
The services provided by the Keiskamma community health workers include home-based care visits, regular reporting to nursing staff on critical cases, and monitoring adherence to (but not limited to) ARVs and TB, hypertension and diabetes medication. Now, these services are in jeopardy, as the Keiskamma Trust faces a funding crisis.
Following the termination of a donor-funding agreement, the trust is no longer able to pay the community health workers who are part of the programme, which requires R1.2 million per annum in operational funding. The Eastern Cape Health Department has agreed to provide sufficient funding to pay 10 community health workers per annum. This falls far short of the funds required to pay stipends for the 80 community health workers in the programme.
The Keiskamma community health workers are the cornerstone of the success of the health programme in the area; without them, women such as 27-year-old Zukiswa (name changed) face certain death.
Zukiswa lives in Mgabaga Village with her husband of five years, Moses (name changed), and her two children – a three-year-old daughter and a one-year-old, son Her husband works as a mechanic, fixing cars in the yard of their small home. Zukiswa does not work, and the family’s only other source of income is the child grant received from the state. However, this is insufficient to feed the entire family; it covers formula and nappies for the youngest child, and a modest amount of food. Zukiswa’s emaciated frame is testament to this fact.
She says that she has always been slight in build; but what is clear is that Zukiswa is wasting away. She tested positive for HIV in 2015. She was initiated on treatment, but has since stopped taking her medication. Her reason for not taking her medication is that there is no food in the house.
Zukiswa cowers on the corner of the couch, the only piece of furniture in the lounge, while Nontobeko perches on a bench opposite her. Though it is not stated openly, it is clear that Zukiswa is afraid of her husband. Moses has also tested positive, but has opted not to start ARV treatment. This increases the chances that Zukiswa a will become re-infected if she does not resume her treatment.
On numerous occasions, Nontobeko has explained to Zukiswa that taking her medication means that she will increase her life expectancy, so can she raise her children. She has on occasion requested support from the Department of Social Development, to provide food parcels; however, this has only been a stopgap measure. And as Zukiswa continues not to adhere to her treatment, Nontobeko is fearful that this young mother will not survive the year.
Nontobeko, like the other 80 community health workers employed by Keiskamma Trust, provides a lifeline for the women she looks after. Without her, many would be unable to access health care at all.
Tuberculosis (TB) is still a crisis in South Africa. Here are 10 quick facts about the state of TB in South Africa.
Tuberculosis (TB) remains a crisis in South Africa. It is the top cause of death indicated on death reports. There are over 400 000 cases of TB in South Africa every year. TB cases are slowly coming down, but it is not happening nearly fast enough.
One of the biggest problems with TB is that we do not diagnose people fast enough and get them on to treatment fast enough. This is bad for the health of people with TB, but also contributes to the spread of TB in our communities. Two potential solutions are active case finding (ACF) and contact tracing. ACF is when healthcare workers or community healthcare workers go out and look for people with TB. Contact tracing is when we trace the family and/or work contacts of someone with TB and then test them for TB as well. Most experts agree that government must invest more in ACF and contact tracing, but unfortunately government has not shown much ambition in this regard. This lack of ambition is probably because government does not want to employ more people.
Another critical problem in our response to TB is the poor infection control measures in most public spaces. In taxis, or in waiting rooms at clinics, or at Home Affairs offices, often the windows are not opened and all the people present breathe the same air. In addition, many prisons are overcrowded and create ideal conditions for the transmission of TB. Here too, government has not shown much ambition in dealing with the problem.
There are over 20 000 cases of drug-resistant TB (DR TB) in South Africa per
year at the moment. It appears that the rates of DR TB are going up – something which surely constitutes a public health emergency. DR TB is much more difficult and more expensive to treat than normal TB. There is also evidence suggesting that most people with DR TB did not develop the drug resistance while being treated for normal TB, but were infected with TB that was already drug-resistant.
Until recently, treatment for multiple drug-resistant TB (MDR TB) took two years, and often resulted in severe side effects such as deafness. However, the World Health Organisation recently recommended a new nine-month regimen with fewer side effects for the treatment of MDR TB. South Africa is in the process of introducing this new, shorter regimen.
While the new nine-month MDR TB regimen is an improvement on previous regimens, it still entails a large number of pills and injections, and has is associated with substantial side effects. The good news, however, is that a number of trials are under way to test even shorter regimens that will contain no injections, and hopefully will have even fewer side effects. We should start seeing results from these trials in 2019.
Extensively drug resistant TB (XDR TB) is the most difficult form of TB to treat, and over 70% of people with XDR TB in South Africa die within five years. There is good news, however: an ongoing trial in South Africa called Nix-TB is showing much higher cure rates for XDR TB than we’ve ever seen before. In the Nix-TB trial, people are treated with three drugs: bedaquiline, pretomanid and linezolid.
While bedaquiline and linezolid are already registered and available in South Africa, pretomanid is not yet registered. Pretomanid is not being developed by a pharmaceutical company, but by a non-profit called the TB Alliance. Donors should work with the TB Alliance to make pretomanid available under compassionate-use concessions, so that people in South Africa with XDR TB can access the drug.
People living with HIV are at higher risk of contracting TB. For this reason, people are given isoniazid preventative therapy (IPT) to prevent the development of TB. For years IPT treatment rates in South Africa were very low, but recent figures suggest that many more people are now receiving IPT and being protected against TB.
IPT works well and can be taken for six months or a year, or even longer. It consists of a pill you must take every day. However, there is a new form of TB-preventative therapy called 3HP, which consists of isoniazid and another drug called rifapentine. The 3HP regimen involves taking pills only once a week, for a period of 12 weeks. If ongoing trials of 3HP in South Africa are successful, 3HP will replace IPT at some point in the next five years.
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
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
Mineral-rich, prosperous, the glitter of gold – that’s supposed to be the promise of the towns the sit atop the ore-rich western fringe of Gauteng.
But while mining giants may have cashed in for generations, many more labourers have been casualties of a long legacy of exploitation and shocking workplace practices.
There isn’t a clear sustainability plan for this sunset industry, leaving people who have flocked here in the hope of work and a better life with uncertain futures. Their present realities are still about competing for scarce jobs with few opportunities. They struggle to make ends meet in homes and communities that are underdeveloped, stuttering along with poor infrastructure, from a lack of basic services like piped water, electricity and proper sanitation, to clinics that are overcrowded and understaffed, and hospitals where maintenance and upgrading have not taken place in years.
People before profits
Richard Moloko (43) knows first-hand about the tough life on mines. In 2008 he was working for one of Carltonville’s big gold mines as a machine operator. That year, he was also diagnosed with HIV. It was a shock he says, but what was worse was that starting treatment that year took its toll on his body.
‛I would get dizzy and nauseous sometimes. Because I was working with flammable things on the mines they said I shouldn’t do my job anymore. After some time I was fired,’ says Moloko.
Initially, he thought that he would be offered another job, something that wouldn’t have comprised his or anyone else’s safety. Instead, he was sent home and now, eight years later, Moloko is still unemployed. He lives with his brother in Khutsong, a settlement outside Carltonville.
Moloko is on ARV treatment and gets his medicines from the local clinic, about 4 km from his home. The Welverdiend Clinic is small and cramped and sometimes he waits for hours. But generally there are no problems with stockouts, and that’s a relief, says Moloko. Still, he’s not completely well and he rolls up his sleeves to show a skin condition that won’t heal. He hasn’t been able to see a specialist, nor has the clinic referred his case to other hospitals in the municipality where he could find help.
Moloko’s health issues, though, concern him less than his lack of employment. He’s never been able to challenge his employers for firing him and now, eight years later, the company has changed ownership several times. He doesn’t know where to begin to take on the fight and he doesn’t have the resources to do so.
‛It does make me cross that this happened and that I can’t do anything about it. I accepted my HIV status, my employers should have too. I feel I was discriminated against. I am still discriminated against when I go look for work. But even so, I don’t hide that I am HIV positive. I always disclose, I’m not ashamed,’ he says.
Quiet and desperate on the western front
There’s an odd stillness for a mid-week morning in Extension 5 in Khutsong on the western rim of Gauteng. The blustery spring day has driven people indoors, but even so there are few signs of people stirring among the rows and rows of new RDP houses, as you’d expect in a sprawling location
Most people are away in town about 10 km away, looking for jobs, locals say. Many of the houses stand empty – curtains are drawn and everything is shut and locked. Locals says that the RDP houses are uninhabited because people can’t afford to live so far away from the centre of town, Nor can they maintain the upkeep of their homes, or pay for utilities like electricity bills in the sections of the settlement that has been electrified. People also can’t count on water to run from taps, even in those houses that have piped water.
Local Treatment Action Campaign (TAC) leaders like Tsediso Mokoena and Tshepo Maboe say that, to an outsider, the pastel-coloured RDP houses look like a step in the right direction for development. They acknowledge that efforts to improve the shortage of proper housing is a good thing, but they criticise the authorities for not considering the bigger picture by providing better planning and infrastructure.
‛They now say that this is a dolomite area and there are problems with the water, so people have to rely on Jojo tanks and water tankers for water, and they have to use portable toilets. They haven’t built proper roads here, so people can’t get in and out to town easily; it’s too expensive for many people. It’s like they, the council, didn’t know what they were doing when they developed here,’ says Mokoena.
At the end of July, a sinkhole in the area led to the collapse of the water pipes feeding water to Khutsong Extensions 4, 5 and the Welverdiend area, where the local clinic is located. The ground is confirmed to be unstable and water services remain interrupted, intermittent at best.
Unemployment has also hit hard here, making life much tougher for the likes of Nonzwakazi Mamane (39). She was absorbed into a community works programme launched across Gauteng in 2010. The programme is aimed at providing limited employment to the most vulnerable communities. In Khutsong, the project is to clean up the neighbourhood and tend to community vegetable gardens – with food security being one of the priority focus areas for the programme.
Mamane’s stipend is about R600 a month. It’s too little to survive on, she says, but without it she has nothing. The food gardens that are supposed to help supplement her, her husband and her three children’s diets, are failing because there is no piped water to keep the thirsty plants thriving. The community is also expected to buy its own seeds, fertilisers and gardening implements.
‛They say we are in a dolomite area so they stopped pumping water to us for over four months now. You don’t know when the water will come in the taps, it can be two o’clock in the morning and you’re sleeping then you don’t get water,’ says Mamane.
To water the gardens, the people on the project have to carry what they can in watering cans and buckets from a water tank to the gardens. It’s simply too much labour to be sustainable.
Water is top of mind for Mamane in a season of severe drought that has hit large parts of South Africa. Without water it’s not just that the vegetable gardens can’t grow, but hygienic sanitation is compromised and the risk of illness and disease increases. Already, raw sewage runs down the dust alleys that separate the government houses.
Mamane is worried about getting sick, because it means relying on the nearby clinic. Welverdiend Clinic is 4 km away and she has to catch a taxi to get there. ‛You can wait three hours. Last time I was there they told me I was supposed to have a pap smear, but they didn’t have the equipment to do it. It’s a very small clinic and they don’t have proper rooms, the space is just divided up and there’s no privacy for the patients,’ she says.
It’s a collapse of so many things for the likes of Mamane. ‛I’m going to be turning 40, I have to look after my three children and I can’t find a proper job. I don’t know what to do,’ she says, picking up her filled watering cans and heading home.
A friend in need
An old sewing machine whirrs inside an RDP house in Khutsong Extension 5. Florina Mothabeng (74) is hunched over the machine; she pauses only to hear more clearly what her friend Elizabeth Sholo is saying.
The two friends meet like this most days to pass a few hours of the day. Mothabeng is chirpy and chatty. Her house is one of about 18,000 that were part of a massive housing development launched in 2009 in the municipality. The houses were meant to be built on land that was safe for development and the housing project was meant to introduce an integrated rental model for Khutsong locals.
Mothabeng lives on her own, as does Sholo. It’s difficult for elderly people to look after themselves on their own. While Mothabeng says she’s fine and has little to complain about, she reveals that she’s on a slew of tablets for hypertension. She says she’s mostly satisfied with the service from the mobile clinic, which she can reach quite easily and where they have her medicines every month, she says.
But then she motions with her eyes and a little head nod that the questions about medical care should really be directed at her friend. She doesn’t want to put Sholo on the spot but she knows Sholo deserves better care and is not getting it.
Sholo obliges by lifting up a bandaged hand. She removes the wad of gauze and bandage to reveal a hand that’s badly deformed and scarred. This is an old injury from 2009, when Sholo was caught in a shack fire. They hand is all by useless. It still hurts, says Sholo.
At the time of the fire she was treated at the Leratong Hospital in Mogale City but her burns turned septic. Still, Sholo was sent home and had to learn to adjust to living with a damaged hand that still causes her pain.
At home, Sholo has to look after herself. The adult child she used to live with was killed in a car accident some years ago. Both grannies live alone and Mothabeng jokes that her children only visit to borrow the Tupperware she has in neat stacked tiers on her kitchen cabinet. She quips that if she had DStv then her grandchildren would also come visit her.
Jokes aside Mothabeng worries for her friend, who can’t remember exactly how old she is and also has failing eyesight. Sholo seems resigned to this existence and just asks for some help to wind the length of bandage back around her hand.
‛My heart is sore to see her like this,’ says Mothabeng.
A step too far
It’s been more than 18 months since Sibongile Kratshi (40) has been to a clinic or hospital. She’s HIV positive and is on ARVs. Kratshi knows she needs to have a blood test and to see a doctor, but it’s too painful to walk, to make the journey.
Kratshi was diagnosed with HIV in 2009. Since then, she’s suffered a stroke that has affected her speech and her movement. Her feet are constantly swollen and it hurts for her to shuffle to open a door that’s just a few paces from the sofa where Kratshi spends most of her day. She says she can hardly leave the house, her disability has become so bad. A small radio plays all day to keep her company.
Kratshi has previously been told she needs to see a physiotherapist to help improve her mobility. Such help could help her to get crutches or a wheelchair and the necessary medical approval to apply for a disability grant. But she’s physically unable to get anywhere, and only has her 14-year-old son to assist her.
The teenager picks up his mother’s ARVs every month and every time he brings back the same message: that the nurses need her to come in for tests. Neither they nor she know what her current CD4 count is.
It doesn’t help that Kratshi also loathes clinic visits. She says of the local Welverdiend Clinic: ‛I don’t like to go to the clinic; the nurses treat me badly and there is no privacy there.’ Her speech has been affected by the stroke and she dreads coming across an impatient nurse who will be rude and disrespectful as she struggles to make herself understood.
Even though there is a mobile clinic that services greater Khusong area once a month, Kratshi says she will not make it the few hundred metres without considerable pain. Even if she could, the mobile clinic services will not be able to draw blood or give her results.
Instead, she falls back into the sofa, turns up the radio and waits for her son to come home from school.
A message for a better future
The baby Beauty Modise is balancing on her hip won’t stop crying – the 16-month-old wants her mother’s full attention.
Modise is 24 and this is her second child. She was a mother at 19 with her first child. Unmarried and with two children before the age of 25, this wasn’t the future she imagined for herself when she was a West Rand schoolgirl.
‛I wish that I was told good information growing up. People would say things to me like, ‟Don’t go around with boys” but they didn’t say, ‟Unprotected sex can make you pregnant,”’ says Modise, who is now a volunteer with the organisation SRHR (Sexual Reproduction Health Rights).
The organisation is a coalition between the TAC and Youth Friendly Services (YFS). Its primary aim is to raise awareness about sexual health and rights for young people. They speak at schools and also campaign door-to-door.
‛It helps that we are also young people speaking to other young people. For me, the message I want to give them is that they mustn’t make the same mistakes that I made.
‛It’s not easy to be a mother when you are so young. I never went to study because there is no one else to look after my babies and today I am unemployed. The father of my children is 25 and he is also unemployed. We survive only on piece jobs and that is very hard,’ says Modise.
Currently, there are 10 SRHR volunteers for the Leratong municipal district, both men and young women. Modise says having volunteers who are young and are both male and female means they have a better reach and a better chance to reach their target audience.
She says she’s committed to working with the NGO, helping the youth in her community, saying no young person should have the same pressure she has had just as they’re about to start their adult lives.
‛I want to say to school kids, stay in school, work hard for a better education and a better future, don’t be like me,’ she says.
The recently published outputs of the Thembisa mathematical model of HIV in South Africa paint a remarkable picture of the history of HIV in this country. For the period from 1990 to 2015, we’ve plotted five graphs below using the estimates published on the Thembisa website. For all the graphs, a solid line indicates data which have been ‘matched’ against available survey data, while a dashed line represents data that are more uncertain as they are the Thembisa model’s projections or ‘best guesses’ based on previous trends in the data.
1. Life expectancy
This graph shows life expectancy at birth in South Africa. It shows a dramatic drop to 53.6 as the HIV epidemic grew to its peak in 2005. The impressive increases since then has been attributed to the wide rollout of ARVs by the state (see next graph). This graph also makes it clear that, impressive as these increases are, they are mostly just a recovery to pre-HIV levels. Life expectancy in 1995 was 62; 20 years later in 2015 it was estimated to again be 62.
2. Antiretroviral treatment (ART)
This graph shows the total number of people in South Africa receiving antiretroviral treatment. Comparing this to the previous graph, notice how dramatically life expectancy increased as antiretrovirals (ARVs) became more widely used from the mid-2000s.
3. Number of new infections and HIV deaths
The blue line on this graph shows the number of new HIV infections in South Africa by year. The good news is that the rate of new infections is decreasing from its peak of around 570 000 per year at the turn of the century. The red line represents HIV deaths per year and shows that yearly deaths peaked in 2005 at around 280 000 and then started declining (note the similar time that ARVs became more widely used in the previous graph). Notice how the red line is lower than the blue line – in other words, more people are becoming newly infected with HIV than people are dying of HIV. The result of this, as we will see in the next graph, is that the number of people living with HIV in South Africa is increasing. (Not shown on the graph: by 2015 a total of around 3.5 million people have died of HIV-related causes in South Africa.)
4. Number of people living with HIV
This graph shows the number of people living with HIV in South Africa. That this number is continuing to increase is both a bad and a good thing. As we can see from the previous graph, this effect is driven by the still high rate of new HIV infections (bad) and by the fact that people living with HIV are living longer and no longer dying at the same rates as before (good).
5. HIV prevalence
This graph shows HIV prevalence in South Africa. It is worth including here since HIV prevalence figures are often quoted in the media. Prevalence in this case is an indication of the percentage of the population who are living with HIV in a particular year. Prevalence is driven by the same forces driving the total number of people living with HIV (shown in the previous graph). The one key difference is that it also factors in that the total population of South Africa is growing. If you extend the model’s predictions into the future, HIV prevalence is expected to peak in 2016 and 2017 at 12.8% and then starts coming down slowly – but the total number of people living with HIV is only predicted to reach a peak of around 7.9 million during 2030.
As the dust settles in Durban and the circus moves on, we reflect on a few of the bigger moments of AIDS 2016. Below are some of the highlights we think may turn out to be significant.
Ban Ki-Moon in town to talk medicines
For a few hours on Monday 18 July United Nations Secretary-General Ban Ki-Moon was in Durban. He was there to talk about HIV, but also to talk about access to medicines. Late in 2015 he had appointed a High Level Panel (HLP) to consider problems with access to medicines and the lack of innovation in important disease areas. That he chose to travel to Durban on the eve of receiving the HLP’s report on these issues is significant.
On Monday morning Anele Yawa, General Secretary of the Treatment Action Campaign, presented a memorandum to Ban Ki-Moon urging him to take steps to “never again let people die because they cannot access medicines”. If part of Ban Ki-Moon’s mission in Durban was to take the temperature ahead of receiving the HLP report, he would have found it to be scorching hot. Whether that has any influence on what happens with the HLP report and to what extent the report and its recommendations lives or dies within the United Nations remains to be seen.
Close to 10 000 people in ‘Treatment for All!’ march
In the moment last week most reminiscent of 2000, close to 10 000 people led by the Treatment
Action Campaign marched to the Durban Convention Centre on Monday to hand memorandums to various high-ranking persons in the AIDS world including UNAIDS chief Michel Sidibe, Pepfar head Deborah Birx and deputy president Cyril Ramaphosa. The march was convened under the banner of “treatment for all now!”. Activists emphasised that 20 million people living with HIV need treatment, but do not have access to it. The march showed that large numbers of people can still be mobilised to demand that leaders do better in the AIDS response. (You can read the march memo here)
UNAIDS U-turn on “end of AIDS” language
One of the big stories of AIDS 2016 is the shift away from “end of AIDS” rhetoric from UNAIDS. In a move welcomed by activists, UNAIDS Executive Director Michel Sidibe said that we are not currently heading toward an end to AIDS and TB. Along with a number of other speakers at the conference he highlighted the reduced funding available for the AIDS response and the fact that the rate of new HIV infections is not coming down. But, whether the change of course from UNAIDS together with the show of power on the streets of Durban will be enough to push the global AIDS response back on track is unclear.
Disappointing results from TasP trial
There was great hope that the TasP (Treatment as Prevention) trial would show that providing more people with treatment earlier will reduce the rate of new infections in a community. Unfortunately, this important trial failed to show a significant reduction in new infections in communities with early treatment. The problem appears to be to get enough people tested and then to get those people to initiate treatment. In better news, new findings from the Partners trial confirmed that people who are stable on treatment with undetectable viral loads do not transmit HIV to their sexual partners. The sobering message from TasP then is that we’ll need to do a lot more to actually get people tested and on treatment, but Partners confirms that getting it right will have a huge impact on new infections.
A potential turning point for community healthcare workers
In another notable statement from UNAIDS, Sidibe said that the world needs to train a million more community healthcare workers (CHWs). He said that South Africa should have 200 000. This is significant since the line from the Minister of Health in South Africa has until now been that 40 000 CHWs are enough for South Africa. It is now up to activists around the world to use Sidibe’s comments to push for the training and employment of many more CHWs.
Questions about young women and girls
Much lofty rhetoric at this year’s conference focused on the extremely high infection rates in young women and girls. Much of the rhetoric was of course not from young people. When young people did speak out – interrupting South African Minister of Health Dr Aaron Motsoaledi – it was to say they want access to condoms and sanitary towels in schools.
Speech of the conference delivered by Justice Edwin Cameron
On Tuesday morning Justice Edwin Cameron delivered the prestigious Jonathan Mann lecture. Apart from being humorous and moving, the speech had a remarkable moral force and clarity. One of the disappointments of AIDS 2016 was that more people did not name and shame countries for discriminatory laws that undermine both the rights of human beings and the AIDS response.
Civil society march against crackdown by Indian government
On the morning of 21 July activists marched from the conference to the Indian Consulate in Durban. The activists were protesting the Indian government’s crackdown on civil society groups such as the Lawyers Collective and India’s yielding to pressure from the United States on intellectual property. The activists say that India’s status as the pharmacy of the developing world is under threat and with it the global supply of quality generic AIDS medicines. The memorandum was endorsed by current, future and past leaders of the International AIDS Society.
New evidence supports new models of care
One of the key themes of the 2016 conference was that we need to change the way healthcare systems deliver services to people living with HIV if we want to provide all people living with HIV with treatment. The evidence is in. It is now up to healthcare systems to start implementing more task-shifting, adherence clubs, and care models requiring fewer clinic visits. There is also new evidence suggesting that offering people treatment on the same day as testing HIV positive leads to more people starting treatment. Not surprisingly, a community healthcare worker-based programme helped to improve TB detection rates in a study in Malawi.
While it is hard to change the inertia of old ways of delivering care, we now seem to have reached a critical mass of evidence on what we need to do to make healthcare systems much more effective and efficient. Integrating these new ways of doing things must be a top priority for health departments in high HIV and TB burden countries.
Breast cancer protest at an AIDS conference
In a show of solidarity with breast cancer patients across the world, activists covered the Roche
stand at the conference with hundreds of bras. The activists were protesting the high prices that Roche is charging for the breast cancer drug trastuzumab in South Africa and other countries. In South Africa a course of the drug costs a half a million Rand. One of the protestors was a breast cancer patient from South Africa who has not been able to access trastuzumab. Her cancer has recently spread – something taking trastuzumab could potentially have prevented.
Key populations including sex workers, men who have sex with men and injecting drug users are still marginalised and suffer the “internal nightmare of shame and stigma” despite the strides that have been made in the response to the AIDS epidemic. This was the message delivered by Constitutional Court Judge Edwin Cameron when he delivered the Jonathan Mann Lecture at the International AIDS Conference today (Tuesday).
Cameron reminded delegates that it had been 35 years since the Western world was alerted to AIDS, and since this first report, 35 million people had died of AIDS-related illnesses. In 2015 alone, 1.1 million people.
“These last 35 years, since then, have been long. For many of us, it has been an arduous and exhausting and often dismaying journey,” said Cameron, himself openly living with HIV. He referred to the AIDS denialism era in which South Africa saw a reported 300 000 people dying as a result of a tacit refusal by the Mbeki government to treat people living with HIV.
Following a protracted and sustained advocacy campaign and court action led by civil society, South Africa finally introduced anti-retroviral treatment in the public health system in 2004.
Cameron acknowledged that access to life saving treatment had saved the lives of millions globally and that this had been hard won through focused activism. “We honour the part, in treatment availability and accessibility, of angry, principled and determined activists, in South Africa’s Treatment Action Campaign and elsewhere. For millions of poor people, their anger brought the gift of life,” he said.
He cautioned the global community against declaring the fight to curb the epidemic won, and made particular reference to South Africa saying that too many people were still denied access to ARVs.
“In South Africa, despite our many successes, well over six million people are living with HIV and globally, of the 36.7 million people living with HIV at the end of 2015, fewer than half had access to ARVs,” he said.
“Most of those still in need of ARVs are poor, marginalised and stigmatised – stigmatised by poverty, sexual orientation, gender identity, by the work they do, by their drug-taking and by being in prison.”
Cameron paid tribute to Dr Jonathan Mann who pioneered work with HIV in prisons saying that Mann recognised HIV stigma was driven by laws that specifically criminalise transmission of HIV and exposure by another to it. Cameron labelled the laws “vicious” and “ill-considered and explained that by criminalising undefined “exposure”, these legislators ignored the science of AIDS which has demonstrated that HIV is easily transmitted.
Although the South African government has announced that from September 2016 it would roll out a programme which would see people all who test HIV positive receiving treatment regardless of CD4 count, Cameron believes that healthcare for men who have sex with men (MSMs) is insufficient.
“They lack programs in awareness, education, outreach, condom provision and access to ARVs,” he said. He quoted a study by Professor Chris Beyrer which showed that the means to end HIV infections and AIDS deaths amongst men having sex with men is available however “the world is still failing”.
“For this, there is one reason only – ignorance, prejudice, hatred and fear,” said Cameron. “The world has not yet accepted diversity in gender identity and sexual orientation as a natural and joyful fact of being human.”
Cameron made an impassioned plea for sex workers to be treated with dignity and respect. He called for police protection for sex workers rather than “exploitation and assault and humiliation”.
He invited activists from across Africa and the Caribbean to rise from their seats and join him on stage in solidarity against the stigmatisation of these key populations and called for renewed vigour in tackling the issues that were a barrier to equal treatment.
By Edwin Cameron, Constitutional Court of South Africa
It is a great privilege and an honour to be here.
At the start of a very busy conference, with many stresses and demands and anguishes, I want to start by asking us to pause quietly for just a few moments.
It has been 35 years since the Western world was alerted to AIDS. The first cases of a baffling, new, terrifying, unknown syndrome were first reported in the northern summer of 1981. The reports were carried in the morbidity and mortality weekly reports of the CDC on 5 June 1981.
These last 35 years, since then, have been long. For many of us, it has been an arduous and exhausting and often dismaying journey.
Since this first report, 35 million people have died of AIDS illnesses – in 2015 alone, 1.1 million people.
We have felt the burden of this terrible disease in our bodies, on our minds, on our friends and colleagues, on our loved ones and our communities.
AIDS exposes us in all our terrible human vulnerability. It brings to the fore our fears and prejudices. It takes its toll on our bodily organs and our muscles and our flesh. It has exacted its terrible toll on our young people and parents and brothers and sisters and neighbours.
So let us pause, first, in remembrance of those who have died –
those for whom treatment didn’t come in time
those for whom treatment wasn’t available, or accessible
those denied treatment by our own failings as planners and thinkers and doers and leaders
those whom the internal nightmare of shame and stigma put beyond reach of intervention and help.
These years have demanded of us a long and anguished and grief-stricken journey.
But it has also been a journey of light – a journey of technological, scientific, organisational and activist triumph.
So we must pause, second, to celebrate the triumphs of medicine, science, activism, health care professional dedication and infrastructure that have brought ARVs to so many millions.
Indeed, the fact that I am here today at all is a tribute to the activists, researchers, doctors and scientists in the audience.
Many of you were responsible for the breakthroughs that led to the combination anti-retroviral treatment that I was privileged to start in 1997 – and which has kept me alive for the last 19 years.
I claim no credit and seek no praise for surviving. It felt like an unavoidable task.
All of us here today who are taking ARVs – let us raise our hearts and humble our heads in acknowledgment of our privilege – and often plain luck – in getting treatment on time. That treatment has given us life.
So let us pause, third, to honour the doctors – the scientists – the researchers – the wise physicians and strong counsellors who have saved lives and healed populations in this epidemic.
As important, fourth, let us pause to honour the activists, whose work made treatment available to those who would not otherwise have received it.
We pause to honour the part, in treatment availability and accessibility, of angry, principled and determined activists, in South Africa’s Treatment Action Campaign and elsewhere. For millions of poor people, their anger brought the gift of life.
Without their courage, strategic skill and passion, medication would have remained unimaginably expensive, out of reach to most people with HIV. They led a successful campaign that saved millions of lives.
The fact that many millions of people across the world are, like me, receiving ARV treatment, is a credit to their work.
They taught us an important lesson. Solidarity and support are not enough. Knowledge and insight are not enough. To save lives, we need more. We need action – enraged, committed, principled, strategically ingenious action.
They refused to acquiesce in a howling moral outrage. This was the notion that life-saving treatment – treatment that was available, and that could be cheaply manufactured – would not given to poor people, most of them black, because of laws protecting intellectual property and patent-holders’ profits.
The Treatment Action Campaign and their world-wide allies frontally tackled this. They changed the way we think about healthcare and essential medicines access.
What is more, without the Treatment Action Campaign, President Mbeki’s nightmare flirtation with AIDS denialism between 1999 and 2004 would never have been defeated.
Instead, the TAC took to the streets in protest. They demanded treatment for all. And when President Mbeki proved obdurate, they took to the courts.
Because of my country’s beautiful Constitution, they won an important victory. Government was ordered to start making ARV treatment publicly available.
Today my country has the world’s largest publicly provided anti-retroviral treatment program.
More than 3.1 million people, like me, are receiving ARVs from the public sector.
I am particularly proud that when someone with HIV registers for treatment in South Africa, they should not be asked to show an identity document or a passport or citizenship papers. That is as it should be. The imperatives and ethics of public health know no artificial boundaries.
In the sad history of this epidemic, the triumphs of AIDS activists, on five continents, are a light-point of joy.
So there is much to celebrate. I celebrate the joy of life every day with the medication – which keeps a deadly virus effectively suppressed in my arteries and veins, enabling me to live a life of vigour and action and joy.
But we must not forget that AIDS continues to inflict a staggering cost on this continent and on our world.
What is more important than my survival, and that of many millions of people in Africa and elsewhere on successful ARV treatment, is those who are not yet receiving it.
There still remains so much that should be done. More importantly, there still remains so much that can be done.
Too many people are still denied access to ARVs. In South Africa, despite our many successes, well over six million people are living with HIV. And, though about half of South Africans with HIV are still not on ARVs, from September this year ARVs will be provided to all with HIV, regardless of CD4 count.
Globally, of the 36.7 million people living with HIV at the end of 2015, fewer than half had access to ARVs.
Worse, the pattern of ARV availability is one that reflects our own weaknesses and vices as humans – our prejudices and hatreds and fears, our selfish claiming for ourselves what we do not grant to others.
Most of those still in need of ARVs are poor, marginalised and stigmatised – stigmatised by poverty, sexual orientation, gender identity, by the work they do, by their drug-taking and by being in prison.
HIV and the Law
Dr Jonathan Mann, to whom this lecture is dedicated, did pioneer work in recognising the links between health and human rights. He stressed that to address AIDS, “we must confront those particular forms of inequity and injustice – unfairness, discrimination – not in the abstract, but in its specific and concrete manifestations which fuel the spread of AIDS.”
He recognised that the perils of HIV are enormously increased by laws that specifically criminalise transmission of HIV and exposure of another to it. This was also confirmed by the wonderful and authoritative work the Global Commission on HIV and the Law has recently done.
These laws are vicious, ill-considered, often over-broad and intolerably vague. By criminalising undefined “exposure”, they ignore the science of AIDS, which shows how difficult HIV is to transmit. Apart from driving those at risk of HIV away from testing and treatment, they enormously increase the stigma that surrounds HIV and AIDS.
Across this beautiful continent of Africa, men who have sex with men (MSMs) remain chronically under-served. They lack programs in awareness, education, outreach, condom provision and access to ARVs. As a recent study by Professor Chris Beyrer and others has shown, we have the means to end HIV infections and AIDS deaths amongst men having sex with men. Yet “the world is still failing”.
For this, there is one reason only – ignorance, prejudice, hatred and fear. The world has not yet accepted diversity in gender identity and sexual orientation as a natural and joyful fact of being human.
Seventy eight countries in the world continue to criminalise same-sex sexual conduct. Thirty four of them are on this wide and wonderful continent of Africa.
It is a shameful state of affairs. As a proudly gay man I have experienced the sting of ostracism, of ignorance and hatred. But I have also experienced the power of redeeming love and acceptance and inclusiveness.
We do not ask for tolerance, or even acceptance. We claim what is rightfully ours. That is our right to be ourselves, in dignity and equality with other humans.
Discrimination on the ground of sexual orientation or gender identity is a colossal and grievous waste of time and social energy.
As our beautiful Archbishop Desmond Tutu has said, when we face so many devastating problems – poverty, drought, disease, corruption, malgovernance, war and conflict – it is absurd that we waste so much time and energy on sexual orientation (“what I do in bed with whom”.)
The sooner we accept the natural fact that gender and orientation diversity exists naturally between us, the quicker we can join together our powers of humanity to create better societies together.
The same applies to sex workers. Sex workers are perhaps the most reviled group in human history – indispensable to a portion of mostly heterosexual males in any society, but despised, marginalised, persecuted, beaten up and imprisoned.
Sex workers work. Their work is work with dignity.
Why do people do sex work? Well, ask a sex worker –
To buy groceries, and pay their rent, to study, to send their children to school, and to send money to their parents and extended family.
It is hard work. Perilous work. Sex workers have a tough, dangerous job. They deserve our love and respect and support – not our contempt and condemnation.
They deserve police protection, not exploitation and assault and humiliation.
More importantly, they deserve access to every bit of HIV knowledge and power that can protect them from infection and can help them to protect others from infection.
Pre-exposure prophylaxis (PrEP) works for sex workers. It should be made available to them, as a matter of urgent priority, as part of all national AIDS treatment programs.
In September 2015, the World Health Organization, recognizing PrEP’s efficacy, recommended that PreP be provided to all “people at a substantial risk of HIV,” including sex workers.
When we in South Africa launched our three-year National Sex Worker HIV Plan in March 2016, we proposed providing PrEP to sex workers. WHO recognized South Africa as the “first country in Africa to translate this recommendation into national policy.”
Beginning last month (June 2016), the first programs began providing daily PrEP to sex workers in South Africa.
Criminalising sex workers is a profound evil and a distraction from the important work of building a humane society.
Especially vulnerable too are injecting drug users. Upon them are visited the vicious consequences of perhaps the most colossal public policy mistake of the last 80 years – the war on drugs.
The vulnerability of injecting drug users is evident in the high percentage of injecting drug users with HIV. Throughout the world, of about 13 million injecting drug users, 1.7 million (13%) are living with HIV.
They are denied elementary life-saving services. This is not on the supposedly “dark” continent of Africa – but in the United States of America. If you want an example of evidence-ignoring public policy, that causes loss of life and injury, and spread of HIV, do not look complacently to President Mbeki’s South Africa twelve years ago – look to the United States of America, now, and the federal government’s refusal to make needle substitution available to IDUs . While the US government’s decision to partially lift this ban on federal funding for needle exchange programs earlier this year is a welcome development, this decision was only spurred by an outbreak of new HIV cases among drug users in the United States,and the delay has undoubtedly resulted in preventable HIV infections.Injecting drug users living with HIV are further denied access to treatment. And the United States and Canada, healthcare providers are less likely to prescribe ARVs for injecting drug users, because they assume that IDUs are less likely to adhere to treatment and/or will not respond to it. This is in spite of research showing similar responses and survival rates for those who do have access to ARVs.
Taming the beast
We know exactly what we have to do to tame this epidemic.
We have to empower young people and especially young girls, to make health seeking choices when thinking about sex and when engaging in it.
We have to redouble our prevention and education efforts.
Prevention remains a key necessity in all our strategies about AIDS.
Second, we have to test, test, test, test, test, test and test. We cannot promote consensual testing enough. Testing is the gateway to knowledge, power, understanding and action.
Without testing there can be no access to treatment. The more we test, the more we know and the more we can do.
Testing must always be with the consent of the person tested. But we have to be careful that we do not impose unnecessarily burdensome requirements for HIV testing.
HIV is now a fully medically manageable disease. Consent to testing should be capable of being implied and inferred. We must remove barriers to self-testing.
I speak of this with passion – because, by making it more difficult for health care workers to test, we increase the stigma and the fear surrounding HIV.
We must make it easier to test, not harder. Gone are the terrible days when testing was a gateway only to discrimination, loss of benefits and ostracism.
In all this, we must be attentive to the big understated, underexplored, under-researched issue in the epidemic. That is the effect of the internalisation of stigma within the minds of those who have HIV and who are at risk of it.
Internalised stigma has its source in outside ignorance, hatred, prejudice and fear.
But these very qualities are imported into the mind of many of us with HIV and at risk of it.
Located deeply within the self, self-blame, self-stigma and self-paralysing fear are all too often deadly.
We must recognise internalised stigma.
I experienced its frightening, deadening effects in my own life. Millions still experience it. We must talk about it. And we must find practical ways to reduce its colossally harmful effects.
And, most of all, we must fix our societies. As my friend and comrade, Mark Heywood, has recently written, we have medically tamed AIDS. But we have not tamed the social and political determinants of HIV, particularly the overlapping inequalities on which it thrives – gender, education, access to health care, access to justice. That is why prevention strategies are not succeeding.
A better response to HIV, Mark rightly says, needs a better world. Governments must deliver on their human rights obligations. Activists and scientists must join struggles for meaningful democracy, gender equality and social justice. Activists must insist on equal quality education, health and social services; investment in girls and plans backed by money to stem chronic hunger and malnutrition.
But, to end, I want to return to the light points in our struggle against the effects of this disease over the last 30 years.
I want to end with a thrilling fact – this is that, unexpectedly, joyously, beyond our wildest dreams, perinatal and paediatric ARVs have proved spectacularly and brilliantly successful.
First, let us rejoice that perinatal transmission of HIV can be completely eliminated. It was about this that the Treatment Action Campaign fought President Mbeki’s government all the way to the Constitutional Court, the Court in which I am now privileged to sit.
Now we know how effectively we can protect babies at birth and before birth from infection with HIV.
In South Africa, the rate of mother-to-child transmission of HIV is now reduced to 4%. Worldwide, in 2015, 77% of all pregnant women received treatment to prevent perinatal transmission of HIV.
Last year, Cuba became the first country to eliminate mother to child transmission of HIV entirely.In 2016, Thailand, Belarus, and Armenia have also reached this milestone.
More even, fifteen years ago we didn’t know how well babies and toddlers would tolerate ARVs.
We didn’t know just a decade ago how young children born with HIV would thrive on ARVs.
And would they take their ARVS? Would they grow to normalcy?
Instead of this uncertainty, we now know, triumphantly, that ARVs work wonderfully for children born with HIV.
I want to rejoice in the beauty and vigour of my godson Andy Morobi. Andy and I became family twelve years ago, at the end of 2004.
He is young, energetic, ambitious and enormously talented. He was born with HIV. He has been on ARVs for the last eight years. Like me, he owes his life to the medical and social miracle of anti-retroviral treatment.
I want to end on another light point. I want to honour the treatment activists from Africa, Europe, North America, South America, Australasia and Asia, who fought for justice in this epidemic.
I want to honour them, like Dr Jonathan Mann, to whom this lecture is dedicated. Like my mentor, Justice Michael Kirby of Australia, for their energy and courage and determination and sheer resourceful and resilience in fighting for justice in this epidemic.
And I want to end by celebrating the fact that we have sex workers here this morning. They are wearing the T-shirts in the slide a few minutes ago. The T-shirt say: “THIS IS WHAT A SEX WORKER LOOKS LIKE”
And, most of all, as a gay white man who has lived a life privileged by my race and my profession and my maleness, I ask that we celebrate the astonishing courage of transgender activists, of lesbians and gay men across the continent of Africa and in the Caribbean.
They are claiming their true selves. They do so often at the daily risk of violence, attack, arrest and imprisonment.
They have the right to be their beautiful selves. They are claiming a right to be full citizens of Africa, the Islands and the world. They have done so at extraordinary risk.
They know that they cannot live otherwise.
It is to these brave people that this conference should be dedicated:
To the sex workers, injecting drug users, migrants, lesbian, gays and transgendered people, the children, the activists, those in prison, the poor and the vulnerable.
It lies within our means to do everything that will ensure whole lives and whole bodies for everyone with HIV and at risk of it.
All it requires is a passion and a commitment and a courage starting within ourselves. Starting within each of ourselves. Starting now.
In the early days of the AIDS epidemic, the high price of antiretroviral medicines meant many lives were unnecessarily lost. While the global AIDS movement managed to force lower prices for key ARVs, the wider battle has not yet been won. Today, many people with hepatitis C, various cancers, drug-resistant tuberculosis and other conditions still cannot get the medicines they need to survive. This article explains the how inequality extends to drug development.
There are two broad problems with the way society currently pays for medicines.
The first, the innovation problem, is that we are not investing enough money and energy into finding treatments for diseases mostly affecting poor people. This is why most of our tuberculosis (TB) treatments today are more than fifty years old and not very good.
The second, the price problem, is that many of the medicines that are developed are sold at such high prices that people cannot afford them. This is why many people with hepatitis C cannot afford the highly effective new hepatitis C cures on the market. For these people the new cures might as well not exist.
The innovation problem
Last year, tuberculosis killed more people than any other infectious disease on the planet, including HIV. At 1.5 million deaths, it far outstripped headline-making outbreaks like Ebola (11,315 deaths in 21 months). Yet, in 2014 humanity invested less than US$700 million in TB research – only about a third of the two billion a year that the World Health Organisation estimates is required to bring an end to TB. Of this US$700 million, less than US$100 million was invested by the pharmaceutical industry. In fact, a number of large pharmaceutical companies have stopped doing TB research altogether.
The first part of this problem is simple. Since most people needing TB treatment are poor, pharmaceutical companies see little potential profit in developing new TB treatments. Companies choose rather to invest in researching medicines that will sell in rich countries – medicines for diabetes, heart disease, or erectile dysfunction.
The second part of the problem is more puzzling: given that industry does not invest, one would expect governments to step in to fill the gap. However, with the exception of the United States, governments do not. While the BRICS countries (Brazil, Russia, India, China and South Africa) have over 40% of the global TB burden, they contribute less than 4% of global investment in TB research.
The price problem
When the patent system does deliver important new medicines, as it sometimes does, those medicines are often priced out of reach for many of the people who need it. So, for example, the breakthrough hepatitis C drug sofosbuvir is priced at US$84 000 for an 84-day course. Similarly, high prices mean that women in South Africa who need the breast cancer drug trastuzumab often can’t afford its R500 000 price tag.
Companies argue that they have to ask these high prices to recoup their investment in developing the drugs and to fund their investment in developing new medicines. In recent years this argument has begun to wear very thin.
A United States senate investigation in 2014 found that the pricing of sofosbuvir had nothing to do with how much it costs to develop the drug. Rather than basing prices on the investments made into a drug, companies are typically setting prices at levels that maximise profits – even if that means many people can’t access the drug in question.
At a more fundamental level, high prices charged by pharmaceutical companies have brought into question the basic social contract between the public and the pharmaceutical industry.
The thinking is that the people, through our governments, grant patent monopolies to companies in return for investment in new medicines. However, enforcement of this social contract is very one-sided. While companies almost always get and maintain their patent monopolies, there is no enforcement of the expectation on companies to invest in research. Typically, companies invest only between 8 and 18% of revenue in research and development (R&D), while they typically spend double on marketing and advertising. In addition, the way in which companies spend their R&D funds is completely non-transparent.
All the available evidence suggests that we are not getting much bang for our buck in the current system where there is no obligation on industry to reciprocate high prices with high investment in R&D.
We have other options
Various solutions to these problems have been under discussion at the World Health Organisation (WHO) over the last decade – with very little progress to show for it. In addition, in 2015 the Secretary General of the United Nations, Ban Ki-moon, convened a High Level Panel to look at exactly these problems. Even if the HLP comes up with strong recommendations, it will be up to governments to make those recommendations a reality.
Some possible solutions include:
An R&D agreement or treaty
Given that industry is failing to invest in diseases that have an impact on poor people, governments have a responsibility to step in and fill that investment gap. One solution is an R&D treaty or agreement. Countries would all contribute to a central fund. Money in this fund would then be used to fund research in neglected areas like TB. This is a simple and workable solution. The only thing that is lacking is political will. Even if rich countries like the United States and Germany oppose such a treaty or agreement, there is nothing preventing other countries from going ahead without them.
When governments invest in research, they often do so in a way that allows companies to patent the products of that research. In this way, governments end up paying twice – once through research grants and again when paying high prices for patented medicines. If governments invest in a delinked way, they will not allow this double-payment to happen. In such a case, governments will fund research through grants and prizes and then ensure that all the research is paid for up front and that the research cost is “delinked” from the sale price of the eventual product. The so-called 3P Project (see our previous issue) is an example of a delinked model.
Bring balance to the system
International law allows for steps to be taken to balance the worst excesses or exploitation of patent monopolies. These balancing measures are commonly referred to as TRIPS flexibilities (Trade-Related Aspects of Intellectual Property Rights) and they include allowances for: compulsory licenses (overriding patents); only granting patents for truly innovative products and not for reformulations or new uses of old drugs; and for the public to file oppositions to the granting of specific patents.
The problem is that due to trade pressure from the United States Trade Representative, many countries have not written these TRIPS flexibilities into their national law – and if they have, they are often afraid to use them.
Doing away with pharmaceutical patents altogether
One of the remarkable things about the history of patents and medicines is that there is no evidence that providing increased patent protection around the world has led to greater medical advances. In fact, in the golden age of medical discovery from the 1940s to 1970s, much of the world did not offer any patent protection on medicines. There was also no increase in innovation following the TRIPS agreement in 1995, which compelled all World Trade Organisation member countries to provide for at least 20 years of patent protection.
It would of course not make sense to simply remove the patent system and not replace it with anything else. The world, after all, is in desperate need of new medicines. Governments would have to redirect the money they would have spent on purchasing patented medicines to providing research grants and sponsoring prize funds for the development of new medicines. All indications are that such a transition would in fact see R&D spending increase dramatically – given how little industry currently spends on R&D as a percentage of revenue.
Lotti Rutter is a Senior Researcher for Treatment Action Campaign
Marcus Low is an editor of Spotlight
“You are aware of the exploding prevalence of cancer around the world and in our own country. We have just moved in a circle. Just as the price of ARVs were unaffordable then, cancer drugs are devilishly unaffordable today. If no drastic action is taken today, we are going to be counting body bags like we are at war.”
Dr Aaron Motsoaledi, Health Minister of South Africa, 2016 budget vote speech. “Rationing is the ultimate consequence of high drug prices. Unsurprisingly, this is unpopular and is causing a backlash. In a number of US states, politicians are seeking to pass legislation forcing drug companies to disclose more information about the cost of producing their high-priced remedies. There is even talk of capping prices. The industry argues that such caps would drive capital out of the industry, cutting innovation and ultimately harming patients. But that is a hard argument to sustain when companies such as Gilead and Vertex are earning gross margins of 90 per cent and share prices are sky high. Pharmaceutical innovation has been one of the great successes of the past century, improving the lives of people immeasurably round the globe. But if the current dispensation is to continue, the industry must learn to price with greater restraint.”
Financial Times, August 16, 2016.
“The patent system is expensive. A decade-old study reckons that in 2005, without the temporary monopoly patents bestow, America might have saved three-quarters of its $210-billion bill for prescription drugs. The expense would be worth it if patents brought innovation and prosperity. They don’t.”
We are in a very exciting time for HIV treatment (ART) for three reasons.
South Africa, the country with the biggest HIV treatment programme, has agreed to make ART available to everyone who is living with HIV.
An important new HIV drug – called dolutegravir – is expected to be available soon in low-income countries at a low price.
Other developments may lead to treatment with only one or two drugs – instead of three, and two-monthly injections – instead of pills.
Over 17 million people with HIV are receiving ART worldwide. This is less than half of the over 36 million people living with HIV.
In 2015, the Strategic Timing of AntiRetroviral Treatment (START) and TEMPRANO studies showed the benefit of ART at all CD4 counts – even when higher than 500. This led the World Health Organisation (WHO) to recommend that everyone with HIV should start treatment. South Africa has also recently adopted this “treat all” strategy, doubling the number of HIV-positive people eligible for treatment.
The WHO also decided to recommend one main first-line combination for everyone in low- and middle-income countries (LMIC) including South Africa. This is a single pill with efavirenz (EFV), tenofovir disoproxil fumarate (TDF) and either emtricitabine (FTC), or lamivudine (3TC). This simplified first-line ART in low-and middle-income countries including South Africa.
This is a very good combination. It is good at reducing even high viral load and it has been used by millions of people for over ten years.
However, a newer combination might have fewer side effects and therefore might be better. It will also reduce viral load quicker and have less risk or drug resistance. This will use dolutegravir instead of efavirenz and a new version of TDF called TAF.
Will everyone switch to the new combination straight away?
Even though studies have already proven the advantages of the newer drugs, there are still some gaps in the studies. The needs of HIV-positive people are different in LMIC. This is because there are larger populations of women of childbearing age, children, and people with TB and other co-infections.
Data from using these newer drugs universally on these groups of people are not yet available. The studies that approved dolutegravir and TAF were run in high-income countries. Information about the dose and compatibility with other antiretrovirals were mostly gained from studies in men – and not from studies in women in countries like South Africa.
What are the new drugs and what studies are still needed?
The integrase inhibitor dolutegravir (DTG) has many properties that make it an important potential drug for use in LMIC:
It only needs a 50mg once-daily dose. This means pills can be much smaller and cheaper to produce.
It has a very high barrier to drug resistance.
It is good at reducing viral load quickly and keeping it undetectable.
It has few side effects.
It has the potential to be low-cost.
It is easy to co-formulate with other HIV drugs in a single pill.
DTG was superior to EFV in the so-called SINGLE () trial in people receiving first-line treatment. Other DTG studies have shown it to be superior – or non-inferior – to other commonly used antiretrovirals in high-income countries both in first- and second-line treatment. But DTG studies have not yet included significant numbers of people who would be treated in LMIC.
The main studies for DTG had approximately 80% men and few non-white participants. They enrolled very few people co-infected with other diseases (a few with hepatitis B and none with TB or malaria). People with drug resistance were not included (especially with resistance to NRTIs (nucleoside/nucleotide reverse transcriptase inhibitors).
Information about treating HIV/TB coinfection with a DTG-based regimen is limited.
A Phase I study in HIV-negative people showed that the TB drug rifampicin lowers drug levels of DTG. This study suggested a higher DTG dose will overcome the interaction – ie. taking 50 mg twice a day rather than once a day. Another study will give results on this strategy later in 2016. Other studies are looking at drug levels in people with TB, they could show that the current 50mg once-daily dose might be okay, despite the lower levels.
Information about DTG in pregnant women is also limited – although this is always the case with every new HIV drug. Early results suggest DTG drug levels in pregnancy are similar to those in non-pregnant adults but that they are lower compared with postpartum.
A small number of women became pregnant in the DTG studies and early-use programme, and numbers of use during pregnancy will increase in high-income countries. So far only 10 first trimester and 18 second/third trimester exposures have been reported to the Antiretroviral Pregnancy Registry (APR) of 31 July 2015. From these data there were none and one congenital defect respectively.
Several studies are planned or ongoing to look at DTG use in pregnancy.
Tenofovir alafenamide (TAF)
TAF is a new version of tenofovir and has the potential to replace TDF.
It only uses a low dose (25mg as opposed to TDF at 300mg once-daily doses).
It has lower risk of bone and kidney side effects.
The lower dose should make it less expensive than TDF.
TDF is currently the major driver of cost in LMIC generic first-line combinations. The Clinton Health Access Initiative (CHAI) estimates that TAF could lower the cost of first-line ART by as much as 50%. In South Africa this would allow a US$160 million reduction on the annual cost of ART by 2018.
As with DTG, there is currently less information about TAF with TB treatment and during pregnancy. Very few studies have used TAF in combination with DTG.
There are no data yet on interactions between TAF and rifampicin, but a significant interaction is predicted. This comes from modelling drug interactions between TAF and carbamazepine.
A drug-drug interaction study in HIV-negative participants to look at the interaction between TAF and rifampicin is being planned, followed by a study in people with TB.
Other pending studies will look at using TAF during pregnancy, including one looking at DTG and TAF together in an ART regimen in pregnant women.
How studies in South Africa will help global treatment
One very important study will start this year in South Africa. This will provide important new results for both dolutegravir and TAF.
The study – called ADVANCE will include approximately 1050 HIV positive people to compare three combinations for first-line treatment.
DTG/TAF plus FTC
DTG/TDF plus FTC
EFV/TDF plus FTC
The results will be used to decide whether DTG/TAF/FTC (or 3TC) becomes the preferred first-line in WHO guidelines.
The main results will be the proportion of people with undetectable viral load after 48 weeks, though the study will run for two years.
There will also be sub-studies that will help to address the potential issues with TB coinfection and with pregnancy.
These three study groups will clarify when dolutegravir and TAF are best used – including with each other.
The DTG/TDF/FTC arm is included in the case drug interactions between TAF and rifampicin result in different side effects or in cases there are difference in pregnant women. Having data to support DTG use with TDF will still be able to show benefits over current standard of care.
The efavirenz group is the current standard of care in first-line in all LMIC. FTC and 3TC are interchangeable in almost all guidelines. Because this combination has been so widely used, the WHO needs a large new study to prove whether newer drugs are better before guidelines can be changed.
If successful, at least one generic manufacturer has already agreed to produce the new DTG/TAF/FTC FDC at a lower price than EFV/TDF/FTC.
Other future ARVs and strategies
Several other exciting advances might offer new options for treatment.
The first of these is the potential for ART to be given by long-acting (LA) injections rather than daily pills.
This research has always created a lot of interest and two drugs in late stage development show this can work. The two drugs are a new integrase inhibitor called cabotegravir LA and NNRT called rilpivirine LA. Both drugs have produced good results as oral drugs. Both are combined into the same dual injection, which only needs to be given every two months.
There are a few important cautions to be aware of.
The first is that the injection needs quite a large volume. Currently each treatment needs several injections into the buttocks. Even though most people reported discomfort from the injection, overall people in studies were happy with results compared to taking pills.
Secondly, these drug stay in the body for a long time. This makes it important to start with oral medication in case someone has serious side effects.
Thirdly, we need to understand how to safely stop long-acting drugs in order to minimise the chance of drug resistance. This will be especially important if there are problems with drug supply.
The following three drugs are also worth watching out for:
A new entry inhibitor (called fostemsavir).
A drug from a new class – a maturation inhibitor – currently called BMS-955176.
Very early results from a compound called EFdA. This drug might be available from a slow release deport that only needs to be replaced once a year.
Finally, tentative results from several small studies suggest that the properties of dolutegravir might enable this drug to be used in a unique way.
Early results reported that some people might be able to reduce their combination to a two-drug combination of dolutegravir plus 3TC. Even more surprising was that most people kept their viral load undetectable for up to six months after switching to dolutegravir as a single drug.
Together with the discussions earlier in this article on the cost of ART and the importance of wider access to ART, if larger studies show this reduced drug strategy to be safe, this will have global implications for how ART is used.
This could result in better treatment, using fewer drugs and which is therefore also less expensive. But this definitely needs further research before anyone tries this outside of a study.
Polly Clayden is the Co-founder of i-Base and an advocate, activist and journalist.
Simon Collins is a Treatment Advocate and co-founder of HIV i-Base.