A group of infectious disease and public health experts are calling on the Department of Health and Minister Aaron Motsoaledi to reintroduce a national action plan addressing antimicrobial resistance (AMR).
An open letter from over 70 doctors, scientists and public health advisors states that antibiotic resistance is becoming a “growing threat” in the country and poses a threat to universal health coverage through the National Health Insurance.
Latest figures show that over one-million deaths a year worldwide are directly caused by AMR. This number is projected to increase. Nearly five-million people die with an antibiotic-resistant infection. Over the next 25 years, nearly 40-million people are projected to die from AMR.
The open letter also called on the department to reinstate a ministerial advisory committee on AMR or to establish a similar scientific body.
“The lack of a robust scientific advisory body limits the government’s capacity to develop evidence-based policies,” the letter reads. The establishment of a scientific body would “empower the government to make strategic, data-driven decisions to combat this pressing health threat effectively”.
The former Ministerial Advisory Committee was disbanded in November 2023.
Marc Mendelson, an infectious disease specialist at Groote Schuur Hospital who has been outspoken about the threat of AMR for many years, said: “AMR is a current pandemic which is wreaking havoc, is not being attended to properly and not being taken seriously enough in South Africa.”
Mendelson said that there are “more and more people having to be treated for highly resistant bacterial infections in our healthcare system”. AMR leads to an increase in morbidity, mortality, hospital costs, and also has socio-economic consequences, he said. Common medical interventions such as surgery “becomes much riskier” with AMR.
Department of Health spokesperson Foster Mohale said that the department would only comment once the letter was formally presented, which is expected to happen at 5pm on Thursday.
Health workers have long relied on Body Mass Index as a way to measure whether people are within a healthy weight range. Now, a collection of top researchers have made the case for a new way to understand and diagnose obesity. In part two of this special Spotlight series, we take a look at what this new framing might mean for South Africa.
If we are going to tackle the global rise in obesity, our understanding of the condition needs to change. That is according to a Lancet Commission convened by a global group of 58 experts from different medical specialties. While we have historically thought of obesity as a risk factor for other diseases like diabetes, the commission’s recent report published in the journal Lancet Diabetes and Endocrinology concludes that obesity is sometimes better thought of as a disease itself – one that can directly cause severe health symptoms (see part one of this series for a detailed discussion of this argument).
By categorising obesity as a disease, public health systems and medical aid schemes around the world would be more likely to cover people for weight-loss drugs or weight-loss surgery, according to the report. At present, these services are often only financed if a patient’s obesity has already led to other diseases. This is given that obesity is not viewed as a stand-alone chronic illness.
But if we’re going to redefine obesity as a disease, or at least some forms of it, then we need good clinical definitions and ways to measure it. For a long time, this has posed challenges, according to the Lancet report.
The perils of BMI
At present, health workers often rely on Body Mass Index (BMI) to gauge whether a patient is within a healthy weight range. BMI is measured by taking a person’s weight in kilograms and dividing it by their height in meters squared.
A healthy weight is typically considered to be between 18.5 and 25. A person whose BMI is between 25 and 30 is considered to be overweight, while someone with a BMI of over 30 is considered to have obesity. But according to the Lancet report, this is a crude measure, and one which provides very little information about whether a person is actually ill.
One basic issue is that a person can have a high BMI even if they don’t have a lot of excess fat. Instead, they may simply have a lot of muscle or bone. Indeed, the report notes that some athletes are in the obese BMI range.
Even when a high BMI does indicate that a person has obesity, it still doesn’t tell us where a person’s fat is stored and this is vital medical information. If excess fat is stored in the stomach and chest, then it poses more severe health risks than when it is stored in the limbs or thighs. This is because excess fat will do more harm if it surrounds vital organs.
The lead author of the Lancet report, Professor Frances Rubino, says that the pitfalls of BMI have long been understood, but practitioners have continued to use it.
“BMI is still by and large the most used approach everywhere, even though medical organisations have [raised issues] for quite some time,” he tells Spotlight.
“The problem is that even when we as individuals or organisations say BMI is no good, we haven’t provided an alternative. And so, inevitably, the ease of calculating BMI and the uncertainties about alternatives makes you default back to BMI.”
To deal with this problem, the report advocates for several alternative techniques for measuring obesity which offer more precision.
The first option is to use tools that directly measure body composition like a DEXA scanner. This is a sophisticated x-ray machine which can be used to distinguish between fat, bone and muscle. It can also be used to determine where fat is concentrated. It’s thus a very precise measurement tool, but the machines are expensive and the scans can be time-consuming.
Alternatively, the report recommends using BMI in combination with another measure like waist-to-hip ratio, waist-to-height ratio or simply waist circumference. If two of these alternative measures are used, then BMI can be removed from the picture.
These additional metrics are clinically useful because they provide information about where fat is stored. For instance, a larger waistline inevitably indicates a larger stomach. Indeed, studies have found that above a certain level, a larger waist circumference is linked to a higher chance of dying early, even when looking at people with the same BMI.
The report thus offers a more accurate way to measure obesity in the clinical setting. But its authors argue that this is only the first step when making a diagnosis. The second is to look at whether a patient’s obesity has actually caused health problems as this isn’t automatically the case. They acknowledge for instance that there are some people with obesity who “appear to be able to live a relatively healthy life for many years, or even a lifetime”.
The report refers to these cases as “preclinical obesity”. Such patients don’t have a disease as such, according to the report, but still have an increased risk of facing health issues in the future. As such, the report’s authors argue that they should be monitored and sometimes even treated, depending on factors like family history.
By contrast, cases of obesity which have directly caused health problems are referred to as “clinical obesity”. These cases, according to the report, should be treated immediately just like any other serious disease. It lists a series of medical symptoms associated with clinical obesity that would allow health workers to make an appropriate diagnosis.
The recommendation is thus for health workers to determine whether a person has obesity through the metrics listed above, and then to determine whether it is clinical or preclinical by evaluating a patient’s symptoms. This will inevitably guide the treatment plan.
How does this relate to SA?
Professor Francois Venter, who runs the Ezintsha research centre at WITS university, says the Lancet report offers a good starting point for South Africa, but it has to be adapted for our own needs and context.
“It’s a big step forward from BMI which grossly underdiagnoses and overdiagnoses obesity,” says Venter, who adds that additional metrics like waist circumference are a “welcome addition”.
The view that clinical obesity is a disease that needs to be immediately treated is also correct, according to Venter. Though he adds that the public health system in South Africa is not in a financial position to start handing out weight-loss medicine to everyone who needs it.
“The drugs are hugely expensive,” says Venter, “and they have side effects, so you need a lot of resources to support people taking them.” But while it may not yet be feasible to treat all cases of clinical obesity in South Africa, Venter believes we should use the diagnostic model offered by the Lancet Commission to begin identifying at least some people with clinical obesity so that they can begin treatment.
“You have to start somewhere, and for that you need a good staging system,” he says. “Let’s use the Lancet Commission and start to see if we can identify a few priority people and screen them and start to work on the drug delivery system.”
Yet while Venter believes that the commission makes important contributions, he also cautions that we need more data on obesity in Africa before we can apply all of its conclusions to our own context.
“If you go to the supplement of the Lancet Commission, there’s not a single African study there. It all comes from Europe, North America and Asia. It’s not the commission’s fault but [there is a lack of data on Africa].”
This is important as findings that apply to European or Asian populations may not necessarily hold for others. Consider the following case.
As noted, the commission states that BMI is not sufficient to determine whether someone is overweight and must therefore be complemented with other measures. But it states that if someone’s BMI is above 40 (way above the current threshold for obesity), then this can “pragmatically be assumed” without the need for further measures.
But this may not hold in Africa, says Venter.
“The commission says that if your BMI is over 40, which is very big, you can infer that this person has got obesity and they are sick and need to lose weight. I don’t know if we can say that in Africa, where we often have patients who are huge, and yet they are very active, and when you [look at] their blood pressure and all their metabolics, they’re actually pretty healthy,” he notes. “So, I think they’re sometimes jumping to conclusions about African populations that we don’t have data on,” adds Venter.
Is South Africa ready to move past BMI?
Another concern is that while the Lancet Commission may offer useful recommendations for advanced economies, its starting assumptions may not be as relevant for countries like South Africa.
For instance, while specialists agree that BMI is a crude measure of obesity, direct measures like DEXA scans are “out of our reach economically”, according to Professor Susan Goldstein, who leads PRICELESS-SA, a health economics unit at the South African Medical Research Council.
And while supplementing BMI with the other metrics like waist circumference may be doable, health experts told Spotlight that at present healthcare workers in South Africa aren’t even measuring BMI alone.
Dr Yogan Pillay, a former deputy director-general at the national health department who now runs TB and HIV delivery at the Gates Foundation, told Spotlight: “I can’t tell you how few people in the public sector have their BMI monitored at all. Community health workers are supposed to be going out and measuring BMI, but even that’s not happening”.
Goldstein also suggests that the monitoring of BMI in South Africa is limited. “If you go into the clinic for your blood pressure, do they say: ‘How’s your BMI?’ No, I doubt that,” says Goldstein. “It’s just not one of the measures that [gets done].”
She adds that South Africa could introduce the combination of metrics proposed by the commission, like waist circumference combined with BMI, but says it would simply require “a lot of re-education of health workers”.
Prevention vs treatment
For Goldstein, the commission is correct to regard clinical obesity as a disease which needs to be treated, but we also shouldn’t view medication as the only way forward.
“We have to remember that prevention is very important,” says Goldstein. “We have to focus on food control, we have to look at ultra-processed foods, and unless we do that as well [in addition to medication] we are going to lose this battle.”
The National Health Department already has a strategy document for preventing obesity, but some of its recommendations have been critiqued for focusing on the wrong problems. For instance, to prevent childhood obesity, the strategy document recommends reforming the Life Orientation curriculum and educating tuck shop vendors so that both students and food sellers have more information about healthy eating. But as Spotlight previously reported, there are no recommendations to subsidise healthy foods or to increase their availability in poor areas, which several experts believe is more important than educational initiatives.
Venter also highlights the importance of obesity prevention, though he emphasises that this shouldn’t be in conflict with a treatment approach – instead, we need to push for both.
“The [prevention] we need to do is fix the food supply… and the only way you do that is to decrease the cost of unprocessed food.” But while this may help prevent future cases of obesity, it doesn’t help people who are already suffering from obesity, says Venter. And since such people comprise such a large share of the population, we can’t simply ignore them, he says.
“Even if you fix the entire food industry tomorrow, those [people who are already obese] are going to remain where they are because simply changing your diet isn’t going to do diddly squat [when you already have obesity],” he adds. (Part 1 discusses this in more detail).
Goldstein adds that increasing access to treatment would also inevitably reduce the costs of “hypertension, diabetes, osteoarthritis, and a whole range of other illnesses if it’s properly managed”.
One way to advance access to medication would be for the government to negotiate reduced prices of GLP-1 drugs, she says. (Spotlight previously reported on the prices and availability of these medicines in South Africa here.)
Funding
A final concern that has been raised about the Lancet commission is about its source of funding.
“I don’t know how one gets around this,” says Goldstein, “but there were 58 experts on the commission, 47 declared conflicts of interest.”
Indeed, the section of the commission that lists conflicts of interest spans over 2 000 words (roughly the size of this article). This includes research grants and consulting fees from companies like Novo Nordisk and Eli Lilly, which produce anti-obesity drugs.
In response, Rubino told Spotlight that “people who work in the medical profession obviously work and consult, and the more expertise they have, the more likely they are to be asked by somebody to advise. So sometimes people have contracts to consult a company – but that doesn’t mean that they necessarily make revenue if the company has better sales. You get paid fees for your services as a consultant”.
Rubino says this still has to be declared as it may result in some bias, even if it is unconscious, but “if you wanted to have experts who had zero relationship [to companies] of any sort then you might have to wonder if there is expertise available there… the nature of any medical professional is that the more expertise they have, the more likely that they have engaged in work with multiple stakeholders”.
For Venter, there is some truth to this. “It’s very difficult to find people in the obesity field that aren’t sponsored by a drug company,” he says. “Governments don’t fund research… and everyone else doesn’t fund research. Researchers go where the research is funded.”
This doesn’t actually solve the problem, says Venter, as financing from drug companies can always influence the conclusions of researchers. It simply suggests that the problem is bigger than the commission. Ultimately, he argues that the authors should at least be applauded for providing such granular details about conflicts of interest.
Rubino adds that while researchers on the commission may have historically received money from drug companies for separate research studies or consulting activities, none of them received money for their work on the commission itself.
“This commission has been working for more than four years since conception… An estimate of how many meetings we had is north of 700, and none of us have received a single penny [for doing this],” he says.
Disclosure: The Gates Foundation is mentioned in this article. Spotlight receives funding from the Gates Foundation but is editorially independent – an independence that the editors guard jealously. Spotlight is a member of the South African Press Council.
Neisseria gonorrhoeae Bacteria Scanning electron micrograph of Neisseria gonorrhoeae bacteria, which causes gonorrhea. Captured by the Research Technologies Branch (RTB) at the NIAID Rocky Mountain Laboratories (RML) in Hamilton, Montana. Credit: NIAID. Photo by National Institute of Allergy and Infectious Diseases on Unsplash
By Catherine Tomlinson
Two new antibiotics offer hope for people with gonorrhoea that is resistant to currently available drugs. Yet, it might be years before the people who need these medicines can get them. Spotlight unpacks why these new antibiotics are important and what needs to happen before they can be used in South Africa.
Gonorrhoea is a sexually transmitted infection known for its ability to quickly mutate to evade the antibiotics used to treat it. Its symptoms include pain when urinating and genital discharge, but many people don’t notice any symptoms at all. If gonorrhoea is not treated, it can cause serious problems including infertility, chronic pain and complications in babies who risk developing infections that can cause eye damage and blindness.
Gonorrhoea treatment has been something of a cat-and-mouse game as the bacteria continuously developed resistance against the antibiotics used to treat it. From the 1990s to the early 2000s, the antibiotic ciprofloxacin was used to treat gonorrhoea in South Africa, sometimes combined with another one called doxycycline. But as high levels of ciprofloxacin resistance emerged, South Africa replaced this course of therapy with a regimen of cefixime and doxycycline. Gonorrhoea treatment was changed again in 2015, due to concerns regarding the emergence of cefixime-resistance.
The treatment regimen adopted in 2015 remains the standard of care in South Africa and much of the world today. It involves an intermuscular injection of ceftriaxone, combined with oral azithromycin pills. Although, some countries now recommend using high dose injectable ceftriaxone on its own, due to high levels of azithromycin resistance.
While most gonorrhoea cases are still treatable with ceftriaxone, the emergence of ceftriaxone-resistant gonorrhoea has been identified as a major global health threat.
“The last effective drug we have, ceftriaxone, already indicates increasing gonococcal resistance. Without new antibiotics, we will have no easy treatment options. This is a great concern that will have a major impact in disease control efforts,” warned the World Health Organization (WHO).
This is why two new antibiotics, zoliflodacin and gepotidacin, are considered such a big deal. They are the first new medicines developed for gonorrhoea in over 30 years. Both are in new classes of antibiotics, which is to say they attack the bacterium in a different way than previous medicines. Because of this, they have little cross resistance with existing treatments and therefore offer important treatment options for people for whom the old medicines no longer work.
How widespread is ceftriaxone-resistance in South Africa?
How urgently we need access to the new medicines in South Africa will depend largely on how many people here are resistant to ceftriaxone. Unfortunately, we don’t have a clear picture of drug-resistant gonorrhoea in the country.
South Africa introduced a syndromic management approach for sexually transmitted infections (STIs) in the mid-1990s, as recommended by the WHO. This means that people reporting STI symptoms at health facilities are treated according to their symptoms, rather than results of a lab test.
This approach to STIs helps to reduce the cost burden of laboratory diagnosis and allows for immediate treatment initiation without waiting for laboratory results since some patients are “lost” over this period as they do not return to health facilities for their test results and treatment.
A challenge with treating STIs according to symptoms rather than laboratory results is that many STIs present with similar symptoms. This can lead to misdiagnosis and incorrect treatment as well as asymptomatic infections going undiagnosed and untreated.
Thus, without lab testing, combined with routine STI screening to identify asymptomatic cases, it is difficult to understand the true burden of gonorrhoea in the country or to measure the extent of drug resistance.
A systematic review, however, indicates that while azithromycin resistance is a challenge in South Africa, there was not yet evidence of ceftriaxone resistance as of 2022.
The National Institutes of Communicable Diseases (NICD) classified ceftriaxone-resistant gonorrhoea a notifiable condition in 2017, meaning that any diagnosed cases must be reported to it. The NICD did not respond to a query from Spotlight as to whether there have been any confirmed cases of ceftriaxone-resistant gonorrhoea in South Africa to date.
While South Africa is not yet facing a ceftriaxone-resistance crisis, experts are of the view that it is only a matter of time before this public health challenge reaches our borders, as global cases are increasing and the drug-resistant strain is transmittable.
Some access to zoliflodacin
Given the risk of a ceftriaxone-resistance crisis, it is important that the two new antibiotics, zoliflodacin and gepotidacin, become available here as soon as possible. These new antibiotics have quite different histories.
Zoliflodacin was developed by GARDP – a non-profit organisation working to accelerate the development of new antibiotics – together with the private biopharmaceutical company Innoviva.
In November 2023, GARDP shared the results of its phase 3 trial of zoliflodacin, which took place in South Africa, Thailand, Belgium, the Netherlands and the United States. It tested the effectiveness of a single dose of oral zoliflodacin compared with the current standard of care treatment for gonorrhoea, which is an injection of ceftriaxone combined with oral azithromycin.
The trial showed that a single dose of zoliflodacin works just as well as the standard of care. The results have not yet been published in a peer-reviewed journal.
Zoliflodacin has also “been shown to be active against all multidrug-resistant strains of Neisseria gonorrhoeae (the gonorrhoea bacteria), including those resistant to ceftriaxone, the last remaining recommended antibiotic treatment”, GARDP’s R&D Project Leader for STIs, Pierre Daram, told Spotlight.
He added that Innoviva is in the process of applying to get the greenlight to use zoliflodacin in the United States. At the same time, GARDP is planning to apply for approval in some of its own regions, starting with Thailand and South Africa.
GARDP is also working on a programme to make the unregistered drug available for patients who have no other treatment options.
“The zoliflodacin managed access programme is about to be activated,” Daram said. “The aim is to provide early access to zoliflodacin, prior to regulatory approval in a country, in response to individual patient requests by clinicians and whereby certain regulatory and clinical criteria are met.” South Africa will be one of the countries covered under this programme, said Daram.
He explained that individual patient requests for treatment will be received from treating clinicians through an online platform. “Based on information provided by the clinician and certain pre-determined regulatory and clinical criteria being met, GARDP will make a case-by-case decision as to whether zoliflodacin will be made available.” Daram added: “Consideration is given to both clinical as well as diagnostic criteria for documentation of treatment failure.”
Access to gepotidacin remains uncertain
Shortly after results for zoliflodacin were announced, GlaxoSmithKline (GSK) also shared positive findings for their new antibiotic in treating gonorrhoea. In April 2024, the company reported that a phase 3 trial showed that taking two doses of oral gepotidacin worked just as well as the standard treatment.
The results of this trial, which was conducted in Australia, Germany, Mexico, Spain, the United Kingdom, and the United States, were published in the Lancet medical journal in May.
While gepotidacin represents an important new treatment option for gonorrhoea, there is no indication that it will be available in South Africa any time soon.
Gepotidacin has not yet been registered for the treatment of gonorrhoea but was approved in March in the United States for treating uncomplicated urinary tract infections (UTIs) in women and girls over 12. The medicine will thus have a much larger market in the US than if it was only registered for treating gonorrhoea.
The price that GSK will charge for gepotidacin has not yet been disclosed, but a spokesperson told Spotlight it is set to be launched in the US in the second half of 2025.
“[T]he price in the US will be disclosed when the product will be commercialized,” said the GSK spokesperson.
The company did not respond to Spotlight’s questions regarding the company’s plans to register and market gepotidacin in South Africa.
What happens next?
With the launch of the zoliflodacin managed access programme, clinicians in South Africa will soon be able to apply for the medicine for patients that are resistant to existing drugs. Given that ceftriaxone-resistance is rare in the country, the number of patients in the country that will be eligible for zoliflodacin is likely to be small.
Securing broader access to zoliflodacin or gepotidacin, potentially for use as a first line gonorrhoea treatment appears to be a long way off. While GARDP is planning to file for registration of zoliflodacin in South Africa, GSK has not indicated whether they will follow suit for gepotidacin.
Providing the new antibiotics for first line gonorrhoea treatment could expand delivery and uptake, as the new drugs are both oral tablets and would remove the need for an injection to treat gonorrhoea, said Professor Nigel Garrett, who is the Chief Scientific Officer at the Desmond Tutu Health Foundation.
If zoliflodacin and gepotidacin are approved and made affordable in South Africa, they could also play a vital role in strengthening the country’s efforts to preserve the long-term effectiveness of other antibiotics.
Ceftriaxone “is a really important drug to keep, [to] make sure that there isn’t too much resistance against it,” Garret told Spotlight. He explained that the medicine is needed to treat sepsis occurring in hospitals, as well as meningitis.
There are two vaccines against shingles – an often painful and debilitating condition caused by the same virus that causes chickenpox – but neither are available in South Africa. Photo by Mika Baumeister on Unsplash
By Catherine Tomlinson
The only shingles vaccine on the market in South Africa was discontinued last year. A newer and better vaccine is being used in some other countries, but has not yet been registered in South Africa, though it can be obtained by those with money who are willing to jump through some hoops.
Shingles is a common and painful condition that mostly affects the elderly and people with weakened immune systems. It generally appears with a telltale red rash and cluster of red blisters on one side of one’s body, often in a band-like pattern.
“Shingles is pretty awful to get – it’s extremely painful, and some people can get strokes, vision loss, deafness and other horrible manifestations as complications,” said infectious disease specialist Professor Jeremy Nel. “Shingles really is something to avoid, if at all possible,” he added.
One way to prevent the viral infection is by getting vaccinated against it. But while two vaccines against shingles have been developed and broadly used in the developed world, neither of these are currently available in South Africa.
Two vaccines
Zostavax, from the pharmaceutical company MSD, was the first vaccine introduced to prevent shingles. It was approved for use in the United States in 2006 and in South Africa in 2011. It is 51% effective against shingles in adults over 60.
A more effective vaccine, Shingrix, that is over 90% effective in preventing shingles was introduced by GlaxoSmithKline (GSK) in the United States in 2016. It is not yet authorised for use in South Africa, but GSK has submitted paperwork for approval with the South African Health Products Regulatory Authority (SAHPRA), said the company spokesperson, Kamil Saytkulov.
The superior protection offered by Shingrix compared to Zostavax quickly made it the dominant shingles vaccine on the market. As a result, MSD discontinued the production and marketing of Zostavax. MSD spokesperson Cheryl Reddy said Zostavax was discontinued globally in March 2024. Before then, the vaccine was sold in South Africa’s private healthcare system for about R2 300, but it was never widely available in government clinics or hospitals.
No registered and available vaccine
Since Zostavax has been discontinued and Shingrix remains unregistered, the only way to access a vaccine against shingles in South Africa is by going through the onerous process of applying to SAHPRA for a Section 21 authorisation – a legal mechanism that allows the importation of unregistered medicines when there is an unmet medical need.
“Access will only be available to those who are able to get Section 21 approval” and “this is a costly and time-consuming process, requiring motivation by a doctor,” said Dr Leon Geffen, director of the Samson Institute For Ageing Research.
The cost of the two-dose Shingrix vaccine imported through Section 21 authorisations is currently around R15 600, said Dr Albie de Frey, CEO of the Travel Doctor Corporation.
People who do go through the effort of getting Section 21 authorisation typically have to pay this price out of their own pockets.
“Shingrix is not covered [by Discovery Health] as it is unregistered in South Africa and is therefore considered to be a General Scheme Exclusion,” Dr Noluthando Nematswerani, Chief Clinical Officer at Discovery Health, told Spotlight.
The Department of Health did not respond to queries regarding whether Section 21 processes are being pursued for priority patients in the public sector or whether there has been any engagement with GSK regarding the price of this product.
People who receive organ transplants, for example, should be prioritised to receive the shingles vaccine as the medications they are given to suppress their immune system puts them at a high risk of developing shingles.
Why is the price of Shingrix so high?
Unlike South Africa, where companies must sell pharmaceutical products at a single, transparent price in the private sector, the United States has no such requirement. Even so, the US Centers for Disease Control and Prevention (CDC) pays $250 or R4600 for the two-dose Shingrix vaccine through CDC contracts. This is less than a third of the price charged when Shingrix is imported into South Africa.
Equity Pharmaceuticals, based in Centurion in Gauteng, is importing GSK’s Shingrix for patients that receive Section 21 authorisations to use the unregistered vaccine. It is unclear what price Equity Pharmaceuticals is paying GSK for Shingrix to be imported into South Africa under Section 21 approvals, or what Equity Pharmaceuticals’ mark up on the medicine is.
When asked about the price of Shingrix in South Africa, Saytkulov told Spotlight: “Equity Pharmaceuticals is not affiliated with GSK nor is it a business partner or agent of GSK. Therefore, we cannot provide any comments with regards to pricing of a non-licensed product, which has been authorized for importation through Section 21.”
Equity Pharmaceuticals also said it was difficult to comment on the price. “The price of a Section 21 product depends on a number of fair considerations, including the forex rate, the quantity, transportation requirements, and the country of importation. Once the price and lead time are defined for an order, the information is shared with the healthcare provider to discuss with their patient and the medical aid,” the company’s spokesperson Carel Bouwer told Spotlight
Nematswerani pointed out that “Section 21 pricing is not regulated” and that price can change due to many factors including supplier costs, product availability, and inflation.
What causes shingles?
Shingles is caused by the same highly infectious virus that causes chickenpox. Most people are infected with the varicella-zoster virus (VZV) during childhood. Chickenpox occurs when a person is first infected by VZV. When a person recovers from chickenpox, the VZV virus remains dormant in their body but can reactivate later in life as one’s immune system weakens. This secondary infection that occurs, typically in old age when the dormant virus reactivates, is called shingles.
People who were naturally infected with chickenpox, as well as those vaccinated against chickenpox with a vaccine containing a weakened form of the VZV virus, can get shingles later in life.
But, people who were vaccinated against chickenpox have a significantly lower risk of developing shingles later in life compared to those who naturally contracted chickenpox, according to the World Health Organization (WHO).
The chickenpox vaccine is available in South Africa’s private sector but is not provided in the public sector as part of government’s expanded programme on immunisation. Chickenpox is usually mild in most children, but those with weakened immune systems at risk of severe or complicated chickenpox should be vaccinated against it, said Professor James Nuttall, a paediatric infectious diseases sub-specialist at the Red Cross War Memorial Children’s Hospital and the University of Cape Town.
Who should be vaccinated against shingles?
South Africa does not have guidelines regarding who should receive the shingles vaccine and when they should receive it. The US CDC recommends that all adults over 50 receive the two-dose Shingrix vaccine. They also recommend that people whose immune systems can’t defend their body as effectively as it should, like those living with HIV, should get the vaccine starting from age 19.
While Shingrix works better than Zostavax at preventing shingles, it has other advantages that make it a safer and better option for people with weak immune systems.
The Zostavax vaccine contains a weakened live form of the VZV virus and thus poses a risk of complications in people with severely weakened immune systems. “In the profoundly immunosuppressed, the immune system might not control the replication of this weakened virus,” explained Nel. The Shingrix vaccine does not contain any live virus and therefore does not present this risk.
In March 2025, the WHO recommended that countries where shingles is an important public health problem consider the two-dose shingles vaccine for older adults and people with chronic conditions. “[T]he vaccine is highly effective and licensed for adults aged 50 years and older, even if they’ve had shingles before,” according to the WHO. It advised countries to look at how much the vaccine costs compared to the benefits before deciding to use it.
The cost of not vaccinating against shingles
The cost of not vaccinating against shingles is high for people who develop the condition, as well as the health system.
“[T]he risk of getting shingles in your lifetime is about 20 to 30%…by the age of 80 years, the prevalence is almost 50%,” said Geffen. “Shingles is often a painful debilitating condition, with significant morbidity. It can result in chronic debilitating pain which affects sleep, mood and overall function,” he added.
Beyond preventing shingles and its complications, new evidence suggests that getting the shingles vaccine may also reduce one’s risk of developing dementia and heart disease.
In April, a large Welsh study published in Nature reported that people who got the Zostavax vaccine against shingles were 20% less likely to develop dementia seven years after receiving the vaccine compared to those who were not vaccinated.
In May, a South Korean study published in the European Heart Journal reported that people vaccinated against shingles had a 23% lower risk of cardiovascular events, such as strokes or heart disease for up to eight years after vaccination.
Professor Adrie Bekker explains the findings of a study on two novel formulations for the administration of dolutegravir in babies born to mothers living with HIV. (Photo: Biénne Huisman/Spotlight)
By Biénne Huisman
Research led by Professor Adrie Bekker is paving the way for an important HIV medicine to be made available to neonates in a way that is both safe and much more convenient than previous options. Spotlight met with the passionate clinician-scientist at her office in Cape Town.
Two new ways of giving the important HIV medicine dolutegravir to newborn babies have been found to be safe and effective, according to new research done in Cape Town. The new findings support for the first time the broader use of dolutegravir in infants who are less than 28 days old.
Dolutegravir is recommended by the World Health Organization (WHO) for infants, children and adults and is the preferred HIV medicine in South Africa. It exists in a scored 10 milligram child-friendly dispersible tablet. But until now, there hasn’t been any guidance on how to safely use it for newborns in their first four weeks of life. A study called PETITE-DTG aimed to bridge this critical gap in neonatal HIV care.
Forty-one full-term babies, each weighing at least 2 kilograms and born to mothers receiving dolutegravir-based HIV treatment, were enrolled in the study at Tygerberg Hospital to test two paediatric formulations of dolutegravir.
The first method involved using a 5 milligram dispersible tablet dissolved in 5 millilitres of water and given every second day for the first 14 days of life, then once daily until the baby was four weeks old. This was administered with a syringe.
The second method involved using a novel 5 milligram mint-flavoured film the size of a fingernail that dissolves on the tongue in seconds. It followed the same dosing schedule as the first method.
Findings showed that both formulations were safe and effective, achieving drug concentrations comparable to adults receiving 50 milligram of dolutegravir twice daily.
The study’s findings were presented at the Conference on Retroviruses and Opportunistic Infections in March. Researchers are currently writing up the final results of the study for publication in a peer-reviewed medical journal.
Professor Adrie Bekker, a neonatologist from the University of Stellenbosch is co-principal investigator of the PETITE-DTG study alongside Dr Tim Cressey, a clinical pharmacologist from the University of Chiang Mai in Thailand.
“The study results confirmed that the regimen [both 5 milligram dolutegravir formulations] was safe, effective, and highly acceptable to mothers, with the dolutegravir film being particularly easy to administer,”
says Bekker, speaking to Spotlight in her office at Stellenbosch University’s medical campus next to Tygerberg Hospital.
In examining dosing safety and efficacy, she says that the study found that both formulations “achieved target concentrations” in the neonates, without the newborn babies experiencing any adverse effects related to the medicine. All neonates were HIV negative at the end of the study.
Babies born to a mother living with HIV may need antiretroviral medicines for the prevention or treatment of HIV. Bekker explains that neonates are currently given an older type of liquid HIV medication that doesn’t taste good, costs more than dolutegravir, is harder to give properly, and can’t be stored for long.
The novel film method was popular with mums in the study, who cited its simplicity of administering and dose accuracy as highly advantageous, with no risk of the medicine being spit out or other spillage.“I wash and dry my hands and I cut the paper, it’s quick. As soon as I put it on his tongue, it just dissolves in a few seconds, he enjoys it,” said one mother, as quoted on a poster highlighting the results of the study.
Commenting on the film strip, Bekker notes it is one of the least disruptive ways to give medication.
“So what has been amazing to me is that the babies seem to be completely oblivious of what is happening when the mother puts the film in their mouth,” she says pointing out a video clip on her desktop of a film strip being placed in a tiny baby’s mouth.
“If they were crying, they would just keep on crying. If they were sleeping, they would just keep on sleeping. If they were happy, they would just keep on being happy. It really is the most unintrusive way of administering medication.”
Bekker says the colourless dolutegravir film is made by the Indian multinational pharmaceutical company Laurus Labs. Previously, it had only been tested in adults and is not yet commercially available. “It’s actually never even been used in children…And so our study for the first time tested the dolutegravir film in newborns to see what drug levels are found in a baby when you use it,” she says.
She says the research findings have been presented to the World Health Organization (WHO) and expects they will be included in the organisation’s upcoming updated dosing guidelines for infants and children.
Commenting on dolutegravir for neonates, Bekker says: “I think the first step is to actually get this recommendation into the WHO guidelines. As soon as the WHO releases their updated HIV guidelines, then countries can decide whether they want to adopt it or not.”
Commenting on the availability and possible roll-out of dolutegravir for neonates, she adds: “The generic 10 milligram dolutegravir scored dispersible tablet is already available and being used in children. What we’ve shown now is that 5 milligram of dolutegravir with this dosing strategy is safe for neonates…The film is a bit more complicated because it is not yet commercially available. And we don’t know the price of the drug; all of that will need to be discussed and negotiated with the company and relevant parties before it can become available.”
The PETITE-DTG research has been welcomed by fellow scientists.
“Adrie Bekker and her colleagues at Tygerberg Hospital and in Thailand have done great work and are really moving the field forward for neonatal antiretroviral treatment,” says Associate Professor James Nuttall, a paediatric infectious diseases sub-specialist at the Red Cross War Memorial Children’s Hospital and the University of Cape Town.
He says the research “provides really nice information about how we could use our existing drugs to treat neonates, potentially”.
Nuttall described the new film as extraordinary, and suggested that it might eventually replace the current drug formulations.
For Nuttall though, making provision for using a pill like the scored 10 milligram dispersible tablet that’s already available and routinely used to treat children in South African hospitals is more immediately relevant. “Using this 5 milligram dispersible tablet in neonates and working out the dosing schedule for that, that’s the real advance of this study to me, the big win.”
He anticipates these findings to be implemented in South Africa in the next few years. “From what I understand, she [Bekker] has presented this to WHO already. And once it gets accepted and included into WHO guidelines, then countries tend to really take note and follow, that’s when it makes its way into national guidelines…”
While the study focused on healthy full-term babies weighing at least two kilograms, Nuttall noted that many babies born to mothers living with HIV are either premature or have low birth weight. “So this dosing and safety information doesn’t yet apply to those children,” he said.
Bekker already has her eye set on assessing dosing safety for pre-term newborns. “So obviously our dream is to extend this to pre-term babies,” she says. “And there is a possibility that a 2.5 milligram dolutegravir film may be a good dose for pre-term neonates. Obviously, that will have to be studied very rigorously first.”
Other research goals include the hope of being involved in studies assessing long-acting antiretroviral drugs in neonates. Bekker notes that the WHO-led Paediatric Drug Optimisation group identified long-acting cabotegravir injectables as a high research priority for HIV prevention in neonates. She adds that developing patches with tiny microneedles that deliver HIV medication could hold great promise for treating newborns in the future.
Commenting on the PETITE-DTG study, Dr Moherndran Archary, who has been at the forefront of South Africa’s HIV response for children, said: “Professor Bekker’s research has directly impacted access to life-saving HIV medication for newborn infants – the most vulnerable of populations who have not traditionally benefited from the significant advances in HIV treatment.”
The PETITE-DTG study is one of many under the Unitaid-funded BENEFIT Kids project aiming to improve treatment for children with HIV or multidrug-resistant tuberculosis. UNITAID is a global health initiative that, amongst others, funds research and helps facilitate the more rapid introduction of new health technologies.
Mycobacterium tuberculosis drug susceptibility test. Photo by CDC on Unsplash
By Catherine Tomlinson
Health research in South Africa has been plunged into crisis with the abrupt termination of several large research grants from the US, with more grant terminations expected in the coming days and weeks. Professor Ntobeko Ntusi, head of the South African Medical Research Council, tells Spotlight about efforts to find alternative funding and to preserve the country’s health research capacity.
Health research in South Africa is facing an unprecedented crisis due to the termination of funding from the United States government. Though exact figures are hard to pin down, indications are that more than half of the country’s research funding has in recent years been coming from the US.
Many health research units and researchers that receive funding from the US National Institutes of Health (NIH) have in recent weeks been notified that their grants have been terminated. This funding is being slashed as part of the efforts by US President Donald Trump’s administration to reduce overall federal spending and end spending that does not align with its political priorities.
Specifically, the administration has sought to end spending supporting LGBTQ+ populations and diversity, as well as equity and inclusion. As many grants for HIV research have indicators of race, gender, and sexual orientation in their target populations and descriptions, this area of research has been particularly hard hit by the cuts. There have also been indications that certain countries, including South Africa and China, would specifically be targeted with NIH cuts.
On 7 February, President Donald Trump issued an executive order stating that the US would stop providing assistance to South Africa in part because it passed a law that allowed for the expropriation of land without compensation, and separately because the South African government took Israel to the International Court of Justice on charges of genocide in Gaza.
Prior to the NIH cuts, some local research funded through other US entities such as the US Agency for International Development (USAID), and the Centers for Disease Control and Prevention (CDC) were also terminated.
How much money is at risk?
“In many ways the South African health research landscape has been a victim of its own success, because for decades we have been the largest recipients of both [official development assistance] funding from the US for research [and] also the largest recipients of NIH funding outside of the US,” says president and CEO of the SAMRC Professor Ntobeko Ntusi.
Determining the exact amount of research funds we get from the US is challenging. This is because funding has come from several different US government entities and distributed across various health research organisations. But the bulk of US research funding in South Africa clearly came from the NIH, which is also the largest funder of global health research.
According to Ntusi, in previous years, the NIH invested, on average, US$150 million – or almost R3 billion – into health research in South Africa every year.
By comparison, the SAMRC’s current annual allocation from government is just under R2 billion, according to Ntusi. “Our baseline funding, which is what the national treasury reflects [approximately R850 million], is what flows to us from the [Department of Health],” he says, adding that they also have “huge allocations” from the Department of Science, Technology and Innovation. (Previous Spotlight reporting quoted the R850 million figure from Treasury’s budget documents, and did not take the additional funds into account.)
How is the SAMRC tracking US funding terminations
Ntusi and his colleagues have been trying to get a clearer picture of the exact extent and potential impacts of the cuts.
While some US funding given to research units in South Africa flows through the SAMRC, the bulk goes directly to research units from international research networks, larger studies, and direct grants. Keeping track of all this is not straight-forward, but Ntusi says the SAMRC has quite up to date information on all the terminations of US research awards and grants.
“I’ve been communicating almost daily with the deputy vice-chancellors for research in all the universities, and they send me almost daily updates,” says Ntusi. He says heads of research units are also keeping him informed.
According to him, of the approximately US$150 million in annual NIH funding, “about 40%…goes to investigator-led studies with South Africans either as [principal investigators] or as sub-awardees and then the other 60% [comes from] network studies that have mostly sub-awards in South Africa”.
Figures that Ntusi shared with Spotlight show that large tertiary institutions like the University of the Witwatersrand, the University of Cape Town, and the University of Stellenbosch, could in a worst case scenario lose over R200 million each, while leading research units, like the Desmond Tutu Health Foundation and the Centre for the AIDS Programme of Research in South Africa, could each lose tens of millions. The SAMRC figures indicate that while many grants have already been terminated, there are also a substantial number that have not been terminated.
Where will new money come from?
Ntusi says the SAMRC is coordinating efforts to secure new funding to address the crisis.
“We have been leading a significant fundraising effort, which…is not for the SAMRC, but for the universities who are most affected [and] also other independent research groups,” he says. “As the custodian of health research in the country, we are looking for solutions not just for the SAMRC but for the entire health research ecosystem.”
Ntusi explains that strategically it made more sense to have a coordinated fundraising approach rather than repeating what happened during COVID-19 when various groups competed against each other and approached the same funders.
“Even though the SAMRC is leading much of this effort, there’s collective input from many stakeholders around the country,” he says, noting that his team is in regular communication with the scientific community, the Department of Health, and Department of Science, Technology and Innovation.
The SAMRC is also asking the Independent Philanthropic Association of South Africa, and large international philanthropies for new funding. He says that some individuals and philanthropies have already reached out to the SAMRC to find out how they can anonymously support research endeavours affected by the cuts.
Can government provide additional funds?
Ntusi says that the SAMRC is in discussions with National Treasury about providing additional funds to support health researchers through the funding crisis.
The editors of Spotlight and GroundUp recently called on National Treasury to commit an extra R1 billion a year to the SAMRC to prevent the devastation of health research capacity in the country. They argued that much larger allocations have previously been made to bail out struggling state-owned entities.
Government has over the last decade spent R520 billion bailing out state-owned entities and other state organs.
How will funds raised by the SAMRC be allocated?
One dilemma is that it is unlikely that all the lost funding could be replaced. This means tough decisions might have to be made about which projects are supported.
Ntusi says that the SAMRC has identified four key areas in need of support.
The first is support for post-graduate students. “There’s a large number of postgraduate students…who are on these grants” and “it’s going to be catastrophic if they all lose the opportunity to complete their PhDs,” he says.
Second is supporting young researchers who may have received their first NIH grant and rely entirely on that funding for their work and income, says Ntusi. This group is “really vulnerable [to funding terminations] and we are prioritising [their] support…to ensure that we continue to support the next generation of scientific leadership coming out of this country,” he says.
A third priority is supporting large research groups that are losing multiple sources of funding. These groups need short-term help to finish ongoing projects and to stay afloat while they apply for new grants – usually needing about 9 to 12 months of support, Ntusi explains.
The fourth priority, he says, is to raise funding to ethically end clinical and interventional studies that have lost their funding, and to make sure participants are connected to appropriate healthcare. Protecting participants is an important focus of the fundraising efforts, says Ntusi, especially since many people involved in large HIV and TB studies come from underprivileged communities.
Ultimately, he says they hope to protect health research capacity in the country to enable South African health researchers to continue to play a meaningful and leading role in their respective research fields.
“If you reflect on what I consider to be one of the greatest successes of this country, it’s been this generation of high calibre scientists who lead absolutely seminal work, and we do it across the entire value chain of research,” says Ntusi. “I would like to see…South Africa [continue to] make those meaningful and leading pioneering contributions.”
For centuries, it was believed that tuberculosis spread primarily when a vulnerable person spends hours in a poorly ventilated space with someone infectious. But new findings suggest that much TB transmission also occurs through casual contact.
Conventional thinking held that enclosed spaces such as households, prisons, and shelters, where people spent long periods of time together, were where most TB transmission took place. But new data suggest that casual contact at social settings like shopping malls, restaurants, bars, and places of worship also account for much TB transmission.
A recent study found that close contact explained only 9% of TB transmission links, while casual contact accounted for 49%. The study, called CONTEXT (Casual Contact and Migration in XDR TB), was conducted in KwaZulu-Natal.
The study’s lead author, Professor Neel Gandhi of Emory University in Atlanta, recently presented the findings at the Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco. The work has not yet been published in a peer-reviewed medical journal.
The new findings come in the context of other research (much of which was conducted in Cape Town) that suggest TB could be transmitted through breathing, and growing evidence that people with asymptomatic TB can transmit the infection.
Where transmission occurs
Gandhi tells Spotlight that TB transmission has traditionally been linked to prolonged, close contact, with previous studies showing that 9 to 30% of cases could be attributed to this type of contact. A compelling alternative argument, he says, is that the remaining 70% of transmission occurs due to casual contact in community settings – which is what their research sought to explore.
He elaborates: “For much of history, we have thought that most TB transmission occurs through close and prolonged contact, meaning that a susceptible person is spending a lot of time in a poorly ventilated area with somebody who is infectious. And so most often we think of households as places where transmission occurs; or congregate settings, places like prisons or homeless shelters.”
On defining casual contact, he says: “In our research, we wanted to understand less intense forms of contact where transmission can occur. So, we understood where people lived, but we also asked them where they spent time in a typical week. The phrase we used was: ‘where do you spend two hours or more, most weeks?’ To try to identify the places people spend substantial amounts of time; and seeing whether they crossed paths with somebody else to whom their molecular fingerprints (of their TB bacteria infection) match.”
Genotyping, and geomapping
In their study, Gandhi and his colleagues made use of both genotyping and geospatial mapping to figure out where TB transmission likely occurred.
Genotyping, explains Gandhi, is a technology developed about 30 years ago that allows us to examine the genetic code of TB bacteria, and to compare similarity between patients’ bacteria.
“TB is a bacteria that keeps its genetic code similar across many generations of replication. In layman’s terms, we call this molecular fingerprinting. If I were to transmit TB to somebody else; my TB bacteria and that person’s TB bacteria’s genetic codes would look very similar – almost identical – so we could use this fingerprinting technique by sequencing the genomes of the two TB bacteria to try to fully get a sense of what the likelihood of transmission was.”
Commenting on their geospatial methodology, he says: “When our participants told us where they live or where they spend time in the community, or where they get outpatient healthcare; our team went to those sites and captured a GPS coordinates.
“Just like we use GPS for mapping when we’re trying to get around town, we would get specific coordinates… If two people went to the same shop, they might have used different names for that shop, or let’s say they went to a shopping mall, they may have used different names for those places; but we used GPS coordinates allowing us to determine whether they were at the same place or close to one another. And we used the concept of proximity to try to understand the likelihood that they may have crossed paths.”
In the study they used the metric of “community proximity” defined as a radius of 500 metres, or less.
Gandhi illustrates the nuance of geomapping, using his university campus: “So the example I like to give is; I work in a building called the School of Public Health. Across the courtyard is the School of Nursing. If you just asked me, where do you work? I would tell you, I work in this building. If you ask the next person where they work, they may say, I work in the School of Nursing. That wouldn’t match up in terms of place name. But if we used a radius of 100 metres or 500 metres, we can determine that we work very close to one another. And there’s a cafe in yet another building that we may have eaten lunch in at the same time. TB being an airborne disease, I don’t have to sit next to that person or even to know that person; if I’m infectious, I could have transmitted to them if they were sitting and eating in the same room.”
Essentially, the researchers used genotyping, particularly molecular fingerprinting to help understand the likelihood of transmission between people who have drug resistant TB. And once individuals with similar molecular fingerprints were found, they used geomapping to see whether these patients could be connected through close contact – and if not close contact, then through casual contact.
He adds: “The most common place people told us were friends and family members’ homes. Then the next most common was places of shopping so shopping malls.”
At CROI, Gandhi responded to a question from a conference delegate around risk, saying that there appears to be a greater risk of TB transmission in social settings than previously understood.
Symptoms and disease
To Spotlight, he says more work is needed to understand why casual contact transmission is happening. “And it connects to another topic in the TB community that is gaining a lot of attention currently, which is trying to understand what the association is between symptoms and having TB disease,” says Gandhi.
He notes that the challenge for researchers moving forward is understanding the link between infectiousness and symptoms – specifically, understanding when a person becomes infectious, even if they show no symptoms.
Most TB public health interventions are still based on the assumption that people with TB will present at health facilities with classic TB symptoms such as persistent cough, night sweats, fever, weight loss, and chest pain. South Africa has however in recent years been offering TB tests to asymptomatic people thought to be at high risk of TB, as part of its targeted universal testing strategy.
“So you may have heard of this concept of what some people have called subclinical TB or asymptomatic TB. And that is to say, if you were to test a group of people who didn’t come to a health clinic, but let’s say you were on a street corner and you tested everybody who went by for TB, we’re coming to appreciate that as many as 50% of people may not either have any symptoms or may not have symptoms that are worrisome enough for them to seek healthcare, but are actually testing positive for TB disease,” Gandhi adds.
Gandhi says this reminds him of the early days of COVID-19, when scientists weren’t sure if people only became infectious after showing symptoms.
“Eventually we learned that people were infectious probably for a few days before they developed symptoms. And in the TB world, this may be an area we need to investigate. If there’s the possibility that somebody is infectious when they have absolutely no symptoms, they would go about their regular activities; going to work, going to school, going shopping, going to religious ceremonies, going to restaurants, and they may unknowingly be infectious with TB. So this is the challenge.”
The bigger picture
Commenting on the findings, Robert Wilkinson, Honorary Professor in the Department of Medicine at the University of Cape Town and director of the Centre for Infectious Diseases Research in Africa, says: “It is interesting, and the proportion of transmission estimated to occur outside the household is a low estimate, but not incompatible with other estimates.”
He notes that the phenomenon of transmission occurring after brief casual contact is not novel though, and has been investigated in previous studies.
Asked how the findings presented by Gandhi might affect the outlook on TB interventions, Wilkinson says: “Whilst close household exposure to infectious tuberculosis should prompt clinical evaluation especially if there are symptoms, finding a close contact by conventional contact tracing approaches is far from invariable. Therefore, in high incidence environments like South Africa more attention needs to be placed on mass radiographic (X-ray) and, or microbiological screening of asymptomatic persons.”
In a recent public lecture called ‘Hunting Bosons, Finding the Bummock’, Emeritus Professor in Medicine at the University of Cape Town, Robin Wood, former CEO of the Desmond Tutu Health Foundation, states: “I think we are changing the paradigm of tuberculosis.” He notes that research now targets “hidden reservoirs of TB transmission beyond visible, symptomatic cases… [as] TB silently spreads within communities through carriers who exhibit no symptoms yet contribute to transmission.” Asked about Gandhi’s findings, Wood told Spotlight he would reserve comment until the data is submitted for further peer review and publication.
Study details
The 305 respondents in the CONTEXT study were patients with extensively drug-resistant TB or pre-extensively drug-resistant TB. They were diagnosed between 2019 and 2022 in the eThekwini, Ilembe, Umgungundlovu, and Ugu regions. The average age was 36 years, with 137 (45%) women and 216 (73%) people living with HIV.
The study was conducted in collaboration with the Durban-based Centre for the AIDS Programme of Research in South Africa (CAPRISA).
“CAPRISA played a leadership role in conceptualising the science, development of the protocol and data collection instruments, oversight of all aspects of field work, including screening and enrolling patients, obtaining informed consent from patients or their proxy’s, field and laboratory data collection, data verification and data clean-up activities for all data used in this study,” says CAPRISA’s deputy director, Professor Kogieleum Naidoo.
CONTEXT was funded through the United States National Institutes of Health (NIH), the world’s largest health research funder which has in recent weeks terminated several grants in South Africa and elsewhere. “The funding period has ended,” says Gandhi. “Now we’re analysing all of the data, so it won’t be impacted by any changes happening at NIH.”
The number of people living with HIV in South Africa has for the first time reached the eight million mark. Of these, around 6.2 million are on treatment, according to new estimates.
The number of people living with HIV in South Africa continues to rise, surpassing eight million in 2024. This is according to just-released estimates from Thembisa, the leading mathematical model of HIV and TB in South Africa. The eight million amounts to 12.8% of the population.
The continued rise is due to the fact that there are more people becoming newly infected with HIV than there are people with HIV who are dying. The increasing numbers are thus a reflection of the fact that antiretroviral medicines are keeping people alive who would otherwise have died.
There was an estimated 178 000 new HIV infections in 2023/2024 (mid-2023 to mid-2024). Over the same period, around 105 000 people with HIV passed away – 53 000 due to HIV-related causes and 52 000 for reasons not related to HIV.
The estimates of new HIV infections are slightly higher than in last year’s Thembisa publications. According to Dr Leigh Johnson, of the University of Cape Town and the key developer of the Thembisa model, this is mainly due to the model factoring in new evidence that condom usage is declining.
78% treatment coverage
Of the eight million people living with HIV, around 6.2 million, or 78%, were taking antiretroviral treatment in 2024. Around one in five people living with the virus were thus not on treatment. Treatment is recommended for everyone living with HIV.
On the UNAIDS 95-95-95 targets, also endorsed in South Africa’s National Strategic Plan for HIV, TB and STIs 2023 – 2028, the middle target, helping people start and stay on treatment, continues to be the main area of underperformance. Around 95% of people living with HIV in South Africa knew their status in 2024, around 81.5% of these were on antiretroviral treatment, and of those on treatment, around 92% had viral suppression. (Note that the 78% treatment coverage figure is the product of multiplying the performance on the first two 95 targets.)
There continues to be stark gender disparities in South Africa’s HIV epidemic. On the one hand, there are many more women living with HIV than men – 5.2 million compared to 2.6 million as of mid-2024. On the other hand, slightly more men died of HIV-related causes than women in 2023/2024 – 27 100 men compared to 24 200 women.
Worrying trends
One ongoing area of concern is that many people only start treatment once their immune systems have been severely compromised. In 2023/2024, around 54 000 adults started treatment for the first time with CD4 counts below 200 cells/mm3. A CD4 count above 500 cells/mm3 is generally considered to be healthy. CD4 cells are a type of white blood cell that is vital to the functioning of the immune system. People who start treatment with low CD4 counts tend to have worse long-term outcomes.
The latest Thembisa outputs also contain worrying findings on the extent to which people drop in and out of care. In 2023/2024, an estimated 714 000 people restarted antiretroviral treatment after previously having stopped for at least a month – of these, around 326 000 had CD4 counts below 200 cells/mm3.
Finally, on a more positive note, the latest Thembisa outputs continue to show a rise in life expectancy in South Africa. As shown in the above graph, life expectancy declined severely round the turn of the century, largely due to people dying of AIDS, but then increased over time as antiretroviral therapy started keeping people living with HIV alive. The blip in 2020 and 2021 is due to the COVID-19 pandemic.
Note: This article is based on outputs from Thembisa version 4.8 – published in late March 2025. We have quoted 2023/2024 figures since they are based on more data, and thus more reliable than the estimates for 2024/2025. We have rounded some numbers to make the text more accessible. Graphs were made using the R package ggplot2. Spotlight will soon publish an #InTheSpotlight special briefing in which we will unpack the Thembisa 4.8 outputs in more detail.
Mycobacterium tuberculosis drug susceptibility test. Photo by CDC on Unsplash
By Catherine Tomlinson
Both TB treatment and TB preventive therapy involve taking lots of pills, usually for several months. Researchers are working on new long-acting formulations that might, for example, reduce an entire course of TB preventive therapy to a single injection.
The biggest HIV news of last year was that an injection containing an antiretroviral called lenacapavir provides six months of protection against HIV infection per shot. While it will be several years before the jabs become widely available, experts nevertheless hailed the development as a potential game-changer. In some countries, HIV treatment is already available as injections – containing the antiretrovirals cabotegravir and rilpivirine – administered every two months.
Scientists working on tuberculosis (TB) are trying to replicate the successes of the HIV field and develop similarly long-acting formulations of TB medicines. The good news is that they have several exciting products under development – the bad news is that the research is still at a very early stage and the pivotal studies that will tell us if these products work are likely still years away.
But if they work, they could make a big difference to patients. That is because TB treatment and TB preventive therapy mostly still requires swallowing lots of pills over a long period of time. There is some good evidence that many people would prefer long-acting injections.
The case for long-acting TB medicines
TB preventive therapy is used to stop someone suspected of having latent TB infection from falling ill with TB. In South Africa, such preventive therapy is recommended for all close contacts of someone sick with TB. Typically, it involves taking tablets for three or six months (a one-month course has been shown to work, but is not widely available). There is research that shows that the shorter the regimen the more likely it is to be completed.
The hope is that a long-acting product might do away with swallowing tablets altogether and reduce an entire course of preventive therapy to a single injection. This is likely to be more convenient for patients as well as come with the benefit of perfect treatment completion rates.
TB preventive therapy is a simpler target for long-acting formulations than TB treatment since it typically involves only one or two drugs and treatment durations are shorter. TB treatment typically takes six or more months to complete and usually involves taking four different drugs – often four for two months and then only two for the remaining four months in what is called the continuation phase. Some of the current thinking is that the continuation phase could potentially be replaced by long-acting formulations of TB medicines. This could shorten the duration of TB treatment to just two months of taking tablets.
Not an easy nut to crack
As explained by Dr Eric Nuermberger of Johns Hopkins University, not all TB medicines available as tablets make good candidates for translation to long-acting injectable formulations. He was presenting on long-acting TB drugs at the Conference for Retroviruses and Opportunistic Infections (CROI), recently held in San Francisco.
Nuermberger outlined three key characteristics that are needed for long-acting formulations. These are low water solubility (so the drug doesn’t dissolve to quickly), low clearance in plasma (so that the body doesn’t clear the drug too quickly), and high drug potency (so that a small volume of drug can be effective for a long period of time).
One key challenge, according to Nuermberger, is that scientists do not yet have reliable biomarkers to measure the effectiveness of long-acting TB preventive therapy in phase II trials. Biomarkers, such as blood levels of certain proteins, could in theory offer scientists a faster way to assess if TB preventative therapy is working, without having to monitor clinical trial participants for long periods of time to determine treatment outcomes.
Writing in the journal Clinical Infectious Diseases, scientists working to develop long-acting TB products explained: “The inability to culture or otherwise quantify viable bacteria during latent TB infection and the lack of validated surrogate biomarkers mean that there is no opportunity to obtain initial proof of efficacy… which is usually the domain of phase 2 trials. Instead, the development of new TPT regimens requires bridging directly from preclinical studies and phase 1 trials to phase 3 trials, which are themselves long and require large numbers of participants.”
However, they added that “[t]he search for biomarkers that act as prospective signatures of risk for developing TB disease is a very active research area and an important scientific priority for the field”.
Back at CROI, Nuermberger also told participants that most products in the pipeline remain at pre-clinical stages and are still being tested in mice. He explained that differences in how depot drugs — drugs released slowly over time — work in mice and humans make it hard to apply findings from mice to humans. But modeling is being done to help bridge this gap.
‘Expanded remarkably’
Despite these challenges, Nuermberger said “the number of long-acting drug formulations in development [for TB] has really expanded remarkably in the last few years, which is a very promising development”.
The product that is furthest along in the development pipeline, but still at a very early stage of research, is a long-acting form of bedaquiline. This drug is currently used for the treatment of drug-resistant forms of TB and falls in a class of antibiotics known as diarylquinolines.
The Belgian pharmaceutical company Janssen is currently running a phase I trial of long-acting injectable bedaquiline in Austria. Phase I trials are conducted in a small group of healthy individuals to assess the safety and tolerability of an experimental medicine. In the phase 1 bedaquiline trial, researchers are investigating the safety and tolerability of different doses of long-acting injectable bedaquiline.
Several other long-acting TB medicines are being investigated in preclinical research, including long-acting versions of the TB medicines rifabutin and rifapentine, as well as the second generation diarylquinolines, TBJ-876 and TBA-587, which are under development by the TB Alliance. The second generation diarylquinolines are being tested on their own and in combination with pretomanid and telacebec.
In addition, the University of Liverpool, Johns Hopkins University, University of Southern Denmark, University of North Carolina and the US pharmaceutical company Inflamamasome Therapeutics, are all involved in pre-clinical research on long-acting formulations. These efforts are supported financially by Unitaid, the US National Institutes of Health, and the Gates Foundation.
The treatments being developed include aqueous nanoparticle suspensions, in-situ forming implants, and rod implants. Aqueous nanoparticle suspensions are drugs turned into tiny particles and delivered in a water-based solution via injection. In-situ forming implants are injected as a liquid that then solidifies into an implant under the skin. Rod implants are small, rod-shaped devices inserted under the skin with a needle-like tool after numbing the area with a local anaesthetic.
What users prefer
At CROI, delegates also learned about patient and provider preferences for long-acting TB treatment.
Dr Marcia Vermeulen from the University of Cape Town presented the results of a survey involving over 400 patients in South Africa and India, as well as 94 healthcare providers.
Seventy-five percent of healthcare workers said they would prescribe a long-acting injectable product rather than pills for tuberculosis preventative therapy if it was priced the same or lower. Similarly, 75% of patients said they would try an injectable product for TB prevention if it became available.
“As a TB survivor, I am excited about long-acting TB treatment as it doesn’t require frequent facility visits, saving a person’s time and money, and can thereby increase adherence and improve treatment outcomes,” TB Proof’s Phumeza Tisile told Spotlight.
She added that communities should be at the heart of rollout plans because they understand the needs of people affected by TB and know how to communicate effectively to encourage involvement and adoption.
Disclosure: The Gates Foundation is mentioned in this article. Spotlight receives funding from the Gates Foundation but is editorially independent – an independence that the editors guard jealously. Spotlight is a member of the South African Press Council.
Finance Minister Enoch Godongwana holding a copy of the 2025 Budget Speech. (Photo: Parliament of RSA via X)
By Charles Parry, Funeka Bango, Tamara Kredo, Wanga Zembe, Michelle Galloway, Renee Street and Caradee Wright
While the 2025 national budget boosts health spending, researchers from the South African Medical Research Council stress the need for strong accountability measures. They also raise concerns about rising VAT and omissions related to US funding cuts and climate change.
The 2025 budget speech by Finance Minister Enoch Godongwana saw a welcome boost to the health budget with an increased allocation from R277 billion in 2024/2025 to R329 billion in 2027/2028. This signals a government that is responding to the dire health needs of the public sector, that serves more than 80% of the South African population.
As researchers at the South African Medical Research Council (SAMRC), we listened with interest and share our reflections on some of the critical areas of spend relevant for health and wellbeing.
We note the increase in investment in human resources for health and allocations for early childhood development and social grants. At the same time, we also raise concern about increasing VAT, with knock-on effects for the most vulnerable in our country. There were also worrying omissions in the speech, such as addressing the impact of the United States federal-funding freeze on healthcare services nationally, and a noticeable absence of comment on government’s climate-change plans.
Health and the link with social development: Recognising the importance of early childhood development
Education and specifically early childhood development (ECD) is known to have critical impacts on children’s health and wellbeing, with longstanding effects into youth and adulthood. In South Africa, eight million children go hungry every day, and more than a third of children are reported to live in households below the food poverty line, that is below the income level to meet basic food requirements, not even covering other basic essentials such as clothes.
While the increase in the number of registered ECDs is laudable, many more ECD centres in low-income areas remain unregistered, which means they do not get support from the government in terms of subsidies and oversight.
Social grants
The increase in social grants is welcomed. However, the marginal increase of the Child Support Grant (CSG) by only R30, from R530 to R560, is too little to impact on the high levels of child hunger and malnutrition. The release of the Child Poverty Review in 2023, which highlighted the eight million children going hungry every day, including CSG recipients, proposed the immediate increase of the CSG to at least the Food Poverty Line (R796 in 2024).
Social relief of distress still too small
The Social Relief of Distress (SRD) Grant is an important source of income for low-income, working-age, unemployed adults. Its continuance in 2025 is welcomed. However, it remains too small at R370 per person per month, and the stringent means-test criteria which disrupt continuous receipt from month-to-month, makes it an unreliable, unpredictable source of income for low-income individuals.
Strengthening the healthcare workforce
The Minister stated that “R28.9 billion is added to the health budget, mainly to keep about 9 300 healthcare workers in our hospitals and clinics”. It will also be used to employ 800 post-community service doctors, and to ensure that our pharmacies do not run out of medicines. The speech highlighted the necessary commitment to strengthening the healthcare system, specifically human resources for health.
Considering the pressures on resources, primarily due to the escalating disease burden and challenges within the health workforce, the proposed budget increase from R179 billion to R194 billion – an increase of 8.2% – to maintain the current workforce and employ additional healthcare workers signifies a positive step forward that will aid in addressing staff shortages.
Despite the gains in health spending, the proposed increase in VAT raises substantial concerns to partially negate the potential benefits to the health sector. As the World Bank reports that approximately 60% of people living in South Africa live below the poverty line, increases to VAT will likely drive poverty levels higher.
A focus on other forms of taxation may be better, more evidence-based, and less likely to disproportionately affect those at the highest levels of poverty.
On the issue of alcohol taxes, often mischaracterised as “sin taxes” rather than “health taxes”, the Minister has proposed excise duties of 6.75% on most products for 2025/26. This is 2% above consumer inflation, which stands at 4.75%.
Raising alcohol prices through higher excise taxes is globally recognised as an effective way to address alcohol-related harms. National Treasury is to be commended for adjusting alcohol excise tax rates above CPI in the 2025/26 Budget. This is a move in the right direction, but it does not address the current anomalies in tax rates across different products. This failure to address shortcomings in the excise tax regime is expected, given the release of a discussion document on alcohol excise taxes in December 2024 with a February 2025 response date. The earliest we can expect substantial changes in excise tax rates is in February 2026.
From a public-health perspective, it makes sense to link alcohol excise taxes to the absolute alcohol content of the product to standardise across products. Ethanol is ethanol. The current differential in excise tax rates on different alcohol products is indefensible. Specifically, it makes no sense to tax wine and beer so much less than spirits in terms of absolute alcohol content. Wine, especially bag-in-box wine, is the cheapest product on the market in South Africa, and its affordability increases consumption, leading to more societal harm.
Beer is the most consumed product in the country and is increasingly sold in larger, non-resealable containers. A 2015 SAMRC study in Gauteng found the highest level of heavy episodic drinking with beer products, largely due to their affordability, especially in larger, non-resealable containers. Heavy episodic drinking is a major public-health concern in South Africa, with 43.0% of current drinkers engaging in heavy episodic drinking at least monthly, 50.9% of male and 30.3% of female drinkers. Increasing the excise tax on beer is a powerful tool that the state can use to reduce the level of such behaviour.
Additionally, it makes sense to have lower taxes on alcohol products with lower alcohol content, as this could shift consumption to less harmful products. The current excise tax regimen does not account for this within a single product type like beer or wine, as all products are taxed at the same rate regardless of their alcohol content.
During the COVID-19 pandemic, we saw the benefits of decreased access to alcohol: fewer injuries, fewer unnatural deaths, and communities less disrupted by patrons visiting liquor outlets. While no one advocates for total liquor sales bans, increasing excise taxes on wine and beer would decrease alcohol consumption and reduce harms on drinkers, on others around them, and on society more broadly.
Acute risk to lives with knock on effects due to US federal funding cuts
We believe the South African government has a responsibility to step into the gap left by the sudden US federal funding freeze on HIV and TB services. The US President’s Emergency Plan for AIDS Relief (PEPFAR) funds 17% of HIV and TB services in South Africa and covers salaries for thousands of health workers, including the vital services of community health workers.
The implications for people living with HIV and TB and affected by the externally funded services will be devastating. It will also have ripple effects on the health system as we see inevitable increases in demand for health services to address advancing illness, effects on families caring for ill relatives or losing income.
This area needs to be addressed and clear communication from the National Department of Health is urgently awaited. The US funding cuts clearly impact on essential research funding available to institutions like the SAMRC and no indication has been given in the budget of any plans to augment or replace such funding.
National Health Insurance for South Africa’s public sector
The Minister addressed budget allocations for NHI implementation, specifically, the mid-term indirect and direct conditional grants for NHI were R8.5 billion and R1.4 billion respectively. Although these amounts in themselves are minor compared to other health-budget allocations, allocations for infrastructure (R37.4 billion over the mid-term economic framework period) and additionally allocations for digital patient health information systems, chronic medicine dispensing and distribution systems, and medicine stock surveillance systems are vital for healthcare efficiency and improved outcomes.
Least said not soonest mended: climate change – ‘no comment’?
From a climate-crisis perspective, although the budget speech did not explicitly mention climate change or its related health challenges, there seems to be positive steps being taken to address these issues. Initiatives such as clean energy projects and efforts to improve water management have the potential to benefit all sectors of society, while helping to mitigate the health risks associated with climate change.
Promising spend on health, but who will measure the impact?
Ultimately, increasing health spend is a promising step to increase access to quality health services for South Africa’s population. However, this is not enough, government must seize the opportunity to translate the budget increase into improved health outcomes. The effectiveness of the additional funds must be maximised through efficiency, transparency, and sound governance. The government can reinforce the integrity of public-health services by aligning these increases with robust accountability measures.
Government-academic partnerships represent an opportunity to share knowledge, technical skills and resources to support evidence-informed decision-making for national health decision-making and strengthen monitoring and evaluation mechanisms. There are many examples of this working well, and we trust that the SAMRC, along with the network of higher education institutions are well placed to provide the necessary support.
*Parry, Bango, Kredo, Zembe, Galloway, Street and Wright are researchers with the SAMRC.
Note: Spotlight aims to deepen public understanding of important health issues by publishing a variety of views on its opinion pages. The views expressed in this article are not necessarily shared by the Spotlight editors.
