A Phase 2 feasibility study published today (30 July) in the prestigious Nature Communications Medicine journal has shown that early vitrectomy surgery treatment for acute endophthalmitis can be potentially more beneficial to patients’ vision compared with the current antibiotic-first approach.
This is a bacterial infection, affecting the fluid and tissue inside the eye. It is a rare condition (1 in 1000 to 2000 patients), but is a devastating complication from any form of eye surgery or eye injection, and can lead to sight loss and blindness. Treatment guidelines only exist for cataract treatment, and the conventional approach across ophthalmology has been to repeat intravitreal antibiotic injections during the early phase of the condition, then conduct a vitrectomy if this has not proved effective.
Thirty years ago, research indicated the potential benefits of immediate vitrectomy for patients developing endophthalmitis after cataract surgery, but this is seldom carried out. Since then, the development of small gauge (23-, 25 and 27-) pars plana vitrectomy (PPV), wide-angle viewing systems and the routine use of silicone oil have led to a significant evolution for the procedure. This 21-centre national UK study of 63 patients is the first randomised control trial to evaluate the potential benefits of carrying out the vitrectomy at an early stage, within 48-96 hours of diagnosis of endophthalmitis following any type of invasive eye procedures.
After six months, patients receiving this treatment had a median improvement of 40 letters (range 28-70 letters) compared with those having an initial regime of up to six months of antibiotics (median 13 letters increase in vision, range 0-66 letters). The median improvement for the new approach therefore shows over three times the median sight improvement of the conventional treatment.
Importantly, these improvements came earlier for patients too, bringing relief and recovery from what can be a painful condition as well as removing the psychological shadow of potential sight loss from them sooner. At the six-month cut-off period, this study shows these patients can potentially achieve greater improvements in acuity which, if this endures, further increases the social benefit.
Early vitrectomy also showed lower rates of non-serious adverse events (47% vs 68%) and retinal detachment.
The feasibility of the approach and its acceptability to patients and surgeons were validated by the study team. These promising results are based on a sample of 63 so have relatively low levels of statistical significance, but point to the merits of conducting a larger Phase 3 clinical trial.
Lead author Mahi Muqit, senior vitreoretinal consultant at Moorfields Eye Hospital and associate professor at the Institute of Ophthalmology at UCL, said:
“This important new study shows the potential short-term and long-term potential benefits to patients given an early vitrectomy if they contract endophthalmitis after their eye procedure. As using this intervention at diagnosis shows clear potential to improve clinical outcomes, we now intend to take this forward to a definitive Phase 3 randomised clinical trial that can definitively answer this question.”
Dr Hermann Reuter founded SAHARA, a non-profit organisation in George that provides support groups and free medication for people affected by harmful substance use. (Photo: Nasief Manie/Spotlight)
By Sue Segar for Spotlight
Dr Hermann Reuter did pioneering work treating HIV in the early 2000s in Cape Town and in the rural Eastern Cape. Today, his focus is substance abuse, which he believes is the country’s biggest health issue after HIV. Spotlight spent time with him to learn about his work in the Garden Route city of George.
On a Tuesday afternoon, just before 14:00, Jodie Fonseca, walks into a small consulting room inside the Central Clinic in the Garden Route town of George.
The 37-year-old, who says she has been addicted to heroin for 20 years, is here to fetch her supply of medication used to treat her substance use disorder. The slight, weary looking woman is welcomed warmly by two men as she takes her seat.
“How’s it going?” says Dr Hermann Reuter, a bespectacled man with a strong German accent. He’s wearing a T-shirt with the words Substance Survivor on the front. He looks at her file and dispenses tablets into a bottle.
Brian Faul, a volunteer behavioural change counsellor, chats and jokes with Fonseca. He describes himself to us as a recovering alcoholic, sober for 26 years.
Outside the consulting room, a line of about 30 people, needing help with substance use, have gathered in the narrow corridor in this typical inner-city government clinic. They range from gaunt older women in trackpants to young men in frayed hoodies. Some are seated and others stand patiently waiting.
Reuter hands Fonseca a bottle of pills. “See you next month for your medication,” he tells her.
“Remember, we’re always here if you have issues. We’re an open door, hey.”
Faul urges Fonseca to return to the clinic on Friday, when he runs group and individual counselling sessions for people with addiction.
Fonseca is here to attend a weekly outpatient service, run by the NGO Smoking and Alcohol Harms Alleviation and Rehabilitation Association (SAHARA). Founded in George by Reuter five years ago, the NGO offers free medical-assisted outpatient rehabilitation, and counselling in the form of support groups to people with substance addiction.
Currently, these services are not offered in the public healthcare system in George, but thanks to a relationship with the Western Cape health department, SAHARA uses a consulting room in Central Clinic for a few hours to run the Tuesday methadone programme and the Friday counselling services. On Wednesdays, through a similar arrangement, the NGO runs a programme in Thembalethu clinic.
An addict since 17
Desperate to “get away from the heroin”, Fonseca, a mother of three, tells Spotlight she moved to George from Johannesburg a few months ago.
“Johannesburg was just a battle. I ended up on the streets and lost everything,” she says. “The lifestyle and the familiarity just kept my boyfriend and I in the cycle. Heroin is so easily accessible up there. I’d just had enough. I wanted to get on the methadone programme.”
Fonseca says while it was a struggle for her to get onto a programme in Johannesburg, it was smooth sailing in George with Reuter helping her on her first visit to the clinic. “I was amazed and grateful, actually speechless,” she says. “I walked in and said to him, ‘I can’t carry on in this lifestyle. I feel the next time I pick up I’ll … make sure it’s a deadly dose’.”
Fonseca says the counselling sessions have been helpful too. “Brian downloaded a breathing app to help with my anxiety. It calms me and helps me sleep,” she says.
She dreams of a normal life, back with her children and to spend time with her mother, “my rock”, who she says is in poor health.
Fonseca is by no means alone in having become addicted to heroin. As previously reported by Spotlight, rates of heroin use in South Africa have been on the up. It is estimated that a few hundred thousand people in the country take the drug every day.
A stream of people with substance-use disorders
Next to enter the consulting room are a father and his teenage son. One can sense the love between them, but there’s tension. It’s their first visit, and they’re here because the son wants to quit his marijuana habit. The concerned father asks Reuter to test his son’s urine to check whether his son is using other drugs, like crystal meth, on top of marijuana. The son insists he only uses marijuana.
Intervening gently, Reuter says there’s no need for a urine test. “The treatment for cannabis (marijuana) and crystal meth is the same; there will be no benefit from additional information,” he says. The dad nods. Both agree to return to the clinic for more counselling.
Next to see Reuter are Peter-John Truter and his twin brother, Kenneth, both 36, and addicted to heroin. They tell Spotlight their mother died of breast cancer when they were three-months old and they were lovingly raised by a relative in Mitchells Plain, Cape Town. Initially hard-working and sporty children, they started using “weed, alcohol, ecstasy and tik” as teenagers, before discovering heroin in their 20s.
“Drugs took over the Cape Flats. Wherever you went, people were drinking, smoking tik or whatever. It’s the weekend thing. Our area became infected with heroin. We moved from smoking to mainlining (injecting),” says Peter-John.
The brothers tried rehab several times. Their heartbroken adoptive mother sent them to George, thinking there were no drugs there. They found dealers immediately. Both are now on the methadone programme and sometimes attend counselling.
Next in the small consulting room is a young man who’s addicted to the medication Tramadol.
“I started taking it for toothache and got up to 20 tablets a day. It made me feel good, like I was on drugs, but I started passing out in the street,” he says.
Reuter explains that the treatment for Tramadol addiction is the same as for heroin addiction. Both drugs are opioids.
“No cold turkey with methadone”
Reuter explains that heroin addiction is treated with methadone Opioid Substitution Treatment (OST). Methadone is a synthetic opioid that is typically taken once a day.
“It sits on the same receptor as heroin, so people don’t suffer withdrawal. There’s no cold turkey or cramping. They can go back to normal life quite quickly if they stick to this,” he says.
The first six months of the treatment is usually “a bit up and down”, Reuter says, but the programme has seen most addicts moving back into their homes and into jobs.
“Most people on the programme stop the methadone at some stage, so you won’t see them here anymore. The people you see here today are those who are still on the street and struggling – or who started recently,” he says.
It’s clinic closing time but a few people still need support. Reuter, undaunted, carries his box of medication and continues outside. A small group of users join him.
There we meet Sarah Lessing who says she has been clean from heroin for four years since joining Reuter’s programme. She’s brought two youngsters who live in the mountains outside George.
“In George, there’s unfortunately nowhere for people without a support system to go,” says Lessing. She recalls how she decided to give up heroin, after her partner who also used heroin died. “I had to literally walk past my dealer to get to the taxi to go to Dr Reuter’s clinic.” Fully recovered, she feels part of his “lifesaving” mission to work with other people struggling with addiction.
Thembalethu’s Wednesday clinic
The next morning, Reuter is working in George’s Thembalethu clinic. The service here is offered every Wednesday for people struggling mainly with alcohol and nicotine use.
The first hour is spent with community health workers. SAHARA has been sub-contracted to manage about 65 health workers from five clinics in the district trained in substance use, as well as mental healthcare. Reuter says that, with substance use and mental health issues at crisis levels, it is essential health workers have this capacity added to their skillset.
As part of a Western Cape government youth wellness and substance prevention programme called Planet Youth, the community health workers will be working with schools in their areas to link health and education; and to teach people about the dangers of alcohol and cigarettes.
“Now that we are entrusted with community health workers, we want to expand their scope of practise, so they support the schools, including the relationship between the schools and parents,” says Reuter.
Soon after 09:00, a stream of service users has entered the consulting room. There’s an old man with a walking stick, a few middle-aged women, and some very young people.
Switching from English to Afrikaans to isiXhosa, Reuter greets every person. “You are taking a big step today … we can help you with these tablets, and with our support group,” he says.
A 29-year-old woman tells Spotlight she’s been smoking cigarettes since she was 17. She’s lost count of how many cigarettes she smokes daily and says she feels sick all the time. “It doesn’t even help my stress,” she says.
A man who works as a painter says he hopes to give up alcohol and smoking. “I’ve been smoking since 1984. At weekends, I drink and smoke till I’m dizzy. I don’t even have tastebuds till Wednesday or Thursday,” he says.
More and more people arrive. Reuter listens to each one, and packs medicines for each. For nicotine, he’s got bupropion, and when funds are sufficient, varenicline. “Bupropion helps quit smoking by reducing cravings and withdrawal symptoms. Varenicline is a nicotine receptor blocker. It reduces withdrawal symptoms and reduces enjoyment of smoking,” he explains. He says it’s safe to use these with other medications and during pregnancy but people who have epilepsy must be properly consulted.
For those wanting to reduce alcohol use, he prescribes diazepam and naltrexone. “Diazepam reduces withdrawal symptoms by working on the GABA (gamma-aminobutyrid acid) system, which is the main inhibitory neurotransmitter in the central nervous system… Naltexone blocks the euphoria caused by alcohol-induced endorphins,” he explains.
David Nongogo says he joined Reuter’s programme about five years back and is now a regular at the clinic to encourage others. “It took me only three weeks to get off smoking and drinking,” he says.
“I won’t ever go back there. There’s a drink they make in the township, called ‘iginja’ made from a powder you brew into alcohol. If you drink it, you don’t even know when you need to urinate. You just urinate. I found myself there. If it wasn’t for the programme, I wouldn’t be here,” he says.
Reuter’s public health journey
Well-known for his groundbreaking work in HIV treatment and activism, Reuter graduated in medicine from Stellenbosch University in the early nineties. Politically involved from an early age, he worked for the Treatment Action Campaign (TAC) in the Western Cape in the late nineties. He then ran HIV treatment programmes in Khayelitsha, Cape Town and Lusikisiki in the rural Eastern Cape for Medecins Sans Frontieres (MSF). He also ran HIV services for the health department in KwaZulu-Natal. In 2004, Reuter received the Rural Doctor of the Year Award from the Rural Doctors Association of Southern Africa (RuDASA) for his efforts in providing HIV medicines in remote areas of the country. In 2020, Reuter published this moving article looking back at the role of some key people in the struggle for antiretrovirals in South Africa.
Reuter moved to George in 2015 where, besides running SAHARA, he works as Community-Based Education Coordinator in the Garden Route, for the Division of Primary Health Care in the Department of Family, Community and Emergency Care of the Faculty of Health Sciences at the University of Cape Town.
Reuter’s passion these days is what he calls the “neglected problem” of substance abuse which, he says, is the country’s second biggest health issue after HIV. He says the health system carries the high costs of the harm and illness caused by substance misuse. He argues that it is more cost-effective to treat addiction before it takes hold. This, he feels, should be done at primary care level, as opposed to dealing with the fallout in public hospitals.
He says government should carry the cost of substance abuse medications and points out that the public health system does not currently provide methadone or other medications for treating substance abuse as they are not on the essential medicines list, and clinics are not authorised to keep them on site.
The public health system does not currently provide methadone, a synthetic opioid typically taken once daily, or other medications used to treat substance use disorders. (Photo: Nasief Manie/Spotlight)
“So, I arrive with my stock, hand it out, and monitor people to ensure they are safe on the medication,” says Reuter. “I am registered as a dispensing doctor so can buy the medication wholesale and distribute it.” His funding comes from a charity in Canada called Child.
George, he says, is no different from any other town in South Africa.
“Over weekends, the hospital is overwhelmed with trauma cases … clearly linked to alcohol abuse. Like other hospitals, we see numerous people with complications arising from smoking, like cardiovascular issues, lung disease, and cancer.”
He continues: “I see families in tears every week, saying ‘our child is stealing and doing drugs, and is not our child anymore’.”
Treat the substance use, not the repercussions
Reuter says he became disillusioned with medicine when he realised he was just working at the tail end of people’s misery. “I knew that the social context in which people lived needed to change. Rather than putting a plaster on much bigger problems, issues should be dealt with much earlier,” he says.
He is disappointed that more doctors are not advocating for medications for treating substance abuse to be made available in government facilities.
“It reminds me of the early days of HIV. We knew there were medicines that worked and not many doctors were prepared to stand up and advocate for it,” he says.
Reuter says that the government’s approach to tackling substance use is not ideal. He explains that the Department of Social Development is tasked with issues relating to substance abuse.
“But substance use is a medical problem. There are many social causes and social problems caused by it. The Department of Health should be dealing with it because the complications down the line are so expensive, and [they do end up] paying for all of them. We should be medically treating substance users to save the health department from these costs,” he says.
A few positives
On the plus side, SAHARA’s integration of its services into the local clinics is yielding results. Community health worker at Thembalethu clinic, Gcobisa Kraai, says she is learning so much about the treatment of substance abuse. “I can see the community really wants this service. Substances are killing our communities,” she says.
Reuter says last year his NGO treated 2 400 people for smoking, 1 400 for alcohol use, with more than 50 people on methadone. “Our budget cannot treat more people, so we restrict clinics where we work so that we have medication for the whole year,” he says. “If we had more funding, we could be at more clinics.”
Angiogenesis. Credit: Scientific Animations CC BY-4.0
In the rare disease progeria, blood vessels deteriorate prematurely. A study from Karolinska Institutet shows how different cell types in the vascular wall undergo progressive changes and accumulate mutations over time. The findings are published in the journal Genome Medicine.
Hutchinson–Gilford progeria syndrome (HGPS) is a genetic disorder that causes remarkable premature ageing. Most patients die during their teenage years from cardiovascular disease, but the precise mechanisms underlying vascular damage remain unclear.
In the new study, researchers analysed cells from the aorta of mice carrying the same genetic mutation found in people with progeria. Using single-cell RNA sequencing, which enables gene activity to be studied in individual cells, they tracked how the vascular wall changes over time. In total, nearly 9000 cells from mice of different ages were analysed.
“This approach allows us to follow, step by step, how different cell types are affected throughout the course of the disease,” says Maria Eriksson, professor at the Department of Medicine, Huddinge, Karolinska Institutet.
Reduced numbers of smooth muscle cells
The researchers focused particularly on vascular smooth muscle cells, which provide blood vessels with strength and elasticity and are essential for normal vascular function. They observed that these cells gradually declined in number.
“Smooth muscle cells are progressively lost both in HGPS and during normal ageing. As these cells die, the vessel wall becomes weaker and more susceptible to disease,” says Lara Garcia Merino, doctoral student at the same department and first author of the study.
The study also showed that smooth muscle cells accumulated higher numbers of so-called somatic mutations, meaning genetic alterations that arise during an individual’s lifetime. The mutation burden was associated with increased cellular stress and activation of genes involved in DNA damage responses.
“This is the first evidence that the accumulation of somatic mutations is a hallmark of vascular disease in HGPS,” says Maria Eriksson.
Reveals a new mechanism
The findings link DNA damage to cellular stress, loss of cellular identity and cell death, thereby revealing a previously unrecognised mechanism driving irreversible vascular injury.
The researchers also found evidence that changes in cell behaviour may be influenced by signalling between different cell types within the vessel wall, suggesting that the process is not driven solely by alterations within individual cells.
“We see that cells undergo multiple changes over time, from stress to identity changes and ultimately cell death. Our results suggest that several different mechanisms interact in the development of vascular damage in progeria,” says Lara Garcia Merino.
The researchers believe that the findings may contribute to a better understanding of how vascular damage develops in progeria and underline the importance of initiating treatment early, before irreversible DNA damage has accumulated.
“New gene-editing approaches can correct the disease-causing mutation in HGPS, but correcting the mutation alone is unlikely to reverse damage in cells that have already accumulated a large number of somatic mutations. Early intervention is therefore essential,” says Maria Eriksson.
The study also provides new insights into the biological processes underlying normal vascular ageing. Several important similarities exist between HGPS and the cardiovascular disease that affects the general population. HGPS is therefore widely used as a model for understanding normal ageing and vascular disease.
The researchers emphasise that further studies are needed to confirm the findings in humans.
The study was conducted in collaboration with researchers from, among others, the Indian Institute of Technology in India and the University of Bergen in Norway. The research was funded by the Swedish Research Council, the European Research Council (ERC), the Swedish Cancer Society and the Center for Innovative Medicine, among others.
Compression wraps are unlikely to help venous leg ulcers heal faster than standard compression treatments, according to a clinical trial led by University of Manchester and York researchers.
The findings of the study, funded by the National Institute of Health and Care Research (NIHR) suggest the wraps may not be the best first-line option for patients receiving strong compression therapy.
Venous leg ulcers affect thousands of people and can take months to heal, causing pain, reduced mobility and a significant burden on healthcare services.
Strong compression is an important treatment for people with venous leg ulcers, to improve blood flow in the lower leg and support healing.
It can be provided in different ways, including bandages systems that can have two or four layers, compression stockings that have two layers and adjustable compression wraps that fasten around the leg with Velcro-style straps.
All these compression approaches aim to deliver the same level of compression but differ in how they are applied, how easy they are to use and how comfortable people find them.
Wraps have become increasingly popular because they can be adjusted and, in some cases, self-applied by people with leg ulcers or those around them. However, there has been limited high-quality evidence comparing compression wraps with other commonly used strong compression treatments.
The researchers carried out a large randomised controlled trial involving 637 adults receiving care at 33 mainly community sites across the UK.
Participants were assigned to be offered either compression wraps, two-layer compression bandages, or established evidence-based compression treatments (four-layer bandages or two-layer compression stockings).
The researchers found that ulcers healed more slowly in patients offered compression wraps than in those offered established evidence-based compression treatments.
Patients receiving compression wraps also appeared to heal more slowly than those treated with two-layer compression bandages, although this difference was not statistically significant.
The study found that two-layer compression bandages performed similarly to established evidence-based compression treatments.
The findings provide some of the strongest evidence to date comparing commonly used compression therapies for venous leg ulcers.
A separate companion process evaluation found patients liked compression wraps because they were comfortable, easy to adjust, and could be removed for showering,
However, these same features may also mean that people are more likely to loosen or remove the wraps, potentially reducing the amount of therapeutic compression delivered and helping explain the slower healing observed in the trial.
Together, the studies suggest compression wraps should not routinely be the first choice for most people with venous leg ulcers.
However, they may still be appropriate for some patients where comfort, independence or self-management are particularly important, provided patients receive clear advice on maintaining effective compression.
Jo Dumville, Professor of Applied Health Research from the University of Manchester said: “Venous leg ulcers can have a major impact people’s quality of life and place a significant burden on healthcare services, so it is important that health professionals have robust evidence to guide treatment decisions”.
“Our study compared three commonly used strong compression approaches in a real-world NHS setting and suggested that that compression wraps do not improve healing times when compared with established evidence-based treatments.”
Catherine Arundel, Senior Research Fellow at the University of York said: “While some uncertainty remains, these findings suggest that compression wraps are unlikely to offer a healing advantage as a first-line treatment”.
“The results will help clinicians, patients and healthcare providers make informed decisions about the most appropriate therapies for managing venous leg ulcers.”
The paper Compression therapies for venous leg ulcers: The VENous Ulcer Study 6 (VenUS 6), an open, multicentre, randomised clinical trial is published in PLOS Medicine https://doi.org/10.1371/journal.pmed.1005154
The companion process evaluation Compression therapies for the treatment of venous leg ulcers: a mixed method process evaluation in a randomised controlled trial, VenUS6 is published in Trials https://doi.org/10.1186/s13063-023-07681-7
If you’re a black, 34-year-old South African woman living with HIV, antiretroviral (ARV) treatment options have likely been limited to tenofovir disoproxil fumarate (TDF), lamivudine (3TC) and the ‘gold standard’ dolutegravir (DTG).
Now, another once-a-day, three-drug regimen has been found to be as effective as DTG in supressing HIV viral load.
Not only is the once daily regimen of tenofovir disoproxil fumarate (TDF), lamivudine (3TC) and doravirine non-inferior to DTG, it is associated with significantly less weight gain and has a better lipid profile than the combination favoured and recommended as first-line in many countries, and increasingly in low-and-middle income countries.
These were the end point findings of the South African Opti-DOR study presented at the 2026 International AIDS Society Conference on HIV Science on 31 July and published in the Journal of the American Medical Association (JAMA).
Dr Joana Woods, Senior Research Clinician at Ezintsha at the University of the Witwatersrand (Wits) and lead author, says:“The findings are important because although second-generation ARVs such as dolutegravir and bictegravir are highly effective HIV medicines, they have been consistently associated with substantial weight gain and new onset obesity, particularly among women and black populations and especially when combined with TAF. This has raised concern about long-term cardiometabolic risk, including diabetes and cardiovascular disease.”
In primary healthcare, prevention is better than having to deal with long term consequences. This is why in a country like South Africa with widespread HIV and NCDs, managing weight gain in people living with HIV is critical to their health.
“So if you can start an ARV that’s not going to cause as much weight gain, or not cause weight gain at all, or have an alternative, that would be first prize. And that’s the premise of this study,” says Woods.
About the OPTI-DOR Study
The Africa Health Research Institute (AHRI) ran the rural arm of the Opti-DOR study at the AHRI-Somkhele site in rural northern KwaZulu-Natal province.
“By including participants from both rural KwaZulu-Natal and urban Gauteng, we can be confident that these findings are relevant to people living with HIV in different communities across South Africa,” says Professor Limakatso Lebina, Principal Investigator at the rural AHRI-Somkhele study and Director of Science at AHRI.
The AHRI site enrolled 178 participants between December 2023 and March 2025, with the Johannesburg site enrolling the rest, for a total of 600.
Participants were randomised in a 1:1 ratio to receive either oral daily doravirine (TDF/3TC/DOR) or dolutegravir (TAF/FTC/DTG).
Weight gain differed significantly between the two study groups. Median weight gain at week 48 was 3.0 kg with doravirine (TDF/3TC/DOR) compared with 5.0 kg with dolutegravir (TAF/FTC/DTG).
Increases in total body fat percentage were also significantly lower with doravirine (TDF/3TC/DOR) at 1.5%, versus 2.2%.
“These results add some clarity to a challenge that has frustrated both doctors and patients for years: how to treat HIV effectively without causing significant weight gain,” says Lebina. “For many patients, especially black women who are disproportionately affected by treatment-associated weight gain, this could be a game changer. It offers an important new treatment option that supports long-term health while maintaining excellent HIV control.”
Non-inferior yet drug resistance potential
Woods emphasises that the efficacy of doravirine is dependent on patients’ absolute adherence to taking it. If doravirine is taken properly, HIV viral load will be suppressed. However, failure to adhere can cause drug resistance.
“Doravirine is non-inferior to dolutegravir in the sense that if you take the drug properly, you will suppress it [HIV viral load]. If you don’t take it properly, you will likely become resistant. That unfortunately is one of the downsides of using doravirine.”
In the Opti-DOR clinical trial, seven patients developed resistance to the drug. These participants were then switched over to dolutegravir and successfully suppressed again.
Woods emphasises that doravirine is unlikely to be a replacement for DTG: “It is not a replacement. It has to be targeted to patients who are at risk of gaining more weight – and complications thereof.”
Despite drug resistance, the data prove that doravirine is not inferior to dolutegravir and that it causes less weight gain.
Research into action
Doravarine is already an available and registered drug.
The researchers have alerted the South African National Department of Health and the South African Health Products Regulatory Authority.
“Imagine you’re a diabetic and you only have access to one drug? It’s the same thing with HIV. Yes, the drug they have at the moment is really top of the tops, but it doesn’t suit everybody. You have to have options. Until we can cure HIV, you’ve got to make it as easy as possible for people to take their treatment. That’s what it comes down to.”
Key findings of the Opti-DOR study at week 48
Doravirine [TDF/3TC/DOR] was non-inferior to dolutegravir [TAF/FTC/DTG] for viral suppression.
Viral suppression was achieved by 89.0% of participants on doravirine [TDF/3TC/DOR] and 90.7% on dolutegravir [TAF/ FTC/DTG].
Median weight gain was significantly lower with doravirine [TDF/3TC/DOR]: 3.0 kg versus 5.0 kg.
Total body fat percentage increased less with doravirine [TDF/3TC/DOR]: 1.5% versus 2.2%.
Lipid changes favoured doravirine [TDF/3TC/DOR].
Glycaemic measures and blood pressure were similar between arms.
No emergent integrase inhibitor resistance was observed.
Bone mineral density declined more with doravirine [TDF/3TC/DOR].
Serious adverse events and major laboratory abnormalities were infrequent across and similar between both groups, and not considered treatment related.
An international research team led by the Medical University of Vienna reports on a new treatment strategy that has made a kidney transplant possible for a patient with no realistic chance of receiving a suitable donor organ. As the case study demonstrates for the first time, the use of a new drug from the field of cancer medicine can achieve a substantial and sustained reduction in antibodies against potential transplants, a level not previously attained. This significantly improves the prospects of a successful organ transplant even in cases with a particularly unfavourable initial immunological profile. The results have recently been published in the New England Journal of Medicine and could open up new perspectives in transplant medicine.
The new drug Teclistamab is currently used to treat blood cancer (myeloma). It specifically eliminates those cells in the blood and bone marrow that produce antibodies against foreign structures. Due to this unique mechanism of action, the substance has now also come to the attention of transplant medicine: the research team led by Georg Böhmig and Martina Schatzl (Clinical Department of Nephrology and Dialysis, Department of Medicine III, MedUni Vienna) applied it for the first time as part of a case study in a dialysis-dependent patient with a highly unfavourable initial immunological profile.
The 37-year-old had developed particularly pronounced HLA sensitisation following two previous kidney transplants. In this process, the immune system produces antibodies against tissue markers of potential donor organs, known as HLA (Human Leukocyte Antigens). These antibodies significantly limit the availability of suitable organs. In the specific case of the study, the calculated probability (cPRA value) of ever finding a compatible donor kidney for the patient was actually zero. Consequently, the study participant’s name had been on the waiting list for more than twelve years, whilst his condition progressively deteriorated.
Successful transplant after 31 weeks of therapy
Treatment with teclistamab over a period of 31 weeks turned the tide: the drug achieved such a substantial and sustained reduction in antibodies against tissue antigens as is not possible with the methods currently available for HLA sensitisation. “During the course of therapy, HLA markers from donor kidneys, against which there had previously been strong antibody reactions, were gradually classified as acceptable,” reports lead author Martina Schatzl. Eventually, a suitable organ was found and successfully transplanted. “The patient is doing very well today; his kidney function is excellent, and he no longer needs dialysis,” adds study leader Georg Böhmig.
Further studies on benefits and risks needed
20 to 30 per cent of patients on the waiting list for donor kidneys are affected by significant HLA sensitisation, some of whom have no chance of receiving a suitable organ. Existing procedures for so-called desensitisation aim to reduce the number of antibodies prior to transplantation, but are only effective to a limited extent and for a short period. The treatment approach described in the case study, by contrast, directly intervenes in antibody production and sustainably reduces the immune response over a longer period. “This could herald a paradigm shift in transplant medicine and open up new prospects for a group of patients who have been particularly disadvantaged until now,” says Böhmig.
Detailed immunological results from the current case study also suggest that the new treatment strategy might also be applicable in xenotransplantation – that is, the transplantation of organs from genetically modified pigs – as well as in blood-group-incompatible transplants. “Looking ahead, an extension to other forms of organ transplantation, such as heart transplantation, as well as use in the post-transplant setting to treat antibody-mediated rejection reactions, also seems conceivable,” says Böhmig. However, before the new treatment strategy can be used in clinical practice, its benefits and risks must be systematically investigated. A study of this kind is already being planned at MedUni Vienna.
Through Cipla’s voluntary licensing agreement with Merck (MSD), Cipla may support potential future access to generic alimatravir, an investigational medicine being studied for HIV-1 pre-exposure prophylaxis (PrEP).
The announcement underscores Cipla’s role in supporting responsible partnerships at a critical moment for the global HIV response, as global leaders, researchers and healthcare professionals convene in Brazil this week for the world’s largest HIV and AIDS conference.
Through the agreement, Cipla may produce generic alimatravir following completion of development, applicable regulatory approvals, technology-transfer requirements and any other country-specific requirements. The voluntary licensing agreement builds on Cipla’s vertically integrated capabilities across the pharmaceutical value chain, enabling the company to support the development and manufacturing activities, under the terms of the agreement.
As one of Africa’s leading pharmaceutical companies, Cipla has contributed to improving access to critical HIV medicines and prevention-related public-health programmes across the continent. In the early 2000s, Cipla made quality, affordable antiretrovirals available at less than $1 per day, contributing to wider access to HIV treatment during a critical period in the global HIV response.
Building on this legacy, Cipla continues to strengthen its contribution to public health through the development, manufacture and distribution of high-quality, affordable medicines that support national and regional HIV priorities, where such medicines are appropriately authorised and supplied in accordance with local requirements.
Paul Miller, CEO of Cipla Africa, said: “Cipla’s vision has always been to make quality healthcare more accessible for patients who need it most. This licensing agreement reflects our long-standing commitment to supporting responsible innovation in HIV prevention for the patients and communities we serve. We believe that expanding future access, where permitted by applicable regulatory requirements, requires extensive manufacturing expertise, reliable supply chains and strategic partnerships that can translate scientific innovations into real-world impact.”
Investment in Local Manufacturing, Sustainable Access
Cipla’s manufacturing network and established presence across African markets position the company to support widespread, sustainable access to HIV medicines. Through decades of experience in producing and supplying medicines at scale, Cipla has helped strengthen healthcare systems and HIV treatment programmes.
The company also remains committed to supporting local healthcare priorities by investing in local manufacturing capabilities and working collaboratively with governments and healthcare professionals to improve access to life-saving medicines. Cipla has been supplying the South African government with equitable access to HIV medication for a number of years. These efforts align with broader ambitions to strengthen pharmaceutical manufacturing capacity on the continent, reinforcing Cipla’s commitment to secure and ensure reliable ARV supply.
Most recently for example, Cipla made significant investments in its local manufacturing facility, upgrading the capacity of the ARV production line with the installation of a new Countec bottle line and increased its tablet filing capacity by 190%. The company is able to locally produce 475 million ARV tablets annually and has upscaled its manufacturing capabilities to ensure sufficient capacity to meet current demand and support near‑term growth, ensuring continuity of supply. Cipla’s overall manufacturing capacity is 1,625 billion tablets annually.
“With a long history of leadership in HIV treatment and prevention, Cipla remains dedicated to helping shape a future where innovative healthcare solutions are accessible, affordable and available to communities across Africa. We want people to live a long and healthy life as part of our ethos of caring for life,” said Paul Miller, CEO of Cipla Africa.
*According to Statistics South Africa, the number of people living with HIV in the country is estimated to be approximately 8 million (12,7% of the population)[1].
Important regulatory notice: Alimatravir is an investigational medicine. It is not registered by the South African Health Products Regulatory Authority (SAHPRA), has not been approved for sale or supply in South Africa, and is not currently available in South Africa. Its safety, quality and efficacy have not been evaluated or approved by SAHPRA. This communication is a corporate announcement about a voluntary licensing agreement and is not intended to promote, recommend or encourage the use of any medicine.
Alimatravir remains investigational and no claims are made regarding its safety, efficacy or suitability. No availability in South Africa is implied by this announcement. Any future availability remains subject to successful completion of development, regulatory approval and applicable local authorization requirements.
Large-scale study results call for earlier cardiovascular screening for women who experience menopause before age 40
Photo by Hush Naidoo on Unsplash
Women who reach menopause before age 40 face a meaningfully higher risk of developing high blood pressure than those who go through menopause after age 45, according to a new study of more than 107 000 women. Risk peaked among women who reached menopause prematurely between the ages of 25 and 35 years. The results of the study are published online today in Menopause, the journal of The Menopause Society.
Hormone shifts during the menopause transition are known to influence a woman’s overall disease risk, and earlier menopause has previously been linked to higher rates of coronary heart disease and stroke. However, evidence connecting the timing of menopause directly to hypertension has been inconsistent, with some prior meta-analyses finding an association and others finding none.
A key challenge has been separating the direct hormone effects of menopause from indirect effects driven by weight gain, metabolic changes, and other cardiovascular risk factors that tend to accompany the menopause transition.
To address this gap, researchers analysed data from 107 836 postmenopausal women enrolled in the UK Biobank between 2006 and 2010, following them for a median of nearly 15 years through the end of 2003. The study classified women by age at menopause – normal (after age 45), early (ages 40 to 45), and premature (before age 40) – as well as by type of menopause (natural vs surgical) and tracked new diagnoses of high blood pressure over time.
Over the follow-up period, 18 508 women (17.2%) were diagnosed with hypertension. The risk climbed steadily as age at menopause dropped: 16.6% of women with normal age at menopause developed hypertension, compared to 18.8% of women with early menopause and 22.6% of women with premature menopause. After adjusting for more than 50 variables – including weight, lifestyle habits, family history, and lab values – women with premature menopause still had a 12.3% higher risk of developing hypertension than women who reached menopause after age 45.
A further analysis modelling age at menopause on a continuous scale found that risk peaks not at the traditional premature-menopause cutoff of age 40 but between the ages 25 and 35, suggesting the cardiovascular risk associated with premature menopause may be concentrated in an even younger group of women than previously defined. Surgical menopause was associated with higher hypertension rates in initial analyses, but that association did not hold once other risk factors were considered.
Based on these findings, the study authors recommend that clinicians treat age at menopause as a distinct cardiovascular risk factor, particularly for women who reach menopause before age 40. In addition to individualised counselling on hormone therapy, they point to earlier identification and management of high blood pressure as an opportunity to help reduce long-term cardiovascular risk in this group of women.
“The results of this study highlight the potential adverse long-term health outcomes associated with premature menopause, and in particular, the need to regularly screen for cardiovascular risk factors such as hypertension. Use of hormone therapy is also routinely recommended in women with premature menopause at least until the natural age of menopause unless contraindications exist,” says Dr Stephanie Faubion, medical director for The Menopause Society.
Dr Katlego Mothudi is the Managing Director of the Board of Healthcare Funders, an industry representative body for medical aid schemes, administrators and managed care providers.
By Katlego Mothudi
With plans in motion to roll out universal health coverage in South Africa, Dr Katlego Mothudi, of the Board of Healthcare Funders, argues that revising the compulsory prescribed minimum benefits that medical schemes must provide can be a tool to deliver meaningful improvements today while laying the foundations for a more sustainable healthcare system.
South Africa’s journey towards universal health coverage will not be defined by a single policy or piece of legislation, but by the practical reforms that make quality healthcare more accessible and affordable for more people. Achieving this goal requires, among other things, tackling structural barriers that continue to drive up the cost of medical scheme cover and place private healthcare beyond the reach of millions of people in South Africa. One of the most important, yet often overlooked, barriers is the outdated framework governing prescribed minimum benefits (PMBs).
PMBs are the set of conditions and services that every medical scheme is legally required to cover, regardless of the plan a member chooses. Their existence is critical, created with the intention of ensuring scheme members do not lose access to catastrophic care in the event of serious illness. PMBs ensure that members are not reliant on an over-burdened public sector during medical emergencies. And although this principle remains important, the framework has not kept pace with South Africa’s changing disease burden, evolving models of care, or the cost of delivering healthcare.
20 years of PMB limbo
Regulations made under the Medical Schemes Act require PMBs to be reviewed every two years. This must be carried out by the Department of Health together with the Council of Medical Schemes, provincial health departments and other stakeholders. In practice, this has happened only once, more than 20 years ago.
The current review process has been underway for close to a decade without conclusion. As a result, the outdated PMB framework has become one of the most significant contributors to medical scheme costs and thus an inefficient health policy. Actuaries advise that roughly 60% of a scheme’s budget goes towards funding PMBs before any other benefit is considered. This used to be approximately 40% when the PMB was amended in 2003.
The consequences of this laborious review process directly impact household budgets. The most basic scheme cover now costs a single beneficiary in the region of R1 600 a month, with a family of three facing around R4 000. For most working people in South Africa, that is simply unaffordable, and it is a significant reason why medical scheme membership has stagnated even as the population has grown. Furthermore, South Africa’s healthcare “missing middle” has grown to an estimated 8 million people who access private healthcare, paying out-of-pocket, without belonging to a medical scheme.
An out-of-date framework
If the PMB list were redesigned today, using current clinical evidence, the country’s evolving disease burden, and the realities of healthcare affordability, many of its benefits would likely look very different. The current framework no longer reflects what the system can sustainably provide. And because it consumes such a large portion of every scheme’s budget, it crowds out the very things that would make cover more affordable and more useful – primary care, early intervention and prevention.
At a recent Board of Healthcare Funders conference, Dr Fatima Hoosain, a specialist breast and endocrine surgeon, set out the numbers plainly: a mammogram and ultrasound cost in the region of R2 500. Left undetected until the disease has progressed, that same patient may require R100 000 in radiation therapy, R200 000 in chemotherapy, and, for HER2-positive cancers which typically can quickly spread from the breasts to other areas of the body, roughly R7 000 every three weeks for a year in targeted biological therapy. Early detection does not only save lives, but it is also, by a wide margin, the cheaper pathway. From a cardiology perspective, Dr Martin Mpe, president of the South African Heart Association, made the same point at the conference. He argued that the cheapest way to treat a heart attack is to prevent it, and that the system needs to start rewarding prevention rather than paying only for treatment after the fact.
Rather than expanding access, an outdated PMB framework has unintentionally limited it.
A PMB framework anchored in 1999-era diagnosis-and-treatment logic has little room for rewarding the prevention and early detection that would keep patients out of the expensive end of the system altogether. Importantly, reform does not mean stripping away protection. It means modernising the list so that mandatory cover reflects today’s clinical realities. It also means rethinking how the package is defined. The current approach is built around a long, condition-by-condition diagnostic list, a modern framework could instead focus on the essential health services people need most, including preventative care, primary healthcare services, medicines on an essential medicines list, and diagnostics on an essential diagnostics list. It could also emphasise the areas where the disease burden is greatest.
A core service package
This aligns closely with the Board of Healthcare Funders’ (BHF) recent commitment to explore a Core Service Package as a practical step towards universal health coverage. By focusing on the services that deliver the greatest health benefit within available resources, such an approach would place prevention and patients at the centre of the health system while creating greater flexibility to expand affordable access.
The BHF has previously worked to operationalise South Africa’s national Essential Medicines List (EML) within the private funding environment, partnering with MediKredit in 2021 to launch a NAPPI-coded mapping tool that helps funders align benefit design and claims systems with the EML, improve medicine access, and reduce out-of-pocket costs. This existing groundwork offers an affordable, prevention-oriented foundation on which a modernised PMB package could be built.
The evidence of where the current framework falls short is already available. Annually, the Council for Medical Schemes reports on out-of-pocket expenditure, which exceeded R40 billion last year. When people spend that much of their own money on healthcare, over and above their contributions, they are pointing directly to where their cover is failing.
A broader set of changes
PMB reform does not stand alone, and it will not by itself fix affordability. It is the entry point to a broader set of changes that reinforce one another. The most important of these is regulated tariff reform. South Africa currently lacks a transparent, predictable mechanism for setting provider prices, and this absence has driven costs upward for years. Allowing schemes and willing providers to negotiate fair tariffs, within a properly regulated framework, published for transparency, would bring discipline and predictability to pricing and give members clarity on what they are paying for.
Alongside this, permitting schemes to offer low-cost benefit options, a subset of the proposed revised PMBs and based on services rendered in the public sector clinics, would extend affordable, primary-care-based cover to millions of people in South Africa who currently fall outside the system and pay out-of-pocket for private care.
None of these reforms require new legislation or a wholesale restructuring of the health system. They can be pursued within the existing regulatory framework, and PMB modernisation is the logical place to begin, because it addresses the highest single cost in every member’s contribution and unlocks the room to fund better, more preventive care.
For members, this shift would be felt less as a change to their PMB entitlements and more as a change in what their contribution actually buys before a crisis ever occurs. Money currently locked into funding late-stage, high-cost treatment for conditions that could often have been caught earlier could instead support routine age- and risk-appropriate cancer screenings, cardiovascular risk assessments and blood pressure checks, diabetes screening and management support, and the kind of primary care consultations that catch problems while they are still cheap and simple to treat. None of this is about giving members less. It is about intervening earlier, so that fewer members ever need the R100 000 radiation course, the R200 000 chemotherapy regimen, or the cardiac admission that better screening or blood pressure control could have prevented.
There is an understandable reluctance to reopen the PMB framework, given how long the review has already taken and how contested the terrain can be. The longer reform is delayed, the greater the affordability pressures on households and the greater the strain on the broader health system.
Reforming prescribed minimum benefits is ultimately about far more than updating a list of conditions. It is about creating the flexibility to expand access, strengthen prevention and make medical scheme cover affordable for more people in South Africa.
*Mothudi is the Managing Director of the Board of Healthcare Funders, which represents around 45 medical aid schemes in South Africa, including GEMS and Bonitas.
*This piece was published by Spotlight – health journalism in the public interest. 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.
Navigating patient confidentiality, social media and professional boundaries
Photo by National Cancer Institute on Unsplash
Thursday 13th August 2026
18:00 – 19:45
Earn 2 ethics CPD points
During this webinar, the HPCSA Booklet 5: Confidentiality – Protecting and Providing Information and HPCSA Booklet 16: Ethical Guidelines on social media will be explored from a South African legal and ethical practice perspective. The webinar will offer insights into the complexities of digital communication, including WhatsApp and social media use, consent, online reviews and cybersecurity, while focusing on protecting patient confidentiality and public trust across all forms of communication.
The audience will have an opportunity to listen and engage with clinical, legal and medicolegal subject matter experts. During the webinar, a range of learning opportunities will be offered including short lectures, interactive case studies, audience polling and Q&A.
This webinar will focus on healthcare practitioners engaging in digital communication with patients and colleagues. Administrative staff working in these practices are welcome to join the discussion.
Joining us as panellists will be Emma Sadleir, South Africa’s leading expert on social media law, and Dr Isabel do Vale, a practising medical practitioner and President-elect of APRASSA. Attendance will qualify for 2 Ethics CPD points and EthiQal Recognition Programme points.
