Tag: 3/8/26

Early Vitrectomy for Bacterial Eye Infection Offers Hope to Patients

Photo: Unsplash

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.”

Source: World Association of Eye Hospitals

Dr Hermann Reuter Says the Biggest Battle after HIV in SA is Addiction – and It Is Being Ignored

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.”

This article was first published by Spotlight – health journalism in the public interest. Sign up to the Spotlight newsletter.

Somatic Mutations Linked to Vascular Damage in Progeria

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.

Source: Karolinska Institutet

Leg Ulcer Wraps Offer No Healing Advantage, Trial Finds

Photo by Etactics Inc on Unsplash

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 trialVenUS6  is published in Trials https://doi.org/10.1186/s13063-023-07681-7

Source: University of Manchester

Another HIV Treatment Option – but with Less Weight Gain

SA study finds doravirine works as well as dolutegravir to supress HIV viral load, enabling choice for those living with HIV.

Photo by Miguel Á. Padriñán

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.

Read the full story from Wits University.