A research team at Saarland University has demonstrated in a clinical study that a widely used anti-allergy nasal spray containing the active ingredient azelastine can significantly reduce the risk of infection with the SARS-CoV-2 virus. The results of the placebo-controlled trial involving 450 healthy participants have now been published in JAMA Internal Medicine.
The trial, led by Professor Robert Bals, Director of the Department of Internal Medicine V at Saarland University Medical Center and Professor of Internal Medicine at Saarland University, divided the 450 participants into two groups. The treatment group of 227 individuals used an azelastine nasal spray three times a day over a 56-day period. During that same period, the 223 participants in the control group used a placebo spray three times a day. Robert Bals summarised the key finding as follows: ‘During the observation period, 2.2% of the participants in the azelastine group became infected with SARS-CoV-2; in the placebo group, it was 6.7%—three times as many.’ All infections were confirmed by PCR testing.
In addition to showing a marked reduction in coronavirus infections, the azelastine group also displayed fewer symptomatic SARS-CoV-2 infections, a lower overall number of confirmed respiratory infections, and, unexpectedly, a reduced incidence of rhinovirus infections, another major cause of respiratory illness. In the treatment group, 1.8% developed a rhinovirus infection, compared to 6.3% in the placebo group—a proportion similar to that seen for SARS-CoV-2.
Azelastine nasal spray has been available for decades as an over-the-counter treatment for hay fever. Previous in vitro studies on azelastine had already suggested antiviral effects against SARS-CoV-2 and other respiratory viruses. ‘This clinical trial is the first to demonstrate a protective effect in a real-world setting,’ says Professor Bals.
For Robert Bals, the results suggest practical applications: ‘Azelastine nasal spray could provide an additional easily accessible prophylactic to complement existing protective measures, especially for vulnerable groups, during periods of high infection rates, or before travelling.’ But Professor Bals also stressed the importance of further research: ‘Our results highlight the need for larger, multicentre trials to continue exploring the use of azelastine nasal sprays as an on-demand preventive treatment, and to examine its potential effectiveness against other respiratory pathogens.’
Besides Professor Bals, the randomised, double-blind phase 2 study ‘CONTAIN’ also involved the Institute of Clinical Pharmacy (Professor Thorsten Lehr, Dr. Dominik Selzer), the Institute of Virology (Professor Sigrun Smola), and the Saarbrücken-based pharmaceutical company URSAPHARM Arzneimittel GmbH, which sponsored the study and manufactured the investigational product. The Helmholtz Institute for Pharmaceutical Research Saarland (HIPS) contributed through the research groups of Professor Smola and Professor Bals. The project serves as an excellent example of successful collaboration between academic research, industry partners and public health initiatives in the Saarland region.
Blood pressure matters at all ages. Children with higher blood pressure at age 7 may be at an increased risk of dying of cardiovascular disease by their mid-50s, according to preliminary research presented at the American Heart Association’s Hypertension Scientific Sessions 2025. The study is simultaneously published in JAMA.
“We were surprised to find that high blood pressure in childhood was linked to serious health conditions many years later. Specifically, having hypertension or elevated blood pressure as a child may increase the risk of death by 40% to 50% over the next five decades of an individual’s life,” said Alexa Freedman, Ph.D., lead author of the study and an assistant professor in the department of preventive medicine at the Northwestern University’s Feinberg School of Medicine in Chicago. “Our results highlight the importance of screening for blood pressure in childhood and focusing on strategies to promote optimal cardiovascular health beginning in childhood.”
Previous research has shown that childhood blood pressure is associated with an increased risk of cardiovascular disease in adulthood, and a 2022 study found that elevated blood pressure in older children (average age of 12 years) increased the risk of cardiovascular death by middle age (average age of 46 years). The current study is the first to investigate the impact of both systolic (top number) and diastolic (bottom number) blood pressure in childhood on long-term cardiovascular death risk in a diverse group of children. Clinical practice guidelines from the American Academy of Pediatrics recommend checking blood pressure at annual well-child pediatric appointments starting at age 3 years.
“The results of this study support monitoring blood pressure as an important metric of cardiovascular health in childhood,” said Bonita Falkner, MD, FAHA, an American Heart Association volunteer expert. “Moreover, the results of this study and other older child cohort studies with potential follow-up in adulthood will contribute to a more accurate definition of abnormal blood pressure and hypertension in childhood.” Falkner, who was not involved in this study, is emeritus professor of paediatrics and medicine at Thomas Jefferson University.
The researchers used the National Death Index to follow up on the survival or cause of death as of 2016 for approximately 38,000 children who had their blood pressures taken at age 7 years as part of the Collaborative Perinatal Project (CPP), the largest US study to document the influence of pregnancy and post-natal factors on the health of children. Blood pressure measured in the children at age 7 years were converted to age-, sex-, and height-specific percentiles according to the American Academy of Pediatrics clinical practice guidelines. The analysis accounted for demographic factors as well as for childhood body mass index, to ensure that the findings were related to childhood blood pressure itself rather than a reflection of children who were overweight or had obesity.
After follow-up through an average age of 54 years, the analysis found:
Children who had higher blood pressure (age-, sex-, and height-specific systolic or diastolic blood pressure percentile) at age 7 were more likely to die early from cardiovascular disease as adults by their mid-50s. The risk was highest for children whose blood pressure measurements were in the top 10% for their age, sex and height.
By 2016, a total of 2,837 participants died, with 504 of those deaths attributed to cardiovascular disease.
Both elevated blood pressure (90-94th percentile) and hypertension (≥ 95th percentile) were linked with about a 40% to 50% higher risk of early cardiovascular death in adulthood.
Moderate elevations in blood pressure were also important, even among children whose blood pressure was still within the normal range. Children who had blood pressures that were moderately higher than average had a 13% (for systolic) and 18% (for diastolic) higher risk of premature cardiovascular death.
Analysis of the 150 clusters of siblings in the CPP found that children with the higher blood pressure at age 7 had similar increases in risk of cardiovascular death when compared to their siblings with the lower blood pressure readings (15% increase for systolic and 19% for diastolic), indicating that their shared family and early childhood environment could not fully explain the impact of blood pressure.
“Even in childhood, blood pressure numbers are important because high blood pressure in children can have serious consequences throughout their lives. It is crucial to be aware of your child’s blood pressure readings,” Freedman said.
The study has several limitations, primarily that the analysis included one, single blood pressure measurement for the children at age seven, which may not capture variability or long-term patterns in childhood blood pressure. In addition, participants in the CPP were primarily Black or white, therefore the study’s findings may not be generalisable to children of other racial or ethnic groups. Also, children today are likely to have different lifestyles and environmental exposures than the children who participated in the CPP in the 1960s and 1970s.
Study details, background and design:
38 252 children born to mothers enrolled at one of 12 sites across the U.S. as part of the Collaborative Perinatal Project between 1959-1965. 50.7% of participants were male; 49.4% of mothers self-identified as Black, 46.4% reported as white; and 4.2% of participants were Hispanic, Asian or other groups.
This analysis reviewed blood pressure taken at age 7, and these measures were converted to age-, sex-, and height-specific percentiles according to the American Academy of Pediatrics Clinical Practice Guideline for Screening and Management of High Blood Pressure in Children and Adolescents.
Survival through 2016 and the cause of death for the offspring of CPP participants in adulthood were retrieved through the National Death Index.
Survival analysis was used to estimate the association between childhood blood pressure and cardiovascular death, adjusted for childhood body mass index, study site, and mother’s race, education and marital status.
In addition, the sample included 150 groups of siblings, and the researchers examined whether the sibling with higher blood pressure was more likely to die of cardiovascular disease than the sibling with lower blood pressure. This sibling analysis allowed researchers to ask how much shared family and early childhood factors might account for the mortality risk related to blood pressure.
The health department has plans to roll out lenacapavir, a twice-yearly HIV prevention injection, in a select group of public sector clinics by April 2026. Meanwhile, little progress has been made towards rolling out a two-monthly prevention injection, despite the four-year head start this product had on lenacapavir.
Injections that provide months of protection at a time against HIV infection have been hailed by several leading experts as game-changers with the potential to help end the HIV epidemic.
The two antiretroviral-containing injections leading the field are long-acting cabotegravir (CAB-LA) and lenacapavir. Both have been shown to effectively eliminate the risk of contracting HIV in large clinical trials. The main difference between the two shots is that CAB-LA provides two months of protection at a time, while lenacapavir provides six.
CAB-LA captured global attention back in 2020 when pivotal trial results showed that the two-monthly injection was more effective than daily prevention pills in preventing HIV infection. Lenacapavir was thrust into the spotlight four years later in 2024 when two large trials demonstrated that the twice-yearly injection provided almost perfect protection against HIV.
There are still no clear plans for providing CAB-LA in South Africa’s public sector clinics, despite the four-year head start that it had on lenacapavir. By contrast, lenacapavir injections could be available in some select public sector clinics by April of next year, according to reporting by Bhekisisa.
How CAB-LA fell behind
In July 2022, the World Health Organization (WHO) recommended CAB-LA as a tool to prevent HIV and by December 2022 it was registered for use in South Africa.
In February 2023 though, South Africa’s National Essential Medicines Committee stated that it could not recommend the use of CAB-LA in the country because the medicine’s manufacturer, ViiV Healthcare, had yet to share how much it would charge the country for the shots.
It was only in late 2023 that ViiV provided pricing details for public sector procurement in certain low-and middle- income countries, including South Africa. That price was around R540 ($30) per dose or R3 240 ($180) per person per year, which the health department said was unaffordable for the country.
The price has since dropped slightly to around R2 880 ($160) per person per year, Mitchell Warren, from the US-based HIV advocacy organisation AVAC, told Spotlight.
In 2024, the health department requested further details from ViiV on its CAB-LA pricing but there is no indication that any progress has been made towards securing a lower price and enabling local procurement of CAB-LA for public sector facilities.
Khadija Jamaloodien, the top official for health products procurement in the National Department of Health, told Spotlight the department could not comment on whether there have been any developments towards local procurement of CAB-LA.
A spokesperson for ViiV told Spotlight: “We have not received any orders to date for CAB-LA for PrEP to supply to South Africa”. PrEP, or pre-exposure prophylaxis, refers to taking an injection to prevent HIV infection.
What about CAB-LA in the private sector?
For those using private healthcare in South Africa, CAB-LA also remains inaccessible. ViiV has not launched CAB-LA in the private sector or disclosed the price at which it will sell CAB-LA through private pharmacies.
ViiV did not respond to Spotlight’s questions regarding its plans and timelines for launching CAB-LA in the country’s private sector.
PEPFAR steps in, but doesn’t deliver
After the health department balked at ViiV’s CAB-LA price for the public sector, the United States President’s Emergency Plan for AIDS Relief (PEPFAR) announced plans to kick start the rollout of CAB-LA in South Africa and some other African countries.
PEPFAR pledged to buy CAB-LA from ViiV for donation to ten African countries during 2024 and 2025. The largest donation of 231 000 CAB-LA doses was designated for South Africa.
While some of the PEPFAR-donated stock began reaching countries before the Trump administration halted foreign aid on 20 January, according to Warren, South Africa never received any of the promised doses.
These donations are no longer expected, given cuts to the agency’s capacity and budget under the Trump administration.
The US State Department did not respond to Spotlight’s questions seeking confirmation that the CAB-LA donations would no longer be delivered, but our health department told Spotlight it doesn’t expect to receive this donation.
Gilead leapfrogs ViiV
Amid the delays and uncertainty surrounding CAB-LA’s pricing and rollout, Gilead, the company that manufactures lenacapavir, has positioned their product to become the first long-acting injectable form of HIV prevention available at any real scale in South Africa.
While lenacapavir is not yet registered in South Africa, Hasina Subedar, the senior technical advisor for HIV prevention in the National Department of Health, told Bhekisisa that it plans to start rolling out lenacapavir in 300 public clinics by April 2026 – less than 10% of the well over 3000 clinics in the country.
SAHPRA authorisation is expected to be granted in the coming months, as lenacapavir has already been recommended for marketing authorisation through the EU medicines for all (EU-M4All) initiative – a process which includes regulators from South Africa. In addition to securing local registration, lenacapavir must also receive a positive recommendation from South Africa’s National Essential Medicines List Committee to enable its rollout.
Gilead has secured a deal with the Global Fund for HIV, TB and Malaria, as well as private donors, that will allow lenacapavir to be rolled out in eight African countries, including in South Africa at a cost to country of R1080 ($60) per person per year.
Under this deal, private donations from the Children’s Investment Fund Foundation (CIFF) will also contribute toward procurement of lenacapavir. CIFF contributions will be above and beyond the $60 contributed by countries per person per year.
While the amount that Gilead will recoup for a year’s supply of lenacapavir under the deal has not been disclosed, it is speculated to be between R1800 ($100) and R2 160 ($120), according to Warren.
He added that Gilead’s deal with the Global Fund will allow countries to begin budgeting and planning for lenacapavir’s rollout using Gilead’s product while they await availability of more affordable generic products in a few years’ time.
The lack of transparency around Gilead’s pricing is uncommon in South Africa, which has strong legal requirements for medicine price transparency. Despite transparency concerns, the National Department of Health has indicated that they will participate in Gilead’s Global Fund arrangement.
By keeping the price secret, two advocacy groups, the Health Justice Initiative and Health Gap, have argued that the deal will undermine efforts in countries not included in the arrangement to negotiate and secure affordable pricing of lenacapavir.
Are HIV prevention injections cost effective for South Africa?
Local researchers have crunched the numbers to establish whether CAB-LA and lenacapavir offer good value for money.
These analyses compared the cost-effectiveness of HIV injections to the widely available prevention pills in public clinics, Lise Jamieson, senior researcher at WITS HE2RO, told Spotlight
The prevention pills provided by the National Department of Health are purchased for R1000 per person per year, said Jamaloodien.
Jamieson said that, according to modelling, prevention injections will avert more HIV infections than prevention pills. Generally speaking, products that provide protection for longer periods are more effective since their efficacy is less dependent on people regularly taking pills or going to the clinic to get an injection. We can thus accept a higher price for lenacapavir (providing six month of protection) than for CAB-LA (only two months of protection) because modelling indicates that this product will avert more HIV infections and delivers more treatment cost savings over time.
Jamieson said according to the latest iteration of their cost-effectiveness modelling, which has not yet been published, CAB-LA needs to be capped around R1800 ($100) per person per year to be cost effective, while lenacapavir needs to be capped around R3600 ($170) per person per year.
Based on this analysis, for South Africa to roll out lenacapavir at $60 per person per year is highly cost-effective, while buying CAB-LA at $160 per person per year is not cost-effective.
Lenacapavir use also requires fewer clinic visits per year than CAB-LA (two versus six) which places less of a strain on health facilities and providers.
Cheaper generic versions of lenacapavir and CAB-LA are expected to become available in 2027.
Lenacapavir generics, Warren said, are expected to enter the market around the same time as generic CAB-LA despite CAB-LA’s initial head start. This is because Gilead was quicker to license generic manufacturers and used a faster licensing approach than ViiV, he added.
Compared to CAB-LA, Warren said it would be faster to show that the generic version of lenacapavir works the same as the original – a necessary step before generic products can be approved. Added to this, he noted that generic companies would likely move faster to bring lenacapavir to market because buyers showed more interest in it.
How will procurement of lenacapavir be funded?
While lenacapavir is cost effective for South Africa at $60 per person per year, purchasing it may nevertheless be challenging given the country’s tight healthcare budget.
HIV prevention pills are procured domestically in South Africa, but Jamieson said the country will need additional funds or donor support to roll out lenacapavir.
The National Department of Health and the Global Fund agreed to allocate R520 million of the country’s Global Fund grant towards buying lenacapavir, Bhekisisa reported in July. This allocation will allow more than 450 000 people in the country to access lenacapavir over the next three years.
Can lenacapavir turn the tide on the epidemic?
In addition to looking at the cost-effectiveness of long acting injectables, Jamieson and her colleagues have modelled how the rollout of injectable HIV prevention options will impact new HIV infections in the country.
Jamieson said if South Africa initiates roughly 1 million people on lenacapavir over the next year and then increase access to reach 4 million people in the next 20 years, HIV incidence could fall below 0.1% by 2038 – with a projected 3.5 million people on lenacapavir by then. At this level, the country would effectively end the HIV epidemic.
Scaling up lenacapavir to this level will require significant political will and additional investment above and beyond what has already been committed by the Global Fund.
Meanwhile, researchers are working on new versions of lenacapavir and CAB-LA that could double the length of protection offered by each.
As Spotlight previously reported, there are promising signs for a lenacapavir formulation that could provide 12 months of protection as opposed to the current six, and a CAB-LA formulation that could provide four months of protection rather than two. HIV prevention tablets that provide a month of protection at a time are also under development. It however remains to be seen whether these new formulations will succeed in the pivotal clinical trials testing their safety and effectiveness.
AI-based medicine will revolutionise care including for Alzheimer’s and diabetes, predicts a technology expert, but it must be accessible to all patients
AI image created with Gencraft
Healing with Artificial Intelligence, written by technology expert Daniele Caligiore, uses the latest science research to highlight key innovations assisted by AI such as diagnostic imaging and surgical robots.
From exoskeletons that help spinal injury patients walk to algorithms that can predict the onset of dementia years in advance, Caligiore explores what he describes as a ‘revolution’ that will change healthcare forever.
Economically, the market for AI in healthcare is experiencing rapid growth, with forecasts predicting an increase in value from around USD 11 billion in 2021 to nearly USD 188 billion by 2030, reflecting an annual growth rate of 37%. AI is already being used in some countries, for example to search through genetic data for disease markers, or to assist with scheduling and other administrative tasks – and this trend is set to continue.
However, the author caveats his predictions of progress by warning these technologies may widen existing inequality. Caligiore suggests that AI-based medicine must be available to all people, regardless of where they live or how much they earn, and that people from low-income nations must not be excluded from cutting-edge care which wealthier nations can access.
Other challenges posed by the advancement of AI in healthcare includes who takes responsibility for treatment decisions, especially when a procedure goes wrong. This is a particular challenge given widespread concerns around explainable AI, as many advanced AI systems operate as black boxes, making decisions through complex processes that even their creators cannot fully understand or explain.
Caligiore says AI should support doctors and patients, not replace doctors who, says the author, have a ‘unique ability to offer empathy, understanding, and emotional support’.
“AI should be viewed as a tool, not a colleague, and it should always be seen as a support, never a replacement,” writes Caligiore.
“It is important to find the right balance in using AI tools, both for doctors and patients. Patients can use AI to learn more about their health, such as what diseases may be associated with their symptoms or what lifestyle changes may help prevent illness. However, this does not mean AI should replace doctors.”
Despite his warnings, Caligiore is largely optimistic about the impact of AI in healthcare: “Like a microscope detecting damaged cells or a map highlighting brain activity during specific tasks, AI can uncover valuable insights that might go unnoticed, aiding in more accurate and personalized diagnoses and treatments,” he says.
In any case, Caligiore predicts the healthcare landscape will look ‘dramatically different’ in a few years, with technology acting as a ‘magnifying glass for medicine’ to enable doctors to observe the human body with greater precision and detail.
Examples of where AI will make profound impacts in healthcare include, regenerative medicine, where gene and stem cell therapies repair damaged cells and organs. Spinal cord injury patients are among those who could benefit.
AI may also provide personalised therapies, suggesting treatments tailored to specific individuals often based on their unique genetic profile. Studies are being conducted into targeting different tremor types in Parkinson’s and breast cancer subtypes
The convergence of regenerative medicine, genetically modified organisms (GMOs), and AI is the next frontier in medicine, Caligiore suggests. Genetically modified organisms (GMOs), living organisms whose genetic material has been altered through genetic engineering techniques, have already paved the way for personalised gene therapies.
Blending real and virtual worlds may also prove useful to healthcare, for example the ‘metaverse’ – group therapy where patients participate with an avatar, or ‘digital twins’ – AI simulations of a patient’s body and brain on a computer so doctors can identify underlying causes of disease and simulate the effects of various therapies for specific patients to help doctors make more informed decisions.
These advances and others will reshape the doctor-patient relationship, according to Healing with Artificial Intelligence, but the author suggests the key is for patients and clinicians to keep a critical mindset about AI.
Caligiore warns that role of physicians will evolve as AI becomes more integrated into healthcare but the need for human interactions will remain ‘central to patient care’.
“While healthcare professionals must develop technical skills to use AI tools, they should also nurture and enhance qualities that AI cannot replicate – such as soft skills and emotional intelligence. These human traits are essential for introducing an emotional component into work environments,” he explains.
In this month’s podcast, QuickNews looks at a new Lancet study, “Non-autoimmune, insulin-deficient diabetes in children and young adults in Africa.” In this study, researchers report that a significant subset of what has previously been classified as Type 1 diabetes in sub-Saharan Africa may in fact be a distinct, novel form of the disease.
The individuals in this subset did not exhibit the typical autoimmune markers (islet autoantibodies) usually found in classic Type 1 diabetes in other parts of the world. The researchers instead identified a novel, non-autoimmune, insulin-deficient subtype of diabetes that is also distinct from Type 2 diabetes.
Further evidence of this new subtype was found in Black individuals in the USA, albeit less frequently, but not in White individuals. The discovery throws a spotlight on the heterogeneity of diabetes diagnoses in sub-Saharan Africa, and points to the need to consider alternative causes and explore new prevention and treatment strategies for this distinct form of the disease.
