Difficulty Sleeping Linked to Indicators of Poor Cardiometabolic Health

Sleeping man
Photo by Mert Kahveci on Unsplash

In the first study of its kind, University of South Australia researchers report that people who reported trouble sleeping were on average more likely to have indicators of poor cardiometabolic health – inflammatory markers, cholesterol and body weight – which can contribute to type 2 diabetes. The study was published in The Science of Diabetes Self-Management and Care.

Type 2 diabetes affects more than 422 million people around the globe.

As the Christmas season starts to ramp up, the UniSA researchers are reminding people to prioritise a good night’s sleep as new research shows that a troubled sleep may be associated with risk factors for type 2 diabetes.

UniSA researcher Dr Lisa Matricciani says different aspects of sleep are associated with risk factors for diabetes.

“Everyone knows that sleep is important. But when we think about sleep, we mainly focus on how many hours of sleep we get, when we should also be looking at our sleep experience as a whole,” Dr Matricciani says.

“How soundly we sleep, when we go to bed and get up, and how regular our sleep habits are, may be just as important as sleep duration.”

“In this study, we examined the association of different aspects of sleep, and risk factors for diabetes, and found a connection between those who had troubled sleep and those who were at risk of type 2 diabetes.”

The study assessed more than 1000 Australian adults* with a median age of 44.8 years. Researchers examined a range of sleep characteristics: self-report trouble sleeping, duration, timing, efficiency, and day-to-day sleep length variability.

“People who reported having trouble sleeping were also more likely to have a higher body mass index, as well as blood markers of cholesterol and inflammation,” Dr Matricciani says.

“When it comes down to the crunch, we know we must prioritise our sleep to help stay in good health. More research is needed, but as this study shows, it’s important to think about sleep as a whole, not just as one aspect.”

Notes

  • *Most participants (87%) were mothers.
  • 48% of all participants reported that they never had troubled sleep.

Source: University of South Australia

Injections against HIV could be Manufactured Locally and Cheaply, Says Aspen Pharmacare

Female scientist in laboratory
Photo by Gustavo Fring on Pexels

In 2020, pharmaceutical company ViiV Healthcare announced that a bimonthly injection of its new drug, cabotegravir, prevents HIV infection. More than two years later, the drug is still unaffordable in countries where HIV is highly prevalent.

Local medicines manufacturer Aspen Pharmacare says that licences should be given to African producers so that cabotegravir can be made more affordable and accessible.

Cabotegravir can be used to prevent HIV infection. This is known as Pre-Exposure Prophylaxis, or PreP. Currently, PrEP is only available in pill form and has to be taken daily. A bimonthly injection is an appealing alternative that, if made widely available, can make a big dent in the HIV infection rate. 

Globally, 1.5-million people are infected with HIV and about 650,000 people die of AIDS every year. UNAIDS’s target of reducing annual infections to fewer than 500,000 by 2020 was not reached. It is widely accepted among experts that prevention as well as treatment is necessary to end the epidemic.

Although the World Health Organisation has recommended cabotegravir for PrEP, it is unaffordable, especially in developing countries where HIV is most prevalent. The Clinton Health Access Initiative (CHAI) has estimated that cabotegravir could be manufactured for just over $65 (R1100) a year.

According to The Guardian, ViiV’s not-for-profit price for cabotegravir is estimated to be $240-$270 (R4,059-R4,567) for a full year’s supply for one patient.

But in the United States, a full year’s supply for one person of cabotegravir is sold for more than $22,000 (R370,000). In the UK a year’s supply is $9,275.

In comparison, oral PrEP costs about R686 for a full year’s supply for one patient in South Africa. Cabotegravir is not yet approved by the South African Health Products Regulatory Authority.

Stavros Nicolaou, group senior executive strategic trade at Aspen Pharmacare, says that there is local capability to manufacture cabotegravir but licences have not yet been granted. The company invested heavily in sterile equipment, needed to produce injections, during the Covid-19 pandemic. This can be used to produce cabotegravir.

Aspen is the biggest producer of antiretrovirals (ARVs) in Africa. Nicolaou says that giving licences to African producers is crucial to ensuring the equitable supply of medication.

ViiV has committed to allowing generic versions of the drug to be manufactured but has said that the process is complicated. Cabotegravir is currently only manufactured at one site in the UK.

In July, activists interrupted presentations during the AIDS 2022 conference in Montreal, calling on ViiV to lower the price of cabotegravir. Doctors Without Borders (Médecins Sans Frontières) has urged ViiV to make the drug available in high-prevalence countries and to be more transparent about its pricing and manufacturing process.

ViiV has come to an agreement with the Medicines Patent Pool (MPP), a nonprofit organisation that will facilitate the process of awarding licences to manufacturers.

But Dr Andrew Hill from the Department of Pharmacology at the University of Liverpool says that the agreement is highly restrictive.

Hill says that many countries have been excluded from the list, particularly those in South America and Asia, including those with high HIV infection rates.

He says that most of the world’s population could be reached if cabotegravir was made available at the CHAI price of $65 (R1100) per patient per year. That it is not yet widely available is a “failure of public health”, he told GroundUp.

In South Africa, where just under 14% of the population has HIV, the announcement of cabotegravir two years ago was widely celebrated among clinicians.

The researchers we spoke to suggest that the uptake of cabotegravir would be higher than that of PreP tablets and so it would be more effective. Most new infections in Sub-Saharan Africa are among women and adolescent girls. Cabotegravir offers them a discreet alternative and one that doesn’t require daily adherence.

“It’s very frustrating,” says Juliet Houghton, CEO of the Southern African HIV Clinicians Society. Houghton says that if cabotegravir can be rolled out in pharmacies across the country, with pharmacists allowed to administer it, it will greatly increase the uptake of PrEP and reduce infections.

“We can’t just keep treating people for HIV,” Houghton says. “Prevention has to be the way forward.”

“We need to look at PreP closer to the way we look at contraception,” says Andy Gray, senior lecturer in Pharmacology at the University of KwaZulu-Natal. Offering more choices that fit into a variety of lifestyles is likely to improve the uptake of PrEP, he says.

Dr Yogan Pillay, country director for CHAI, says that governments and civil organisations need to pressure ViiV and MPP to increase the availability of cabotegravir.

“That 82% of the 250 000 adolescent girls and women that acquired HIV in 2021 are in Sub-Saharan Africa makes it imperative that cabotegravir is made available at an affordable price as soon as possible,” Pillay says.

“We need this drug, we need it now, and we need truckloads,” says Professor Francois Venter, executive director of Ezintsha at Wits. “It works very well. It is safe. And while we still have to figure out how to use it best, we can’t do that with nothing in hand.”

A spokesperson for ViiV Healthcare told GroundUp: “We believe cabotegravir long-acting (LA) for PrEP has the potential to change the shape of the HIV epidemic and we are ambitious for the impact we can have together with global health partners to bring this medicine to those who need it.”

ViiV says that at first, three generic manufacturers will be selected by MPP.

“Enabling up to three generics in the first instance allows for competition but avoids a fractured market with too many manufacturers and a risk of there not being enough demand to sustain the long-term manufacturing commitments to be made by licensees,” ViiV said.

ViiV also said they are working with various partners to ensure that Cabotogrevir is accessible to countries in Sub-Sarahan Africa.

“We know that affordability is a real challenge in these countries, and we are working with our partners to look at affordable pricing, demand and innovative funding mechanisms to help enable access for people who could benefit from PrEP,” ViiV said.

ViiV says that CHAI’s price estimation is unrealistic because of the complexity of the manufacturing process.

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Source: GroundUp

Scientists Unravel The Neurology Underlying Soothing Touch

Man wearing mask with headache
Source: Usman Yousaf on Unsplash

People can achieve some pain relief by rubbing or pressing a part of their body associated with the pain. Observing for the first time how this phenomenon plays out in the brains of mice, MIT scientists suggest that pain-responsive cells in the brain quiet down when these neurons also receive touch inputs.

The team’s discovery, reported in the journal Science Advances, offers researchers a deeper understanding of the complicated relationship between pain and touch and could offer some insights into chronic pain in humans. “We’re interested in this because it’s a common human experience,” says investigator Fan Wang. “When some part of your body hurts, you rub it, right? We know touch can alleviate pain in this way.” But, she says, the phenomenon has been very difficult for neuroscientists to study.

Modelling pain relief

The spinal cord may be where touch-mediated pain relief begins, as prior studies have found pain-responsive neurons that reduce activity in response to touch. But there have been hints that the brain was involved, too. Wang says this aspect of the response has been largely unexplored, because it can be hard to monitor the brain’s response to painful stimuli amidst all the other neural activity happening there. particularly when an animal moves.

So while her team knew that mice respond to a potentially painful stimulus on the cheek by wiping their faces with their paws, they couldn’t follow the specific pain response in the animals’ brains to see if that rubbing helped settle it down. “If you look at the brain when an animal is rubbing the face, movement and touch signals completely overwhelm any possible pain signal,” Wang explains.

She and her colleagues have found a way around this obstacle. Instead of studying the effects of face-rubbing, they have focused their attention on a subtler form of touch: the gentle vibrations produced by the movement of the animals’ whiskers. Mice use their whiskers to explore, moving them back and forth in a rhythmic motion known as whisking to feel out their environment. This motion activates touch receptors in the face and sends information to the brain in the form of vibrotactile signals. The human brain receives the same kind of touch signals when a person shakes their hand as they pull it back from a painfully hot pan — another way we seek touch-mediate pain relief.

Whisking away pain

Wang and her colleagues found that this whisker movement alters the way mice respond to bothersome heat or a poke on the face – both of which usually lead to face rubbing. “When the unpleasant stimuli were applied in the presence of their self-generated vibrotactile whisking … they respond much less,” she says. Sometimes, she says, whisking animals entirely ignore these painful stimuli.

In the brain’s somatosensory cortex, where touch and pain signals are processed, the team found signalling changes that seem to underlie this effect. “The cells that preferentially respond to heat and poking are less frequently activated when the mice are whisking,” Wang says. “They’re less likely to show responses to painful stimuli.” Even when whisking animals did rub their faces in response to painful stimuli, the team found that neurons in the brain took longer to adopt the firing patterns associated with that rubbing movement. “When there is a pain stimulation, usually the trajectory the population dynamics quickly moved to wiping. But if you already have whisking, that takes much longer,” Wang says.

Wang notes that even in the fraction of a second before provoked mice begin rubbing their faces, when the animals are relatively still, it can be difficult to sort out which brain signals are related to perceiving heat and poking and which are involved in whisker movement. Her team developed computational tools to disentangle these, and are hoping other neuroscientists will use the new algorithms to make sense of their own data.

Whisking’s effects on pain signalling seem to depend on dedicated touch-processing circuitry that sends tactile information to the somatosensory cortex from the ventral posterior thalamus. When that pathway was blocked, whisking no longer dampened the animals’ response to painful stimuli. Now, Wang says, she and her team are eager to learn how this circuitry works with other parts of the brain to modulate the perception and response to painful stimuli.

The new findings might shed light on a condition called thalamic pain syndrome, a chronic pain disorder that can develop in patients after a stroke that affects the brain’s thalamus, says Wang. “Such strokes may impair the functions of thalamic circuits that normally relay pure touch signals and dampen painful signals to the cortex.”

Source: MIT

Removing Tumours – Without the Scalpel

A novel technology described in the journal Nanoscale enables targeted destruction of cancerous tumours, via a combination of ultrasound and the injection of nanobubbles into the bloodstream. Unlike invasive treatment methods or the injection of microbubbles into the tumour itself, this latest technology enables the destruction of the tumour in a non-invasive manner.

Dr Tali Ilovitsh at Tel Aviv University said: “Our new technology makes it possible, in a relatively simple way, to inject nanobubbles into the bloodstream, which then congregate around ​​the cancerous tumour. After that, using a low-frequency ultrasound, we explode the nanobubbles, and thereby the tumour.”

At present, the usual cancer treatment is surgical removal of the tumour, in combination with complementary treatments such as chemotherapy and immunotherapy.

Therapeutic ultrasound to destroy the cancerous tumour is a non-invasive alternative to surgery, a method which comes with advantages and disadvantages. On the one hand, it allows for localised and focused treatment; the use of high-intensity ultrasound can produce thermal or mechanical effects by delivering powerful acoustic energy to a focal point with high spatial-temporal precision. This method has been used to effectively treat solid tumours deep within in the body. Moreover, it makes it possible to treat patients who are unfit for tumour resection surgery. The disadvantage is that the heat and high intensity of the ultrasound waves could cause damage to neighbouring healthy tissues.

Reducing off-target damage

In the current study, Dr Ilovitsh and her team sought to overcome this problem. In the experiment, which used an animal model, the researchers were able to destroy the tumour by injecting nanobubbles into the bloodstream (as opposed to what has been until now, which is the local injection of microbubbles into the tumour itself), in combination with low-frequency ultrasound waves, with minimal off-target effects.

“The combination of nanobubbles and low frequency ultrasound waves provides a more specific targeting of the area of the tumour, and reduces off-target toxicity,” explains Dr Ilovitsh.

“Applying the low frequency to the nanobubbles causes their extreme swelling and explosion, even at low pressures. This makes it possible to perform the mechanical destruction of the tumours at low-pressure thresholds.”

“Our method has the advantages of ultrasound, in that it is safe, cost-effective, and clinically available, and in addition, the use of nanobubbles facilitates the targeting of tumours because they can be observed with the help of ultrasound imaging.”

Dr Ilovitsh adds that the use of low-frequency ultrasound also increases the depth of penetration, minimises distortion and attenuation, and enlarges the focal point. “This can help in the treatment of tumours that are located deep with the body, and in addition facilitate the treatment of larger tumour volumes. The experiment was conducted in a breast cancer tumour lab model, but it is likely that the treatment will also be effective with other types of tumours, and in the future, also in humans.”

Source: Tel Aviv University

Hyperbaric Therapy Reduces Neuroinflammation in Autism

Depiction of a human brain
Image by Fakurian Design on Unsplash

A new study at Tel Aviv University showed significant improvements in social skills and the condition of the autistic brain through hyperbaric therapy. The study which is reported in the journal International Journal of Molecular Sciences, was conducted on lab models of autism.

Hyperbaric medicine, where patients sit in special high-pressure chambers while breathing pure oxygen, is considered safe and, besides treating decompression sickness in divers, is already in use for other conditions. The use of hyperbaric medicine to treat autism is contentious, with many holding that it is based on pseudoscience. In recent years, scientific evidence has been accumulating that unique protocols of hyperbaric treatments improve the supply of blood and oxygen to the brain, thereby improving brain function.

Changes observed in the brain included a reduction in neuroinflammation, which is known to be associated with autism. A significant improvement was also found in the social functioning of the animal models treated in the pressure chamber. The study’s success has many implications regarding the applicability and understanding of treating autism using pressure chamber therapy.

The breakthrough was led by doctoral student Inbar Fischer, from the laboratory of Dr Boaz Barak of Tel Aviv University.

Improved brain function

“The medical causes of autism are numerous and varied, and ultimately create the diverse autistic spectrum with which we are familiar,” explains Dr Barak. “About 20% of autistic cases today are explained by genetic causes, that is, those involving genetic defects, but not necessarily ones that are inherited from the parents. Despite the variety of sources of autism, the entire spectrum of behavioural problems associated with it are still included under the single broad heading of ‘autism,’ and the treatments and medications offered do not necessarily correspond directly to the reason why the autism developed.”

In the preliminary phase of the study, a girl carrying the mutation in the SHANK3 gene, which is known to lead to autism, received treatments in the pressure chamber, conducted by Prof Shai Efrati. After the treatments, it was evident that the girl’s social abilities and brain function had improved considerably.

In the next stage, and in order to comprehend the success of the treatment more deeply, the team of researchers at Dr Barak’s laboratory sought to understand what being in a pressurised chamber does to the brain. To this end, the researchers used lab models carrying the same genetic mutation in the SHANK3 gene as that carried by the girl who had been treated. The experiment comprised a protocol of 40 one-hour treatments in a pressure chamber over several weeks.

“We discovered that treatment in the oxygen-enriched pressure chamber reduces inflammation in the brain and leads to an increase in the expression of substances responsible for improving blood and oxygen supply to the brain, and therefore brain function,” explains Dr Barak. “In addition, we saw a decrease in the number of microglial cells, immune system cells that indicate inflammation, which is associated with autism.”

Increased social interest

“Beyond the neurological findings we discovered, what interested us more than anything was to see whether these improvements in the brain also led to an improvement in social behaviour, which is known to be impaired in autistic individuals,” adds Dr Barak. “To our surprise, the findings showed a significant improvement in the social behaviour of the animal models of autism that underwent treatment in the pressure chamber compared to those in the control group, who were exposed to air at normal pressure, and without oxygen enrichment. The animal models that underwent treatment displayed increased social interest, preferring to spend more time in the company of new animals to which they were exposed in comparison to the animal models from the control group.”

Inbar Fischer concludes, “the mutation in the animal models is identical to the mutation that exists in humans. Therefore, our research is likely to have clinical implications for improving the pathological condition of autism resulting from this genetic mutation, and likely also of autism stemming from other causes. Because the pressure chamber treatment is non-intrusive and has been found to be safe, our findings are encouraging and demonstrate that this treatment may improve these behavioral and neurological aspects in humans as well, in addition to offering a scientific explanation of how they occur in the brain.”

Source: Tel Aviv University

Down Syndrome Research Should Expand Focus to the Whole Cell

Human chorosomes. Source: NIH

Researchers propose in The American Journal of Human Genetics a new way of looking at Down syndrome, suggesting that when an extra chromosome is present, the impact on the cell depends less on which chromosome is duplicated and more on the presence of extra DNA.

“Understanding the complexity and general nature of disease phenotypes allows us to see a bigger picture and not get stuck focusing on a single gene, due to its presence on the extra chromosome,” says lead author Maria Krivega, developmental biologist at Heidelberg University.

Every cell starts out with extra chromosomes during early embryogenesis; however, this DNA gets sorted into pairs after about a week of growth. When this process goes awry, it often leads to death of the embryo, with only a few being able to survive with the extra DNA, like in the case of Down syndrome.

By taking a step back and looking at the entire cell, researchers were able to create a new understanding of these syndromes. Krivega and her collaborators took a critical look at recent evidence suggesting that Down syndrome phenotypes arise not only because of increased dosage of genes on chromosome 21 but also because of global effects of chromosome gain.

The researchers sifted through published datasets of proteins and RNA of individuals with Down syndrome and compared these to laboratory made cells with trisomies of chromosomes 3, 5, 12, and 21. What they found from this comparison was that it didn’t matter which chromosome was in excess, the cells all had decreased ability to replicate, survive, and maintain their DNA.

“We were interested to find out why cells with imbalanced chromosomal content – in other words, aneuploid – are capable of surviving,” says Krivega. “It was particularly exciting to me to learn if viable aneuploid embryonic cells have similarities with aneuploid cancer cells or cell lines, derived in the laboratory.”

Additionally, they found that the adaptive T cell immune system was underdeveloped in all cells, while the innate immune system seemed to be overactive. The authors suggest that this is a consequence of general chromosome gain. This research can be expanded into autoimmune diseases, such as Alzheimer disease or acute leukemias in trisomy chr. 8 or 21, that also exist without any connection to aneuploidy.

“We hope that our work elucidating a complex trisomy phenotype should help to improve such kids’ development,” says Krivega.

Source: Cell Press

Study Pushes Back Date of Omicron’s Origin

PCR device for detecting pathogens like SARS-CoV-2 (symbolic image) © Charité | Arne Sattler

Seemingly out of nowhere, the Omicron variant was first detected in South Africa and rapidly spread around the world. Now, a study published in the journal Science shows that Omicron’s predecessors existed on the African continent long before cases were first identified, suggesting that Omicron emerged gradually over several months in different countries across Africa.

Since the beginning of the pandemic, the coronavirus has been constantly changing. The biggest leap seen in the evolution of SARS-CoV-2 to date was observed by researchers a year ago, when a variant was discovered that differed from the genome of the original virus by more than 50 mutations. First detected in a patient in South Africa in mid-November 2021, the variant later named Omicron BA.1 spread to 87 countries around the world within just a few weeks. By the end of December, it had replaced the previously dominant Delta variant worldwide.

Since then, speculations about the origin of this highly transmissible variant have centred around two main theories: Either the coronavirus jumped from a human to an animal where it evolved before infecting a human again as Omicron, or the virus survived in a person with a compromised immune system for a longer period of time and that’s where the mutations occurred. A new analysis of COVID samples collected in Africa before the first detection of Omicron now casts doubt on both these hypotheses.

The analysis was carried out by an international research team led by Prof Jan Felix Drexler, a scientist at the Institute of Virology at Charité and the German Center for Infection Research (DZIF). Other key partners in the European-African network included Stellenbosch University in South Africa and the Laboratory of Viral Hemorrhagic Fever (LFHB) in Benin. The scientists started by developing a special PCR test to specifically detect the Omicron variant BA.1. They then tested more than 13 000 respiratory samples from COVID9 patients that had been taken in 22 African countries between mid-2021 and early 2022. In doing so, the research team found viruses with Omicron-specific mutations in 25 people from six different countries who contracted COVID in August and September 2021 – two months before the variant was first detected in South Africa.

To learn more about Omicron’s origins, the researchers also sequenced the viral genome of some 670 samples. Such sequencing makes it possible to detect new mutations and identify novel viral lineages. The team discovered several viruses that showed varying degrees of similarity to Omicron, but they were not identical.

“Our data show that Omicron had different ancestors that interacted with each other and circulated in Africa, sometimes concurrently, for months,” explains Prof Drexler. “This suggests that the BA.1 Omicron variant evolved gradually, during which time the virus increasingly adapted to existing human immunity.” In addition, the PCR data led the researchers to conclude that although Omicron did not originate solely in South Africa, it first dominated infection rates there before spreading from south to north across the African continent within only a few weeks.

“This means Omicron’s sudden rise cannot be attributed to a jump from the animal kingdom or the emergence in a single immunocompromised person, although these two scenarios may have also played a role in the evolution of the virus,” says Prof Drexler.

“The fact that Omicron caught us by surprise is instead due to the diagnostic blind spot that exists in large parts of Africa, where presumably only a small fraction of SARS-CoV-2 infections are even recorded. Omicron’s gradual evolution was therefore simply overlooked. So it is important that we now significantly strengthen diagnostic surveillance systems on the African continent and in comparable regions of the Global South, while also facilitating global data sharing. Only good data can prevent policymakers from implementing potentially effective containment measures, such as travel restrictions, at the wrong time, which can end up causing more economic and social harm than good.”

Source: Charité – Universitätsmedizin Berlin

First HIV Prevention Injection Approved in SA

Image of a syring for vaccination
Photo by Mika Baumeister on Unsplash

By Marcus Low

The South African Health Products Regulatory Authority (SAHPRA) has authorised an injection containing the antiretroviral cabotegravir for use to prevent HIV infection, according to drugmaker ViiV Healthcare.

“We are very pleased that this week, SAHPRA granted regulatory approval of Apretude or cabotegravir long-acting injectable,” ViiV Healthcare spokesperson Catherine Hartley told Spotlight. “It brings a much-needed innovative HIV prevention option to the communities that need it most, including women and adolescent girls where challenges with adherence, limited efficacy, and stigma have hindered the impact of current PrEP options.”

At the time of publication, SAHPRA had not yet confirmed the registration, although Spotlight understands a media statement on the issue is imminent. The regulator received ViiV Healthcare’s initial application for approval in November 2021.

ViiV Healthcare has not disclosed at what price it will offer the shot in South Africa or other African countries. The company has, through a deal with the Geneva-based Medicines Patent Pool, agreed to grant voluntary licenses to at least three generic producers that could potentially supply the injection to South Africa. It is however expected to take three to five years before any of the generics will be ready.

Executive Director of the HIV prevention organisation AVAC confirmed news of the authorisation late Wednesday in a social media post, calling it a critical step in making the injection available to millions that could benefit from the shot.

Thursday’s announcement makes South Africa at least the third African country to approve the shot for use, following similar approvals in Zimbabwe, Uganda, and Botswana. A duo of large clinical trials led in part by South African researchers found that people who were given an injection of the antiretroviral cabotegravir every other month were about 80% less likely to contract HIV than those on the HIV prevention pill.

The bi-monthly shot likely outperformed the pill, the World Health Organization explains in new guidelines, mainly because it was easier for people to get an injection every two months than to take the pills every day.

Previously, Spotlight reported that pilot projects are slated to begin providing access to the HIV prevention shot early next year. Demonstration projects run in partnership with the national health department and research organisations the Wits Reproductive Health and HIV Institute and Ezintsha are expected to offer patients a choice of the HIV prevention shot, pill, or monthly vaginal ring.

The pilot projects, sometimes called “demonstration” projects, will be looking to help answer major questions about an eventual national rollout, including how to create national awareness campaigns about the HIV prevention injection and how to provide it outside of hospitals and clinics and closer to communities.

SAHPRA authorisation marks the first step toward an eventual national rollout, according to national health department HIV prevention technical advisor Hasina Subedar. Subedar spoke to Spotlight in July at the International AIDS Conference. In particular, the finer details of the registration – which are still not public – will guide who can and can’t receive the shot, for instance.

Many will be watching to see whether the injection will be made available to pregnant and breastfeeding people, who remain at high risk for contracting HIV in South Africa. Early data presented at the International AIDS Conference in July suggests that the injection is safe to use during pregnancy, although research is ongoing.

Republished from Spotlight under a Creative Commons 4.0 Licence.

Source: Spotlight

Alzheimer’s Drug Breakthrough Hailed as ‘Momentous’

Photo by Matteo Vistocco on Unsplash

An 18-month randomised controlled trial of the new Alzheimer’s drug lecanemab has been hailed as “momentous” after encouraging Phase III trial results. The effects, while moderate, stand in contrast to virtually all other Alzheimer’s drug development efforts which have ended in failure.

According to the trial results published in the New England Journal of Medicine, lecanemab slows the rate of progression of Alzheimer’s by about 25%, though it is only really effective if the disease is caught early. Cognitive assessment scores as well as positron-emission tomography (PET) imaging of amyloid showed benefits.

This may be of great benefit to those who already know that they are already at risk of the disease, such as actor Chris Hemsworth who, at age 39, is taking a break from acting after he discovered that he has a high genetic risk of Alzheimer’s.

At present, the only FDA-approved drug to slow the progression of Alzheimer’s, Aduhelm, is of questionable benefit at best, is exorbitantly expensive and there has been an official probe into alleged irregularities in its approval process.

The 1975 trial participants were 50–90 years old with early Alzheimer’s disease (mild cognitive impairment or mild dementia due to Alzheimer’s disease) with evidence of amyloid on PET or by cerebrospinal fluid testing. Participants were randomised to receive intravenous lecanemab (10mg/kg of body weight every 2 weeks) or placebo.

The primary end point was the change from baseline at 18 months in the score on the Clinical Dementia Rating–Sum of Boxes (CDR-SB; range, 0 to 18, with higher scores indicating greater impairment). Key secondary end points included change in amyloid burden on PET, and on other cognitive impairment assessment scores.

 The mean CDR-SB score at baseline was approximately 3.2 in both groups. The adjusted least-squares mean change from baseline at 18 months was 1.21 with lecanemab and 1.66 with placebo. In a substudy involving 698 participants, there were greater reductions in brain amyloid burden with lecanemab than with placebo. Other cognitive assessments favoured lecanemab as well. Lecanemab resulted in infusion-related reactions in 26.4% of the participants and amyloid-related imaging abnormalities with oedema or effusions in 12.6%.

Protecting Patients with Automatic External Defibrillators (AEDs)

Automated external defibrillators (AEDs) are an important lifesaving technology and may have a role to play in treating workplace cardiac arrest. Most sudden cardiac deaths occur outside of the hospital, and many patients visiting doctors’ practices are already at risk for cardiovascular events, many going there because they are already feeling unwell as a precursor to a cardiac arrest.

It is estimated that 5% or less of victims of sudden cardiac deaths are successfully resuscitated and discharged alive from the hospital. 

In a study on public access defibrillation (PAD), communities with volunteers trained in CPR and the use of AEDs had twice as many victims survive compared to communities with volunteers trained only in CPR.

There are potential risks that come with the improper use of these devices. It is therefore essential to do thorough research before purchasing a specific product.

Why install an AED in my practice?

The primary purpose of an AED is to assist in the detection of heart arrhythmias. When an arrhythmia is identified with the use of an AED, a shock can be delivered to the heart to help normalise the function and rhythm of the patient’s heart.

In addition to being a tool used in the treatment of heart arrhythmia, another critical purpose that an AED device serves is to help restore a heartbeat in cases where a patient had suffered a sudden cardiac arrest (SCA), where patients may be saved if a shock is delivered inside a three minute window.

A 2021 study of out-of-hospital cardiac arrests in Cape Town found a rate of 23.2 per 100 000 population – likely an underestimate. Less than one in 10 cases had resuscitation attempts, and the average time for arrival of emergency services was 26 minutes. Thus, placing automated external defibrillators (AEDs) in the workplace can mean the difference between life and death.

AED use within the first three minutes after a patient experiences a cardiac arrest has an efficacy rate of about 80%. Performing CPR together with an AED is proven to be a significant improvement of efficacy rate compared to the CPR method alone. Therefore, it is necessary to install AEDs in the workplace, which will likely be granted the highest level of protection and make employees rest assured.

When does an AED shock?

The most common abnormal rhythm that causes cardiac arrest is ventricular fibrillation (VF). Electric shock can prevent ventricular fibrillation and restore the heart to its natural rhythm. An AED is applied to the casualty using two chest pads. The machine delivers electrical shocks to the heart muscle through the chest pad, which double as sensors to detect electrical activity. If the machine senses electrical activity with a heartbeat, it will not give an electric shock. Therefore, AEDs are very safe because they do not produce shock unless required. Products such as the AED7000 also feature locks preventing unintentional defibrillation.

Is it safe to use an AED?

Many associate AEDs with their specialised in-hospital equivalents, which require specialist training for safe use. Use of an AED device is usually considered exceptionally safe: the mechanism underlying the procedure is designed to ensure the patient will not be harmed when the device is use appropriately. Many newer models, such as the AED7000 series or the i-PAD NF1200, come with a smart system, which guides the rescuers through the procedure, ensuring the safety of both the patient and the person conducting the defibrillation.

Is it legal to use an AED on a patient?

There have been some concerns about the use of an AED device on patients of cardiac arrest. The concerns are primarily related to the fear of being sued by the patient when these devices are used. While South Africa lacks a Good Samaritan law to protect bystanders when assisting a patient, there is also no legal obligation for a member of the public to assist. However, doctors are legally required to render assistance in an emergency if they are able to do so.

Generally speaking, an AED is considered a safe device. Nevertheless, there are cases where the use of these devices could be considered inappropriate, for example, when the patient’s heart stops due to problems other than ventricular fibrillation, and thus cannot be saved by defibrillation. In these cases, there may be certain legalities involved when someone does decide to use an AED on such a patient.

The good news is that most AEDs will tell you whether or when it is appropriate to give a shock when you apply the pads on the patient’s chest. However, it’s always best to provide non-medically trained staff with AED knowledge and CPR training.