Day: December 1, 2021

Paxlovid Ramped up and No ‘Red Flags’ for Omicron Yet

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In the face of a renewed global surge in COVID cases, Pfizer has ramped up production of Paxlovid, even while the efficacy of Merck’s molnupiravir appears to be less than believed.

Pfizer is now expecting to make 80 million courses of Paxlovid by the end of 2022, Pfizer CEO Albert Bourla told CNBC, a significant increase over its earlier planned capacity of 50 million courses.

This news came after Merck reported the risk reduction in hospitalisation and death from its COVID antiviral, molnupiravir, fell from 50% in the interim analysis to 30% in the final analysis. The reduction came after results were updated with participants that became evaluable after the interim analysis. This drop has led to predictions of increased demand for Paxlovid, which has shown an 89% risk reduction in outpatients.

The increase in production comes just in time to fight the Omicron variant, for which South Africa is now better prepared, according to experts.

‘No red flags’
According to Professor Salim Abdool Karim, director of the Centre for the Aids Programme of Research in South Africa, the numbers appear to be on the rise across all continents, but as yet there are “no red flags” he said.

Omicron has been identified by South African scientists as a major driver of the spike in cases in Gauteng.

“We have been amazed at how fast the numbers are going up,” he said. “But we were not caught with our pants down. We expected and prepared for a fourth wave. [The scientists] gave us the best fighting chance by giving us information early. We didn’t know exactly when it would come and what it would look like,” Prof Karim said, speaking to the Daily Maverick.

While a number of mutations enable the variant to escape immunity, a clear picture of Omicron’s nature won’t emerge for two to four weeks, he cautioned.

Speaking about travel bans imposed on South Africa by Mauritius, Rwanda, Egypt and the Seychelles, President Cyril Ramaphosa said ahead of a West African tour: “I am concerned. Out of due respect to them, they have their own reasons. We would like to have a discussion with them in a way we prefer that they do not react like our former colonisers who are very quick to close Africa down,” Ramaphosa told journalists.

EU accelerates child vaccinations
EU President von der Leyen has said that vaccines for children aged five to 11 will be available in the bloc by December 13, a week ahead of schedule and that she is pushing for the consideration of mandatory vaccination. This comes amidst news that Omicron was detected in the Netherlands before its first detection in South Africa. Meanwhile, in Asia, South Korea has reported its first five cases of Omicron.

How One Hospital Met the COVID Surge Head-on

Photo by Artem Podrez on Unsplash

Since March of 2020, the COVID pandemic has put an unprecedented strain on hospitals as large surges of intensive care unit patients overwhelmed hospitals. To meet this challenge, Beth Israel Deaconess Medical Center (BIDMC) expanded ICU capacity by 93% and maintained surge conditions during the nine weeks in the first quarter of 2020.

In a pair of papers and a guest editorial published in Dimensions of Critical Care Nursing, a team of nurse-scientists at Beth Israel Deaconess Medical Center (BIDMC) report on almost doubling the hospital’s ICU capacity; identifying, training and redeploying staff; and developing and implementing a proning team to manage patients with acute respiratory distress syndrome during the first COVID surge.

“As COVID was sweeping through the nation, we at BIDMC were preparing for the projected influx of highly infectious, critically ill patients,” said lead author Sharon C. O’Donoghue, DNP, RN, a nurse specialist in the medical intensive care units at BIDMC. “It rapidly became apparent that a plan for the arrival of highly infectious critically ill patients as well as a strategy for adequate staffing protecting employees and assuring the public that this could be managed successfully were needed.”

After setting up a hospital incident command structure to clearly define roles, open up lines of communication and develop surge plans, BIDMC’s leadership began planning for the impending influx of COVID patients in February 2020.

BIDMC – a 673 licensed bed teaching hospital affiliated with Harvard Medical School – has nine specialty ICUs located on two campuses for a total of 77 ICU beds. Informed by an epidemic surge drill conducted at BIDMC in 2012, it was determined that the trigger to open extra ICU space would be when 70 ICU beds were occupied. When this milestone was met on March 31, 2020, departmental personnel had a 12-hour window to convert two 36-bed medical-surgical units into additional ICU space, providing an additional 72 beds.

“Because the medical-surgical environment is not designed to deliver an ICU level of care, many modifications needed to be made and the need for distancing only added to the difficulties,” said senior author Susan DeSanto-Madeya, PhD, RN, FAAN, a Beth Israel Hospital Nurses Alumna Association endowed nurse scientist. “Many of these rooms were originally designed for patient privacy and quiet, but a key safety element in critical care is patient visibility, so we modified the spaces to accommodate ICU workflow.”

Modifications included putting windows in all patient room doors, and repositioning beds and monitors so patients and screens could be easily seen without entering the room. Lines of visibility were augmented with mirrors and baby monitor systems as necessary. Care providers were given two-way radios to decrease the number of staff required to enter a room when hands-on patient care was necessary. Mobile supply carts and workstations helped streamline workflow efficiency.

Besides stockpiling and managing medical equipment including PPE, ventilators and oxygen, increasing ICU capacity also required redeploying 150 staff trained in critical care. The hospital developed a recall list for former ICU nurses, as well as medical-surgical nurses that could care for critically ill patients on teams with veteran ICU nurses.

Education and support was provided from . In-person, socially-distanced workshops were developed for each group, after which nurses were assigned to shadow an ICU nurse to reduce anxiety, practice new skills and gain confidence.

“Staff identified the shadow experience as being most beneficial in preparing them for deployment during the COVID surge,” said O’Donoghue. “Historically, BIDMC has had strong collaborative relationships with staff from different areas and these relationships proved to be vital to the success of all the care teams. The social work department played a major role in fostering teams, especially during difficult situations.”

One of the redeployment teams was the ICU proning team. Proning is known to improve oxygenation in patients with acute respiratory distress syndrome is a complex intervention, takes time and is not without its potential dangers to the patient and staff alike. The coalition maximised resources and facilitated more than 160 interventions between March and May of 2020.

“Although the pandemic was an unprecedented occurrence, it has prepared us for potential future crises requiring the collaboration of multidisciplinary teams to ensure optimal outcomes in an overextended environment,” O’Donoghue said. “BIDMC’s staff rose to the challenge, and many positive lessons were learned from this difficult experience.”

“We must continue to be vigilant in our assessment of what worked and what did not work and look for ways to improve health care delivery in all our systems,” said DeSanto-Madeya, who is also an associate professor at the College of Nursing at the University of Rhode Island. “The memories from this past year and a half cannot be forgotten, and we can move forward confidently knowing we provided the best care possible despite all the hardships.”

Source: Beth Israel Deaconess Medical Center

Too Few Children with HIV are Virally Suppressed

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Globally, less than two thirds of children and adolescents living with HIV who are receiving treatment are virally suppressed, according to new research published in The Lancet HIV.

Viral suppression [PDF] for HIV means that treatments are protecting health and preventing the transmission of HIV to others. UNAIDS has set a target of achieving 95% viral suppression among all people living with HIV on treatment by 2030.

“We estimate viral suppression one, two and three years after people start taking antiviral treatment, so that we can understand how well the treatments are working over time,” said Professor Matthew Law from the Kirby Institute.

“The data among adults on treatment in our studies show that viral suppression was achieved in an estimated 79% of adults at one year, and 65% at three years. However, viral suppression is poorer among children, at an estimated 64% at one year and 59% at three years.”

Senior study author, Dr Azar Kariminia from the Kirby Institute, said there are unique barriers to achieving viral suppression for children and adolescents. “It can be challenging for them to take treatment regularly, and children rely on caregivers who are often having to manage their own medical needs. There are also a range of factors that stem from stigma and discrimination, including a fear of disclosing the child’s HIV status.”

For this study, the researchers analysed data from 21 594 children/adolescents and 255 662 adults from 148 sites in 31 countries who initiated treatment between 2010 and 2019.

Dr Annette Sohn, from amfAR’s TREAT Asia program, is Co Principal Investigator for IeDEA Asia-Pacific (along with Prof. Law). She says that “while there has been substantial progress in the global response to HIV, the needs of children and adolescents often fall behind those of adults. Our efforts must extend beyond ensuring access to paediatric medicines to address the social and developmental challenges they face in growing up with HIV if we are to achieve the WHO targets by 2030.”

Viral load testing is essential to find out whether HIV treatments are working effectively. It is recommended by WHO at six and 12 months following the initiation of treatment, and then every 12 months thereafter. While viral load testing is common in high-income countries, scaling up accessible viral load testing in resource-limited settings remains a challenge.

With Australian government funding, the Kirby Institute and the Papua New Guinea Institute of Medical Research (PNGIMR) are partnering with the PNG government and a consortium of partners are implementing a program called ‘ACT-UP PNG’ which will scale up HIV viral load testing in two provinces with high HIV rates.

“Our work is ensuring that infants and children are afforded the same access to testing and treatment as other people with HIV,” says Dr Janet Gare from the PNGIMR and a Co-Principal Investigator on ACT-UP-PNG.

Instead of doing viral load testing in distant laboratories, ACT-UP PNG provides same-day molecular point-of-care testing in HIV clinics.

“This brings HIV viral load testing closer to patients, which currently includes children aged 10 and older, and adolescents,” says Dr Gare. “However, we are also pioneering the implementation of a diagnostic platform that will allow the same access to timely HIV viral load testing and results for infants six to eight weeks of age, and children up to nine years, who are currently unable to be included in point-of-care methods.”

Scientia Associate Professor Angela Kelly-Hanku says that these technologies will make testing for viral suppression in infants and children easier.

“We cannot end AIDS without addressing the inequalities that exist between paediatric and adult HIV programs. Projects like ACT-UP make a real difference and bring us closer to achieving the UNAIDS targets.”

Source: University of New South Wales

A Surprising Benefit of Dapagliflozin in Patients with Heart Failure

Photo by Artem Podrez from Pexels

Dapagliflozin, widely used to treat type 2 diabetes, was shown to improve symptoms and physical limitations in patients with heart failure with preserved ejection fraction, according to clinical trial results reported in Nature Medicine.

Heart failure with preserved ejection fraction (HFpEF) occurs when the heart’s lower left chamber is unable to fill with blood properly. The condition accounts for approximately half of all heart failure cases and disproportionally affects older individuals. Patients with HFpEF can experience a host of debilitating symptoms linked to cardiometabolic abnormalities, including physical limitations, impaired cognition and poor quality of life. Life expectancy is also reduced for patients with this diagnosis, with 50% of patients with the diagnosis not expected to survive more than five years.

Finding ways to improve patients’ health and developing or identifying therapeutic interventions that not only reduce hospitalisation but also improve patient survival is key, the researchers said, but at present there are no available treatments that improve patient survival for patients with HFpEF.

Previous studies have shown that sodium glucose cotransporter 2 (SGLT2) inhibitors – which inhibit SGLT2 receptor proteins produced by the kidneys and are used to treat type 2 diabetes – reduces risk of cardiovascular death and heart failure-related hospitalisation in patients with HFpEF.

For this trial, the researchers measured patient-reported symptoms, physical limitations and function in patients with HFpEF who were taking dapagliflozin, an SGLT2 inhibitor drug.

A total of 324 patients with HFpEF, 56.8% women, were randomised to receive either dapagliflozin or placebo for 12 weeks and at the end of the trial were evaluated using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score, a measure of heart failure-related health status.
“It’s important to note the percentage of women that were enrolled in this study because usually women are under-enrolled in clinical trials,” pointed out study co-author Professor Sadiya Khan.

Compared to the placebo group, an overall improvement in patient-reported symptoms, physical limitations and exercise function was seen in the dapagliflozin group. Adverse events were also similar between both groups, the authors reported.

“It was definitely surprising and very exciting to see such a stark difference between the treatment group and the placebo group, that there was this clear separation that happened even over a short period of time,” Prof Khan said, adding that next steps will be to investigate dapagliflozin’s precise molecular mechanisms that enable its effectiveness.

Source: Northwestern University

Improved Wound Healing with Platelet-rich Plasma

Image by Dian Polekhina on Unsplash

New research suggests that wound healing could be enhanced by replicating platelet-rich plasma from our blood to create implants introduced into the wound.

Platelet-rich plasma (PRP) is a natural healing substance in our blood. Researchers explored ways of enhancing the wound healing process by extracting PRP from the blood of a patient with a complex skin wound and manipulating it through 3D printing to form an implant for tissue repair which can be used to treat difficult-to-heal skin wounds in a single surgical procedure.

The results, which are reported in Advanced Functional Materials, showed that application of the 3D-printed PRP implant helped to speed up the healing of the wound by enabling efficient vascularisation and inhibiting fibrosis, which are both essential for effective wound healing.

Professor Fergal O’Brien, at RCSI University of Medicine and Health Sciences said: “Existing literature suggests that while the PRP already present in our blood helps to heal wounds, scarring can still occur. By 3D-printing PRP into a biomaterial scaffold, we can increase the formation of blood vessels while also avoiding the formation of scars, leading to more successful wound healing.

“As well as promising results for skin wound healing, this technology can potentially be used to regenerate different tissues, therefore dramatically influencing the ever-growing regenerative medicine, 3D printing and personalised medicine markets.”

Source: RCSI

Pharma Giants Draw Their Plans Against Omicron

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As world leaders seek to reassure an anxious world about the emergence of Omicron, Moderna’s CEO believes that vaccines will not have the same level of effectiveness against the new variant. Meanwhile, other major vaccine developers such as Oxford University maintain that it is still too early as yet to draw conclusions, and existing vaccines can be updated in a matter of months.

In an interview with the Financial Times, Moderna CEO Stéphane Bancel said that “in no world” would vaccines protect against Omicron at the same level as they did against Delta. He added that he thought it would be “material drop”, though data was still to come. However, the scientists he spoke to had all said “‘This is not going to be good’.” This is because 32 of the variant’s 50 mutations are on the Spike protein, which current vaccines are designed to target.

He noted the reduced effectiveness of existing vaccines against Delta, saying that scientists had not expected such a high level of mutation to emerge for another two to three years. His comments come in stark contrast to others who stress that there is no information yet to suggest that Omicron is any more serious than previous variants, or that vaccines are less effective against it.

Oxford University released a statement saying they were monitoring the situation, but stood ready to produce a new vaccine if necessary.

“Despite the appearance of new variants over the past year, vaccines have continued to provide very high levels of protection against severe disease and there is no evidence so far that Omicron is any different.

“However, we have the necessary tools and processes in place for rapid development of an updated COVID vaccine if it should be necessary.”

Pfizer’s CEO Albert Bourla said in an interview with CNBC that his company had already started work on an updated vaccine, which would be ready in 100 days.

In the Netherlands, scientists from the country’s National Institute of Public Health said that they had detected Omicron on flights that had arrived from Southern Africa before the official announcement of the discovery by South Africa. The country is now trying to locate and isolate some 5000 individuals who arrived in the country from the region.