Thousands of the UK’s most vulnerable people will be among the first in the world to access life-saving, cutting-edge antiviral and antibody treatments from today, the government has announced.
A national study ‘PANORAMIC’, run by the University of Oxford in close collaboration with GP hubs, has now launched and is recruiting around 10,000 UK patients at risk of serious illness from COVID-19 to have the opportunity to take the treatment molnupiravir at home after receiving a positive PCR test.
Those at highest risk who test positive for the virus – for example, people who are immunocompromised, cancer patients or those with Down’s syndrome – will also be able to access either molnupiravir or the novel monoclonal antibody Ronapreve outside of the study from 16 December.
This will ensure the treatments can help protect those most at risk from the virus over the winter months, reducing the number of hospitalizations and therefore pressures on the NHS. This will be significant for those who have compromised immune systems and for whom the vaccines can therefore be less effective.
Molnupiravir has shown in clinical trials to reduce the risk of hospitalization or death for at-risk, non-hospitalized adults with mild to moderate COVID-19 by 30% and Ronapreve reduced the risk by 70%.
Health and Social Care Secretary Sajid Javid said:
The UK is a world-leader in rolling out innovative treatments to the patients who need them and today is a historic milestone in our battle against the virus, deploying the first medicines vulnerable people will be able to take outside of hospital and in the comfort of their own homes to protect themselves.
This opens up a new era for the treatment of COVID-19, one where we can begin to cover every phase of contracting this deadly disease – whether it be before you catch it, just after you catch it, if you develop symptoms or if you require hospital care.
If you’re eligible, please sign up to the study as soon as possible and play your part in history.”
Deputy Chief Medical Officer for England Professor Jonathan Van-Tam said:
Throughout this pandemic, we have rapidly identified and deployed some of the world’s best treatments for COVID-19 to UK patients – including dexamethasone, tocilizumab and sarilumab.
Antivirals will be a vital intervention for years to come, helping to protect those that can’t mount the same antibody response to the vaccines.
This is really positive news for the future of our response to COVID-19 – please sign up to the study if you’re eligible as soon as you can.”
National study for molnupiravir
The study, which is currently for molnupiravir, has been launched today to allow medical experts to gather further data on the potential benefits this treatment brings to vaccinated patients, and will help the NHS to develop plans for rolling out the antiviral to further patients next year.
It’s open to anyone in the UK, provided they:
receive a positive PCR test;
feel unwell with symptoms of COVID-19 that started in the last five days; and
are aged 50 and over or 18 to 49 with an underlying health condition that puts them more at risk of severe COVID-19.
If eligible, people who receive a positive PCR test will be contacted by the study team or a local healthcare professional, for example their GP, to sign up to the trial. Alternatively, people can sign up themselves through the study’s website. It is crucial that eligible participants enroll in the study urgently to ensure that they have the opportunity to access antiviral treatments within the first five days of COVID-19 symptoms.
Taking part in the study will require participants to complete a daily diary for 28 days through the PANORAMIC website or receive a phone call from the trial team on days 7, 14 and 28 to speak about their symptoms. The first set of results from the trial are anticipated in early 2022.
Targeted deployment of molnupiravir and Ronapreve
For treatment access outside of the study, those in the highest risk group will be informed by the NHS if they have a condition that will make them eligible to receive these treatments, should they test positive for COVID-19. The eligible cohorts have been determined by an independent expert group commissioned by DHSC and included in a clinical policy agreed by all four Chief Medical Officers in the UK.
These patients will be able to keep a PCR test at home from NHS Test and Trace to support rapid testing, so they can access the treatments as soon as possible after symptoms begin.
Eligible patients who receive a positive test will be assessed over the phone by an expert clinician from an NHS COVID Medicines Delivery Unit (CMDU), who will review and discuss with the patient what the most appropriate treatment would be for them.
Those being prescribed a monoclonal antibody treatment will be invited to attend the CMDU, while those receiving molnupiravir can either get someone to collect it for them or have it delivered to their home. The NHS has been setting up CMDUs since the summer.
The government has secured 480,000 courses of molnupiravir from pharmaceutical company Merck Sharp and Dohme (MSD). It has also secured 250,000 courses of the antiviral PF-07321332, which is currently has completed phase 3 trials.
Chair of the Antivirals Taskforce Eddie Gray said:
This is an important advancement for the treatment of COVID-19 in the UK and marks a significant step in the Antivirals Taskforce’s ambition to roll out two novel antivirals to patients.
Work is still underway to identify further options as soon as we can – to protect as many vulnerable people across the country as possible.”
Antivirals are treatments used to either treat those who are infected with a virus or protect exposed individuals from becoming infected. They target the virus at an early stage, preventing progression to more severe, or even critical, symptoms.
The Antivirals Taskforce will continue to look at a number of further options, spanning a range of different antiviral mechanisms. Alongside the work of the Therapeutics Taskforce, this will ensure as many people as possible can be protected from COVID-19, future variants and other future diseases.
Since the beginning of the pandemic, the UK has proven itself to be a world-leader in identifying and rolling out effective treatments for COVID-19 – including the world’s first treatment dexamethasone, which has since saved over a million lives worldwide.
The UK’s renowned life sciences sector makes it the ideal base for the brightest of global innovators to research and progress cutting-edge treatments for COVID-19 through the clinical trials process here in Britain.
Professor Chris Butler, Professor of Primary Care at the University of Oxford’s Nuffield Department of Primary Care Health Sciences and Co-Chief Investigator of PANORAMIC, said:
Studies in relatively small numbers of people with COVID-19 who have not yet been vaccinated have generated optimism that these new antiviral medicines, if used at scale, could reduce the need for people to be admitted to hospital and help them recover faster.
The PANORAMIC trial is a world-first study for generating the evidence we urgently need about large scale, early treatment with novel antiviral medicines of people who are mostly all vaccinated, still well enough to be in the community, and who are at higher risk of complications from COVID-19.”
Professor Stephen Powis, NHS England’s National Medical Director, said:
The rollout of monoclonal antibodies and antivirals represents another weapon in our arsenal to reduce the risk of patients at highest risk becoming seriously ill and needing hospitalization from COVID-19.
It represents another achievement for the NHS following our world leading vaccination programme that has now delivered 100 million vaccinations in England, including over 17 million booster vaccines.
Getting vaccinated is the best way to protect you and your loved ones from COVID-19 and I would urge everyone to come forward to get vaccinated – whether that’s your first, second or booster jab.”
Source Here: news-medical.net
Unraveling How Strigoractone Hormone Regulates Massive Gene Networks Controlling Plant Growth
As sessile organisms, plants have to continually adapt their growth and architecture to the ever-changing environment. To do so, plants have evolved distinct molecular mechanisms to sense and respond to the environment and integrate the signals from outside with endogenous developmental programs.
New research from Nitzan Shabek’s laboratory at the UC Davis College of Biological Sciences, published in Nature Plants, unravels the underlying mechanism of protein targeting and destruction in a specific plant hormone signaling pathway.
Our lab aims at deciphering sensing mechanisms in plants and understanding how specific enzymes function can be regulated at the molecular levels. We have been studying a new plant hormone signal, strigolactone, that governs numerous processes of growth and development including branching and root architecture.”
Nitzan Shabek, assistant professor of biochemistry and structural biology, Department of Plant Biology
The work stems from a study by Shabek, published in Nature in 2018, unravelling molecular and structural changes in an enzyme, MAX2 (or D3) ubiquitin ligase. MAX2 was found in locked or unlocked forms that can recruit a strigolactone sensor, D14, and target for destruction a DNA transcriptional repressor complex, D53. Ubiquitins are small proteins, found in all eukaryotes, that “tag” other proteins for destruction within a cell.
To find the key to unlock MAX2 and to better understand its molecular dynamics in plants, postdoctoral fellows Lior Tal and Malathy Palayam, with junior specialist Aleczander Young, used an approach that integrated advanced structural biology, biochemistry, and plant genetics.
“We leveraged structure-guided approaches to systemically mutate MAX2 enzyme in Arabidopsis and created a MAX2 stuck in an unlocked form”, said Shabek, “some of these mutations were made by guiding CRISPR/Cas9 genome editing thus providing us a discovery platform to study and analyze the different signaling outputs and illuminate the role of MAX2 dynamics.”
They found that in the unlocked conformation, MAX2 can target the repressor proteins and biochemically decorate them with small ubiquitin proteins, tagging them for destruction. Removing these repressors allows other genes to be expressed – activating a massive gene network that governs shoot branching, root architecture, leaf senescence, and symbiosis with fungi, Shabek said.
Sending these repressors to the proteasome disposal complexes requires the enzyme to relock again. The team also showed that MAX2 not only target the repressors proteins, but once it is locked the strigolactone sensor itself gets destroyed, returning the system to its original state.
Finally, the study uncovered the key to the lock, an organic acid metabolite that can directly trigger the conformational switch.
“Beyond the implication in plants signaling, this is the first work that placed a primary metabolite as a direct new regulator of this type of ubiquitin ligase enzymes and will open new avenues of study in this direction,” Shabek said.
Additional coauthors on the paper are specialist Mily Ron and Professor Anne Britt, Department of Plant Biology. The study was supported by NSF CAREER and EAGER grants to Shabek. X-ray crystallography data was obtained at the Advanced Light Source, Lawrence Berkeley National Laboratory, a U.S. Department of Energy user facility.
Tal, L., et al. (2022) A conformational switch in the SCF-D3/MAX2 ubiquitin ligase facilitates strigolactone signalling. Nature Plants. doi.org/10.1038/s41477-022-01145-7.
Original Article: news-medical.net
UrFU Sociologists Identify Digital Fears Among Young People
Sociologists at the Ural Federal University (UrFU) have identified digital fears among young people. According to experts, these are additional fears that do not replace, but complement and reinforce traditional ones. They emerged against the background of uncertainty, the growth of forces beyond human control. Developed emotional intelligence, creativity, and the ability to collaborate help to overcome them.
In the study, sociologists interviewed 1,050 people aged 18-30. Respondents were asked to assess which digital risks concern them most. The study was launched in 2020 and the results were published in April 2022 in the Changing Societies & Personalities journal.
The first group of fears is influence and control. It touches on the problem of interference with privacy by technical means. This category is the most significant for young people: 55.8% are afraid of total control by means of video-surveillance and monitoring software on their mobile devices. 48.5% of respondents believe they are at risk of wiretapping, tracking content in social networks, and inability to keep correspondence secret.”
Natalia Antonova, Professor, Department of Applied Sociology, UrFU
45.8% of young people fear the manipulative influence of the media and an increase in fake news. At the same time, only 27.8% and 18.1% of respondents are concerned about microchipping and genetic manipulation, respectively. It is likely that these threats seem more controllable, both from the individual (through control of food choices, medical procedures, etc.) and from government programs, the researchers believe.
The second group of concerns is crime and security. Here young people are wary of illegal actions using digital technology.
“One of the main fears of 56% of young people is the security of personal data. This is related both to the growth of personal information in social networks and messengers, and to the growth of hacker attacks and viruses. 42.9% of young citizens are afraid of Internet fraudsters, and 25.8% are afraid of losing important information, including smashing their phones, not saving data, forgetting their passwords, or being without an Internet connection,” explains Sofia Abramova, Associate Professor at the Department of Applied Sociology at UrFU.
The third group of fears is based on changes in the way and pace of life, ways of interaction. Thus, 28.4% of respondents indicate a constant lack of time, the acceleration of communications, and worries about not being able to complete all tasks in time. Respondents are also concerned about the growth of online communications and communications with electronic systems (bots, autoresponders, product systems, etc.).
“As a result, 15.3% of young people raise problems related to increasing social distrust against the background of increasing dependence of human life and health on other people and electronic systems: in public transport, planes, elevators, medical intervention,” explains Sofia Abramova.
Respondents also fear the negative consequences of technological development. For example, 22.2% of young citizens fear the robotization of labor processes and the displacement of humans by robots. 14.6% speak directly about negative emotions in relation to the expansion of artificial intelligence.
The fifth type of fear is social inequality. Young people negatively assess the growth of inequality in access to information resources and technology, the exclusion of citizens from the economy depending on the level of digital competence and education, and age. As a result, they fear that benefits will be distributed more and more unequally, both among the inhabitants of the country and between countries.
“It is noteworthy that young people are simultaneously afraid of total surveillance via phone and afraid of being left without mobile devices. Fears shape the irrational behavior of the digital generation, entailing serious transformations in everyday life,” says Natalia Antonova.
Abramova, S.B., et al. (2022) Digital Fears Experienced by Young People in the Age of Technoscience. Changing Societies & Personalities. doi.org/10.15826/csp.2022.6.1.163.
Original Source: news-medical.net
Study demonstrates increased incidence of SARS-CoV-2 Omicron breakthrough infection in cancer patients
In a recently published article in the journal Cancer Cell, scientists have demonstrated the incidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in cancer patients residing in Austria and Italy. The study reveals an induction in Omicron breakthrough infections in patients with hematologic and solid cancers.
Study: Enhanced SARS-CoV-2 breakthrough infections in patients with hematologic and solid cancers due to Omicron. Image Credit: Lightspring/Shutterstock
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative pathogen of the coronavirus disease 2019 (COVID-19) pandemic, has been found to cause severe infections in immunocompromised patients, including cancer patients. Moreover, a relatively lower level of neutralizing antibodies in response to COVID-19 vaccines has also been observed in cancer patients, especially those receiving B cell-targeting therapies.
The emergence of SARS-CoV-2 variants with improved immune fitness, such as delta and Omicron variants, has caused a sharp increase in breakthrough infections even in fully vaccinated individuals. However, the vaccines still show high protective efficacy against severe and fatal infections. COVID-19 vaccines have shown acceptable efficacy against severe disease, even in Omicron-infected cancer patients. However, the isolation and quarantine measures associated with SARS-CoV-2 infection may impair the routine administration of anticancer therapy, which can reduce the survival prognosis in cancer patients.
In the current study, the scientists have assessed the incidence of SARS-CoV-2 infection in cancer patients throughout the pandemic.
The study included 3,959 cancer patients, of whom 77% had solid cancer, and 23% had hematologic cancer. About 69% of the patients did not receive any anticancer treatment at the time of COVID-19 vaccination. Regarding vaccine coverage, about 85% of the patients had received at least one vaccine dose, and 15% remained unvaccinated. The incidence of SARS-CoV-2 infection in these patients was assessed between February 2020 and 2022.
SARS-CoV-2 infection was detected in about 24% of the patients during the study period. During the delta-dominated wave, vaccine breakthrough infection was observed in 43% of the patients. In contrast, a significantly higher percentage of breakthrough infection (70%) was observed among the patients during the Omicron-dominated wave. During both delta and Omicron waves, cancer patients receiving systemic anticancer treatment showed a significantly higher percentage of breakthrough infection than those not receiving treatment (83% vs. 56%).
Regarding disease severity irrespective of vaccination status, a higher frequency of COVID-19-related hospitalization was observed during the delta wave compared to that during the Omicron wave. However, a relatively shorter duration of hospital stay was observed in vaccinated patients compared to that in unvaccinated patients. In addition, only 9% of patients with breakthrough infections were admitted to the intensive care unit (ICU). This highlights the protective efficacy of COVID-19 vaccines against severe disease.
Humoral immune response to vaccination
To determine vaccine-induced antibody response against delta and Omicron variants, the scientists measured blood levels of anti-delta and anti-Omicron spike receptor-binding domain (RBD) antibodies in a total of 78 cancer patients. In the analysis, they also included 25 healthcare workers as controls.
In response to vaccination, healthcare workers showed higher levels of total anti-spike antibodies compared to cancer patients. The lowest level of wildtype RBD-specific antibodies was observed in hematologic cancer patients receiving B cell-targeted treatment, followed by hematologic cancer patients not receiving B cell-targeted treatment and patients with solid tumors. A similar trend was observed for delta- and Omicron-specific spike RBD antibodies.
The serum samples collected from hematologic cancer patients without B cell-targeted treatment and solid tumor patients significantly inhibited the interaction between wildtype/delta RBD and angiotensin-converting enzyme 2 (ACE2; host cell receptor for viral entry). However, a significantly lower level of inhibition was observed for patients receiving B cell-targeted treatment. Importantly, a marked reduction in inhibition of Omicron RBD – ACE2 interaction was observed for all patients with solid tumors and hematologic cancer.
The study demonstrates an increased incidence of vaccine breakthrough infections but a reduced disease severity among patients with solid tumors and hematologic cancer during the Omicron wave compared to the delta wave.
The study also highlights that COVID-19 vaccine-induced antibody response is lower in cancer patients than in healthy individuals. The reduction in antibody response is highest among hematologic patients receiving B cell-targeted treatment. Overall, a significant impairment in vaccine-induced Omicron neutralization has been observed in cancer patients.
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