Treatment with Aficamten Associated with Significant Improvements in Symptoms and Quality of Life
Additional Data Presented in Poster Session Shows Patients with Worsening Heart Failure and LVEF ≤30% Have Disproportionately High Risk of Heart Failure Hospitalization
https://finance.yahoo.com/news/cytokinetics-presents-data-redwood-hcm-134500721.html
The U.S. is experiencing increased circulation of enterovirus D68 (EV-D68), a virus linked with a rare neurologic complication that can cause paralysis in children, according to CDC surveillance data.
Alongside increasing cases of rhinovirus (RV) and EV, mounting emergency department visits for acute respiratory illness have been reported in children and adolescents, and EV-D68 is turning up in more and more of these cases, reported Kevin C. Ma, PhD, of the CDC's Epidemic Intelligence Service, and colleagues.
"Health care facilities should be prepared for possible increases in pediatric health care use associated with severe EV-D68-associated respiratory illness," the group warned in the Morbidity and Mortality Weekly Report.
The findings follow recent reports from providers about rising pediatric hospitalizations potentially linked with the virus, and of particular concern is that biennial outbreaks of EV-D68 -- typically falling on even years (2014, 2016, 2018) -- have been linked to increasing cases of acute flaccid myelitis (AFM).
"Providers should have a high index of clinical suspicion for AFM in patients with acute flaccid limb weakness, neurologic signs and symptoms, or neck or back pain who have a recent history of respiratory illness or fever," wrote Ma and colleagues. "Children with AFM can experience rapid progression of weakness and should be promptly hospitalized and referred to specialty care."
So far this year, 15 cases of AFM have been confirmed (of 45 under investigation), but the circulation of EV-D68 is currently similar to peak levels observed in 2018, when 238 cases of the rare neurologic complication were recorded. The year 2020 was an exception, at 33 cases, with the lower number attributed to increased precautions due to COVID-19. AFM cases in years ending in odd numbers (2015, 2017, 2019) ranged from 22 to 47.
Acute respiratory illness from EV-D68 typically affects young children, the group explained, and severity varies.
While "typical signs and symptoms include cough, nasal congestion, wheezing, and dyspnea," infections with EV-D68 can also exacerbate asthma or reactive airway disease (RAD), and "children with a history of asthma/RAD might be more likely to require medical care," according to Ma and co-authors.
To assess EV-D68 trends, the CDC investigators gathered and analyzed data from three sources: emergency department visits for acute respiratory illness or asthma/RAD in the National Syndromic Surveillance Program; positive RV/EV test results from the National Respiratory and Enteric Virus Surveillance System (NREVSS); and the detection of EV-D68 in children hospitalized or visiting emergency department for acute respiratory illness in the New Vaccine Surveillance Network (NVSN).
NREVSS data showed that the weekly positive RV/EV results in 2022 appeared to be increasing at a rate comparable to that of past EV-D68 outbreak years, doubling from 15.8% to 31.4% from week 32 to week 35. This marked the fourth highest proportion when compared to prior years (31.7% in 2015 to 41.5% in 2014, for example).
Of 5,633 children in the NVSN presenting to emergency departments with acute respiratory illness from March to September 2022, RV/EV was detected in 26.4%. Overall, EV-D68 was identified in 17.4% of these RV/EV cases, but that number surged to 56% by the end of the surveillance period.
In addition to looking out for AFM, the CDC advised that clinicians should also consider and test for polio, due to the clinical similarity of acute flaccid paralysis from poliovirus, and "given the detection of a paralytic polio case and wastewater samples positive for poliovirus in New York during summer 2022."
Disclosures
No conflicts of interest were disclosed.
Primary Source
Morbidity and Mortality Weekly Report
https://www.medpagetoday.com/infectiousdisease/generalinfectiousdisease/100957
Be alert for potentially severe manifestations of monkeypox in patients who are immunocompromised or co-infected with HIV, the CDC told healthcare workers on Thursday.
"People who are immunocompromised due to HIV or other conditions are at higher risk for severe manifestations of monkeypox than people who are immunocompetent," the agency said in a health advisory to its Health Alert Network, adding that "the HIV status of all sexually active adults and adolescents with suspected or confirmed monkeypox should be determined."
Of the patients with severe manifestations "for whom CDC has been consulted," the majority had HIV with CD4 counts below 200 cells/mL, indicating "substantial immunosuppression," the agency noted.
These severe manifestations have included cases involving atypical or persistent rash requiring amputation of an extremity; secondary bacterial or fungal infections; lesions in sensitive areas resulting in severe pain or urethral or bowel strictures; and comorbidities involving organ systems, including myocarditis, transverse myelitis, bowel lesions, penile necrosis, and others.
The news arrives as the U.S. records its third known monkeypox-associated death in Ohio. To date, over 25,000 monkeypox cases have been reported in the U.S., 38% of which involved patients co-infected with HIV.
Researchers have highlighted monkeypox severity and outcomes in people with HIV before.
For example, a study in The Lancet about a 2017-2018 monkeypox outbreak in Nigeria reported seven deaths in a population of 122 patients, with four of the seven co-infected with HIV.
More recently, papers on the current outbreak have reported conflicting results about the association between monkeypox severity and HIV co-infection. CDC data involving more than 1,300 monkeypox patients showed a higher rate of hospitalizations for those with HIV (8% vs 3% for those without HIV), with higher rates for those whose HIV was not virally suppressed. Conversely, German researchers reported that the clinical characteristics in HIV-infected versus non-infected monkeypox patients were largely similar.
The new CDC advisory recommends that monkeypox treatment include optimization of immune function for people with immunocompromising conditions, such as limiting the use of immunosuppressive medications when "not otherwise clinically indicated," and offering antiretroviral therapy for those living with HIV.
Severe immunocompromising conditions can including those with autoimmune disease where immunodeficiency is a clinical component; leukemia or lymphoma, transplant recipients; and those treated with high-dose steroids, alkylating agents, antimetabolites, radiation, or tumor necrosis factor (TNF) inhibitors.
On a case-by-case basis, medications such as oral and intravenous tecovirimat (Tpoxx), cidofovir or brincidofovir, and vaccinia immune globulin intravenous should be considered, "although there are no data on effectiveness in treating human monkeypox with these medical countermeasures," according to the CDC.
Clinicians should gather repeat lesion swabs in patients with persistent monkeypox DNA, and continue tecovirimat beyond 14 days (but not more than 90 days), "until there is clinical improvement," the advisory stated.
Modifications to the dose, frequency, and duration of tecovirimat may be necessary, depending on the patient's clinical condition, disease progression, or therapeutic response. The advisory encouraged clinicians to consult with the CDC Monkeypox Response Clinical Escalations team when appropriate.
The following severe manifestations seen in monkeypox patients were reported to the CDC, although the advisory did not include information about HIV status:
The advisory also urged healthcare providers and public health jurisdictions to encourage patients to enroll in the AIDS Clinical Trials Group STOMP trial to evaluate the efficacy of tecovirimat for monkeypox.
https://www.medpagetoday.com/infectiousdisease/generalinfectiousdisease/101007
Europe's medicines regulator has backed using AstraZeneca's preventative COVID-19 drug as a treatment for the disease and also endorsed its therapy against a major cause of pneumonia.
The regulator's recommendations are usually followed by the European Commission when it takes a final decision on drug approvals.
AstraZeneca said on Friday the European Medicines Agency (EMA) had backed Evusheld as a treatment for adults and adolescents with COVID who do not need supplemental oxygen and who are at increased risk of their disease worsening.
The antibody cocktail was previously only approved as a preventative treatment for people with compromised immune systems who see little or no benefit from vaccines.
The EMA also endorsed Beyfortus for the prevention of RSV lower respiratory tract disease in infants.
RSV is a leading cause of pneumonia in toddlers and the elderly, but the complex molecular structure of the virus and safety concerns have stymied efforts to develop a vaccine since the virus was first discovered in 1956.
AstraZeneca is developing Beyfortus, chemically called nirsevimab, along with Sanofi. Others in the race to get an RSV vaccine or therapy approved include Pfizer, J&J, Moderna and GSK.
In July, the company forecast prescriptions of the COVID therapy would help drive group sales growth of more than 20% this year. The long-acting antibody treatment, launched in December, generated $445 million of sales in the second quarter.
https://www.yahoo.com/video/2-eu-regulator-backs-wider-063125723.html
An official at the European Union's drugs regulator said on Tuesday the COVID-19 pandemic was not over, contradicting U.S. President Joe Biden, and that a planned vaccination campaign in the region during the cold season was key to fighting it.
"We in Europe still consider the pandemic as ongoing and it's important that member states prepare for rollout of the vaccines and especially the adaptive vaccines to prevent further spread of this disease in Europe," the European Medicines Agency's (EMA) Chief Medical Officer Steffen Thirstrup told a media briefing, referring to vaccines targeting specific strains of the virus.
He was asked to comment on Biden's remark in an interview broadcast on Sunday that "the pandemic is over".
"I cannot obviously answer why President Biden came to that conclusion," Thirstrup said.
The World Health Organization has said the pandemic remains a global emergency but the end could be in sight if countries use the tools at their disposal.
During the media briefing, EMA officials reaffirmed a call by the agency's Executive Director Emer Cooke made last week in a Reuters Next Newsmaker interview that people in Europe should take whatever COVID-19 booster is available and recommended to them in the coming months.
Apart from the original COVID vaccines, the EMA has in recent weeks endorsed a number of vaccines adapted to the Omicron variant of the virus for use as booster shots to ease the burden from a feared surge in infections during autumn and winter in Europe.
The EMA's head of vaccines strategy, Marco Cavaleri, said the agency was also looking into the use of the adapted shots as a primary course of vaccination and that there were discussions on the types of data that could support such an approval
https://www.yahoo.com/news/eu-health-regulator-says-covid-140955025.html
Britain’s health minister on Thursday pledged to cut waiting times for doctors’ appointments and launched a fund to support social care, in a plan that drew criticism for not doing enough to solve a staffing crisis in the National Health Service (NHS).
Britain’s state-funded NHS, which has provided healthcare free at the point of use since 1948, has seen the COVID-19 pandemic increase demand from patients and create backlogs for elective care while facing its worst ever staffing crisis with thousands of vacancies.
Record numbers have been waiting to start routine treatment, ambulance response times have ballooned while face-to-face appointments with general practitioner (GP) doctors are hard to come by as staffing problems hinder the health service. read more
“We expect backlogs to rise before they fall as more patients come forward for diagnosis and treatment after the pandemic,” Health Secretary Therese Coffey told lawmakers.
In her first major statement in the role, Coffey said that she would make changes to take the burden off GPs, by providing more services through pharmacies and changing staffing rules, with the aim that anyone who needs to see a GP should be able to within two weeks.
Coffey said her A, B, C and D of priorities were ambulances, backlogs, care and doctors and dentists.
She said that improving how quickly patients were discharged could help free up beds in hospitals and reduce ambulance delays, and launched a 500 million pound ($564 million) fund to help get people out of hospital and into adult social care.
She also said that the million volunteers who stepped forward during the pandemic should do so again, but lawmakers were sceptical of the plan.
Conservative Jeremy Hunt, a former health minister, said “it’s not more targets the NHS needs, it’s more doctors,” and the opposition Labour Party also said the staffing crisis needed to be solved.
“There is still no plan that comes close to meeting the scale of the challenge,” Labour health spokesman Wes Streeting said.
https://www.pharmalive.com/britain-launches-plan-to-ease-doctor-waiting-lists/
Japan's Shionogi & Co Ltd said on Wednesday its oral treatment for COVID-19 demonstrated a significant reduction in symptoms compared with a placebo in a Phase III trial in Asia.
The drug, a protease inhibitor known as ensitrelvir, met its primary endpoint in a trial conducted among predominantly vaccinated patients with mild to moderate cases of COVID-19, the company said in a statement.
Shionogi's shares reversed an early decline after the announcement, closing 1.1% higher in Tokyo versus a 1.5 drop in the benchmark Nikkei gauge.
Ensitrelvir met the trial's goal in reducing five key symptoms of the Omicron variant of COVID-19 within 72 hours of onset, the company said.
Regulatory authorities in Japan previously denied emergency approval for use of the pill, saying they wanted to see more data on its effectiveness. There are also concerns the drug could pose risk to pregnancies, based on results from animal studies.
Shionogi said it has shared top-line data from the Phase III study with Japanese regulators as part of deliberations on approval of the drug.
Shionogi has global aspirations for the drug, also known as S-217622 and by the brand name Xocova, which would compete with COVID-19 pills from Pfizer Inc and Merck & Co Inc that have already been approved in Japan and elsewhere.
The company has signed an agreement to sell about a million doses to the government, pending the drug's approval.
Chief Executive Isao Teshirogi has said annual production of the drug could reach 10 million doses. The firm has received U.S. government support for a global Phase III trial.
