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Shionogi & Co., Ltd. today announced that two late-breaking poster presentations featuring results from clinical trials on its novel COVID-19 oral antiviral ensitrelvir would be published as posters at the 33rd European Congress of Clinical Microbiology & Infectious Diseases.
Ensitrelvir, known as Xocova® 125 mg tablet in Japan, received emergency regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) to treat SARS-CoV-2 infection.
Recently, ensitrelvir was granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
The first late-breaking poster presentation included a post-hoc analysis of the Phase 3 part showing that viral rebound and symptom recurrence were infrequently seen up to 21 days after treatment with ensitrelvir.
Viral RNA rebound by PCR testing was observed in 7.8% of the ensitrelvir 125 mg group (n=590) and 4.7% in the placebo group (n=574). Symptom recurrence was rare and was not associated with viral RNA rebound.
Although RNA rebound was observed in a few patients, there was only one (1/310) low-level viral titer positive in follow-up, suggesting no concerns for infectivity or transmission.
A second late-breaking poster presentation included new results from the study (Phase 2b/3 part) of patients who tested positive for SARS-CoV-2 but were either asymptomatic or had only mild symptoms at the time of randomization.
These results were based on 572 patients who were followed up for ten days after randomization. Ensitrelvir 125 mg showed a significant reduction from baseline viral RNA on Day 4, a reduction of 1.12 log10 copies/mL versus placebo (p<0.0001).
The time to the first negative SARS-CoV-2 culture was significantly shorter with ensitrelvir 125 mg compared to placebo (a median time of 38.3 hours versus 66.7 hours, p<0.0001, respectively).
Although these results were exploratory, the reduction in viral RNA and faster time to a negative viral culture may be predicted to reduce the period of infectivity, which may have implications for reducing the risk of transmission.
In a subset of 70 asymptomatic patients, ensitrelvir 125 mg (n=23) showed a numerical reduction in the proportion of patients developing symptoms.
In the 502 patients presenting with mild symptoms treated with ensitrelvir 125 mg (n=171), a numerical reduction in the proportion reporting a worsening of symptoms compared with placebo was observed.
Ensitrelvir was well tolerated, and no new safety concerns were identified.
A separate Phase 3 study of ensitrelvir (SCORPIO-HR) is underway across Asia, Africa, North America, and Europe in non-hospitalized adults who have tested positive for SARS-CoV-2. It includes those with and without risk factors for severe disease and regardless of vaccination status. Shionogi also plans to initiate a post-exposure prevention global Phase 3 study, SCORPIO-PEP.
“We are encouraged by these new data regarding the potential reduction of transmission among asymptomatic patients and patients with mild COVID-19 symptoms,” said Isao Teshirogi, Ph.D., in a press release on April 5, 2023.
“We are continuing to evaluate ensitrelvir in multiple patient populations through our robust global clinical program and look forward to continued scientific exchange on this important compound.”
Ensitrelvir remains an investigational drug outside of Japan and has not been approved outside of Japan.
Other COVID-19 antiviral news is posted at Coronavirus Today.
The Canadian Food Inspection Agency (CFIA) recently confirmed a dog in Ontario had contracted avian influenza (bird flu) and died.
The CFIA reported on April 1, 2023; the dog was infected with bird flu after chewing on a wild goose.
“Based on the current evidence in Canada, the risk to the general public remains low, and current scientific evidence suggests that the risk of a human contracting avian influenza from a domestic pet is minor,” the CFIA stated.
Canada has previously reported bird flu infections have led to the demise of bears, foxes, and skunks.
Other bird flu news is posted at PrecisionVaccinations.com/BirdFlu.
The United Arab Emirates Ministry of Health and Prevention (MoHAP) today announced it urges the public to be aware of the Marburg virus causing hemorrhagic fever.
And to avoid traveling to Tanzania and Equatorial Guinea unless necessary due to the recent spread of the Marburg virus.
The MoHAP said in a statement on April 4, 2023, if travel is unavoidable, necessary precautions should be taken to avoid exposure to the disease, such as avoiding close contact with patients, touching contaminated surfaces, and refraining from visiting caves and mines.
This announcement comes after several Arab countries have already advised their citizens to postpone traveling to those two countries due to the same concern.
Both the U.S. Department of State and Centers for Disease Control and Prevention have issued travel alerts related to these Marburg outbreaks.
As of April 5, 2023, no Marburg preventive vaccine is authorized in the U.S.
InflaRx N.V. today announced that Gohibic (vilobelimab), a first-in-class monoclonal anti-human complement factor C5a antibody, has been granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
The FDA granted EUA based on Phase 3 clinical trial results showing a significant relative reduction in 28-day all-cause mortality of 23.9% compared to placebo in critically IMV COVID-19 patients.
As of January 26, 2023, the FDA had withdrawn its EUA(s) for monoclonal antibodies (mAbs) for COVID-19.
“COVID-19 treatments remain a priority for CDER, as the disease continues to impact the lives of Americans,” said Center Director Patrizia Cavazzoni, M.D. “Today's authorization offers another potentially lifesaving treatment option for the sickest COVID-19 patients.”
The Annals of Internal Medicine recently published results from a study that concluded early mAb treatment among outpatients with COVID-19 was associated with a lower risk of hospitalization or death.
Prof. Niels C. Riedemann, CEO and Founder of InflaRx, commented in a press release on April 4, 2023, "We are thrilled and very proud that the FDA has issued a EUA for vilobelimab to treat this very sick patient group, recognizing the lifesaving potential of this first-in-class drug."
"Despite the availability of vaccines and other treatments for earlier disease stages of COVID-19, many patients are still developing viral sepsis and are progressing to critical status, which often requires invasive mechanical ventilation."
"As a consequence, we continue to see mortality rates in the range of approximately 2,000 COVID-19-reported deaths per week in the U.S., as reported by the U.S. Centers for Disease Control and Prevention."
"Today's announcement brings new hope to these patients and their loved ones, and we will work diligently to make this important new treatment available to patients as rapidly as possible."
InflaRx stated it plans to apply for full approval to treat critically ill COVID-19 patients in Europe.
Additional mAbs news is posted at CoronavirusToday.com.
Global News reported today the Canadian Food Inspection Agency (CFIA) confirmed a dog in Oshawa, Ontario, contracted avian influenza (bird flu) and died.
On April 1, 2023, the CFIA reported the dog was infected with bird flu after chewing on a wild goose.
“Further testing is underway,” CFIA said in a related statement. “It is the only case of its kind in Canada.”
“Based on the current evidence in Canada, the risk to the general public remains low, and current scientific evidence suggests that the risk of a human contracting avian influenza from a domestic pet is minor,” the CFIA stated.
Previously, on August 30, 2022, a case of H5N1 infection in a black bear was confirmed in Quebec.
And in May 2022, two red fox kits in Ontario tested positive for HPAI.
Those kits were the first reported cases of the current HPAI outbreak in a wild mammal in North America.
Additional news regarding mammals infected with bird flu is posted at Precision Vaccinations.
And bird flu vaccine news is posted at this link.
The Annals of Internal Medicine today published the results from a University of Pittsburgh Medical Center hypothetical randomized study that estimated administering monoclonal antibodies (mAbs) within two days of a COVID-19 diagnosis lowered the risk of hospitalization or death by about 39%.
The risk for hospitalization or death at 28 days was 4.6% in 2571 treated patients and 7.6% in 5135 nontreated control patients (risk ratio [RR], 0.61 [95% CI, 0.50 to 0.74]). In sensitivity analyses, the corresponding RRs for 1- and 3-day treatment grace periods were 0.59 and 0.49, respectively.
In subgroup analyses, those receiving mAbs when the Alpha and Delta variants were presumed to be predominant had estimated RRs of 0.55 and 0.53, respectively, compared with 0.71 for the Omicron variant period.
Relative risk estimates for individual mAb products all suggested a lower risk for hospitalization or death. The RR was 0.45 (CI, 0.28 to 0.71) among immunocompromised patients.
mABS are human-made antibodies designed to prevent a pathogen, such as the coronavirus that causes COVID-19, from entering human cells, replicating, and causing serious illness.
The U.S. Food and Drug Administration granted emergency use authorization to five different COVID-19 mAbs treatments between 2020 and 2022.
As of April 4, 2023, one mAbs (Gohibic) is authorized for use in the U.S.
Australia's Department of Health and Aged Care recently announced the Vaxzevria (AstraZeneca) COVID-19 is no longer available in-country.
Australia initially confirmed AstraZeneca's vaccine for use as a primary course and booster dose in people aged 18 years and over in February 2021.
And the government provisionally approved for use in Australia as a booster on February 8, 2022.
As of April 4, 2023, Pfizer, Moderna, or Novavax COVID-19 vaccines are the preferred COVID-19 vaccines for people under 60 years.
This assessment was based on the higher risk and observed severity of a rare side effect called thrombosis with thrombocytopenia after receiving AstraZeneca in people under 60 years compared with those aged 60 years or older.
Previously, the Australian Technical Advisory Group on Immunisation recommended in February 2023 that all adults are eligible for a 2023 booster dose this year, provided they have not had a COVID-19 vaccine dose or been infected with COVID-19 within the previous six months.
The U.S. Federal Retail Pharmacy Program for COVID-19 Vaccination is part of the government’s strategy to ensure access to COVID-19 vaccines during the pandemic.
As of March 9, 2023, more than 301 million COVID-19 vaccines have been administered in the U.S. since 2020.
One aspect of this success story is that about 90% of Americans live within 5 miles of a community pharmacy.
To offer these vaccines, the U.S. government spent over $30 billion on COVID-19 vaccines, including the new bivalent boosters, reported Kaiser Family Foundation News.
As of April 4, 2023, the COVID-19 vaccines continue to be provided free of charge to the U.S. population.
Over twenty-five authorized COVID-19 vaccines and therapies are listed in the Precision Vaccinations library.
According to a new study published in Health Affairs, most hospitals in the U.S. are not fulfilling patient privacy promises made when websites were launched in the late 1990s.
Published in April 2023, this study by researchers at the University of Pennsylvania found that third-party tracking was present on 98.6 percent of hospital websites, including data transfers to large technology companies, social media companies, advertising firms, and data brokers.
By including third-party tracking apps on websites, hospitals are facilitating the profiling of their patients by third parties, such as major tech companies and data brokers.
This analysis included hospitals in health systems, hospitals with a medical school affiliation, and hospitals serving more urban patient populations, all exposing visitors/patients to high levels of data tracking.
These data include a person's medication and vaccination histories.
In addition to personal privacy concerns, these practices may lead to increased online health-related advertising targeting patients' mobile phones.
In 1996, the privacy rule within the Kassebaum-Kennedy Act (HIPAA) offered initial privacy protection for a person's health information.
