Stewardship / Resistance Scan for Mar 22, 2021

News brief

New guide helps antibiotic developers with stewardship, access plans

A coalition of groups funding antibiotic research and development today released new guidance for developers of antibacterial products to integrate stewardship and access into their plans.

The Stewardship & Access Plan (SAP) Development Guide provides companies working on new antibiotics and other products targeting antibiotic-resistant bacteria, including vaccines and diagnostics, with strategies to ensure their products will be used responsibly and will be widely accessible in low- and middle-income countries.

The document was produced at the request of companies that receive funding from CARB-X (the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator) to help them meet the stewardship and access obligations required of CARB-X awardees once their projects reach clinical trials. Each company that receives CARB-X funding must produce an SAP within 90 days of their product entering phase 3 trials.

Developed collaboratively by members of CARB-X, the Wellcome Trust, the Global Antibiotic Research and Development Partnership, the Access to Medicine Foundation, the Biomedical Advanced Research and Development Authority, and others, the document provides an overview of strategies and activities that product developers can adopt to create SAPs that meet the funding requirements. Beyond CARB-X awardees, it aims to encourage other antibacterial product developers, and the governments and organizations supporting them, to integrate stewardship and access principles into their efforts.

"Antibacterial innovation must go hand-in-hand with responsible use and access. Otherwise, innovative drugs that are meant to help patients risk contributing to the global burden of antibiotic-resistance," CARB-X Executive Director Kevin Outterson, JD, said in a CARB-X press release. "We all must do our part to see that antibacterials are used responsibly and that patients who need them have access to them."

"The Guide represents a new benchmark for what can be expected from companies preparing to market innovative antibiotics, as they should proactively develop robust plans enabling worldwide stewardship and equitable access alongside market entry plans," said Tim Jinks, PhD, head of the Drug-Resistant Infections Program at Wellcome Trust.

"We are delighted to see the publication of the guide and hope that these insights inform the wider pharmaceutical, scientific and global health community, as well as CARB-X awardees."
Mar 22 CARB-X press release
Mar 22 SAP development guide

New African Union plan aims to limit emergence, spread of AMR

The African Union (AU) late last week released its 5-year plan for antimicrobial resistance (AMR) control.

Under the plan, which was developed by an AMR task force representing agencies involved in the human, animal, and plant health sectors, the AU will work with member states and other stakeholders over the next 5 years to improve surveillance of antimicrobial use and resistant microorganisms, delay the emergence and limit the transmission of AMR, and mitigate the harm from resistant organisms.

Goals of the plan include increasing the number of member states that monitor and track antibiotic use and the number of humans, animals, and food products tested for resistant pathogens; encouraging more physicians, veterinarians, and food producers to adhere to guidelines for prudent antimicrobial use; boosting infection control and prevention programs and diagnostic testing in healthcare facilities; and strengthening water, sanitation, and hygiene in all settings.

To achieve these goals, the AU says it will advocate for policies and laws that enable long-term prevention and control of AMR, engage civil society organizations on AMR, hire and train staff to perform AMR surveillance and control measures, and collaborate with partners to develop a list of priority areas for academic research.

The AU also says it will convene a panel of experts to identify high-level AMR targets and will produce annual reports on progress in achieving those targets.
Mar 19 African Union AMR plan 2020-2025

News Scan for Mar 22, 2021

News brief

COVID-19 linked with far higher death, hospitalization rate than flu

Compared with the 2014 to 2019 flu seasons, COVID-19's effect in March and April 2020 resulted in a dramatically higher rate of deaths, mechanical ventilation procedures, and hospitalizations at the Beth Israel Deaconess Medical Center (BIDMC) in Boston, according to a study published in the Journal of General Internal Medicine late last week.

The researchers looked at 1,634 hospitalized patients, 582 with COVID-19 (median age, 66) and 1,052 with influenza (median age, 68). On average, 210 patients were hospitalized at BIDMC during each 8-month flu season, compared with the 582 COVID-19 patients in just 2 months of the pandemic. While 29.9% of COVID-19 patients required mechanical ventilation, 8.0% who were admitted for the flu needed it—a median of 17 COVID patients per week vs 1 flu patient. Overall, from March through April 2020, 119 patients with COVID-19 died (20.4%) versus 34 flu patients who died (3.2%).

The researchers note that COVID patients who needed mechanical ventilation tended to need it longer than flu patients did (median 14.3 days vs 3.3 days). They were also much more likely to be in good health prior to COVID-19 (25.2% had no major comorbidities vs 3.6%). In general, 177 COVID-19 patients (30.4%) needed vasopressor support versus 74 flu patients (7.0%).

Physical distancing began in Boston Mar 15, 2020, and the stay-at-home order followed on Mar 24. While this likely reduced the volume of COVID-19 cases, the researchers also point out that flu cases each year are decreased by vaccination, an option not available for COVID-19 at the time.
Mar 18 J Gen Intern Med study
Mar 19 BIDMC press release

Analysis highlights equitable COVID-related hospital resource allocation

The University of Miami's critical standard of care (CSC) resource guidelines did not show bias against Black or Hispanic hospitalized patients, according to a study published in JAMA Network Open late last week, but a commentary argues that including comorbidities at all may cause bias, and that classification in the CSC may be too skewed toward "highest priority" to be useful.

The University of Miami's guidelines tried to mitigate biases by integrating short- and long-term prognosis, measuring only the worst comorbidity, and using SOFA (sequential organ failure assessment) scores. To assess their guidelines, the researchers looked at 1,127 adult patients (5,613 patient-days) who were admitted to a COVID-19 ward or who needed mechanical ventilation or high-flow nasal cannula from May 26 to Jul 14, 2020. Of the cohort, 69.4% were classified as highest priority, 22.6% as middle priority, and 8.0% low priority.

Compared with White patients, no significant associations between maximum or minimum priority score and race were found. For instance, the maximum priority score, or the score that would likely lead to denial of treatment, had an adjusted incidence rate ratio (IRR) of 1.00 in Black patients (95% confidence interval [CI]; 0.89 to 1.12; 28.7% of cohort), 0.95 in Asian patients (95% CI; 0.62 to 1.45; 0.7% of cohort), and 0.93 in multiracial patients (95% CI, 0.72 to 1.19; 2.8% of cohort). In comparison with non-Hispanic patients, Hispanic patients had an adjusted IRR of 1.00 (95% CI, 0.89 to 1.13; 54.2% of cohort).

"Although the inclusion of comorbid conditions was not associated with racialized differences in priority score in the study by Gershengorn et al, the inequitable distribution of life-limiting health conditions—an individual-level manifestation of structural racism—nevertheless makes their inclusion in CSC guidelines problematic," the commentary states. It adds that limiting the number of SOFA points for comorbidities with the strongest racial associations and doing analysis on disability discrimination would further ensure equity.

"With more than 70% of patients stratified into the highest priority group, their utility in critical care triage is suspect," the commentary concludes. "Secondary tie-breaker criteria may be needed to improve the ability of CSC guidelines to more broadly and effectively guide the allocation of resources."
Mar 19 JAMA Netw Open study
Mar 19 JAMA Netw Open commentary

Fatal H5N6 avian flu case reported in China

China reported one more human H5N6 avian flu case, which involves a 50-year-old man from Guangxi province who died from his infection, according to a statement today from Hong Kong's Centre for Health Protection (CHP).

The man's symptoms began on Feb 16, and he was hospitalized on Feb 17 for severe pneumonia. He died on Mar 2. No details on his exposure to the virus was noted in the CHP report. Guangxi province is in southern China on the border with Vietnam.

Poultry outbreaks involving H5N6 have been reported in China and a few other Asian nations, but so far China has been the only country to report human cases. Since the first human case was reported in 2014, China has now reported 30 infections, many of them fatal.
Mar 22 CHP statement

Global flu patterns stay low and sporadic

Flu levels across the globe remained low, with only a few parts of the world reporting circulation, with mostly sporadic detections, the World Health Organization (WHO) said in its latest update, which covers the last half of February.

The latest snapshot should be considered in the context of the COVID-19 pandemic, for which response measures may be affecting flu virus transmission, the WHO said.

Some countries in western and eastern Africa have reported flu activity in recent weeks, and cases continue to be reported in Laos, mainly involving the H3N2 strain. In India, H3N2 detections increased.

Countries reporting sporadic detections include Colombia, Azerbaijan, Saudi Arabia, and Armenia.

Globally, of the few respiratory specimens that tested positive for flu, 48.6% were influenza A and 51.4% were influenza B. Of the subtyped influenza A viruses, 65.6% were H3N2.
Mar 15 WHO global flu update