News Scan for Jul 07, 2021

News brief

WHO recommends new rapid molecular tests for TB

The World Health Organization (WHO) today issued an update to its consolidated guidelines on the detection of tuberculosis (TB) and drug-resistant TB.

The update includes three new classes of rapid molecular tests recommended by the WHO: moderate-complexity automated NAATs (nucleic acid amplification tests) for the initial detection of TB and resistance to rifampicin and isoniazid, low-complexity automated NAATs for detection of resistance to isoniazid and second-line anti-TB agents, and high-complexity hybridization-based NAATs for the detection of pyrazinamide resistance. An accompanying operational handbook aims to help facilitate implementation and roll-out of the tests by national TB programs.

The WHO estimates that more than a third of TB patients and two-thirds of those with drug-resistant TB go undetected. The agency hopes that the high diagnostic accuracy of rapid molecular tests, along with quick turnaround times, will lead to major improvements in the early detection of TB and drug-resistant TB.

"Ensuring that everyone can obtain a rapid and accurate diagnosis, followed by treatment according to the latest WHO guidelines, will save lives and reduce suffering," Tereza Kasaeva, director of the WHO Global TB Programme, said in a press release. "We call for rapid action and stakeholder support in ensuring these updates are rapidly implemented to enable access to the latest technologies and innovations."
Jul 7 WHO press release

Antibiotic stewardship interventions affect hospital in Oman

A series of antimicrobial stewardship (AMS) interventions by clinical pharmacists at a hospital in Oman had a significant clinical impact and helped reduce costs, researchers reported yesterday in the International Journal of Infectious Diseases.

The retrospective analysis of clinical pharmacists' (CPs') interventions at the 500-bed tertiary care hospital found that of the 828 interventions related to antimicrobial use in 2018, 62% involved intensive care unit patients, followed by patients admitted under medicine specialties (16%) and hematology/oncology patients (7%). The most common type of intervention was adjustment of the dosing regimen (42%), followed by deletion of the antimicrobial order (34%). The three antibiotics that most commonly required modification were meropenem, piperacillin/tazobactam, and vancomycin.

The most common type of clinical impact associated with the intervention was improving the efficacy of the treatment, which was reported in 45% of cases. Preventing unnecessary antimicrobial exposures was reported with 30%. Most of the interventions (64%) were graded as major. The projected net annual cost savings from the interventions, including cost reduction and cost avoidance, was US $193,320.

"We believe that our study not only demonstrates the important value of CPs in ID [infectious diseases] treatment, but also provides powerful evidence for policy/decision makers to consider the establishment of a formal AMS program at our institution," the study authors wrote.
Jul 6 Int J Infect Dis study

Valneva receives FDA breakthrough designation for chikungunya vaccine

Valneva, a pharmaceutical company based in France, today announced that its candidate single-dose vaccine against chikungunya virus—called VLA1553—has received breakthrough therapy designation by the US Food and Drug Administration (FDA), a step that will expedite the review process.

In a statement, Juan Carlos Jaramillo, MD, the company's chief medical officer, said, "Chikungunya is a major, growing public health threat and VLA1553 targets long lasting protection against the chikungunya virus with a single shot. We will continue to work closely with the FDA to bring a preventative solution to the market as soon as possible."

The company said it has completed enrollment for its phase 3 trial, designed to test immunogenicity and safety at 28 days following immunization, with topline data expected this summer. The live attenuated vaccine is the only chikungunya product in phase 3 trials.

To make the vaccine more accessible to low- and middle-income countries, Valneva signed an agreement with Brazil's Butantan Institute to develop, make, and market the vaccine. Support for development came from the Coalition for Epidemic Preparedness Innovations (CEPI) and the European Union Horizon 2020 program. The vaccine had previously received fast-track designation from the FDA and PRIME designation from the European Medicines Agency.
Jul 7 Valneva press release

WHO: Few global flu detections, mainly influenza B

Global flu activity in the middle 2 weeks of June remained below expected levels in both hemispheres, with little activity except for a slight increase in influenza B, especially in China, the WHO said in its latest global update.

Sporadic detections were reported in western and eastern Africa, as well as in India.

Of respiratory samples that tested positive for flu at national labs in the middle of June, 89% were influenza B, all the Victoria lineage. Of the subtyped influenza A viruses, 85.7% were 2009 H1N1 and 14.3% were H3N2.

The WHO included the caveats that social measures and changes in surveillance related to the COVID-19 pandemic could make it difficult to interpret flu patterns.
Jul 5 WHO global flu update

COVID-19 Scan for Jul 07, 2021

News brief

Low testosterone in men tied to severe COVID-19

New data presented at the European Association of Urology congress this week show that men with low testosterone who were hospitalized for severe COVID-19 during the first wave of infections in Milan, Italy, were more likely to need intensive care and mechanical ventilation, and they had a sixfold increased risk of death.

The findings come from San Raffaele University Hospital in Milan, where researchers compared 286 male COVID-19 patients who presented for emergency care, with 305 healthy controls who donated blood at the hospital from February to May 2020. Both groups had hormone testing, and low testosterone was defined as 9.2 nanomoles per liter (nmol/L).

Ninety percent of the males with severe COVID had low testosterone, compared with 17% of controls. And men with severe COVID-19 had very low levels of the male sex hormone: Those admitted to intensive care or who died had just 0.7 to 1.0 nmol/L, and those with more mild disease also had low levels (3 to 4 nmol/L).

"We never expected to see such a high proportion of Covid patients with these extremely low levels of testosterone, in comparison to a similar group of healthy men. The relationship is very clear: the lower the testosterone, the higher the severity of the condition and likelihood of death," said Andrea Salonia, MD, PhD, a specialist in urology and endocrinology at San Raffaele Hospital.

In a press release, Salonia said it was not clear if COVID-19 infections caused a drop in testosterone or was a pre-exiting condition in the patients.
Jul 6 European Association of Urology press release

Swiss study: Almost 40% of patients had long COVID after 7 to 9 months

Seven to 9 months postacute COVID-19 infection, 39.0% of 410 adults still had symptoms of long COVID-19, according to a study yesterday in the Annals of Internal Medicine.

The researchers included symptomatic outpatients in Geneva enrolled from Mar 18 to May 15, 2020. Of those who responded to follow-up at 7 to 9 months post-infection, 39.0% still had symptoms, of which half experienced one or two symptoms (27.6% and 26.4%, respectively).

Of 311 participants who checked in at all three follow-up points (enrollment, 30 to 45 days, 7 to 9 months), 37% had symptom resolution at the 30- to 45-day mark, and 19% more had resolution at 7 to 9 months, for a total of 56%.

At 7 to 9 months, the most common symptom was fatigue (20.7%), and of the 85 patients who experienced it, 27.0% said it was bad enough to restrict strenuous physical activity. A little over 10% of patients who still experienced symptoms reported shortness of breath (11.7% of 48), with 60.4% saying that it occurred even when walking up a slight hill or hurrying on ground level. Other frequent symptoms included loss of taste or smell (16.8%) and headache (10.0%).

Almost three quarters of the 7- to 9-month cohort (72.4%) had no prior COVID risks (eg, hypertension), the researchers note, and 67.1% were females. The average age of the original 629 participants enrolled at baseline was 42.1 years.

"Recognition of postacute sequelae of SARS-CoV-2 and potential predictors is important in reaching a more thorough understanding of the disease and its long-term effects," the researchers write. "With a high prevalence of symptoms at 7 to 9 months, physicians should continue to monitor patients with COVID-19 over the long term."
Jul 6 Ann Intern Med study

Less than 5% of COVID-19 studies have plan to factor in sex, analysis finds

Although sex is associated with different COVID-19 mortality rates and can affect pharmacological side effects, only 4% of COVID-19 studies on ClinicalTrials.gov explicitly plan to include them as a variable, according to a Nature Communications study yesterday.

The researchers looked at 4,420 registered COVID-19 studies from Jan 1, 2020, to Jan 26, 2021 and found that 21.2% addressed sex and gender solely in the context of recruitment, 5.4% planned sex-matched or representative samples or emphasized sex reporting, and 4.0% explicitly stated there was a plan to include sex as a variable.

While some study summaries may not mention their complete plans, the researchers note that only 17.8% of 45 COVID randomized clinical trials (RCTs) published by Dec 15, 2020, report sex-disaggregated analyses.

Most studies that mention sex as an analytical variable are observational and patient registry studies (132 [74.2%]) or have matching/reporting (153 [64.6%]), data showed. Also, only 1.3% of 1,161 pharmacological intervention RCTs and 2.4% of 1,314 other interventional studies have registered a plan to consider sex as an analytical variable.

This issue has had low priority throughout the pandemic, the researchers write, adding, "Ignoring sex and gender aspects of COVID-19 is not scientifically or ethically justifiable, and interventional trials should be designed to account for these variables."
Jul 6 Nat Commun study