Screening all patients for hepatitis C testing in ED may find more cases than targeted approach

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Hepatitis C virus
xrender / iStock

A new randomized clinical trial conducted at three US emergency departments (EDs) concludes that screening all adults for hepatitis C virus (HCV) testing identifies significantly more cases than screening based on individual patient risk, although low proportions sought treatment.

Researchers in Denver; Baltimore; and Jackson, Mississippi, randomly assigned 147,498 patients to receive nontargeted HCV screening or risk-based screening, with 18 months of follow-up. 

Screening is critical because most HCV infections cause no symptoms and thus go undetected, the authors noted. EDs "have been a focus of screening efforts, as they serve large numbers of at-risk patients who commonly do not access health care elsewhere," they wrote. 

The team published their findings yesterday in JAMA.

Low percentages followed up

Relative to targeted HCV screening, nontargeted screening found a significantly higher incidence of HCV infections (relative risk, 1.34). Nontargeted screening of 73,847 patients led to 9,867 (13.4%) tested for HCV, yielding 154 new diagnoses. Targeted screening of 73,651 patients identified 23,400 (31.8%) high-risk patients, resulting in 4,640 (6.3%) patients tested and 115 diagnoses. 

The substantial decrease in patients who went from diagnosis to SVR12 highlights an urgent need for innovative models of HCV treatment.

Yet only small percentages of patients with diagnoses sought follow-up care (19.5% nontargeted and 24.3% targeted), started direct-acting antiviral (DAA) treatment (15.6% and 17.4%, respectively), completed DAA treatment (12.3% and 12.2%), and achieved a sustained virologic response by 12 weeks (SVR12; 9.1% and 9.6%).

"The substantial decrease in patients who went from diagnosis to SVR12 highlights an urgent need for innovative models of HCV treatment," the researchers concluded.

In an editor's note, Preeti Malani, MD, MSJ, of the University of Michigan, and Stephen Schenkel, MD, MPP, of the University of Maryland, pointed out that while the difference between the screening approaches met the threshold for statistical significance, the nontargeted approach offered HCV testing to three times as many patients and tested more than double the number for a relatively small absolute difference in diagnoses and similar treatment outcomes. 

"From a practical standpoint, both approaches likely brought logistical challenges to already busy EDs and represented substantial, and potentially nongeneralizable, commitment in the 3 participating EDs," they wrote.

Senate committee advances CDC director confirmation

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The Senate Health, Education, Labor and Pensions Committee yesterday voted to advance a vote on President Donald Trump's nominee to lead the US Centers for Disease Control and Prevention (CDC)—Susan Monarez, PhD—to a full Senate vote, Politico reported.

Susan Monarez
Photo: Courtesy of Senate HELP Committee

Monarez was appointed acting director in January, but the CDC has been without a director since late March, when the White House withdrew its original nominee, David Weldon, MD, and named Monarez as the nominee. Weldon was deemed to not have the votes needed to pass Senate confirmation.

Party-line vote amid concerns about Kennedy influence

Her approval came along party lines, 12 to 11. Bill Cassidy, MD, (R-LA), who chairs the committee, said Monarez is committed to improving transparency at the CDC and properly communicating health guidance, which he said is especially important against the backdrop of reemerging health threats such as measles.

However, Democrats raised concerns about Monarez standing by while Health and Human Services Secretary Robert F. Kennedy Jr. spreads misinformation about vaccines.

Monarez previously served as deputy director of the Advanced Research Projects Agency for Health within HHS and has held several other roles in government, including with the Office of Science and Technology Policy and the National Security Council, both within the executive branch.

Her work has included strategies to combat antimicrobial resistance, and Monarez has led projects to use artificial intelligence and machine learning to improve health outcomes. 

So far there is no vote scheduled in the full Senate to finalize Monarez's confirmation.

FDA approves Moderna COVID vaccine for kids under 12 at higher risk

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Moderna COVID vaccine vials
Courtesy of Moderna

Vaccine maker Moderna announced today that the US Food and Drug Administration (FDA) has granted full approval of its Spikevax (mRNA-1273) COVID vaccine for children 6 months to 11 years old. But, because federal officials in May restricted its recommendations for COVID-19 vaccines to adults 65 and older and to people of all ages who are at increased risk for severe disease, Spikevax will be available only to kids in that age range who are at higher risk.

"COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions. Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization," said Moderna CEO Stéphane Bancel, MBA, MEng. "We appreciate the FDA's diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease."

Doses will be available this fall

"Moderna expects to have its updated Spikevax vaccine available for eligible populations in the U.S. for the 2025-2026 respiratory virus season," the Moderna news release states.

Spikevax first received full FDA approval in January 2022 in adults after being available on an emergency use basis earlier in the pandemic. Last year the FDA expanded the approval to people 12 years and older.

Moderna expects to have its updated Spikevax vaccine available for eligible populations in the U.S. for the 2025-2026 respiratory virus season.

On May 31 the FDA approved Moderna's next-generation mRNA COVID vaccine, called mNexspike (mRNA-1283). It targets a portion of the SARS-CoV-2 spike protein for virus neutralization, allowing for a dose that's one fifth the size of Spikevax. It will be available for the upcoming 2025-26 respiratory virus season to seniors and those 12 to 64 years who are at risk of severe COVID-19.

Both vaccines are based on JN.1 lineage strains, which in May the FDA approved for use this coming season.

Quick takes: WHO arbovirus guidance, H5N1 in US mammals, re-blocking southern border livestock imports

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  • The World Health Organization (WHO) today published new clinical guidance for treating four arboviral diseases: dengue, chikungunya, Zika, and yellow fever. The resource for clinicians treating patients with suspected or confirmed infections is the first that covers all four diseases. Arbovirus infections are a growing public health threat, putting 5.6 billion people at risk, the WHO said in a statement. The diseases are spreading to new areas and increasing the risk of outbreaks beyond tropical and subtropical regions owing to multiple factors that include climate change, population growth, and increased travel and urbanization. Mainland France, for example, is battling chikungunya outbreaks in seven departments, according to the latest weekly communicable disease update from the European Centre for Disease Prevention and Control. For clinicians, diagnosing the diseases can be challenging, because symptoms for the four often overlap and resemble other diseases, and multiple arboviruses can co-circulate.
  • The US Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) has reported four more H5N1 avian flu detections in wild and captive mammals, two of them with recent sample collection dates. One involves a domestic cat from New Jersey's Mercer County that was sampled on June 30, with testing that revealed an H5 result on July 3. Another with a June collection date is a raccoon from Parmer County in Texas. The other detections involve two raccoons, one in Bronx County, New York, that was sampled in January and one in Randall County, Texas, that was sampled in March.
  • Within 2 weeks of the start of a phased reopening of livestock imports at the southern US border, the USDA this week reversed the move, following new evidence that the New World screwworm (NWS) threat is spreading northward. The USDA is working on a plan to raise and release more sterile flies to curb the northward spread of NWS, which can lead to cattle loss and sporadic infections in people. Mexico's agriculture ministry this week reported a new case in a part of Veracruz state that is about 160 miles north of the current sterile-fly zone. The detection is 370 miles from the US border. In May, two earlier detections that were less than 700 miles away triggered the initial southern border closures to the import of Mexican cattle, bison, and horses.

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