Top Infectious Disease News of the Week— December 30, 2018

#5: New Clinical Practice Guidelines for Seasonal Influenza

A decade after issuing clinical practice guidelines for influenza, the Infectious Diseases Society of America has issued updated recommendations for health care professionals related to the diagnosis, treatment, prevention, and outbreak management of seasonal flu. The reissued guidelines reflect the approval of new antiviral drugs that can reduce the duration and severity of the flu; improvements in flu-testing products; and a new acknowledgement of risk factors that could portend disease severity.

“The previous guidelines were written in 2008, just before the 2009 influenza epidemic,” Andrew Pavia, MD, professor and chief of infectious disease at the University of Utah in Salt Lake City and a member of the committee responsible for writing the guidelines, told Contagion®. “And we’ve learned a great deal since then.”

There were 3 main factors driving the new guidelines, he said. One is that more people are at high risk of influenza complications than previously thought. Pregnant women who contract the flu can suffer serious illness due to alterations in the immune system, as well as the lungs and heart, according to the US Centers for Disease Control and Prevention. Fever, which often goes along with the flu, can cause defects in the fetus. Also at risk are people who are morbidly obese, possibly due to obesity’s role in systemic inflammation.

Read about the new guidelines for seasonal influenza.

#4: Plumbing Contamination Linked with Cluster of Infections from Rare Sphingomona Species

A new study published in the New England Journal of Medicine details a genomic and epidemiologic investigation into a small outbreak of multidrug-resistant Sphingomonas koreensis infections that occurred at a National Institutes of Health (NIH) Clinical Center, which investigators concluded was linked with contamination in the facility’s plumbing system.

Health care-associated infection (HAI) rates are down overall in the United States but remain a problem in health care settings. In 2015 there were an estimated 687,000 HAIs in US acute care hospitals, and 72,000 hospital patients with HAIs died during their hospitalizations. Although surgical site infections, pneumonia, and Clostridium difficile infections account for most HAIs, the NEJM study detailed a cluster of infections caused by waterborne Sphingomonas species, including S koreensis, an uncommon gram-negative bacterium that was first documented as a human pathogen in a 2015 study.

According to the report by NIH investigators, 6 patients at the NIH Clinical Center in Bethesda, Maryland, became infected with Sphingomonas species during a 6-month period in 2016. The investigators conducted whole genome sequencing on the isolates from patients infected with Sphingomonas and tested water samples from the faucets in their hospital rooms.

Read about the source of the Sphingomona clusters.

#3: Vaxchora: What ID Pharmacists Should Know

Lyophilized CVD 103-HgR (Vaxchora, PaxVax) is the only vaccine approved in the United States to prevent cholera. The US Food and Drug Administration approved the vaccine in 2016 for adults between the ages of 18 and 64 who are traveling to areas of active cholera transmission.

Vaxchora is a single-dose oral live vaccine suspension that should be administered at least 10 days before traveling to a cholera-affected area. Patients who have a history of a severe allergic reaction (eg anaphylaxis) to any ingredient in the vaccine or to a previous cholera vaccine, should not receive it. The vaccine may be shed in the stool for at least 7 days, and there is a potential to transmit the vaccine strain to nonvaccinated individuals, especially patients who are immunocompromised.

Patients should avoid eating or drinking for 60 minutes before and after oral ingestion of the vaccine. Additionally, administration should be avoided with systemic antibiotics, because they may reduce the efficacy of the vaccine.

Vaxchora should not be given to patients who have received oral or parenteral antibiotics in the previous 14 days; however, it is unknown how long individuals should wait after finishing an antibiotic to receive the vaccine.

Read about what pharmacists should know about Vaxchora.

#2: Better HIV Virologic Response Seen With Single-Tablet Regimens

Since the introduction of antiretroviral therapy, treatment for HIV has evolved from complex multiple-tablet regimens to single once-daily pills. According to the results of a new study, for people living with HIV, these single-tablet regimens may provide better virologic response and control than multiple-tablet regimens.

“Understanding the impact of single-tablet regimens is especially important today, as we stand on the verge of multiple effective agents being available as generic formulations with the potential to decrease the cost of antiretroviral therapy, and affect significant cost-savings nationally,” the study authors wrote. “These cost-savings may result in a ‘desimplification’ of treatment as patients on currently branded single-tablet regimens may be asked to change to a less costly multiple-pill alternative.”

To assess the differences in outcomes between single-tablet and multiple-tablet regimens, the investigators followed 218 patients enrolled in the Infectious Disease Practice at the New Jersey Medical School in Newark, New Jersey, between 2007 and 2013. Of these patients, 103 (47%) received a single-tablet regimen and 115 (53%) received a multiple-tablet regimen. Patients taking a single-tablet regimen were less likely to be female (25% vs 44%) and less likely to be black (54% vs 70%). Patients taking a multiple-tablet regimen had higher rates of substance abuse history (53% vs 39%).

Read about the HIV virologic response with single-tablet regimens.

#1: Infections Linked With Umbilical Cord Stem Cells Result in FDA Warning, Product Recall: Public Health Watch

Stem cells save lives.

They may also be a source of infection.

The US Food and Drug Administration (FDA) has issued a warning to pharmaceutical company Genetech, Inc. after unapproved umbilical cord blood-derived stem cell products marketed by the company and distributed by Liveyon were found to have caused 12 cases of bloodstream and/or joint infections in patients who had received them via injection or infusion in outpatient clinics in Texas (7 cases), Florida (4 cases), and Arizona (1 case). All 12 patients affected were hospitalized—1 for nearly 2 months; as yet, no fatalities have been linked with the stem cell products.

“The company’s failure to put in place appropriate safeguards may have led to serious blood infections in patients,” FDA Commissioner Scott Gottlieb, MD, said in a statement announcing the warning. “We remain committed to supporting the development of safe and effective cell-based regenerative medicine and advancing our comprehensive regenerative medicine policy framework.”

In addition to the specific warning to Genetech, the FDA has issued letters reiterating its compliance and enforcement policies to other manufacturers and health care providers who may be offering stem cell treatments. Dr. Gottlieb noted that to date, though, the agency has been “discouraged by the overall lack of manufacturers” who are willing to work with it in improving oversight and quality control in stem cell processing.

“The letters…are a reminder that there’s a clear line between appropriate development of these products and practices that sidestep important regulatory controls needed to protect patients,” he added. “We’ll be increasing our oversight related to cell-based regenerative medicine as part of our comprehensive plan to promote beneficial innovation while protecting patients.”

In a report on the FDA warning published on December 21, 2018, TheWashington Post noted that the US stem cell industry has grown significantly in recent years, with hundreds of clinics nationally selling the products for the treatment of conditions ranging from Parkinson’s disease to multiple sclerosis. Currently, the only FDA-approved indication for umbilical cord blood-derived stem cells is hematopoietic or immunologic reconstitution.

Read about infections linked with umbilical cord stem cells.