News Scan for Oct 02, 2018

News brief

Combo antibiotic for CRE infections performs well in phase 3 trial

The results of a phase 3 randomized, controlled clinical trial show that monotherapy with the antibiotic/beta-lacatamase inhibitor combination Vabomere (meropenem-vaborbactam) in patients with carbapenem-resistant Enterobacteriaceae (CRE) infections was associated with increased clinical cure, decreased mortality, and reduced kidney toxicity compared with the best available therapy (BAT). The results were published yesterday in Infectious Diseases and Therapy.

In the Targeting Antibiotic Non-susceptible Gram-negative Organisms (TANGO) II trial, 77 patients with confirmed CRE infection from 27 hospitals in eight countries were randomized 2:1 to receive meropenem-vaborbactam alone for 7 to 14 days or BAT (mono/combination therapy with polymyxins, aminoglycosides, tigecycline; or ceftazidime-avibactam alone). Forty-seven patients with confirmed CRE infection formed the primary analysis population. Efficacy end points included clinical cure, day-28 all-cause mortality, microbiologic cure, and overall success (clinical cure plus microbiologic eradication). The most common infection types were bacteremia and complicated urinary tract infections (cUTIs).

In the primary analysis population, cure rates were 65.6% (21/32) for patients receiving meropenem-vaborbactam and 33.3% (5/15) for BAT patients at end of treatment and 59.4% (19/32) and 26.7% (4/15) at test of cure. Day-28 all-cause mortality was 15.6% (5/32) and 33.3% (5/15) for meropenem-vaborbactam versus BAT, respectively. In the safety population, meropenem-vaborbactam was associated with fewer drug-related adverse events (24% [12/50] vs. 44% [11/25]), fewer serious adverse events (34% [17/50] vs. 44% [11/25]), and fewer kidney-related adverse events (4% [2/50] vs. 24% [6/25]) than BAT was.

Exploratory risk-benefit analyses of composite clinical failure or nephrotoxicity also favored meropenem-vaborbactam over BAT, 31.3% (10/32) to 80% (12/15).

The authors of the study conclude that the results indicate that meropenem-vaborbactam, which was approved by the US Food and Drug Administration in 2017 for use in cUTI patients based on results from the TANGO I trial, "will be a valuable addition to the antimicrobial armamentarium against CRE pathogens."
Oct 1 Infect Dis Ther study

New North American trade deal keeps food safety measures intact

The new version of the North American trade deal announced yesterday leaves existing food safety provisions in place, though two Canadian think tanks had proposed including at least a bilateral food protection system between the United States and Canada, Food Safety News (FSN) reported today.

Earlier in the discussions, the Canadian Agri-Food Policy Institute and the Canada Institute of the Wilson Center produced an 8-page discussion paper that urged Canada and the United States to establish a joint risk assessment organization for food safety.

According to FSN, the section of the new agreement that covers sanitary and phytosanitary measures doesn't include any of the suggested reforms and contains language similar to the previous North American Free Trade Agreement (NAFTA) objectives, such as strengthening communication and cooperation between the parties and advancing science-based decision making.

Expert panels subjected to legal oversight and relying on relevant international standards will handle scientific and technical food safety disputes among the parties, according to the agreement, which is now called the United States-Mexico-Canada Agreement (USMCA).
Oct 2 FSN report

Flu Scan for Oct 02, 2018

News brief

Flu shows signs of decline in some Southern Hemisphere regions

As the Southern Hemisphere's flu season winds down, disease levels in temperate South American and southern Africa countries decreased or have peaked in recent weeks, according to the latest global flu update from the World Health Organization (WHO).

In Australia, flu activity rose over the last month but still remained low, with levels in New Zealand remaining below the seasonal threshold. In recent weeks southern Africa experienced a second wave of flu activity, with influenza B the most commonly detected virus.

Elsewhere, some parts of South and Southeast Asia reported increasing flu activity, including India and Laos, both of which are reporting mainly 2009 H1N1 detections, and Thailand, which is reporting cocirculation of both influenza A viruses—H1N1 and H3N2.

In the Caribbean and Central America, flu activity remained low except in Haiti, El Salvador, and Nicaragua.

Globally, of flu viruses that tested positive during the first half of September, 84.4% were influenza A. Of subtyped influenza A viruses, 65.3% were 2009 H1N1 and 34.7% were H3N2.
Oct 1 WHO global flu update

Study: High-dose vaccine may offer advantages for seniors

The high-dose flu vaccine provided better protection against influenza hospitalization for seniors than the standard vaccine, according to a new study that matched study by age and residence.

To compare the vaccines, researchers from the Oregon Public Health Division examined immunization registry records and hospitalizations for lab-confirmed flu in the Portland area during the 2016-17 flu season. They published their findings yesterday in Vaccine.

Based on earlier studies comparing vaccines, they noted that the "healthy vaccine" phenomenon can inflate vaccine effectiveness (VE), while an "at-risk vaccinee" bias can deflate VE estimates. As another way to compare the two vaccines, they measured how they performed in groups matched by age, gender, residence type, race-ethnicity, provider bias, and zip code.

The first simple aggregate comparison of the two vaccine groups showed no added effectiveness against flu-related hospitalization. However, adding different categories increased VE, with the final analysis of 23,712 matched pairs suggesting that the high-dose vaccine was 30.7% more effective in preventing flu-related hospitalization (95% confidence interval, 8% to 48%).

The team suggested that VE studies include matching factors that reflect local geographic areas, age, and other potential provider biases. "As a caution, calculating vaccine effectiveness based on aggregate, non-matched methods from large datasets likely will produce distorted results and should be avoided," the authors wrote.
Oct 1 Vaccine abstract