Antimicrobial Resistance Scan for Nov 08, 2016

News brief

FDA advisory panel recommends new antibiotic for approval

An advisory panel to the US Food and Drug Administration (FDA) voted on Nov 3 to recommend a new antibiotic to treat community-acquired pneumonia (CABP), despite concerns over liver toxicity.

In a 7-6 vote, members of the FDA's Antimicrobial Drugs Advisory Committee recommended approval of the drug solithromycin, a macrolide antibiotic that has activity against macrolide-resistant CABP pathogens. But while the panel voted unanimously (13-0) that there was substantial evidence of solithromycin's efficacy, and that the drug works as well as moxifloxacin in patients with CABP, they also voted 12-1 that the risk of hepatoxicity has not been adequately characterized.

Reuters reports that clinical trials of solithromycin showed greater number of patients taking the drug developed elevated liver enzymes than those taking moxifloxacin, a possible sign of underlying liver damage. But there were no cases of acute liver injury. The panel recommended that drug maker Cempra Inc. be required to conduct additional studies on potential liver damage after the drug is approved.

"We appreciate the meaningful discussion from today's panel. Their supportive view and thoughtful comments on approaches to ensuring appropriate use are consistent with Cempra’s commitment to make solithromycin available to the right patients for a five to seven day course of an oral and/or IV macrolide as monotherapy for CABP," Cempra president and CEO Prabhavathi Fernandes PhD, said in a company press release.

Cempra argues that new antibiotics for the treatment of CABP are much needed, as rates of pneumococcal resistance to macrolides can exceed 50%.

The FDA is not bound by the advisory panel's recommendations.
Nov 4 Cempra Inc. press release
Nov 4 Reuters story

Study finds limiting use of '4C' antibiotics can reduce C diff infection rates

A new study out of Scotland suggests that limiting the use of antibiotics associated with Clostridium difficile infection risk can reduce C difficile infection rates in hospital and community populations.

The study, published Nov 4 in the Lancet Infectious Diseases, was an observational and quasi-experimental time-series analysis that aimed to measure the impact of an antibiotic stewardship program (ASP) in northeast Scotland that emphasized reduction in hospital and community use of antibiotics linked to C difficile infection. The antibiotics—known as the 4Cs—included ciprofloxacin/fluoroquinolones, co-amoxiclav, clindamycin, and cephalosporins. After implementation, use of the 4C antibiotics was reduced by 50% in hospitals and the community.

Other infection control and prevention measures in the ASP included a hand-hygiene campaign, national auditing and inspections of hospital environment cleanliness, and reduced inappropriate use of proton-pump inhibitors. The total effect of interventions, which were initiated in 2009, was defined as the difference between the C difficile infection burden with the ASP and projected scenarios without stewardship.

From 1997 to 2012, investigators identified 4,885 cases of hospital-onset C difficile and 1,625 cases of community-onset C difficile. Controlling for multiple cofounders, the authors estimated that after implementation of the ASP, C difficile infection prevalence fell by 68% in hospitals and 45% in the community compared to projected scenarios without the ASP. Further analysis indicated that declines in C difficile could be explained by the removal of antibiotic selection pressure favoring multidrug-resistant ribotypes R001 and R027, which have been associated with higher incidence and more severe disease. No significant effects from other measures of the ASP were identified.

"Our study adds to existing evidence that antibiotic stewardship might be an effective tool for the control of C difficile infection in both hospitals and the community," the authors wrote.
Nov 4 Lancet Infect Dis study
Nov 4 Lancet Infect Dis commentary

News Scan for Nov 08, 2016

News brief

Essential medicine cost feasible for low- and middle-income countries

Yesterday The Lancet released their Commission on Essential Medicines Policies report, which focuses on how to pay for essential medicines in nations with varying income levels. Included in the report is the first model for estimating the cost of providing essential medicines in the poorest nations.

The model, developed by University of California, Los Angeles (UCLA) researchers, looked at the cost of 200 essential medicine "baskets" for low- to middle-income countries, and discovered the cost would between $77 billion and $152 billion each year, or about $13 to $25 per capita annually. This comes out to $1 to $2 per person, per month. That cost is feasible, though challenging, they concluded.

The Lancet said the commission's report is a synthesis of 30 years' work on essential medicines, a set of medicines based on the World Health Organization’s (WHO) list of medicines that do not require specialized tertiary care and treat some of the most common diseases in the world, including HIV/AIDS, diabetes, cardiovascular diseases, mental illness, and respiratory conditions.

The commission's report is meant to help shape decision-making and global health guidelines for the next 20 years. Twenty-one experts helped author the report.
Nov 7 UCLA press release
Nov 7 Lancet report

Prevalence of vaccine-type HPV reduced by half

A new study in the Journal of Infectious Diseases shows that human papillomavirus (HPV) vaccination in the United States has dramatically reduced the prevalence of vaccine-type HPV strains in only 2 years.

Between 2009 and 2012, the proportion of women ages 18 to 26 who received the HPV vaccine doubled from 17.1% to 34.5%. This study used data from the National Health and Nutrition Examination Survey (NHANES) from 2009-2010 and 2011-2012 to determine if the increase in vaccination coverage corresponded to a reduction of vaccine-type HPV strains.

Researchers found that the prevalence of vaccine-type HPV decreased almost 45% from 15.4% in 2009-2010 to 8.5% in 2011-2012 in women ages 18 to 26. The prevalence of high-risk vaccine-type HPV in 2009-2010 was 13.1%, but was reduced to 6.5% by 2012.

"The finer examination reported here shows an impressive drop in VT [vaccine type] prevalence between 2009 and 2012 and enriches our understanding of the effects of the HPV vaccine in the US and what we can expect in the future. Our findings suggest that the VT HPV prevalence among 18-26 year-old women in the US will continue its rapid decline. This will be helped by the introduction of routine vaccination among males," the authors concluded.
Nov 7 J Infect Dis study

Americas chikungunya total grows by 440

The number of chikungunya cases in the Americas so far this year grew by 440 cases last week to reach 303,547 suspected, confirmed, and imported infections, according to the latest update from the Pan American Health Organization (PAHO).

The weekly increase is similar to the 452-case rise seen the previous week. Most of the new cases were from Mexico, Costa Rica, El Salvador, Bolivia, and Colombia. One death was removed from last week's total, putting the number for the year at 105.

The United States has reported six more imported chikungunya cases this year, lifting its total to 119.

Many countries have not reported any new illnesses for several weeks.

Starting in the Caribbean territory of St. Martin, the Americas' chikungunya outbreak began in 2013 and has now sickened 2,181,987 people.
Nov 4 PAHO update