News Scan for Sep 11, 2019

News brief

DRC Ebola total grows by 7 more cases, to 3,091

Seven more confirmed Ebola infections were reported today in the Democratic Republic of the Congo (DRC), raising the outbreak's overall total to 3,091, according the World Health Organization (WHO) online Ebola dashboard. Health officials are also investigating 451 suspected cases.

One more person died from Ebola, listing the fatality count to 2,071.

Meanwhile, an update today from the DRC's multisector Ebola response committee (CMRE) on three cases reported yesterday said one patient is from Beni and two are from Mambasa.
WHO online dashboard
Sep 10 CMRE report

In other developments, Ridgeback Biotherapeutics recently announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation for mAb114, one of the two drugs used and studied in the DRC's Ebola treatment centers that stood out as more effective, based on an August announcement by health officials.

Breakthrough therapy designation is intended to speed the development and review of drugs for serious or life-threatening conditions.

The drug is a monoclonal antibody isolated from a human survivor of the 1995 Ebola outbreak in Kikwit, DRC.

Wendy Holman, chief executive officer of Miami-based Ridgeback Therapeutics, said in a Sep 6 company statement, said the company is grateful to the researchers and study participants. "The FDA's decision to grant mAb114 Breakthrough Therapy designation for the treatment of Ebola reflects a recognition of the promising efficacy and safety data that has been collected to date for this investigational drug.  We plan to work closely with the FDA as we continue to advance our development program for mAb114."
Sep 6 Ridgeback Therapeutics statement


HPV vaccine may provide herd protection against oral subtypes in men

A study of adults found who had not been vaccinated against human papillomavirus (HPV) from 2009 to 2016 found evidence of herd protection against oral HPV infections, according to research letter published in the Journal of the American Medical Association (JAMA) yesterday.

The study was done as part of the National Health and Nutrition Examination Survey, which tracks the health and nutritional status of US adults and children over time using interviews, physical exams, and lab tests. Men and women ages 18 to 59 were assessed for oral HPV infection using an oral rinse test that detects viral DNA.

Over the period of the study, which included 13,676 people, HPV vaccination rates increased from 0% to 5.8% in men and from 7.3% to 15.1% in women.

Testing revealed that, in unvaccinated men, oral HPV subtypes covered by the vaccine declined from 2.7% in 2009 and 2010 to 1.6% in 2015 and 2016. Prevalence of the HPV types not covered by the vaccine, however, didn't change. In unvaccinated women, there was no change in oral HPV prevalence for either HPV type.

The findings reveal that vaccine-type oral HPV prevalence dropped by 37% in men between the first years and last years of the study period, suggesting herd protection against those strains, likely from women in the US population who had been vaccinated. The team wrote that the results are consistent with findings on herd protection against genital HPV infections in unvaccinated women between 2004 and 2014. And that the lack of herd protection against oral HPV infections in unvaccinated woman could reflect low statistical power due to low prevalence in women.

Researchers concluded that herd protection estimates should be factored into evaluation of cost-effectiveness of HPV vaccination in men older than 26 years.
Sep 10 JAMA research letter


Study links fluoroquinolone use to higher risk of heart condition

A new study in the Journal of the American College of Cardiology found an association between current fluoroquinolone use and increased risk of leaky heart valves, adding to a number of adverse events linked to the drugs.

Using data from the FDA's adverse reporting system database and a random sample of more than 9 million patients from a health claims database, a team of Canadian researchers conducted a disproportionality analysis to identify cases of fluoroquinolone-related aortic or mitral valve regurgitation—blood leakage that can cause blood backflow into the heart—reported to the FDA and a case-control analysis to compare these cases with valvular regurgitation reported for non-quinolone antibiotics.

Given fluoroquinolones' in vitro ability to damage connective tissue and collagen, and other reported adverse events that have been linked to their use, the researchers hypothesized that fluoroquinones could damage the connective tissue of the aortic and mitral valves and thus increase the risk for valvular regurgitation.

In the disproportionality analysis, the team noted102 reported events of fluoroquinolone-related valvular regurgitation and 6,099 reports with other drugs from 2004 to 2018, for an odds ratio of 1.45 (95% confidence interval [CI], 1.20 to 1.77). In the case-control study, which involved a total of 12,505 cases and 125,020 control subjects, the adjusted rate ratios [RRs] for current users of fluoroquinolones compared with amoxicillin and azithromycin users were 2.40 (95% CI, 1.82 to 3.16) and 1.75 (95% CI, 1.34 to 2.29), respectively. The adjusted RRs for recent and past fluoroquinolone users when compared with amoxicillin were 1.47 (95% CI, 1.03 to 2.09) and 1.06 (95% CI, 0.91 to 1.21), respectively. 

While noting that the findings need to be confirmed, the authors of the study say the increased risk observed in their study suggests "it might be prudent to consider antibiotics that are chemically distinct to FQs [fluoroquinolones] in patients with a previous history of valvular regurgitation who require antibacterial therapy."

In December 2018, the FDA warned that fluoroquinolones can increase the risk aortic dissension and should not be used in patients who have an increased risk of the condition. The agency has also added boxed warnings that fluoroquinolones can increase the risk of peripheral neuropathy and potentially permanent side effects involving tendons, muscles, joints, nerves, and the central nervous system.
Sep 9 J Am Coll Cardiol study

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