Flu Scan for Feb 17, 2016

News brief

ECDC expert panel says stay course on flu antiviral drugs

An expert panel convened by the European Centre for Disease Prevention and Control (ECDC) said today it has found no significant new scientific evidence to change current indications for the use of antiviral drugs to treat influenza.

The 11-member expert group, in an ECDC report, said, "This ECDC Expert Opinion confirms earlier assessments by ECDC and national authorities that there is no significant new evidence from [randomized controlled trials] to support any changes to the approved indications and recommended use of neuraminidase inhibitors in EU/EEA Member States."

The experts focused on the neuraminidase inhibitors oseltamivir (Tamiflu) and zanamivir (Relenza), which are currently authorized for treating flu in the European Union. Their literature review included the most recent meta-analyses.

Current ECDC guidelines recommend the drugs for patients with severe influenza and those at high risk for complications, as well as to prevent the flu in vulnerable family members. The report notes that these guidelines mesh with those of the World Health Organization and a number of countries.

The experts note that all three recent meta-analyses point to the importance of initiating treatment early, ideally within 48 hours of symptom onset (and within 36 hours in the case of zanamivir for children). They add, however, that observational studies indicate some benefit in reducing mortality if the drugs are started even 4 to 5days after symptom onset in hospitalized patients.

The panel concluded, "While the reviews considered for this Expert Opinion add to the evidence on the beneficial and adverse impacts of neuraminidase inhibitors, it is clear that further studies are needed to strengthen the evidence base overall, in particular for severe clinical end points and for individual risk groups."

The ECDC welcomes feedback on the document till Mar 16.
Feb 17 ECDC report landing page, with instructions on providing comments
Feb 17 commentary on the report in Influenza and Other Respiratory Viruses

Nigeria reports two more H5N1 avian flu outbreaks

Nigeria responded to two more H5N1 avian influenza outbreaks in the past week, according to a report today from Nigerian officials to the World Organization for Animal Health (OIE), adding to multiple recent H5N1 outbreaks since the virus reappeared in Nigeria last year.

The first outbreak occurred on a farm in the town of Batagarawa in Nigeria's northwestern Katsina state. Of the 5,000 birds on the farm, 60 became ill and died, and 4,940 were culled to prevent further spread of the virus.

The second H5N1 outbreak occurred on a farm in the large city of Jos in Nigeria's Plateau state. Of 6,200 birds on the affected farm, 100 birds sickened and died, and the remaining 6,100 were destroyed.

The OIE report cites "poor farm biosecurity" as a factor in the outbreaks.
Feb 17 OIE report

News Scan for Feb 17, 2016

News brief

Saudi Arabia reports two MERS cases; US vaccine trial begins

Saudi Arabia's Ministry of Health (MOH) reported two more MERS cases today, both of which occurred in Riyadh.

The first patient is a 53-year-old Saudi man who is in stable condition, the MOH said. The other patient is a 24-year-old foreigner who is hospitalized in an intensive care unit (ICU).

The source of both patients' MERS-CoV (Middle East respiratory syndrome coronavirus) infections is listed as "primary," indicating no contact with known sources of infection. Neither man is a healthcare worker or had contact with camels.

Saudi Arabia's total of MERS cases since 2012 has reached 1,298, including 740 recoveries, 554 deaths, and 4 patients still receiving treatment, the MOH said.
Feb 17 MOH update

In related news, the first participants in a phase 1 clinical trial to evaluate a MERS-CoV candidate vaccine were vaccinated yesterday, according to a press release from the US Military HIV Research Program (MHRP). The trial will examine the vaccine’s safety and immunogenicity.

The trial, which has enrolled 75 participants, is taking place at the Walter Reed Army Institute of Research in Silver Spring, Md. The candidate vaccine, GLS-5300, is manufactured by Inovio Pharmaceuticals and GeneOne Life Science, Inc., and is the first MERS vaccine to be evaluated in humans.
Feb 16 MHRP press release
Jan 29 CIDRAP News scan on MERS vaccine trial

Study details intensive treatment in US, European Ebola patients

Ebola patients in the United States and Europe required close monitoring and intensive treatment, but 82% of them survived, according to a study of all 27 US and European patients today in the New England Journal of Medicine.

The study comes as the World Health Organization (WHO) today noted no new Ebola cases in West Africa. The agency said in its weekly update that all contacts of the most recent patients in Sierra Leone completed follow-up on Feb 11, but efforts to locate untraced contacts will continue for another week. The most recent cases were confirmed in mid-January.

In the study, the Working Group of the US–European Clinical Network on Clinical Management of Ebola Virus Disease Patients in the US and Europe noted that the patients who had Ebola virus disease (EVD) ranged from 25 to 75 years old, with a median age of 36. Nineteen (70%) of the patients were men, 9 of 26 patients (35%) had coexisting conditions, and 22 (81%) were healthcare workers.

The most common symptoms at illness onset were fatigue (80% of patients) and fever (68%). Nearly all the patients received intravenous fluids and electrolyte supplementation; 9 (33%) required mechanical ventilation; 5 (19%) had continuous renal-replacement therapy; 22 (81%) received antibiotics; and 23 (85%) were prescribed investigational therapies.

The investigators noted that serum Ebola viral RNA levels peaked at a median of 7 days after illness onset, and the median time from the onset of symptoms to clearance of virus from the blood was 17.5 days. Five patients died, including 3 who had respiratory and renal failure, for a mortality of 18.5% and survivorship of 81.5%.
Feb 17 N Engl J Med study
Feb 17 WHO Ebola update

FDA to consider use of skin-infection drug Teflaro in children

The US Food and Drug Administration (FDA) has accepted Allergan Plc's filing of an application to expand the indications for its antibiotic ceftaroline fosamil (Teflaro)—used to treat certain types of skin infections and community-acquired pneumonia—to include children, the Dublin-based company announced yesterday.

If Allergan's supplemental new drug application is approved, the drug's use will be expanded to include children from the age of 2 months who have acute bacterial skin and skin structure infections (ABSSSI), including those caused by methicillin-resistant Staphylococcus aureus (MRSA), and community-acquired bacterial pneumonia (CABP) caused by Staphylococcus pneumoniae and other designated bacteria, the firm said in a press release.

The medication was approved in 2010 for adults with ABSSSI and CABP caused by certain susceptible bacteria. Allergan said ceftaroline fosamil is a cephalosporin with activity against both gram-positive and gram-negative pathogens.

David Nicholson, PhD, Allergan's executive vice president, said ABSSSI and CABP have a significant impact among children, especially those under 5 years old. "This acceptance brings us one step closer to providing another choice for physicians to properly treat pediatric patients with ABSSSI and CABP, including those infections caused by difficult-to-treat pathogens," he said.

The company said its application was based on the results of five clinical studies of Teflaro in pediatric patients, including one active-controlled study in children with ABSSSI, two active-controlled studies in patients with CABP, and two pharmacokinetic studies.
Feb 16 Allergan press release