Flu Scan for Jun 27, 2018

News brief

Novel one-dose antiviral receives FDA priority review

The US Food and Drug Administration (FDA) has granted fast-track approval for a new oral antiviral with a different mechanism of action than neuraminidase inhibitors that offers one-dose treatment, according to a Jun 25 statement from Genentech, part of the Roche Group. The drug, called baloxavir marboxil, was approved in Japan in February for the treatment of influenza A and B in adult and pediatric patients.

Called Xofluza in Japan, the drug is an endonuclease inhibitor that blocks viral replication by inhibiting cap-dependent endonuclease activity of the viral polymerase, a process known as "cap snatching." The drug is designed to target oseltamivir-resistant strains and avian flu viruses including H5N1 and H7N9. Clinical studies have found that baloxavir marboxil and oseltamivir similarly reduce symptom duration and fever, but that the new drug more quickly stopped viral shedding.

Sandra Horning, MD, Genentech's chief medical officer and head of global product development, said, "The severity of the recent flu season underscores the need for new options beyond currently available treatments, and if approved, baloxavir marboxil would be the first flu medicine with a novel proposed mechanism of action in nearly 20 years."

The indication the FDA is considering is for acute uncomplicated flu in people ages 12 and older, and the company said a regulatory decision is expected by Dec 24, 2018. A phase 3 trial of the drug is underway in people ages 12 and older who are at high risk of flu complications. The drug was developed by Japan-based Shionogi and is being developed by Roche Group, which holds worldwide rights, excluding Japan and Taiwan.
Jun 25 Genentech press release


Seasonal flu on the rise in some Southern Hemisphere locations

Influenza levels are on the rise in some parts of the Southern Hemisphere, including South Africa and tropical countries in the Americas, but activity remains under seasonal thresholds in other countries in the region, the World Health Organization (WHO) said in its latest global flu update.

In South Africa, 2009 H1N1 is the predominant virus, though Brazil is reporting increasing detections of both 2009 H1N1 and H3N2. Elsewhere in South America, flu levels varied by country, with 2009 H1N1 and influenza B increasing in temperate parts of Bolivia and 2009 H1N1 illnesses increasing in Peru. Flu in Australia and New Zealand remained at interseasonal levels, with New Caledonia continuing to report influenza B activity.

Countries in southern Asia reported low levels, except for the Maldives, which reported a sharp increase in H3N2 activity in recent weeks. In Northern Hemisphere temperate zone countries, flu activity returned to interseasonal levels.

Globally, of specimens tested between May 28 and Jun 10, 71.1% were influenza A and 28.9% were influenza B. Of subtyped influenza A viruses, 72.8% were 2009 H1N1 and 27.2% were H3N2. Of the characterized influenza B viruses, 74% belonged to the Yamagata lineage.
Jun 25 WHO global flu update


Bulgaria, Russia, and Taiwan report more high path avian flu in poultry

In the latest avian flu developments, three countries—Bulgaria, Russia, and Taiwan—reported more outbreaks involving different strains, according to the latest notifications from the World Organization for Animal Health (OIE).

Bulgaria, which has been reporting sporadic highly pathogenic H5N8 outbreaks since early March, reported an event that began on Jun 13 at a poultry farm in Dobric, located in the northeastern part of the country. The virus killed 1,715 of 13,820 poultry, and the surviving birds were culled to control the spread of the disease.

In Russia, the agriculture ministry reported 11 more outbreaks involving highly pathogenic H5 from four different oblasts in the country's west: Samarskaya, Saratovskaya, Orlovskaya, and Penzenskaya. The outbreaks began between Jun 8 and Jun 21, and all involved backyard poultry. Taken together, the virus killed 122 of 2,167 birds, and authorities destroyed the survivors as part of the outbreak response.

Elsewhere, Taiwan reported two more outbreaks from highly pathogenic H5N2, part of ongoing activity involving that and other strains since 2015. The two new events began between Jun 21 and Jun 22, and both involved meat duck farms in Yunlin County. Between the two locations, the virus killed 400 of 6,607 birds, and the remaining ones were culled.
Jun 24 OIE report on H5N8 in Bulgaria
Jun 27 OIE report on H5 in Russia
Jun 27 OIE report on H5N2 in Taiwan

News Scan for Jun 27, 2018

News brief

Three more tested for suspected Ebola in DRC outbreak

Intensive surveillance activities in the Democratic Republic of Congo's Ebola virus outbreak have turned up three more suspected cases in the remote town of Bikoro, according to an update today from the country's health ministry.

Tests on earlier reported suspected illnesses have ruled out two infections, putting the outbreak total at 57 cases, including 38 confirmed, 15 probable, and 4 suspected cases. The number of people who have died from Ebola remained at 29.

In other outbreak developments, the ministry said the last 51 remaining contacts of the last lab-confirmed cases will complete their 21-day monitoring periods as of midnight tonight. Over the response period, health workers have monitored 1,706 contacts.

Global health officials have said they are cautiously optimistic that the outbreak has been contained. Vaccination activities continue, and 3,330 people have now been immunized with the experimental VSV-EBOV vaccine.
Jun 27 DRC health ministry Ebola update


Inovio reports promising clinical trial findings for MERS-CoV vaccine

Inovio today announced promising findings from a phase 1 study of a MERS-CoV vaccine that it is developing with GeneOne Life Science. Currently, there are no drugs or treatments approved for use against Middle East respiratory syndrome coronavirus (MERS-CoV), which has sickened at least 2,200 people since the virus was first detected in humans in 2012, 790 of them fatally.

The open-label, dose-escalation trial of INO-4700 (GLS-5300) was conducted in partnership with Walter Reed Army Institute of Research in Maryland, according to a press release from Inovio. The vaccine prompted an antibody response in 94% of participants 2 weeks after the third dose. No statistically significant antibody response rate differences were seen among the three different doses, and participants maintained antibody response through 60 weeks after dosing.

Researchers presented their findings yesterday in Seoul, South Korea, at the WHO-IVI Joint Symposium for MERS-CoV Vaccine Development.

In April, the Coalition for Epidemic Preparedness Innovations (CEPI) awarded Inovio $56 million to develop the MERS-CoV vaccine through phase 2, with an overarching goal of getting a MERS-CoV vaccine available for stockpiling as soon as possible for emergency use.

Inovio said it and GeneOne Life Science plan on launching a phase 1/2 study of the vaccine in the third quarter of 2018, which will take place in South Korea with $34 million in funding from the Samsung Foundation through the International Vaccine Institute.
Jun 27 Inovio press release


Study shows clinical differences between dengue, Zika viruses

Dengue and Zika viruses co-circulate in many tropical regions, and overlapping presentation can make clinical diagnosis a challenge.  A new case-control discovery cohort study published in Emerging Infectious Diseases identified key differences in a group of patients from Singapore.

Dengue is endemic in Singapore, and Zika has been circulating since 2016 through the Southeast Asia region.

The study was conducted at the National University Hospital, where 121 patients were tested for both viruses: 34 had Zika virus and 87 had dengue infection. Several clinical indices distinguished the viruses, including conjunctivitis, which indicated Zika virus infection (odds ratio [OR] 30.1, 95% confidence interval [CI] 9.57–94.44; p < 0.001). Fever, myalgia, and headache, however, were more likely to be found in dengue patients (OR 0.05, 0.20, and 0.12, respectively).

Dengue patients also had lower platelet counts and monocytosis. Platelets and monocytes in Zika patients were within normal ranges.

"These simple clinical assessments using conjunctivitis and basic blood count parameters will be helpful in regions of the world where both Zika virus and DENV are endemic," the authors concluded.
Jun 26 Emerg Infect Dis study

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