Adverse Outcomes More Likely in Infants Born to Mothers Who Get the Flu

MedicalResearch.com Interview with:

Kim NewsomeCDC

Kim Newsome

Kim Newsome, MPH
National Center on Birth Defects and Developmental Disabilities
CDC 

MedicalResearch.com: What is the background for this study?

Response: This study supports data from previous studies that have shown increased risks for infants born to pregnant women who are severely ill with flu.

MedicalResearch.com: What are the main findings?

Response: Our study found that severely ill women with 2009 H1N1 influenza during pregnancy were more likely to have adverse birth outcomes (such as their baby being born preterm or of low birth weight) than women without influenza. 

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Flu: Novel Oral Single Dose Antiviral Baloxavir Marboxil Reduced Symptoms in High Risk Patients

MedicalResearch.com Interview with:

Mark Eisner MD MPH Vice President and Global Head of Respiratory Actemra, ID, and Metabolism Clinical Development at Genentech Professor of Clinical Medicine University of California, San Francisco

Dr. Mark Eisner


Mark Eisner MD MPH

Mark D. Eisner, MD, MPH
Vice President, Product Development Immunology, Infectious Disease, and Ophthalmology
Genentech

 

MedicalResearch.com: What is the background for this study?
Would you briefly explain how 
baloxavir marboxil differs from other flu treatments? 

Response: CAPSTONE-2 is a Phase III multicenter, randomized, double-blind study that evaluated a single dose of baloxavir marboxil compared with placebo and oseltamivir in people 12 years and older who are at a high risk of complications from the flu. The high risk inclusion criteria in CAPSTONE-2 were aligned with the Centers for Disease Control and Prevention (CDC), which defines people at high risk for serious flu complications to include adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, diabetes or heart disease. For these people, flu can lead to hospitalization or even death. Participants enrolled in the study were randomly assigned to receive a single dose of 40 mg or 80 mg of baloxavir marboxil (according to body weight), placebo or 75 mg of oseltamivir twice a day for five days.

The FDA recently accepted a New Drug Application (NDA) and granted Priority Review to baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older. The NDA was based on results from the Phase III CAPSTONE-1 study of a single dose of baloxavir marboxil compared with placebo or oseltamivir 75 mg, twice daily for five days, in otherwise healthy people with the flu. Results from a placebo-controlled Phase II study in otherwise healthy people with the flu were included as supporting data in the NDA. The FDA is expected to make a decision on approval by December 24, 2018.

Baloxavir marboxil is a first-in-class, single-dose investigational oral medicine with a novel proposed mechanism of action designed to target the influenza A and B viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1). Unlike other currently available antiviral treatments, baloxavir marboxil is the first in a new class of antivirals designed to inhibit the cap-dependent endonuclease protein within the flu virus, which is essential for viral replication. By inhibiting this protein, baloxavir marboxil prevents viral replication earlier in the flu virus life cycle. Continue reading