Single Dose Baloxavir marboxil (Xofluza) Has Potential To Improve Treatment of High-Risk Flu

MedicalResearch.com Interview with:

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

Dr. Eisner

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

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

Response: CAPSTONE-2 is a Phase III multicenter, randomized, double-blind study that evaluated the efficacy and safety of 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 Centers for Disease Control and Prevention (CDC) 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, morbid obesity or heart disease.

A total of 2,184 participants enrolled in the study and were randomly assigned to receive a single, oral dose of 40 mg or 80 mg of baloxavir marboxil (according to body weight), placebo or 75 mg of oseltamivir twice daily for five days. The primary objective of the study evaluated the efficacy of a single dose of baloxavir marboxil compared with placebo by measuring the time to improvement of influenza symptoms. Key secondary endpoints compared outcomes in baloxavir marboxil versus placebo or oseltamivir – these included time to resolution of fever, time to cessation of viral shedding, infectious virus detection in swabs of the nose and throat, prescription of antibiotics and influenza-related complications.

Genentech announced initial results from the study on July 16, 2018 but the full data was presented for the first time during a late-breaking oral presentation at the annual IDWeek meeting in San Francisco, CA on October 6, 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 (e.g. H7N9, H5N1). Baloxavir marboxil is the first potential influenza treatment to demonstrate a clinically meaningful benefit for people highly vulnerable to serious influenza complications in clinical trials.

The FDA 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. Continue reading

Real World Treatment of Serious Infections with Ceftolozane/Tazobactam

MedicalResearch.com Interview with:

Thomas P. Lodise Jr., PharmD, PhD Clinical Pharmacist at the Stratton VA Medical Center in Albany, NY Albany College of Pharmacy and Health Sciences Albany, NY

Dr. Lodise

Thomas P. Lodise Jr., PharmD, PhD
Clinical Pharmacist at the Stratton
VA Medical Center in Albany, NY
Albany College of Pharmacy and Health Sciences
Albany, NY

MedicalResearch.com: What is the background for this study? How does Ceftolozane/Tazobactam differ from other antibiotics for serious Gram-negative infections including Pseudomonas aeruginosa?

Response: Treatment of patients with Gram-negative infections is increasingly difficult due to rising resistance to commonly used agents. Ceftolozane/tazobactam (C/T) is a potent anti-pseudomonal agent with broad Gram-negative coverage that is indicated for complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) and is currently being studied for ventilated nosocomial pneumonia. C/T differs from other antibiotics in terms of its potency against multi-drug resistant Pseudomonas aeruginosa, one of the most concerning and difficult-to-treat Gram-negative pathogens. This study evaluates C/T in a large database of US hospitals to better understand treatment patterns and associated outcomes.

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Bezlotoxumab (Zinplava)For Prevention of Recurrent C. Difficile Infection

MedicalResearch.com Interview with:
Richard Hengel, MD, FRCPC, FACP Atlanta ID Group
Richard Hengel, MD, FRCPC, FACP

Atlanta ID Group

MedicalResearch.com: What is the background for this study? How does Bezlotoxumab differ from other medications for recurrent C. difficile infections?

Response: Clostridium difficile infection (CDI) is now the most common hospital acquired infection in the United States, accounting for significant morbidity and mortality, not only in the US, but around the world. Despite standard antibiotic therapy targeting the Clostridium difficile bacterium directly, recurrent infection is common, occurring in a quarter to a third of patients, often frail individuals with other concurrent medical problems. These patients can have multiple recurrences leading to their progressive deterioration over time. Until recently, the only treatment for CDI included antibiotics. More recently, fecal microbiota transplant is a promising, but as yet, FDA unapproved therapy. Bezlotoximab is a new FDA approved treatment for recurrent Clostridium difficile infection (rCDI) that compliments standard antibiotics. Bezlotoxumab is a monoclonal antibody targeting toxin B produced by Clostridium difficile during CDI. In two large treatment trials, bezotoxumab, in addition to standard-of-care antibiotics, reduced the frequency of CDI recurrences from about 28% to about 18%. In this study, we set out to see if this new drug performed as well in actual clinical practice as it did in the published clinical trials.

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