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Pfizer's Zavicefta matches standard-of-care in treating hospital-acquired pneumonia in phase 3 study

Published 25 April 2017

Results from the phase 3 REPROVE study assessing Pfizer's fixed-dose antibacterial combo Zavicefta (ceftazidime-avibactam) in patients with hospital-acquired pneumonia (HAP) demonstrated a comparable cure rate to carbapenem antibiotic therapy, considered the standard of care.

Clinical cure was the primary endpoint of the study and defined as a complete resolution of all signs and symptoms of infection.

In addition, patients treated with Zavicefta and Meropenem experienced comparable rates of tolerability consistent with the known profile of ceftazidime alone. The results of the REPROVE study were presented today at the 27th annual meeting of the European Congress of Clinical Microbiology and Infectious Disease (ECCMID) in Vienna.

Professor Antoni Torres, MD, PhD, FERS, Respiratory Institute, Hospital Clinic of Barcelona, University of Barcelona, Spain and lead investigator of REPROVE said: “Hospital-acquired pneumonia has become more prevalent and difficult to treat because of the emergence of increased resistance to carbapenems thereby limiting treatment options.

“These study results expand physician options in effectively treating patients with hospital-acquired pneumonia.”

Jill Inverso, Vice President of Pfizer Global Medical Affairs, Critical Care Medicines said: “The REPROVE results validate the use of Zavicefta for the treatment of certain Gram-negative infections among patients with limited treatment options.

“The recent introduction of Zavicefta in select European Markets together with planned future global launches reaffirms our continued commitment to the delivery of new antibiotic therapies that address the needs of patients with serious infections.”

REPROVE Top-Line Results

REPROVE was a Phase III, prospective, multi-center, randomized, non-inferiority trial to assess the efficacy, safety and tolerability of Zavicefta (ceftazidime-avibactam) administered intravenously as a two-hour infusion (2000mg/500mg every 8 hours) as compared to Meropenem (meropenem for injection) administered intravenously as a 30-minute infusion (1000mg every 8 hours) among adult patients with clinically diagnosed HAP or ventilator-associated pneumonia (VAP). The study included 879 patients in 23 countries.

Results showed that patients treated with Zavicefta experienced statistically equivalent rates of clinical cure 21-25 days from randomization in both the clinically modified intent-to-treat (cMITT2) population and clinically evaluable (CE3) population.

More specifically, clinical cure rates in the cMITT population and the CE population treated with Zavicefta were 68.8 percent and 77.4 percent, respectively, compared to clinical cure rates of 73.0 percent and 78.1 percent in the meropenem treatment arm. Similar efficacy was observed in a subgroup analysis of VAP patients in both the cMITT and CE populations.

All-cause mortality rate at day 28 from randomization was also similar in the two groups. Safety and tolerability observations for ceftazidime-avibactam were consistent with the comparator and the known profile for ceftazidime alone.



Source: Company Press Release