REPRISE

ZAVICEFTA: Proven efficacy for adult patients with cUTIs and cIAIs, investigated in 3 clinical trials: REPRISE, RECLAIM and RECAPTURE1-3

REPRISE: The first pathogen-directed clinical trial for ZAVICEFTA examining its efficacy against ceftazidime-resistant Gram-negative bacteria1

Effective against serious Gram-negative infections, including strains resistant to ceftazidime1

An international, randomised, open-label, Phase III trial.1
     • ZAVICEFTA versus best available therapy
        – 97% of patients received a carbapenem as best available therapy 

Trial population:1
     • cUTI or cIAI caused by ceftazidime-resistant Gram-negative pathogens
     • N=333 patients
        – Randomised patients
        – mMITT population, N=302 

*Formal statistical comparison not performed; corresponding CIs for the efficacy of best available therapy were used to provide context for descriptive estimates of ceftazidime-avibactam efficacy.
The mMITT population comprised all patients with a diagnosis of cUTI or cIAI with at least one ceftazidime-resistant Gram-negative pathogen and who received at least one dose of study drug. 
Preferred best available therapy options for cUTI and cIAI were 5–21 days of treatment with meropenem, imipenem, doripenem, colistin and (for cIAI) tigecycline, administered intravenously, but any therapy, including combination treatment, was permitted.

Abbreviations:
AE, adverse event; CI, confidence interval; cIAI, complicated intra-abdominal infection; cUTI, complicated urinary tract infection; HAP, hospital-acquired pneumonia; mMITT, microbiologically modified intention-to-treat; VAP, ventilator-associated pneumonia.

References:
1. Carmeli Y, et al. Lancet Infect Dis 2016;16:661–73.
2. Mazuski JE, et al. Clin Infect Dis 2016;62:1380–9.
3. Wagenlehner FM, et al. Clin Infect Dis 2016;63:754–62

Prescribing Information
Meronem IV 1g – SPC 
Legal Category: POM.       Basic NHS Cost: 10 vial pack £206.28
Meronem IV 500mg – SPC 
Legal Category: POM.       Basic NHS Cost: 10 vial pack £103.14

 

Piperacillin/tazobactam
Tazocin 2 g/0.25 g Powder for Solution for Infusion – SPC
Legal category: POM.       Basic NHS cost: 1 vial pack £7.65 
Tazocin 4  g/0.5 g Powder for Solution for Infusion – SPC
Legal category: POM.       Basic NHS cost: 1 vial pack £15.17 
 
Tygacil 50 mg Powder for Solution for Infusion – SPC
Legal Category: POM.       Basic NHS Cost: 10 vial pack £323.10
 
ZAVICEFTA® 2 g/0.5 g Powder for Concentrate for Solution for Infusion – SPC
Legal category: POM.       Basic NHS price: 10 vial pack £857.00.

PP-ZVA-GBR-0700.  October 2019