6th March 2017

Pivotal Study

 

A double-blind, randomised placebo-controlled trial (RCT) investigating the efficacy and safety of XIFAXAN® 550 mg bd in cirrhotic patients with recurrent HE. 1

Patients with chronic liver disease and with Conn score 0 or 1 were randomised to treatment with either placebo (N=159) or XIFAXAN® 550 mg bd (N=140) for 6 months.*

*91% of patients (n=273) received concomitant lactulose during the study.

 

Proportion of patients experiencing breakthrough HE episodes
Primary end-point


Adapted from Bass et al. 2010ITT Population

  • There was a significantly reduced relative risk of an episode of HE in the XIFAXAN® 550 mg bd group compared with the placebo group over a 6 month period
  • Relative risk reduction 58% (calculated from hazard ratio with XIFAXAN®, 0.42; 95% confidence interval [CI], 0.28 to 0.64; p<0.001)


  • There was a significantly reduced relative risk of hospitalisation related to HE in the XIFAXAN® 550 mg bd group compared with the placebo group over a 6 month period
  • Relative risk reduction 50% (calculated from hazard ratio with XIFAXAN®, 0.50; 95% confidence interval [CI], 0.29 to 0.87; p=0.01)
Proportion of patients experiencing HE-related hospitalisations
Secondary end-point

Adapted from Bass et al. 2010ITT Population


GL-HEP-XIF-2000171   April 2021
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Date of preparation: May 2020 Job Code: UKE-HEP-XIF-2000012 © 2019 Norgine

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Seven UK participating centres agreed a standardised data collection pro-forma. Patients with chronic liver disease who were treated with rifaximin-α for secondary prevention of overt hepatic encephalopathy (OHE) were included.* Details of all causes of HE and emergency hospital admissions were requested at 3, 6 and 12 months before and after rifaxamin-α initiation. Clinical data were recorded at baseline, at 3, 6 and 12 months before and after rifaximin-α initiation.
87% of patients (n=282) were taking concomitant lactulose.
*Some patients included were on 3 x 400 mg daily as this was prior to the launch of the K licensed dose of XIFAXAN® 550 mg twice a day.

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An observational study including 127 patients from the Netherlands. Conducted between September 2015 to May 2018.
AIM: To assess hospital resource use, bacterial infections and adverse events in the 6 months before and after rifaximin-α initiation in patients with overt hepatic encephalopathy.

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Costing Details

Inpatient costs were estimated in UK£ at 2013/14 prices from published NHS sources at a mean cost of £513(€569.43)* per day for non-elective admissions for liver disease.1

Rifaximin-α drug costs were calculated from the price published in the British National Formulary of £259(€287.75)* for 56 550mg tablets2, giving an annual drug treatment cost per patient of £3,379(€3750.69)* for the licensed dose of 550mg twice daily.

Please note that costs from this study were based on UK NHS sources and the UK BNF and have been calculated by using GBP to Euro conversion rate mentioned below. These prices may differ from local EU prices of XIFAXAN®.
*Values in Euros converted from values in Pound Sterling at an exchange rate of £1:€1.11 (correct as 03.11.20).

References

  1. NHS reference costs. Available at: www.gov.uk/government/publications/nhs-reference-costs-2013-to-2014, 2013-14
  2. Joint Formulary Committee. British National Formulary. Available at: https://bnf.nice.org.uk/medicinal-forms/rifaximin.html
A retrospective, observational, multicentre study including 145 patients from 11 UK NHS centres. Conducted from Aug 2014 to Jun 2015.
AIM: To compare resource use in the 6 and 12 months before and after rifaximin-α initiation in UK patients with HE.
INCLUSION CRITERIA: Clinical diagnosis of HE. HE diagnosed prior to rifaximin-α initiation. Initiated on rifaximin-α at least 12 months prior data collection.
EXCLUSION CRITERIA: Rifaximin-α initiated at other hospitals. Medical records unavailable.

Details of hospitalisations and hospital visits were extracted from NHS Trust electronic databases. Analysis included only alive patients at the end of 6 and 12 month periods.
IMPRESS study was sponsored and funded by Norgine

Rifaximin-α initiation dose was 1100mg/day (licensed dose) in 30%, 1200 mg/day in 64%, and other doses in 6% of patients, respectively.
This study included patients started on rifaximin-a prior to the launch of XIFAXAN® 550mg bd. 82% of patients (n=119) were taking concomitant lactulose at baseline.

An observational study including 127 patients from the Netherlands. Conducted between September 2015 to May 2018.
AIM: To assess hospital resource use, bacterial infections and adverse events in the 6 months before and after rifaximin-α initiation in patients with overt hepatic encephalopathy.

The study was sponsored by the Foundation for Liver and Gastrointestinal Research Rotterdam (SLO) to which an educational grant was provided by Norgine B.V., Amsterdam, the Netherlands.


Rifaximin-α initiation dose was 1100 mg per day (licensed dose) and was raised to 1650 mg per day in 11 patients due to recurrence of overt hepatic encephalopathy while on 1100 mg per day. 97.6% of patients (n=124) were taking concomitant lactulose at baseline.


* Optional use of lactulose (~90% patients in 'All rifaximin-α' group received concomitant lactulose).

References

  1. Bass NM, et al. N Engl J Med 2010;362(12):1071-81