The only licensed treatment for the reduction in recurrence of overt hepatic encephalopathy (OHE)1


Evidence supporting XIFAXAN® 550mg treatment

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Long-term Data

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Real world evidence

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Guidelines

The impact of hepatic encephalopathy (HE)2

Hepatic encephalopathy is a major complication of cirrhosis.2

Approximately 50% of people with cirrhosis will develop clinically apparent hepatic encephalopathy at some stage after diagnosis - the risk being around 5-25% within 5 years.2

Hospital admissions are common and inpatient stays often prolonged. The presence of hepatic encephalopathy is associated with a significant increase in mortality; survival after the first episode is 42% at 1 year and 23% at 3 years.2

What are the potential benefits of XIFAXAN® therapy?

Compared to placebo plus lactulose, XIFAXAN® plus lactulose has been proven to:


Reduce further OHE breakthrough episodes by 23.8%
(absolute reduction; 58% relative reduction) 3
Potentially protecting patients from persistent and cumulative deficits (memory, response, learning) of each OHE episode 4
Reduce OHE-related hospitalisations by 9%
(absolute reduction; 50% relative reduction) 3
Easing the costs of hospitalisations (admissions, inpatient costs, length of stay), thereby reducing the burden on your healthcare system 5
Significantly improve patients’ QoL
(p values ranged from 0.0022 to 0.0436) 6
Corresponding to improvement in fatigue, abdominal symptoms, systemic symptoms, activity, emotional function and worry 6

 
Common adverse reactions are dizziness, headache, depression, dyspnoea, upper abdominal pain, abdominal distension, diarrhoea, nausea, vomiting, ascites, rashes, pruritus, muscle spasms, arthralgia and peripheral oedema. 1
For a full list of adverse reactions, please refer to the XIFAXAN® Summary of Product Characteristics.

Adverse event reporting


Adverse events should be reported to your regulatory agency. Adverse events should also be reported to either your local distributor or by emailing GPharmacoVigilance@norgine.com.
GL-HEP-XIF-2000169 April 2021
Adverse events should be reported to your regulatory agency. Adverse events should also be reported to either your local distributor or by emailing GPharmacoVigilance@norgine.com.


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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. XIFAXAN® Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/medicine/27427

  2. National Institute for Health and Care Excellence (NICE). National guideline 50 - Cirrhosis in over 16s: assessment and management. July 2016. Available at: https://www.nice.org.uk/guidance/ng50/resources/cirrhosis-in-over-16s-assessment-and-management-1837506577093

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

  4. Bajaj J S, Schubert C M et al. Gastroenterol 2010;138:2332-2340

  5. Orr J G, Currie C J et al. Liver Int 2016;36:1295-1303

  6. Sanyal A, et al. Aliment Pharmacol Ther 2011;34:853-861