New Study Shows Rifaximin Significantly Reduced the Number and Length of Hospitalisations in Patients With Overt Hepatic Encephalopathy (HE) Awaiting Liver Transplatation

Amsterdam (ots/PRNewswire) -

- Rifaximin significantly reduced the incidence of all-cause hospital
admissions in HE patients with advanced cirrhosis on the waiting
list for liver transplantation
- Rifaximin contributed to improved outcomes in HE patients on the
waiting list helping patients stay out of hospital for longer

Norgine B.V. highlighted results of an independent, investigator
initiated trial showing significant reductions in the number and
length of hospital admissions when rifaximin is used to treat
end-stage liver disease patients with overt hepatic encephalopathy
(HE).[1]

The real world study published today in the peer-reviewed journal
Alimentary Pharmacology and Therapeutics showed that rifaximin, when
prescribed for the treatment of acute or chronic HE, or for secondary
prevention of HE in patients with advanced cirrhosis who are on the
waiting list for liver transplantation, significantly reduced the
incidence of all-cause hospital admissions (mean length of stay: 9
days; 95%CI 6-12 in rifaximin-treated patients vs. 14 days; 95%CI
7-21 in the naïve group). This included serious medical complications
such as spontaneous bacterial peritonitis (an acute infection in the
abdomen that occurs without warning or a clear cause), ascites (an
abnormal build-up of fluid in the abdomen that can cause infection)
and variceal bleeding (dilated blood vessels in the oesophagus or
stomach that can cause internal bleeding). On average, HE patients on
the transplant waiting list who did not receive rifaximin tended to
stay 5 days longer in hospital when admitted due to complications.[1]

Patients on rifaximin also avoided re-hospitalisation for longer
and were less likely to require urgent liver transplantation due to
deterioration of their condition (odds ratio 0.29; 95% CI
0.89-0.93).[1]

"End-stage liver disease patients already have a poor prognosis
and low quality of life; hepatic encephalopathy is a further
devastating complication. This study demonstrates the potential value
of rifaximin for those vulnerable patients and its impact on
improving outcomes and reducing the need for hospitalisation," said
Dr. Debbie Shawcross, Lead Investigator of the study, Reader and
Honorary Consultant in Hepatology at the Department of Liver
Sciences, King's College London.

The study evaluated for two years 101 patients who had at least
two episodes of overt HE whilst they were waiting for a liver
transplant. The use of lactulose, which is the standard of care
treatment (SOC) for patients with overt HE, was not significantly
different between the rifaximin-treated and the naïve group.[1]

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Notes to Editors:

About the study

The study examined the outcomes of patients listed for liver
transplantation with a diagnosis of hepatic encephalopathy (HE) on
rifaximin compared to those naïve to the drug. Real world data from
patient records of those listed for liver transplantation over a
2-year period were retrospectively reviewed. Patients were included
if they had at least two episodes of overt HE resulting in
hospitalisation or were encephalopathic at the time of assessment. Of
the 622 patients listed for transplantation, 101 were listed with HE.
66 patients were treated with rifaximin and 35 were naïve at listing.
The use of concurrent lactulose was not significantly different
between groups. Median MELD score was similar [15 (14-16)
rifaximin-treated and 16 (14-18) rifaximin-naive]. Patients on the
waiting list treated with rifaximin had reduced all-cause hospital
admissions, episodes of spontaneous bacterial peritonitis and
variceal bleeding. Mean length of stay was 9 (95%CI 6-12) in the
rifaximin-treated group versus 14 days (95%CI 7-21) in the
rifaximin-naïve group. Multivariate regression analysis demonstrated
that rifaximin was independently associated with an increase in
average days to readmission (adjusted effect estimate 71, 95% CI
3-140 days) and reduced likelihood of requirement for prioritisation
on the waiting list (odds ratio 0.29; 95% CI 0.89-0.93). The study
concluded that rifaximin prescribed for HE in patients listed for
liver transplantation improved outcomes on the waiting list with a
significant reduction in admissions related to spontaneous bacterial
peritonitis, ascites and variceal bleeding.[1]

About Hepatic Encephalopathy (HE)

HE is a serious, potentially life-threatening chronic condition
associated with liver cirrhosis.[2] HE is a significant complication
of advanced chronic liver disease and occurs in up to 40% of patients
and often remains under-diagnosed and under-treated.[3],[4] HE is
debilitating and can significantly impact the life of patients and
their carers. People with liver disease who develop HE are
approximately twice as likely to die, when compared with liver
disease patients without the condition over the same time period.[5]

Hepatic encephalopathy results from a damaged liver that is not
able to detoxify the blood as efficiently as usual. Toxins build up
in the bloodstream and eventually in the brain, which leads to
neurological disorders.[3]

About Norgine

Norgine is a leading European specialist pharmaceutical company
with a direct commercial presence in all major European markets.
Norgine specialises in gastroenterology, hepatology, cancer and
supportive care. In 2018, Norgine's total net product sales were EUR
395 million, up 15 per cent.

Norgine employs over 1,300 people across its commercial,
development and manufacturing operations and manages all aspects of
product development, production, marketing, sale and supply.

In 2012, Norgine established a complementary business, Norgine
Ventures, supporting innovative healthcare companies through the
provision of debt-like financing in Europe and the US. For more
information, please visit www.norgineventures.com

NORGINE and the sail logo are trademarks of the Norgine group of
companies.

About Alfasigma

Alfasigma is a multinational pharmaceutical company headquartered
in Italy, employing more than 2,800 people worldwide. In 2018,
revenues exceeded EUR1,05 billion.

Outside of its core Italian market, Alfasigma has 17 subsidiaries
in Europe, Asia, North and Central America and Africa, and has
authorised distributors in more than 70 countries. Approximately half
of the turnover comes from internally developed proprietary products,
one of which is rifaximin.

For more information, please visit www.alfasigma.com

References

1. Salehi S, Tranah TH, Lim S, et al. Rifaximin reduces the incidence
of spontaneous bacterial peritonitis, variceal bleeding and
all-cause admissions in patients on the liver transplant waiting
list. Aliment Pharmacol Ther. 2019;00:1-7.
https://doi.org/10.1111/apt.15326 [Last accessed: June 2019]
2. Morgan M. Chapter 8: Hepatic Encephalopathy in Patients with
Cirrhosis. In: Dooley JS, Lok A, Burroughs A, Heathcote J,
editors. Sherlock's Diseases of the Liver and Biliary System. 12th
ed: Blackwell Publishing Ltd; 2011
3. Hepatic Encephalopathy in Chronic Liver Disease: 2014 Practice
Guideline by the European Association for the Study of the Liver
and the American Association for the Study of Liver Diseases.
Journal of Hepatology 2014; 61(3):642-659
4. Mullen KD. Review of the final report of the 1998 Working Party on
definition, nomenclature and diagnosis of hepatic encephalopathy.
Aliment Pharmacol Ther. 2007 Feb; 25 Suppl 1:11-6
5. Morgan, C.LI et al, Mortality associated with hepatic
encephalopathy in patients with severe liver disease, Journal of
Hepatology 2014; 60 (Abstract P452): S219

GL/COR/0519/0189, Date of preparation June 2019

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