Xifaxan(R) (rifaximin) Treatment Following Overt Hepatic Encephalopathy (OHE) Hospitalization Associated with Reduced Risk of 30-Day OHE Rehospitalization
Bausch Health Companies announced new data showing that patients hospitalized for overt hepatic encephalopathy (OHE) had a reduced risk of 30-day rehospitalization when treated with Xifaxan® (rifaximin) after discharge, regardless of prior treatment. The claims-based analysis of 7,880 OHE patients revealed that those receiving only lactulose upon discharge had a higher risk of 30-day OHE rehospitalization compared to Xifaxan recipients (adjusted OR: 1.63-2.73, p<0.05).
Prior to hospitalization, 27.1% of patients were treated with Xifaxan, 24.1% with lactulose, and 48.8% received no treatment. The findings support AASLD treatment guidelines recommending Xifaxan as an add-on to lactulose after breakthrough OHE episodes to prevent recurrence. Up to 80% of cirrhosis patients eventually develop some form of HE.
Bausch Health Companies ha annunciato nuovi dati che mostrano come i pazienti ricoverati per encefalopatia epatica evidente (OHE) abbiano un rischio ridotto di riospedalizzazione entro 30 giorni se trattati con Xifaxan® (rifaximina) dopo la dimissione, indipendentemente dal trattamento precedente. L'analisi basata su reclami di 7.880 pazienti con OHE ha rilevato che chi riceveva solo lattulosio alla dimissione presentava un rischio maggiore di riospedalizzazione per OHE entro 30 giorni rispetto ai pazienti trattati con Xifaxan (OR aggiustato: 1,63-2,73, p<0,05).
Prima del ricovero, il 27,1% dei pazienti era trattato con Xifaxan, il 24,1% con lattulosio e il 48,8% non riceveva alcun trattamento. I risultati supportano le linee guida AASLD che raccomandano Xifaxan come aggiunta al lattulosio dopo episodi di OHE per prevenire le recidive. Fino all'80% dei pazienti con cirrosi sviluppa eventualmente una qualche forma di encefalopatia epatica.
Bausch Health Companies anunció nuevos datos que muestran que los pacientes hospitalizados por encefalopatía hepática manifiesta (OHE) tuvieron un riesgo reducido de rehospitalización a los 30 días cuando fueron tratados con Xifaxan® (rifaximina) después del alta, independientemente del tratamiento previo. El análisis basado en reclamaciones de 7,880 pacientes con OHE reveló que aquellos que recibieron solo lactulosa al alta presentaron un mayor riesgo de rehospitalización por OHE a los 30 días en comparación con los que recibieron Xifaxan (OR ajustado: 1.63-2.73, p<0.05).
Antes de la hospitalización, el 27.1% de los pacientes fue tratado con Xifaxan, el 24.1% con lactulosa y el 48.8% no recibió tratamiento. Los hallazgos respaldan las guías de tratamiento de la AASLD que recomiendan Xifaxan como complemento a la lactulosa después de episodios de OHE para prevenir recurrencias. Hasta el 80% de los pacientes con cirrosis eventualmente desarrollan alguna forma de encefalopatía hepática.
Bausch Health Companies는 명백한 간성 뇌병증(OHE)으로 입원한 환자들이 퇴원 후 Xifaxan®(리팍시민)으로 치료받을 경우 이전 치료와 상관없이 30일 내 재입원 위험이 감소한다는 새로운 데이터를 발표했습니다. 7,880명의 OHE 환자를 대상으로 한 청구 기반 분석 결과, 퇴원 시 락툴로오스만 투여받은 환자는 Xifaxan을 투여받은 환자에 비해 30일 내 OHE 재입원 위험이 더 높았다(조정된 OR: 1.63-2.73, p<0.05)고 나타났습니다.
입원 전 환자의 27.1%는 Xifaxan으로, 24.1%는 락툴로오스로 치료받았으며 48.8%는 치료를 받지 않았습니다. 이 결과는 AASLD 치료 지침에서 돌파성 OHE 에피소드 후 재발 방지를 위해 락툴로오스에 Xifaxan을 추가하는 것을 권고하는 내용을 뒷받침합니다. 간경변 환자의 최대 80%가 결국 어떤 형태로든 간성 뇌병증을 겪게 됩니다.
Bausch Health Companies a annoncé de nouvelles données montrant que les patients hospitalisés pour encéphalopathie hépatique manifeste (OHE) présentaient un risque réduit de réhospitalisation à 30 jours lorsqu'ils étaient traités par Xifaxan® (rifaximine) après leur sortie, quel que soit le traitement antérieur. L'analyse basée sur les données de remboursement de 7 880 patients atteints d'OHE a révélé que ceux recevant uniquement du lactulose à la sortie avaient un risque plus élevé de réhospitalisation pour OHE à 30 jours comparé aux patients traités par Xifaxan (OR ajusté : 1,63-2,73, p<0,05).
Avant l'hospitalisation, 27,1 % des patients étaient traités par Xifaxan, 24,1 % par lactulose, et 48,8 % ne recevaient aucun traitement. Ces résultats soutiennent les recommandations de l'AASLD qui préconisent Xifaxan en complément du lactulose après des épisodes d'OHE pour prévenir les récidives. Jusqu'à 80 % des patients atteints de cirrhose développent finalement une forme d'encéphalopathie hépatique.
Bausch Health Companies hat neue Daten veröffentlicht, die zeigen, dass Patienten, die wegen offensichtlicher hepatischer Enzephalopathie (OHE) hospitalisiert wurden, ein reduziertes Risiko einer erneuten Hospitalisierung innerhalb von 30 Tagen hatten, wenn sie nach der Entlassung mit Xifaxan® (Rifaximin) behandelt wurden, unabhängig von vorherigen Behandlungen. Die auf Abrechnungsdaten basierende Analyse von 7.880 OHE-Patienten ergab, dass diejenigen, die bei Entlassung nur Lactulose erhielten, ein höheres Risiko für eine 30-tägige OHE-Rehospitalisierung im Vergleich zu den Xifaxan-Empfängern hatten (adjustierte OR: 1,63-2,73, p<0,05).
Vor der Hospitalisierung wurden 27,1 % der Patienten mit Xifaxan, 24,1 % mit Lactulose behandelt, und 48,8 % erhielten keine Behandlung. Die Ergebnisse unterstützen die AASLD-Behandlungsrichtlinien, die Xifaxan als Zusatz zu Lactulose nach Durchbruch-Episoden von OHE zur Rezidivprävention empfehlen. Bis zu 80 % der Leberzirrhose-Patienten entwickeln schließlich eine Form der hepatischen Enzephalopathie.
- Clinical data demonstrates Xifaxan reduces risk of 30-day OHE rehospitalization
- Results support AASLD treatment guidelines recommending Xifaxan as add-on treatment
- Large-scale analysis of 7,880 patient claims validates treatment efficacy
- 48.8% of analyzed patients received no treatment prior to hospitalization
- Some patients still leave hospital without guideline-based treatment recommendations
Insights
Positive clinical data reinforces Xifaxan's efficacy for OHE, potentially expanding adoption in an underserved patient population with growing prevalence.
The new claims-based analysis for Bausch Health's Xifaxan provides real-world evidence substantiating the drug's clinical benefit in reducing 30-day rehospitalizations for overt hepatic encephalopathy patients. This data reinforces AASLD treatment guidelines that already recommend Xifaxan as an add-on to lactulose after OHE episodes.
What's particularly noteworthy is the significant treatment gap revealed in this analysis. Prior to hospitalization, 48.8% of patients received no treatment, while only 27.1% were treated with Xifaxan. This suggests substantial opportunity for increased Xifaxan utilization among eligible patients.
The demonstrated 63-173% increased risk (adjusted OR: 1.63-2.73, p<0.05) of rehospitalization for patients on lactulose alone versus those receiving Xifaxan provides compelling evidence for clinicians and payers. For Bausch Health, this reinforces the value proposition of an established product in their portfolio during a period when healthcare systems are increasingly focused on reducing rehospitalizations and their associated costs.
With cirrhosis cases rising, as mentioned in the release, the potential patient population for Xifaxan in OHE appears to be growing, representing a possible tailwind for this particular product line within Bausch Health's diversified portfolio.
New real-world evidence confirms Xifaxan significantly reduces 30-day OHE rehospitalizations, supporting current guidelines while highlighting substantial undertreatment of patients.
This claims-based analysis provides important validation for what hepatologists already recommend in practice - Xifaxan as adjunct therapy to lactulose following OHE episodes. The data showing 1.63-2.73 times higher risk of 30-day rehospitalization for patients receiving only lactulose underscores the clinical benefit of combination therapy.
The pathophysiology here is clear: in cirrhosis, gut-derived neurotoxins like ammonia bypass the damaged liver and reach the brain, causing the cognitive and neurological symptoms of hepatic encephalopathy. Xifaxan (rifaximin) works by reducing intestinal bacterial production of these toxins, addressing a key driver of OHE episodes.
What's concerning from a clinical perspective is that nearly half (48.8%) of the analyzed patients received no treatment prior to hospitalization, despite OHE being a serious complication with up to 80% of cirrhosis patients eventually developing some form of hepatic encephalopathy. This suggests significant gaps in guideline-adherent care.
OHE episodes mark the decompensated phase of cirrhosis and are associated with increased mortality. Each hospitalization not only impacts patient quality of life but signals disease progression. The growing prevalence of chronic liver disease makes these findings particularly relevant, as early intervention with appropriate therapy could substantially reduce the burden of this complication on patients and healthcare systems alike.
New analysis suggests efficacy of Xifaxan to mitigate OHE rehospitalizations irrespective of treatment history
LAVAL, QC / ACCESS Newswire / May 6, 2025 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), a global, diversified pharmaceutical company, and its gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), today announced new data showing that people hospitalized due to overt hepatic encephalopathy (OHE) had a reduced risk of OHE-related rehospitalization within 30 days if treated with Xifaxan® (rifaximin) following hospital discharge regardless of prior treatment. These findings, based on a claims-based analysis, will be presented today at Digestive Disease Week® (DDW) 2025 in San Diego, CA.
"This analysis reinforces the use of Xifaxan to help prevent OHE rehospitalizations," said Arun Jesudian, MD, Director of Inpatient Liver Services at NYPH/Weill Cornell. "Cases of chronic liver disease and cirrhosis are growing, and these conditions can be debilitating for patients and their families. Providing patients with optimal, guideline-based treatment regimens is imperative because preventing recurrence and rehospitalizations not only benefits patients but also helps reduce burden on the broader healthcare system."
In patients with cirrhosis, an occurrence of fully symptomatic overt hepatic encephalopathy (OHE) is one of the key complications that defines the decompensated phase of the disease and is associated with worsening outcomes, morbidity, and mortality.1 Because in cirrhosis a damaged liver does not function normally, toxins from the gut can enter the bloodstream and travel to the brain, where they can affect neurotransmission precipitating OHE episodes. These episodes may present as alterations in consciousness, cognition, and behavior.2,3 Up to
Results of this claims-based analysis showed that patients who received lactulose only upon hospital discharge had a higher risk of 30-day OHE rehospitalization compared to those who received Xifaxan (adjusted OR: 1.63-2.73, p<0.05) regardless of pre-hospitalization treatment. Additionally, the risk of 30-day OHE rehospitalization increased with descending tiers of quality of care (QoC), defined as high-, intermediate- or low-quality based on AASLD guidelines (intermediate vs. high QoC: OR = 1.44, low vs. high QoC: OR = 2.45, all p<0.05). Results remained consistent for Medicare- and Medicaid-insured patients.
"Xifaxan has been proven to effectively reduce the risk of OHE recurrence, so it is concerning to know that some patients leave the hospital without guideline-based treatment recommendations," said Aimee Lenar, Executive Vice President of US Pharma at Bausch Health. "It is vital to recognize hepatic encephalopathy in people with liver disease in the hospital setting and to ensure they have access to high-quality, holistic care upon discharge."
The analysis used claims data from the Komodo Research Data (January 2016 - September 2023) to identify commercially-insured patients with an initial OHE hospitalization. Of the 7,880 OHE patient claims data analyzed, prior to hospitalization, 27.1 percent (n=2,135) were treated with Xifaxan, 24.1 percent with lactulose and
About XIFAXAN
INDICATION
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (OHE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
IMPORTANT SAFETY INFORMATION
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients.
Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to rifaximin.
In clinical studies, the most common adverse reactions for XIFAXAN (alone or in combination with lactulose) were:
HE (≥
10% ): Peripheral edema (17% ), constipation (16% ), nausea (15% ), fatigue (14% ), insomnia (14% ), ascites (13% ), dizziness (13% ), urinary tract infection (12% ), anemia (10% ), and pruritus (10% )IBS-D (≥
2% ): Nausea (3% ), ALT increased (2% )
INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required.
XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus.
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please click here for full Prescribing Information.
About Bausch Health
Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. Our gastroenterology business, Salix Pharmaceuticals, is one of the largest specialty pharmaceutical businesses in the world and has licensed, developed and marketed innovative products for the treatment of gastrointestinal diseases for more than 30 years. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
References
Vilstrup H, Amodio P, Bajaj J, et al. Hepatic encephalopathy in chronic liver disease: 2014 practice guideline by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver. Hepatology. 2014;60(2):715-735. doi:10.1002/hep.27210
Vince AJ, Burridge SM. Ammonia production by intestinal bacteria: the effects of lactose, lactulose and glucose. J Med Microbiol. 1980;13(2):177-191. doi:10.1099/00222615-13-2-177
Khan A, Ayub M, Khan WM. Hyperammonemia is associated with increasing severity of both liver cirrhosis and hepatic encephalopathy. Int J Hepatol. 2016;2016:6741754. doi:10.1155/2016/6741754
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SOURCE: Bausch Health Companies Inc
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FAQ
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