S0988 Health Outcomes in Patients With Hepatic Encephalopathy Managed Through Telemedicine and a Specialized Pharmacy Team

INTRODUCTION: Cirrhosis predisposes patients (pts) to multiple costly complications, including hepatic encephalopathy (HE). Hospital readmissions are common and ∼1/3 are due to recurrent HE. Based on a Phase 3 registration trial (NEJM 2010; 362: 1071-81), the recommended HE treatment is lactulose +/- rifaximin which is sometimes limited by formulary restrictions/cost. This study assesses the rifaximin approval process, pt compliance and health outcomes in pts with HE in GI/hep practices that use telemedicine and a dedicated pharmacy team with expertise in liver disease. METHODS: This IRB-approved, ongoing, observational registry captures long-term health outcomes and pharmacy support data every 6 months in cirrhotic pts with at least stage 1 HE taking rifaximin. Concomitant lactulose was allowed per physician discretion. Pts were seen in an office setting and then largely managed via telemedicine. Office visits were scheduled when medically necessary. Analyses comparing this real-world dataset to the rifaximin-treated subgroup in the NEJM trial were also performed. RESULTS: In this registry cohort of 1215 pts, ∼1/2 had HCV, ∼1/4 had NASH/NAFLD and ∼1/4 had alcoholic cirrhosis; 11.1% had a history of HCC. 98.5% of rifaximin prescriptions were accepted with the first prior authorization request and ∼80% started treatment <15 days from prescription submission. Baseline characteristics between the registry cohort and the NEJM cohort are in Table 1. After 6 months of rifaximin-treatment, fewer pts in the registry cohort were non-compliant with dosing (6.4% vs 15.8%, P = 0.0006), fewer had HE-related hospitalizations (2.7% vs 13.6%; P < 0.0001) and fewer worsened/died (15.6% vs 26.4%; P < 0.0001) compared to the NEJM cohort. After 6 months, 73.4% remained on rifaximin, 15.7% opted out, 4.9% were lost to follow up and 6.0% died. During the 6-month period, 17.3% of pts visited an ER/urgent care facility and 18.2% were hospitalized. The hospitalizations were HE-related in 22.8%. The odds of having a detrimental outcome (death, >hospitalizations or > ER/urgent care visits) was higher for pts whose baseline MELD was ≥12.0 compared to pts whose baseline MELD was < 12.0 (Table 2). CONCLUSION: Pts with HE who are closely monitored through telemedicine and managed by a specialized pharmacy team tend to do well in an outpatient setting. This cohort of patients had low rates of non-compliance, fewer hospitalizations and deaths/worsening disease compared to the rifaximin-treated group in the NEJM trial.Table 1.: Baseline Characteristics of Registry Cohort versus NEJM CohortTable 2.: Detrimental Outcomes Based on Baseline MELD / = 12