Transplant Institute, Loma Linda University Medical Center Redlands, CA, United States
Michael Volk, MD1, Rebecca Burne, PhD2, Annie Guérin, MSc2, Sherry Shi, MSc2, George Joseph, MS, PhD3, Zeev Heimanson, PharmD4, Maliha Ahmad, MD5 1Transplant Institute, Loma Linda University Medical Center, Redlands, CA; 2Analysis Group, Inc., Montreal, PQ, Canada; 3Bausch Health US, LLC, Bridgewater, NJ; 4Salix Pharmaceuticals, Bridgewater, NJ; 5Liver Disease Services, St. Joseph’s Health, Paterson, NJ
Introduction: Prophylaxis is advocated for preventing HE recurrence in patients (pts) with a history of overt HE. Rifaximin is indicated for reduction in risk of overt HE recurrence in adults. We hypothesized that treatment with rifaximin ± lactulose would be associated with lower rates of emergency department (ED) visits vs treatment with lactulose alone.
Methods: Analyses were done using 2 US commercial claim databases: IBM® MarketScan® Commercial Database (Jul 1, 2014–Jun 30, 2019) and Optum’s de-identified Clinformatics® Data Mart Database (Jul 1, 2014–Mar 31, 2020). Pts with HE treated with rifaximin 550 mg (regardless of tablets/d; ± lactulose) or lactulose alone were identified via algorithm developed with clinical experts. Analysis included pts aged 18–64 y at index date (first prescription fill), with ≥6 mo of continuous enrollment before and ≥30 d after index date. Treatment episodes for each pt were defined based on current/recent exposure and classified as rifaximin (± lactulose) or lactulose only. The analysis focused on treatment episodes with high adherence (proportion of days covered [PDC] ≥80%; calculated at episode level, with PDC defined as the sum of days with treatment on hand divided by duration of treatment episode). Lactulose mean daily dose for PDC was conservatively assumed to be 15 mL/d (per clinical expert input). Differences between rifaximin (± lactulose) and lactulose treatment episodes were compared using an incident risk ratio (IRR), adjusted for potential confounding factors.
Results: 7675 pts from the MarketScan database were included, contributing 9632 rifaximin- and 4348 lactulose-adherent episodes. In the Optum database, 3530 pts were identified (rifaximin adherent episodes, n=3680; lactulose, n=2103). The mean ± SD duration of follow-up in the 2 databases was 14.5 ± 12.6 mo and 13.9 ± 13.1 mo, respectively. For the MarketScan database, there was a 25% decrease in the number of days with ED services used when comparing rifaximin vs lactulose treatment-adherent episodes (adjusted IRR, 0.75; 95% CI, 0.68–0.83; P<0.001). For the Optum database, there was an 18% decrease in the number of days with ED services used when comparing rifaximin vs lactulose treatment-adherent episodes (adjusted IRR, 0.82; 95% CI, 0.73–0.93; P=0.002).
Discussion: These real-world data indicate that treatment with rifaximin (± lactulose) in pts at risk for HE may reduce ED healthcare utilization vs treatment with lactulose alone.
Disclosures:
Michael Volk: Bausch Health US, LLC – Consultant.
Rebecca Burne: Analysis Group, Inc. – Employee.
Annie Guérin: Analysis Group, Inc. – Employee.
Sherry Shi: Analysis Group, Inc. – Employee.
George Joseph: Bausch Health US, LLC – Employee.
Zeev Heimanson: Salix Pharmaceuticals – Employee.
Maliha Ahmad: Bausch Health US, LLC – Consultant.
Michael Volk, MD1, Rebecca Burne, PhD2, Annie Guérin, MSc2, Sherry Shi, MSc2, George Joseph, MS, PhD3, Zeev Heimanson, PharmD4, Maliha Ahmad, MD5. P1788 - Emergency Department Utilization in Patients With Hepatic Encephalopathy (HE) Treated With Rifaximin (± Lactulose) versus Lactulose Alone, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.
