Aparna Goel, MD

Panelists discuss how recent FDA regulatory actions regarding obeticholic acid have raised concerns about its long-term safety profile and accessibility, leading health care teams to develop strategies for supporting patients through treatment transitions while navigating insurance coverage and access challenges for newer primary biliary cholangitis (PBC) therapies.

Panelists discuss how transitioning patients from obeticholic acid to seladelpar or elafibranor requires close monitoring of liver biochemistry, pruritus severity, medication adverse effects, and quality of life measures while providing clear patient education about expected timeline for symptom improvement and potential adjustment periods.

Panelists discuss how clinicians may transition patients to newer agents due to factors such as inadequate biochemical response, tolerability issues (particularly pruritus), or patient preference, while carefully considering the need for washout periods based on each drug's pharmacokinetics and mechanism of action.

Panelists discuss how long-term safety monitoring for second-line primary biliary cholangitis (PBC) therapies requires systematic assessment of liver function, lipid profiles, and potential drug-specific adverse effects while emerging 5-year safety data for seladelpar continues to demonstrate a favorable risk profile compared with other treatment options.

Panelists discuss how the safety profiles of second-line primary biliary cholangitis (PBC) therapies in compensated cirrhosis show varying levels of risk, with recent abstracts from EASL and AASLD 2024.

Panelists discuss how managing primary biliary cholangitis (PBC) in women of childbearing age requires careful consideration of pregnancy risk categories for different medications, with UDCA being the safest option during pregnancy, while second-line therapies require strict contraception and careful monitoring of hormone interactions to ensure optimal safety and efficacy.

Panelists discuss how hepatotoxicity risks vary among second-line primary biliary cholangitis (PBC) treatments, with seladelpar and elafibranor showing favorable hepatic safety profiles compared to obeticholic acid, though all require regular liver function monitoring and dose adjustments based on individual patient response and disease severity.

Panelists discuss how safety considerations for primary biliary cholangitis (PBC) treatment include monitoring liver function tests, managing pruritus and fatigue, assessing drug interactions, and evaluating individual patient factors like pregnancy status and comorbidities, which all influence the choice between ursodeoxycholic acid and second-line therapies.

Panelists discuss how sustained treatment success in primary biliary cholangitis (PBC) requires regular monitoring of biochemical response markers, assessing patient adherence, managing potential adverse effects, and making timely adjustments to treatment strategies based on individual patient responses to seladelpar and elafibranor.

Panelists discuss how seladelpar showed remarkable efficacy in the RESPONSE trial, demonstrating significant improvements in alkaline phosphatase levels and other biochemical markers compared with placebo.

Panelists discuss how elafibranor demonstrated significant efficacy in the ELATIVE trial, which strengthens confidence in its role as a long-term treatment option for patients with primary biliary cholangitis (PBC) who inadequately respond to ursodeoxycholic acid.

Panelists discuss how some patients with primary biliary cholangitis (PBC) have an inadequate response to ursodeoxycholic acid and require second-line treatments, with options including obeticholic acid, seladelpar, and elafibranor, which improve bile acid homeostasis and reduce inflammation.

Panelists discuss how the main treatment goals for patients with primary biliary cholangitis (PBC) include improving liver biochemistry, preventing disease progression to cirrhosis, managing symptoms, and enhancing overall quality of life through regular monitoring and appropriate therapeutic interventions.

Panelists discuss how ursodeoxycholic acid is the first-line treatment for primary biliary cholangitis (PBC), with early initiation being crucial for optimal outcomes and prevention of disease progression.

Panelists discuss how primary biliary cholangitis (PBC) often presents asymptomatically but can be diagnosed through elevated alkaline phosphatase levels, positive antimitochondrial antibodies, and liver biopsy when necessary.