Clinical outcome indicators in chronic hepatitis B and C: A primer for value-based medicine in hepatology.

Background & Aims: Chronic liver diseases (CLDs) are major health problems that require complex and costly treatments. Liver-specific clinical outcome indicators (COIs) able to assist both clinicians and administrators in improving the value of care are presently lacking. The Value-Based Medicine in Hepatology (VBMH) study aims to fill this gap, devising and testing a set of COIs for CLD, that could be easily collected during clinical practice.

Optimising the clinical strategy for autoimmune liver diseases: Principles of value-based medicine.

Background: Autoimmune hepatitis, primary biliary cholangitis, and primary sclerosing cholangitis represent the three major autoimmune liver diseases (AILDs). Their management is highly specialized, requires a multidisciplinary approach and often relies on expensive, orphan drugs. Unfortunately, their treatment is often unsatisfactory, and the care pathway heterogeneous across different centers.

Interferon beta-1a alone or in combination with ribavirin: a randomized trial to compare efficacy and safety in chronic hepatitis C.

Aim: To compare the efficacy and safety of recombinant human IFN beta-1a alone or in combination with ribavirin in treatment-naive subjects with chronic hepatitis C.

Methods: Open, randomized trial was performed in 6 Italian tertiary centers: 102 of the 108 patients screened were randomized to receive 6 MIU of recombinant human IFN beta-1a subcutaneously daily for 24 wk, alone (Group 1, n = 51) or in combination with ribavirin 1,000 to 1,200 mg/d (Group 2, n = 51).

Results: The end-of-treatment virologic response rate was 29.