Surrogate Markers of Portal Pressure

Subjects will be recruited from the outpatient setting of the West Haven VA Medical Center
and the Yale Liver Clinic. Subjects between 18-85 years of age with compensated cirrhosis due
to chronic hepatitis C virus (HCV) infection who will be starting anti-viral therapy to treat
HCV within the next 3 months will be eligible for this study. 33 subjects (assuming 10% loss
to follow-up) will be recruited and their participation will last from 6-12 months. The
expected duration of the study is 2 years.

The primary end point of the study is to correlate the change (from baseline to after
completing anti-HCV therapy) in ICG retention test, LS and SS as measured by ARFI with HVPG.
After consent has been obtained, subjects will undergo ICG retention test, ARFI imaging and
HVPG measurements before and after HCV therapy. Blood samples, demographic and clinical data
will be collected before and after HCV therapy. Correlations between changes in HVPG and
changes in ICG, LS and SS will be assessed. With 30 patients , we will have 80% power to
perform a hypothesis test of the Pearson correlation assuming an observed correlation of 0.70
and a two-sided type I error rate of 0.05.

Inclusion Criteria:

- Age 18-85

- HCV infection (HCV-RNA positive)

- Compensated cirrhosis will be defined histologically and/or clinically (presence of
compatible lab findings (platelet count ≤ 150,000, total bilirubin ≥ 2, serum albumin
≤ 3.5, INR ≥ 1.2) PLUS compatible physical exam features (cutaneous stigmata,
gynecomastia in men, or splenomegaly) OR compatible radiological findings (nodular
liver surface, splenomegaly, and/or collaterals). (The ultimate confirmation of the
diagnosis of cirrhosis will be a baseline HVPG > 5 mmHg)

- Planned anti-HCV therapy in the next 3 months

Exclusion Criteria:

- Any clinically-evident complication of cirrhosis that defines decompensation :
jaundice, ascites, variceal hemorrhage, overt hepatic encephalopathy)

- Hepatocellular carcinoma

- Co-infection with HBV or HIV

- Ongoing alcohol abuse

- Occlusive portal thrombosis,

- Presence of comorbid conditions conferring a life expectancy<1 year, history of
allergy to iodides, pregnancy