Surrogate Markers of Portal Pressure
Surrogate Markers of Portal Pressure
This is a prospective longitudinal study that will evaluate if changes (pre and post therapy)
 in indocyanine green (ICG) retention test and liver stiff ness (LS) and spleen stiffness (SS)
 as measured by acoustic radiofrequency impulse (ARFI) correlate with changes in portal
 pressure as determined by the hepatic vein pressure gradient (HVPG) in patients with
 compensated hepatitis C virus (HCV) cirrhosis undergoing antiviral therapy.
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