The HepQuant SHUNT Test for Monitoring Liver Disease and Treatment Effects by Measuring Liver Function and Physiology

The HepQuant study is to run parallel to the Gilead clinical trials,GS-US-416-2124 trial of
Alcoholic Hepatitis, GS-US-384-1943 trial of non-alcoholic steatohepatitis (NASH) fibrosis
Stage 3 (STELLAR-3), and, GS-US-384-1944 trial of NASH and compensated cirrhosis (STELLAR-4).
The time points for the HepQuant SHUNT tests coincide with pre-specified time points within
the Gilead clinical trials. Subjects enrolled in GILEAD's STELLAR and Alcoholic hepatitis
trials may participate concurrently in this HepQuant sponsored investigational device study
at participating US sites only (IDEs as listed above) once approved by the applicable
IRB/IEC.

The main eligibility criteria for enrollment into the HepQuant study is enrollment into one
of the three Gilead clinical trials listed above.

The HepQuant SHUNT Test is minimally-invasive and measures hepatocyte function and inflow to
the liver from the simultaneous clearances (hepatic filtration rates, HFRs) of cholate from
systemic and portal circulations. The Test quantifies portal-systemic shunting (SHUNT) and
generates a liver disease severity index (DSI). DSI is a score from 0 (no disease) to 50
(terminal illness) that is a composite of both HFRs and correlates with stage of fibrosis,
presence of varices, especially large varices, and risk for future clinical outcomes. DSI is
the primary output variable from the HepQuant SHUNT test. The HepQuant SHUNT test potentially
satisfies the unmet medical need for a minimally-invasive test of global liver function and
physiology

Inclusion Criteria:

The key inclusion criteria for this HepQuant Parallel Study are the inclusion criteria into
one of the Gilead selonsertib trials (GS-US-416-2124, GS-US-384-1943 or 1944). Once that
has been met, subjects must:

- Be able to ingest liquid by mouth

- Have venous access to support a peripheral IV and 6 blood draws

Exclusion Criteria:

The key exclusion criteria for this HepQuant Parallel Study are the exclusion criteria for
one of the Gilead selonsertib trials (GS-US-416-2124, GS-US-384-1943 or 1944). If this has
been met, the subject is not eligible to participate in HepQuant. If no exclusion criteria
has been met for the Gilead selonsertib trial, ADDITIONAL exclusions for HepQuant are:

- Subject should not have had first dose of selonsertib

- Subject cannot take anything by mouth

- Subject cannot be hypersensitive to eggs, albumin preparations, any ingredient in the
formulation, or component of the container

- Subject cannot have intercurrent medical or surgical illness (eg: acute MI, acute
cerebral hemorrhage, sepsis)

- subject cannot have had extensive resection of large segments of small intestine
(short gut)

- Subject cannot have severe gastroparesis