Table 3.

Risks discussed in the informed consent process

Acute HCV infection risk

Fulminant hepatitis

Fibrosing cholestatic hepatitis

Chronic HCV infection

Chronic hepatitis leading to cirrhosis

End-stage liver disease, liver cancer, need for liver transplant, death

Extrahepatic manifestations including mixed cryoglobulinemia

Risk of DAA failure

Virologic failure, development of resistance

Incorrect genotyping test*

Risk of HCV transmission to household or sexual partners

Side effects of DAAs

Risk of undergoing transplantations**

Discovery of new medical problems during pre-transplant evaluation

Surgical procedure risks

Risks of Immunosuppression

Risks related to stored blood samples and loss of privacy

^*Would not be relevant if a pan-genotypic DAA regimen was used

^**Additionally, a full comprehensive clinical consent for transplantation takes place outside of this protocol. Abbreviations: HCV = hepatitis C virus, DAAs = direct-acting antivirals