Real World Study: Genotype 1 Chronic HCV Treatment and Evaluation of Real World SVR and PROs

This is a Phase IV, open-label, multi-center study to evaluate the real world sustained
virological response rate, subject adherence, and subject reported outcomes during and after
treatment of non-cirrhotic genotype 1 chronic hepatitis C subjects aged 18 years and older,
with the AbbVie 3 direct-acting antiviral (3-DAA) regimen of VIEKIRA PAK (ombitasvir,
paritaprevir/r, dasubuvir), with or without ribavirin.

Subjects may be treatment-naïve or treatment experienced with pegylated-interferon based
regimens excluding regimens with direct-acting antiviral agents. The study will be conducted
at multiple Kaiser Permanente Southern California Medical Centers.

The primary objective of this open label study is to evaluate the rate of sustained
virological response rate 12 weeks after completion of treatment (SVR12) with VIEKIRA PAK,
with or without ribavirin in a large real world setting.

Key Inclusion Criteria

- Male or female at least 18 years of age at time of screening.

- Subject, if female must not use estrogen-containing hormonal contraception including
oral, injectable, implantable, patch and ring varieties during study drug treatment

- Subject, if male, who is not surgically sterile and is sexually active with female
partner of childbearing potential must agree to practice 2 effective contraceptive
methods for study duration

- Subject must have at least one of the following indicators of chronic hepatitis C
virus infection prior to study enrollment: Positive anti-HCV antibody or HCV RNA >
10,000 IU/mL at least 6 months before screening, and positive for HCV RNA at the time
of screening, or HCV RNA > 10,000 IU/mL at screening and liver biopsy consistent with
chronic HCV infection

- Subject has a screening laboratory result indicating HCV genotype 1-infection

Key Exclusion Criteria

- Subject, if female is pregnant or is breastfeeding, of if male, with female partner
who is currently pregnant

- Subject has positive test result for hepatitis B surface antigen or confirmed positive
anti-HIV antibody test

- Subject received study contraindicated medications prior to study drug administration

- Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inducers of
cytochrome P450 2C8 (CYP2C8) or strong inhibitors of CYP2C8 within 2 weeks of the
respective medication/supplement prior to initial dose of study drug.

- Clinically significant abnormalities or co-morbidities, other than HCV infection that
in opinion of the investigator makes subject unsuitable for this study or drug regimen

- Current enrollment in another interventional clinical study or prior or current use of
any investigational or commercially available anti-HCV agents other than interferon or
ribavirin including previous exposure to ABT450 (paritaprevir) , ABT-267 (ombitasvir)
or ABT-333 (dasabuvir) or receipt of any investigational product within 6 weeks prior
to study drug administration

- Prior treatment of chronic HCV infection with a direct acting antiviral agent(s):
telaprevir, boceprevir, sofosbuvir, simeprevir, or other direct acting antiviral

- History of solid organ transplant

- Evidence of cirrhosis

- History of liver decompensation: ascites noted on a physical exam, imaging or other
test; variceal bleeding; hepatic encephalopathy

- Confirmed presence of hepatocellular carcinoma indicated on computed tomography,
magnetic resonance, or other imaging techniques within 3 months prior to screening

- HCV genotype performed during screening indicates infection with any genotype other
than genotype 1

- Recent history of drug or alcohol abuse that could, in the opinion of the
investigator, affect adherence to the study protocol