Intervention: Grazoprevir
Trial phase: Phase 1
ATC code: J05AP11 | J05AP54
SMILES: C=C[C@@H]1C[C@]1(NC(=O)[C@@H]1C[C@@H]2CN1C(=O)[C@H](C(C)(C)C)NC(=O)O[C@@H]1C[C@H]1CCCCCc1nc3ccc(OC)cc3nc1O2)C(=O)NS(=O)(=O)C1CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
Eligibility criteria:
Inclusion criteria:

has a Body Mass Index (BMI) ≥18.5 kg/m² and ≤36.0 kg/m²
has chronic compensated, genotype 1 HCV infection
has no cirrhosis of the liver as confirmed by FibroSure®/Fibro Test® and/or local country procedure (e.g. transient elastography/Fibroscan)
does not require anticoagulants, nonsteroidal anti-inflammatory agents, and aspirin for at least fourteen (14) days preceding the initial liver biopsy and continuing throughout the entire study
if is a female participant of reproductive potential, is willing to use 2 medically acceptable forms of contraception for 2 weeks prior to start of treatment through 2 weeks after last study treatment
if is a male participant with a partner(s) of reproductive potential, is willing to use 2 medically acceptable forms of contraception from first dose to 90 days after last dose

Exclusion criteria:

has a history of stroke, chronic seizures, or major neurological disorder
has received previous treatment with a direct-acting antiviral (DAA)
has evidence of high grade bridging fibrosis from prior liver biopsy within 3 years of study entry
has evidence or history of chronic hepatitis not caused by HCV infection including but not limited to non-HCV viral hepatitis, nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, or autoimmune hepatitis
has clinical or laboratory evidence of cirrhosis or other advanced liver disease
has decompensated liver disease as indicated by a history of ascites, hepatic encephalopathy, or bleeding esophageal varices
has been diagnosed with, or suspected of having, hepatocellular carcinoma (HCC)
has clinically significant abnormality on an electrocardiogram (ECG)
is co-infected with human immunodeficiency virus (HIV)
is positive for Hepatitis B surface antigen (HBsAg) or other evidence of active Hepatitis B infection
has a history of gastric bypass surgery, bowel resection or other disorder that may interfere with absorption
has a history of clinically significant uncontrolled endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
has clinically significant neoplastic disease
uses alcohol to excess, defined as greater than 3 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [354 mL], wine [118 mL], or distilled spirits [29.5 mL]) per day
is a current regular user (including use of any illicit drugs) or history of drug (including alcohol) abuse within the last 3 months
has undergone surgery, donation of 1 unit of blood (approximately 500 mL) or participation in another investigational study within a period of 4 weeks prior to the screening visit
has a history of multiple and/or severe allergies, or anaphylactic reaction or intolerability to prescription or nonprescription drugs or food
is pregnant or lactating
is expecting to donate eggs or sperm