Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic Hepatitis C Virus (HCV) Genotype 3 (GT3) Infection (MK-5172-083)
Status and phase
Completed
Phase 2
Conditions
Hepatitis C
Treatments
Drug: Ribavirin
Drug: Grazoprevir
Drug: Elbasvir
Drug: Sofosbuvir
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
This is a randomized, multi-site, open-label trial of the co-administration of a fixed-dose combination (FDC) of EBR 50 mg + GZR (100 mg) (EBR/GZR) and SOF 400 mg, with and without RBV, in treatment-naïve (TN) and treatment-experienced (TE) participants with chronic HCV GT3 infection with compensated cirrhosis.
Enrollment
101 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- has HCV RNA (>= 10,000 IU/mL in peripheral blood) at screening
- has documented HCV GT3 (with no evidence of non-typeable or mixed GT infection)
- has compensated cirrhosis of the liver
- has liver imaging within 6 months of Day 1 with no evidence of hepatocellular carcinoma (HCC)
- is either HCV TN or TE (i.e., has documented prior virologic failure or intolerance to peg-interferon/ribavirin)
- is otherwise healthy as determined by medical history, physical examination, electrocardiogram (ECG), and clinical laboratory measurements
- has compensated cirrhosis of the liver
- is TN or TE (i.e., documented prior virologic failure or intolerance to peg-interferon/ribavirin)
- is not of reproductive potential, or agrees to not impregnate a partner or become pregnant for at least 2 weeks prior to the first dose of study drug, and for 7 months after the final dose of study drug (or longer if dictated by local regulations)
Exclusion criteria
- has previously received one or more doses of a direct-acting antiviral (DAA)
- has evidence of decompensated liver disease
- is coinfected with hepatitis B (hepatitis B surface antigen [HBsAg] positive)
- has a recent (within 5 years) history of malignancy or is under evaluation for HCC or other suspected malignancy
- is currently or has participated (within past 30 days) in a study with an investigational compound
- has clinically-relevant drug or alcohol abuse within the past 12 months of screening
- is a female and is pregnant or breast-feeding
- is a male whose female partner is/are pregnant
- has any of the following:
- organ transplants
- poor venous access
- history of gastric surgery or malabsorption disorder
- current or history of clinically significant cardiac abnormalities or dysfunction
- chronic pulmonary disease
- hemoglobinopathy
- history of hospitalization within 3 months prior to enrollment
- medical or surgical condition that may result in need for hospitalization during the course of the study
- any condition requiring, or likely to require, chronic systemic administration of corticosteroids, tumor necrosis factor (TNF) antagonists, or other immunosuppresant drugs during the course of the study
- any condition, prestudy laboratory or ECG abnormality, or history of any illness, which could confound results of the study or pose additional risks in administering study drugs in the opinion of the investigator
- has a life-threatening serious AE (SAE) during the screening period
- has evidence of history of chronic hepatitis not caused by HCV
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
101 participants in 5 patient groups
Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks
Experimental group
Description:
TN HCV GT3 participants will take 1 fixed-dose combination (FDC) tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg once-daily (q.d.) with RBV (200 mg capsules; weight-based dosing) twice-daily (b.i.d.) for 8 weeks.
Treatment:
Drug: Sofosbuvir
Drug: Elbasvir
Drug: Grazoprevir
Drug: Ribavirin
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks
Experimental group
Description:
TN HCV GT3 participants will take 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
Treatment:
Drug: Sofosbuvir
Drug: Elbasvir
Drug: Grazoprevir
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks
Experimental group
Description:
TE HCV GT3 participants will take 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
Treatment:
Drug: Sofosbuvir
Drug: Elbasvir
Drug: Grazoprevir
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks
Experimental group
Description:
TE HCV GT3 participants will take 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
Treatment:
Drug: Sofosbuvir
Drug: Elbasvir
Drug: Grazoprevir
Drug: Ribavirin
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
Experimental group
Description:
TE HCV GT3 participants will take 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
Treatment:
Drug: Sofosbuvir
Drug: Elbasvir
Drug: Grazoprevir
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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