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)
NCT ID: NCT02601573
Last Updated: 2019-08-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
101 participants
INTERVENTIONAL
2016-01-05
2017-01-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks
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.
Sofosbuvir
SOF 400 mg tablet taken q.d. by mouth in the morning with food.
Grazoprevir
GZR 100 mg is a component of the MK-5172A FDC tablet (also containing EBR 50 mg) and was taken q.d. by mouth in the morning.
Elbasvir
EBR 50 mg is a component of the MK-5172A FDC tablet (also containing GZR 100 mg) and was taken q.d. by mouth in the morning.
Ribavirin
RBV 200 mg capsules taken b.i.d. (morning and evening) by mouth at a total daily dose ranging from 800 mg to 1400 mg (total daily dose was based on participant body weight).
Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks
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.
Sofosbuvir
SOF 400 mg tablet taken q.d. by mouth in the morning with food.
Grazoprevir
GZR 100 mg is a component of the MK-5172A FDC tablet (also containing EBR 50 mg) and was taken q.d. by mouth in the morning.
Elbasvir
EBR 50 mg is a component of the MK-5172A FDC tablet (also containing GZR 100 mg) and was taken q.d. by mouth in the morning.
Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks
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.
Sofosbuvir
SOF 400 mg tablet taken q.d. by mouth in the morning with food.
Grazoprevir
GZR 100 mg is a component of the MK-5172A FDC tablet (also containing EBR 50 mg) and was taken q.d. by mouth in the morning.
Elbasvir
EBR 50 mg is a component of the MK-5172A FDC tablet (also containing GZR 100 mg) and was taken q.d. by mouth in the morning.
Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks
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.
Sofosbuvir
SOF 400 mg tablet taken q.d. by mouth in the morning with food.
Grazoprevir
GZR 100 mg is a component of the MK-5172A FDC tablet (also containing EBR 50 mg) and was taken q.d. by mouth in the morning.
Elbasvir
EBR 50 mg is a component of the MK-5172A FDC tablet (also containing GZR 100 mg) and was taken q.d. by mouth in the morning.
Ribavirin
RBV 200 mg capsules taken b.i.d. (morning and evening) by mouth at a total daily dose ranging from 800 mg to 1400 mg (total daily dose was based on participant body weight).
Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
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.
Sofosbuvir
SOF 400 mg tablet taken q.d. by mouth in the morning with food.
Grazoprevir
GZR 100 mg is a component of the MK-5172A FDC tablet (also containing EBR 50 mg) and was taken q.d. by mouth in the morning.
Elbasvir
EBR 50 mg is a component of the MK-5172A FDC tablet (also containing GZR 100 mg) and was taken q.d. by mouth in the morning.
Interventions
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Sofosbuvir
SOF 400 mg tablet taken q.d. by mouth in the morning with food.
Grazoprevir
GZR 100 mg is a component of the MK-5172A FDC tablet (also containing EBR 50 mg) and was taken q.d. by mouth in the morning.
Elbasvir
EBR 50 mg is a component of the MK-5172A FDC tablet (also containing GZR 100 mg) and was taken q.d. by mouth in the morning.
Ribavirin
RBV 200 mg capsules taken b.i.d. (morning and evening) by mouth at a total daily dose ranging from 800 mg to 1400 mg (total daily dose was based on participant body weight).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Foster GR, Agarwal K, Cramp ME, Moreea S, Barclay S, Collier J, Brown AS, Ryder SD, Ustianowski A, Forton DM, Fox R, Gordon F, Rosenberg WM, Mutimer DJ, Du J, Gilbert CL, Asante-Appiah E, Wahl J, Robertson MN, Barr E, Haber B. Elbasvir/grazoprevir and sofosbuvir for hepatitis C virus genotype 3 infection with compensated cirrhosis: A randomized trial. Hepatology. 2018 Jun;67(6):2113-2126. doi: 10.1002/hep.29852. Epub 2018 Apr 19.
Other Identifiers
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2015-003187-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MK-5172-083
Identifier Type: OTHER
Identifier Source: secondary_id
5172-083
Identifier Type: -
Identifier Source: org_study_id
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