Efficacy and Safety of Combination Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Sofosbuvir + Pegylated Interferon + Ribavirin in Hepatitis C Virus Genotype 1, 4 or 6 Infection (MK-5172-077)

PHASE3CompletedINTERVENTIONAL
Enrollment

257

Participants

Timeline

Start Date

February 27, 2015

Primary Completion Date

November 26, 2015

Study Completion Date

February 16, 2016

Conditions
Hepatitis C
Interventions
DRUG

Sofosbuvir

400 mg tablets, taken orally (PO) every day (QD) for 12 weeks.

BIOLOGICAL

PegIntron

PegIntron administered subcutaneously every week (QW) at 1.5 mcg/kg for 12 weeks.

DRUG

Ribavirin

Capsule and/or tablet administered PO twice daily (BID) based on weight (1000 - 1200 mg) for 12 weeks.

DRUG

Grazoprevir/Elbasvir (100 mg/50 mg) FDC

Grazoprevir/Elbasvir (100 mg/50 mg) FDC, taken PO QD for 12 weeks.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02358044 - Efficacy and Safety of Combination Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Sofosbuvir + Pegylated Interferon + Ribavirin in Hepatitis C Virus Genotype 1, 4 or 6 Infection (MK-5172-077) | Biotech Hunter | Biotech Hunter