Safety and Efficacy of Vaniprevir (MK-7009) With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) in Treatment-Experienced Hepatitis C Virus (HCV) Participants (MK-7009-009)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 2

Conditions

Hepatitis C, Chronic

Treatments

Drug: Placebo (PBO)

Drug: Ribavirin (RBV)

Drug: Pegylated Interferon (Peg-IFN)

Drug: Vaniprevir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00704405

7009-009

2007_659 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC) participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of study therapy (SVR24).

Enrollment

285 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Has chronic HCV genotype 1 infection
Is treatment-experienced
For the non-cirrhotic population, has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma; for the cirrhotic population, has had a liver biopsy with evidence of cirrhosis and without evidence of hepatocellular carcinoma.

Exclusion criteria

Has not tolerated previous course peg-IFN and RBV
Is unlikely to tolerate at least 24 weeks of continuous therapy with Peg-IFN and RBV
Is co-infected with Human Immunodeficiency Virus (HIV) and/or hepatitis B
Consumes excessive amounts of alcohol
Has a history of drug or alcohol abuse
If female, participant is pregnant or breastfeeding
Has been in a clinical trail with an investigational drug in the last 30 days
Has used IFN/Peg-IFN and RBV in the last 3 months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

285 participants in 5 patient groups, including a placebo group

24-wk Vaniprevir 600 mg + Peg-IFN/RBV

Experimental group

Description:

Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) twice daily (b.i.d.) and Peg-IFN 180 mcg injection once weekly for 24 weeks.

Treatment:

Drug: Vaniprevir

Drug: Pegylated Interferon (Peg-IFN)

Drug: Ribavirin (RBV)

24-wk Vaniprevir 600 mg + 24-wk PBO + Peg-IFN/RBV

Experimental group

Description:

Vaniprevir 600 mg (total daily dose) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 24 weeks, followed by PBO and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for an additional 24 weeks.

Treatment:

Drug: Vaniprevir

Drug: Pegylated Interferon (Peg-IFN)

Drug: Placebo (PBO)

Drug: Ribavirin (RBV)

48-wk Vaniprevir 300 mg + Peg-IFN/RBV

Experimental group

Description:

Vaniprevir 300 mg (total daily dose, taken once daily \[q.d.\]) and RBV (1000 mg or 1200 mg total daily dose based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.

Treatment:

Drug: Vaniprevir

Drug: Pegylated Interferon (Peg-IFN)

Drug: Ribavirin (RBV)

48-wk Vaniprevir 600 mg + Peg-IFN/RBV

Experimental group

Description:

Vaniprevir 600 mg and RBV (1000 mg or 1200 mg based on body weight) b.i.d. and Peg-IFN 180 mcg injection once weekly for 48 weeks.

Treatment:

Drug: Vaniprevir

Drug: Pegylated Interferon (Peg-IFN)

Drug: Ribavirin (RBV)