Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection

Safety, Antiviral Effect and Pharmacokinetics of BI 207127 in Combination With BI 201335 and With or Without Ribavirin for 4, 16, 24, 28 or 40 Weeks in Patients With Chronic HCV Genotype 1 Infection (Randomized Phase Ib/II)

The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating.

The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV.

A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa.

This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and Part 3.

Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated: 362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83 patients randomized and treated)

Study Overview

• Status: Completed
• Conditions: Hepatitis C, Chronic
• Intervention / Treatment: Drug: BI 207127; Drug: BI 201335; Drug: BI 207127; Drug: BI 201335; Drug: Ribavirin; Drug: Ribavirin; Drug: BI 207127; Drug: BI 207127; Drug: BI 207127; Drug: Ribavirin; Drug: Ribavirin; Drug: BI 207127; Drug: BI 201335; Drug: BI 201335; Drug: Ribavirin; Drug: BI 207127; Drug: BI 207127; Drug: BI 207127; Drug: BI 207127; Drug: BI 207217

• Study Type: Interventional
• Enrollment (Actual): 488
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Heidelberg, Victoria, Australia
      • 1241.21.61002 Boehringer Ingelheim Investigational Site
    • Melbourne, Victoria, Australia
      • 1241.21.61001 Boehringer Ingelheim Investigational Site
• Austria
  • Linz, Austria
    • 1241.21.43003 Boehringer Ingelheim Investigational Site
  • Wien, Austria
    • 1241.21.43001 Boehringer Ingelheim Investigational Site
  • Wien, Austria
    • 1241.21.43002 Boehringer Ingelheim Investigational Site
• France
  • Clichy, France
    • 1241.21.33005 Boehringer Ingelheim Investigational Site
  • Grenoble cédex 9, France
    • 1241.21.33007 Boehringer Ingelheim Investigational Site
  • Lyon, France
    • 1241.21.33003 Boehringer Ingelheim Investigational Site
  • Marseille, France
    • 1241.21.33001 Boehringer Ingelheim Investigational Site
  • Montpellier, France
    • 1241.21.33002 Boehringer Ingelheim Investigational Site
  • Paris, France
    • 1241.21.33004 Boehringer Ingelheim Investigational Site
  • Paris, France
    • 1241.21.33008 Boehringer Ingelheim Investigational Site
  • Vandoeuvre Cedex, France
    • 1241.21.33006 Boehringer Ingelheim Investigational Site
• Germany
  • Berlin, Germany
    • 1241.21.49002 Boehringer Ingelheim Investigational Site
  • Berlin, Germany
    • 1241.21.49003 Boehringer Ingelheim Investigational Site
  • Düsseldorf, Germany
    • 1241.21.49007 Boehringer Ingelheim Investigational Site
  • Esslingen, Germany
    • 1241.21.49005 Boehringer Ingelheim Investigational Site
  • Frankfurt am Main, Germany
    • 1241.21.49001 Boehringer Ingelheim Investigational Site
  • Hamburg, Germany
    • 1241.21.49006 Boehringer Ingelheim Investigational Site
  • Hannover, Germany
    • 1241.21.49009 Boehringer Ingelheim Investigational Site
  • Leipzig, Germany
    • 1241.21.49004 Boehringer Ingelheim Investigational Site
  • Mainz, Germany
    • 1241.21.49008 Boehringer Ingelheim Investigational Site
• New Zealand
  • Auckland NZ, New Zealand
    • 1241.21.64001 Boehringer Ingelheim Investigational Site
• Portugal
  • Aveiro, Portugal
    • 1241.21.35103 Boehringer Ingelheim Investigational Site
  • Coimbra, Portugal
    • 1241.21.35104 Boehringer Ingelheim Investigational Site
  • Lisboa, Portugal
    • 1241.21.35101 Boehringer Ingelheim Investigational Site
  • Lisboa, Portugal
    • 1241.21.35105 Boehringer Ingelheim Investigational Site
  • Porto, Portugal
    • 1241.21.35102 Boehringer Ingelheim Investigational Site
• Romania
  • Bucharest, Romania
    • 1241.21.40001 Boehringer Ingelheim Investigational Site
  • Bucharest, Romania
    • 1241.21.40002 Boehringer Ingelheim Investigational Site
  • Bucharest, Romania
    • 1241.21.40003 Boehringer Ingelheim Investigational Site
• Spain
  • Barcelona, Spain
    • 1241.21.34002 Boehringer Ingelheim Investigational Site
  • Barcelona, Spain
    • 1241.21.34005 Boehringer Ingelheim Investigational Site
  • Madrid, Spain
    • 1241.21.34003 Boehringer Ingelheim Investigational Site
  • Madrid, Spain
    • 1241.21.34004 Boehringer Ingelheim Investigational Site
  • Majadahonda-Madrid, Spain
    • 1241.21.34001 Boehringer Ingelheim Investigational Site
  • Valencia, Spain
    • 1241.21.34006 Boehringer Ingelheim Investigational Site
• Switzerland
  • Basel, Switzerland
    • 1241.21.41003 Boehringer Ingelheim Investigational Site
  • Bern, Switzerland
    • 1241.21.41006 Boehringer Ingelheim Investigational Site
  • St. Gallen, Switzerland
    • 1241.21.41001 Boehringer Ingelheim Investigational Site
  • Zürich, Switzerland
    • 1241.21.41002 Boehringer Ingelheim Investigational Site
• United States
  • California
    • La Jolla, California, United States
      • 1241.21.0003 Boehringer Ingelheim Investigational Site
    • San Diego, California, United States
      • 1241.21.0006 Boehringer Ingelheim Investigational Site
    • San Francisco, California, United States
      • 1241.21.0004 Boehringer Ingelheim Investigational Site
  • Florida
    • Palm Harbor, Florida, United States
      • 1241.21.0011 Boehringer Ingelheim Investigational Site
  • Indiana
    • Valparaiso, Indiana, United States
      • 1241.21.0013 Boehringer Ingelheim Investigational Site
  • Massachusetts
    • Springfield, Massachusetts, United States
      • 1241.21.0008 Boehringer Ingelheim Investigational Site
  • North Carolina
    • Fayetteville, North Carolina, United States
      • 1241.21.0019 Boehringer Ingelheim Investigational Site
  • Texas
    • Arlington, Texas, United States
      • 1241.21.0012 Boehringer Ingelheim Investigational Site
    • Austin, Texas, United States
      • 1241.21.0005 Boehringer Ingelheim Investigational Site
    • Dallas, Texas, United States
      • 1241.21.0007 Boehringer Ingelheim Investigational Site
    • Houston, Texas, United States
      • 1241.21.0010 Boehringer Ingelheim Investigational Site
  • Washington
    • Seattle, Washington, United States
      • 1241.21.0017 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Chronic hepatitis C virus (HCV) infection of genotype (GT) 1
• Parts 1-3:Treatment naive to Interferon -alfa (IFN), Pegylated interferon -alfa (PegIFN), ribavirin (RBV), and any direct acting antiviral agent for chronic hepatitis C
• Part 4: Treatment experienced with confirmed prior virological failure to an approved dose of PegIFN/RBV (null-response)
• HCV RNA >=10,000 IU/mL at screening
• Liver biopsy within two years or fibroscan within six months prior to baseline
• Liver biopsy within two years or fibroscan within 6 months prior to screening
• Age 18-75 years

Exclusion criteria:

• Hepatitis C virus (HCV) infection of mixed genotype
• Evidence of liver disease due to causes other than chronic HCV infection
• Positive ELISA for human immunodeficiency virus (HIV)
• Hepatitis B virus (HBV) infection
• Decompensated liver disease or history of decompensated liver disease
• Active or suspected malignancy within the last 5 years
• Ongoing or historical photosensitivity or recurrent rash
• History of alcohol or drug abuse (except cannabis) within the past 12 months
• Body mass index (BMI)I <18 or > 35 kg/m2
• Usage of any investigational drugs within 30 days prior to enrolment, or 5 half-lives, whichever is longer; o the planned usage of an investigational drug during the course of the current study
• Known hypersensitivity to any ingredient of the study drugs
• A condition that is defined as one which in the opinion of the investigator may interfere with the patient's capability for participation in the trial or may influence the results of the trial
• Alpha fetoprotein >100ng/mL at screening; if >20ng/mL and <=100ng/mL, patients can be included if there is no evidence of liver cancer in an appropriate imaging study within 6 months prior to randomisation
• Total bilirubin > 2 mg/dL with ratio of direct/indirect > 1
• AST or ALT >5xULN
• INR prolonged to >1.7xULN
• Requirement for chronic systemic corticosteroids
• Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to enrolment or 5 half-lives, whichever is longer
• Received silymarin or glycyrrhizin or Sho-saiko-to within 30 days prior to enrolment
• Contraindications pertaining to PegIFN or RBV

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2; 4 weeks of high dose TID BI 207127 and QD BI 201335 in combination with RBV, Part 1	Drug: BI 207127; 28 weeks, high dose, TID; Drug: BI 201335; 40 weeks, QD; Drug: BI 207127; 4 weeks, low dose TID; Drug: BI 201335; 24 weeks, QD; Drug: Ribavirin; 16 weeks, according to label; Drug: Ribavirin; 28 weeks, according to label; Drug: BI 207127; 40 weeks, high dose, TID; Drug: BI 207127; 24 weeks, very high dose, BID; Drug: BI 207127; 16 weeks, standard dose, BID; Drug: Ribavirin; 48 weeks, according to label; Drug: Ribavirin; 40 weeks, according to label; Drug: BI 207127; 16 weeks, high dose, TID; Drug: BI 201335; 28 weeks, QD; Drug: BI 201335; 16 weeks, QD; Drug: Ribavirin; 24 weeks, according to label; Drug: BI 207127; 24 weeks, standard dose, BID; Drug: BI 207127; 16 weeks, high dose, BID; Drug: BI 207127; 24 weeks, high dose, TID; Drug: BI 207127; 4 weeks, high dose, TID
Experimental: 1; 4 weeks of low dose three times per day (TID) BI 207127 and once daily (QD) BI 201335 in combination with RBV, Part 1	Drug: BI 207127; 28 weeks, high dose, TID; Drug: BI 201335; 40 weeks, QD; Drug: BI 207127; 4 weeks, low dose TID; Drug: BI 201335; 24 weeks, QD; Drug: Ribavirin; 16 weeks, according to label; Drug: Ribavirin; 28 weeks, according to label; Drug: BI 207127; 40 weeks, high dose, TID; Drug: BI 207127; 24 weeks, very high dose, BID; Drug: BI 207127; 16 weeks, standard dose, BID; Drug: Ribavirin; 48 weeks, according to label; Drug: Ribavirin; 40 weeks, according to label; Drug: BI 207127; 16 weeks, high dose, TID; Drug: BI 201335; 28 weeks, QD; Drug: BI 201335; 16 weeks, QD; Drug: Ribavirin; 24 weeks, according to label; Drug: BI 207127; 24 weeks, standard dose, BID; Drug: BI 207127; 16 weeks, high dose, BID; Drug: BI 207127; 24 weeks, high dose, TID; Drug: BI 207127; 4 weeks, high dose, TID
Experimental: 3; 16 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2	Drug: BI 207127; 28 weeks, high dose, TID; Drug: BI 201335; 40 weeks, QD; Drug: BI 207127; 4 weeks, low dose TID; Drug: BI 201335; 24 weeks, QD; Drug: Ribavirin; 16 weeks, according to label; Drug: Ribavirin; 28 weeks, according to label; Drug: BI 207127; 40 weeks, high dose, TID; Drug: BI 207127; 24 weeks, very high dose, BID; Drug: BI 207127; 16 weeks, standard dose, BID; Drug: Ribavirin; 48 weeks, according to label; Drug: Ribavirin; 40 weeks, according to label; Drug: BI 207127; 16 weeks, high dose, TID; Drug: BI 201335; 28 weeks, QD; Drug: BI 201335; 16 weeks, QD; Drug: Ribavirin; 24 weeks, according to label; Drug: BI 207127; 24 weeks, standard dose, BID; Drug: BI 207127; 16 weeks, high dose, BID; Drug: BI 207127; 24 weeks, high dose, TID; Drug: BI 207127; 4 weeks, high dose, TID
Experimental: 4; 28 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2	Drug: BI 207127; 28 weeks, high dose, TID; Drug: BI 201335; 40 weeks, QD; Drug: BI 207127; 4 weeks, low dose TID; Drug: BI 201335; 24 weeks, QD; Drug: Ribavirin; 16 weeks, according to label; Drug: Ribavirin; 28 weeks, according to label; Drug: BI 207127; 40 weeks, high dose, TID; Drug: BI 207127; 24 weeks, very high dose, BID; Drug: BI 207127; 16 weeks, standard dose, BID; Drug: Ribavirin; 48 weeks, according to label; Drug: Ribavirin; 40 weeks, according to label; Drug: BI 207127; 16 weeks, high dose, TID; Drug: BI 201335; 28 weeks, QD; Drug: BI 201335; 16 weeks, QD; Drug: Ribavirin; 24 weeks, according to label; Drug: BI 207127; 24 weeks, standard dose, BID; Drug: BI 207127; 16 weeks, high dose, BID; Drug: BI 207127; 24 weeks, high dose, TID; Drug: BI 207127; 4 weeks, high dose, TID
Experimental: 5; 40 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2	Drug: BI 207127; 28 weeks, high dose, TID; Drug: BI 201335; 40 weeks, QD; Drug: BI 207127; 4 weeks, low dose TID; Drug: BI 201335; 24 weeks, QD; Drug: Ribavirin; 16 weeks, according to label; Drug: Ribavirin; 28 weeks, according to label; Drug: BI 207127; 40 weeks, high dose, TID; Drug: BI 207127; 24 weeks, very high dose, BID; Drug: BI 207127; 16 weeks, standard dose, BID; Drug: Ribavirin; 48 weeks, according to label; Drug: Ribavirin; 40 weeks, according to label; Drug: BI 207127; 16 weeks, high dose, TID; Drug: BI 201335; 28 weeks, QD; Drug: BI 201335; 16 weeks, QD; Drug: Ribavirin; 24 weeks, according to label; Drug: BI 207127; 24 weeks, standard dose, BID; Drug: BI 207127; 16 weeks, high dose, BID; Drug: BI 207127; 24 weeks, high dose, TID; Drug: BI 207127; 4 weeks, high dose, TID
Experimental: 6; 28 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 2	Drug: BI 201335; 40 weeks, QD; Drug: BI 201335; 24 weeks, QD; Drug: Ribavirin; 16 weeks, according to label; Drug: Ribavirin; 28 weeks, according to label; Drug: Ribavirin; 48 weeks, according to label; Drug: Ribavirin; 40 weeks, according to label; Drug: BI 201335; 28 weeks, QD; Drug: BI 201335; 16 weeks, QD; Drug: Ribavirin; 24 weeks, according to label; Drug: BI 207217; 28 weeks, high dose BID
Experimental: 7; 28 weeks of TID BI 207127 and QD BI 201335 without RBV, Part 2	Drug: BI 207127; 28 weeks, high dose, TID; Drug: BI 201335; 40 weeks, QD; Drug: BI 207127; 4 weeks, low dose TID; Drug: BI 201335; 24 weeks, QD; Drug: BI 207127; 40 weeks, high dose, TID; Drug: BI 207127; 24 weeks, very high dose, BID; Drug: BI 207127; 16 weeks, standard dose, BID; Drug: BI 207127; 16 weeks, high dose, TID; Drug: BI 201335; 28 weeks, QD; Drug: BI 201335; 16 weeks, QD; Drug: BI 207127; 24 weeks, standard dose, BID; Drug: BI 207127; 16 weeks, high dose, BID; Drug: BI 207127; 24 weeks, high dose, TID; Drug: BI 207127; 4 weeks, high dose, TID
Experimental: 8; 16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3	Drug: BI 207127; 28 weeks, high dose, TID; Drug: BI 201335; 40 weeks, QD; Drug: BI 207127; 4 weeks, low dose TID; Drug: BI 201335; 24 weeks, QD; Drug: Ribavirin; 16 weeks, according to label; Drug: Ribavirin; 28 weeks, according to label; Drug: BI 207127; 40 weeks, high dose, TID; Drug: BI 207127; 24 weeks, very high dose, BID; Drug: BI 207127; 16 weeks, standard dose, BID; Drug: Ribavirin; 48 weeks, according to label; Drug: Ribavirin; 40 weeks, according to label; Drug: BI 207127; 16 weeks, high dose, TID; Drug: BI 201335; 28 weeks, QD; Drug: BI 201335; 16 weeks, QD; Drug: Ribavirin; 24 weeks, according to label; Drug: BI 207127; 24 weeks, standard dose, BID; Drug: BI 207127; 16 weeks, high dose, BID; Drug: BI 207127; 24 weeks, high dose, TID; Drug: BI 207127; 4 weeks, high dose, TID
Experimental: 9; 24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3	Drug: BI 207127; 28 weeks, high dose, TID; Drug: BI 201335; 40 weeks, QD; Drug: BI 207127; 4 weeks, low dose TID; Drug: BI 201335; 24 weeks, QD; Drug: Ribavirin; 16 weeks, according to label; Drug: Ribavirin; 28 weeks, according to label; Drug: BI 207127; 40 weeks, high dose, TID; Drug: BI 207127; 24 weeks, very high dose, BID; Drug: BI 207127; 16 weeks, standard dose, BID; Drug: Ribavirin; 48 weeks, according to label; Drug: Ribavirin; 40 weeks, according to label; Drug: BI 207127; 16 weeks, high dose, TID; Drug: BI 201335; 28 weeks, QD; Drug: BI 201335; 16 weeks, QD; Drug: Ribavirin; 24 weeks, according to label; Drug: BI 207127; 24 weeks, standard dose, BID; Drug: BI 207127; 16 weeks, high dose, BID; Drug: BI 207127; 24 weeks, high dose, TID; Drug: BI 207127; 4 weeks, high dose, TID
Experimental: 10; 24 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 3	Drug: BI 207127; 28 weeks, high dose, TID; Drug: BI 201335; 40 weeks, QD; Drug: BI 207127; 4 weeks, low dose TID; Drug: BI 201335; 24 weeks, QD; Drug: Ribavirin; 16 weeks, according to label; Drug: Ribavirin; 28 weeks, according to label; Drug: BI 207127; 40 weeks, high dose, TID; Drug: BI 207127; 24 weeks, very high dose, BID; Drug: BI 207127; 16 weeks, standard dose, BID; Drug: Ribavirin; 48 weeks, according to label; Drug: Ribavirin; 40 weeks, according to label; Drug: BI 207127; 16 weeks, high dose, TID; Drug: BI 201335; 28 weeks, QD; Drug: BI 201335; 16 weeks, QD; Drug: Ribavirin; 24 weeks, according to label; Drug: BI 207127; 24 weeks, standard dose, BID; Drug: BI 207127; 16 weeks, high dose, BID; Drug: BI 207127; 24 weeks, high dose, TID; Drug: BI 207127; 4 weeks, high dose, TID
Experimental: 11; 16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4	Drug: BI 207127; 28 weeks, high dose, TID; Drug: BI 201335; 40 weeks, QD; Drug: BI 207127; 4 weeks, low dose TID; Drug: BI 201335; 24 weeks, QD; Drug: Ribavirin; 16 weeks, according to label; Drug: Ribavirin; 28 weeks, according to label; Drug: BI 207127; 40 weeks, high dose, TID; Drug: BI 207127; 24 weeks, very high dose, BID; Drug: BI 207127; 16 weeks, standard dose, BID; Drug: Ribavirin; 48 weeks, according to label; Drug: Ribavirin; 40 weeks, according to label; Drug: BI 207127; 16 weeks, high dose, TID; Drug: BI 201335; 28 weeks, QD; Drug: BI 201335; 16 weeks, QD; Drug: Ribavirin; 24 weeks, according to label; Drug: BI 207127; 24 weeks, standard dose, BID; Drug: BI 207127; 16 weeks, high dose, BID; Drug: BI 207127; 24 weeks, high dose, TID; Drug: BI 207127; 4 weeks, high dose, TID
Experimental: 12; 24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4	Drug: BI 207127; 28 weeks, high dose, TID; Drug: BI 201335; 40 weeks, QD; Drug: BI 207127; 4 weeks, low dose TID; Drug: BI 201335; 24 weeks, QD; Drug: Ribavirin; 16 weeks, according to label; Drug: Ribavirin; 28 weeks, according to label; Drug: BI 207127; 40 weeks, high dose, TID; Drug: BI 207127; 24 weeks, very high dose, BID; Drug: BI 207127; 16 weeks, standard dose, BID; Drug: Ribavirin; 48 weeks, according to label; Drug: Ribavirin; 40 weeks, according to label; Drug: BI 207127; 16 weeks, high dose, TID; Drug: BI 201335; 28 weeks, QD; Drug: BI 201335; 16 weeks, QD; Drug: Ribavirin; 24 weeks, according to label; Drug: BI 207127; 24 weeks, standard dose, BID; Drug: BI 207127; 16 weeks, high dose, BID; Drug: BI 207127; 24 weeks, high dose, TID; Drug: BI 207127; 4 weeks, high dose, TID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Rapid Virological Response (RVR)	Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) <25IU/mL at Week 4 of treatment	4 weeks
Part 2: Sustained Virological Response (SVR)	Part 2: Sustained virological response (SVR), defined as HCV RNA <25 IU/mL and undetectable at 12 weeks after end of treatment	From drug administration until 12 weeks after end of treatment, up to 52 weeks
Part 3 and 4: Sustained Virological Response (SVR)	Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA <25IU/mL and undetectable at 12 weeks after end of treatment	From drug administration until 12 weeks after end of treatment, up to 36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Time to Virological Response	Part 1: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.	From drug administration until end of drug administration, up to 4 weeks
Part 2: Time to Virological Response	Part 2: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.	From drug administration until end of drug administration, up to 40 weeks
Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4	Part 1 and 2: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level not detectable at Week 4	4 weeks
Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment	Part 2: Sustained virological response at 4 and 24 weeks after end of treatment	4 weeks and 24 weeks after the end of treatment, up to 64 weeks
Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment	Part 3 and 4: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level <25 IU/mL at week 4 and 12 of treatment	Week 4 and 12
Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment	Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment	up to 28 weeks

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• Zeuzem S, Mantry P, Soriano V, Buynak RJ, Dufour JF, Pockros PJ, Wright D, Angus P, Buti M, Stern JO, Kadus W, Vinisko R, Bocher W, Mensa FJ. Short article: Faldaprevir, deleobuvir and ribavirin in IL28B non-CC patients with HCV genotype-1a infection included in the SOUND-C3 phase 2b study. Eur J Gastroenterol Hepatol. 2016 Aug;28(8):923-6. doi: 10.1097/MEG.0000000000000649.
• Asselah T, Zeuzem S, Soriano V, Bronowicki JP, Lohse AW, Mullhaupt B, Schuchmann M, Bourliere M, Buti M, Roberts SK, Gane EJ, Stern JO, Voss F, Baum P, Gallivan JP, Bocher WO, Mensa FJ. ITPA Genotypes Predict Anemia but Do Not Affect Virological Response with Interferon-Free Faldaprevir, Deleobuvir, and Ribavirin for HCV Infection. PLoS One. 2015 Dec 9;10(12):e0144004. doi: 10.1371/journal.pone.0144004. eCollection 2015.
• Zeuzem S, Soriano V, Asselah T, Gane EJ, Bronowicki JP, Angus P, Lohse AW, Stickel F, Mullhaupt B, Roberts S, Schuchmann M, Manns M, Bourliere M, Buti M, Stern JO, Gallivan JP, Voss F, Sabo JP, Bocher W, Mensa FJ; SOUND-C2 Study Group. Efficacy and safety of faldaprevir, deleobuvir, and ribavirin in treatment-naive patients with chronic hepatitis C virus infection and advanced liver fibrosis or cirrhosis. Antimicrob Agents Chemother. 2015 Feb;59(2):1282-91. doi: 10.1128/AAC.04383-14. Epub 2014 Dec 15.
• Zeuzem S, Soriano V, Asselah T, Bronowicki JP, Lohse AW, Mullhaupt B, Schuchmann M, Bourliere M, Buti M, Roberts SK, Gane EJ, Stern JO, Vinisko R, Kukolj G, Gallivan JP, Bocher WO, Mensa FJ. Faldaprevir and deleobuvir for HCV genotype 1 infection. N Engl J Med. 2013 Aug 15;369(7):630-9. doi: 10.1056/NEJMoa1213557.
• Zeuzem S, Asselah T, Angus P, Zarski JP, Larrey D, Mullhaupt B, Gane E, Schuchmann M, Lohse AW, Pol S, Bronowicki JP, Roberts S, Arasteh K, Zoulim F, Heim M, Stern JO, Nehmiz G, Kukolj G, Bocher WO, Mensa FJ. Faldaprevir (BI 201335), deleobuvir (BI 207127) and ribavirin oral therapy for treatment-naive HCV genotype 1: SOUND-C1 final results. Antivir Ther. 2013;18(8):1015-9. doi: 10.3851/IMP2567. Epub 2013 Apr 4.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: May 3, 2010
• First Submitted That Met QC Criteria: May 26, 2010
• First Posted (Estimate): May 28, 2010

Study Record Updates

• Last Update Posted (Estimate): February 1, 2016
• Last Update Submitted That Met QC Criteria: December 22, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Hepatitis C; Hepatitis C, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Ribavirin
• Other Study ID Numbers: 1241.21; 2009-018197-66 (EudraCT Number: EudraCT)