Efficacy and Safety Study of GS-9256 and GS-9190 Alone and in Combination With Ribavirin for 28 Days in Patients With Chronic Hepatitis C Virus Infection

NCT01072695 | Completed Phase 2

• 1 other identifier: GS-US-196-0112
• Study Type: interventional
• Target: 46
• Locations: 4 countries
• Sites: 12

Brief Summary

This a phase 2, randomized, open-label trial of GS-9256 plus GS-9190, two oral anti HCV drugs, for 28 days with and without ribavirin (RIBA) and with pegylated interferon (PEG)/RIBA in adults with chronic Hepatitis C virus (HCV). In Part A, approximately thirty (30) subjects 18-70 years of age who meet study entry criteria will be randomized (in other words, selected at random, like flipping a coin) to one of the two treatment groups (GS-9256 plus GS-9190 or GS-9256 plus GS-9190 plus RIBA). In Part B, an additional fifteen (15) subjects will receive 75 mg GS-9256 BID plus 40 mg GS-9190 BID in combination with PEG/RIBA. After the 28-day treatment period, subjects will receive PEG/RIBA as standard of care (SOC). Following randomization, subjects will return for a Baseline (Day 1) visit, at which time study medication will be dispensed and subjects will enter a 28 day treatment phase. During the treatment phase, subjects will receive oral study drugs twice daily for 28 days and PEG once weekly for Part B. Subjects then receive PEG/RIBA as local SOC starting on Day 28 (not provided as part of the study). Following completion of the 28-day treatment phase, subjects will be followed for approximately 72 weeks.

Conditions

HCV Infection

Keywords

Hepatitis C; HCV; GS-9256; GS-9190; Genotype 1

Outcome Measures

Primary Outcomes (2)

• Percentage of subjects achieving rapid virologic response (RVR)

  Day 28

• AEs, physical examination and clinical laboratory test findings, vital signs, ECGs

  Throughout first six weeks of study

Secondary Outcomes (2)

• Plasma pharmacokinetics

  Throughout Day 28

• Viral resistance

  Throughout study

Study Arms (3)

Arm 1

EXPERIMENTAL

Drug: GS-9256; Drug: GS-9190

Arm 2

EXPERIMENTAL

Drug: GS-9256; Drug: GS-9190; Drug: Ribavirin

Arm 3

EXPERIMENTAL

Drug: GS-9256; Drug: GS-9190; Drug: Ribavirin; Drug: Peginterferon alfa-2a

Interventions

GS-9256 DRUG

75 mg BID x 28 days

Arm 1; Arm 2; Arm 3

GS-9190 DRUG

40 mg BID x 28 days

Arm 1; Arm 2; Arm 3

Ribavirin DRUG

1000-1200 mg/day given BID

Also known as: COPEGUS

Arm 2; Arm 3

Peginterferon alfa-2a DRUG

180 ug q week

Also known as: Pegasys

Arm 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects, ages 18-70
• Willing able to provide informed consent
• BMI between 18 and 36 kg/m2 (inclusive)
• Chronic HCV infection, genotype 1
• HCV RNA \>/= 3 log, but \< 7.2 log10 IU/ml at screen
• Liver biopsy, FibroTest, or FibroScan indicating absence of cirrhosis
• HCV treatment naïve with imminent plans to start treatment with PEG/RIBA
• QTcF \</= 450 msec at screen
• ALT, AST, GGT \< 5 X ULN at the screening visit
• Creatinine clearance \>= 50 mL/min
• Absolute neutrophil count \>= 1500/mm3
• Hemoglobin \>/= 12 g/dL (female), \>/= 13 g/dL (male)
• Males agree to use of effective contraception and refrain from sperm donation
• Able to comply with dosing instructions and study visits
• Of generally good health

You may not qualify if:

• Females of child-bearing potential or males with female partners who are pregnant or planning to become pregnant
• Infection with other HCV genotype or multiple HCV genotypes
• Poorly controlled diabetes
• Hemoglobinopathy or known retinal disease
• History of sarcoidosis or invasive malignancy
• Untreated or significant psychiatric illness
• Co-infection with hepatitis B virus or human immunodeficiency virus
• Chronic use of systemic immunosuppressive agents
• Autoimmune disorders
• Severe COPD
• History of significant cardiac disease
• Known cirrhosis
• Non-HCV chronic liver disease
• Transplantation
• Suspicion of hepatocellular carcinoma

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (12)

Unknown Facility

Brussels, 1070, Belgium

Location

Unknown Facility

Brussels, 1200, Belgium

Location

Unknown Facility

Clichy, 92110, France

Location

Unknown Facility

La Tronche, 38700, France

Location

Unknown Facility

Paris, 75475, France

Location

Unknown Facility

Düsseldorf, 40237, Germany

Location

Unknown Facility

Frankfurt, 60590, Germany

Location

Unknown Facility

Hamburg, 20099, Germany

Location

Unknown Facility

Hanover, 30625, Germany

Location

Unknown Facility

Würzburg, 97080, Germany

Location

Unknown Facility

London, E1 2AT, United Kingdom

Location

Unknown Facility

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

GS-9256; tegobuvir; Ribavirin; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Juan Betular

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2010
• First Posted: February 22, 2010
• Study Start: February 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: January 1, 2012
• Last Updated: May 31, 2012

Record last verified: 2012-05

Locations

BE (2); FR (3); DE (5); GB (2)