GS-7977 + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 HCV Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon - Full Text View

Purpose

GS7977 in combination with ribavirin(RBV) administered for 12 weeks is safe and effective in patients with Hepatitis C (HCV) genotype 2 or 3 (GT-2 or GT-3) as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12)

Condition	Intervention	Phase
Chronic Hepatitis C	Drug: GS-7977 in combination with ribavirin Drug: GS 7977 placebo in combination with RBV placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 HCV Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon Ribavirin

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:

Efficacy 12 weeks post dosing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The proportion of patients with a sustained virologic response (SVR) 12 weeks after the end of treatment
Description of Safety with GS-7977 and ribavirin [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
The safety and tolerability of GS 7977 + RBV compared to placebo

Secondary Outcome Measures:

Efficacy 4 and 24 weeks post dosing [ Time Frame: 4 weeks and 24 weeks ] [ Designated as safety issue: No ]
To determine the proportion of subjects who attain SVR at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24)
Amount of circulating HCV RNA [ Time Frame: 12 weeks post dosing ] [ Designated as safety issue: No ]
To evaluate the kinetics of circulating HCV RNA during treatment and after treatment discontinuation
Characterization of viral resistance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
To evaluate the emergence of viral resistance to GS 7977 during treatment and after treatment discontinuation

Enrollment:	280
Study Start Date:	March 2012
Estimated Study Completion Date:	February 2013
Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Sugar pill GS 7977 placebo 400 mg QD + RBV placebo BID	Drug: GS 7977 placebo in combination with RBV placebo GS 7977 placebo 400 mg QD + RBV placebo BID
Active Comparator: GS-7977 and ribavirin GS 7977 400 mg QD + RBV BID	Drug: GS-7977 in combination with ribavirin GS 7977 400 mg QD + RBV BID

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Infection with HCV GT 2 or 3
Cirrhosis determination
Subject meets one of the following classifications:
1. IFN unwilling
2. IFN ineligible
3. IFN intolerant
Screening laboratory values within defined thresholds
Subject has not been treated with any investigational drug or device within 30 days of the Screening visit
Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

Prior exposure to an direct-acting antiviral targeting the HCV NS5B polymerase
Pregnant or nursing female or male with pregnant female partner
Current or prior history of clinical hepatic decompensation
History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Excessive alcohol ingestion or significant drug abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01542788

Show 63 Study Locations

Sponsors and Collaborators

Gilead Sciences

More Information

No publications provided by Gilead Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M, Sulkowski MS, Shiffman ML, Lawitz E, Everson G, Bennett M, Schiff E, Al-Assi MT, Subramanian GM, An D, Lin M, McNally J, Brainard D, Symonds WT, McHutchison JG, Patel K, Feld J, Pianko S, Nelson DR. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med. 2013 May 16;368(20):1867-77. doi: 10.1056/NEJMoa1214854. Epub 2013 Apr 23.

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01542788 History of Changes
Other Study ID Numbers:	GS-US-334-0107
Study First Received:	February 17, 2012
Last Updated:	February 19, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

HCV genotype 2 (GT-2)
HCV genotype 3 (GT-3)
HCV
Sustained Virologic Response
Direct Acting Antiviral

Combination Therapy
Interferon intolerant
Interferon ineligible
GS-7977
Ribavirin

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections

RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013

GS-7977 + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 HCV Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon (POSITRON)