Chronic Hepatitis CPhase 3FUSIONNCT01604850

Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)

A Phase 3 study testing SOF and RBV in people with Chronic Hepatitis C, run by Gilead Sciences at 67 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Hepatitis C
What is being tested?: SOF and RBV
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 202 participants
Where: 67 sitesin 4 countries
Study dates: Jun 2012to May 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Infection with HCV genotype 2 or 3
Had cirrhosis determination
Prior treatment failure
Screening laboratory values within defined thresholds
Subject had 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

Who cannot join

Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B 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 have interfered with subject treatment, assessment or compliance with the protocol
Excessive alcohol ingestion or significant drug abuse

Trial locations and contacts

67 sites in 4 countries.

Country

City, postcode or hospital

67 sites in 4 countries

United States51 sites

Texas Clinical Research Institute, LLC
Arlington, Texas, 76012
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, 28801
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309
University of Colorado
Aurora, Colorado, 80045
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, 70809
Comprehensive Clinical Research
Berlin, New Jersey, 08009
Binghamton Gastroenterology Associates
Binghamton, New York, 13903
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42101
SCTI Research Foundation
Coronado, California, 92118
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas, 75219
Duke University Medical Center
Durham, North Carolina, 27710
South Denver Gastroenterology, PC
Englewood, Colorado, 80113
Metropolitan Research
Fairfax, Virginia, 22031
Inova Fairfax Hospital Center for Liver Diseases
Falls Church, Virginia, 22042
University of Florida
Gainesville, Florida, 32610-0277
Gastro One
Germantown, Tennessee, 38138
ID Care
Hillsborough, New Jersey, 08844
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237
Borland-Groover Clinic Baptist
Jacksonville, Florida, 32256
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, 64131
Kaiser Permanente
Los Angeles, California, 90027
Peter J. Ruane, MD, Inc.
Los Angeles, California, 90036
Anthony Mills MD, Inc.
Los Angeles, California, 90069
Johns Hopkins University
Lutherville, Maryland, 21093
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060
University of Miami
Miami, Florida, 33136
Minnesota Gastroenterology, P.A.
Minneapolis, Minnesota, 55414
Nashville Gastrointestinal Specialists, Inc
Nashville, Tennessee, 37211
Advanced Research Institute
New Port Richey, Florida, 34653
Mount Sinai School of Medicine
New York, New York, 10029
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502
Henry Ford Health System
Novi, Michigan, 48377
Orlando Immunology Center (ACH)
Orlando, Florida, 32803-1851
Internal Medicine Specialists
Orlando, Florida, 32806
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University Gastroenterology
Providence, Rhode Island, 02905
The Miriam Hospital
Providence, Rhode Island, 02906
Bon Secours St. Mary's Hospital of Richmond, Inc.
Richmond, Virginia, 23226
Alamo Medical Research
San Antonio, Texas, 78215
UCSD Antiviral Research Center
San Diego, California, 92103
Medical Associates Research Group, Inc.
San Diego, California, 92123
Kaiser Permanente
San Diego, California, 92154
Quest Clinical Research
San Francisco, California, 94115
Southwest C.A.R.E. Center
Santa Fe, New Mexico, 87505
Virginia Mason Medical Center
Seattle, Washington, 98101
The Research Institute
Springfield, Massachusetts, 01105
Whitman Walker Clinic
Washington D.C., District of Columbia, 20009
South Florida Center of Gastroenterology, P.A.
Wellington, Florida, 33414
Digestive Health Specialists, PA
Winston-Salem, North Carolina, 27103

Other trials in United States

Canada12 sites

University of Calgary
Calgary, Alberta, T2N 4Z6
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
University of Alberta Hospital
Edmonton, Alberta, T6G 2X8
Hopital St. Luc
Montreal, Quebec, H2X 3J4
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Toronto Liver Centre
Toronto, Ontario, M6H 3M1
Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9
University of British Columbia
Vancouver, British Columbia, V6Z 2C9
(G.I.R.I.) Gastrointestinal Research Institute
Vancouver, British Columbia, V6Z 2K5
University of Manitoba Health Sciences Center
Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

New Zealand2 sites

Auckland Clinical Studies Limited
Auckland, 1640
Christchurch Hospital
Christchurch, 8011

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Puerto Rico2 sites

Clinical Research Puerto Rico Inc
San Juan, PR, 00909-1711
Fundacion De Investigacion De Diego
San Juan, PR, 00927

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About this study

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection

Conditions: Chronic Hepatitis C
Being tested: SOF, RBV, Placebo to match SOF, Placebo to match RBV
Keywords: HCV genotype 2 (GT-2), HCV genotype 3 (GT-3), HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, Treatment Experienced, GS-7977, Ribavirin
Medical subject headings: Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SOFDrug
Also called Sovaldi®, GS-7977, PSI-7977
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
RBVDrug
Ribavirin (RBV) tablets was administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Placebo to match SOFDrug
Placebo to match SOF was administered orally once daily.
Placebo to match RBVDrug
Placebo to match RBV was administered orally twice daily.

Study groups in NCT01604850
Study group	Role	What they receive
SOF+RBV+placebo	Experimental	Participants were randomized to receive SOF+RBV for 12 weeks followed by placebo to match SOF plus placebo to match RBV for 4 weeks. Receives: Drug: SOF; Drug: RBV; Drug: Placebo to match SOF; Drug: Placebo to match RBV
SOF+RBV	Experimental	Participants were randomized to receive SOF+RBV for 16 weeks. Receives: Drug: SOF; Drug: RBV

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Achieving SVR12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy.
For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Measured: Posttreatment Week 12
Adverse Events Leading to Permanent Discontinuation of Study Drug
Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment.
Measured: Baseline to Week 16

Secondary outcomes (4)

Percentage of Participants Achieving SVR4
SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy.
For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Measured: Posttreatment Week 4
Percentage of Participants Achieving SVR24
SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy.
For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Measured: Posttreatment Week 24
Percentage of Participants With Viral Breakthrough
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.
For the purposes of this efficacy analysis, assessments were made during active treatment (up to Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Measured: Up to 16 weeks
Percentage of Participants With Viral Relapse
Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Measured: End of treatment to posttreatment Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012May 2013

First posted24 May 2012 (estimated)
Study startJun 2012
Primary completionFeb 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 202 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01604850
Sponsor's protocol ID: GS-US-334-0108
Acronym: FUSION
Status last verified: May 2014
First submitted: 21 May 2012
Last updated: 28 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Puoti M, Orkin C, Hunt SL. Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes. J Infect Dis. 2015 Aug 1;212(3):367-77. doi: 10.1093/infdis/jiv005. Epub 2015 Jan 12.
PubMed 25583164
Stepanova M, Nader F, Cure S, Bourhis F, Hunt S, Younossi ZM. Patients' preferences and health utility assessment with SF-6D and EQ-5D in patients with chronic hepatitis C treated with sofosbuvir regimens. Aliment Pharmacol Ther. 2014 Sep;40(6):676-85. doi: 10.1111/apt.12880. Epub 2014 Jul 15.
PubMed 25040192
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; POSITRON Study; FUSION Study. 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.
PubMed 23607593

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection
ClinicalTrials.gov ID: NCT01604850
Acronym / sponsor ID: FUSION / GS-US-334-0108
Conditions: Chronic Hepatitis C
Keywords: HCV genotype 2 (GT-2), HCV genotype 3 (GT-3), HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, Treatment Experienced, GS-7977
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 202 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Feb 2013 (actual)
Study completion: May 2013 (actual)
First posted: 24 May 2012 (estimated)
Results: Posted 1 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
SOF+RBV+placebo	Experimental	Drug: SOF, Drug: RBV, Drug: Placebo to match SOF, Drug: Placebo to match RBVParticipants were randomized to receive SOF+RBV for 12 weeks followed by placebo to match SOF plus placebo to match RBV for 4 weeks.
SOF+RBV	Experimental	Drug: SOF, Drug: RBVParticipants were randomized to receive SOF+RBV for 16 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Infection with HCV genotype 2 or 3
Had cirrhosis determination
Prior treatment failure
Screening laboratory values within defined thresholds
Subject had not been treated with any investigational drug or device within 30 days of the screening visit

Key exclusion criteria (5 listed)

Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B 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 have interfered with subject treatment, assessment or compliance with the protocol
Excessive alcohol ingestion or significant drug abuse

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SOFAlso: Sovaldi®, GS-7977, PSI-7977Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.	Drug	SOF+RBV, SOF+RBV+placebo
RBVRibavirin (RBV) tablets was administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).	Drug	SOF+RBV, SOF+RBV+placebo
Placebo to match SOFPlacebo to match SOF was administered orally once daily.	Drug	SOF+RBV+placebo
Placebo to match RBVPlacebo to match RBV was administered orally twice daily.	Drug	SOF+RBV+placebo

Primary outcome

Percentage of Participants Achieving SVR12
Time frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Adverse Events Leading to Permanent Discontinuation of Study Drug
Time frame: Baseline to Week 16
Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment.

4 secondary outcomes

Percentage of Participants Achieving SVR4
Time frame: Posttreatment Week 4
Percentage of Participants Achieving SVR24
Time frame: Posttreatment Week 24
Percentage of Participants With Viral Breakthrough
Time frame: Up to 16 weeks
Percentage of Participants With Viral Relapse
Time frame: End of treatment to posttreatment Week 24

Results and safety

Results posted to the registry on 1 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SOF+RBV+Placebo	103	51
SOF+RBV	99	69

Primary outcome: Percentage of Participants Achieving SVR12

Time frame: Posttreatment Week 12. Number. Unit: percentage of participants

Measure	SOF+RBV+Placebo n = 100	SOF+RBV n = 95
Value	51.0	72.6

SOF+RBV+Placebo vs SOF+RBV: Proportion difference: -22.4 (95% CI -34.4 to -10.3), p < 0.001, Cochran-Mantel-Haenszel

Population analysed: The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug.

Primary outcome: Adverse Events Leading to Permanent Discontinuation of Study Drug

Time frame: Baseline to Week 16. Number. Unit: participants

Measure	SOF+RBV+Placebo n = 103	SOF+RBV n = 98
Value	1	0

Population analysed: The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to posttreatment Week 24 plus 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SOF+RBV+Placebo	5 of 103 (4.9%)	92 of 103 (89.3%)	Not reported
SOF+RBV	3 of 98 (3.1%)	86 of 98 (87.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25583164Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Puoti M, Orkin C, Hunt SL. Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes. J Infect Dis. 2015 Aug 1;212(3):367-77. doi: 10.1093/infdis/jiv005. Epub 2015 Jan 12.
Derived from this study: PubMed 25040192Stepanova M, Nader F, Cure S, Bourhis F, Hunt S, Younossi ZM. Patients' preferences and health utility assessment with SF-6D and EQ-5D in patients with chronic hepatitis C treated with sofosbuvir regimens. Aliment Pharmacol Ther. 2014 Sep;40(6):676-85. doi: 10.1111/apt.12880. Epub 2014 Jul 15.
Derived from this study: PubMed 23607593Jacobson 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; POSITRON Study; FUSION Study. 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.

Related trials for Chronic Hepatitis C

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RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
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Active, not recruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

67 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SOF and RBV in people with Chronic Hepatitis C, run by Gilead Sciences at 67 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Canada, New Zealand, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving SVR12 (time frame: Posttreatment Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01604850, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2014.