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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT01604850

First received: May 21, 2012

Last updated: May 9, 2014

Last verified: May 2014

History of Changes

Results First Received: March 31, 2014

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
Condition:	Chronic Hepatitis C
Interventions:	Drug: SOF Drug: RBV Drug: Placebo to match SOF Drug: Placebo to match RBV

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled in a total of 57 study sites in the United States, Canada, and New Zealand. The first participant was screened on 04 June 2012. The last participant observation was on 08 May 2013.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
277 participants were screened and 202 were randomized. Of those participants randomized, 201 received at least one dose of study drug, and comprise the Safety Analysis Set; 195 of those participants with genotypes 2 or 3 HCV infection were treated and comprise the Full Analysis Set.

Reporting Groups

	Description
SOF+RBV+Placebo	Participants were randomized to receive sofosbuvir (SOF)+ribavirin (RBV) for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks. Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets.
SOF+RBV	Participants were randomized to receive sofosbuvir+RBV for 16 weeks. Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets.

Description

SOF+RBV+Placebo

Participants were randomized to receive sofosbuvir (SOF)+ribavirin (RBV) for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.

Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets.

SOF+RBV

Participants were randomized to receive sofosbuvir+RBV for 16 weeks.

Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets.

Participant Flow: Overall Study

	SOF+RBV+Placebo	SOF+RBV
STARTED	103	99
Enrolled and Treated	103	98
COMPLETED	51	69
NOT COMPLETED	52	30
Enrolled but never treated	0	1
Efficacy Failure	50	29
Lost to Follow-up	1	0
Subject withdrew consent	1	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants in the Safety Analysis Set (randomized and received at least 1 dose of study drug) were analyzed for baseline characteristics.

Reporting Groups

	Description
SOF+RBV+Placebo	Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks. Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets.
SOF+RBV	Participants were randomized to receive sofosbuvir+RBV for 16 weeks. Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets.
Total	Total of all reporting groups

Description

SOF+RBV+Placebo

Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.

Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets.

SOF+RBV

Participants were randomized to receive sofosbuvir+RBV for 16 weeks.

Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets.

Total

Total of all reporting groups

Baseline Measures

	SOF+RBV+Placebo	SOF+RBV	Total
Number of Participants [units: participants]	103	98	201
Age [units: years] Mean (Standard Deviation)	54 (7.7)	54 (7.8)	54 (7.8)
Gender [units: participants]
Female	30	31	61
Male	73	67	140
Race/Ethnicity, Customized [units: participants]
Black or African American	5	1	6
White	88	86	174
Asian	7	5	12
American Indian/ Alaska Native/ First Nations	1	3	4
Hawaiian or Pacific Islander	0	1	1
Other	2	2	4
Region of Enrollment [units: participants]
United States	74	76	150
Canada	26	17	43
New Zealand	3	5	8
Hepatitis C Virus (HCV) genotype [units: participants]
Genotype 1	3	3	6
Genotype 2	36	32	68
Genotype 3	64	63	127
HCV RNA [units: log10 IU/mL] Mean (Standard Deviation)	6.5 (0.67)	6.5 (0.63)	6.5 (0.65)
HCV RNA Category [units: participants]
< 6 log10 IU/mL	26	29	55
≥ 6 log10 IU/mL	77	69	146
IL28 Genotype ^[1] [units: participants]
CC	31	30	61
CT	53	56	109
TT	19	12	31
Cirrhosis (Y/N) [units: participants]
No	66	66	132
Yes	36	32	68
Missing	1	0	1
Response to Prior HCV Treatment [units: participants]
Nonresponse	25	25	50
Relapse/Breakthrough	78	73	151

[1]	CC, CT, and TT alleles are different forms of the IL28b gene.

Outcome Measures

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1. Primary:

Percentage of Participants Achieving SVR12 [ Time Frame: Posttreatment Week 12 ]

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2. Primary:

Adverse Events Leading to Permanent Discontinuation of Study Drug [ Time Frame: Baseline to Week 16 ]

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3. Secondary:

Percentage of Participants Achieving SVR4 [ Time Frame: Posttreatment Week 4 ]

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4. Secondary:

Percentage of Participants Achieving SVR24 [ Time Frame: Posttreatment Week 24 ]

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5. Secondary:

Percentage of Participants With Viral Breakthrough [ Time Frame: Up to 16 weeks ]

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6. Secondary:

Percentage of Participants With Viral Relapse [ Time Frame: End of treatment to posttreatment Week 24 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years

Results Point of Contact:

Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
e-mail: ClinicalTrialDisclosures@gilead.com

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

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.

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.

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.

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01604850 History of Changes
Other Study ID Numbers:	GS-US-334-0108
Study First Received:	May 21, 2012
Results First Received:	March 31, 2014
Last Updated:	May 9, 2014
Health Authority:	United States: Food and Drug Administration

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