Phase 3 Study of Sofosbuvir and Ribavirin (FISSION)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Gilead Sciences

ClinicalTrials.gov Identifier:

NCT01497366

First received: December 19, 2011

Last updated: March 4, 2014

Last verified: March 2014

History of Changes

Results First Received: January 15, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Hepatitis C
Interventions:	Drug: Sofosbuvir Drug: PEG Drug: 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 90 study sites in the United States, Australia, New Zealand, Canada, Sweden, Italy, and the Netherlands. The first participant was screened on 19 December 2011. The last participant observation was on 08 April 2013.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
666 participants were screened and 527 were randomized; 499 participants received at least 1 dose of study drug, and comprise the Safety Analysis Set. The 496 participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug comprise the Full Analysis Set.

Reporting Groups

	Description
Sofosbuvir+RBV	Participants were randomized to receive sofosbuvir+ribavirin (RBV) for 12 weeks.
PEG+RBV	Participants were randomized to receive PEG+RBV for 24 weeks.

Participant Flow: Overall Study

	Sofosbuvir+RBV	PEG+RBV
STARTED	263	264
Randomized But Not Treated	7	21
COMPLETED	224	176
NOT COMPLETED	39	88
Virologic failure	2	50
Lost to Follow-up	11	10
Withdrawal by Subject	6	6
Initiated Non-protocol HCV Treatment	7	0
Other	5	0
Death	1	1
Randomized but not treated	7	21

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.
Safety Analysis Set

Reporting Groups

	Description
Sofosbuvir+RBV	Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
PEG+RBV	Participants were randomized to receive PEG+RBV for 24 weeks.
Total	Total of all reporting groups

Baseline Measures

	Sofosbuvir+RBV	PEG+RBV	Total
Overall Participants Analyzed [Units: Participants]	256	243	499

Age [Units: Years] Mean (Standard Deviation)	48 (10.8)	48 (11.4)	48 (11.0)

Gender [Units: Participants]
Female	85	87	172
Male	171	156	327

Ethnicity (NIH/OMB) [Units: Participants]
Hispanic or Latino	41	31	72
Not Hispanic or Latino	215	212	427
Unknown or Not Reported	0	0	0

Race/Ethnicity, Customized [Units: Participants]
Black or African American	12	5	17
White	223	212	435
Asian	14	15	29
American Indian/Alaska Native/First Nations	4	4	8
Hawaiian or Pacific Islander	2	6	8
Black and White	1	0	1
South American	0	1	1

Region of Enrollment [Units: Participants]
United States	165	151	316
Canada	15	24	39
Australia	32	29	61
Netherlands	3	1	4
Italy	8	4	12
New Zealand	29	30	59
Sweden	4	4	8

Hepatitis C Virus (HCV) genotype [Units: Participants]
Genotype 1	3	0	3
Genotype 2	70	67	137
Genotype 3	183	176	359

Baseline HCV RNA [Units: Log10 IU/mL] Mean (Standard Deviation)	6.0 (0.82)	6.0 (0.78)	6.0 (0.80)

Baseline HCV RNA Category [Units: Participants]
< 6 log10 IU/mL	108	106	214
≥ 6 log10 IU/mL	148	137	285

IL28b genotype [Units: Participants]
CC	108	106	214
CT	121	98	219
TT	25	38	63
Missing	2	1	3

Cirrhosis [Units: Participants]
No	205	189	394
Yes	50	50	100
Missing	1	4	5

Outcome Measures

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1. Primary:

Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12) [ Time Frame: Post-treatment Week 12 ]

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2. Secondary:

Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities [ Time Frame: Up to 24 weeks plus 30 days following the last dose of study drug ]

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3. Secondary:

Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24) [ Time Frame: Post-treatment Week 24 ]

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4. Secondary:

Percentage of Participants With HCV RNA < LLOQ on Treatment [ Time Frame: Up to 12 Weeks ]

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5. Secondary:

Change From Baseline in HCV RNA [ Time Frame: Baseline to Week 12 ]

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6. Secondary:

Percentage of Participants With Virologic Failure During Treatment [ Time Frame: Baseline up to Week 24 ]

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7. Secondary:

Percentage of Participants With Viral Relapse Following Treatment [ Time Frame: Up to Post-treatment 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):

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.

Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, Schultz M, Davis MN, Kayali Z, Reddy KR, Jacobson IM, Kowdley KV, Nyberg L, Subramanian GM, Hyland RH, Arterburn S, Jiang D, McNally J, Brainard D, Symonds WT, McHutchison JG, Sheikh AM, Younossi Z, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 May 16;368(20):1878-87. doi: 10.1056/NEJMoa1214853. Epub 2013 Apr 23.

Responsible Party:	Gilead Sciences
ClinicalTrials.gov Identifier:	NCT01497366 History of Changes
Other Study ID Numbers:	P7977-1231
Study First Received:	December 19, 2011
Results First Received:	January 15, 2014
Last Updated:	March 4, 2014

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