Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01359644
• Collaborator: Pharmasset (Industry)
• Enrollment: 350
• Locations: 18
• Arms: 10
• Duration (Months): 28
• Patients Per Site: 19.4
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C	Drug: PSI-7977; Drug: Daclatasvir; Drug: Ribavirin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination With BMS-790052 With or Without Ribavirin in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotypes 1, 2, or 3
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A: PSI-7977 + Daclatasvir Genotype 1a or 1b	Drug: PSI-7977; Tablets, oral, 400 mg, once daily; Drug: Daclatasvir; Tablets, oral, 60 mg, once daily; Other Names: BMS-790052
Experimental: Treatment B: PSI-7977 + Daclatasvir Genotype 2 or 3	Drug: PSI-7977; Tablets, oral, 400 mg, once daily; Drug: Daclatasvir; Tablets, oral, 60 mg, once daily; Other Names: BMS-790052
Experimental: Treatment C: PSI-7977 + Daclatasvir Genotype 1a or 1b	Drug: PSI-7977; Tablets, oral, 400 mg, once daily; Drug: Daclatasvir; Tablets, oral, 60 mg, once daily; Other Names: BMS-790052
Experimental: Treatment D: PSI-7977 + Daclatasvir Genotype 2 or 3	Drug: PSI-7977; Tablets, oral, 400 mg, once daily; Drug: Daclatasvir; Tablets, oral, 60 mg, once daily; Other Names: BMS-790052
Experimental: Treatment E: PSI-7977 + Daclatasvir + Ribavirin Genotype 1a or 1b	Drug: PSI-7977; Tablets, oral, 400 mg, once daily; Drug: Daclatasvir; Tablets, oral, 60 mg, once daily; Other Names: BMS-790052 ; Drug: Ribavirin; Tablets, oral, 200 mg; Other Names: Copegus ®
Experimental: Treatment F: PSI-7977 + Daclatasvir+ Ribavirin Genotype 2 or 3	Drug: PSI-7977; Tablets, oral, 400 mg, once daily; Drug: Daclatasvir; Tablets, oral, 60 mg, once daily; Other Names: BMS-790052 ; Drug: Ribavirin; Tablets, oral, 200 mg; Other Names: Copegus ®
Experimental: Treatment G: PSI-7977 + Daclatasvir Hepatitis C virus genotype 1, treatment-naive patients Genotype 1a or 1b	Drug: PSI-7977; Tablets, oral, 400 mg, once daily; Drug: Daclatasvir; Tablets, oral, 60 mg, once daily; Other Names: BMS-790052
Experimental: Treatment H: PSI-7977 + BMS-790052 + Ribavirin Hepatitis C virus genotype 1, treatment-naive patients Genotype 1a or 1b	Drug: PSI-7977; Tablets, oral, 400 mg, once daily; Drug: Daclatasvir; Tablets, oral, 60 mg, once daily; Other Names: BMS-790052 ; Drug: Ribavirin; Tablets, oral, 200 mg; Other Names: Copegus ®
Experimental: Treatment I: PSI-7977 + Daclatasvir Patients who experienced telaprevir/boceprevir treatment failure Genotype 1a or 1b	Drug: PSI-7977; Tablets, oral, 400 mg, once daily; Drug: Daclatasvir; Tablets, oral, 60 mg, once daily; Other Names: BMS-790052
Experimental: Treatment J: PSI-7977 + Daclatasvir + Ribavirin Patients who experienced telaprevir/boceprevir treatment failure Genotype 1a or 1b	Drug: PSI-7977; Tablets, oral, 400 mg, once daily; Drug: Daclatasvir; Tablets, oral, 60 mg, once daily; Other Names: BMS-790052 ; Drug: Ribavirin; Tablets, oral, 200 mg; Other Names: Copegus ®

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12) [Follow-up Week 12]

   SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA <25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir.

Secondary Outcome Measures

1. Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24) [Follow-up Week 24]

   SVR24 was defined as participant's hepatitis C virus RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 24. DCV=daclatasvir, SOF=sofosbuvir.

2. Percentage of Participants With Viral Breakthrough During the Treatment Period [First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)]

   Viral breakthrough is defined as any confirmed increase in viral load ≥1 log from nadir or any confirmed hepatitis C virus RNA levels ≥25 IU/mL on or after Week 8.

3. Percentage of Participants Who Experienced Viral Relapse During Follow-up Period [Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)]

   Viral relapse during follow-up is defined as any confirmed quantifiable hepatitis C virus (HCV) RNA ≥25 IU/mL with HCV RNA levels less than the lower limit of quantitation, target detected or target not detected, ie, HCV RNA <25 IU/mL at the end of treatment.

4. Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24 [Baseline, Follow-up week 24]

   Change from baseline in log10 HCV RNA at scheduled sampling time.

5. Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy [First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)]

   AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe.

6. Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period [AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)]

   AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Men and women, ages 18 to 70 years.

• Participants infected with hepatitis C virus (HCV) genotype 1, 2, or 3, with no previous exposure to an interferon formulation (ie, interferon-alpha, pegylated interferon-alpha) ribavirin, or other HCV-specific direct-acting antiviral (including daclatasvir and PSI-7977).

• Patients should have chronic hepatitis C genotype 1a, 1b, 2, or 3 as documented by: positive test results for anti-HCV antibody; HCV RNA; or a HCV genotype at least 6 months prior to screening, and HCV RNA and anti-HCV antibody at the time of screening.

Exclusion Criteria:

• Evidence of a medical condition associate with chronic liver disease other than HCV.

• History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis.

• History of hemophilia.

• History of torsade de pointes.

• Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment.

• History of gastrointestinal disease or surgical procedure (except cholecystectomy).

• History of clinically significant cardiac disease.

• Blood transfusion within 4 weeks prior to study drug administration.

• Poor venous access.

• Any other medical, psychiatric, and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern California Liver Centers	Coronado	California	United States	92118
2	Research And Education, Inc.	San Diego	California	United States	92105
3	University Of Colorado Denver & Hospital	Aurora	Colorado	United States	80045
4	University Of Florida Hepatology	Gainesville	Florida	United States	32610
5	Orlando Immunology Center	Orlando	Florida	United States	32803
6	Miami Research Associates	South Miami	Florida	United States	33143
7	Mercy Medical Center	Baltimore	Maryland	United States	21202
8	Johns Hopkins University	Lutherville	Maryland	United States	21093
9	University Of Michigan Health System	Ann Arbor	Michigan	United States	48109
10	Bronx Va Medical Center 3c Sub-J	Bronx	New York	United States	10468
11	Weill Cornell Medical College	New York	New York	United States	10021
12	Options Health Research, Llc	Tulsa	Oklahoma	United States	74104
13	Healthcare Research Consultants	Tulsa	Oklahoma	United States	74135
14	University Of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
15	Alamo Medical Research	San Antonio	Texas	United States	78215
16	Metropolitan Research	Annandale	Virginia	United States	22003
17	Dean Clinic	Madison	Wisconsin	United States	53715
18	Local Institution	San Juan		Puerto Rico	00927

Sponsors and Collaborators

• Bristol-Myers Squibb
• Pharmasset

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS clinical trial educational resource

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT01359644
• Other Study ID Numbers: AI444-040
• First Posted: May 25, 2011
• Last Update Posted: Oct 23, 2015
• Last Verified: Sep 1, 2015

• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Ribavirin; Sofosbuvir

Study Results

Participant Flow

Recruitment Details	The study was conducted at 18 centres in 2 countries.
Pre-assignment Detail	A total of 350 participants were enrolled, and 211 were randomized and received study drug.

Arm/Group Title	Treatment A: Sofosbuvir + Daclatasvir	Treatment B: Sofosbuvir + Daclatasvir	Treatment C: Sofosbuvir + Daclatasvir	Treatment D: Sofosbuvir + Daclatasvir	Treatment E: Sofosbuvir + Daclatasvir + Ribavirin	Treatment F: Sofosbuvir + Daclatasvir + Ribavirin	Treatment G: Sofosbuvir + Daclatasvir	Treatment H : Sofosbuvir + Daclatasvir + Ribavirin	Treatment I: Sofosbuvir + Daclatasvir	Treatment J: Sofosbuvir + Daclatasvir + Ribavirin
Arm/Group Description	Participants with hepatitis C virus (HCV) genotypes 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.	Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.	Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.	Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.	Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.	Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.	Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.	Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.	Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.	Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
Period Title: Treatment Period
STARTED	15	16	14	14	15	14	41	41	21	20
COMPLETED	15	15	13	14	15	12	41	41	21	20
NOT COMPLETED	0	1	1	0	0	2	0	0	0	0
Period Title: Treatment Period
STARTED	15	16	14	14	15	13	41	41	21	20
COMPLETED	15	16	14	14	15	12	40	39	21	20
NOT COMPLETED	0	0	0	0	0	1	1	2	0	0

Baseline Characteristics

Arm/Group Title	Treatment A: Sofosbuvir + Daclatasvir	Treatment: Sofosbuvir + Daclatasvir	Treatment C: Sofosbuvir + Daclatasvir	Treatment D: Sofosbuvir + Daclatasvir	Treatment E: Sofosbuvir +Daclatasvir + Ribavirin	Treatment F: Sofosbuvir + Daclatasvir + Ribavirin	Treatment G: Sofosbuvir + Daclatasvir	Treatment H: Sofosbuvir +Daclatasvir + Ribavirin	Treatment I: Sofosbuvir + Daclatasvir	Treatment J: Sofosbuvir +Daclatasvir +Ribavirin	Total
Arm/Group Description	Participants with hepatitis C virus genotype 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.	Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.	Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.	Participants with genotype-2 or -3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks..	Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.	Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.	Participants with genotype1 a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks..	Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.	Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg once daily and daclatasvir, 60 mg, once daily for 24 weeks.	Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavarin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg) and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.	Total of all reporting groups
Overall Participants	15	16	14	14	15	14	41	41	21	20	211
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.1 (10.18)	50.6 (8.53)	52.7 (7.39)	49.7 (10.49)	50.9 (11.72)	48.8 (12.27)	50.9 (11.56)	53.1 (9.53)	56.6 (9.89)	52.6 (10.89)	52.0 (10.37)
Age, Customized (participants) [Number]
<65 years	15 100%	15 93.8%	14 100%	13 92.9%	15 100%	13 92.9%	39 95.1%	38 92.7%	18 85.7%	19 95%	199 94.3%
>= 65 years	0 0%	1 6.3%	0 0%	1 7.1%	0 0%	1 7.1%	2 4.9%	3 7.3%	3 14.3%	1 5%	12 5.7%
Sex: Female, Male (Count of Participants)
Female	8 53.3%	5 31.3%	5 35.7%	8 57.1%	8 53.3%	9 64.3%	21 51.2%	20 48.8%	8 38.1%	8 40%	100 47.4%
Male	7 46.7%	11 68.8%	9 64.3%	6 42.9%	7 46.7%	5 35.7%	20 48.8%	21 51.2%	13 61.9%	12 60%	111 52.6%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
Description	SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA <25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir.
Time Frame	Follow-up Week 12

Outcome Measure Data

Analysis Population Description

The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.

Arm/Group Title	Treatment-naive Participants With Genotype 1	Treatment-naive Participants With Genotype 2 or 3	Telaprevir or Boceprevir Failures With Genotype 1
Arm/Group Description	Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.	Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.	Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks.
Measure Participants	126	44	41
DCV/SOF with ribavirin (n=56, 14, 20)	96.4 642.7%	85.7 535.6%	95.0 678.6%
DCV/SOF without ribavirin (n=70, 30, 21)	100.0 666.7%	93.3 583.1%	100.0 714.3%
DCF/SOF All	98.4 656%	90.9 568.1%	97.6 697.1%

2. Secondary Outcome

Title	Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
Description	SVR24 was defined as participant's hepatitis C virus RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 24. DCV=daclatasvir, SOF=sofosbuvir.
Time Frame	Follow-up Week 24

Outcome Measure Data

Analysis Population Description

The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here the 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.

Arm/Group Title	Treatment-naive Participants With Genotype 1	Treatment-naive Participants With Genotype 2 or 3	Telaprevir/Boceprevir Failures With Genotype 1
Arm/Group Description	Participants with genotype 1a or 1b and no previous exposure to an interferon formulation or ribavirin or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir 400 mg tablets + daclatasvir 60 mg tablets ± ribavirin (a total daily dose of 1000 mg/1200mg) tablets once daily for 12 or 24 weeks.	Participants with genotype 2 or 3 and no previous exposure to an interferon formulation or ribavirin or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.	Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks.
Measure Participants	126	44	41
DCV/SOF with ribavirin (n=56, 14, 20)	94.6 630.7%	92.9 580.6%	100.0 714.3%
DCV/SOF without ribavirin (n=70, 30, 21)	95.7 638%	93.3 583.1%	100.0 714.3%
DCV/SOF All	95.2 634.7%	93.2 582.5%	100.0 714.3%

3. Secondary Outcome

Title	Percentage of Participants With Viral Breakthrough During the Treatment Period
Description	Viral breakthrough is defined as any confirmed increase in viral load ≥1 log from nadir or any confirmed hepatitis C virus RNA levels ≥25 IU/mL on or after Week 8.
Time Frame	First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)

Outcome Measure Data

Analysis Population Description

The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.

Arm/Group Title	Treatment-naive Participants With Genotype 1	Treatment-naive Participants With Genotype 2 or 3	Telaprevir or Boceprevir Failures With Genotype 1
Arm/Group Description	Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.	Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.	Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
Measure Participants	126	44	41
DCV/SOF with ribavirin (n=56, 14, 20)	0 0%	0 0%	0 0%
DCV/SOF without ribavirin (n=70, 30, 21)	0 0%	3.3 20.6%	0 0%

4. Secondary Outcome

Title	Percentage of Participants Who Experienced Viral Relapse During Follow-up Period
Description	Viral relapse during follow-up is defined as any confirmed quantifiable hepatitis C virus (HCV) RNA ≥25 IU/mL with HCV RNA levels less than the lower limit of quantitation, target detected or target not detected, ie, HCV RNA <25 IU/mL at the end of treatment.
Time Frame	Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)

Outcome Measure Data

Analysis Population Description

The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.

Arm/Group Title	Treatment-naive Participants With Genotype 1	Treatment-naive Participants With Genotype 2 or 3	Telaprevir or Boceprevir Failures With Genotype 1
Arm/Group Description	Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.	Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.	Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
Measure Participants	126	44	41
DCV/SOF with ribavirin (n=56, 14, 20)	0 0%	0 0%	0 0%
DCV/SOF without ribavirin (n=70, 30, 21)	1.4 9.3%	3.3 20.6%	0 0%

5. Secondary Outcome

Title	Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24
Description	Change from baseline in log10 HCV RNA at scheduled sampling time.
Time Frame	Baseline, Follow-up week 24

Outcome Measure Data

Analysis Population Description

The analysis was performed in all treated participants who received at least 1 dose of active study therapy.

Arm/Group Title	Treatment A: Sofosbuvir + Daclatasvir	Treatment B: Sofosbuvir + Daclatasvir	Treatment C: Sofosbuvir + Daclatasvir	Treatment D: Sofosbuvir + Daclatasvir	Treatment E: Sofosbuvir + Daclatasvir + Ribavirin	Treatment F: Sofosbuvir + Daclatasvir + Ribavirin	Treatment G: Sofosbuvir + Daclatasvir	Treatment H: Sofosbuvir + Daclatasvir + Ribavirin	Treatment I: Sofosbuvir + Daclatasvir	Treatment J: Sofosbuvir + Daclatasvir + Ribavirin
Arm/Group Description	Participants with hepatitis C virus genotypes 1a or 1b received sofosbuvir, 400 mg, once daily) for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.	Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.	Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.	Participants with genotype 2 or 3 received with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.	Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.	Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.	Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.	Participants with genotype 1a or 1b received with sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.	Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure were administered with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.	Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets at AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
Measure Participants	15	15	14	14	15	13	39	38	21	20
Baseline	1.28 (1.258)	0.95 (0.0)	0.95 (0.0)	0.98 (0.114)	0.95 (0.0)	0.95 (0.0)	0.95 (0.0)	0.95 (0.0)	0.95 (0.0)	0.95 (0.0)
Change at Follow-up week 24	-5.19 (1.478)	-5.23 (1.601)	-5.67 (0.336)	-5.83 (0.509)	-5.77 (0.583)	-5.61 (0.610)	-5.19 (0.490)	-5.48 (0.576)	-5.39 (0.386)	-5.36 (0.380)

6. Secondary Outcome

Title	Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy
Description	AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe.
Time Frame	First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of study drug.

Arm/Group Title	Daclatasvir + Sofosbuvir + Ribivirin (12 Weeks)	Daclatasvir + Sofosbuvir With Ribivirin (24 Weeks)	Daclatasvir + Sofosbuvir Without Ribivirin (12 Weeks)	Daclatasvir + Sofosbuvir Without Ribivirin (24 Weeks)
Arm/Group Description	Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.	Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 24 weeks.	Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.	Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
Measure Participants	41	49	41	80
Deaths	0 0%	0 0%	0 0%	0 0%
SAEs	1 6.7%	6 37.5%	1 7.1%	7 50%
AEs leading to discontinuation	0 0%	1 6.3%	0 0%	1 7.1%
Gr 3 Phosporus	3 20%	1 6.3%	0 0%	1 7.1%
Gr 3 Fasting serum glucose	0 0%	1 6.3%	1 7.1%	2 14.3%
Gr 3 Serum glucose	0 0%	2 12.5%	0 0%	1 7.1%
Gr 3 Total cholesterol	1 6.7%	0 0%	0 0%	1 7.1%
Gr 3 Uric acid	1 6.7%	0 0%	0 0%	0 0%

7. Secondary Outcome

Title	Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period
Description	AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe
Time Frame	AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of study drug and entered follow-up period

Arm/Group Title	Daclatasvir + Sofosbuvir + Ribivirin (12 Weeks)	Daclatasvir + Sofosbuvir With Ribivirin (24 Weeks)	Daclatasvir + Sofosbuvir Without Ribivirin (12 Weeks)	Daclatasvir + Sofosbuvir Without Ribivirin (24 Weeks)
Arm/Group Description	Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.	Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 24 weeks.	Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.	Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
Measure Participants	41	48	41	80
Deaths	0 0%	0 0%	0 0%	0 0%
SAEs	2 13.3%	4 25%	2 14.3%	4 28.6%
Grade 3-4 Lab Abnormalities: Serum glucose	1 6.7%	0 0%	0 0%	0 0%

Adverse Events

Arm/Group Title	Treatment A: Sofosbuvir + Daclatasvir		Treatment B: Sofosbuvir + Daclatasvir		Treatment C: Sofosbuvir + Daclatasvir		Treatment D: Sofosbuvir + Daclatasvir		Treatment E: Sofosbuvir + Daclatasvir + Ribavirin		Treatment F: Sofosbuvir + Daclatasvir + Ribavirin		Treatment G: Sofosbuvir + Daclatasvir		Treatment H : Sofosbuvir + Daclatasvir + Ribavirin		Treatment I: Sofosbuvir + Daclatasvir		Treatment J: Sofosbuvir + Daclatasvir + Ribavirin
Arm/Group Description	Participants with hepatitis C virus (HCV) genotypes 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.		Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks		Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.		Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.		Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.		Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks		Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.		Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.		Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.		Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
All Cause Mortality
	Treatment A: Sofosbuvir + Daclatasvir		Treatment B: Sofosbuvir + Daclatasvir		Treatment C: Sofosbuvir + Daclatasvir		Treatment D: Sofosbuvir + Daclatasvir		Treatment E: Sofosbuvir + Daclatasvir + Ribavirin		Treatment F: Sofosbuvir + Daclatasvir + Ribavirin		Treatment G: Sofosbuvir + Daclatasvir		Treatment H : Sofosbuvir + Daclatasvir + Ribavirin		Treatment I: Sofosbuvir + Daclatasvir		Treatment J: Sofosbuvir + Daclatasvir + Ribavirin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Treatment A: Sofosbuvir + Daclatasvir		Treatment B: Sofosbuvir + Daclatasvir		Treatment C: Sofosbuvir + Daclatasvir		Treatment D: Sofosbuvir + Daclatasvir		Treatment E: Sofosbuvir + Daclatasvir + Ribavirin		Treatment F: Sofosbuvir + Daclatasvir + Ribavirin		Treatment G: Sofosbuvir + Daclatasvir		Treatment H : Sofosbuvir + Daclatasvir + Ribavirin		Treatment I: Sofosbuvir + Daclatasvir		Treatment J: Sofosbuvir + Daclatasvir + Ribavirin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/15 (13.3%)		0/16 (0%)		2/14 (14.3%)		3/14 (21.4%)		2/15 (13.3%)		2/14 (14.3%)		1/41 (2.4%)		1/41 (2.4%)		0/21 (0%)		2/20 (10%)
Gastrointestinal disorders
Abdominal pain	0/15 (0%)		0/16 (0%)		1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/14 (0%)		0/41 (0%)		0/41 (0%)		0/21 (0%)		0/20 (0%)
Colitis	0/15 (0%)		0/16 (0%)		0/14 (0%)		1/14 (7.1%)		0/15 (0%)		0/14 (0%)		0/41 (0%)		0/41 (0%)		0/21 (0%)		0/20 (0%)
General disorders
Suprapubic pain	0/15 (0%)		0/16 (0%)		1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/14 (0%)		0/41 (0%)		0/41 (0%)		0/21 (0%)		0/20 (0%)
Infections and infestations
Gastroenteritis	0/15 (0%)		0/16 (0%)		1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/14 (0%)		0/41 (0%)		0/41 (0%)		0/21 (0%)		0/20 (0%)
Injury, poisoning and procedural complications
Accidental overdose	0/15 (0%)		0/16 (0%)		0/14 (0%)		1/14 (7.1%)		1/15 (6.7%)		0/14 (0%)		0/41 (0%)		0/41 (0%)		0/21 (0%)		0/20 (0%)
Overdose	0/15 (0%)		0/16 (0%)		0/14 (0%)		0/14 (0%)		1/15 (6.7%)		0/14 (0%)		0/41 (0%)		1/41 (2.4%)		0/21 (0%)		1/20 (5%)
Comminuted fracture	1/15 (6.7%)		0/16 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/14 (0%)		0/41 (0%)		0/41 (0%)		0/21 (0%)		0/20 (0%)
Metabolism and nutrition disorders
Hypokalaemia	0/15 (0%)		0/16 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/14 (0%)		0/41 (0%)		0/41 (0%)		0/21 (0%)		1/20 (5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	0/15 (0%)		0/16 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		1/14 (7.1%)		0/41 (0%)		0/41 (0%)		0/21 (0%)		0/20 (0%)
Nervous system disorders
Cerebrovascular accident	0/15 (0%)		0/16 (0%)		1/14 (7.1%)		0/14 (0%)		0/15 (0%)		0/14 (0%)		0/41 (0%)		0/41 (0%)		0/21 (0%)		0/20 (0%)
Psychiatric disorders
Anxiety	1/15 (6.7%)		0/16 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		1/14 (7.1%)		0/41 (0%)		0/41 (0%)		0/21 (0%)		0/20 (0%)
Renal and urinary disorders
Renal failure acute	0/15 (0%)		0/16 (0%)		0/14 (0%)		1/14 (7.1%)		0/15 (0%)		0/14 (0%)		0/41 (0%)		0/41 (0%)		0/21 (0%)		0/20 (0%)
Respiratory, thoracic and mediastinal disorders
Pleuritic pain	1/15 (6.7%)		0/16 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/14 (0%)		0/41 (0%)		0/41 (0%)		0/21 (0%)		0/20 (0%)
Skin and subcutaneous tissue disorders
Psoriasis	0/15 (0%)		0/16 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/14 (0%)		1/41 (2.4%)		0/41 (0%)		0/21 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Treatment A: Sofosbuvir + Daclatasvir		Treatment B: Sofosbuvir + Daclatasvir		Treatment C: Sofosbuvir + Daclatasvir		Treatment D: Sofosbuvir + Daclatasvir		Treatment E: Sofosbuvir + Daclatasvir + Ribavirin		Treatment F: Sofosbuvir + Daclatasvir + Ribavirin		Treatment G: Sofosbuvir + Daclatasvir		Treatment H : Sofosbuvir + Daclatasvir + Ribavirin		Treatment I: Sofosbuvir + Daclatasvir		Treatment J: Sofosbuvir + Daclatasvir + Ribavirin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/16 (0%)		0/14 (0%)		0/14 (0%)		0/15 (0%)		0/14 (0%)		0/41 (0%)		0/41 (0%)		0/21 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.