Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6 (ATOMIC)

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ClinicalTrials.gov Identifier: NCT01329978

Recruitment Status : Completed

First Posted : April 6, 2011

Results First Posted : May 26, 2014

Last Update Posted : May 26, 2014

Sponsor:

Information provided by (Responsible Party):

Gilead Sciences

Tracking Information

First Submitted Date ^ICMJE

March 30, 2011

First Posted Date ^ICMJE

April 6, 2011

Results First Submitted Date

January 6, 2014

Results First Posted Date

May 26, 2014

Last Update Posted Date

May 26, 2014

Study Start Date ^ICMJE

March 2011

Actual Primary Completion Date

August 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) [ Time Frame: Post-treatment Week 24 ]
SVR24 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 24 weeks after the last dose of study drug.
Percentage of Participants Who Experienced Adverse Events [ Time Frame: Baseline (Day 1) to post-treatment Day 30 ]
Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.

Original Primary Outcome Measures ^ICMJE

Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 12 or 24 weeks ]
To assess the safety of PSI-7977 in combination with PEG/RBV for 12 or 24 weeks of treatment
Efficacy of PSI-7977 in subjects treated for 12 or 24 weeks [ Time Frame: 12 or 24 weeks ]
To assess the efficacy of PSI-7977 with PEG/RBV for 12 or 24 weeks of treatment as measured by HCV RNA levels of detection.

Change History

Complete list of historical versions of study NCT01329978 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12) [ Time Frame: Post-treatment Week 12 ]
SVR12 was defined as HCV RNA < LOD 12 weeks after the last dose of study drug.
Change in HCV RNA at Week 2 [ Time Frame: Baseline (Day 1) to Week 2 ]
Change in HCV RNA at Week 4 [ Time Frame: Baseline (Day 1) to Week 4 ]
Change in HCV RNA at Week 8 [ Time Frame: Baseline (Day 1) to Week 8 ]
Change in HCV RNA at Week 12 [ Time Frame: Baseline (Day 1) to Week 12 ]
Percentage of Participants With HCV RNA < LOD at Week 2 [ Time Frame: Week 2 ]
Percentage of Participants With HCV RNA Below < LOD at Week 4 [ Time Frame: Week 4 ]
Percentage of Participants With HCV RNA Below < LOD at Week 8 [ Time Frame: Week 8 ]
Percentage of Participants With HCV RNA Below < LOD at Week 12 [ Time Frame: Week 12 ]
Percentage of Participants With HCV RNA Below < LOD at Week 24 [ Time Frame: Week 24 ]
Percentage of Participants With ALT Normalization at Week 12 [ Time Frame: Baseline (Day 1) to Week 12 ]
ALT normalization was defined as ALT > ULN at baseline and ALT ≤ ULN at Week 12.
Percentage of Participants With ALT Normalization at Week 24 [ Time Frame: Baseline (Day 1) to Week 24 ]
ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Week 24.
Percentage of Participants With ALT Normalization at Post-treatment Week 4 [ Time Frame: Baseline (Day 1) to Post-treatment Week 4 ]
ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Post-treatment Week 4.
Percentage of Participants With Virologic Failure During Treatment [ Time Frame: Baseline (Day 1) to Week 24 ]
Virologic failure was defined as either
- HCV RNA ≥ 15 IU/mL after having previously had HCV RNA < 15 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement (ie, breakthrough);
- > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement (ie, rebound);or
- HCV RNA persistently ≥ 15 IU/mL through 8 weeks of treatment (ie, nonresponse)
Baseline was Day 1 for all groups.
Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse). [ Time Frame: End of treatment to Post-treatment Week 24 ]
Viral relapse was defined as HCV RNA < 15 IU/mL at end of treatment, confirmed with 2 consecutive values or last available measurement.

Original Secondary Outcome Measures ^ICMJE

Change in circulating HCV ribonucleic acid (RNA) [ Time Frame: 12 or 24 weeks ]
To assess the change in circulating HCV RNA in patients over 12 or 24 weeks of dosing.
Number of participants with Sustained Viral Response (SVR) post-treatment [ Time Frame: Week 12 or Week 24 ]
To assess the SVR at Week 12 or Week 24 after treatment.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6

Official Title ^ICMJE

The ATOMIC Study: A Multicenter, Open-label, Randomized, Duration Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic HCV Infection Genotype 1,4, 5, or 6

Brief Summary

The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Hepatitis C, Chronic

Intervention ^ICMJE

Drug: Sofosbuvir
Sofosbuvir (SOF) administered as a 400 mg tablet orally once daily
Other Names:
- Sovaldi®
- GS-7977
- PSI-7977
Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Other Name: Copegus®
Drug: PEG
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

Other Name: Pegasys®

Study Arms

Experimental: SOF+PEG+RBV 12 weeks
Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks.
Interventions:
- Drug: Sofosbuvir
- Drug: RBV
- Drug: PEG
Experimental: SOF+PEG+RBV 24 weeks
Participants were randomized to receive sofosbuvir+PEG+RBV for 24 weeks.
Interventions:
- Drug: Sofosbuvir
- Drug: RBV
- Drug: PEG
Experimental: SOF+PEG+RBV 12 week/Rerandomization Group
Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks, then were rerandomized to receive sofosbuvir only or sofosbuvir+RBV for 12 additional weeks.
Interventions:
- Drug: Sofosbuvir
- Drug: RBV
- Drug: PEG

Publications *

Kowdley KV, Lawitz E, Crespo I, Hassanein T, Davis MN, DeMicco M, Bernstein DE, Afdhal N, Vierling JM, Gordon SC, Anderson JK, Hyland RH, Dvory-Sobol H, An D, Hindes RG, Albanis E, Symonds WT, Berrey MM, Nelson DR, Jacobson IM. Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial. Lancet. 2013 Jun 15;381(9883):2100-7. doi: 10.1016/S0140-6736(13)60247-0. Epub 2013 Mar 15.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

332

Original Estimated Enrollment ^ICMJE

325

Actual Study Completion Date

August 2012

Actual Primary Completion Date

August 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Males and females with Chronic Hepatitis C (HCV) Genotype 1,4,5,6, or indeterminate
Naive to previous HCV treatment

Exclusion Criteria:

Positive for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
History of any other clinically significant chronic liver disease

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Puerto Rico, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01329978

Other Study ID Numbers ^ICMJE

P7977-0724

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Gilead Sciences

Study Sponsor ^ICMJE

Gilead Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Robert H. Hyland, DPhil

Gilead Sciences

PRS Account

Gilead Sciences

Verification Date

April 2014

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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