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Completed

NCT Number: NCT01329978

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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fundacion de Investigacion de Diego, San Juan, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sofosbuvir

Drug

Sofosbuvir (SOF) administered as a 400 mg tablet orally once daily

Other names: Sovaldi®, GS-7977, PSI-7977

RBV

Drug

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 names: Copegus®

PEG

Drug

Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

Other names: Pegasys®

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. Change in HCV RNA at Week 2

    Time frame: Baseline (Day 1) to Week 2

  3. Change in HCV RNA at Week 4

    Time frame: Baseline (Day 1) to Week 4

  4. Change in HCV RNA at Week 8

    Time frame: Baseline (Day 1) to Week 8

  5. Change in HCV RNA at Week 12

    Time frame: Baseline (Day 1) to Week 12

  6. Percentage of Participants With HCV RNA < LOD at Week 2

    Time frame: Week 2

  7. Percentage of Participants With HCV RNA Below < LOD at Week 4

    Time frame: Week 4

  8. Percentage of Participants With HCV RNA Below < LOD at Week 8

    Time frame: Week 8

  9. Percentage of Participants With HCV RNA Below < LOD at Week 12

    Time frame: Week 12

  10. Percentage of Participants With HCV RNA Below < LOD at Week 24

    Time frame: Week 24

  11. 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.

  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.

  13. 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.

  14. 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.

  15. 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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

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

Acronym: ATOMIC

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 6, 2011
Registry last updated
May 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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