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Efficacy and Safety of Sofosbuvir/Ledipasvir ± Ribavirin in Japanese Participants With Chronic Genotype 1 HCV Infection

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ClinicalTrials.gov Identifier: NCT01975675
Recruitment Status : Completed
First Posted : November 5, 2013
Results First Posted : June 26, 2015
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or treatment-experienced Japanese participants with chronic genotype 1 HCV infection. Participants receive 12 weeks of treatment and continue assessments during a 24-week posttreatment follow-up period.

Condition or disease Intervention/treatment Phase
Chronic HCV Infection Drug: LDV/SOF Drug: RBV Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 341 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 1 HCV Infection
Study Start Date : October 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis C

Arms and Interventions
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Arm Intervention/treatment
Experimental: LDV/SOF (treatment naive)
Treatment-naive participants will receive LDV/SOF for 12 weeks.
 Drug: LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • GS-5885
Experimental: LDV/SOF+RBV (treatment naive)
Treatment-naive participants will receive LDV/SOF plus RBV for 12 weeks.
 Drug: LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • GS-5885

Drug: RBV
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, > 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)
Other Name: Copegus®
Experimental: LDV/SOF (treatment experienced)
Treatment-experienced participants will receive LDV/SOF for 12 weeks.
 Drug: LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • GS-5885
Experimental: LDV/SOF+RBV (treatment experienced)
Treatment-experienced participants will receive LDV/SOF plus RBV for 12 weeks.
 Drug: LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • GS-5885

Drug: RBV
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, > 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)
Other Name: Copegus®


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12), Treatment-naive, Noncirrhotic Participants [ Time Frame: Posttreatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

  2. Percentage of Participants With Sustained Virologic Response at 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

  3. Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 12 weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ]
    SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

  2. Percentage of Participants Experiencing Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]

    Virologic failure was defined as

    On-treatment virologic failure:

    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)

    Virologic relapse:

    - Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body weight ≥ 40 kg
  • HCV RNA ≥ 10^5 IU/mL at screening

Exclusion Criteria:

  • Current or prior history of any clinically-significant illness (other than HCV)
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of a non-HCV etiology
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975675


Locations
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Japan
Ichikawa, Chiba, Japan, 272-8516
Kurume, Fukuoka, Japan, 830-0011
Ogaki, Gifu, Japan, 503-0864
Sapporo, Hokkaido, Japan, 060-8648
Nishinomiya, Hyogo, Japan, 663-8501
Matsumoto, Nagano, Japan, 390-8621
Omura, Nagasaki, Japan, 856-8562
Suita, Osaka, Japan, 565-0871
Izunokuni, Shizuoka, Japan, 410-2295
Chiyoda-ku, Tokyo, Japan, 101-8643
Itabashi-ku, Tokyo, Japan, 173-8610
Musashino, Tokyo, Japan, 180-8610
Shinjuku, Tokyo, Japan, 162-8566
Kofu, Yamanashi, Japan, 400-0027
Akita, Japan, 010-0933
Chiba, Japan, 260-0856
Gifu, Japan, 500-8513
Okayama, Japan, 700-8558
Yamagata, Japan, 990-9585
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Steven Knox Gilead Sciences
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01975675    
Other Study ID Numbers: GS-US-337-0113
First Posted: November 5, 2013    Key Record Dates
Results First Posted: June 26, 2015
Last Update Posted: November 16, 2018
Last Verified: June 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Hepatitis C
Disease Attributes
Pathologic Processes
Blood-Borne Infections
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
 RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Sofosbuvir
Ledipasvir
Antiviral Agents
Anti-Infective Agents