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Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01858766
First received: May 10, 2013
Last updated: July 27, 2016
Last verified: July 2016
  Purpose
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.

Condition Intervention Phase
Hepatitis C
Drug: SOF
Drug: VEL
Drug: RBV
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Naive Subjects With Chronic HCV Infection

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

  • Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ] [ Designated as safety issue: No ]
    SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

  • Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ] [ Designated as safety issue: No ]

    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.


Enrollment: 379
Study Start Date: April 2013
Study Completion Date: August 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOF+VEL 25 mg 12 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816
Experimental: SOF+VEL 100 mg 12 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816
Experimental: SOF+VEL 25 mg 12 Weeks (GT2/4/5/6)
Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816
Experimental: SOF+VEL 100 mg 12 Weeks (GT2/4/5/6)
Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816
Experimental: SOF+VEL 25 mg 12 Weeks (GT3)
Participants with genotype 3 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816
Experimental: SOF+VEL 100 mg 12 Weeks (GT3)
Participants with genotype 3 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816
Experimental: SOF+VEL 25 mg 8 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 8 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816
Experimental: SOF+VEL 25 mg + RBV 8 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816
Drug: RBV
200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Name: Ribasphere®
Experimental: SOF+VEL 100 mg 8 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 8 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816
Experimental: SOF+VEL 100 mg + RBV 8 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816
Drug: RBV
200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Name: Ribasphere®
Experimental: SOF+VEL 25 mg 8 Weeks (GT2)
Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg for 8 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816
Experimental: SOF+VEL 25 mg + RBV 8 Weeks (GT2)
Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816
Drug: RBV
200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Name: Ribasphere®
Experimental: SOF+VEL 100 mg 8 Weeks (GT2)
Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg for 8 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816
Experimental: SOF+VEL 100 mg + RBV 8 Weeks (GT2)
Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi®
Drug: VEL
Tablet administered orally once daily
Other Name: GS-5816
Drug: RBV
200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Name: Ribasphere®

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic HCV infection
  • Body mass index (BMI) ≥ 18 kg/m^2
  • HCV RNA ≥ 10000 IU/mL at screening
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male
  • Must not have cirrhosis

Exclusion Criteria:

  • Current or prior history of clinically significant illness other than HCV
  • Screening ECG with clinically significant abnormalities
  • Prior exposure to HCV specific direct acting antiviral agent
  • Prior treatment of HCV with interferon or ribavirin
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of non-HCV etiology
  • Hepatitis B
  • Active drug abuse
  • Use of any prohibited concomitant medications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01858766

  Show 51 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: John McNally, PhD Gilead Sciences
  More Information

Publications:
Everson GT, Tran TT, Towner WJ , Davis MN, Wyles D, Nahass R, McNally J, Brainard DM, Han L, Doehle B, Mogalian E, Symonds WT, McHutchison JG, Morgan T, Chung RT. Safety and Efficacy of Treatment with the Interferon-Free, Ribavirin-Free Combination of Sofosbuvir + GS-5816 for 12 Weeks in Treatment Naive Patients with Genotype 1-6 HCV Infection. Journal of Hepatology, Volume 60, Issue 1, Supplement, Page S46. April 2014 (EASL 2014).
Tran TT, Morgan TR, Thuluvath PJ, Etzkorn K, Hinestrosa F, Tong M, McNally J, Brainard DM, Han L, Doehle B, Mogalian E, McHutchison JG, Chung RT, Everson GT. Safety and Efficacy of Treatment with Sofosbuvir+ GS-5816±Ribavirin for 8 or 12 Weeks in Treatment Naïve Patients with Genotype 1-6 HCV Infection. Hepatology (2014), 60: 4 (suppl) 237A.
Doehle B, Gontcharova V, Chodavarapu1 RK, McNally J, Chung RT, Everson GT, McHutchison JG, Miller MD, Mo H. Resistance Analysis of Treatment-Naive HCV Genotype 1-6 Infected Patients Treated with Sofosbuvir in Combination with GS-5816 for 12 Weeks. Hepatology (2014), 60: 4 (suppl) 1138A.

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01858766     History of Changes
Other Study ID Numbers: GS-US-342-0102 
Study First Received: May 10, 2013
Results First Received: July 27, 2016
Last Updated: July 27, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Hepatitis
HCV Genotype 1
HCV Genotype 2
HCV Genotype 3
HCV Genotype 4
HCV Genotype 5
HCV Genotype 6
treatment naive

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on December 02, 2016