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Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection (ASTRAL-2)

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ClinicalTrials.gov Identifier: NCT02220998
Recruitment Status : Completed
First Posted : August 20, 2014
Results First Posted : November 15, 2016
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants with chronic genotype 2 hepatitis C virus (HCV) infection.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: SOF/VEL Drug: SOF Drug: RBV Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 269 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection
Study Start Date : September 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arms and Interventions
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Arm Intervention/treatment
Experimental: SOF/VEL
SOF/VEL FDC for 12 weeks
 Drug: SOF/VEL
SOF/VEL (400/100 mg) FDC tablet administered orally once daily
Other Names:
  • Epclusa®
  • GS-7977/GS-5816
Experimental: SOF+RBV
SOF+RBV for 12 weeks
 Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977

Drug: RBV
RBV 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)


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) 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, 15 IU/mL) at 12 weeks after stopping study treatment.

  2. 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 SVR 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 With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12 [ Time Frame: Weeks 1, 2, 4, 6, 8, 10, and 12 ]
  3. Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12 [ Time Frame: Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12 ]
  4. Percentage of Participants With 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to provide written informed consent
  • HCV RNA ≥ 10^4 IU/mL
  • HCV genotype 2
  • Chronic HCV infection (≥ 6 months)
  • Females of childbearing potential must have a negative serum pregnancy test
  • Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
  • Must be of generally good health, with the exception of chronic HCV infection, as determined by the investigator.

Exclusion Criteria:

  • Current or prior history of clinically-significant illness (other than HCV that may interfere with treatment, assessment or compliance with the protocol;
  • Screening electrocardiogram (ECG) with clinically significant abnormalities
  • Laboratory results outside of acceptable ranges at Screening
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
  • 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): NCT02220998


Locations
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Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Anu Osinusi, MD Gilead Sciences
More Information
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Publications of Results:
Asselah T, Charlton M, Feld J, Foster GR, Mcnally J, Brainard DM, et al. The ASTRAL Studies: Evaluation of SOF/GS-5816 Single Tablet Regimen for the Treatment of Genotype 1-6 HCV Infection [Poster P1332]. J Hepatol 2015;62:S855-S6.
Sulkowski, MS., Brau N., Lawitz E., Shiffman ML, Towner WL, Ruane PJ et al. A Randomized Controlled Trial of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks Compared to Sofosbuvir with Ribavirin for 12 Weeks in Genotype 2 HCV Infected Patients: The Phase 3 ASTRAL-2 Study [Oral 205] Hepatology 2015; 62: 1 (SUPPL) 313A.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02220998    
Other Study ID Numbers: GS-US-342-1139
First Posted: August 20, 2014    Key Record Dates
Results First Posted: November 15, 2016
Last Update Posted: November 15, 2018
Last Verified: September 2016
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
Keywords provided by Gilead Sciences:
Hepatitis C
HCV
cirrhosis
Sofosbuvir
Sovaldi
SOF/VEL
 GS-5816
GS-7977
liver
Treatment naive
Treatment Experience
genotype 2
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents