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

NCT02220998 | Completed Phase 3 Results DMC

• 1 other identifier: GS-US-342-1139
• Study Type: interventional
• Target: 269
• Locations: 2 countries
• Sites: 51

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.

Conditions

Hepatitis C Virus Infection

Keywords

Hepatitis C; HCV; cirrhosis; Sofosbuvir; Sovaldi; SOF/VEL; GS-5816; GS-7977; liver; Treatment naive; Treatment Experience; genotype 2

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

  SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

  Posttreatment Week 12

• Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

  Up to 12 weeks

Secondary Outcomes (4)

• Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

  Posttreatment Weeks 4 and 24

• Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12

  Weeks 1, 2, 4, 6, 8, 10, and 12

• Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12

  Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12

• Percentage of Participants With Virologic Failure

  Up to Posttreatment Week 24

Study Arms (2)

SOF/VEL

EXPERIMENTAL

SOF/VEL FDC for 12 weeks

Drug: SOF/VEL

SOF+RBV

EXPERIMENTAL

SOF+RBV for 12 weeks

Drug: SOF; Drug: RBV

Interventions

SOF/VEL DRUG

SOF/VEL (400/100 mg) FDC tablet administered orally once daily

Also known as: Epclusa®, GS-7977/GS-5816

SOF/VEL

SOF DRUG

SOF 400 mg tablet administered orally once daily

Also known as: Sovaldi®, GS-7977, PSI-7977

SOF+RBV

RBV DRUG

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)

SOF+RBV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (51)

Unknown Facility

Long Beach, California, 90822, United States

Location

Unknown Facility

Los Angeles, California, 90027, United States

Location

Unknown Facility

Los Angeles, California, 90036, United States

Location

Unknown Facility

Los Angeles, California, 90048, United States

Location

Unknown Facility

Los Angeles, California, 90057, United States

Location

Unknown Facility

Los Angeles, California, 90073, United States

Location

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Palo Alto, California, 94304, United States

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Pasadena, California, 91105, United States

Location

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Sacramento, California, 95817, United States

Location

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San Diego, California, 92103, United States

Location

Unknown Facility

San Diego, California, 92123, United States

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San Diego, California, 92154, United States

Location

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San Francisco, California, 94110, United States

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Unknown Facility

San Francisco, California, 94118, United States

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Unknown Facility

Aurora, Colorado, 80045, United States

Location

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Bradenton, Florida, 34205, United States

Location

Unknown Facility

Gainesville, Florida, 32610-0272, United States

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Jacksonville, Florida, 32256, United States

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Miami, Florida, 33136, United States

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Orlando, Florida, 32803, United States

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Unknown Facility

Wellington, Florida, 33414, United States

Location

Emory university

Atlanta, Georgia, 30308, United States

Location

Unknown Facility

Atlanta, Georgia, 30308, United States

Location

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Marietta, Georgia, 30060, United States

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Chicago, Illinois, 60611, United States

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Chicago, Illinois, 60637, United States

Location

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Indianapolis, Indiana, 46237, United States

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Monroe, Louisiana, 71280, United States

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Baltimore, Maryland, 21205, United States

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Lutherville, Maryland, 21093, United States

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Boston, Massachusetts, 02129, United States

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Detroit, Michigan, 48202, United States

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St Louis, Missouri, 63104, United States

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Santa Fe, New Mexico, 87505, United States

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Great Neck, New York, 11021, United States

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New York, New York, 10021, United States

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New York, New York, 10029, United States

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The Bronx, New York, 10468, United States

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Asheville, North Carolina, 28801, United States

Location

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Philadelphia, Pennsylvania, 19104, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Pittsburgh, Pennsylvania, 15240, United States

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Providence, Rhode Island, 02905, United States

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Germantown, Tennessee, 38138, United States

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Nashville, Tennessee, 37211, United States

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Arlington, Texas, 76012, United States

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San Antonio, Texas, 78215, United States

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Norfolk, Virginia, 23502, United States

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Richmond, Virginia, 23226, United States

Location

Unknown Facility

Richmond, Virginia, 23298, United States

Location

Unknown Facility

San Juan, 00909, Puerto Rico

Location

Related Publications (5)

• 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.

  RESULT

• 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.

  RESULT

• Foster GR, Afdhal N, Roberts SK, Brau N, Gane EJ, Pianko S, Lawitz E, Thompson A, Shiffman ML, Cooper C, Towner WJ, Conway B, Ruane P, Bourliere M, Asselah T, Berg T, Zeuzem S, Rosenberg W, Agarwal K, Stedman CA, Mo H, Dvory-Sobol H, Han L, Wang J, McNally J, Osinusi A, Brainard DM, McHutchison JG, Mazzotta F, Tran TT, Gordon SC, Patel K, Reau N, Mangia A, Sulkowski M; ASTRAL-2 Investigators; ASTRAL-3 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. N Engl J Med. 2015 Dec 31;373(27):2608-17. doi: 10.1056/NEJMoa1512612. Epub 2015 Nov 17.

  PMID: 26575258 RESULT

• Jacobson IM, Bourgeois S, Mathurin P, Thuluvath P, Ryder SD, Gerken G, Hernandez C, Vanstraelen K, Scherbakovsky S, Osinusi A, Tedesco D, Foster GR. The tolerability of sofosbuvir/velpatasvir for 12 weeks in patients treated in the ASTRAL 1, 2 and 3 studies: A pooled safety analysis. J Viral Hepat. 2023 May;30(5):448-454. doi: 10.1111/jvh.13814. Epub 2023 Mar 2.

  PMID: 36740893 DERIVED

• Younossi ZM, Stepanova M, Feld J, Zeuzem S, Sulkowski M, Foster GR, Mangia A, Charlton M, O'Leary JG, Curry MP, Nader F, Henry L, Hunt S. Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis. Clin Gastroenterol Hepatol. 2017 Mar;15(3):421-430.e6. doi: 10.1016/j.cgh.2016.10.037. Epub 2016 Nov 12.

  PMID: 27847279 DERIVED

MeSH Terms

Conditions

Hepatitis C; Fibrosis

Interventions

sofosbuvir-velpatasvir drug combination; Sofosbuvir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences

ClinicalTrialDisclosures@gilead.com

Study Officials

• Anu Osinusi, MD

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 20, 2014
• Study Start: September 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 15, 2018
• Results First Posted: November 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

US (50); PR (1)