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Hepatitis C Virus InfectionPhase 3ASTRAL-2NCT02220998

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

A Phase 3 study testing SOF/VEL, SOF and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 51 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C Virus Infection
What is being tested?
SOF/VEL, SOF and RBV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
269 participants
Where
51 sitesin 2 countries
Study dates
Sep 2014to Sep 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

51 sites in 2 countries.

51 sites in 2 countries

United States50 sites

  • Study site

    Arlington, Texas, 76012

  • Study site

    Asheville, North Carolina, 28801

  • Emory university

    Atlanta, Georgia, 30308

  • Study site

    Atlanta, Georgia, 30308

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Baltimore, Maryland, 21205

  • Study site

    Boston, Massachusetts, 02129

  • Study site

    Bradenton, Florida, 34205

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Gainesville, Florida, 32610-0272

  • Study site

    Germantown, Tennessee, 38138

  • Study site

    Great Neck, New York, 11021

  • Study site

    Indianapolis, Indiana, 46237

  • Study site

    Jacksonville, Florida, 32256

  • Study site

    Long Beach, California, 90822

  • Study site

    Los Angeles, California, 90027

  • Study site

    Los Angeles, California, 90036

  • Study site

    Los Angeles, California, 90048

  • Study site

    Los Angeles, California, 90057

  • Study site

    Los Angeles, California, 90073

  • Study site

    Lutherville, Maryland, 21093

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Miami, Florida, 33136

  • Study site

    Monroe, Louisiana, 71280

  • Study site

    Nashville, Tennessee, 37211

  • Study site

    New York, New York, 10021

  • Study site

    New York, New York, 10029

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    Orlando, Florida, 32803

  • Study site

    Palo Alto, California, 94304

  • Study site

    Pasadena, California, 91105

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Pittsburgh, Pennsylvania, 15240

  • Study site

    Providence, Rhode Island, 02905

  • Study site

    Richmond, Virginia, 23226

  • Study site

    Richmond, Virginia, 23298

  • Study site

    Sacramento, California, 95817

  • Study site

    San Antonio, Texas, 78215

  • Study site

    San Diego, California, 92103

  • Study site

    San Diego, California, 92123

  • Study site

    San Diego, California, 92154

  • Study site

    San Francisco, California, 94110

  • Study site

    San Francisco, California, 94118

  • Study site

    Santa Fe, New Mexico, 87505

  • Study site

    St Louis, Missouri, 63104

  • Study site

    The Bronx, New York, 10468

  • Study site

    Wellington, Florida, 33414

Other trials in United States

Puerto Rico1 site

  • Study site

    San Juan, 00909

Other trials in Puerto Rico

About this study

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

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.

Being tested
SOF/VEL, SOF, RBV
Keywords
Hepatitis C, HCV, cirrhosis, Sofosbuvir, Sovaldi, SOF/VEL, GS-5816, GS-7977, liver, Treatment naive, Treatment Experience, genotype 2
Medical subject headings
Hepatitis C, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SOF/VELDrug

    Also called Epclusa®, GS-7977/GS-5816

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

  • SOFDrug

    Also called Sovaldi®, GS-7977, PSI-7977

    SOF 400 mg tablet administered orally once daily

  • RBVDrug

    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)

Study groups in NCT02220998
Study groupRoleWhat they receive
SOF/VELExperimentalSOF/VEL FDC for 12 weeks
Receives: Drug: SOF/VEL
SOF+RBVExperimentalSOF+RBV for 12 weeks
Receives: Drug: SOF; Drug: RBV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Posttreatment Week 12

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

    Measured: Up to 12 weeks

Secondary outcomes (4)

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

    SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

    Measured: Posttreatment Weeks 4 and 24

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

    Measured: 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

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

  4. Percentage of Participants With Virologic Failure

    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.

    Measured: Up to Posttreatment Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJul 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
269 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02220998
Sponsor's protocol ID
GS-US-342-1139
Acronym
ASTRAL-2
Status last verified
Sep 2016
First submitted
18 Aug 2014
Last updated
15 Nov 2018
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • 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.

  • 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.

    PubMed 26575258

  • 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.

    PubMed 36740893

  • 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.

    PubMed 27847279

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SOF/VEL, SOF and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 51 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (time frame: Posttreatment Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02220998, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018; AzTrials last refreshed its copy on 6 Nov 2026.

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