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Hepatitis CPhase 3NCT01667731

Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults

A Phase 3 study testing SOF and RBV in people with Hepatitis C and Human Immunodeficiency Virus, run by Gilead Sciences at 27 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

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are coinfected with HIV-1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Human Immunodeficiency Virus
What is being tested?
SOF and RBV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
27 sitesin 2 countries
Study dates
Jul 2012to Feb 2014
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
  • Male or female, age ≥ 18 years with chronic HCV and HIV-1 infection
  • HCV RNA > 1 x 10^4 IU/mL at screening
  • Infection with HCV genotype 1, 2 or 3 as determined at screening
  • HIV-1 infection confirmed with positive ELISA or Western blot at screening
  • Medical records must be sufficient to be categorized on interferon (IFN) eligibility or prior treatment history with PEG/RBV.
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  • Confirmation of chronic HCV infection
  • Ability to determine presence/absence of cirrhosis.
  • HIV antiretroviral therapy (ARV) criteria of one of the following:
  • ARV untreated with a CD4 T-cell count > 500 cells/mm^3
  • On a stable, protocol-approved, ARV for > 8 weeks prior to screening with a CD4 T-cell count > 200 cells/mm^3 and a documented undetectable plasma HIV-1 RNA level for ≥ 8 weeks preceding the screening visit
  • Approved HIV antiretroviral medications based on drug interaction studies
  • Not been treated with any investigational drug or device within 30 days of the screening visit
  • Females if confirmed that she is not pregnant or nursing of non-childbearing potential or of childbearing potential but has a negative serum pregnancy test at screening and agrees to use protocol approved method of birth control from screening through 6 months after the last dose of RBV
  • Males who agree to consistently and correctly use a condom while their female partner agrees to use protocol approved method of birth control from screening through 7 months after the last dose of RBV
  • Must be of generally good health as determined by the investigator.
  • Liver imaging within 6 months of baseline/Day 1 is required in cirrhotic patients only, to exclude hepatocellular carcinoma (HCC)

Who cannot join

  • Non-genotype 1/2/3 or mixed genotype at screening
  • Genotype 1 with prior treatment for HCV
  • Poor control with ARV regimen
  • Prior exposure to a direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
  • Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
  • A new AIDS-defining condition diagnosed within 30 days prior to screening
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  • Active, serious infection (other than HIV or HCV) requiring parenteral antibiotics, antivirals or antifungals within 30 days prior to baseline
  • Infection with hepatitis B virus (HBV)
  • Contraindication to RBV therapy
  • Chronic use of systemically administered immunosuppressive agents (eg, prednisone equivalent > 10 mg/day)
  • History of solid organ transplantation or malignancy diagnosed or treated within 5 years
  • Current or prior history of clinical hepatic decompensation or other significant gastrointestinal disorder

Trial locations and contacts

27 sites in 2 countries.

27 sites in 2 countries

United States26 sites

  • Study site

    Allentown, Pennsylvania

  • Study site

    Birmingham, Alabama

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Coronado, California

  • Study site

    Dallas, Texas

  • Study site

    Durham, North Carolina

  • Study site

    Hillsborough, New Jersey

  • Study site

    Houston, Texas

  • Study site

    Kansas City, Missouri

  • Study site

    Los Angeles, California

  • Study site

    Lutherville, California

  • Study site

    Miami, Florida

  • Study site

    New York, New York

  • Study site

    Oakland, California

  • Study site

    Orlando, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Providence, Rhode Island

  • Study site

    Sacramento, California

  • Study site

    San Francisco, California

  • Study site

    Santa Fe, New Mexico

  • Study site

    Seattle, Washington

  • Study site

    Springfield, Massachusetts

  • Study site

    Tampa, Florida

  • Study site

    Torrance, California

  • Study site

    Washington D.C., District of Columbia

Other trials in United States

Puerto Rico1 site

  • Study site

    San Juan

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Open-label Study to Investigate the Efficacy and Safety of GS-7977 Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are coinfected with HIV-1.

Being tested
SOF, RBV
Keywords
Hepatitis C, Chronic, HCV, HIV, Human Immunodeficiency Virus, Co-Infected
Medical subject headings
Hepatitis C, Acquired Immunodeficiency Syndrome, Bronchiolitis Obliterans Syndrome

What participants receive

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

  • SOFDrug

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

    Sofosbuvir (SOF) 400 mg tablet administered orally once daily

  • RBVDrug

    Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Study groups in NCT01667731
Study groupRoleWhat they receive
SOF+RBV 12 Weeks (GT 2/3, TN)ExperimentalTreatment-naive (TN) participants coinfected with HIV-1 and genotype (GT) 2 or genotype 3 HCV infection will receive SOF+RBV for 12 weeks.
Receives: Drug: SOF; Drug: RBV
SOF+RBV 24 Weeks (GT 2/3, TE)ExperimentalTreatment-experienced (TE) participants coinfected with HIV-1 and genotype 2 or genotype 3 HCV infection will receive SOF+RBV for 24 weeks.
Receives: Drug: SOF; Drug: RBV
SOF+RBV 24 Weeks (GT 1, TN)ExperimentalTreatment-naive (TN) participants coinfected with HIV-1 and genotype 1 HCV infection will receive SOF+RBV for 24 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) at 12 Weeks After Discontinuation of Therapy (SVR12)

    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.

    Measured: Posttreatment Week 12

  2. Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

    The percentage of participants discontinuing any study drug due to an adverse event was summarized.

    Measured: Up to 24 weeks

Secondary outcomes (8)

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

    SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.

    Measured: Posttreatment Weeks 4 and 24

  2. Change From Baseline in HCV RNA at Week 1

    Measured: Baseline; Week 1

  3. Change From Baseline in HCV RNA at Week 2

    Measured: Baseline; Week 2

  4. Change From Baseline in HCV RNA at Week 4

    Measured: Baseline; Week 4

  5. Change From Baseline in HCV RNA at Week 6

    Measured: Baseline; Week 6

  6. Change From Baseline in HCV RNA at Week 8

    Measured: Baseline; Week 8

  7. Percentage of Participants Experiencing On-treatment Virologic Failure

    On-treatment virologic failure was defined as:

    1. Viral breakthrough: HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
    2. Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values (second confirmation value may have been posttreatment) or with a last available on-treatment measurement and no subsequent follow-up values, or
    3. Nonresponse: HCV RNA persistently ≥ LLOQ through 8 weeks of treatment

    Measured: Up to 24 weeks

  8. Percentage of Participants Experiencing Viral Relapse

    Viral relapse was defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) at end of treatment, but did not achieve an SVR.

    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 posted17 Aug 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionNov 2013
  4. Study completionFeb 2014

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01667731
Sponsor's protocol ID
GS-US-334-0123
Status last verified
Nov 2014
First submitted
9 Aug 2012
Last updated
21 Nov 2014
Data monitoring committee
Yes

Publications

  • Saeed S, Strumpf EC, Walmsley SL, Rollet-Kurhajec K, Pick N, Martel-Laferriere V, Hull M, Gill MJ, Cox J, Cooper C, Klein MB; Canadian Co-Infection Cohort Study; Cohen J, Conway B, Cooper C, Cote P, Cox J, Gill J, Haider S, Harris M, Haase D, Hull M, Montaner J, Moodie E, Pick N, Rachlis A, Rouleau D, Sandre R, Tyndall JM, Vachon ML, Walmsley S, Wong D. How Generalizable Are the Results From Trials of Direct Antiviral Agents to People Coinfected With HIV/HCV in the Real World? Clin Infect Dis. 2016 Apr 1;62(7):919-926. doi: 10.1093/cid/civ1222. Epub 2016 Jan 6.

    PubMed 26743093

  • Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Puoti M, Orkin C, Hunt SL. Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes. J Infect Dis. 2015 Aug 1;212(3):367-77. doi: 10.1093/infdis/jiv005. Epub 2015 Jan 12.

    PubMed 25583164

  • Sulkowski MS, Naggie S, Lalezari J, Fessel WJ, Mounzer K, Shuhart M, Luetkemeyer AF, Asmuth D, Gaggar A, Ni L, Svarovskaia E, Brainard DM, Symonds WT, Subramanian GM, McHutchison JG, Rodriguez-Torres M, Dieterich D; PHOTON-1 Investigators. Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. JAMA. 2014 Jul 23-30;312(4):353-61. doi: 10.1001/jama.2014.7734.

    PubMed 25038354

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SOF and RBV in people with Hepatitis C and Human Immunodeficiency Virus, run by Gilead Sciences at 27 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 17 inclusion and 12 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 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 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 21 Nov 2014). 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) at 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 NCT01667731, which also lists 3 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 21 Nov 2014.

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