Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection

NCT01682720 | Completed Phase 3 Results DMC

• 2 other identifiers: GS-US-334-01332012-001942-16
• Study Type: interventional
• Target: 421
• Locations: 9 countries
• Sites: 68

Brief Summary

This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.

Conditions

Hepatitis C

Keywords

HCV; Genotype 2; Genotype 3

Outcome Measures

Primary Outcomes (2)

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

  SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ, ie, \< 25 IU/mL) 12 weeks following the last dose of study drug. Data for this outcome measure was not collected for the Placebo 12 Weeks (GT2/3) group.

  Posttreatment Week 12

• Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

  The percentage of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was analyzed.

  Up to 24 weeks

Secondary Outcomes (2)

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

  Posttreatment Weeks 4 and 24

• Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse

  Up to Posttreatment Week 24

Study Arms (3)

Placebo 12 Weeks (GT2/3)

PLACEBO COMPARATOR

Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.

Drug: Placebo to match SOF; Drug: Placebo to match RBV

SOF 12 Weeks (GT2/3)

EXPERIMENTAL

Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.

Drug: SOF; Drug: RBV

SOF 24 Weeks (GT3)

EXPERIMENTAL

SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.

Drug: SOF; Drug: RBV

Interventions

SOF DRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily

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

SOF 12 Weeks (GT2/3); SOF 24 Weeks (GT3)

RBV DRUG

Ribavirin (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)

SOF 12 Weeks (GT2/3); SOF 24 Weeks (GT3)

Placebo to match SOF DRUG

Placebo to match SOF administered orally once daily

Placebo 12 Weeks (GT2/3)

Placebo to match RBV DRUG

Placebo to match RBV administered orally in a divided daily dose

Placebo 12 Weeks (GT2/3)

Eligibility Criteria

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

You may qualify if:

• Age \> 18 with chronic genotype 2 or 3 HCV infection
• HCV RNA \> 10,000 IU/mL at screening
• Subjects must be treatment naive or treatment experienced
• Presence or absence of cirrhosis; a liver biopsy may be required
• Healthy according to medical history and physical examination with the exception of HCV diagnosis
• Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication

You may not qualify if:

• Prior use of any other inhibitor of the HCV NS5B Polymerase
• History of any other clinically significant chronic liver disease
• Evidence of or history of decompensated liver disease
• HIV or chronic hepatitis B virus (HBV) infection
• Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
• Chronic use of immunosuppressive agents or immunomodulatory agents
• History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study or not be in the best interest of the subject in the opinion of the investigator

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (77)

Medizinische Universitat Graz

Graz, A-8036, Austria

Location

Medizinische Universitat Wien

Vienna, 1090, Austria

Location

Wilhelminenspital

Vienna, 1160, Austria

Location

West Tallinn Central Hospital

Tallinn, 10617, Estonia

Location

Tartu University Hospital

Tartu, 51014, Estonia

Location

CHRU de Lille, Hopital Claude Huriez

CHRU Lille, 59037, France

Location

CHU Estaing

Clermont-Ferrand, 63003, France

Location

Hopital Beaujon

Clichy, 92110, France

Location

Hopital Henri Mondor

Créteil, 94000, France

Location

Département Hépatogastroentérologie - CHU de Grenoble

Grenoble, 38043, France

Location

Hopital Saint Joseph

Marseille, 13008, France

Location

Hopital Saint Eloi

Montpellier, 34295, France

Location

Hopital de l Archet 2

Nice, 6202, France

Location

Hopital Saint Antoine

Paris, 75012, France

Location

Hopital Pitie Salpetriere

Paris, 75013, France

Location

Hopitaux Universitaires

Paris, 75679, France

Location

Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN

Pessac, 33604, France

Location

CHU Pontchaillou - Hématologie Clinique

Rennes, 35033, France

Location

Centre Hospitalier Universitaire de Strasbourg

Strasbourg, 67091, France

Location

CHU de Nancy, Hôpital de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Praxiszentrum

Freiburg im Breisgau, Baden-Wurttemberg, 79098, Germany

Location

Leber- and Studienzentrum am Checkpoint

Berlin, 10969, Germany

Location

Universitaetsklinikum Bonn

Bonn, 53125, Germany

Location

Heinrich Heine Unversitat

Düsseldorf, 40225, Germany

Location

JWG-Universität Frankfurt

Frankfurt am Main, 60590, Germany

Location

Asklepios Klinik Sankt Georg H

Hamburg, 20099, Germany

Location

Universitatsklinikum

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannov

Hanover, 30625, Germany

Location

Medizinische Klinik IV, Dep. o

Heidelberg, 69120, Germany

Location

Gastroenterologische Gemeinsch

Herne, 44623, Germany

Location

Leberstudienzentrum Kiel

Kiel, 24146, Germany

Location

Universitaetsklinikum Leipzig

Leipzig, 4103, Germany

Location

Klinikum der Universität Münch

München, 81377, Germany

Location

Centrum fuer interdisziplinaere Medizin Muenster GmbH

Münster, D-48143, Germany

Location

Ospedale Casa Sollievo

San Giovanni Rotondo, Foggia, 71013, Italy

Location

Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi

Bologna, 40138, Italy

Location

Ospedale S. Annunziata

Florence, 50011, Italy

Location

Ente Ospedaliero Ospedali Galliera

Genova, 16128, Italy

Location

Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Azienda Ospedaliera Ospedale Niguarda Cà Granda

Milan, 20162, Italy

Location

University of Padova

Padua, 35100, Italy

Location

University of Palermo

Palermo, 90127, Italy

Location

Azienda Ospedaliero Universitaria di Parma

Parma, 43100, Italy

Location

Fondazione PTV - Policlinico Tor Vergata

Roma, 133, Italy

Location

INMI "Lazzaro Spallanzani" I.R.C.C.S.

Roma, 149, Italy

Location

Azienda Ospedaliera Universitaria San Giovanni Battista di Torino

Torino, 10126, Italy

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Leids Universitair Medisch Centrum

Leiden, 2300 RC, Netherlands

Location

UMC St. Radboud - Gastroenterology

Nijmegen, 6500 HB, Netherlands

Location

Erasmus MC

Rotterdam, 3015 CE, Netherlands

Location

Wojewodzki Szpital Specjalistyczny im Dluskeigo

Bialystok, 15-540, Poland

Location

Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego

Lodz, 91-347, Poland

Location

SP ZOZ Wojewodzki Szpital Zakazny w Warszawie

Warsaw, 01-201, Poland

Location

NZOZ Centrum Badan Klinicznych

Wroclaw, 50-349, Poland

Location

Hospital Universitari Vall d'H

Barcelona, 08035, Spain

Location

Hospital Casa de la Maternidad

Barcelona, 08036, Spain

Location

Hospital Carlos III

Madrid, 28029, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Puerta de Hierro Maja

Majadahonda, 28222, Spain

Location

Complejo Hospitalario de Especialidades Virgen de la Victoria

Málaga, 29071, Spain

Location

Hospital Universitario Marques

Santander, 39008, Spain

Location

Valme Hospital

Seville, 41014, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Sahlgrenska University Hospital

Gothenburg, 41685, Sweden

Location

Skånes Universitetssjukhus, Lund

Lund, 22185, Sweden

Location

Skanes Universitetssjukhus

Malmo, 20502, Sweden

Location

Karolinska Instituet

Stockholm, 14186, Sweden

Location

University of Birmingham

Edgbaston, Birmingham, B15 2TH, United Kingdom

Location

Southampton University Hospital NHS Trust

Southhampton, Hampshire, SO41 3QP, United Kingdom

Location

King's College Hospital

Denmark Hill, London, SE5 9RS, United Kingdom

Location

The Liver Unit

Paddington, London, W2 1NY, United Kingdom

Location

North Manchester General Hospital

Crumpsall, Manchester, M8 5RB, United Kingdom

Location

Bristol Royal Infirmary

Bristol, BS2 8HW, United Kingdom

Location

Queen Marys University of London

London, E1 2AT, United Kingdom

Location

Royal Free Hospital and University College London Hospital

London, NW3 2PF, United Kingdom

Location

Chelsea & Westminster Hospital

London, SW109NH, United Kingdom

Location

Nottingham University Hospitals-NHS

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (2)

• Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, Illeperuma A, Svarovskaia E, Brainard DM, Symonds WT, Subramanian GM, McHutchison JG, Weiland O, Reesink HW, Ferenci P, Hezode C, Esteban R; VALENCE Investigators. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014 May 22;370(21):1993-2001. doi: 10.1056/NEJMoa1316145. Epub 2014 May 4.

  PMID: 24795201 RESULT

• 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.

  PMID: 25583164 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

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

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, Inc.

ClinicalTrialDisclosures@gilead.com

Study Officials

• Rob Hyland, DPhil

  Gilead Sciences Study Director

  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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 11, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2014
• Last Updated: October 9, 2014
• Results First Posted: October 9, 2014

Record last verified: 2014-10

Locations

FR (15); SE (4); AU (3); GB (10); ES (2); DE (14); IT (12); PL (4); NL (4)