Chronic HCV InfectionPhase 2NCT02010255

Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant

A Phase 2 study testing LDV/SOF and RBV in people with Chronic HCV Infection, run by Gilead Sciences at 34 sites in 12 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 ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic HCV Infection
What is being tested?: LDV/SOF and RBV
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 334 participants
Where: 34 sitesin 12 countries
Study dates: Jan 2014to Aug 2015
Phase: Phase 2
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

Able to provide written informed consent
Chronic genotype 1 and/or 4 HCV infection
Normal ECG
Negative serum pregnancy test for female subjects
Male subjects and female subjects of childbearing potential must agree to use contraception
Able to comply with the dosing instructions for study drug and able to complete the study schedule of assessments, including all required post treatment visits

Who cannot join

Serious or active medical or psychiatric illness
HIV or hepatitis B viral (HBV) infection
Stomach disorder that could interfere with the absorption of the study drug
Treated with an anti-HCV medication in the last 30 days
Any prior exposure to an HCV nonstructural protein (NS)5a-specific inhibitor
Use of human granulocyte-macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other therapeutic hematopoietic agents within 2 weeks of screening

Show all 13Show fewer

History of clinically significant medical condition associated with other chronic liver disease
Active spontaneous bacterial peritonitis at screening
Females who are breastfeeding
Infection requiring systemic antibiotics
Participated in a clinical study with an investigational drug or biologic within the last 30 days
Active or history (last 6 months) of drug or alcohol abuse
History of organ transplant other than liver, kidney, or corneal.

Trial locations and contacts

34 sites in 12 countries.

Country

City, postcode or hospital

34 sites in 12 countries

Canada6 sites

Division of Gastroenterology, University of Alberta, Edmonton
Edmonton, Alberta, T6G 2C2
London Health Sciences Centre-University Hospital
London, Ontario, N6A 5A5
Hopital St. Luc
Montreal, Quebec, H1T 2M4
McGill University Health Centre \\ Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
University Health Network // Toronto General Hospital
Toronto, Ontario, M5G 2C4
University of British Columbia and Vancouver General Hospital
Vancouver, British Columbia, V5Z 3P1

Other trials in Canada

France4 sites

Hospital Beaujon
Clichy, 92118
Hospital Mondor \\ Service d'Hépatologie et de Gastroentérologie,
Créteil, 94010
Hopital Saint-Eloi
Montpellier, 34295
Hopital Paul Brousse
Villejuif, 94804

Other trials in France

Germany4 sites

Universitätsklinikum RWTH Aachen
Aachen, 52074
Universitätsklinikum Essen - klinikum für Gastroenterolgie und Hepatologie
Essen, 45122
University Hospital Johann Wolfgang Goethe University, Department of Internal Medicine I
Frankfurt, 60590
Medical School of Hannover
Hanover, 30625

Other trials in Germany

Spain4 sites

Hospital General Universitari Vall d' Hebron
Barcelona, 8035
Hospital Clinic i Provincial
Barcelona, 8036
Puerta de Hierro, Madrid
Madrid, 28220
Hospital Universitario y Politecnico La Fe de Valencia
Valencia, 46009

Other trials in Spain

United Kingdom3 sites

University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH
Royal Infirmary of Edinburgh \\ Scottish Liver Transplant Unit-Edinburgh
Edinburgh, EH3 9YW
Kings College Hospital, Institute of Liver Studies
London, SE5 9RS

Other trials in United Kingdom

Australia2 sites

Royal Prince Alfred Hospital, University of Sydney
Camperdown, New South Wales, 2050
Austin Repatriation Hospital (Melbourne) // Victorian Transplant Centre
Heidelberg, Victoria, 3084

Other trials in Australia

Austria2 sites

Medizinische Universitaet Innsbruck
Innsbruck, A-6020
Medizinische Universitat Wien
Vienna, 1090

Other trials in Austria

Belgium2 sites

UCL St-Luc Brussels
Brussels, 1200
Universitair Ziekenhuis Gent
Ghent, 9000

Other trials in Belgium

Italy2 sites

IRCCS Cà Grande Ospedale Maggiore Policlinico
Milan, 20122
Azienda Ospedaliera San Giovanni, Battista di Torino \\ Professor of Gastroenterology-San Giovanni Battista Hospital-University of Torino
Torino, 10126

Other trials in Italy

Netherlands2 sites

Leids Universitair Medisch Centrum
Leiden, 2333 ZA
Erasmus MC in Rotterdam
Rotterdam, 3015 CE

Other trials in Netherlands

Switzerland2 sites

University of Berne
Bern, 3010
University Hospital Zurich
Zurich, CH-8091

Other trials in Switzerland

New Zealand1 site

Auckland City Hospital
Auckland, 1023

Other trials in New Zealand

About this study

Official title: A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant

Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;
Cohort B: post-liver transplant, with or without cirrhosis;
Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups)
Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.

Conditions: Chronic HCV Infection
Being tested: LDV/SOF, RBV

What participants receive

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

LDV/SOFDrug
Also called Harvoni®, GS-5885/GS-7977
LDV/SOF FDC tablet administered orally once daily
RBVDrug
RBV tablets administered orally in a divided daily dose

Study groups in NCT02010255
Study group	Role	What they receive
Cohort A, Group 1 (12 wk): CPT Class B (7-9)	Experimental	LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9) Receives: Drug: LDV/SOF; Drug: RBV
Cohort A, Group 1 (24 wk): CPT Class B (7-9)	Experimental	LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9) Receives: Drug: LDV/SOF; Drug: RBV
Cohort A, Group 2 (12 wk): CPT Class C (10-12)	Experimental	LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12) Receives: Drug: LDV/SOF; Drug: RBV
Cohort A, Group 2 (24 wk): CPT Class C (10-12)	Experimental	LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12) Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis	Experimental	LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3 Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis	Experimental	LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3 Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 4 (12 wk): CPT Class A (5-6)	Experimental	LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6) Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 4 (24 wk): CPT Class A (5-6)	Experimental	LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6) Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 5 (12 wk): CPT Class B (7-9)	Experimental	LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9) Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 5 (24 wk): CPT Class B (7-9)	Experimental	LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9) Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 6 (12 wk): CPT Class C (10-12)	Experimental	LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12) Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 6 (24 wk): CPT Class C (10-12)	Experimental	LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12) Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 7 (12 wk): FCH	Experimental	LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH Receives: Drug: LDV/SOF; Drug: RBV
Cohort B, Group 7 (24 wk): FCH	Experimental	LDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH Receives: Drug: LDV/SOF; Drug: RBV

What is being measured

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

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
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
Measured: Up to 24 weeks

Secondary outcomes (23)

Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)
SVR2 was defined as HCV RNA < LLOQ at 2 weeks after stopping study treatment.
Measured: Posttreatment Week 2
Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Measured: Posttreatment Week 4
Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)
SVR8 was defined as HCV RNA < LLOQ at 8 weeks after stopping study treatment.
Measured: Posttreatment Week 8
Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Measured: Posttreatment Week 24
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 on 2 consecutive measurements while on treatment), or
- Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on 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
Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12
pTVR was defined as HCV RNA < LLOQ at Week 12 after transplant.
Measured: Posttreatment Week 12
Percentage of Participants With HCV RNA < LLOQ at Week 1
Measured: Week 1
Percentage of Participants With HCV RNA < LLOQ at Week 2
Measured: Week 2
Percentage of Participants With HCV RNA < LLOQ at Week 4
Measured: Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 6
Measured: Week 6
Percentage of Participants With HCV RNA < LLOQ at Week 8
Measured: Week 8
Percentage of Participants With HCV RNA < LLOQ at Week 12
Measured: Week 12
Percentage of Participants With HCV RNA < LLOQ at Week 16
Measured: Week 16
Percentage of Participants With HCV RNA < LLOQ at Week 20
Measured: Week 20
Percentage of Participants With HCV RNA < LLOQ at Week 24
Measured: Week 24
HCV RNA Levels and Change From Baseline at Week 1
Measured: Baseline; Week 1
HCV RNA Levels and Change From Baseline at Week 2
Measured: Baseline; Week 2
HCV RNA Levels and Change From Baseline at Week 4
Measured: Baseline; Week 4
HCV RNA Levels and Change From Baseline at Week 6
Measured: Baseline; Week 6
HCV RNA Levels and Change From Baseline at Week 8
Measured: Baseline; Week 8
HCV RNA Levels and Change From Baseline at Week 12
Measured: Baseline; Week 12
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score
Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.
Measured: Baseline to Posttreatment Week 4
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score
CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for entry into the study was 12); higher scores/increased scores indicate greater severity of disease. Groups are arranged by cohort, then by duration of treatment, then by CPT class at baseline.
Measured: Baseline to Posttreatment Week 4

Timeline

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

Jan 2014Aug 2015

First posted12 Dec 2013 (estimated)
Study startJan 2014
Primary completionMay 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic HCV InfectionStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 334 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02010255
Sponsor's protocol ID: GS-US-337-0124
Other IDs: 2013-002802-30
Status last verified: May 2016
First submitted: 9 Dec 2013
Last updated: 19 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
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

Manns M, Samuel D, Gane EJ, Mutimer D, McCaughan G, Buti M, Prieto M, Calleja JL, Peck-Radosavljevic M, Mullhaupt B, Agarwal K, Angus P, Yoshida EM, Colombo M, Rizzetto M, Dvory-Sobol H, Denning J, Arterburn S, Pang PS, Brainard D, McHutchison JG, Dufour JF, Van Vlierberghe H, van Hoek B, Forns X; SOLAR-2 investigators. Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial. Lancet Infect Dis. 2016 Jun;16(6):685-697. doi: 10.1016/S1473-3099(16)00052-9. Epub 2016 Feb 18.
PubMed 26907736

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Chronic HCV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant
ClinicalTrials.gov ID: NCT02010255
Acronym / sponsor ID: GS-US-337-0124
Conditions: Chronic HCV Infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 334 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: Jan 2014
Primary completion: May 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 12 Dec 2013 (estimated)
Results: Posted 20 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;
Cohort B: post-liver transplant, with or without cirrhosis;
Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups)
Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 14

Arm	Type	Receives
Cohort A, Group 1 (12 wk): CPT Class B (7-9)	Experimental	Drug: LDV/SOF, Drug: RBVLDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
Cohort A, Group 1 (24 wk): CPT Class B (7-9)	Experimental	Drug: LDV/SOF, Drug: RBVLDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
Cohort A, Group 2 (12 wk): CPT Class C (10-12)	Experimental	Drug: LDV/SOF, Drug: RBVLDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Cohort A, Group 2 (24 wk): CPT Class C (10-12)	Experimental	Drug: LDV/SOF, Drug: RBVLDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis	Experimental	Drug: LDV/SOF, Drug: RBVLDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis	Experimental	Drug: LDV/SOF, Drug: RBVLDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
Cohort B, Group 4 (12 wk): CPT Class A (5-6)	Experimental	Drug: LDV/SOF, Drug: RBVLDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
Cohort B, Group 4 (24 wk): CPT Class A (5-6)	Experimental	Drug: LDV/SOF, Drug: RBVLDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
Cohort B, Group 5 (12 wk): CPT Class B (7-9)	Experimental	Drug: LDV/SOF, Drug: RBVLDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
Cohort B, Group 5 (24 wk): CPT Class B (7-9)	Experimental	Drug: LDV/SOF, Drug: RBVLDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
Cohort B, Group 6 (12 wk): CPT Class C (10-12)	Experimental	Drug: LDV/SOF, Drug: RBVLDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
Cohort B, Group 6 (24 wk): CPT Class C (10-12)	Experimental	Drug: LDV/SOF, Drug: RBVLDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
Cohort B, Group 7 (12 wk): FCH	Experimental	Drug: LDV/SOF, Drug: RBVLDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
Cohort B, Group 7 (24 wk): FCH	Experimental	Drug: LDV/SOF, Drug: RBVLDV/SOF (90/400 mg) plus RBV (weight-based: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Able to provide written informed consent
Chronic genotype 1 and/or 4 HCV infection
Normal ECG
Negative serum pregnancy test for female subjects
Male subjects and female subjects of childbearing potential must agree to use contraception

Key exclusion criteria (13 listed)

Serious or active medical or psychiatric illness
HIV or hepatitis B viral (HBV) infection
Stomach disorder that could interfere with the absorption of the study drug
Treated with an anti-HCV medication in the last 30 days
Any prior exposure to an HCV nonstructural protein (NS)5a-specific inhibitor

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LDV/SOFAlso: Harvoni®, GS-5885/GS-7977LDV/SOF FDC tablet administered orally once daily	Drug	Cohort A, Group 1 (12 wk): CPT Class B (7-9), Cohort A, Group 1 (24 wk): CPT Class B (7-9), Cohort A, Group 2 (12 wk): CPT Class C (10-12), Cohort A, Group 2 (24 wk): CPT Class C (10-12), Cohort B, Group 3 (12 wk): F0-F3 Fibrosis, Cohort B, Group 3 (24 wk): F0-F3 Fibrosis, Cohort B, Group 4 (12 wk): CPT Class A (5-6), Cohort B, Group 4 (24 wk): CPT Class A (5-6), Cohort B, Group 5 (12 wk): CPT Class B (7-9), Cohort B, Group 5 (24 wk): CPT Class B (7-9), Cohort B, Group 6 (12 wk): CPT Class C (10-12), Cohort B, Group 6 (24 wk): CPT Class C (10-12), Cohort B, Group 7 (12 wk): FCH, Cohort B, Group 7 (24 wk): FCH
RBVRBV tablets administered orally in a divided daily dose	Drug	Cohort A, Group 1 (12 wk): CPT Class B (7-9), Cohort A, Group 1 (24 wk): CPT Class B (7-9), Cohort A, Group 2 (12 wk): CPT Class C (10-12), Cohort A, Group 2 (24 wk): CPT Class C (10-12), Cohort B, Group 3 (12 wk): F0-F3 Fibrosis, Cohort B, Group 3 (24 wk): F0-F3 Fibrosis, Cohort B, Group 4 (12 wk): CPT Class A (5-6), Cohort B, Group 4 (24 wk): CPT Class A (5-6), Cohort B, Group 5 (12 wk): CPT Class B (7-9), Cohort B, Group 5 (24 wk): CPT Class B (7-9), Cohort B, Group 6 (12 wk): CPT Class C (10-12), Cohort B, Group 6 (24 wk): CPT Class C (10-12), Cohort B, Group 7 (12 wk): FCH, Cohort B, Group 7 (24 wk): FCH

Primary outcome

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.
Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
Time frame: Up to 24 weeks

23 secondary outcomes

Percentage of Participants With SVR 2 Weeks After Discontinuation of Therapy (SVR2)
Time frame: Posttreatment Week 2
Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
Time frame: Posttreatment Week 4
Percentage of Participants With SVR 8 Weeks After Discontinuation of Therapy (SVR8)
Time frame: Posttreatment Week 8
Percentage of Participants With SVR 24 Weeks After Discontinuation of Therapy (SVR24)
Time frame: Posttreatment Week 24
Percentage of Participants With Virologic Failure
Time frame: Up to Posttreatment Week 24
Percentage of Participants With Posttransplant Virologic Response (pTVR) at Posttransplant Week 12
Time frame: Posttreatment Week 12
Percentage of Participants With HCV RNA < LLOQ at Week 1
Time frame: Week 1
Percentage of Participants With HCV RNA < LLOQ at Week 2
Time frame: Week 2
Percentage of Participants With HCV RNA < LLOQ at Week 4
Time frame: Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 6
Time frame: Week 6
Percentage of Participants With HCV RNA < LLOQ at Week 8
Time frame: Week 8
Percentage of Participants With HCV RNA < LLOQ at Week 12
Time frame: Week 12
Percentage of Participants With HCV RNA < LLOQ at Week 16
Time frame: Week 16
Percentage of Participants With HCV RNA < LLOQ at Week 20
Time frame: Week 20
Percentage of Participants With HCV RNA < LLOQ at Week 24
Time frame: Week 24
HCV RNA Levels and Change From Baseline at Week 1
Time frame: Baseline; Week 1
HCV RNA Levels and Change From Baseline at Week 2
Time frame: Baseline; Week 2
HCV RNA Levels and Change From Baseline at Week 4
Time frame: Baseline; Week 4
HCV RNA Levels and Change From Baseline at Week 6
Time frame: Baseline; Week 6
HCV RNA Levels and Change From Baseline at Week 8
Time frame: Baseline; Week 8
HCV RNA Levels and Change From Baseline at Week 12
Time frame: Baseline; Week 12
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in MELD Score
Time frame: Baseline to Posttreatment Week 4
Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 4 in CPT Score
Time frame: Baseline to Posttreatment Week 4

Results and safety

Results posted to the registry on 20 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A, Group 1 (12 wk): CPT Class B (7-9)	28	22
Cohort A, Group 1 (24 wk): CPT Class B (7-9)	28	26
Cohort A, Group 2 (12 wk): CPT Class C (10-12)	25	18
Cohort A, Group 2 (24 wk): CPT Class C (10-12)	26	20
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis	52	48
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis	49	49
Cohort B, Group 4 (12 wk): CPT Class A (5-6)	34	33
Cohort B, Group 4 (24 wk): CPT Class A (5-6)	33	32
Cohort B, Group 5 (12 wk): CPT Class B (7-9)	22	21
Cohort B, Group 5 (24 wk): CPT Class B (7-9)	23	23
Cohort B, Group 6 (12 wk): CPT Class C (10-12)	3	1
Cohort B, Group 6 (24 wk): CPT Class C (10-12)	5	4
Cohort B, Group 7 (12 wk): FCH	3	3
Cohort B, Group 7 (24 wk): FCH	3	2

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

Time frame: Posttreatment Week 12. Number. Unit: percentage of participants

Measure	Cohort A, Group 1 (12 wk): CPT Class B (7-9) n = 26	Cohort A, Group 1 (24 wk): CPT Class B (7-9) n = 25	Cohort A, Group 2 (12 wk): CPT Class C (10-12) n = 21	Cohort A, Group 2 (24 wk): CPT Class C (10-12) n = 25	Cohort B, Group 3 (12 wk): F0-F3 Fibrosis n = 52	Cohort B, Group 3 (24 wk): F0-F3 Fibrosis n = 49	Cohort B, Group 4 (12 wk): CPT Class A (5-6) n = 34	Cohort B, Group 4 (24 wk): CPT Class A (5-6) n = 33	Cohort B, Group 5 (12 wk): CPT Class B (7-9) n = 22	Cohort B, Group 5 (24 wk): CPT Class B (7-9) n = 23	Cohort B, Group 6 (12 wk): CPT Class C (10-12) n = 3	Cohort B, Group 6 (24 wk): CPT Class C (10-12) n = 5	Cohort B, Group 7 (12 wk): FCH n = 3	Cohort B, Group 7 (24 wk): FCH n = 2
Value	84.6	96.0	81.0	76.0	94.2	100.0	97.1	97.0	95.5	100.0	33.3	80.0	100.0	100.0

Population analysed: Full Analysis Set: participants who were randomized and received at least one dose of study drug. Participants in Cohort A who received a liver transplant prior to the lower bound of the Posttreatment Week 12 visit were not included in the analysis.

Primary outcome: Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event

Time frame: Up to 24 weeks. Number. Unit: percentage of participants

Measure	Cohort A, Group 1 (12 wk): CPT Class B (7-9) n = 28	Cohort A, Group 1 (24 wk): CPT Class B (7-9) n = 28	Cohort A, Group 2 (12 wk): CPT Class C (10-12) n = 25	Cohort A, Group 2 (24 wk): CPT Class C (10-12) n = 26	Cohort B, Group 3 (12 wk): F0-F3 Fibrosis n = 52	Cohort B, Group 3 (24 wk): F0-F3 Fibrosis n = 49	Cohort B, Group 4 (12 wk): CPT Class A (5-6) n = 34	Cohort B, Group 4 (24 wk): CPT Class A (5-6) n = 33	Cohort B, Group 5 (12 wk): CPT Class B (7-9) n = 22	Cohort B, Group 5 (24 wk): CPT Class B (7-9) n = 23	Cohort B, Group 6 (12 wk): CPT Class C (10-12) n = 3	Cohort B, Group 6 (24 wk): CPT Class C (10-12) n = 5	Cohort B, Group 7 (12 wk): FCH n = 3	Cohort B, Group 7 (24 wk): FCH n = 2
Discontinued LDV/SOF	3.6	3.6	0.0	7.7	1.9	0.0	0.0	3.0	0.0	0.0	0.0	20.0	0.0	0.0
Discontinued Any Study Drug	3.6	7.1	16.0	23.1	5.8	6.1	0.0	15.2	18.2	17.4	33.3	20.0	0.0	0.0

Population analysed: Safety Analysis Set: participants who were randomized and received at least one dose of study drug

23 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 24 weeks on treatment plus 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A, Group 1 (12 wk): CPT Class B (7-9)	3 of 28 (10.7%)	25 of 28 (89.3%)	Not reported
Cohort A, Group 1 (24 wk): CPT Class B (7-9)	6 of 28 (21.4%)	25 of 28 (89.3%)	Not reported
Cohort A, Group 2 (12 wk): CPT Class C (10-12)	13 of 25 (52%)	23 of 25 (92%)	Not reported
Cohort A, Group 2 (24 wk): CPT Class C (10-12)	10 of 26 (38.5%)	23 of 26 (88.5%)	Not reported
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis	9 of 52 (17.3%)	49 of 52 (94.2%)	Not reported
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis	5 of 49 (10.2%)	48 of 49 (98%)	Not reported
Cohort B, Group 4 (12 wk): CPT Class A (5-6)	3 of 34 (8.8%)	27 of 34 (79.4%)	Not reported
Cohort B, Group 4 (24 wk): CPT Class A (5-6)	7 of 33 (21.2%)	30 of 33 (90.9%)	Not reported
Cohort B, Group 5 (12 wk): CPT Class B (7-9)	5 of 22 (22.7%)	20 of 22 (90.9%)	Not reported
Cohort B, Group 5 (24 wk): CPT Class B (7-9)	6 of 23 (26.1%)	20 of 23 (87%)	Not reported
Cohort B, Group 6 (12 wk): CPT Class C (10-12)	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Cohort B, Group 6 (24 wk): CPT Class C (10-12)	2 of 5 (40%)	5 of 5 (100%)	Not reported
Cohort B, Group 7 (12 wk): FCH	2 of 3 (66.7%)	3 of 3 (100%)	Not reported
Cohort B, Group 7 (24 wk): FCH	1 of 2 (50%)	2 of 2 (100%)	Not reported

Limitations and caveats (from the sponsor): There were no limitations affecting the analysis or results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26907736Manns M, Samuel D, Gane EJ, Mutimer D, McCaughan G, Buti M, Prieto M, Calleja JL, Peck-Radosavljevic M, Mullhaupt B, Agarwal K, Angus P, Yoshida EM, Colombo M, Rizzetto M, Dvory-Sobol H, Denning J, Arterburn S, Pang PS, Brainard D, McHutchison JG, Dufour JF, Van Vlierberghe H, van Hoek B, Forns X; SOLAR-2 investigators. Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial. Lancet Infect Dis. 2016 Jun;16(6):685-697. doi: 10.1016/S1473-3099(16)00052-9. Epub 2016 Feb 18.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shampa De-Oertel, PhD study director

Gilead Sciences

34 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LDV/SOF and RBV in people with Chronic HCV Infection, run by Gilead Sciences at 34 sites in 12 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 6 inclusion and 13 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 19 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 34 sites in Canada, France, Germany, Spain, United Kingdom and 7 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 20 Jun 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 NCT02010255, which also lists 1 linked publication.

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 19 Nov 2018.