Chronic Hepatitis CPhase 2LEPTONNCT02202980

Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection

A Phase 2 study testing LDV/SOF, RBV and SOF/VEL in people with Chronic Hepatitis C, run by Gilead Sciences at 2 sites in New Zealand.

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 antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic 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 Hepatitis C
What is being tested?: LDV/SOF, RBV and SOF/VEL
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 273 participants
Where: 2 sitesNew Zealand
Study dates: 4 Aug 2014to 9 May 2016
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

Willing and able to provide written informed consent
Chronic HCV infection
Cirrhosis determination (liver biopsy may be required)
Screening laboratory values within specified limits
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Specific genotype, prior medical history, or concurrent disease as required by the specific study group

Who cannot join

History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Pregnant or nursing female, or male with pregnant female partner
Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
Use of any prohibited concomitant medications
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

2 sites in 1 country.

New Zealand2 sites

Study site
Auckland
Study site
Christchurch

Other trials in New Zealand

About this study

Official title: A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection

This study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.

Conditions: Chronic Hepatitis C
Being tested: LDV/SOF, RBV, SOF/VEL, VOX
Medical subject headings: Hepatitis C, Chronic

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
90/400 mg FDC tablet administered orally once daily
RBVDrug
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/VELDrug
Also called Epclusa®, GS-7977/GS-5816
400/100 mg FDC tablet administered orally once daily
VOXDrug
Also called GS-9857
100 mg tablet administered orally once daily with food

Study groups in NCT02202980
Study group	Role	What they receive
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)	Experimental	Participants who previously received ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) for ≥ 12 weeks without achieving sustained virologic response at 12 weeks following treatment (SVR12) will receive LDV/SOF+RBV for 24 weeks. Receives: Drug: LDV/SOF; Drug: RBV
LDV/SOF+RBV 12 Weeks (Cohort 1 Group 2)	Experimental	Participants who previously received a sofosbuvir-based regimen without achieving SVR12 were initially enrolled to receive LDV/SOF+RBV for 12 weeks (excluding participants who previously received LDV/SOF+RBV for ≥ 12 weeks). Participants who did not achieve sustained virologic response at 12 weeks were then moved to Cohort 1 Group 1. Receives: Drug: LDV/SOF; Drug: RBV
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)	Experimental	Participants with genotype 2 (GT2) HCV infection will receive LDV/SOF FDC for 12 weeks. Receives: Drug: LDV/SOF
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)	Experimental	Participants with GT2 HCV infection will receive LDV/SOF FDC for 8 weeks. Receives: Drug: LDV/SOF
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)	Experimental	Participants with genotypes 1 (GT1), 2 (GT2), or 4 (GT4) HCV infection and extrahepatic manifestations of chronic HCV infection will receive LDV/SOF FDC for 12 weeks. Receives: Drug: LDV/SOF
LDV/SOF+RBV 12 Weeks GT3 (Cohort 3 Group 2)	Experimental	Participants with genotype 3 (GT3) HCV infection and extrahepatic manifestations of chronic HCV infection will receive LDV/SOF FDC plus RBV for 12 weeks. Receives: Drug: LDV/SOF; Drug: RBV
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)	Experimental	Treatment-naive participants with GT1 HCV infection without cirrhosis will receive VOX only on Day 1 followed by sofosbuvir/velpatasvir (SOF/VEL) + voxilaprevir (VOX) for 6 weeks. Receives: Drug: SOF/VEL; Drug: VOX
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)	Experimental	Treatment-naive participants with GT1 HCV infection without cirrhosis will receive SOF/VEL+VOX for 4 weeks. Receives: Drug: SOF/VEL; Drug: VOX
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)	Experimental	Treatment-naive participants with GT1 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks. Receives: Drug: SOF/VEL; Drug: VOX
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)	Experimental	Treatment-naive participants with GT3 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks. Receives: Drug: SOF/VEL; Drug: VOX
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)	Experimental	Treatment-experienced participants with GT1 HCV infection with cirrhosis who were previously treated with pegylated interferon (Peg-IFN)+RBV will receive SOF/VEL+VOX for 6 weeks. Receives: Drug: SOF/VEL; Drug: VOX
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)	Experimental	Treatment-experienced participants with GT3 HCV infection with cirrhosis who were previously treated with Peg-IFN+RBV will receive SOF/VEL+VOX for 6 weeks. Receives: Drug: SOF/VEL; Drug: VOX
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)	Experimental	Treatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with non-structural protein (NS3/4A) protease inhibitor (PI) will receive SOF/VEL+VOX for 6 weeks. Receives: Drug: SOF/VEL; Drug: VOX
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)	Experimental	Treatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with direct-acting antivirals (DAA) will receive SOF/VEL+VOX for 6 weeks. Receives: Drug: SOF/VEL; Drug: VOX
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)	Experimental	Treatment-experienced participants with GT3 HCV infection with or without cirrhosis who were previously treated with DAA will receive SOF/VEL+VOX for 8 weeks. Receives: Drug: SOF/VEL; Drug: VOX

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 Permanently Discontinued Any Study Drug Due to an Adverse Event
Measured: Up to 24 weeks

Secondary outcomes (3)

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
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
Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
Measured: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)

Timeline

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

4 Aug 20149 May 2016

First posted29 Jul 2014 (estimated)
Study start4 Aug 2014
Primary completion16 Mar 2016
Study completion9 May 2016

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 (3)Papers the sponsor has linked to this study.
Other trials for Chronic Hepatitis CStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 273 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02202980
Sponsor's protocol ID: GS-US-337-1468
Acronym: LEPTON
Status last verified: Nov 2017
First submitted: 25 Jul 2014
Last updated: 16 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
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

Gane EJ, Svarovskaia ES, Hyland RH, Stamm LM, Osinusi A, Brainard DM, Chodavarapu K, Miller MD, Mo H, Schwabe C. Resistance Analysis of Treatment-Naive and DAA-Experienced Genotype 1 Patients with and without Cirrhosis Who Received Short-Duration Treatment with Sofosbuvir/GS-5816+ GS-9857 [Poster 713]. J Hepatol 2015;62:563A
Gane EJ, Schwabe C, Hyland RH, Yang Y, Svarovskaia E, Stamm LM, Brainard DM, McHutchison JG, Stedman CA. Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naive or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections. Gastroenterology. 2016 Sep;151(3):448-456.e1. doi: 10.1053/j.gastro.2016.05.021. Epub 2016 May 27.
PubMed 27240903
Gane EJ, Hyland RH, Yang Y, Svarovskaia E, Stamm LM, Brainard DM, McHutchison JG, Stedman CAM. Efficacy of Ledipasvir Plus Sofosbuvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2 Infection. Gastroenterology. 2017 May;152(6):1366-1371. doi: 10.1053/j.gastro.2017.01.017. Epub 2017 Jan 27.
PubMed 28137593

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?

See locations

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RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Chronic Hepatitis C trials

Study at a glance

From the registry record, last updated by the sponsor on 16 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 Assess the Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection
ClinicalTrials.gov ID: NCT02202980
Acronym / sponsor ID: LEPTON / GS-US-337-1468
Conditions: Chronic Hepatitis C
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 273 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 4 Aug 2014 (actual)
Primary completion: 16 Mar 2016 (actual)
Study completion: 9 May 2016 (actual)
First posted: 29 Jul 2014 (estimated)
Results: Posted 17 Nov 2017

Clinical summary

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

This study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 15

Arm	Type	Receives
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)	Experimental	Drug: LDV/SOF, Drug: RBVParticipants who previously received ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) for ≥ 12 weeks without achieving sustained virologic response at 12 weeks following treatment (SVR12) will receive LDV/SOF+RBV for 24 weeks.
LDV/SOF+RBV 12 Weeks (Cohort 1 Group 2)	Experimental	Drug: LDV/SOF, Drug: RBVParticipants who previously received a sofosbuvir-based regimen without achieving SVR12 were initially enrolled to receive LDV/SOF+RBV for 12 weeks (excluding participants who previously received LDV/SOF+RBV for ≥ 12 weeks). Participants who did not achieve sustained virologic response at 12 weeks were then moved to Cohort 1 Group 1.
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)	Experimental	Drug: LDV/SOFParticipants with genotype 2 (GT2) HCV infection will receive LDV/SOF FDC for 12 weeks.
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)	Experimental	Drug: LDV/SOFParticipants with GT2 HCV infection will receive LDV/SOF FDC for 8 weeks.
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)	Experimental	Drug: LDV/SOFParticipants with genotypes 1 (GT1), 2 (GT2), or 4 (GT4) HCV infection and extrahepatic manifestations of chronic HCV infection will receive LDV/SOF FDC for 12 weeks.
LDV/SOF+RBV 12 Weeks GT3 (Cohort 3 Group 2)	Experimental	Drug: LDV/SOF, Drug: RBVParticipants with genotype 3 (GT3) HCV infection and extrahepatic manifestations of chronic HCV infection will receive LDV/SOF FDC plus RBV for 12 weeks.
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)	Experimental	Drug: SOF/VEL, Drug: VOXTreatment-naive participants with GT1 HCV infection without cirrhosis will receive VOX only on Day 1 followed by sofosbuvir/velpatasvir (SOF/VEL) + voxilaprevir (VOX) for 6 weeks.
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)	Experimental	Drug: SOF/VEL, Drug: VOXTreatment-naive participants with GT1 HCV infection without cirrhosis will receive SOF/VEL+VOX for 4 weeks.
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)	Experimental	Drug: SOF/VEL, Drug: VOXTreatment-naive participants with GT1 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks.
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)	Experimental	Drug: SOF/VEL, Drug: VOXTreatment-naive participants with GT3 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks.
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)	Experimental	Drug: SOF/VEL, Drug: VOXTreatment-experienced participants with GT1 HCV infection with cirrhosis who were previously treated with pegylated interferon (Peg-IFN)+RBV will receive SOF/VEL+VOX for 6 weeks.
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)	Experimental	Drug: SOF/VEL, Drug: VOXTreatment-experienced participants with GT3 HCV infection with cirrhosis who were previously treated with Peg-IFN+RBV will receive SOF/VEL+VOX for 6 weeks.
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)	Experimental	Drug: SOF/VEL, Drug: VOXTreatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with non-structural protein (NS3/4A) protease inhibitor (PI) will receive SOF/VEL+VOX for 6 weeks.
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)	Experimental	Drug: SOF/VEL, Drug: VOXTreatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with direct-acting antivirals (DAA) will receive SOF/VEL+VOX for 6 weeks.
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)	Experimental	Drug: SOF/VEL, Drug: VOXTreatment-experienced participants with GT3 HCV infection with or without cirrhosis who were previously treated with DAA will receive SOF/VEL+VOX for 8 weeks.

Who may qualify

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

Key inclusion criteria (6 listed)

Willing and able to provide written informed consent
Chronic HCV infection
Cirrhosis determination (liver biopsy may be required)
Screening laboratory values within specified limits
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Key exclusion criteria (5 listed)

History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Pregnant or nursing female, or male with pregnant female partner
Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
Use of any prohibited concomitant medications
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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-797790/400 mg FDC tablet administered orally once daily	Drug	LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1), LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1), LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2), LDV/SOF+RBV 12 Weeks (Cohort 1 Group 2), LDV/SOF+RBV 12 Weeks GT3 (Cohort 3 Group 2), LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
RBVTablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)	Drug	LDV/SOF+RBV 12 Weeks (Cohort 1 Group 2), LDV/SOF+RBV 12 Weeks GT3 (Cohort 3 Group 2), LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
SOF/VELAlso: Epclusa®, GS-7977/GS-5816400/100 mg FDC tablet administered orally once daily	Drug	SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1), SOF/VEL+VOX 6 Weeks GT1 (Cohort 4), SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2), SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7), SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3), SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4), SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6), SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5), SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
VOXAlso: GS-9857100 mg tablet administered orally once daily with food	Drug	SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1), SOF/VEL+VOX 6 Weeks GT1 (Cohort 4), SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2), SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7), SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3), SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4), SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6), SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5), SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)

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 Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to 24 weeks

3 secondary outcomes

Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time frame: Posttreatment Weeks 4 and 24
Percentage of Participants With Virologic Failure
Time frame: Up to Posttreatment Week 24
Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
Time frame: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)

Results and safety

Results posted to the registry on 17 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)	14	13
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)	26	24
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)	27	17
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)	32	28
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)	13	7
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)	15	14
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)	15	4
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)	15	12
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)	18	14
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)	17	17
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)	19	19
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)	28	25
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)	30	19
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)	4	4

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

Time frame: Posttreatment Week 12. Number (95% Confidence Interval). Unit: percentage of participants

Measure	LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) n = 14	LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) n = 26	LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) n = 27	LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) n = 32	LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) n = 13	SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) n = 15	SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) n = 15	SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) n = 15	SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) n = 18	SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) n = 17	SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) n = 19	SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) n = 28	SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) n = 30	SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8) n = 4
Value	92.9 (66.1 to 99.8)	96.2 (80.4 to 99.9)	74.1 (53.7 to 88.9)	100.0 (89.1 to 100.0)	76.9 (46.2 to 95.0)	93.3 (68.1 to 99.8)	26.7 (7.8 to 55.1)	86.7 (59.5 to 98.3)	83.3 (58.6 to 96.4)	100.0 (80.5 to 100.0)	100.0 (82.4 to 100.0)	89.3 (71.8 to 97.7)	66.7 (47.2 to 82.7)	100.0 (39.8 to 100.0)

Population analysed: Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug

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

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

Measure	LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1) n = 14	LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1) n = 26	LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2) n = 27	LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1) n = 32	LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2) n = 13	SOF/VEL+VOX 6 Weeks GT1 (Cohort 4) n = 15	SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1) n = 15	SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2) n = 15	SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3) n = 18	SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4) n = 17	SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5) n = 19	SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6) n = 28	SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7) n = 30	SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8) n = 4
Value	7.1	0	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug

3 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)	2 of 14 (14.3%)	12 of 14 (85.7%)	0 of 14
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)	1 of 26 (3.8%)	15 of 26 (57.7%)	0 of 26
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)	2 of 27 (7.4%)	21 of 27 (77.8%)	0 of 27
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)	3 of 32 (9.4%)	24 of 32 (75%)	0 of 32
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)	2 of 13 (15.4%)	11 of 13 (84.6%)	0 of 13
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)	0 of 15 (0%)	12 of 15 (80%)	0 of 15
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)	0 of 15 (0%)	13 of 15 (86.7%)	0 of 15
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)	0 of 15 (0%)	10 of 15 (66.7%)	0 of 15
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)	0 of 18 (0%)	15 of 18 (83.3%)	0 of 18
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)	0 of 17 (0%)	15 of 17 (88.2%)	0 of 17
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)	2 of 19 (10.5%)	14 of 19 (73.7%)	0 of 19
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)	1 of 28 (3.6%)	21 of 28 (75%)	0 of 28
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)	0 of 30 (0%)	23 of 30 (76.7%)	0 of 30
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)	0 of 4 (0%)	3 of 4 (75%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationGane EJ, Svarovskaia ES, Hyland RH, Stamm LM, Osinusi A, Brainard DM, Chodavarapu K, Miller MD, Mo H, Schwabe C. Resistance Analysis of Treatment-Naive and DAA-Experienced Genotype 1 Patients with and without Cirrhosis Who Received Short-Duration Treatment with Sofosbuvir/GS-5816+ GS-9857 [Poster 713]. J Hepatol 2015;62:563A
Results publication: PubMed 27240903Gane EJ, Schwabe C, Hyland RH, Yang Y, Svarovskaia E, Stamm LM, Brainard DM, McHutchison JG, Stedman CA. Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naive or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections. Gastroenterology. 2016 Sep;151(3):448-456.e1. doi: 10.1053/j.gastro.2016.05.021. Epub 2016 May 27.
Results publication: PubMed 28137593Gane EJ, Hyland RH, Yang Y, Svarovskaia E, Stamm LM, Brainard DM, McHutchison JG, Stedman CAM. Efficacy of Ledipasvir Plus Sofosbuvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2 Infection. Gastroenterology. 2017 May;152(6):1366-1371. doi: 10.1053/j.gastro.2017.01.017. Epub 2017 Jan 27.
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.

Gilead Study Director study director

Gilead Sciences

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LDV/SOF, RBV and SOF/VEL in people with Chronic Hepatitis C, run by Gilead Sciences at 2 sites in New Zealand.

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 5 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 16 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 2 sites in New Zealand. 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 17 Nov 2017). 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 NCT02202980, 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 16 Nov 2018.