Chronic HCV InfectionPhase 3NCT02074514

Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection

A Phase 3 study testing Sofosbuvir and RBV in people with Chronic HCV Infection, run by Gilead Sciences at 13 sites in India.

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 sofosbuvir (SOF) + ribavirin (RBV) in treatment-naive adults with chronic genotype 1 or 3 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?: Sofosbuvir and RBV
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 117 participants
Where: 13 sitesIndia
Study dates: Mar 2014to Nov 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

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

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

Who may be able to join

HCV RNA ≥10^4 IU/mL at screening
Confirmed chronic HCV genotype 1 or 3 infection
HCV treatment naive
Approximately 30% of individuals may have compensated cirrhosis at screening

Who cannot join

Any other chronic liver disease
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Current or prior history of clinical hepatic de-compensation
Contraindication to RBV therapy, e.g., history of clinically significant hemoglobinopathy (sickle cell disease, thalassemia).
Chronic use of systemically administered immunosuppressive agents
History of solid organ transplantation

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

India13 sites

Study site
Chandigarh, Chandigarh, 160012
Study site
Coimbatore, Tamil Nadu, 641 005
Study site
Gurgaon, Haryana, 122 001
Study site
Hyderabad, Andhra Pradesh, 500 004
Study site
Jaipur, Rajasthan, 302004
Study site
Kochi, Kerala, 682040
Study site
Kolkata, West Bengal, 700 020
Study site
Lucknow, Uttar Pradesh, 226014
Study site
Ludhiana, Punjab, 141001
Study site
Mumbai, Maharashtra, 400012
Study site
New Delhi, National Capital Territory of Delhi, 110029
Study site
New Delhi, National Capital Territory of Delhi, 110070
Study site
Surat, Gujarat, 395002

Other trials in India

About this study

Official title: A Phase 3b, Multi-Center, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Chronic Genotype 1 or 3 Hepatitis C Virus Infection

Conditions: Chronic HCV Infection
Being tested: Sofosbuvir, RBV

What participants receive

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

SofosbuvirDrug
Also called Sovaldi®, GS-7977, PSI-7977
400 mg tablet administered orally once daily
RBVDrug
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)

Study groups in NCT02074514
Study group	Role	What they receive
Sofosbuvir+RBV 16 weeks	Experimental	Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 16 weeks. Receives: Drug: Sofosbuvir; Drug: RBV
Sofosbuvir+RBV 24 weeks	Experimental	Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 24 weeks. Receives: Drug: Sofosbuvir; 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 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug.
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 (2)

Percentage of Participants With Sustained Virologic Response (SVR) 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 after stopping study treatment, respectively.
Measured: Posttreatment Weeks 4 and 24
Percentage of Participants With Virologic Failure and Viral Relapse
Virologic failure was defined as:
- On-treatment virologic failure:
- Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
- Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
- Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
- Virologic relapse:
- Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Measured: Up to Posttreatment Week 24

Timeline

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

Mar 2014Nov 2015

First posted28 Feb 2014 (estimated)
Study startMar 2014
Primary completionSep 2015
Study completionNov 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 (3)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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02074514
Sponsor's protocol ID: GS-US-334-0116
Status last verified: Sep 2016
First submitted: 26 Feb 2014
Last updated: 25 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Shah S, Acharya SK, Mehta R., Kapoor D, Duseja A, Koshy A, et al. (2016) "Sofosbuvir Plus Ribavirin in the Treatment of Chronic HCV Infection in India." Hepatol Int. 10 (Suppl 1): S15.
Shah S, Chowdhury A, Mehta R, Kapoor D, Duseja A, Koshy A, et al. Sofosbuvir plus Ribavirin Results in High SVR4 Rates in Patients with Chronic HCV Genotype 1 or 3 Infection in India (Poster L-47). 56th Annual Conference of Indian Society of Gastroenterology; 2015, November, 19-22 Indore, India.
Shah SR, Chowdhury A, Mehta R, Kapoor D, Duseja A, Koshy A, Shukla A, Sood A, Madan K, Sud R, Nijhawan S, Pawan R, Prasad M, Kersey K, Jiang D, Svarovskaia E, Doehle B, Kanwar B, Subramanian M, Acharya SK, Sarin S. Sofosbuvir plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 or 3 infection in India. J Viral Hepat. 2017 May;24(5):371-379. doi: 10.1111/jvh.12654. Epub 2016 Dec 9.
PubMed 27933698

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

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
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 HCV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3b, Multi-Center, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Chronic Genotype 1 or 3 Hepatitis C Virus Infection
ClinicalTrials.gov ID: NCT02074514
Acronym / sponsor ID: GS-US-334-0116
Conditions: Chronic HCV Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Sep 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 28 Feb 2014 (estimated)
Results: Posted 25 Oct 2016

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sofosbuvir+RBV 16 weeks	Experimental	Drug: Sofosbuvir, Drug: RBVParticipants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 16 weeks.
Sofosbuvir+RBV 24 weeks	Experimental	Drug: Sofosbuvir, Drug: RBVParticipants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 24 weeks.

Who may qualify

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

Key inclusion criteria (4 listed)

HCV RNA ≥10^4 IU/mL at screening
Confirmed chronic HCV genotype 1 or 3 infection
HCV treatment naive
Approximately 30% of individuals may have compensated cirrhosis at screening

Key exclusion criteria (6 listed)

Any other chronic liver disease
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Current or prior history of clinical hepatic de-compensation
Contraindication to RBV therapy, e.g., history of clinically significant hemoglobinopathy (sickle cell disease, thalassemia).
Chronic use of systemically administered immunosuppressive agents

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
SofosbuvirAlso: Sovaldi®, GS-7977, PSI-7977400 mg tablet administered orally once daily	Drug	Sofosbuvir+RBV 16 weeks, Sofosbuvir+RBV 24 weeks
RBV200 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)	Drug	Sofosbuvir+RBV 16 weeks, Sofosbuvir+RBV 24 weeks

Primary outcome

Percentage of Participants With Sustained Virologic Response 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) 12 weeks following the last dose of study drug.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to 24 weeks

2 secondary outcomes

Percentage of Participants With Sustained Virologic Response (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 and Viral Relapse
Time frame: Up to Posttreatment Week 24

Results and safety

Results posted to the registry on 25 Oct 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
SOF+RBV 16 Weeks	59	56
SOF+RBV 24 Weeks	58	54

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

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

Measure	SOF + RBV 16 Weeks GT1 n = 30	SOF + RBV 24 Weeks GT1 n = 28	SOF + RBV 16 Weeks GT3 n = 29	SOF + RBV 24 Weeks GT3 n = 30
Value	90 (73.5 to 97.9)	96.4 (81.7 to 99.9)	100.0 (88.1 to 100.0)	93.3 (77.9 to 99.2)

Population analysed: Full Analysis Set (FAS): participants with genotype 1 or 3 HCV infection who were randomized 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	SOF + RBV 16 Weeks n = 59	SOF + RBV 24 Weeks n = 58
Value	0	3.4

Population analysed: Safety Analysis Set

2 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
SOF + RBV 16 Weeks	1 of 59 (1.7%)	32 of 59 (54.2%)	Not reported
SOF + RBV 24 Weeks	1 of 58 (1.7%)	27 of 58 (46.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationShah S, Acharya SK, Mehta R., Kapoor D, Duseja A, Koshy A, et al. (2016) "Sofosbuvir Plus Ribavirin in the Treatment of Chronic HCV Infection in India." Hepatol Int. 10 (Suppl 1): S15.
Results publicationShah S, Chowdhury A, Mehta R, Kapoor D, Duseja A, Koshy A, et al. Sofosbuvir plus Ribavirin Results in High SVR4 Rates in Patients with Chronic HCV Genotype 1 or 3 Infection in India (Poster L-47). 56th Annual Conference of Indian Society of Gastroenterology; 2015, November, 19-22 Indore, India.
Derived from this study: PubMed 27933698Shah SR, Chowdhury A, Mehta R, Kapoor D, Duseja A, Koshy A, Shukla A, Sood A, Madan K, Sud R, Nijhawan S, Pawan R, Prasad M, Kersey K, Jiang D, Svarovskaia E, Doehle B, Kanwar B, Subramanian M, Acharya SK, Sarin S. Sofosbuvir plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 or 3 infection in India. J Viral Hepat. 2017 May;24(5):371-379. doi: 10.1111/jvh.12654. Epub 2016 Dec 9.

Related trials for Chronic HCV Infection

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
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

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.

Kathryn Kersey, MSc study director

Gilead Sciences

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sofosbuvir and RBV in people with Chronic HCV Infection, run by Gilead Sciences at 13 sites in India.

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

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in India. 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 25 Oct 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 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 NCT02074514, 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 25 Oct 2016.