Hepatitis C Virus InfectionPhase 3ASTRAL-5NCT02480712

Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

A Phase 3 study testing SOF/VEL in people with Hepatitis C Virus Infection, run by Gilead Sciences at 15 sites in United States.

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

The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatitis C Virus Infection
What is being tested?: SOF/VEL
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 107 participants
Where: 15 sitesUnited States
Study dates: 1 Jul 2015to 22 Jun 2016
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
HCV genotype 1, 2, 3, 4, 5, 6
Cirrhosis determination, a fibroscan or liver biopsy may be required
HIV-1 infection
Use of protocol specified method(s) of contraception
Screening laboratory values within defined thresholds

Who cannot join

Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC) or other malignancy (with the exception of certain resolved skin cancers)
Screening ECG with clinically significant abnormalities
Pregnant or nursing female or male with pregnant female partner
Infection with hepatitis B virus (HBV)
Use of any prohibited concomitant medications as described in the protocol
Chronic use of systemically administered immunosuppressive agents
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Study site
Atlanta, Georgia
Study site
Baltimore, Maryland
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Durham, North Carolina
Study site
Los Angeles, California
Study site
Lutherville, Maryland
Study site
New York, New York
Study site
Richmond, Virginia
Study site
San Diego, California
Study site
San Francisco, California
Study site
The Bronx, New York
Study site
Torrance, California

Other trials in United States

About this study

Official title: A Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection

Conditions: Hepatitis C Virus Infection
Being tested: SOF/VEL
Medical subject headings: Hepatitis C

What participants receive

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

SOF/VELDrug
Also called GS-7977/GS-5816, Epclusa®
400/100 mg fixed-dose combination (FDC) tablet administered orally once daily

Study groups in NCT02480712
Study group	Role	What they receive
SOF/VEL	Experimental	Participants will receive SOF/VEL for 12 weeks Receives: Drug: SOF/VEL

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) 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 12 weeks

Secondary outcomes (6)

Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Measured: Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ on Treatment
Measured: Up to 12 Weeks
HCV RNA Change From Baseline/Day 1
Measured: Baseline to Week 12
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 That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment
Measured: Up to 12 Weeks
Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12
Measured: Week 12; Posttreatment Week 12

Timeline

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

1 Jul 201522 Jun 2016

First posted24 Jun 2015 (estimated)
Study start1 Jul 2015
Primary completion29 Apr 2016
Study completion22 Jun 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 (2)Papers the sponsor has linked to this study.
Other trials for Hepatitis C Virus 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02480712
Sponsor's protocol ID: GS-US-342-1202
Acronym: ASTRAL-5
Status last verified: Apr 2017
First submitted: 22 Jun 2015
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

Wyles D, Brau N, Kottilil S, Daar E, Workowski K, Luetkemeyer A, et al. Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Patients Co-Infected with HCV and HIV-1: The Phase 3 ASTRAL-5 Study [Abstract PS104]. 2016 European Association for the Study of the Liver (EASL), Barcelona, Spain.
Wyles D, Brau N, Kottilil S, Daar ES, Ruane P, Workowski K, Luetkemeyer A, Adeyemi O, Kim AY, Doehle B, Huang KC, Mogalian E, Osinusi A, McNally J, Brainard DM, McHutchison JG, Naggie S, Sulkowski M; ASTRAL-5 Investigators. Sofosbuvir and Velpatasvir for the Treatment of Hepatitis C Virus in Patients Coinfected With Human Immunodeficiency Virus Type 1: An Open-Label, Phase 3 Study. Clin Infect Dis. 2017 Jul 1;65(1):6-12. doi: 10.1093/cid/cix260.
PubMed 28369210

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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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 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
ClinicalTrials.gov ID: NCT02480712
Acronym / sponsor ID: ASTRAL-5 / GS-US-342-1202
Conditions: Hepatitis C Virus Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 1 Jul 2015 (actual)
Primary completion: 29 Apr 2016 (actual)
Study completion: 22 Jun 2016 (actual)
First posted: 24 Jun 2015 (estimated)
Results: Posted 1 Jun 2017

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SOF/VEL	Experimental	Drug: SOF/VELParticipants will receive SOF/VEL for 12 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)

HCV RNA ≥ 10^4 IU/mL at screening
HCV genotype 1, 2, 3, 4, 5, 6
Cirrhosis determination, a fibroscan or liver biopsy may be required
HIV-1 infection
Use of protocol specified method(s) of contraception

Key exclusion criteria (8 listed)

Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC) or other malignancy (with the exception of certain resolved skin cancers)
Screening ECG with clinically significant abnormalities
Pregnant or nursing female or male with pregnant female partner
Infection with hepatitis B virus (HBV)

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
SOF/VELAlso: GS-7977/GS-5816, Epclusa®400/100 mg fixed-dose combination (FDC) tablet administered orally once daily	Drug	SOF/VEL

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) 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 12 weeks

6 secondary outcomes

Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time frame: Posttreatment Weeks 4 and 24
Percentage of Participants With HCV RNA < LLOQ on Treatment
Time frame: Up to 12 Weeks
HCV RNA Change From Baseline/Day 1
Time frame: Baseline to Week 12
Percentage of Participants With Virologic Failure
Time frame: Up to Posttreatment Week 24
Percentage of Participants That Maintained HIV-1 RNA < 50 Copies/mL While On HCV Treatment
Time frame: Up to 12 Weeks
Serum Creatinine Change From Baseline At the End of Treatment and At Posttreatment Week 12
Time frame: Week 12; Posttreatment Week 12

Results and safety

Results posted to the registry on 1 Jun 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
SOF/VEL 12 Weeks	107	96

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/VEL 12 Weeks n = 106
Value	95.3 (89.3 to 98.5)

Population analysed: Full Analysis Set: All enrolled participants who received at least one dose of study drug.

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

Time frame: Up to 12 weeks. Number. Unit: percentage of participants

Measure	SOF/VEL 12 Weeks n = 106
Value	1.9

Population analysed: Safety Analysis Set

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 12 Weeks Plus 30 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)	2 of 56 (3.6%)	34 of 56 (60.7%)	Not reported
SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)	0 of 35 (0%)	19 of 35 (54.3%)	Not reported
SOF/VEL 12 Weeks (Non TDF Containing Regimens)	0 of 15 (0%)	9 of 15 (60%)	Not reported

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 publicationWyles D, Brau N, Kottilil S, Daar E, Workowski K, Luetkemeyer A, et al. Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Patients Co-Infected with HCV and HIV-1: The Phase 3 ASTRAL-5 Study [Abstract PS104]. 2016 European Association for the Study of the Liver (EASL), Barcelona, Spain.
Derived from this study: PubMed 28369210Wyles D, Brau N, Kottilil S, Daar ES, Ruane P, Workowski K, Luetkemeyer A, Adeyemi O, Kim AY, Doehle B, Huang KC, Mogalian E, Osinusi A, McNally J, Brainard DM, McHutchison JG, Naggie S, Sulkowski M; ASTRAL-5 Investigators. Sofosbuvir and Velpatasvir for the Treatment of Hepatitis C Virus in Patients Coinfected With Human Immunodeficiency Virus Type 1: An Open-Label, Phase 3 Study. Clin Infect Dis. 2017 Jul 1;65(1):6-12. doi: 10.1093/cid/cix260.
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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Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
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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

15 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 SOF/VEL in people with Hepatitis C Virus Infection, run by Gilead Sciences at 15 sites in United States.

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 8 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 15 sites in United States. 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 1 Jun 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 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 NCT02480712, which also lists 2 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.