Chronic Hepatitis CPhase 3NCT01783678
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults
A Phase 3 study testing Sofosbuvir and RBV in people with Chronic Hepatitis C and Human Immunodeficiency Virus, run by Gilead Sciences at 24 sites in 6 countries.
Trial summary
This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C, Human Immunodeficiency Virus
- 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
- 275 participants
- Where
- 24 sitesin 6 countries
- Study dates
- Jan 2013to Jul 2014
- 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
- Age ≥ 18 years with HIV-1 and chronic HCV genotype 1, 2, 3, or 4 co-infection
- HCV RNA > 10,000 IU/mL at screening
- HCV treatment history:
- Treatment-naive for HCV genotypes 1, 2, 3, or 4, or
- Treatment-experienced for HCV genotypes 2 or 3
- HIV antiretroviral (ARV) criteria:
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- On a stable, protocol-approved, HIV ARV regimen with undetectable HIV RNA for > 8 weeks prior to screening, or
- ARV untreated for ≥ 8 weeks prior to screening, with a CD4 T-cell count > 500 cells/mm^3
- Presence or absence of cirrhosis; a liver biopsy may be required
- Healthy according to medical history and physical examination with the exception of HCV and HIV diagnosis
- Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication
Who cannot join
- HCV genotype 1 or 4 with previous HCV treatment
- Poor control with HIV ARV regimen requiring a possible dose modification of therapy within 4 weeks of study medication dosing
- A new AIDS-defining condition diagnosed within 30 days prior to screening
- Prior use of any other inhibitor of the HCV NS5B polymerase
- History of any other clinically significant chronic liver disease
- Evidence of or history of decompensated liver disease
Show all 11Show fewer
- Chronic hepatitis B virus (HBV) infection
- Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
- Chronic use of immunosuppressive agents or immunomodulatory agents
- Clinically relevant drug or alcohol abuse within 12 months of screening
- History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study or not be in the best interest of the participant in the opinion of the investigator
Trial locations and contacts
24 sites in 6 countries.
24 sites in 6 countries
Germany6 sites
Study site
Berlin
Study site
Bonn
Study site
Düsseldorf
Study site
Frankfurt
Study site
Hamburg
Study site
Würzburg
Italy5 sites
Study site
Bergamo
Study site
Milan
Study site
Naples
Study site
Rome
Study site
Torino
Australia4 sites
Study site
Darlinghurst, New South Wales
Study site
Melbourne, Victoria
Study site
Parkville, Victoria
Study site
Sydney, New South Wales
United Kingdom3 sites
Study site
Glasgow
Study site
London
Study site
Sussex
About this study
Official title: A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects
This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.
- Conditions
- Chronic Hepatitis C, Human Immunodeficiency Virus
- Being tested
- Sofosbuvir, RBV
- Medical subject headings
- Hepatitis C, Chronic, Acquired Immunodeficiency Syndrome
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
Sofosbuvir 400 mg tablet administered orally once daily
RBVDrug
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
| Study group | Role | What they receive |
|---|---|---|
| Genotype 2 treatment-naive | Experimental | Treatment-naive (TN) participants with HIV-1 and genotype 2 HCV coinfection will receive sofosbuvir plus RBV for 12 weeks. Receives: Drug: Sofosbuvir; Drug: RBV |
| Genotype 2/3 treatment-experienced | Experimental | Treatment-experienced (TE) participants with HIV-1 and genotype 2 or 3 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks. Receives: Drug: Sofosbuvir; Drug: RBV |
| Genotype 1/3/4 treatment-naive | Experimental | Treatment naive (TN) participants with HIV-1 and genotype 1, 3, or 4 HCV co-infection will receive sofosbuvir plus RBV 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 (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks following the last dose of study drug.
Measured: Posttreatment Week 12
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
Measured: Up to 24 weeks
Secondary outcomes (7)
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively.
Measured: Posttreatment Weeks 4 and 24
HCV RNA Change From Baseline at Week 1
Measured: Baseline; Week 1
HCV RNA Change From Baseline at Week 2
Measured: Baseline; Week 2
HCV RNA Change From Baseline at Week 4
Measured: Baseline; Week 4
HCV RNA Change From Baseline at Week 6
Measured: Baseline; Week 6
HCV RNA Change From Baseline at Week 8
Measured: Baseline; Week 8
Percentage of Participants Experiencing Virologic Failure
On-treatment virologic failure was defined as either:
- Virologic 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
- Nonresponse (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment).
Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period, having achieved HCV RNA < LLOQ at last on-treatment visit."
Measured: Baseline 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.
- First posted5 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionJul 2014
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anuj Gaggar, MD, PhD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783678
- Sponsor's protocol ID
- GS-US-334-0124
- Status last verified
- Apr 2015
- First submitted
- 31 Jan 2013
- Last updated
- 30 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Molina JM, Orkin C, Iser DM, Zamora FX, Nelson M, Stephan C, Massetto B, Gaggar A, Ni L, Svarovskaia E, Brainard D, Subramanian GM, McHutchison JG, Puoti M, Rockstroh JK; PHOTON-2 study team. Sofosbuvir plus ribavirin for treatment of hepatitis C virus in patients co-infected with HIV (PHOTON-2): a multicentre, open-label, non-randomised, phase 3 study. Lancet. 2015 Mar 21;385(9973):1098-106. doi: 10.1016/S0140-6736(14)62483-1. Epub 2015 Feb 4.
PubMed 25659285Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Puoti M, Orkin C, Hunt SL. Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes. J Infect Dis. 2015 Aug 1;212(3):367-77. doi: 10.1093/infdis/jiv005. Epub 2015 Jan 12.
PubMed 25583164
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. 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 Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects
- ClinicalTrials.gov ID
- NCT01783678
- Acronym / sponsor ID
- GS-US-334-0124
- Conditions
- Chronic Hepatitis C, Human Immunodeficiency Virus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Feb 2013 (estimated)
- Results
- Posted 30 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Genotype 2 treatment-naive | Experimental | Drug: Sofosbuvir, Drug: RBVTreatment-naive (TN) participants with HIV-1 and genotype 2 HCV coinfection will receive sofosbuvir plus RBV for 12 weeks. |
| Genotype 2/3 treatment-experienced | Experimental | Drug: Sofosbuvir, Drug: RBVTreatment-experienced (TE) participants with HIV-1 and genotype 2 or 3 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks. |
| Genotype 1/3/4 treatment-naive | Experimental | Drug: Sofosbuvir, Drug: RBVTreatment naive (TN) participants with HIV-1 and genotype 1, 3, or 4 HCV co-infection will receive sofosbuvir plus RBV 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 (11 listed)
- Age ≥ 18 years with HIV-1 and chronic HCV genotype 1, 2, 3, or 4 co-infection
- HCV RNA > 10,000 IU/mL at screening
- HCV treatment history:
- HIV antiretroviral (ARV) criteria:
- Presence or absence of cirrhosis; a liver biopsy may be required
Key exclusion criteria (11 listed)
- HCV genotype 1 or 4 with previous HCV treatment
- Poor control with HIV ARV regimen requiring a possible dose modification of therapy within 4 weeks of study medication dosing
- A new AIDS-defining condition diagnosed within 30 days prior to screening
- Prior use of any other inhibitor of the HCV NS5B polymerase
- History of any other clinically significant chronic liver disease
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-7977Sofosbuvir 400 mg tablet administered orally once daily | Drug | Genotype 1/3/4 treatment-naive, Genotype 2 treatment-naive, Genotype 2/3 treatment-experienced |
| RBVRibavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg) | Drug | Genotype 1/3/4 treatment-naive, Genotype 2 treatment-naive, Genotype 2/3 treatment-experienced |
Primary outcome
Percentage of Participants With Sustained Virologic Response (SVR) at 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, < 25 IU/mL) 12 weeks following the last dose of study drug.
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Time frame: Up to 24 weeks
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
7 secondary outcomes
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time frame: Posttreatment Weeks 4 and 24
HCV RNA Change From Baseline at Week 1
Time frame: Baseline; Week 1
HCV RNA Change From Baseline at Week 2
Time frame: Baseline; Week 2
HCV RNA Change From Baseline at Week 4
Time frame: Baseline; Week 4
HCV RNA Change From Baseline at Week 6
Time frame: Baseline; Week 6
HCV RNA Change From Baseline at Week 8
Time frame: Baseline; Week 8
Percentage of Participants Experiencing Virologic Failure
Time frame: Baseline up to Posttreatment Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25659285Molina JM, Orkin C, Iser DM, Zamora FX, Nelson M, Stephan C, Massetto B, Gaggar A, Ni L, Svarovskaia E, Brainard D, Subramanian GM, McHutchison JG, Puoti M, Rockstroh JK; PHOTON-2 study team. Sofosbuvir plus ribavirin for treatment of hepatitis C virus in patients co-infected with HIV (PHOTON-2): a multicentre, open-label, non-randomised, phase 3 study. Lancet. 2015 Mar 21;385(9973):1098-106. doi: 10.1016/S0140-6736(14)62483-1. Epub 2015 Feb 4.
- Derived from this study: PubMed 25583164Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Puoti M, Orkin C, Hunt SL. Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes. J Infect Dis. 2015 Aug 1;212(3):367-77. doi: 10.1093/infdis/jiv005. Epub 2015 Jan 12.
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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.
Anuj Gaggar, MD, PhD study director
Gilead Sciences
24 sites in 6 countries: 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 Hepatitis C and Human Immunodeficiency Virus, run by Gilead Sciences at 24 sites in 6 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 11 inclusion and 11 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 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany, Italy, Australia, France, Spain and 1 more country. 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 30 Apr 2015). 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) at 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 NCT01783678, 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 30 Apr 2015.