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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

Primary Purpose

Chronic Hepatitis C, Human Immunodeficiency Virus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sofosbuvir
RBV
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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:

    • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Genotype 2 treatment-naive

Genotype 2/3 treatment-experienced

Genotype 1/3/4 treatment-naive

Arm Description

Treatment-naive (TN) participants with HIV-1 and genotype 2 HCV coinfection will receive sofosbuvir plus RBV for 12 weeks.

Treatment-experienced (TE) participants with HIV-1 and genotype 2 or 3 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks.

Treatment naive (TN) participants with HIV-1 and genotype 1, 3, or 4 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
HCV RNA Change From Baseline at Week 1
HCV RNA Change From Baseline at Week 2
HCV RNA Change From Baseline at Week 4
HCV RNA Change From Baseline at Week 6
HCV RNA Change From Baseline at 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."

Full Information

First Posted
January 31, 2013
Last Updated
April 15, 2015
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01783678
Brief 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 Adults
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C, Human Immunodeficiency Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
275 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Genotype 2 treatment-naive
Arm Type
Experimental
Arm Description
Treatment-naive (TN) participants with HIV-1 and genotype 2 HCV coinfection will receive sofosbuvir plus RBV for 12 weeks.
Arm Title
Genotype 2/3 treatment-experienced
Arm Type
Experimental
Arm Description
Treatment-experienced (TE) participants with HIV-1 and genotype 2 or 3 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks.
Arm Title
Genotype 1/3/4 treatment-naive
Arm Type
Experimental
Arm Description
Treatment naive (TN) participants with HIV-1 and genotype 1, 3, or 4 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir
Other Intervention Name(s)
Sovaldi®, GS-7977, PSI-7977
Intervention Description
Sofosbuvir 400 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Intervention Description
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)
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
Description
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.
Time Frame
Posttreatment Week 12
Title
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Description
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Description
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.
Time Frame
Posttreatment Weeks 4 and 24
Title
HCV RNA Change From Baseline at Week 1
Time Frame
Baseline; Week 1
Title
HCV RNA Change From Baseline at Week 2
Time Frame
Baseline; Week 2
Title
HCV RNA Change From Baseline at Week 4
Time Frame
Baseline; Week 4
Title
HCV RNA Change From Baseline at Week 6
Time Frame
Baseline; Week 6
Title
HCV RNA Change From Baseline at Week 8
Time Frame
Baseline; Week 8
Title
Percentage of Participants Experiencing Virologic Failure
Description
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."
Time Frame
Baseline up to Posttreatment Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anuj Gaggar, MD, PhD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Darlinghurst
State/Province
New South Wales
Country
Australia
City
Sydney
State/Province
New South Wales
Country
Australia
City
Melbourne
State/Province
Victoria
Country
Australia
City
Parkville
State/Province
Victoria
Country
Australia
City
Lyon
Country
France
City
Nice
Country
France
City
Paris
Country
France
City
Berlin
Country
Germany
City
Bonn
Country
Germany
City
Duesseldorf
Country
Germany
City
Frankfurt
Country
Germany
City
Hamburg
Country
Germany
City
Würzburg
Country
Germany
City
Bergamo
Country
Italy
City
Milano
Country
Italy
City
Napoli
Country
Italy
City
Rome
Country
Italy
City
Torino
Country
Italy
City
Barcelona
Country
Spain
City
Madrid
Country
Spain
City
Seville
Country
Spain
City
Glasgow
Country
United Kingdom
City
London
Country
United Kingdom
City
Sussex
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25659285
Citation
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.
Results Reference
derived
PubMed Identifier
25583164
Citation
Younossi 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.
Results Reference
derived

Learn more about this trial

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

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