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

NCT01783678 | Completed Phase 3 Results DMC

• 1 other identifier: GS-US-334-0124
• Study Type: interventional
• Target: 275
• Locations: 6 countries
• Sites: 24

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.

Conditions

Chronic Hepatitis C; Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

  Posttreatment Weeks 4 and 24

• HCV RNA Change From Baseline at Week 1

  Baseline; Week 1

• HCV RNA Change From Baseline at Week 2

  Baseline; Week 2

• HCV RNA Change From Baseline at Week 4

  Baseline; Week 4

• HCV RNA Change From Baseline at Week 6

  Baseline; Week 6

Study Arms (3)

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.

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.

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.

Drug: Sofosbuvir; Drug: RBV

Interventions

Sofosbuvir DRUG

Sofosbuvir 400 mg tablet administered orally once daily

Also known as: Sovaldi®, GS-7977, PSI-7977

Genotype 1/3/4 treatment-naive; Genotype 2 treatment-naive; Genotype 2/3 treatment-experienced

RBV DRUG

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)

Genotype 1/3/4 treatment-naive; Genotype 2 treatment-naive; Genotype 2/3 treatment-experienced

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (24)

Unknown Facility

Darlinghurst, New South Wales, Australia

Location

Unknown Facility

Sydney, New South Wales, Australia

Location

Unknown Facility

Melbourne, Victoria, Australia

Location

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Parkville, Victoria, Australia

Location

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Lyon, France

Location

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Nice, France

Location

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Paris, France

Location

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Berlin, Germany

Location

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Bonn, Germany

Location

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Düsseldorf, Germany

Location

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Frankfurt, Germany

Location

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Hamburg, Germany

Location

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Würzburg, Germany

Location

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Bergamo, Italy

Location

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Milan, Italy

Location

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Napoli, Italy

Location

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Rome, Italy

Location

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Torino, Italy

Location

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Barcelona, Spain

Location

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Madrid, Spain

Location

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Seville, Spain

Location

Unknown Facility

Glasgow, United Kingdom

Location

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London, United Kingdom

Location

Unknown Facility

Sussex, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 25659285 DERIVED

• 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.

  PMID: 25583164 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Acquired Immunodeficiency Syndrome

Interventions

Sofosbuvir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences, Inc.

ClinicalTrialDisclosures@gilead.com

Study Officials

• Anuj Gaggar, MD, PhD

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 5, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2014
• Last Updated: April 30, 2015
• Results First Posted: April 30, 2015

Record last verified: 2015-04

Locations

DE (6); IT (5); FR (3); AU (4); GB (3); ES (3)