Clinical trial NCT01783678: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Human Immunodeficiency Virus
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2013-02-05
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
timeFrame: Posttreatment Weeks 4 and 24
measure: HCV RNA Change From Baseline at Week 1
timeFrame: Baseline; Week 1
measure: HCV RNA Change From Baseline at Week 2
timeFrame: Baseline; Week 2
measure: HCV RNA Change From Baseline at Week 4
timeFrame: Baseline; Week 4
measure: HCV RNA Change From Baseline at Week 6
timeFrame: Baseline; Week 6
measure: HCV RNA Change From Baseline at Week 8
timeFrame: Baseline; Week 8
measure: Percentage of Participants Experiencing Virologic Failure
timeFrame: Baseline up to Posttreatment Week 24
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Melbourne
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
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
Study officials:
affiliation: Gilead Sciences
name: Anuj Gaggar, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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.