Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults
NCT ID: NCT01667731
Last Updated: 2014-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
224 participants
INTERVENTIONAL
2012-07-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SOF+RBV 12 Weeks (GT 2/3, TN)
Treatment-naive (TN) participants coinfected with HIV-1 and genotype (GT) 2 or genotype 3 HCV infection will receive SOF+RBV for 12 weeks.
SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBV
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)
SOF+RBV 24 Weeks (GT 2/3, TE)
Treatment-experienced (TE) participants coinfected with HIV-1 and genotype 2 or genotype 3 HCV infection will receive SOF+RBV for 24 weeks.
SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBV
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)
SOF+RBV 24 Weeks (GT 1, TN)
Treatment-naive (TN) participants coinfected with HIV-1 and genotype 1 HCV infection will receive SOF+RBV for 24 weeks.
SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBV
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)
Interventions
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SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBV
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female, age ≥ 18 years with chronic HCV and HIV-1 infection
* HCV RNA \> 1 x 10\^4 IU/mL at screening
* Infection with HCV genotype 1, 2 or 3 as determined at screening
* HIV-1 infection confirmed with positive ELISA or Western blot at screening
* Medical records must be sufficient to be categorized on interferon (IFN) eligibility or prior treatment history with PEG/RBV.
* Confirmation of chronic HCV infection
* Ability to determine presence/absence of cirrhosis.
* HIV antiretroviral therapy (ARV) criteria of one of the following:
* ARV untreated with a CD4 T-cell count \> 500 cells/mm\^3
* On a stable, protocol-approved, ARV for \> 8 weeks prior to screening with a CD4 T-cell count \> 200 cells/mm\^3 and a documented undetectable plasma HIV-1 RNA level for ≥ 8 weeks preceding the screening visit
* Approved HIV antiretroviral medications based on drug interaction studies
* Not been treated with any investigational drug or device within 30 days of the screening visit
* Females if confirmed that she is not pregnant or nursing of non-childbearing potential or of childbearing potential but has a negative serum pregnancy test at screening and agrees to use protocol approved method of birth control from screening through 6 months after the last dose of RBV
* Males who agree to consistently and correctly use a condom while their female partner agrees to use protocol approved method of birth control from screening through 7 months after the last dose of RBV
* Must be of generally good health as determined by the investigator.
* Liver imaging within 6 months of baseline/Day 1 is required in cirrhotic patients only, to exclude hepatocellular carcinoma (HCC)
Exclusion Criteria
* Genotype 1 with prior treatment for HCV
* Poor control with ARV regimen
* Prior exposure to a direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
* Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
* A new AIDS-defining condition diagnosed within 30 days prior to screening
* Active, serious infection (other than HIV or HCV) requiring parenteral antibiotics, antivirals or antifungals within 30 days prior to baseline
* Infection with hepatitis B virus (HBV)
* Contraindication to RBV therapy
* Chronic use of systemically administered immunosuppressive agents (eg, prednisone equivalent \> 10 mg/day)
* History of solid organ transplantation or malignancy diagnosed or treated within 5 years
* Current or prior history of clinical hepatic decompensation or other significant gastrointestinal disorder
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Anuj Gaggar, MD, PhD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Birmingham, Alabama, United States
Coronado, California, United States
Los Angeles, California, United States
Lutherville, California, United States
Oakland, California, United States
Sacramento, California, United States
San Francisco, California, United States
Torrance, California, United States
Washington D.C., District of Columbia, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Springfield, Massachusetts, United States
Kansas City, Missouri, United States
Hillsborough, New Jersey, United States
Santa Fe, New Mexico, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Allentown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Dallas, Texas, United States
Houston, Texas, United States
Seattle, Washington, United States
San Juan, , Puerto Rico
Countries
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References
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Saeed S, Strumpf EC, Walmsley SL, Rollet-Kurhajec K, Pick N, Martel-Laferriere V, Hull M, Gill MJ, Cox J, Cooper C, Klein MB; Canadian Co-Infection Cohort Study; Cohen J, Conway B, Cooper C, Cote P, Cox J, Gill J, Haider S, Harris M, Haase D, Hull M, Montaner J, Moodie E, Pick N, Rachlis A, Rouleau D, Sandre R, Tyndall JM, Vachon ML, Walmsley S, Wong D. How Generalizable Are the Results From Trials of Direct Antiviral Agents to People Coinfected With HIV/HCV in the Real World? Clin Infect Dis. 2016 Apr 1;62(7):919-926. doi: 10.1093/cid/civ1222. Epub 2016 Jan 6.
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.
Sulkowski MS, Naggie S, Lalezari J, Fessel WJ, Mounzer K, Shuhart M, Luetkemeyer AF, Asmuth D, Gaggar A, Ni L, Svarovskaia E, Brainard DM, Symonds WT, Subramanian GM, McHutchison JG, Rodriguez-Torres M, Dieterich D; PHOTON-1 Investigators. Sofosbuvir and ribavirin for hepatitis C in patients with HIV coinfection. JAMA. 2014 Jul 23-30;312(4):353-61. doi: 10.1001/jama.2014.7734.
Other Identifiers
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GS-US-334-0123
Identifier Type: -
Identifier Source: org_study_id