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`Trial record 8 of 63 for: sofosbuvir | Completed Studies | Phase 2
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`Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-
`Naive Hepatitis C-infected Patients
`
`This study has been completed.
`Sponsor:
`Gilead Sciences
`
`ClinicalTrials.gov Identifier:
`NCT01188772
`
`First Posted: August 25, 2010
`Last Update Posted: April 21, 2014
`
` The safety and scientific validity of this study is the responsibility of the study sponsor and
`investigators. Listing a study does not mean it has been evaluated by the U.S. Federal
`Government. Read our disclaimer for details.
`
`Information provided by (Responsible Party):
`Gilead Sciences
`
`Full Text View
`
`Tabular View
`
`Study Results
`
`Disclaimer
`
`How to Read a Study Record
`
` Purpose
`
`Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive
`sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a
`(PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to an additional 36 weeks.
`Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA level (< 800,000 IU/ml or ≥
`800,000 IU/ml) at baseline. Participants were randomized in a 2:2:1 manner; those who achieved an
`extended rapid virologic response (eRVR) (HCV RNA < lower limit of detection [15 IU/mL] from Weeks 4
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`through 12) received an additional 12 weeks of PEG+RBV. Subjects not achieving eRVR received an
`additional 36 weeks of PEG+RBV.
`
`Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400 mg plus
`PEG+RBV for 12 weeks.
`
`Condition
`
`Intervention
`
`Hepatitis C Virus
`
`Drug: Sofosbuvir
`Drug: Placebo to match sofosbuvir
`
`Phase
`
`Phase 2
`
`Drug: PEG
`
`Drug: RBV
`
`Interventional
`Study Type:
`Study Design: Allocation: Randomized
`Intervention Model: Parallel Assignment
`Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
`Primary Purpose: Treatment
`
`Official Title:
`
`A Multi-center, Placebo-Controlled, Dose Ranging Study to Investigate the Safety,
`Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of
`PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naïve
`Patients With Chronic HCV Infection Genotype 1, and an Open Label Assessment of PSI-
`7977 in Patients With HCV Genotypes 2 or 3
`
`Resource links provided by NLM:
`
`MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C
`
`Drug Information available for: Interferon Ribavirin Sofosbuvir
`
`U.S. FDA Resources
`
`Further study details as provided by Gilead Sciences:
`
`Primary Outcome Measures:
`Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
`[ Time Frame: Baseline to Week 12 plus 30 days ]
`
`Adverse events (AEs) occurring during the sofosbuvir treatment period and for 30 days following the
`last dose of sofosbuvir were summarized across the participant population. A participant was counted
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`once if they had a qualifying event.
`
`Secondary Outcome Measures:
`
`Change in HCV RNA From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]
`Percentage of Participants With Rapid Virologic Response at Week 4 [ Time Frame: Week 4 ]
`
`Rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week
`4 (Day 29)
`
`Percentage of Participants With Complete Early Virologic Response at Week 12 [ Time Frame: Week
`12 ]
`
`Complete early virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL)
`at Week 12
`
`Percentage of Participants With Extended Rapid Virologic Response [ Time Frame: Week 4 to Week
`12 ]
`
`Extended rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL)
`at Week 4 (Day 29) which was maintained through Week 12.
`
`Percentage of Participants With Virologic Response at the End of Treatment [ Time Frame: Week 48
`(genotype 1) or Week 12 (genotype 2/3) ]
`
`End-of-treatment virologic response was defined as HCV RNA below the limit of detection (< 15
`IU/mL) at the last on-treatment visit.
`
`Percentage of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) and
`24 (SVR24) [ Time Frame: Post-treatment Weeks 12 and 24 ]
`
`SVR12 and SVR24 were defined as HCV RNA below the limit of detection (< 15 IU/mL) at post-
`treatment Weeks 12 and 24, respectively.
`
`Plasma Pharmacokinetics of GS-331007 (Cmax at Day 8) [ Time Frame: 1, 2, 4, 8, and 12 hours
`postdose ]
`
`The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the maximum observed
`concentration of drug in plasma (Cmax) at Day 8. Blood samples were collected at 1, 2, and 4 hours
`postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.
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`Plasma Pharmacokinetics of GS-331007 (Cmax at Day 15) [ Time Frame: 1, 2, 4, 8, and 12 hours
`postdose ]
`
`The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 15.
`Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours
`postdose for participants enrolled at selected sites.
`
`Plasma Pharmacokinetics of GS-331007 (Cmax at Day 29) [ Time Frame: 1, 2, 4, 8, and 12 hours
`postdose ]
`
`The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 29.
`Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours
`postdose for participants enrolled at selected sites.
`
`Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 8) [ Time Frame: 1, 2, 4, 8, and 12 hours
`postdose ]
`
`The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the
`plasma concentration versus time curve over the dosing interval (AUCtau) at Day 8. Blood samples
`were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for
`participants enrolled at selected sites.
`
`Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 15) [ Time Frame: 1, 2, 4, 8, and 12 hours
`postdose ]
`
`The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the
`plasma concentration versus time curve over the dosing interval (AUCtau) at Day 15. Blood samples
`were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for
`participants enrolled at selected sites.
`
`Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 29) [ Time Frame: 1, 2, 4, 8, and 12 hours
`postdose ]
`
`The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the
`plasma concentration versus time curve over the dosing interval (AUCtau) at Day 29. Blood samples
`were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for
`participants enrolled at selected sites.
`
`Percentage of Participants Who Developed Resistance to Sofosbuvir [ Time Frame: Baseline to Week
`12 ]
`
`Resistance monitoring was completed in all subjects who received sofosbuvir and who had non-
`response, viral rebound, virologic breakthrough, or HCV RNA plateaus between Day 0 and Week 24.
`
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`147
`Enrollment:
`August 2010
`Study Start Date:
`May 2012
`Study Completion Date:
`Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
`
`Arms
`
`Experimental: Sofosbuvir 200 mg (Genotype 1)
`Participants with genotype 1 HCV infection were
`randomized to receive sofosbuvir 200 mg (2 x 100
`mg tablets)+placebo to match sofosbuvir (2
`tablets)+PEG+RBV for 12 weeks followed by
`PEG+RBV for up to an additional 36 weeks.
`
`Experimental: Sofosbuvir 400 mg (Genotype 1)
`Participants with genotype 1 HCV infection were
`randomized to receive sofosbuvir 400 mg (4 x 100
`mg tablets)+PEG+RBV for 12 weeks followed by
`PEG+RBV for up to an additional 36 weeks.
`
`Assigned Interventions
`
`Drug: Sofosbuvir
`Sofosbuvir tablets were administered
`orally once daily.
`Other Names:
`Sovaldi®
`GS-7977
`PSI-7977
`
`Drug: Placebo to match sofosbuvir
`Placebo tablets to match sofosbuvir were
`administered orally once daily.
`Drug: PEG
`Pegylated interferon alfa-2a (PEG) 180 μg
`was administered once weekly by
`subcutaneous injection.
`Other Name: Pegasys®
`Drug: RBV
`Ribavirin (RBV) was administered as a
`tablet orally according to package insert
`dosing recommendations (Genotype 1: <
`75kg = 1000 mg and ≥ 75 kg = 1200 mg;
`Genotype 2/3: 800 mg).
`Other Name: Copegus®
`
`Drug: PEG
`Pegylated interferon alfa-2a (PEG) 180 μg
`was administered once weekly by
`subcutaneous injection.
`Other Name: Pegasys®
`Drug: RBV
`
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`Active Comparator: Placebo (Genotype 1)
`Participants with genotype 1 HCV infection were
`randomized to receive placebo to match sofosbuvir
`(4 tablets)+PEG+RBV for 12 weeks followed by
`PEG+RBV for up to an additional 36 weeks.
`
`Experimental: Sofosbuvir 400 mg (Genotype 2/3)
`Participants with genotype 2 or 3 HCV infection
`received sofosbuvir 400 mg (4 x 100 mg
`tablets)+PEG+RBV for 12 weeks.
`
`Ribavirin (RBV) was administered as a
`tablet orally according to package insert
`dosing recommendations (Genotype 1: <
`75kg = 1000 mg and ≥ 75 kg = 1200 mg;
`Genotype 2/3: 800 mg).
`Other Name: Copegus®
`
`Drug: Placebo to match sofosbuvir
`Placebo tablets to match sofosbuvir were
`administered orally once daily.
`Drug: PEG
`Pegylated interferon alfa-2a (PEG) 180 μg
`was administered once weekly by
`subcutaneous injection.
`Other Name: Pegasys®
`Drug: RBV
`Ribavirin (RBV) was administered as a
`tablet orally according to package insert
`dosing recommendations (Genotype 1: <
`75kg = 1000 mg and ≥ 75 kg = 1200 mg;
`Genotype 2/3: 800 mg).
`Other Name: Copegus®
`
`Drug: Sofosbuvir
`Sofosbuvir tablets were administered
`orally once daily.
`Other Names:
`Sovaldi®
`GS-7977
`PSI-7977
`
`Drug: PEG
`Pegylated interferon alfa-2a (PEG) 180 μg
`was administered once weekly by
`subcutaneous injection.
`Other Name: Pegasys®
`Drug: RBV
`Ribavirin (RBV) was administered as a
`tablet orally according to package insert
`dosing recommendations (Genotype 1: <
`
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`75kg = 1000 mg and ≥ 75 kg = 1200 mg;
`Genotype 2/3: 800 mg).
`Other Name: Copegus®
`
` Eligibility
`
`Information from the National Library of Medicine
`
`Choosing to participate in a study is an important personal decision. Talk with your
`doctor and family members or friends about deciding to join a study. To learn more
`about this study, you or your doctor may contact the study research staff using the
`contacts provided below. For general information, Learn About Clinical Studies.
`
`18 Years to 70 Years (Adult, Senior)
`Ages Eligible for Study:
`All
`Sexes Eligible for Study:
`Accepts Healthy Volunteers: No
`
`Criteria
`
`Inclusion Criteria:
`
`Males or females aged 18 to 70 years, inclusive, at screening
`
`Documented chronic genotype 1, 2, or 3 HCV infection
`No previous treatment with HCV antiviral mediations
`
`Body mass index (BMI) of greater than 18 kg/m2, but not exceeding 36 kg/m2.
`Liver biopsy obtained within 3 years prior to the Day 1 visit, with a fibrosis classification of non-
`cirrhotic as judged by a local pathologist
`
`Willing to refrain from beginning any new exercise regimens during the first 3 months of the study
`Fasting blood glucose ≤ 300 mg/dl and/or glycosylated hemoglobin (HbA1c) ≤ 8
`History of hypertension only if managed effectively on a stable regimen of two or fewer
`antihypertensives for at least three (3) months prior to screening
`
`Exclusion Criteria:
`
`Females who were breastfeeding
`Males and females of reproductive potential who are unwilling to use an "effective", protocol-specified
`method(s) of contraception during the study
`
`Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab.
`History of any other clinically significant chronic liver disease
`
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`Treatment with herbal/natural remedies with antiviral activity within 30 days prior to baseline.
`Significant history of immunologically mediated disease, cardiac or pulmonary disease, seizure
`disorder or anticonvulsant use
`
`History of ascites, variceal hemorrhage, hepatic encephalopathy, or conditions consistent with
`decompensated liver disease
`Use of medications associated with QT prolongation within 30 days prior to dosing
`
`Screening electrocardiogram (ECG) QTc value greater than 450 ms and/or clinically significant ECG
`findings
`Personal or family history of Torsade de pointes.
`
`Positive results for drugs of abuse test at screening
`Abnormal hematological and biochemical parameters, including alanine aminotransferase (ALT) or
`aspartate aminotransferase (AST) ≥ 5 times the upper limit of the normal range (ULN)
`
`History of major organ transplantation with an existing functional graft
`History of uncontrolled thyroid disease or abnormal thyroid-stimulating hormone (TSH) levels at
`screening
`Clinically significant drug allergy to nucleoside/nucleotide analogs
`
`History or current evidence of psychiatric illness, immunologic disorder, pulmonary, cardiac disease,
`seizure disorder, cancer or history of malignancy that in the opinion of the investigator makes the
`patient unsuitable for the study
`History of systemic antineoplastic or immunomodulatory treatment within 6 months prior to dosing, or
`the expectation of such treatment during the study
`
` Contacts and Locations
`
`Information from the National Library of Medicine
`
`To learn more about this study, you or your doctor may contact the study
`research staff using the contact information provided by the sponsor.
`
`Please refer to this study by its ClinicalTrials.gov identifier (NCT number):
`NCT01188772
`
` Show 23 Study Locations
`
`Sponsors and Collaborators
`
`Gilead Sciences
`
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`Investigators
`Study Director: Robert H. Hyland, DPhil Gilead Sciences
`
` More Information
`
`Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
`
`Lawitz E, Lalezari JP, Hassanein T, Kowdley KV, Poordad FF, Sheikh AM, Afdhal NH, Bernstein DE,
`Dejesus E, Freilich B, Nelson DR, Dieterich DT, Jacobson IM, Jensen D, Abrams GA, Darling JM,
`Rodriguez-Torres M, Reddy KR, Sulkowski MS, Bzowej NH, Hyland RH, Mo H, Lin M, Mader M, Hindes
`R, Albanis E, Symonds WT, Berrey MM, Muir A. Sofosbuvir in combination with peginterferon alfa-2a and
`ribavirin for non-cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C infection: a
`randomised, double-blind, phase 2 trial. Lancet Infect Dis. 2013 May;13(5):401-8. doi: 10.1016/S1473-
`3099(13)70033-1. Epub 2013 Mar 15.
`
`Gilead Sciences
`Responsible Party:
`ClinicalTrials.gov Identifier: NCT01188772 History of Changes
`Other Study ID Numbers:
`P7977-0422
`First Submitted:
`August 23, 2010
`First Posted:
`August 25, 2010
`Results First Submitted:
`January 6, 2014
`Results First Posted:
`February 19, 2014
`Last Update Posted:
`April 21, 2014
`Last Verified:
`April 2014
`
`Keywords provided by Gilead Sciences:
`Hepatitis C Virus
`HCV
`hepatitis
`
`Additional relevant MeSH terms:
`
`Genotype 1
`Genotype 2
`Genotype 3
`
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`Sofosbuvir
`Hepatitis
`Hepatitis A
`Hepatitis C
`Liver Diseases
`Digestive System Diseases
`Hepatitis, Viral, Human
`Virus Diseases
`Enterovirus Infections
`Picornaviridae Infections
`
`RNA Virus Infections
`Flaviviridae Infections
`Interferons
`Ribavirin
`Antineoplastic Agents
`Antiviral Agents
`Anti-Infective Agents
`Antimetabolites
`Molecular Mechanisms of Pharmacological Action
`
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