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This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1 (GT1) or genotype 3 (GT3) hepatitis C virus (HCV) infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF+RBV 16 Weeks | Experimental | SOF+RBV for 16 weeks |
|
| SOF+RBV 24 Weeks | Experimental | SOF+RBV for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF | Drug | Sofosbuvir (SOF) 400 mg tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) at 12 weeks after stopping study treatment. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. | Posttreatment Weeks 4 and 24 |
| Percentage of Participants Experiencing On-treatment Virologic Failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Kersey, MSc | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Clinical Hospital of the Russian Academy of Sciences | Moscow | Russia | ||||
| Central Scientific and Research Institute of Epidemiology of Rospotrebnadzor |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27376706 | Derived | Isakov V, Zhdanov K, Kersey K, Svarovskaia E, Massetto B, Zhu Y, Knox SJ, Bakulin I, Chulanov V. Efficacy of sofosbuvir plus ribavirin in treatment-naive patients with genotype-1 and -3 HCV infection: results from a Russian Phase IIIb study. Antivir Ther. 2016;21(8):671-678. doi: 10.3851/IMP3065. Epub 2016 Jul 4. |
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139 participants were screened.
Participants were enrolled at a total of 16 study sites in Russia. The first participant was screened on 06 June 2013. The last study visit occurred on 27 July 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF+RBV 16 Weeks | Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 16 weeks |
| FG001 | SOF+RBV 24 Weeks | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| RBV | Drug | Ribavirin (RBV) tablets administered orally in a divided daily dose using weight-based dosing (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
|
On-treatment virologic failure was defined as
|
| Up to 24 weeks |
| Percentage of Participants Experiencing Virologic Relapse | Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. | Up to Posttreatment Week 12 |
| Moscow |
| Russia |
| Central Scientific Research Institution of Gastroenterology of Moscow Healthcare Department | Moscow | Russia |
| City Clinical Hospital 24 | Moscow | Russia |
| Clinical Diagnostics and Research Center of Federal Bedgetary Institution | Moscow | Russia |
| Infectious Clinical Hospital No. 1 | Moscow | Russia |
| Institute of Nutrition of Academy of Sciences | Moscow | Russia |
| Institution of Healthcare of Sverdlovsk Region | Moscow | Russia |
| Institution of High Professional Education First Moscow State Medical University | Moscow | Russia |
| Institution of Tumen Region | Moscow | Russia |
| Krasnoyarsk Regional Center for Prevention and Control of AIDS and Infectious Diseases | Moscow | Russia |
| Scientific Research Institution of Emergency Care n.a. N.V. Sclifosovskiy of Moscow | Moscow | Russia |
| Stavropol State Medical University of Ministry of Healthcare | Moscow | Russia |
| Medical Military Academy n.a. S.M. Kirov | Saint Petersburg | Russia |
| Saint-Petersburg Center for Prevention and Control of AIDS and Infectious Diseases | Saint Petersburg | Russia |
| Medical Company Hepatolog | Samara | Russia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF+RBV 16 Weeks, GT1 | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1) |
| BG001 | SOF+RBV 24 Weeks, GT1 | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1) |
| BG002 | SOF+RBV 16 Weeks, GT3 | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3) |
| BG003 | SOF+RBV 24 Weeks, GT3 | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Cirrhosis Status | Number | participants |
| ||||||||||||||||
| IL28b Status | CC, CT, and TT alleles are different forms of the IL28b gene. | Number | participants |
| |||||||||||||||
| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| HCV RNA Category | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) at 12 weeks after stopping study treatment. | Full Analysis Set: participants with genotype 1 or 3 HCV infection who were randomized and received at least one dose of study drug | Posted | Number | percentage of participants | Posttreatment Week 12 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | 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. | Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug | Posted | Number | percentage of participants | Up to 24 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. | Full Analysis Set | Posted | Number | percentage of participants | Posttreatment Weeks 4 and 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing On-treatment Virologic Failure | On-treatment virologic failure was defined as
| Full Analysis Set | Posted | Number | percentage of participants | Up to 24 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Virologic Relapse | Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. | Full Analysis Set | Posted | Number | percentage of participants | Up to Posttreatment Week 12 |
|
Up to 24 weeks plus 30 days
Safety Analysis Set
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SOF+RBV 16 Weeks | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks | 1 | 62 | 16 | 62 | ||
| EG001 | SOF+RBV 24 Weeks | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks | 1 | 65 | 21 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA Version 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 16.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
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| Male |
|
| Yes |
|
| Missing |
|
| CT |
|
| TT |
|
| ≥ 800,000 IU/mL |
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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