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This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + ribavirin (RBV) in treatment-naive adults with chronic genotype 1 or 3 hepatitis C virus (HCV) infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sofosbuvir+RBV 16 weeks | Experimental | Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 16 weeks. |
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| Sofosbuvir+RBV 24 weeks | Experimental | Participants with HCV genotypes 1 and 3 will receive sofosbuvir plus ribavirin for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir | Drug | 400 mg tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug. | Posttreatment Week 12 |
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. | Posttreatment Weeks 4 and 24 |
| Percentage of Participants With Virologic Failure and Viral Relapse |
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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 |
|---|---|---|---|---|---|---|
| Hyderabad | Andhra Pradesh | 500 004 | India | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Shah S, Acharya SK, Mehta R., Kapoor D, Duseja A, Koshy A, et al. (2016) "Sofosbuvir Plus Ribavirin in the Treatment of Chronic HCV Infection in India." Hepatol Int. 10 (Suppl 1): S15. | ||
| Result | Shah S, Chowdhury A, Mehta R, Kapoor D, Duseja A, Koshy A, et al. Sofosbuvir plus Ribavirin Results in High SVR4 Rates in Patients with Chronic HCV Genotype 1 or 3 Infection in India (Poster L-47). 56th Annual Conference of Indian Society of Gastroenterology; 2015, November, 19-22 Indore, India. | ||
| 27933698 | Derived | Shah SR, Chowdhury A, Mehta R, Kapoor D, Duseja A, Koshy A, Shukla A, Sood A, Madan K, Sud R, Nijhawan S, Pawan R, Prasad M, Kersey K, Jiang D, Svarovskaia E, Doehle B, Kanwar B, Subramanian M, Acharya SK, Sarin S. Sofosbuvir plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 or 3 infection in India. J Viral Hepat. 2017 May;24(5):371-379. doi: 10.1111/jvh.12654. Epub 2016 Dec 9. |
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Participants were enrolled at study sites in India. The first participant was screened on 31 March 2014. The last study visit occurred on 30 November 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF+RBV 16 Weeks | Sofosbuvir (Sovaldi®; SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 16 weeks. |
| FG001 | SOF+RBV 24 Weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| RBV | Drug | 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
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Virologic failure was defined as:
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| Up to Posttreatment Week 24 |
| Chandigarh |
| Chandigarh |
| 160012 |
| India |
| Surat | Gujarat | 395002 | India |
| Gurgaon | Haryana | 122 001 | India |
| Kochi | Kerala | 682040 | India |
| Mumbai | Maharashtra | 400012 | India |
| New Delhi | National Capital Territory of Delhi | 110029 | India |
| New Delhi | National Capital Territory of Delhi | 110070 | India |
| Ludhiana | Punjab | 141001 | India |
| Jaipur | Rajasthan | 302004 | India |
| Coimbatore | Tamil Nadu | 641 005 | India |
| Lucknow | Uttar Pradesh | 226014 | India |
| Kolkata | West Bengal | 700 020 | India |
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks.
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set: participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF + RBV 16 Weeks GT1 | SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection |
| BG001 | SOF + RBV 24 Weeks GT1 | SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection |
| BG002 | SOF + RBV 16 Weeks GT3 | SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection |
| BG003 | SOF + RBV 24 Weeks GT3 | SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection |
| 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 |
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| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| HCV genotype | Number | participants |
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| Cirrhosis Status | Number | participants |
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| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| IL28b Status | The CC, CT, and TT alleles are different forms of the IL28b gene. | Number | participants |
| |||||||||||||||
| HCV RNA Category | Number | participants |
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| 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 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug. | Full Analysis Set (FAS): participants with genotype 1 or 3 HCV infection who were randomized into the study and received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 12 |
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| Primary | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Safety Analysis Set | Posted | Number | percentage of participants | Up to 24 weeks |
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| Secondary | Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Weeks 4 and 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Failure and Viral Relapse | Virologic failure was defined as:
| Full Analysis Set | Posted | Number | percentage of participants | Up to Posttreatment Week 24 |
|
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 administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks | 1 | 59 | 32 | 59 | ||
| EG001 | SOF + RBV 24 Weeks | SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks | 1 | 58 | 27 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Haemolysis | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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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 |
|---|---|
| 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 |
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| Not Permitted |
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| Genotype 1b |
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| Genotype 3 |
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| Presence |
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| CT |
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| TT |
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| ≥ 800,000 IU/mL |
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SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection |
|
|
| OG003 | SOF + RBV 24 Weeks GT3 | SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection |
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