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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002457-29 | EudraCT Number |
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This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic hepatitis C virus (HCV) infection. Approximately 50 adults will be randomized (1:1) to receive study drug for 48 weeks or take part in an untreated observational arm for the first 24 weeks followed by study drug for another 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF+RBV | Experimental | Participants will receive SOF+RBV for 48 weeks. |
|
| Observation, then SOF+RBV | Experimental | Participants will undergo 24 weeks of observation and then receive SOF+RBV for 48 additional weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF | Drug | SOF 400 mg tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) 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. For the Observation/SOF+RBV group, SVR12 during the observational period was defined as HCV RNA < LLOQ for 12 consecutive weeks, any time during the observational period. | Posttreatment Week 12 (SOF+RBV) and up to 24 weeks (Observation) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With SVR at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48) | SVR4, SVR24, and SVR48 were defined as HCV RNA < LLOQ at 4, 24, and 48 weeks after stopping study treatment, respectively. | Posttreatment Weeks 4, 24, and 48 |
| Percentage of Participants Experiencing On-Treatment Virologic Failure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shampa De-Oertel, PhD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora | Colorado | United States | ||||
63 participants were screened.
Participants were enrolled at study sites in the United States, Europe, Australia, and New Zealand. The first participant was screened on 27 November 2012. The last study visit occurred on 06 October 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF+RBV (Group 1) | Sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks |
| FG001 | Observation/SOF+RBV (Group 2; Not Treated) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| RBV | Drug | RBV 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) |
|
On-treatment virologic failure was defined as:
|
| Up to 48 weeks |
| Percentage of Participants Experiencing Viral Relapse | Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement. | Up to Posttreatment Week 24 |
| Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at End of Treatment | HVPG closely reflects the degree of portal hypertension in patients with cirrhosis. The end of treatment for the Observation group was defined as the end of the observation period. The treatment period for Group 2 was defined as the end of the observation period to the end of the treatment. Baseline values were the last available values on or prior to first dose date of any study drug. | Baseline; Week 24 (Observation) and Week 48 (SOF+RBV) |
| Change From Baseline in Child-Pugh-Turcotte (CPT) Score | CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. Data are presented as improvement, no change, or worsening in CPT scores at Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV groups). Improvement in CPT score was defined as having a decrease in CPT score from baseline, no change in CPT score was defined as having no change in CPT score from baseline, and worsening in CPT score was defined as having an increase in CPT score from baseline. Baseline values were the last available values on or prior to first dose date of any study drug. | Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV) |
| Change From Baseline in Model for End Stage Liver Disease (MELD) Scores | MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity. Data are presented as improvement, no change, or worsening in MELD scores at Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV groups). Improvement in MELD score was defined as having a baseline MELD score of 11-15 or 16-20 that changed to 0-10, or a baseline MELD score of 16-20 that changed to 11-15; no change in MELD score was defined as having no change in score group (0-10, 11-15, or 16-20) from baseline; and worsening in MELD score was defined as having a baseline MELD score of 0-10 that changed to 11-15 or 16-20, or a baseline MELD score of 11-15 that changed to 16-20. Baseline values were the last available values on or prior to first dose date of any study drug. | Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV) |
| Boston |
| Massachusetts |
| United States |
| Rochester | Minnesota | United States |
| Philadelphia | Pennsylvania | United States |
| Newtown | New South Wales | Australia |
| Leclerc | Clichy | France |
| Grafton | Auckland | New Zealand |
| Barcelona | Barcelona | Spain |
| Majadahonda | Madrid | Spain |
This reporting group only includes participants who were randomized to the Observation/SOF+RBV group who discontinued study prior to receiving study drug.
| FG002 | Observation/SOF+RBV (Group 2; Received Treatment) | This reporting group includes participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants who were randomized and received at least 1 dose of study drug
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SOF+RBV (Group 1) | SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks |
| BG001 | SOF+RBV (Group 2; Received Treatment) | This reporting group includes participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks. |
| BG002 | 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 |
| ||||||||||||||||
| Region of Enrollment | All randomized participants were analyzed for Region of Enrollment (n = 50). | Number | participants |
| |||||||||||||||
| HCV Genotype | 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 |
| ||||||||||||||||
| Hepatic Venous Pressure Gradient (HVPG) | Mean | Standard Deviation | mmHg |
| |||||||||||||||
| Child-Pugh-Turcotte (CPT) Score Category | CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. | Number | participants |
| |||||||||||||||
| Model for End-Stage Liver Disease (MELD) Score | MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity. | 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) 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. For the Observation/SOF+RBV group, SVR12 during the observational period was defined as HCV RNA < LLOQ for 12 consecutive weeks, any time during the observational period. | Participants who were randomized to the study. | Posted | Number | percentage of participants | Posttreatment Week 12 (SOF+RBV) and up to 24 weeks (Observation) |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With SVR at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48) | SVR4, SVR24, and SVR48 were defined as HCV RNA < LLOQ at 4, 24, and 48 weeks after stopping study treatment, respectively. | Participants who were randomized and received at least 1 dose of study drug with available data were analyzed. | Posted | Number | percentage of participants | Posttreatment Weeks 4, 24, and 48 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing On-Treatment Virologic Failure | On-treatment virologic failure was defined as:
| Participants who were randomized and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to 48 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Experiencing Viral Relapse | Viral relapse was defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement. | Participants who were randomized and received at least 1 dose of study drug with available data were analyzed. | Posted | Number | percentage of participants | Up to Posttreatment Week 24 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Hepatic Venous Pressure Gradient (HVPG) at End of Treatment | HVPG closely reflects the degree of portal hypertension in patients with cirrhosis. The end of treatment for the Observation group was defined as the end of the observation period. The treatment period for Group 2 was defined as the end of the observation period to the end of the treatment. Baseline values were the last available values on or prior to first dose date of any study drug. | Participants who were randomized to the study with available data at baseline and end of observation or end of treatment were analyzed. | Posted | Mean | Standard Deviation | mmHg | Baseline; Week 24 (Observation) and Week 48 (SOF+RBV) |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Child-Pugh-Turcotte (CPT) Score | CPT scores, widely used to grade the severity of cirrhosis and to determine the need for liver transplantation, are calculated based on a combination of laboratory values and clinical features. CPT scores can range from 5 to 15, with higher scores indicating a greater severity of disease. Data are presented as improvement, no change, or worsening in CPT scores at Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV groups). Improvement in CPT score was defined as having a decrease in CPT score from baseline, no change in CPT score was defined as having no change in CPT score from baseline, and worsening in CPT score was defined as having an increase in CPT score from baseline. Baseline values were the last available values on or prior to first dose date of any study drug. | Participants who were randomized to the study with available data were analyzed. | Posted | Number | percentage of participants | Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Model for End Stage Liver Disease (MELD) Scores | MELD scores, used to assess prognosis and suitability for transplant, are calculated based on laboratory values only and can range from 6 to 40, with higher scores indicating greater disease severity. Data are presented as improvement, no change, or worsening in MELD scores at Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV groups). Improvement in MELD score was defined as having a baseline MELD score of 11-15 or 16-20 that changed to 0-10, or a baseline MELD score of 16-20 that changed to 11-15; no change in MELD score was defined as having no change in score group (0-10, 11-15, or 16-20) from baseline; and worsening in MELD score was defined as having a baseline MELD score of 0-10 that changed to 11-15 or 16-20, or a baseline MELD score of 11-15 that changed to 16-20. Baseline values were the last available values on or prior to first dose date of any study drug. | Participants who were randomized to the study with available data were analyzed. | Posted | Number | percentage of participants | Baseline; Week 24 (Observation) and Posttreatment Week 4 (SOF+RBV) |
|
Up to 48 weeks plus 30 days
Adverse event data includes all participants who were randomized to the study.
Not provided
| 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 (Group 1) | SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks | 4 | 25 | 23 | 25 | ||
| EG001 | Observation Period Only (Group 2) | This reporting group includes participants who were randomized to the Observation/SOF+RBV group and received up to 24 weeks of observation. | 3 | 25 | 10 | 25 | ||
| EG002 | SOF+RBV Treatment Only (Group 2) | This reporting group includes participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks. | 6 | 21 | 20 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye swelling | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 18.0 | 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 |
| D005355 | Fibrosis |
| D006975 | Hypertension, Portal |
| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| 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 |
Not provided
Not provided
| Male |
|
| White |
|
| Asian |
|
| Other |
|
| United States |
|
| France |
|
| Australia |
|
| Spain |
|
| Genotype 1b |
|
| Genotype 2a/2c |
|
| Genotype 2b |
|
| Genotype 3a |
|
| Genotype 4 |
|
| Genotype 4h |
|
| CT |
|
| TT |
|
| ≥ 800,000 IU/mL |
|
| CPT B (7-10) |
|
| 7 |
|
| 8 |
|
| 9 |
|
| 10 |
|
| 11 |
|
| 12 |
|
| 13 |
|
| 15 |
|
| 16 |
|
|
|
|
| OG003 |
| All SOF+RBV (Groups 1 and 2) |
Participants who received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 48 weeks in both Groups 1 and 2 |
|
|
SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks |
| OG003 | All SOF+RBV (Groups 1 and 2) | Participants who received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks in both Groups 1 and 2 |
|
|
| OG002 | SOF+RBV (Group 2) | SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks |
| OG003 | All SOF+RBV (Groups 1 and 2) | Participants who received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks in both Groups 1 and 2 |
|
|