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This trial was open to participants who had received a liver transplant or had cirrhosis due to chronic HCV. All subjects were treated with daclatasvir+sofosbuvir+ribavirin and were followed for 24 weeks post treatment. Under certain conditions, the treatment duration could have been extended for cirrhotic participants. The study tested the efficacy and safety of this combination for treatment of HCV in cirrhotic and post transplant patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-liver Transplant Cohort | Experimental | Participants with liver transplant received daclatasvir 60 mg, sofosbuvir 400 mg, and ribavirin (based on baseline hemoglobin and creatinine clearance and tolerated dose) tablets daily for 12 weeks and were followed for 24 weeks post treatment. |
|
| Cirrhotic Cohort | Experimental | Cirrhotic participants received daclatasvir 60 mg, sofosbuvir 400 mg, and ribavirin (based on baseline hemoglobin and creatinine clearance and tolerated dose) tablets orally for 12 weeks and were followed for 24 weeks post-treatment. Cirrhotic participants who received a liver transplant while on study treatment were eligible (>3 months post transplant) for a treatment extension of daclatasvir 60 mg, sofosbuvir 400 mg, and ribavirin (dose based on hemoglobin level) tablets orally for an additional 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of HCV Genotype-1 Infected Post-liver Transplanted Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) | SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation (\ | Post-treatment follow-up Week 12 |
| Percentage of Genotype-1 Infected Cirrhotic Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) | SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window. | Post-treatment follow-up Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Sustained Virologic Response at Post-treatment Week 12 (SVR12) for All Genotypes and Genotypes 2, 3, 4, 6 | SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window. |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Miami Schiff Center For Liver Diseases | Miami | Florida | 33136 | United States | ||
| University Of Michigan Health System |
A total of 116 participants were enrolled, of which 113 received study treatment (60 cirrhotic cohort, 53: post-liver transplant cohort). Remaining 3 participants no longer met study criteria. Of the 60 participants in the cirrhotic cohort, 57 did not receive a treatment extension and 3 received a treatment extension after liver transplant.
The study was conducted at 5 centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin | Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
Not provided
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| Sofosbuvir |
| Drug |
|
| Ribavirin | Drug |
|
| Post-treatment follow-up Week 12 |
| Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24 | Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at each visit. | Week 1, 2, 4, 6, 8, 12, End of treatment, Follow-up Week 4, 8, and 24 |
| Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment | Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target not detected, at each on-treatment visit. | Week 1, 2, 4, 6, 8, 12, End of treatment |
| Percentage of Participants With CC or Non-CC Genotype Who Achieved Sustained Virologic Response at 12 Weeks After the Last Dose of Study Drug (SVR12) | Participants categorized into 2 genotypes (CC and non-CC) based on single nucleotide polymorphism in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus RNA levels be \ | Post-treatment follow-up Week 12 |
| Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), AEs Leading to Interruption, Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Death | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. | From start of study treatment up to 7 days post last dose of study treatment (approximately 13 weeks) |
| Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities | Grade 3-4 laboratory abnormalities were defined as: Hemoglobin as 6.50-7.4 g/dL for grade 3 and/or < 6.5 g/dL for grade 4, Platelet count as 25*10^9-50*10^9 /L for grade 3 and/or < 25.000*10^9 /L for grade 4, International normalized ratio as 2.1-3.0*upper limit of normal (ULN) > 3.0*ULN for grade 3 and/or > 3.0*ULN for grade 4, Leukocytes as 1.0*10^9-1.5*10^9/L for grade 3 and/or <1.0*10^9/L for grade 4, Lymphocytes (Absolute) as 0.350*109-0.499*10^9 /L for grade 3 and/or < 0.350*10^9 /L for grade 4, Alanine aminotransferase as 5.1-10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Aspartate aminotransferase as 5.1-10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Alkaline phosphatase as 5.1-10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Bilirubin (Total) as 2.6-5.0*ULN for grade 3 and/or > 5.0*ULN for grade 4, Albumin as < 20 g/L, Lipase (Total) as 3.1-5.0*ULN for grade 3 and/or > 5.0*ULN for grade 4, and Creatinine as 1.9-3.4*ULN for grade 3 and/or ≥ 3.5*ULN for grade 4. | From start of study treatment up to 7 days post last dose of study treatment |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Baylor St. Luke'S Medical Center | Houston | Texas | 77030 | United States |
| American Research Corporation | San Antonio | Texas | 78215 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| FG001 |
| Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin |
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up Period |
|
|
All participants who received at least 1 dose of active study therapy.
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| ID | Title | Description |
|---|---|---|
| BG000 | Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin | Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated. |
| BG001 | Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin | Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated. |
| 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 |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Hepatitis C Virus RNA | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| Hepatitis C Virus RNA distribution | Number | participants |
| ||||||||||||||||
| HCV genotype subtype | Number | participants |
| ||||||||||||||||
| IL-28B rs1297860 Genotype | 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 HCV Genotype-1 Infected Post-liver Transplanted Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) | SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation (\ | All HCV genotype 1 infected post-transplant participants who received at least 1 dose of study therapy. | Posted | Number | 95% Confidence Interval | Percentage of participants | Post-treatment follow-up Week 12 |
|
|
| |||||||||||||||||||||||||
| Primary | Percentage of Genotype-1 Infected Cirrhotic Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) | SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window. | All genotype 1 cirrhotic participants who received at least 1 dose of study therapy. | Posted | Number | 95% Confidence Interval | Percentage of participants | Post-treatment follow-up Week 12 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Sustained Virologic Response at Post-treatment Week 12 (SVR12) for All Genotypes and Genotypes 2, 3, 4, 6 | SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window. | All treated participants who took at least 1 dose of study medication. Here, 'n' signifies participants evaluable for SVR12 at the specified time point in each group, respectively. | Posted | Number | 95% Confidence Interval | Percentage of participants | Post-treatment follow-up Week 12 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Detected or Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment; Follow Up Weeks 4, 8, and 24 | Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target detected or target not detected, at each visit. | All treated participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 1, 2, 4, 6, 8, 12, End of treatment, Follow-up Week 4, 8, and 24 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels Below the Lower Limit of Quantitation Target Not Detected at Each of the Following Weeks: 1, 2, 4, 6, 8, 12, End of Treatment | Participants who responded to treatment were assessed using proportion of subjects with hepatitis C Virus RNA levels below the lower limit of quantitation i.e., 25 IU/mL target not detected, at each on-treatment visit. | All treated participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 1, 2, 4, 6, 8, 12, End of treatment |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With CC or Non-CC Genotype Who Achieved Sustained Virologic Response at 12 Weeks After the Last Dose of Study Drug (SVR12) | Participants categorized into 2 genotypes (CC and non-CC) based on single nucleotide polymorphism in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus RNA levels be \ | All treated participants. Here, 'n' signifies participants evaluable for SVR12 at the specified time point in each group, respectively. | Posted | Number | 95% Confidence Interval | Percentage of participants | Post-treatment follow-up Week 12 |
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), AEs Leading to Interruption, Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Death | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. | All treated participants. | Posted | Number | participants | From start of study treatment up to 7 days post last dose of study treatment (approximately 13 weeks) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Grade 3-4 Laboratory Abnormalities | Grade 3-4 laboratory abnormalities were defined as: Hemoglobin as 6.50-7.4 g/dL for grade 3 and/or < 6.5 g/dL for grade 4, Platelet count as 25*10^9-50*10^9 /L for grade 3 and/or < 25.000*10^9 /L for grade 4, International normalized ratio as 2.1-3.0*upper limit of normal (ULN) > 3.0*ULN for grade 3 and/or > 3.0*ULN for grade 4, Leukocytes as 1.0*10^9-1.5*10^9/L for grade 3 and/or <1.0*10^9/L for grade 4, Lymphocytes (Absolute) as 0.350*109-0.499*10^9 /L for grade 3 and/or < 0.350*10^9 /L for grade 4, Alanine aminotransferase as 5.1-10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Aspartate aminotransferase as 5.1-10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Alkaline phosphatase as 5.1-10.0*ULN for grade 3 and/or > 10.0*ULN for grade 4, Bilirubin (Total) as 2.6-5.0*ULN for grade 3 and/or > 5.0*ULN for grade 4, Albumin as < 20 g/L, Lipase (Total) as 3.1-5.0*ULN for grade 3 and/or > 5.0*ULN for grade 4, and Creatinine as 1.9-3.4*ULN for grade 3 and/or ≥ 3.5*ULN for grade 4. | All treated participants. | Posted | Number | participants | From start of study treatment up to 7 days post last dose of study treatment |
|
From Day 1 up to 7 days post last dose of study treatment (approximately 13 weeks)
Study Start: March 17, 2014; Study Completion: January 5, 2016
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 | Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin | Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated. | 5 | 53 | 38 | 53 | ||
| EG001 | Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin | Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated. | 10 | 60 | 42 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Encephalopathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Localised intraabdominal fluid collection | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Clinical.Trials@bms.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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C549273 | daclatasvir |
| D000069474 | Sofosbuvir |
| D012254 | Ribavirin |
| 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 |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| ≥800,000 IU/mL |
|
| Hepatitis C Virus genotype 1b |
|
| Hepatitis C Virus genotype 2 |
|
| Hepatitis C Virus genotype 3 |
|
| Hepatitis C Virus genotype 4 |
|
| Hepatitis C Virus genotype 5 |
|
| Hepatitis C Virus genotype 6 |
|
| CT |
|
| TT |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
| OG001 |
| Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin |
Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated. |
|
|