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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3682-035 | Other Identifier | Merck Registration Number |
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The study was terminated based on review of Phase 2 efficacy data
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This study is an open-label, multi-center trial to evaluate the novel 2-drug regimen of uprifosbuvir (MK-3682) 450 mg and ruzasvir (MK-8408) 60 mg in participants with chronic hepatitis C virus (HCV) genotype (GT)1, GT2, GT3, GT4, GT5, or GT6 infection. The impact of the study treatment regimen on the percentage of participants with undetectable HCV ribonucleic acid [RNA] 12 weeks after completing study treatment (SVR12) will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Experimental | Participants will receive an oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast and at least one hour before a meal, once a day, for 12 weeks. The GT1 Arm is sub-divided into GT1a and GT1b Arms. GT1a Arm will enroll approximately 35 participants including up to 10 participants who are compensated cirrhotics and GT1b Arm will enroll approximately 15 participants including up to 5 participants who are compensated cirrhotics. |
|
| GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Experimental | Participants will receive an oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast and at least one hour before a meal, once a day, for 12 weeks. The GT2 Arm of the study will enroll approximately 50 participants including up to 15 participants who are compensated cirrhotics. |
|
| GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Experimental | Participants will receive an oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast and at least one hour before a meal, once a day, for 12 weeks. The GT3 Arm of the study will enroll approximately 50 participants including up to 15 participants who are compensated cirrhotics. |
|
| GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uprifosbuvir 450 mg | Drug | 450 mg administered as 3 x 150 mg oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) | The percentage of participants in each arm achieving SVR12 was determined. SVR12 was defined as HCV ribonucleic acid (RNA) levels in plasma < lower limit of quantification (LLOQ) 12 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. | Week 24 (12 weeks after completing study therapy) |
| Percentage of Participants With ≥1 Adverse Events (AEs) | The percentage of participants experiencing an AE during the treatment period and first 2 weeks of follow-up was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to Week 14 (up to 2 weeks after completing study therapy) |
| Percentage of Participants Withdrawing From Study Therapy Due to an AE | The percentage of participants discontinuing from study therapy during the treatment period was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to Week 12 |
| Percentage of Participants With ≥1 Events of Clinical Interest (ECIs) | The percentage of participants with ECIs was determined. ECIs were defined as the following: 1) an overdose of study drug; 2) first instance of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >500 IU/L; 3) first instance of ALT or AST >3x nadir and >3x upper limit of normal (ULN); 4) first instance of estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2; or 4) first instance of serum creatinine >1.3x ULN and elevated from baseline. | Up to Week 14 (up to 2 weeks after completing study therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24) | The percentage of participants in each arm achieving SVR24 was determined. SVR24 was defined as HCV RNA levels in plasma < LLOQ 24 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. For SVR24, participants with GT1 infection were separated into GT1a or GT1b infection. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30739366 | Result | Lawitz E, Poordad F, Anderson LJ, Vesay M, Kelly MM, Liu H, Gao W, Fernsler D, Asante-Appiah E, Robertson MN, Hanna GJ, Barr E, Butterton J, Kowdley KV, Hassanein T, Sahota A, Gordon SC, Yeh WW. Efficacy and safety of ruzasvir 60 mg and uprifosbuvir 450 mg for 12 weeks in adults with chronic hepatitis C virus genotype 1, 2, 3, 4 or 6 infection. J Viral Hepat. 2019 Jun;26(6):675-684. doi: 10.1111/jvh.13079. Epub 2019 Mar 12. | |
| 31108015 |
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Adult participants with hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, or 6 infection were enrolled at 5 study centers in the United States. Participants with HCV GT5 infection were initially intended for inclusion but none were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| FG001 | GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2017 |
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Participants will receive an oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast and at least one hour before a meal, once a day, for 12 weeks. The GT4 Arm of the study will enroll approximately 50 participants including up to 15 participants who are compensated cirrhotics. |
|
| GT5: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Experimental | Participants will receive an oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast and at least one hour before a meal, once a day, for 12 weeks. The GT5 Arm of the study will enroll approximately 25 participants including both non- cirrhotics and compensated cirrhotics. |
|
| GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Experimental | Participants will receive an oral dose of 450 mg uprifosbuvir (3 x 150 mg tablets) and 60 mg ruzasvir (6 x 10 mg capsules) following an overnight fast and at least one hour before a meal, once a day, for 12 weeks. The GT6 Arm of the study will enroll approximately 25 participants including both non- cirrhotics and compensated cirrhotics. |
|
|
| Ruzasvir 60 mg | Drug | 60 mg administered as 6 x 10 mg oral capsules |
|
|
| Week 36 (24 weeks after completing study therapy) |
| Percentage of Participants With Virologic Failure (VF) | The percentage of participants in each arm experiencing VF was determined. VF was defined as: 1) non-response (HCV RNA detected at end of treatment without HCV RNA < LLOQ while on treatment); 2) rebound (>1 log 10 IU/mL increase in HCV RNA from nadir while on treatment); 3) virologic breakthrough (HCV RNA ≥LLOQ after being \ | 12 weeks after the end of all study therapy (24 weeks) |
| Percentage of Participants With Baseline Resistance-Associated Substitutions (RAS) Achieving SVR12 | The percentage of participants in each arm with baseline RAS achieving SVR12 was determined. Analysis of RAS in NS5A or NS5B at baseline was determined. SVR12 was defined as HCV RNA levels in plasma < LLOQ 24 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. | 12 weeks after the end of all study therapy (24 weeks) |
| Derived |
| Lawitz E, Gane E, Feld JJ, Buti M, Foster GR, Rabinovitz M, Burnevich E, Katchman H, Tomasiewicz K, Lahser F, Jackson B, Shaughnessy M, Klopfer S, Yeh WW, Robertson MN, Hanna GJ, Barr E, Platt HL; C-BREEZE-2 Study Investigators. Efficacy and safety of a two-drug direct-acting antiviral agent regimen ruzasvir 180 mg and uprifosbuvir 450 mg for 12 weeks in adults with chronic hepatitis C virus genotype 1, 2, 3, 4, 5 or 6. J Viral Hepat. 2019 Sep;26(9):1127-1138. doi: 10.1111/jvh.13132. Epub 2019 Jul 11. |
Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| FG002 | GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| FG003 | GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| FG004 | GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| BG001 | GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| BG002 | GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| BG003 | GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| BG004 | GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| BG005 | 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 (NIH/OMB) | Count of Participants | 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 Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) | The percentage of participants in each arm achieving SVR12 was determined. SVR12 was defined as HCV ribonucleic acid (RNA) levels in plasma < lower limit of quantification (LLOQ) 12 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. | All participants who received ≥1 dose of study treatment, have data available, who do not have protocol deviations that could substantially affect the results of the endpoint, and who did not discontinue from the study for non-treatment-related reasons, are included. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 24 (12 weeks after completing study therapy) |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With ≥1 Adverse Events (AEs) | The percentage of participants experiencing an AE during the treatment period and first 2 weeks of follow-up was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | All participants who received ≥1 dose of study drug are included. | Posted | Number | Percentage of Participants | Up to Week 14 (up to 2 weeks after completing study therapy) |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Withdrawing From Study Therapy Due to an AE | The percentage of participants discontinuing from study therapy during the treatment period was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | All participants who received ≥1 dose of study drug are included. | Posted | Number | Percentage of Participants | Up to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24) | The percentage of participants in each arm achieving SVR24 was determined. SVR24 was defined as HCV RNA levels in plasma < LLOQ 24 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. For SVR24, participants with GT1 infection were separated into GT1a or GT1b infection. | All participants who received ≥1 dose of study treatment, have data available, who do not have protocol deviations that could substantially affect the results of the endpoint, and who did not discontinue from the study for non-treatment-related reasons, are included. | Posted | Number | Percentage of Participants | Week 36 (24 weeks after completing study therapy) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Failure (VF) | The percentage of participants in each arm experiencing VF was determined. VF was defined as: 1) non-response (HCV RNA detected at end of treatment without HCV RNA < LLOQ while on treatment); 2) rebound (>1 log 10 IU/mL increase in HCV RNA from nadir while on treatment); 3) virologic breakthrough (HCV RNA ≥LLOQ after being \ | All participants who received ≥1 dose of study treatment, have data available, who do not have protocol deviations that could substantially affect the results of the endpoint, and who did not discontinue from the study for non-treatment-related reasons, are included. | Posted | Number | Percentage of Participants | 12 weeks after the end of all study therapy (24 weeks) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Baseline Resistance-Associated Substitutions (RAS) Achieving SVR12 | The percentage of participants in each arm with baseline RAS achieving SVR12 was determined. Analysis of RAS in NS5A or NS5B at baseline was determined. SVR12 was defined as HCV RNA levels in plasma < LLOQ 24 weeks after completing study treatment. Plasma levels of HCV RNA were measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. | All participants who received ≥1 dose of study treatment, and who do not have protocol deviations that could substantially affect the results of the endpoint, and who did not discontinue from the study for non-treatment-related reasons, and who had baseline sequencing data available, are included. | Posted | Number | Percentage of Participants | 12 weeks after the end of all study therapy (24 weeks) |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With ≥1 Events of Clinical Interest (ECIs) | The percentage of participants with ECIs was determined. ECIs were defined as the following: 1) an overdose of study drug; 2) first instance of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >500 IU/L; 3) first instance of ALT or AST >3x nadir and >3x upper limit of normal (ULN); 4) first instance of estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2; or 4) first instance of serum creatinine >1.3x ULN and elevated from baseline. | All participants who received ≥1 dose of study drug are included. | Posted | Number | Percentage of Participants | Up to Week 14 (up to 2 weeks after completing study therapy) |
|
Up to 36 weeks (up to 24 weeks after completing study treatment)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. All participants who received ≥1 dose of study drug are included.
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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 | GT1: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT1 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. | 0 | 69 | 4 | 69 | 25 | 69 |
| EG001 | GT2: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT2 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. | 0 | 29 | 0 | 29 | 8 | 29 |
| EG002 | GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. | 1 | 39 | 1 | 39 | 13 | 39 |
| EG003 | GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. | 0 | 20 | 2 | 20 | 6 | 20 |
| EG004 | GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. | 0 | 3 | 0 | 3 | 2 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Melaena | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oesophagitis haemorrhagic | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Drug withdrawal syndrome | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Jul 10, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000627758 | uprifosbuvir |
| C000621654 | ruzasvir |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| OG004 | GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
|
|
| OG003 | GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| OG004 | GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
|
|
| OG002 |
| GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg |
Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| OG003 | GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| OG004 | GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| OG005 | GT1b: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT1b infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
|
|
| OG002 | GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| OG003 | GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| OG004 | GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| OG005 | GT1b: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT1b infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
|
|
| OG002 |
| GT3: Uprifosbuvir 450 mg + Ruzasvir 60 mg |
Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| OG003 | GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| OG004 | GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
|
|
Participants with HCV GT3 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal.
| OG003 | GT4: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT4 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
| OG004 | GT6: Uprifosbuvir 450 mg + Ruzasvir 60 mg | Participants with HCV GT6 infection took uprifosbuvir 450 mg ruzasvir 60 mg once daily for 12 weeks. Study drug was taken after an overnight fast and at least 1 hour before a meal. |
|
|
|