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The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without sofosbuvir (SOF) and ribavirin (RBV) in DAA treatment-experienced adults with Genotype 1 Chronic Hepatitis C Virus infection. This study will contain 2 parts.
Part 1: Approximately 20 participants and at least 10 of the 20 participants previously treated with the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without RBV, and experienced treatment failure.
Part 2: Approximately 10 participants and all participants previously treated with SOF/ledipasvir and experienced treatment failure.
Efficacy, safety, and demographic analyses were performed separately for the 2 study parts using the intent-to-treat (ITT) population, which consists of all enrolled participants who received at least one dose of study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-DAA with or without SOF and RBV | Experimental | 3-DAA (ombitasvir/paritaprevir/ritonavir once daily [QD] and dasabuvir twice daily [BID]) with and without sofosbuvir (SOF) QD and with or without ribavirin (RBV) BID for 12 or 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ombitasvir/paritaprevir/ritonavir and dasabuvir | Drug | tablet, ombitasvir coformulated with paritaprevir and ritonavir; tablet, dasabuvir |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link) | 12 weeks after the last dose of active drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment | SVR12 was defined as plasma HCV RNA level \ | 12 weeks after the last dose of active drug |
| Percentage of Participants With On-treatment Virologic Failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Cohen, MD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26596948 | Derived | King JR, Dutta S, Cohen D, Podsadecki TJ, Ding B, Awni WM, Menon RM. Drug-Drug Interactions between Sofosbuvir and Ombitasvir-Paritaprevir-Ritonavir with or without Dasabuvir. Antimicrob Agents Chemother. 2015 Nov 23;60(2):855-61. doi: 10.1128/AAC.01913-15. Print 2016 Feb. |
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The intent-to-treat (ITT) population consisted of all enrolled participants who received at least 1 dose of study drug.
Efficacy, safety, and demographic analyses were performed separately for the 2 study parts using the intent-to-treat (ITT) population, which consists of all enrolled participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1, 3-DAA With SOF With or Without RBV | 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 12 or 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sofosbuvir | Drug | tablet |
|
|
| Ribavirin | Drug | tablet |
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On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment. |
| Up to week 24 |
| Percentage of Participants With Post-Treatment Relapse | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment. | Within 12 weeks after the last actual dose of active study drug |
| FG001 |
| Part 2, 3-DAA With RBV |
3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg QD and dasabuvir 250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 24 weeks |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1, 3-DAA With SOF With or Without RBV | 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 12 or 24 weeks |
| BG001 | Part 2, 3-DAA With RBV | 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg QD and dasabuvir 250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 24 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 |
|
| 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 Part 1 Participants With Sustained Virologic Response 12 (SVR12) Weeks Posttreatment | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [](streamdown:incomplete-link) | All Part 1 participants who received at least 1 dose of study drug (ITT population). Per protocol, data from Parts 1 and 2 were not combined for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last dose of active drug |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Part 2 Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment | SVR12 was defined as plasma HCV RNA level \ | All Part 2 participants who received at least 1 dose of study drug (ITT population). Per protocol, data from Parts 1 and 2 were not combined for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after the last dose of active drug |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With On-treatment Virologic Failure | On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment. | All participants who received at least 1 dose of study drug (ITT population). Per protocol, data from Parts 1 and 2 were not combined for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to week 24 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Post-Treatment Relapse | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment. | All participants who received at least 1 dose of study drug (ITT population) with HCV RNA < LLOQ at the end of treatment and completed treatment. Per protocol, data from Parts 1 and 2 were not combined for analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 12 weeks after the last actual dose of active study drug |
|
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is on or after the date of the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
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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 | Part 1, 3-DAA With SOF With or Without RBV | 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily [QD] and dasabuvir [250 mg twice daily [BID]) and sofosbuvir (SOF) 400 mg QD with or without ribavirin (RBV; weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 12 or 24 weeks.](streamdown:incomplete-link) | 2 | 22 | 20 | 22 | ||
| EG001 | Part 2, 3-DAA With RBV | 3-DAA (ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg QD and dasabuvir [250 mg BID) with RBV (weight-based dosing 1000 or 1200 mg divided BID or renally adjusted for participants with creatinine clearance < 50 mL/min) for 24 weeks.](streamdown:incomplete-link) | 0 | 7 | 6 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CELLULITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
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| HAEMOLYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
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| VENTRICULAR EXTRASYSTOLES | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
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| VERTIGO POSITIONAL | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
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| CUSHING'S SYNDROME | Endocrine disorders | MedDRA 20.0 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| DENTAL CARIES | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| DRY MOUTH | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| IMPAIRED GASTRIC EMPTYING | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| MOUTH ULCERATION | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ORAL PAIN | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| CYST | General disorders | MedDRA 20.0 | Systematic Assessment |
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| ENERGY INCREASED | General disorders | MedDRA 20.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| FEELING COLD | General disorders | MedDRA 20.0 | Systematic Assessment |
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| MALAISE | General disorders | MedDRA 20.0 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA 20.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 20.0 | Systematic Assessment |
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| CONJUNCTIVITIS BACTERIAL | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| EAR INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| STAPHYLOCOCCAL SKIN INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| MUSCLE STRAIN | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 20.0 | Systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| CREATININE RENAL CLEARANCE DECREASED | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| GLUCOSE TOLERANCE IMPAIRED | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| INCREASED APPETITE | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| OSTEOPENIA | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| AGITATION | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| EUPHORIC MOOD | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| IRRITABILITY | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| HYPERTONIC BLADDER | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
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| MENOPAUSAL SYMPTOMS | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| PROSTATITIS | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| FLUSHING | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| 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 |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C586094 | ombitasvir |
| C588260 | dasabuvir |
| C000607373 | Viekira Pak |
| C585405 | paritaprevir |
| 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 |
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| Male |
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| Units | Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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