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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3034-025 | Other Identifier | Merck study number |
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The primary objective of this trial is to compare the efficacy of boceprevir (SCH 503034) 800 mg three times a day (TID) orally (PO) in combination with peginterferon alfa-2b (PegIFN-2b) 1.5 µg/kg weekly (QW) subcutaneously (SC) plus weight-based dosing (WBD) of ribavirin (RBV) (600 mg/day to 1400 mg/day) PO to therapy with PegIFN-2b + RBV alone in adult participants coinfected with human immunodeficiency virus (HIV) and previously untreated chronic hepatitis C virus (HCV) genotype 1.
Boceprevir is a potent, orally administered, novel serine protease inhibitor, specifically designed to inhibit the HCV nonstructural protein 3 (NS3) protease and, thereby, inhibit viral replication in HCV-infected host cells. The mechanism of inhibition represents a new mechanism of action compared to both interferon alfa and ribavirin. Based on previous experience with PegIFN-2b and RBV in combination with boceprevir in the HCV-monoinfected population, this combination treatment is expected to provide significant benefit to the HIV/HCV coinfected population. Given the high unmet medical need of these participants and the benefit of the addition of boceprevir to PegIFN-2b/RBV, it is important to demonstrate the safety and efficacy of boceprevir in combination with PegIFN-2b/RBV in participants coinfected with HIV/HCV.
This is a randomized, multi-center trial, double-blinded for boceprevir or placebo in combination with open-label PegIFN-2b/RBV in participants coinfected with HIV and previously untreated chronic HCV (genotype 1), to be conducted in conformance with Good Clinical Practice (GCP). This trial consists of two arms, one control arm (Arm 1) and one experimental arm (Arm 2). Participants in the control arm (Arm 1) may receive boceprevir/PegIFN-2b/RBV via a crossover arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PegIFN-2b + RBV | Placebo Comparator | PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks. |
|
| PegIFN-2b + RBV + Boceprevir | Active Comparator | PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PegIFN-2b | Drug | PegIFN-2b (1.5 μg/kg/week subcutaneously) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Viral Response (SVR) at Follow-up Week 24 (FW24) Among Randomized Participants Who Received At Least One Dose of Trial Medication | SVR24 is defined as undetectable plasma hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from Follow-up Week 12 (FW12) was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL. | Up to Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving SVR24 Among Randomized Participants Who Received At Least One Dose of Boceprevir (Experimental) or Placebo (Control) | SVR24 is defined as undetectable plasma HCV-RNA 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from FW12 was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL. |
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Inclusion Criteria:
Exclusion Criteria:
Key Laboratory Exclusion Criteria:
Hematologic, biochemical, and serologic criteria (growth factors may not be used to achieve trial entry requirements):
Alpha fetoprotein (AFP):
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23768747 | Derived | Sulkowski M, Pol S, Mallolas J, Fainboim H, Cooper C, Slim J, Rivero A, Mak C, Thompson S, Howe AY, Wenning L, Sklar P, Wahl J, Greaves W; P05411 study investigators. Boceprevir versus placebo with pegylated interferon alfa-2b and ribavirin for treatment of hepatitis C virus genotype 1 in patients with HIV: a randomised, double-blind, controlled phase 2 trial. Lancet Infect Dis. 2013 Jul;13(7):597-605. doi: 10.1016/S1473-3099(13)70149-X. Epub 2013 Jun 12. |
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One participant in the pegylated interferon alfa-2b (PegIFN-2b) + ribavirin (RBV) + boceprevir group withdrew from the study after randomization but prior to administration of any study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | PegIFN-2b + RBV | PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks. |
| FG001 | PegIFN-2b + RBV + Boceprevir | PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period |
|
| ||||||||||||||||||||||||
| Follow-up Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PegIFN-2b + RBV | PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Viral Response (SVR) at Follow-up Week 24 (FW24) Among Randomized Participants Who Received At Least One Dose of Trial Medication | SVR24 is defined as undetectable plasma hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from Follow-up Week 12 (FW12) was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL. | All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period. | Posted | Number | percentage of participants | Up to Week 72 |
|
Adverse events were collected from randomization through Week 72.
One participant randomized to the boceprevir arm never received study drug.
Adverse events for the 4 participants who crossed-over to boceprevir treatment at Treatment Week 24 (TW24) are included in the assigned treatment arm (PegIFN-2b + RBV ) until TW24 and are presented separately for the period following the crossover.
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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 | PegIFN-2b+RBV | PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006526 | Hepatitis C |
| D060085 | Coinfection |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| C512204 | N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| RBV | Drug | Ribavirin (600-1400 mg/day, orally, divided into two daily doses) |
|
|
| Placebo to Boceprevir | Drug | Placebo to boceprevir (orally, three times per day) |
|
| Boceprevir | Drug | Boceprevir (800 mg, orally, three times per day) |
|
|
| Up to Week 72 |
| Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR24 | EVR was defined as undetectable HCV-RNA at Treatment Week (TW) 2, 4, 8, or 12. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL. | Up to Week 12 |
| Percentage of Participants With Undetectable HCV-RNA at Follow-up Week 12 (FW12) | The virologic response at FW12 was considered SVR12 with an additional rule for handling missing data: participants with missing HCV-RNA assessment at FW12 but having non-missing, undetectable HCV-RNA assessments at both FW4 and FW24, were assumed to be responders for SVR12. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL. | Up to Week 60 |
| Change From Baseline in log10 HCV-RNA at Treatment Week 4 (TW4) | This is a measure of the change in the amount of HCV-RNA in the plasma at the end of 4 weeks of treatment. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL. | Baseline and Week 4 |
| Percentage of Participants With HCV Virologic Breakthrough or Incomplete Virologic Response/Rebound | Virologic breakthrough is defined as achieving undetectable HCV-RNA and subsequently having an HCV-RNA level of >1000 IU/mL. Incomplete Virologic Response/Rebound is defined as having a one log10 increase in HCV-RNA from the participant's nadir, with an HCV-RNA >1000 IU/mL. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL. | Up to Week 72 |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Non-Compliance with Protocol |
|
| Did not receive treatment |
|
| Futility/crossover to boceprevir |
|
| NOT COMPLETED |
|
|
| BG001 | PegIFN-2b + RBV + Boceprevir | PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
| OG001 | PegIFN-2b + RBV + Boceprevir | PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up. |
|
|
|
| Secondary | Percentage of Participants Achieving SVR24 Among Randomized Participants Who Received At Least One Dose of Boceprevir (Experimental) or Placebo (Control) | SVR24 is defined as undetectable plasma HCV-RNA 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from FW12 was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL. | All randomized participants receiving one dose of boceprevir (PegIFN-2b + RBV + Boceprevir group) or placebo to boceprevir (PegIFN-2b + RBV group), defined as the Modified Intent-to-Treat Population; this includes 2 participants who did not enter the Follow-up Period. | Posted | Number | percentage of participants | Up to Week 72 |
|
|
|
|
| Secondary | Percentage of Participants With Early Virologic Response (EVR) Who Achieved SVR24 | EVR was defined as undetectable HCV-RNA at Treatment Week (TW) 2, 4, 8, or 12. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL. | All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period. No participants had undetectable HCV-RNA at Week 2; the "n" value in the table below represents the number of participants with EVR at that time point. | Posted | Number | percentage of participants | Up to Week 12 |
|
|
|
| Secondary | Percentage of Participants With Undetectable HCV-RNA at Follow-up Week 12 (FW12) | The virologic response at FW12 was considered SVR12 with an additional rule for handling missing data: participants with missing HCV-RNA assessment at FW12 but having non-missing, undetectable HCV-RNA assessments at both FW4 and FW24, were assumed to be responders for SVR12. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL. | All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period. | Posted | Number | percentage of participants | Up to Week 60 |
|
|
|
| Secondary | Change From Baseline in log10 HCV-RNA at Treatment Week 4 (TW4) | This is a measure of the change in the amount of HCV-RNA in the plasma at the end of 4 weeks of treatment. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL. | All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period. | Posted | Number | participants | Baseline and Week 4 |
|
|
|
| Secondary | Percentage of Participants With HCV Virologic Breakthrough or Incomplete Virologic Response/Rebound | Virologic breakthrough is defined as achieving undetectable HCV-RNA and subsequently having an HCV-RNA level of >1000 IU/mL. Incomplete Virologic Response/Rebound is defined as having a one log10 increase in HCV-RNA from the participant's nadir, with an HCV-RNA >1000 IU/mL. HCV-RNA was detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL. | All randomized participants receiving at least one dose of any study medication (Full Analysis Set); this includes 3 participants who did not enter the Follow-Up Period. | Posted | Number | percentage of participants | Up to Week 72 |
|
|
|
| 7 |
| 34 |
| 33 |
| 34 |
| EG001 | PegIFN-2b+RBV+Boceprevir | PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up. | 11 | 64 | 62 | 64 |
| EG002 | Boceprevir Crossover | (After Treatment Week 24) PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) plus boceprevir (800 mg, orally, 3 times per day) for up to 44 weeks with 24 weeks post-treatment follow-up. | 0 | 4 | 4 | 4 |
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| VENTRICULAR FIBRILLATION | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| PANCREATITIS | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| LUNG INFECTION PSEUDOMONAL | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| PELVIC INFLAMMATORY DISEASE | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| POST PROCEDURAL INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| VULVAL ABSCESS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| LIGAMENT RUPTURE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| MENISCUS LESION | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| OVERDOSE | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| LACTIC ACIDOSIS | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| PULMONARY HYPERTENSION | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| CHOLECYSTECTOMY | Surgical and medical procedures | MedDRA 15.0 | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
|
| PALPITATIONS | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| PORPHYRIA | Congenital, familial and genetic disorders | MedDRA 15.0 | Systematic Assessment |
|
| DRY EYE | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| APHTHOUS STOMATITIS | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| CHEILITIS | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| DRY MOUTH | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| ORAL PAIN | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| TONGUE DISCOLOURATION | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| INJECTION SITE ERYTHEMA | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| IRRITABILITY | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| MALAISE | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| PAIN | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| FOLLICULITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| GINGIVAL ABSCESS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| ORAL CANDIDIASIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| TRANSAMINASES INCREASED | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 15.0 | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| HYPERTRIGLYCERIDAEMIA | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| SOMNOLENCE | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| PREGNANCY | Pregnancy, puerperium and perinatal conditions | MedDRA 15.0 | Systematic Assessment |
|
| AFFECT LABILITY | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| APATHY | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| DEPRESSED MOOD | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| DRUG ABUSE | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| NERVOUSNESS | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| SLEEP DISORDER | Psychiatric disorders | MedDRA 15.0 | Systematic Assessment |
|
| METRORRHAGIA | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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The Investigator must provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including, without limitation, slides and texts of oral or other public presentations and texts of any transmission through any electronic media, eg, any computer access system such as the Internet, World Wide Web, etc.) that report any results of the trial. The sponsor shall have the right to review and comment.
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| HCV-RNA undetectable at Week 8 (n=5, 27) |
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| HCV-RNA undetectable at Week 12 (n=8, 38) |
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| Participants with undetectable HCV-RNA |
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| Participants with missing data |
|