Hepatitis C
Conditions
Keywords
Peginterferon, Platelets, Ribavirin, Hepatitis C-related thrombocytopenia, Thrombocytopenia, Hepatitis C, Thrombopoietin
Brief summary
The purpose of this study is to test the safety and tolerability of eltrombopag when used to increase and maintain platelet count. Platelet count to be maintained at a level sufficient to facilitate initiation of antiviral therapy, to minimize antiviral therapy dose reductions, and to avoid permanent discontinuation of antiviral therapy.
Interventions
DRUGEltrombopag
Eltrombopag starting at 25 mg dose and titrated in Part 1 of study to 50, 75, 100 mg. Platelet count must reach sufficient level to allow initiation of antiviral therapy. Eltrombopag dose may be adjusted during antiviral treatment phase of study to maintain platelet count to continue antiviral therapy without adjustment to antiviral dose.
Combination of either peginterferon alfa-2a or alfa-2b with ribavirin at investigator's discretion.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prior participation in protocol TPL103922 or TPL108390 and completed the Week 24 Follow Up Visit in TPL103922 or TPL108390 * Male or female ≥18 years old * Evidence of chronic HCV infection * While participating in TPL103922 or TPL108390, discontinued from study drug due to thrombocytopenia * Appropriate candidate for antiviral therapy with pegylated interferon plus ribavirin * Platelet count \<75,000 * Fertile males and females must use two forms of effective contraception during treatment and for 24 weeks after treatment * Ability to understand and comply with the protocol requirements and instructions * Ability to provide written informed consent
Exclusion criteria
* Decompensated liver disease * Known hypersensitivity, intolerance, or allergy to interferon, ribavirin, eltrombopag, or their ingredients * History of clinically significant bleeding from oesophageal or gastric varices * History of arterial or venous thrombosis and two or more of the following risk factors: hereditary thrombophilic disorders; hormone replacement therapy; systemic contraception (containing estrogen); smoking; diabetes; hypercholesterolemia; medication for hypertension or cancer * Pre-existing cardiac disease (congestive heart failure Grade III/IV) or arrhythmias known to involve the risk of thromboembolic events (e.g. atrial fibrillation) * Evidence of hepatocellular carcinoma * HIV or Hepatitis B infection * Therapy with anti-neoplastic or immunomodulatory treatment within six months prior to eltrombopag therapy * Malignancy diagnosed or treated within the past five years. Except for localized basal or squamous cell carcinoma treated by local excision or malignancies that were adequately treated and, in the opinion of the oncologist, have an excellent chance of cancer-free survival. * Pregnant or nursing women * Men with a female partner who is pregnant * History of alcohol/drug abuse or dependence within six months of the study start unless participating in a controlled rehabilitation programme. * Treatment with an investigational drug or interferon within 30 days or 5 half-lives (whichever is longer) of the screening visit * History or platelet clumping that prevents reliable measurement of platelet counts * Evidence of portal vein thrombosis within three months of baseline visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2 | From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks) | LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units. |
| Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD) | Blood samples were collected for the measurement of hematology chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening. |
| Number of Participants With a Decrease in Visual Acuity During Parts 1 and 2 | From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks) | Visual acuity (VA) is defined as acuteness or clearness of vision. |
| Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2 | From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks) | LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units. |
| Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1 | From the start of investigational product up to the start of antiviral therapy (up to 9 weeks; median of 21 days) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs. |
| Number of Participants With Any AE and Any SAE in Part 2 | From the date of initiation of antiviral therapy (Antiviral Baseline Visit [between Study Day 14 and Study Day 65]) to the completion of the follow-up period (up to Week 96/WD) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs. |
| Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days) | Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening. |
| Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD) | Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening. |
| Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days) | Blood samples were collected for the measurement of hematology parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Particpants Who Initiated Antiviral Therapy | From the start of the investigational product up to 9 weeks (median of 21 days) | The number of participants who completed the Pre-antiviral Phase (Part 1) and proceeded to the Antiviral Phase (Part 2) are summarized. |
| Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR) | From the start of investigational product in Part 2 up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks) | SVR is defined as non-detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the planned treatment period (i.e., Week 48 or 72 for genotype 2/3 or Week 72 for non-genotype 2/3). RVR is defined as undetectable HCV RNA after 4 weeks of antiviral treatment. EVR is defined as clinically significant reduction in HCV RNA (\>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. ETR is defined as undetectable HCV RNA at the end of antiviral treatment. |
| Platelet Counts at the Indicated Time Points | From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks) | Blood samples were collected for the measurement of platelet count. For each participant, the duration of Part 1 treatment varies between 2 and 9 weeks. |
Countries
Australia, Canada, France, Germany, Greece, Italy, Pakistan, Spain, United States
Participant flow
Recruitment details
10\^9 cells (Giga) per liter=Gi/L; participants=par.; polyethylene glycol=Peg; interferon=INF.
Pre-assignment details
In Part (P) 1, the treatment goal was to increase the platelet count to \>=90 Gi/L. In P 2, par. continued on the selected P 1 dose of eltrombopag (dose effectively raising platelets to \>=90 or \>=100 Gi/L). Eltrombopag was given in combination with antiviral therapy (Peg INF alfa-2a or Peg INF alfa-2b and ribavirin) for the duration of treatment.
Participants by arm
| Arm | Count |
|---|---|
| Eltrombopag In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of \<75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams \[mg\] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either \>=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (\>=90 Gi/L or \>=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (\>=90 Gi/L) or Peg IFN alfa-2b (\>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count. | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Part 1 (Pre-Antiviral Treatment Phase) | Withdrawal by Subject | 1 |
| Part 2 (Antiviral Treatment Phase) | Lost to Follow-up | 3 |
| Part 2 (Antiviral Treatment Phase) | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Eltrombopag |
|---|---|
| Age Continuous | 51.3 Years STANDARD_DEVIATION 7.7 |
| Race/Ethnicity, Customized Central/South Asian Heritage | 2 participants |
| Race/Ethnicity, Customized White | 25 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 27 | 25 / 25 |
| serious Total, serious adverse events | 0 / 27 | 5 / 25 |
Outcome results
Primary
Number of Participants With a Decrease in Visual Acuity During Parts 1 and 2
Visual acuity (VA) is defined as acuteness or clearness of vision.
Time frame: From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)
Population: Entire Safety Population: all participants in the Pre-antiviral Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants With a Decrease in Visual Acuity During Parts 1 and 2 | Decrease in Visual Acuity, Yes | 10 Participants |
| Eltrombopag | Number of Participants With a Decrease in Visual Acuity During Parts 1 and 2 | Decrease in Visual Acuity, No | 15 Participants |
| Eltrombopag | Number of Participants With a Decrease in Visual Acuity During Parts 1 and 2 | Decrease in Visual Acuity, Missing or Unknown | 2 Participants |
Primary
Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2
LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.
Time frame: From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)
Population: Entire Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2 | logMAR change, Yes | 4 Participants |
| Eltrombopag | Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2 | logMAR change, No | 21 Participants |
| Eltrombopag | Number of Participants With a logMAR Change >=0.15 During Parts 1 and 2 | logMAR change, Missing or Unknown | 2 Participants |
Primary
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.
Time frame: From the start of investigational product up to the start of antiviral therapy (up to 9 weeks; median of 21 days)
Population: Pre-antiviral Safety Population: all participants who received study drug in the Pre-antiviral Treatment Phase (Part 1) of the study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1 | Any SAE | 0 Participants |
| Eltrombopag | Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) in Part 1 | Any AE | 9 Participants |
Primary
Number of Participants With Any AE and Any SAE in Part 2
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.
Time frame: From the date of initiation of antiviral therapy (Antiviral Baseline Visit [between Study Day 14 and Study Day 65]) to the completion of the follow-up period (up to Week 96/WD)
Population: Antiviral Safety Population: all participants who entered the Antiviral Treatment Phase (Part 2) of the study and who received at least one dose of antiviral therapy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants With Any AE and Any SAE in Part 2 | Any SAE | 5 Participants |
| Eltrombopag | Number of Participants With Any AE and Any SAE in Part 2 | Any AE | 25 Participants |
Primary
Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2
LogMAR (logarithm of the minimum angle of resolution) charts are used to measure an individual's visual acuity. LogMAR, expressed as the (decadic) logarithm of the minimum angle of resolution (range from +1.00 to -0.30), converts the geometric sequence of a traditional chart to a linear scale. As there are 5 letters per line, the total score for a line on the LogMAR chart represents a change of 0.1 log units.
Time frame: From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)
Population: Entire Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2 | logMAR Changes, >=0.10 to <0.20 (Loss of 1 Line) | 6 Participants |
| Eltrombopag | Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2 | logMAR Changes, >=0.20 to <0.30 (Loss of 2 Lines) | 3 Participants |
| Eltrombopag | Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2 | logMAR Changes, >=0.30 (Loss of 3 Lines or more) | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2 | logMAR Changes, <0.10 (No Change or Improvement) | 15 Participants |
| Eltrombopag | Number of Participants With the Indicated Change in logMAR Scale Values During Parts 1 and 2 | logMAR Changes, Missing or Unknown | 2 Participants |
Primary
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1
Blood samples were collected for the measurement of hematology parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
Time frame: From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)
Population: Pre-antiviral Safety Population. Only participants with data available at the specified time point were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | Total neutrophils, Any Increase | 3 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | Total neutrophils, Increase to Grade 1 | 3 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | White Blood cell count, Increase to Grade 4 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | Hemoglobin, Any Increase | 2 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | Hemoglobin, Increase to Grade 1 | 2 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | Hemoglobin, Increase to Grade 2 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | Hemoglobin, Increase to Grade 3 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | Hemoglobin, Increase to Grade 4 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | Lymphocytes, Any Increase | 3 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | Lymphocytes, Increase to Grade 1 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | Lymphocytes, Increase to Grade 2 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | Lymphocytes, Increase to Grade 3 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | Lymphocytes, Increase to Grade 4 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | Total neutrophils, Increase to Grade 2 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | Total neutrophils, Increase to Grade 3 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | Total neutrophils, Increase to Grade 4 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | White Blood cell count, Any Increase | 2 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | White Blood cell count, Increase to Grade 1 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | White Blood cell count, Increase to Grade 2 | 2 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From Screening for the Indicated Hematology Parameters During Part 1 | White Blood cell count, Increase to Grade 3 | 0 Participants |
Primary
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2
Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
Time frame: From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)
Population: Antiviral Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Total bilirubin, Increase to Grade 4 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Alanine amino transferase, Any Increase | 4 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Alanine amino transferase, Increase to Grade 1 | 3 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Alanine amino transferase, Increase to Grade 2 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Alanine amino transferase, Increase to Grade 3 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Alanine amino transferase, Increase to Grade 4 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Albumin, Any Increase | 9 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Albumin, Increase to Grade 1 | 4 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Albumin, Increase to Grade 2 | 5 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Albumin, Increase to Grade 3 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Albumin, Increase to Grade 4 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Alkaline phosphatase, Any Increase | 7 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Alkaline phosphatase, Increase to Grade 1 | 7 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Alkaline phosphatase, Increase to Grade 2 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Alkaline phosphatase, Increase to Grade 3 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Alkaline phosphatase, Increase to Grade 4 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Aspartate amino transferase, Any Increase | 9 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Aspartate amino transferase, Increase to Grade 1 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Aspartate amino transferase, Increase to Grade 2 | 8 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Aspartate amino transferase, Increase to Grade 3 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Aspartate amino transferase, Increase to Grade 4 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Creatinine, Any Increase | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Creatinine, Increase to Grade 1 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Creatinine, Increase to Grade 2 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Creatinine, Increase to Grade 3 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Creatinine, Increase to Grade 4 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Total bilirubin, Any Increase | 16 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Total bilirubin, Increase to Grade 1 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Total bilirubin, Increase to Grade 2 | 5 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Total bilirubin, Increase to Grade 3 | 10 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Uric acid, Any Increase | 5 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Uric acid, Increase to Grade 1 | 4 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Uric acid, Increase to Grade 2 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Uric acid, Increase to Grade 3 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Clinical Chemistry Parameter During Part 2 | Uric acid, Increase to Grade 4 | 0 Participants |
Primary
Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2
Blood samples were collected for the measurement of hematology chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
Time frame: From Day 0 of Part 2 (Antiviral Baseline Visit [between Study Day 14 and Study Day 65) to the completion of the follow-up period (up to Week 96/WD)
Population: Antiviral Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | Hemoglobin, Any Increase | 12 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | Hemoglobin, Increase to Grade 1 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | Hemoglobin, Increase to Grade 2 | 5 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | Hemoglobin, Increase to Grade 3 | 5 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | Hemoglobin, Increase to Grade 4 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | Lymphocytes, Any Increase | 15 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | Lymphocytes, Increase to Grade 1 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | Lymphocytes, Increase to Grade 2 | 3 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | Lymphocytes, Increase to Grade 3 | 3 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | Lymphocytes, Increase to Grade 4 | 8 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | Total neutrophils, Any Increase | 23 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | Total neutrophils, Increase to Grade 1 | 4 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | Total neutrophils, Increase to Grade 2 | 10 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | Total neutrophils, Increase to Grade 3 | 8 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | Total neutrophils, Increase to Grade 4 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | White Blood Cell count, Any Increase | 20 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | White Blood Cell count, Increase to Grade 1 | 5 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | White Blood Cell count, Increase to Grade 2 | 7 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | White Blood Cell count, Increase to Grade 3 | 7 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case DAIDS Grade Increases From the Antiviral Baseline Visit for the Indicated Hematology Parameters During Part 2 | White Blood Cell count, Increase to Grade 4 | 1 Participants |
Primary
Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1
Blood samples were collected for the measurement of clinical chemistry parameters. The DAIDS grades are utilized for measuring the severity of AEs. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, potentially life threatening.
Time frame: From Screening up to the start of antiviral therapy (up to 9 weeks; median of 21 days)
Population: Pre-antiviral Safety Population. Only participants with data available at the specified time point were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Alanine amino transferase, Any Increase | 2 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Alanine amino transferase, Increase to Grade 1 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Alanine amino transferase, Increase to Grade 2 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Alanine amino transferase, Increase to Grade 3 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Alanine amino transferase, Increase to Grade 4 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Albumin, Any Increase | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Albumin, Increase to Grade 1 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Albumin, Increase to Grade 2 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Albumin, Increase to Grade 3 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Albumin, Increase to Grade 4 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Alkaline phosphatase, Any Increase | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Alkaline phosphatase, Increase to Grade 1 | 1 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Alkaline phosphatase, Increase to Grade 2 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Alkaline phosphatase, Increase to Grade 3 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Alkaline phosphatase, Increase to Grade 4 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Aspartate amino transferase, Any Increase | 2 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Aspartate amino transferase, Increase to Grade 1 | 2 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Aspartate amino transferase, Increase to Grade 2 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Aspartate amino transferase, Increase to Grade 3 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Aspartate amino transferase, Increase to Grade 4 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Creatinine, Any Increase | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Creatinine, Increase to Grade 1 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Creatinine, Increase to Grade 2 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Creatinine, Increase to Grade 3 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Creatinine, Increase to Grade 4 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Total bilirubin, Any Increase | 10 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Total bilirubin, Increase to Grade 1 | 6 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Total bilirubin, Increase to Grade 2 | 4 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Total bilirubin, Increase to Grade 3 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Total bilirubin, Increase to Grade 4 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Uric acid, Any Increase | 3 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Uric acid, Increase to Grade 1 | 3 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Uric acid, Increase to Grade 2 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Uric acid, Increase to Grade 3 | 0 Participants |
| Eltrombopag | Number of Participants With the Indicated Worst-case Division of Acquired Immune Deficiency Syndrome (DAIDS) Grade Increases From Screening for the Indicated Clinical Chemistry Parameters During Part 1 | Uric acid, Increase to Grade 4 | 0 Participants |
Secondary
Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR)
SVR is defined as non-detectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks post-completion of the planned treatment period (i.e., Week 48 or 72 for genotype 2/3 or Week 72 for non-genotype 2/3). RVR is defined as undetectable HCV RNA after 4 weeks of antiviral treatment. EVR is defined as clinically significant reduction in HCV RNA (\>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. ETR is defined as undetectable HCV RNA at the end of antiviral treatment.
Time frame: From the start of investigational product in Part 2 up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)
Population: Antiviral Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Antiviral Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR) | SVR, Yes, n=17 | 4 Participants |
| Eltrombopag | Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR) | SVR, No, n=17 | 13 Participants |
| Eltrombopag | Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR) | RVR, Yes, n=12 | 3 Participants |
| Eltrombopag | Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR) | RVR, No, n=12 | 9 Participants |
| Eltrombopag | Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR) | EVR, Yes, n=15 | 15 Participants |
| Eltrombopag | Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR) | EVR, No, n=15 | 0 Participants |
| Eltrombopag | Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR) | ETR, Yes, n=21 | 9 Participants |
| Eltrombopag | Number of Participants Achieving Antiviral Treatment Milestones of Sustained Virological Response (SVR), Rapid Virological Response (RVR), Early Virological Response (EVR), and End of Treatment Response (ETR) | ETR, No, n=21 | 12 Participants |
Secondary
Number of Particpants Who Initiated Antiviral Therapy
The number of participants who completed the Pre-antiviral Phase (Part 1) and proceeded to the Antiviral Phase (Part 2) are summarized.
Time frame: From the start of the investigational product up to 9 weeks (median of 21 days)
Population: Pre-antiviral Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eltrombopag | Number of Particpants Who Initiated Antiviral Therapy | Yes | 25 Participants |
| Eltrombopag | Number of Particpants Who Initiated Antiviral Therapy | No | 2 Participants |
Secondary
Platelet Counts at the Indicated Time Points
Blood samples were collected for the measurement of platelet count. For each participant, the duration of Part 1 treatment varies between 2 and 9 weeks.
Time frame: From the start of investigational product up to the 24-week follow-up visit after the last dose in Part 2 or early withdrawal (up to 96 weeks)
Population: Pre-antiviral Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Week 56, n=1 | 47.0 Gi/L | — |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Week 60, n=1 | 43.0 Gi/L | — |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 1/Week 7, n=5 | 76.2 Gi/L | Standard Deviation 19.88 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Screening, n=27 | 53.1 Gi/L | Standard Deviation 12.9 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 1/Day 1, n=27 | 55.9 Gi/L | Standard Deviation 18.69 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 1/Week 1, n=25 | 73.3 Gi/L | Standard Deviation 29.27 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 1/Week 2, n=16 | 83.2 Gi/L | Standard Deviation 27.9 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 1/Week 3, n=8 | 73.4 Gi/L | Standard Deviation 26.53 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 1/Week 4, n=7 | 75.6 Gi/L | Standard Deviation 19.95 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 1/Week 5, n=5 | 72.2 Gi/L | Standard Deviation 18.29 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 1/Week 6, n=5 | 81.6 Gi/L | Standard Deviation 14.45 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 1/Week 8, n=3 | 91.7 Gi/L | Standard Deviation 22.81 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Antiviral Baseline, n=25 | 132.9 Gi/L | Standard Deviation 33.72 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Week 1, n=25 | 106.7 Gi/L | Standard Deviation 37.8 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Week 2, n=25 | 93.2 Gi/L | Standard Deviation 42.98 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Week 4, n=23 | 80.5 Gi/L | Standard Deviation 30.64 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Week 8, n=21 | 80.3 Gi/L | Standard Deviation 24.4 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Week 12, n=20 | 83.1 Gi/L | Standard Deviation 31.72 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Week 16, n=16 | 85.8 Gi/L | Standard Deviation 27.61 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Week 20, n=14 | 75.3 Gi/L | Standard Deviation 22.54 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Week 24, n=11 | 78.6 Gi/L | Standard Deviation 30.63 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Week 28, n=9 | 90.3 Gi/L | Standard Deviation 50.09 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Week 32, n=7 | 86.1 Gi/L | Standard Deviation 72.12 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Week 36, n=6 | 76.8 Gi/L | Standard Deviation 53.77 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Week 40, n=5 | 55.8 Gi/L | Standard Deviation 27.65 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Week 44, n=5 | 54.4 Gi/L | Standard Deviation 29.18 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Week 48, n=2 | 68.0 Gi/L | Standard Deviation 29.7 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Week 52, n=1 | 49.0 Gi/L | — |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Week 64, n=1 | 43.0 Gi/L | — |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Part 2/Week 68, n=1 | 44.0 Gi/L | — |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Post-treatment/4 Week Follow-up, n=23 | 77.8 Gi/L | Standard Deviation 33.48 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Post-treatment/24 Week Follow-up, n=22 | 52.5 Gi/L | Standard Deviation 17.91 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Investigational product discontinuation, n=26 | 91.3 Gi/L | Standard Deviation 38.78 |
| Eltrombopag | Platelet Counts at the Indicated Time Points | Maximum value post-Baseline, n=26 | 145.5 Gi/L | Standard Deviation 43.68 |