Trial Outcomes & Findings for Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C Liver Disease (NCT NCT00529568)

Last Updated: 2013-11-05

Results Overview

Participants with SVR are defined as those with non-detectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at the end of treatment and all subsequent planned visits up to 24 weeks post-completion of the treatment period of the DB Phase.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

759 participants

Primary outcome timeframe

From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Results posted on

2013-11-05

Participant Flow

The number of enrolled participants in the protocol record (n=759) reflects the number of participants randomized to double-blind treatment after completing the Open-label Phase.

Participant milestones

Participant milestones
Measure	Eltrombopag: Open-label Phase Participants with a platelet count of \<75 giga (10\^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained \<100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during the Open-label Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.	Placebo+Antiviral Therapy: DB Phase Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Open-label Pre-Antiviral Treatment Phase STARTED	805	0	0
Open-label Pre-Antiviral Treatment Phase COMPLETED	759	0	0
Open-label Pre-Antiviral Treatment Phase NOT COMPLETED	46	0	0
Double-bilnd Antiviral Treatment Phase STARTED	0	253	506
Double-bilnd Antiviral Treatment Phase COMPLETED	0	205	404
Double-bilnd Antiviral Treatment Phase NOT COMPLETED	0	48	102

Reasons for withdrawal

Reasons for withdrawal
Measure	Eltrombopag: Open-label Phase Participants with a platelet count of \<75 giga (10\^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was \<100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained \<100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts \>=100 Gi/L during the Open-label Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts \>=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.	Placebo+Antiviral Therapy: DB Phase Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Open-label Pre-Antiviral Treatment Phase Adverse Event	5	0	0
Open-label Pre-Antiviral Treatment Phase Lost to Follow-up	12	0	0
Open-label Pre-Antiviral Treatment Phase Protocol Violation	5	0	0
Open-label Pre-Antiviral Treatment Phase Physician Decision	8	0	0
Open-label Pre-Antiviral Treatment Phase Insufficient Platelet Response	13	0	0
Open-label Pre-Antiviral Treatment Phase Withdrawal by Subject	3	0	0
Double-bilnd Antiviral Treatment Phase Adverse Event	0	10	27
Double-bilnd Antiviral Treatment Phase Protocol Violation	0	1	0
Double-bilnd Antiviral Treatment Phase Lost to Follow-up	0	15	48
Double-bilnd Antiviral Treatment Phase Physician Decision	0	5	8
Double-bilnd Antiviral Treatment Phase Withdrawal by Subject	0	17	19

Baseline Characteristics

Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C Liver Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo+Antiviral Therapy: DB Phase n=253 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=506 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Total n=759 Participants Total of all reporting groups
Age Continuous	52.0 Years STANDARD_DEVIATION 9.15 • n=5 Participants	52.4 Years STANDARD_DEVIATION 8.61 • n=7 Participants	52.3 Years STANDARD_DEVIATION 8.79 • n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	185 Participants n=7 Participants	278 Participants n=5 Participants
Sex: Female, Male Male	160 Participants n=5 Participants	321 Participants n=7 Participants	481 Participants n=5 Participants
Race/Ethnicity, Customized African American (A)/African	4 participants n=5 Participants	8 participants n=7 Participants	12 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized White (W)	188 participants n=5 Participants	388 participants n=7 Participants	576 participants n=5 Participants
Race/Ethnicity, Customized Central/South Asian	16 participants n=5 Participants	43 participants n=7 Participants	59 participants n=5 Participants
Race/Ethnicity, Customized Japanese/East Asian /South East Asian	45 participants n=5 Participants	64 participants n=7 Participants	109 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native and White	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized African A/African and A Indian/Alaska Native and W	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Number of participants categorized into the indicated genotype for Hepatitic C Virus (HCV) Genotype 1	160 participants n=5 Participants	320 participants n=7 Participants	480 participants n=5 Participants
Number of participants categorized into the indicated genotype for Hepatitic C Virus (HCV) Genotype 2	28 participants n=5 Participants	40 participants n=7 Participants	68 participants n=5 Participants
Number of participants categorized into the indicated genotype for Hepatitic C Virus (HCV) Genotype 3	47 participants n=5 Participants	113 participants n=7 Participants	160 participants n=5 Participants
Number of participants categorized into the indicated genotype for Hepatitic C Virus (HCV) Genotype 4	17 participants n=5 Participants	30 participants n=7 Participants	47 participants n=5 Participants
Number of participants categorized into the indicated genotype for Hepatitic C Virus (HCV) Genotype 5	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Number of participants categorized into the indicated genotype for Hepatitic C Virus (HCV) Genotype 6	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Number of participants categorized into the indicated genotype for Hepatitic C Virus (HCV) Genotype 7	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Number of participants categorized into the indicated genotype for Hepatitic C Virus (HCV) Missing	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Number of participants categorized into the indicated Child-Pugh (CP) Class Class A	242 participants n=5 Participants	487 participants n=7 Participants	729 participants n=5 Participants
Number of participants categorized into the indicated Child-Pugh (CP) Class Class B	11 participants n=5 Participants	17 participants n=7 Participants	28 participants n=5 Participants
Number of participants categorized into the indicated Child-Pugh (CP) Class Class C	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Number of participants categorized into the indicated Child-Pugh (CP) Class Missing	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Number of participants with or without previous interferon (IFN) use Naïve	182 participants n=5 Participants	347 participants n=7 Participants	529 participants n=5 Participants
Number of participants with or without previous interferon (IFN) use Experienced	71 participants n=5 Participants	159 participants n=7 Participants	230 participants n=5 Participants
Number of participants with the indicated FibroTest/Acti Test (FibroSURE) score Score: F0/F1/F2	19 participants n=5 Participants	46 participants n=7 Participants	65 participants n=5 Participants
Number of participants with the indicated FibroTest/Acti Test (FibroSURE) score Score: F3/F4	199 participants n=5 Participants	405 participants n=7 Participants	604 participants n=5 Participants
Number of participants with the indicated FibroTest/Acti Test (FibroSURE) score Missing	35 participants n=5 Participants	55 participants n=7 Participants	90 participants n=5 Participants
Number of participants with normal or elevated Baseline values for Alanine Aminotransferase (ALT) Normal	49 participants n=5 Participants	113 participants n=7 Participants	162 participants n=5 Participants
Number of participants with normal or elevated Baseline values for Alanine Aminotransferase (ALT) Elevated	204 participants n=5 Participants	393 participants n=7 Participants	597 participants n=5 Participants
Baseline HCV Ribonucleic Acid (RNA)	1656788.0 International Units per milliliter STANDARD_DEVIATION 2564763.45 • n=5 Participants	1702729.6 International Units per milliliter STANDARD_DEVIATION 3066411.11 • n=7 Participants	1687415.8 International Units per milliliter STANDARD_DEVIATION 2907191.97 • n=5 Participants
Baseline Platelet Count	56.56 Giga (10^9) cells per liter (Gi/L) STANDARD_DEVIATION 13.571 • n=5 Participants	56.85 Giga (10^9) cells per liter (Gi/L) STANDARD_DEVIATION 13.311 • n=7 Participants	56.75 Giga (10^9) cells per liter (Gi/L) STANDARD_DEVIATION 13.390 • n=5 Participants

PRIMARY outcome

Timeframe: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Population: Intent-to-Treat (ITT) Population: all participants randomized in the DB Phase

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=253 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=506 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase	32 participants	97 participants

SECONDARY outcome

Timeframe: From Baseline up to Week 9 in the OL Phase

Population: Safety Population: all participants who had received study drug in the OL Phase

Participants were assessed for a shift from a baseline platelet count of \<75 Gi/L to a count \>=100 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=805 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 100 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase	773 participants	—

SECONDARY outcome

Timeframe: From Baseline up to Week 9 in the OL Phase

Population: Safety Population. Participants with a platelet count \>=100 Gi/L and who initiated antiviral therapy during the DB Phase were analyzed.

In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was \<100 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained \<100 Gi/L. Participants who achieved platelet counts \>=100 Gi/L when receiving any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=759 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase 25 mg	443 participants	—
Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase 50 mg	208 participants	—
Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase 75 mg	77 participants	—
Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase 100 mg	31 participants	—

SECONDARY outcome

Timeframe: OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82)

Population: Safety Population. Only those participants contributing data at the indicated time points were analyzed.

Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=797 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Median Platelet Count at the Indicated Time Points During the OL Phase Baseline, n=797	59.0 Gi/L Interval 12.0 to 95.0	—
Median Platelet Count at the Indicated Time Points During the OL Phase Day 1, n=714	58.0 Gi/L Interval 5.0 to 117.0	—
Median Platelet Count at the Indicated Time Points During the OL Phase Week 1, n=791	77.0 Gi/L Interval 5.0 to 223.0	—
Median Platelet Count at the Indicated Time Points During the OL Phase Week 2, n=530	93.0 Gi/L Interval 9.0 to 489.0	—
Median Platelet Count at the Indicated Time Points During the OL Phase Week 3, n=288	89.0 Gi/L Interval 10.0 to 504.0	—
Median Platelet Count at the Indicated Time Points During the OL Phase Week 4, n=161	90.0 Gi/L Interval 10.0 to 280.0	—
Median Platelet Count at the Indicated Time Points During the OL Phase Week 5, n=98	92.0 Gi/L Interval 9.0 to 252.0	—
Median Platelet Count at the Indicated Time Points During the OL Phase Week 6, n=55	86.0 Gi/L Interval 14.0 to 138.0	—
Median Platelet Count at the Indicated Time Points During the OL Phase Week 7, n=35	78.0 Gi/L Interval 11.0 to 136.0	—
Median Platelet Count at the Indicated Time Points During the OL Phase Week 8, n=24	87.5 Gi/L Interval 15.0 to 146.0	—
Median Platelet Count at the Indicated Time Points During the OL Phase Week 9, n=4	85.5 Gi/L Interval 66.0 to 107.0	—
Median Platelet Count at the Indicated Time Points During the OL Phase Antiviral Baseline, n=48	131.5 Gi/L Interval 76.0 to 274.0	—
Median Platelet Count at the Indicated Time Points During the OL Phase End of Treatment/Withdrawal, n=22	76.5 Gi/L Interval 13.0 to 257.0	—
Median Platelet Count at the Indicated Time Points During the OL Phase Last on Treatment, n=39	87.0 Gi/L Interval 13.0 to 267.0	—
Median Platelet Count at the Indicated Time Points During the OL Phase Week 4 Follow-Up, n=20	42.0 Gi/L Interval 11.0 to 156.0	—
Median Platelet Count at the Indicated Time Points During the OL Phase Week 12 Follow-Up, n=15	43.0 Gi/L Interval 8.0 to 91.0	—
Median Platelet Count at the Indicated Time Points During the OL Phase Week 24 Follow-Up, n=14	41.0 Gi/L Interval 13.0 to 87.0	—

SECONDARY outcome

Timeframe: DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72)

Population: ITT Population. Only those participants contributing data at the indicated time points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=252 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=505 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Median Platelet Count at the Indicated Time Points During the DB Phase Week 20, n=134, 378	50.0 Gi/L Interval 23.0 to 257.0	103.0 Gi/L Interval 21.0 to 373.0
Median Platelet Count at the Indicated Time Points During the DB Phase Week 24, n=99, 263	49.0 Gi/L Interval 19.0 to 200.0	102.0 Gi/L Interval 18.0 to 448.0
Median Platelet Count at the Indicated Time Points During the DB Phase Week 28, n=74, 212	52.5 Gi/L Interval 22.0 to 193.0	102.0 Gi/L Interval 20.0 to 355.0
Median Platelet Count at the Indicated Time Points During the DB Phase Week 32, n=67, 199	49.0 Gi/L Interval 22.0 to 195.0	107.0 Gi/L Interval 14.0 to 295.0
Median Platelet Count at the Indicated Time Points During the DB Phase Week 36, n=63, 185	50.0 Gi/L Interval 16.0 to 198.0	106.0 Gi/L Interval 29.0 to 268.0
Median Platelet Count at the Indicated Time Points During the DB Phase Week 40, n=58, 174	53.7 Gi/L Interval 19.0 to 195.0	106.5 Gi/L Interval 10.0 to 351.0
Median Platelet Count at the Indicated Time Points During the DB Phase Week 44, n=59, 168	53.0 Gi/L Interval 26.0 to 197.0	108.7 Gi/L Interval 26.0 to 330.0
Median Platelet Count at the Indicated Time Points During the DB Phase End of Treatment/Withdrawal, n=240, 468	51.0 Gi/L Interval 10.0 to 275.0	106.5 Gi/L Interval 10.0 to 445.0
Median Platelet Count at the Indicated Time Points During the DB Phase Last on Treatment, n=253, 505	50.0 Gi/L Interval 17.0 to 300.0	105.0 Gi/L Interval 10.0 to 330.0
Median Platelet Count at the Indicated Time Points During the DB Phase 4 week follow up, n=221, 424	63.0 Gi/L Interval 4.0 to 225.0	89.0 Gi/L Interval 12.0 to 333.0
Median Platelet Count at the Indicated Time Points During the DB Phase 12 week follow up, n=209, 430	57.0 Gi/L Interval 15.0 to 285.0	62.0 Gi/L Interval 8.0 to 280.0
Median Platelet Count at the Indicated Time Points During the DB Phase 24 week follow up, n=201, 395	57.0 Gi/L Interval 8.0 to 231.0	59.0 Gi/L Interval 4.0 to 297.0
Median Platelet Count at the Indicated Time Points During the DB Phase Baseline, n=238, 460	140.0 Gi/L Interval 63.0 to 365.0	136.0 Gi/L Interval 43.0 to 400.0
Median Platelet Count at the Indicated Time Points During the DB Phase Week 1, n=247, 494	120.0 Gi/L Interval 42.0 to 366.0	116.0 Gi/L Interval 46.0 to 466.0
Median Platelet Count at the Indicated Time Points During the DB Phase Week 2, n=244, 492	89.5 Gi/L Interval 27.0 to 318.0	124.0 Gi/L Interval 38.0 to 553.0
Median Platelet Count at the Indicated Time Points During the DB Phase Week 4, n=228, 487	51.0 Gi/L Interval 20.0 to 180.0	105 Gi/L Interval 19.0 to 389.0
Median Platelet Count at the Indicated Time Points During the DB Phase Week 6, n=206, 473	49.5 Gi/L Interval 20.0 to 200.0	100.0 Gi/L Interval 22.0 to 417.0
Median Platelet Count at the Indicated Time Points During the DB Phase Week 8, n=192, 473	50.0 Gi/L Interval 10.0 to 191.0	100.0 Gi/L Interval 19.0 to 486.0
Median Platelet Count at the Indicated Time Points During the DB Phase Week 12, n=176, 451	49.7 Gi/L Interval 21.0 to 264.0	104.0 Gi/L Interval 10.0 to 444.0
Median Platelet Count at the Indicated Time Points During the DB Phase Week 16, n=145, 405	48.0 Gi/L Interval 20.0 to 262.0	102.0 Gi/L Interval 13.0 to 365.0

SECONDARY outcome

Timeframe: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Population: ITT Population

The minimum platelet count with antiviral therapy was categorized as follows: \<25 Gi/L; \>=25 to \<50 Gi/L; \>=50 to \<90 Gi/L; \>=90 to \<150 Gi/L; \>=150 Gi/L to \<200 Gi/L; \>=200 Gi/L to \<400 Gi/L; and \>=400 Gi/L.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=253 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=506 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy <25 Gi/L	34 participants	20 participants
Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy >=25 to <50 Gi/L	159 participants	76 participants
Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy >=50 to <90 Gi/L	49 participants	263 participants
Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy >=90 to <150 Gi/L	10 participants	135 participants
Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy >=150 to <200 Gi/L	0 participants	8 participants
Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy >=200 to <400 Gi/L	0 participants	4 participants
Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy >=400 Gi/L	0 participants	0 participants
Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy Missing	1 participants	0 participants

SECONDARY outcome

Timeframe: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Population: ITT Population

RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=253 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=506 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase RVR	34 participants	78 participants
Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase eRVR	27 participants	69 participants

SECONDARY outcome

Timeframe: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Population: ITT Population

EVR is defined as a clinically significant reduction from Baseline in HCV RNA (\>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. cEVR is defined as undetectable HCV RNA after 12 weeks of antiviral treatment.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=253 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=506 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase EVR	103 participants	313 participants
Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase cEVR	57 participants	174 participants

SECONDARY outcome

Timeframe: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Population: ITT Population

ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=253 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=506 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase ETR	59 participants	190 participants
Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase SVR12	29 participants	106 participants

SECONDARY outcome

Timeframe: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Population: ITT Population

Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions \[DRs\]; 1=one DR; 2=two DRs; 3=three DRs; \>3=more than three DRs). When possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, when dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=253 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=506 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase 0	68 participants	231 participants
Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase 1	76 participants	101 participants
Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase 2	40 participants	75 participants
Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase 3	34 participants	47 participants
Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase >3	35 participants	52 participants

SECONDARY outcome

Timeframe: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Population: ITT Population. Only those participants with dose reductions were analyzed.

Time to first dose reduction was calculated as the time period from the first dose to the first dose reduction.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=171 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=208 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase Peginterferon alfa-2a dose reduction, n=171, 208	6.58 weeks Standard Deviation 7.336	10.64 weeks Standard Deviation 9.305
Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase Ribavirin dose reduction, n=79, 189	12.43 weeks Standard Deviation 9.681	10.99 weeks Standard Deviation 8.984

SECONDARY outcome

Timeframe: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Population: ITT Population. One participant could have had more than one dose reduction.

The assigned dose in the DB Phase of peginterferon alfa-2a was 180 micrograms (µg). For peginterferon dose modification, downward adjustments in one-level increments were considered. The lowest dose of peginterferon alfa-2a that was allowed to be administered was 45 µg. When dose adjustment was required for moderate to severe adverse reactions (clinical and/or laboratory), an initial dose reduction to 135 µg was generally adequate. In some cases, a dose reduction to 90 µg or 45 µg was necessary. Dose increases toward the original dose were considered when the adverse reaction was resolved.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=253 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=506 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase <=25%	44 participants	89 participants
Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase >25% to <=34%	33 participants	35 participants
Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase >34% to <=50%	115 participants	112 participants
Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase >50%	33 participants	30 participants

SECONDARY outcome

Timeframe: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Population: ITT Population

The following participants were considered to have discontinued antiviral therapy: participants who were lost to follow-up; participants who withdrew for any reason; participants who died; participants who otherwise did not complete their planned course of antiviral therapy for any reason. The planned duration of antiviral therapy was 48 weeks for participants with Non-Genotype 2/3 and 24 or 48 weeks for participants with Genotype 2/3.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=253 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=506 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase	164 participants	242 participants

SECONDARY outcome

Timeframe: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Population: Pharmacogenetic (PGx) Sub-Population: participants enrolled in this study who provided written informed consent for PGx research with a blood sample for genotyping and who were successfully genotyped for at least one of the two genetic markers under study. Only those participants who were analyzed for SVR and RVR were considered.

There are two genetic variants (rs12979860 and rs8099917) mapping near IL28B associated with both interferon-induced SVR and spontaneous HCV clearance. IL28B genotype distribution by response to antiviral therapy (SVR/RVR responders: those who achieved SVR/RVR; SVR/RVR non-responders: those who did not achieve SVR/RVR) was assessed. The effect of genotype was tested by comparing participants that carried 2 copies of the IL28B favorable response allele versus the others (recessive model). Genotypes at rs12979860 were coded as: CC=1, CT or TT=0; rs8099917 was coded as TT=1, GT or GG=0.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=105 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=205 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) SVR, rs12979860 (CT), R; n=12, 50	2 participants	18 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) SVR, rs12979860 (CC), R; n=12, 50	10 participants	28 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) SVR, rs12979860 (CC), NR; n=105, 205	24 participants	58 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) SVR, rs12979860 (CT), NR; n=105, 205	60 participants	111 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) SVR, rs12979860 (TT), R; n=12, 50	0 participants	4 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) SVR, rs12979860 (TT), NR; n=105, 205	21 participants	36 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) SVR, rs8099917 (TT), R; n=12, 50	11 participants	36 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) SVR, rs8099917 (TT), NR; n=105, 205	48 participants	89 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) SVR, rs8099917 (GT), R; n=12, 50	1 participants	13 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) SVR, rs8099917 (GT), NR; n=105, 205	51 participants	99 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) SVR, rs8099917 (GG), R; n=12, 50	0 participants	1 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) SVR, rs8099917 (GG), NR; n=105, 205	6 participants	17 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) RVR, rs12979860 (CC), R; n=11, 33	6 participants	21 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) RVR, rs12979860 (CC), NR; n=106, 222	28 participants	65 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) RVR, rs12979860 (CT), R; n=11, 33	5 participants	11 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) RVR, rs12979860 (CT), NR; n=106, 222	57 participants	118 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) RVR, rs12979860 (TT), R; n=11, 33	0 participants	1 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) RVR, rs12979860 (TT), NR; n=106, 222	21 participants	39 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) RVR, rs8099917 (TT), R, n=11, 33	9 participants	28 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) RVR, rs8099917 (TT), NR; n=106, 222	50 participants	97 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) RVR, rs8099917 (GT), R; n=11, 33	2 participants	5 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) RVR, rs8099917 (GT), NR; n=106, 222	50 participants	107 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) RVR, rs8099917 (GG), R; n=11, 33	0 participants	0 participants
Number of Participants Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) RVR, rs8099917 (GG), R; n=106, 222	6 participants	18 participants

SECONDARY outcome

Timeframe: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Population: Safety DB Population: all randomized participants who had received study drug in the DB Phase

Blood samples for the assessment of clinical chemistry parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of calcium (low=hypocalcemia; high=hypercalcemia), glu. (low=hypoglycemia; high=hyperglycemia), pot. (low=hypokalemia; high=hyperkalemia), and sod. (low=hyponatremia; high=hypernatremia). Per the DAIDS toxicity table, the grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=252 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=506 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Calcium (hypocalcemia), Any Grade Increase	184 participants	374 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Calcium (hypocalcemia), Increase to G1	140 participants	246 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Calcium (hypocalcemia), Increase to G2	42 participants	122 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Calcium (hypocalcemia), Increase to G3	2 participants	4 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Calcium (hypocalcemia), Increase to G4	0 participants	2 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Calcium (hypercalcemia), Any Grade Increase	2 participants	1 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Calcium (hypercalcemia), Increase to G1	1 participants	1 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Calcium (hypercalcemia), Increase to G2	1 participants	0 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Calcium (hypercalcemia), Increase to G3	0 participants	0 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Calcium (hypercalcemia), Increase to G4	0 participants	0 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Glu. (hypoglycemia), Any Grade Increase	31 participants	90 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Glu. (hypoglycemia), Increase to G1	17 participants	45 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Glu. (hypoglycemia), Increase to G2	10 participants	31 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Glu. (hypoglycemia), Increase to G3	4 participants	9 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Glu. (hypoglycemia), Increase to G4	0 participants	5 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Glu. (hyperglycemia), Any Grade Increase	128 participants	277 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Glu. (hyperglycemia), Increase to G1	31 participants	68 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Glu. (hyperglycemia), Increase to G2	77 participants	161 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Glu. (hyperglycemia), Increase to G3	19 participants	44 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Glu. (hyperglycemia), Increase to G4	1 participants	4 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Pot. (hyperkalemia), Any Grade Increase	3 participants	15 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Pot. (hyperkalemia), Increase to G1	2 participants	7 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Pot. (hyperkalemia), Increase to G2	1 participants	3 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Pot. (hyperkalemia), Increase to G3	0 participants	2 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Pot. (hyperkalemia), Increase to G4	0 participants	3 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Pot. (hypokalemia), Any Grade Increase	53 participants	74 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Pot. (hypokalemia), Increase to G1	48 participants	66 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Pot. (hypokalemia), Increase to G2	5 participants	6 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Pot. (hypokalemia), Increase to G3	0 participants	2 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Pot. (hypokalemia), Increase to G4	0 participants	0 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Sod. (hypernatremia), Any Grade Increase	14 participants	21 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Sod. (hypernatremia), Increase to G1	14 participants	20 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Sod. (hypernatremia), Increase to G2	0 participants	1 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Sod. (hypernatremia), Increase to G3	0 participants	0 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Sod. (hypernatremia), Increase to G4	0 participants	0 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Sod. (hyponatremia), Any Grade Increase	72 participants	128 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Sod. (hyponatremia), Increase to G1	69 participants	118 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Sod. (hyponatremia), Increase to G2	3 participants	8 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Sod. (hyponatremia), Increase to G3	0 participants	1 participants
Number of Participants With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) Sod. (hyponatremia), Increase to G4	0 participants	1 participants

SECONDARY outcome

Timeframe: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Population: Safety DB Population

Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells (low=leukocytopenia). Per the DAIDS toxicity table, grade ranges for each parameter are as follows: Grade (G) 1=mild; G2=moderate; G3=severe; G4=potentially life-threatening.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=252 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=506 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS Tot Neu. (neutropenia), Increase to G4	32 participants	47 participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS WBC (leukocytopenia), Any Grade Increase	191 participants	391 participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS WBC (leukocytopenia), Increase to G1	56 participants	113 participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS Tot Neu. (neutropenia), Increase to G3	73 participants	128 participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS Hemoglobin (anemia), Any Grade Increase	161 participants	361 participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS Hemoglobin (anemia), Increase to G1	46 participants	112 participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS Hemoglobin (anemia), Increase to G2	64 participants	129 participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS Hemoglobin (anemia), Increase to G3	48 participants	114 participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS Hemoglobin (anemia), Increase to G4	3 participants	6 participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS Lym. (lymphocytopenia), Any Grade Increase	136 participants	346 participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS Lym. (lymphocytopenia), Increase to G1	16 participants	43 participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS Lym. (lymphocytopenia), Increase to G2	38 participants	80 participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS Lym. (lymphocytopenia), Increase to G3	48 participants	109 participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS Lym. (lymphocytopenia), Increase to G4	34 participants	114 participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS Tot Neu. (neutropenia), Any Grade Increase	208 participants	394 participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS Tot Neu. (neutropenia), Increase to G1	50 participants	106 participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS Tot Neu. (neutropenia), Increase to G2	53 participants	113 participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS WBC (leukocytopenia), Increase to G2	69 participants	145 participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS WBC (leukocytopenia), Increase to G3	58 participants	110 participants
Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS WBC (leukocytopenia), Increase to G4	8 participants	23 participants

SECONDARY outcome

Timeframe: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3)

Population: Safety DB Population

Ophthalmic (pertaining to eye) assessments were performed during the study. A cataract event is defined as an event ascertained to be a cataract (opacity or cloudiness of the lens of the eye, causing impairment of vision) by at least one of the CEC members (comprised of expert ophthalmologists who provided objective medical review of the blinded ophthalmic data). Per the CEC, cataract events were categorized as: (1) Cataract Progression (CP; progression of cataracts present at BL); and (2) Incident Cataract (IC; development of new cataracts). One eye=unilateral; both eyes=bilateral.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=252 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=506 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication Unilateral CP, Genotype 2/3	0 participants	1 participants
Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication Unilateral CP, Non-genotype 2/3	4 participants	6 participants
Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication Bilateral CP, Genotype 2/3	3 participants	1 participants
Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication Bilateral CP, Non-genotype 2/3	1 participants	7 participants
Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication Unilateral IP, Genotype 2/3	1 participants	4 participants
Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication Unilateral IP, Non-genotype 2/3	1 participants	6 participants
Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication Bilateral IP, Genotype 2/3	3 participants	1 participants
Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication Bilateral IP, Non-genotype 2/3	3 participants	10 participants

SECONDARY outcome

Timeframe: DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72)

Population: Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.

Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with an ECG status of normal, abnormal, CS, or NCS, as determined by the Investigator, was reported. Normal, all ECG parameters within accepted normal ranges. Abnormal, ECG finding(s) outside of normal ranges. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=252 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=505 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase Antiviral BL, Normal, n=232, 478	147 participants	332 participants
Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase Antiviral BL, Abnormal - NCS, n=232, 478	63 participants	103 participants
Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase Antiviral BL, Abnormal - CS, n=232, 478	22 participants	43 participants
Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase End of Treatment, Normal, n=218, 428	134 participants	291 participants
Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase End of Treatment, Abnormal - NCS, n=218, 428	62 participants	103 participants
Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase End of Treatment, Abnormal - CS, n=218, 428	22 participants	34 participants
Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase 24-week FU, Normal, n=194, 383	123 participants	238 participants
Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase 24-week FU, Abnormal - NCS, n=194, 383	49 participants	107 participants
Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase 24-week FU, Abnormal - CS, n=194, 383	22 participants	38 participants
Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase Worst ECG post-BL, Normal, n=252, 505	113 participants	233 participants
Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase Worst ECG post-BL, Abnormal - NCS, n=252, 505	91 participants	171 participants
Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase Worst ECG post-BL, Abnormal - CS, n=252, 505	48 participants	101 participants

SECONDARY outcome

Timeframe: End of Treatment (up to Week 52); and 24-week FU (up to Week 72)

Population: Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.

Duplicate 12-lead ECGs were required at Screening/BL, Antiviral BL, and at 12 weekly intervals during the study. The number of participants with a CS and a NCS change from baseline in ECG status, as determined by the Investigator, was reported. CS, ECG with a CS abnormality that meets exclusion criteria. NCS, ECG with an abnormality not CS or meeting exclusion criteria, per Investigator, based on reasonable standards of clinical judgment. "Not applicable" indicates that information was not provided by the investigator on whether the change from baseline ECG was CS or NCS.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=218 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=428 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase End of Treatment, Not applicable, n=218, 428	0 participants	1 participants
Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase End of Treatment, CS change from BL, n=218, 428	0 participants	7 participants
Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase End of Treatment, NCS change from BL, n=218, 428	218 participants	420 participants
Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase 24-week FU, CS change from BL, n=194, 383	1 participants	4 participants
Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase 24-week FU, NCS change from BL, n=194, 383	193 participants	379 participants

SECONDARY outcome

Population: Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.

Participant's blood pressure was measured at the indicated time points during the study. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Outcome measures

SECONDARY outcome

Population: Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.

Heart rate was measured in participants at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=244 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=490 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase Week 1, n=244, 490	1.16 beats per minute Standard Deviation 8.358	-0.43 beats per minute Standard Deviation 8.629
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase Week 2, n=242, 490	1.89 beats per minute Standard Deviation 8.510	0.78 beats per minute Standard Deviation 9.644
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase Week 4, n=227, 483	2.47 beats per minute Standard Deviation 9.464	1.50 beats per minute Standard Deviation 9.739
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase Week 6, n=205, 470	3.23 beats per minute Standard Deviation 9.158	1.19 beats per minute Standard Deviation 8.708
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase Week 8, n=190, 472	2.91 beats per minute Standard Deviation 9.751	1.78 beats per minute Standard Deviation 9.227
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase Week 12, n=174, 450	4.28 beats per minute Standard Deviation 10.188	2.02 beats per minute Standard Deviation 9.539
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase Week 16, n=143, 403	5.87 beats per minute Standard Deviation 9.975	2.38 beats per minute Standard Deviation 10.419
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase Week 20, n=132, 371	5.73 beats per minute Standard Deviation 9.688	2.10 beats per minute Standard Deviation 9.530
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase Week 24, n=99, 262	3.77 beats per minute Standard Deviation 9.912	2.03 beats per minute Standard Deviation 9.399
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase Week 28, n=74, 211	2.72 beats per minute Standard Deviation 10.038	1.64 beats per minute Standard Deviation 10.328
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase Week 32, n=67, 196	4.28 beats per minute Standard Deviation 8.281	1.62 beats per minute Standard Deviation 9.676
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase Week 36, n=62, 186	5.42 beats per minute Standard Deviation 10.109	2.11 beats per minute Standard Deviation 10.205
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase Week 40, n=59, 171	4.83 beats per minute Standard Deviation 8.919	0.78 beats per minute Standard Deviation 9.895
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase Week 44, n=59, 165	5.53 beats per minute Standard Deviation 11.005	1.16 beats per minute Standard Deviation 8.846
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase End of Treatment, n=237, 467	4.01 beats per minute Standard Deviation 10.606	2.89 beats per minute Standard Deviation 11.134
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase 4-week FU, n=220, 422	4.27 beats per minute Standard Deviation 10.432	2.11 beats per minute Standard Deviation 10.113
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase 12-week FU, n=206, 429	1.73 beats per minute Standard Deviation 9.707	0.74 beats per minute Standard Deviation 9.955
Mean Change From Baseline in Heart Rate at the Indicated Time Points During the DB Phase 24-week FU, n=202, 395	0.14 beats per minute Standard Deviation 9.803	-1.90 beats per minute Standard Deviation 9.176

SECONDARY outcome

Population: Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.

The weight of participants was recorded at the indicated time points. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Outcome measures

Outcome measures
Measure	Placebo+Antiviral Therapy: DB Phase n=248 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=495 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase Week 1, n=248, 492	-0.65 Kilograms (kg) Standard Deviation 2.201	-0.68 Kilograms (kg) Standard Deviation 2.062
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase Week 2, n=244, 495	-0.88 Kilograms (kg) Standard Deviation 1.983	-1.06 Kilograms (kg) Standard Deviation 2.809
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase Week 4, n=229, 488	-1.30 Kilograms (kg) Standard Deviation 2.374	-1.30 Kilograms (kg) Standard Deviation 2.488
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase Week 6, n=207, 476	-1.42 Kilograms (kg) Standard Deviation 2.464	-1.68 Kilograms (kg) Standard Deviation 2.652
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase Week 8, n=191, 473	-1.89 Kilograms (kg) Standard Deviation 2.793	-2.11 Kilograms (kg) Standard Deviation 2.810
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase Week 12, n=175, 453	-2.18 Kilograms (kg) Standard Deviation 2.985	-2.83 Kilograms (kg) Standard Deviation 3.440
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase Week 16, n=145, 406	-2.37 Kilograms (kg) Standard Deviation 3.247	-3.32 Kilograms (kg) Standard Deviation 3.798
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase Week 20, n=134, 378	-3.08 Kilograms (kg) Standard Deviation 3.684	-3.99 Kilograms (kg) Standard Deviation 4.040
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase Week 24, n=99, 265	-4.04 Kilograms (kg) Standard Deviation 4.148	-4.75 Kilograms (kg) Standard Deviation 4.175
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase Week 28, n=74, 212	-4.57 Kilograms (kg) Standard Deviation 4.749	-5.09 Kilograms (kg) Standard Deviation 5.016
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase Week 32, n=67, 200	-4.50 Kilograms (kg) Standard Deviation 4.397	-5.52 Kilograms (kg) Standard Deviation 5.369
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase Week 36, n=63, 188	-4.54 Kilograms (kg) Standard Deviation 4.739	-5.39 Kilograms (kg) Standard Deviation 7.476
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase Week 40, n=59, 174	-4.99 Kilograms (kg) Standard Deviation 4.612	-5.87 Kilograms (kg) Standard Deviation 5.571
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase Week 44, n=59, 168	-4.79 Kilograms (kg) Standard Deviation 5.475	-5.89 Kilograms (kg) Standard Deviation 5.661
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase End of Treatment, n=240, 470	-3.28 Kilograms (kg) Standard Deviation 4.361	-4.69 Kilograms (kg) Standard Deviation 5.180
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase 4-week FU, n=223, 425	-2.78 Kilograms (kg) Standard Deviation 4.318	-3.84 Kilograms (kg) Standard Deviation 6.381
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase 12-week FU, n=210, 434	-1.98 Kilograms (kg) Standard Deviation 4.088	-2.99 Kilograms (kg) Standard Deviation 5.999
Mean Change From Baseline in Weight at the Indicated Time Points During the DB Phase 24-week FU, n=205, 401	-1.36 Kilograms (kg) Standard Deviation 4.568	-1.51 Kilograms (kg) Standard Deviation 7.683

SECONDARY outcome

Population: Safety DB Population. Only those participants contributing data at the indicated time points were analyzed.

The BMI for participants was calculated at the indicated time points as body weight in kilograms divided by height in meters squared. Mean change from Baseline was calculated as the value at the indicated time points minus the value at Baseline.

Outcome measures

Adverse Events

Eltrombopag: OL Phase

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo+Antiviral Therapy: DB Phase

Serious events: 49 serious events

Other events: 226 other events

Deaths: 0 deaths

Eltrombopag+Antiviral Therapy: DB Phase

Serious events: 119 serious events

Other events: 459 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo+Antiviral Therapy: DB Phase n=246 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=494 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase DBP, Week 32, n=67, 197	-0.54 Millimeters of mercury (mmHg) Standard Deviation 10.445	-3.76 Millimeters of mercury (mmHg) Standard Deviation 9.527
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase SBP, Week 1, n=246, 491	-3.00 Millimeters of mercury (mmHg) Standard Deviation 13.541	-2.36 Millimeters of mercury (mmHg) Standard Deviation 12.296
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase SBP, Week 2, n=242, 494	-3.25 Millimeters of mercury (mmHg) Standard Deviation 13.800	-3.74 Millimeters of mercury (mmHg) Standard Deviation 13.122
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase SBP, Week 4, n=228, 485	-3.75 Millimeters of mercury (mmHg) Standard Deviation 13.781	-3.91 Millimeters of mercury (mmHg) Standard Deviation 13.780
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase SBP, Week 6, n=206, 471	-3.36 Millimeters of mercury (mmHg) Standard Deviation 14.405	-3.85 Millimeters of mercury (mmHg) Standard Deviation 14.624
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase SBP, Week 8, n=190, 472	-2.72 Millimeters of mercury (mmHg) Standard Deviation 14.073	-4.33 Millimeters of mercury (mmHg) Standard Deviation 14.401
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase SBP, Week 12, n=175, 452	-2.16 Millimeters of mercury (mmHg) Standard Deviation 15.297	-4.30 Millimeters of mercury (mmHg) Standard Deviation 14.377
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase SBP, Week 16, n=143, 403	-3.16 Millimeters of mercury (mmHg) Standard Deviation 15.426	-4.59 Millimeters of mercury (mmHg) Standard Deviation 13.579
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase SBP, Week 20, n=133, 374	-2.50 Millimeters of mercury (mmHg) Standard Deviation 14.387	-4.12 Millimeters of mercury (mmHg) Standard Deviation 14.908
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase SBP, Week 24, n=99, 263	-1.97 Millimeters of mercury (mmHg) Standard Deviation 14.820	-3.94 Millimeters of mercury (mmHg) Standard Deviation 14.917
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase SBP, Week 28, n=74, 211	-0.69 Millimeters of mercury (mmHg) Standard Deviation 14.663	-4.99 Millimeters of mercury (mmHg) Standard Deviation 14.557
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase SBP, Week 32, n=67, 197	-1.46 Millimeters of mercury (mmHg) Standard Deviation 13.904	-5.61 Millimeters of mercury (mmHg) Standard Deviation 13.523
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase SBP, Week 36, n=62, 186	-1.31 Millimeters of mercury (mmHg) Standard Deviation 13.803	-4.40 Millimeters of mercury (mmHg) Standard Deviation 14.842
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase SBP, Week 40, n=59, 173	0.10 Millimeters of mercury (mmHg) Standard Deviation 13.605	-4.31 Millimeters of mercury (mmHg) Standard Deviation 13.941
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase SBP, Week 44, n=59, 167	0.56 Millimeters of mercury (mmHg) Standard Deviation 11.689	-4.54 Millimeters of mercury (mmHg) Standard Deviation 13.794
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase SBP, End of Treatment, n=238, 468	-2.03 Millimeters of mercury (mmHg) Standard Deviation 13.259	-3.98 Millimeters of mercury (mmHg) Standard Deviation 15.318
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase SBP, 4-week FU, n=221, 426	-1.14 Millimeters of mercury (mmHg) Standard Deviation 14.095	-1.65 Millimeters of mercury (mmHg) Standard Deviation 15.122
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase SBP, 12-week FU, n=207, 432	-0.11 Millimeters of mercury (mmHg) Standard Deviation 14.113	-0.86 Millimeters of mercury (mmHg) Standard Deviation 14.806
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase SBP, 24-week FU, n=203, 398	1.10 Millimeters of mercury (mmHg) Standard Deviation 14.545	0.25 Millimeters of mercury (mmHg) Standard Deviation 14.518
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase DBP, Week 1, n=246, 491	-1.43 Millimeters of mercury (mmHg) Standard Deviation 9.235	-1.37 Millimeters of mercury (mmHg) Standard Deviation 8.224
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase DBP, Week 2, n=242, 493	-1.55 Millimeters of mercury (mmHg) Standard Deviation 9.217	-1.86 Millimeters of mercury (mmHg) Standard Deviation 8.946
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase DBP, Week 4, n=228, 485	-1.84 Millimeters of mercury (mmHg) Standard Deviation 9.726	-2.72 Millimeters of mercury (mmHg) Standard Deviation 9.467
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase DBP, Week 6, n=206, 471	-2.16 Millimeters of mercury (mmHg) Standard Deviation 8.939	-2.95 Millimeters of mercury (mmHg) Standard Deviation 9.859
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase DBP, Week 8, n=190, 472	-1.24 Millimeters of mercury (mmHg) Standard Deviation 9.517	-2.68 Millimeters of mercury (mmHg) Standard Deviation 9.901
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase DBP, Week 12, n=175, 452	-1.31 Millimeters of mercury (mmHg) Standard Deviation 8.781	-3.23 Millimeters of mercury (mmHg) Standard Deviation 10.025
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase DBP, Week 16, n=143, 403	-1.54 Millimeters of mercury (mmHg) Standard Deviation 9.684	-3.31 Millimeters of mercury (mmHg) Standard Deviation 9.899
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase DBP, Week 20, n=133, 374	-0.93 Millimeters of mercury (mmHg) Standard Deviation 10.582	-3.08 Millimeters of mercury (mmHg) Standard Deviation 9.606
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase DBP, Week 24, n=99, 263	-1.66 Millimeters of mercury (mmHg) Standard Deviation 10.207	-3.54 Millimeters of mercury (mmHg) Standard Deviation 9.313
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase DBP, Week 28, n=74, 211	-1.23 Millimeters of mercury (mmHg) Standard Deviation 9.538	-3.42 Millimeters of mercury (mmHg) Standard Deviation 10.502
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase DBP, Week 36, n=62, 186	-0.74 Millimeters of mercury (mmHg) Standard Deviation 9.559	-3.59 Millimeters of mercury (mmHg) Standard Deviation 9.211
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase DBP, Week 40, n=59, 173	0.34 Millimeters of mercury (mmHg) Standard Deviation 9.343	-3.32 Millimeters of mercury (mmHg) Standard Deviation 9.517
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase DBP, Week 44, n=59, 167	0.92 Millimeters of mercury (mmHg) Standard Deviation 9.033	-3.77 Millimeters of mercury (mmHg) Standard Deviation 10.134
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase DBP, End of Treatment, n=238, 468	-1.55 Millimeters of mercury (mmHg) Standard Deviation 9.174	-3.59 Millimeters of mercury (mmHg) Standard Deviation 10.254
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase DBP, 4-week FU, n=221, 426	-0.83 Millimeters of mercury (mmHg) Standard Deviation 9.102	-2.20 Millimeters of mercury (mmHg) Standard Deviation 9.824
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase DBP, 12-week FU, n=207, 432	-0.78 Millimeters of mercury (mmHg) Standard Deviation 10.253	-1.76 Millimeters of mercury (mmHg) Standard Deviation 9.903
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase DBP, 24-week FU, n=203, 398	0.03 Millimeters of mercury (mmHg) Standard Deviation 9.814	-1.61 Millimeters of mercury (mmHg) Standard Deviation 9.339

Measure	Placebo+Antiviral Therapy: DB Phase n=248 Participants Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).	Eltrombopag+Antiviral Therapy: DB Phase n=493 Participants Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to \>=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase Week 6, n=207, 474	-0.50 Kilograms per meters squared (kg/m^2) Standard Deviation 0.871	-0.58 Kilograms per meters squared (kg/m^2) Standard Deviation 0.893
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase Week 28, n=74, 211	-1.67 Kilograms per meters squared (kg/m^2) Standard Deviation 1.731	-1.79 Kilograms per meters squared (kg/m^2) Standard Deviation 1.733
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase Week 1, n=248, 490	-0.23 Kilograms per meters squared (kg/m^2) Standard Deviation 0.771	-0.23 Kilograms per meters squared (kg/m^2) Standard Deviation 0.713
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase Week 2, n=244, 493	-0.31 Kilograms per meters squared (kg/m^2) Standard Deviation 0.691	-0.36 Kilograms per meters squared (kg/m^2) Standard Deviation 0.921
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase Week 4, n=229, 486	-0.46 Kilograms per meters squared (kg/m^2) Standard Deviation 0.823	-0.45 Kilograms per meters squared (kg/m^2) Standard Deviation 0.855
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase Week 8, n=191, 471	-0.66 Kilograms per meters squared (kg/m^2) Standard Deviation 0.967	-0.73 Kilograms per meters squared (kg/m^2) Standard Deviation 0.955
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase Week 12, n=175, 451	-0.77 Kilograms per meters squared (kg/m^2) Standard Deviation 1.055	-0.97 Kilograms per meters squared (kg/m^2) Standard Deviation 1.167
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase Week 16, n=145, 404	-0.85 Kilograms per meters squared (kg/m^2) Standard Deviation 1.158	-1.15 Kilograms per meters squared (kg/m^2) Standard Deviation 1.285
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase Week 20, n=134, 376	-1.11 Kilograms per meters squared (kg/m^2) Standard Deviation 1.324	-1.39 Kilograms per meters squared (kg/m^2) Standard Deviation 1.377
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase Week 24, n=99, 264	-1.46 Kilograms per meters squared (kg/m^2) Standard Deviation 1.509	-1.66 Kilograms per meters squared (kg/m^2) Standard Deviation 1.624
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase Week 32, n=67, 199	-1.64 Kilograms per meters squared (kg/m^2) Standard Deviation 1.586	-1.94 Kilograms per meters squared (kg/m^2) Standard Deviation 1.844
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase Week 36, n=63, 187	-1.65 Kilograms per meters squared (kg/m^2) Standard Deviation 1.703	-1.89 Kilograms per meters squared (kg/m^2) Standard Deviation 2.651
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase Week 40, n=59, 173	-1.81 Kilograms per meters squared (kg/m^2) Standard Deviation 1.671	-2.09 Kilograms per meters squared (kg/m^2) Standard Deviation 1.953
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase Week 44, n=59, 167	-1.73 Kilograms per meters squared (kg/m^2) Standard Deviation 2.007	-2.09 Kilograms per meters squared (kg/m^2) Standard Deviation 1.942
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase End of Treatment, n=240, 468	-1.16 Kilograms per meters squared (kg/m^2) Standard Deviation 1.553	-1.64 Kilograms per meters squared (kg/m^2) Standard Deviation 1.783
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase 4-week FU, n=223, 423	-0.98 Kilograms per meters squared (kg/m^2) Standard Deviation 1.519	-1.35 Kilograms per meters squared (kg/m^2) Standard Deviation 2.306
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase 12-week FU, n=210, 432	-0.70 Kilograms per meters squared (kg/m^2) Standard Deviation 1.434	-1.06 Kilograms per meters squared (kg/m^2) Standard Deviation 2.055
Mean Change From Baseline in Body Mass Index (BMI) at the Indicated Time Points During the DB Phase 24-week FU, n=205, 399	-0.47 Kilograms per meters squared (kg/m^2) Standard Deviation 1.544	-0.53 Kilograms per meters squared (kg/m^2) Standard Deviation 2.736