Trial Outcomes & Findings for A Study of the Effectiveness of Peginterferon Alfa-2a (Pegasys) and Ribavirin Treatment in Slovenian Hepatitis C (HCV) Patients (NCT NCT02556307)

Results Overview

SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (\<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment).

Recruitment status

COMPLETED

Target enrollment

270 participants

Primary outcome timeframe

6 months after the last study drug administration (up to 123.6 weeks)

Results posted on

2016-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Peginterferon Alfa-2a + Ribavirin Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current summaries of product characteristics (SPCs)/local labeling.
Overall Study STARTED	270
Overall Study Treated	268
Overall Study COMPLETED	217
Overall Study NOT COMPLETED	53

Reasons for withdrawal

Reasons for withdrawal
Measure	Peginterferon Alfa-2a + Ribavirin Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current summaries of product characteristics (SPCs)/local labeling.
Overall Study Premature treatment interruption	11
Overall Study Lost to Follow-up	36
Overall Study Change to triple therapy	4
Overall Study Enrolled but not treated	2

Baseline Characteristics

A Study of the Effectiveness of Peginterferon Alfa-2a (Pegasys) and Ribavirin Treatment in Slovenian Hepatitis C (HCV) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peginterferon Alfa-2a + Ribavirin n=268 Participants Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
Age, Continuous	37.7 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants
Sex: Female, Male Male	197 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after the last study drug administration (up to 123.6 weeks)

Population: All treated participants were included in the analysis. Here, 'n' specifies the number of participants included in the analysis as per the specified category (genotype or previous treatment).

SVR was defined as participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of treatment. Undetectable HCV RNA was defined as a single last HCV RNA less than (\<) 20 international units per milliliter (IU/mL). SVR was evaluated based on HCV genotype (G1, G2, G3 and G4), participant's interleukin 28B genotype (CC, CT and TT), and previous treatment (treatment naive or previous treatment).

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=268 Participants Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment G2 (n=9)	67 percentage of participants
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment G3 (n=153)	75 percentage of participants
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment G4 (n=2)	100 percentage of participants
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment CC (n=56)	66 percentage of participants
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment All participants (n=268)	66 percentage of participants
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment G1 (n=104)	51 percentage of participants
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment CT (n=73)	66 percentage of participants
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment TT (n=25)	64 percentage of participants
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment Treatment-naive (n=238)	70 percentage of participants
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Genotype and Previous Treatment Pre-treated (n=30)	30 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 12 and at end of treatment (up to 99.6 weeks)

Population: All treated participants were included in the analysis.

Undetectable HCV RNA=a single last HCV RNA \<20 IU/mL

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=268 Participants Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
Percentage of Participants With Undetectable HCV RNA Week 4	64 percentage of participants
Percentage of Participants With Undetectable HCV RNA Week 12	21 percentage of participants
Percentage of Participants With Undetectable HCV RNA End of treatment	79 percentage of participants

SECONDARY outcome

Timeframe: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

Population: Number of participants analyzed=treated participants with data available for HCV RNA. Here, "n" specifies number of participants with data available for specified category.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=267 Participants Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
HCV RNA Values Baseline (n=267)	3281922 IU/mL Standard Deviation 6039339
HCV RNA Values Week 4 (n=262)	44174 IU/mL Standard Deviation 192056
HCV RNA Values Week 12 (n=219)	21342 IU/mL Standard Deviation 189967
HCV RNA Values End of treatment (n=224)	39436 IU/mL Standard Deviation 335382
HCV RNA Values 6 months post treatment (n=195)	93414 IU/mL Standard Deviation 852266

SECONDARY outcome

Timeframe: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

Population: Number of participants analyzed=treated participants with data available for thrombocyte value. Here, "n" specifies number of participants with data available for specified category.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=265 Participants Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
Thrombocyte Values Baseline (n=265)	206 billion cells per liter Standard Deviation 62.7
Thrombocyte Values Week 4 (n=260)	143 billion cells per liter Standard Deviation 55.0
Thrombocyte Values Week 12 (n=217)	125 billion cells per liter Standard Deviation 48.0
Thrombocyte Values End of treatment (n=224)	140 billion cells per liter Standard Deviation 59.0
Thrombocyte Values 6 months post treatment (n=198)	207 billion cells per liter Standard Deviation 56.0

SECONDARY outcome

Timeframe: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

Population: Number of participants analyzed=treated participants with data available for leukocyte value. Here, "n" specifies number of participants with data available for specified category.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=265 Participants Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
Leukocyte Values Baseline (n=265)	7.0 billion cells per liter Standard Deviation 2.1
Leukocyte Values Week 4 (n=260)	3.8 billion cells per liter Standard Deviation 1.4
Leukocyte Values Week 12 (n=217)	3.4 billion cells per liter Standard Deviation 1.4
Leukocyte Values End of treatment (n=224)	3.6 billion cells per liter Standard Deviation 1.8
Leukocyte Values 6 months post treatment (n=198)	7.1 billion cells per liter Standard Deviation 3.5

SECONDARY outcome

Timeframe: Baseline; Weeks 4, 12, end of treatment (up to 99.6 weeks) and 6 months after end of treatment (up to 123.6 weeks)

Population: Number of participants analyzed=treated participants with data available for hemoglobin. Here, "n" specifies number of participants with data available for specified category.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=265 Participants Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
Hemoglobin Values Baseline (n=265)	147 gram per liter Standard Deviation 14.4
Hemoglobin Values Week 4 (n=260)	129 gram per liter Standard Deviation 16.0
Hemoglobin Values Week 12 (n=260)	129 gram per liter Standard Deviation 16.0
Hemoglobin Values End of treatment (n=224)	122 gram per liter Standard Deviation 16.0
Hemoglobin Values 6 months post treatment (n=198)	143 gram per liter Standard Deviation 14.0

SECONDARY outcome

Timeframe: Up to 99.6 Weeks

Population: All treated participants were included.

Outcome measures

Outcome measures
Measure	Peginterferon Alfa-2a + Ribavirin n=268 Participants Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin Peginterferon alfa-2a	31.0 weeks Standard Deviation 17.1
Treatment Duration (in Weeks) With Peginterferon Alfa-2a and Ribavirin Ribavirin	31.3 weeks Standard Deviation 17.2

Adverse Events

Peginterferon Alfa-2a + Ribavirin

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Peginterferon Alfa-2a + Ribavirin n=268 participants at risk Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
Nervous system disorders Headache	0.37% 1/268 • From signature of informed consent to end of treatment (up to 99.6 weeks) All treated participants were included.
Infections and infestations Sepsis	0.37% 1/268 • From signature of informed consent to end of treatment (up to 99.6 weeks) All treated participants were included.
Psychiatric disorders Depressive disorder	0.37% 1/268 • From signature of informed consent to end of treatment (up to 99.6 weeks) All treated participants were included.
General disorders Sudden death NOS	0.37% 1/268 • From signature of informed consent to end of treatment (up to 99.6 weeks) All treated participants were included.

Other adverse events

Other adverse events
Measure	Peginterferon Alfa-2a + Ribavirin n=268 participants at risk Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
Blood and lymphatic system disorders Leucopenia	5.6% 15/268 • From signature of informed consent to end of treatment (up to 99.6 weeks) All treated participants were included.

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER