Trial Outcomes & Findings for An Observational Study of Peginterferon Alfa-2a Plus Ribavirin for Hepatitis C Virus (HCV) Infection in Austria (NCT NCT02515279)

Last Updated: 2017-04-10

Results Overview

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; and congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non-SAEs.

Recruitment status

COMPLETED

Target enrollment

463 participants

Primary outcome timeframe

Up to 6 years

Results posted on

2017-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	Participants With Hepatitis C All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
Overall Study STARTED	463
Overall Study COMPLETED	359
Overall Study NOT COMPLETED	104

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants With Hepatitis C All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
Overall Study Adverse Event	7
Overall Study Lack of Efficacy	31
Overall Study Lost to Follow-up	9
Overall Study Withdrawal by Subject	18
Overall Study End-of-treatment visit not attended	17
Overall Study Other	22

Baseline Characteristics

An Observational Study of Peginterferon Alfa-2a Plus Ribavirin for Hepatitis C Virus (HCV) Infection in Austria

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With Hepatitis C n=463 Participants All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
Age, Continuous	41.0 years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex/Gender, Customized Female	151 participants n=5 Participants
Sex/Gender, Customized Male	310 participants n=5 Participants
Sex/Gender, Customized Missing	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 years

Population: All participants who were enrolled in the study.

Outcome measures

Outcome measures
Measure	Participants With Hepatitis C n=463 Participants All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) AEs	44.28 percentage of participants
Percentage of Participants With Serious Adverse Events (SAEs) and Adverse Events (AEs) SAEs	3.9 percentage of participants

PRIMARY outcome

Timeframe: 12 months

Population: All participants who were enrolled in the study. N (Number of participants analysed)=participants who were evaluable for this measure.

Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). A participant was considered to have and end of treatment response if there was undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) after completing treatment. Participants with available PCR results were reported.

Outcome measures

Outcome measures
Measure	Participants With Hepatitis C n=446 Participants All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
Percentage of Participants With End of Treatment Response Participants with negative PCR	83.8 percentage of participants
Percentage of Participants With End of Treatment Response Participants with positive PCR	9.7 percentage of participants

PRIMARY outcome

Timeframe: 18 months

Population: All participant who were enrolled in the study. N=number of participants evaluable for this measure.

Clinical response to the treatment was measured by qualitative negative polymerase chain reaction (PCR). SVR24 is defined as the percentage of participants with undetectable HCV RNA 24 weeks after completing treatment.

Outcome measures

Outcome measures
Measure	Participants With Hepatitis C n=144 Participants All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
Percentage of Participants With Sustained Virologic Response 24 (SVR24)	26.6 percentage of participants

Adverse Events

Participants With Hepatitis C

Serious events: 18 serious events

Other events: 148 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Participants With Hepatitis C n=463 participants at risk All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
Blood and lymphatic system disorders Anaemia	1.7% 8/463 • up to 6 years All participant who were enrolled in the study.
Blood and lymphatic system disorders Leukopenia	0.65% 3/463 • up to 6 years All participant who were enrolled in the study.
Blood and lymphatic system disorders Thrombocytopenia	0.22% 1/463 • up to 6 years All participant who were enrolled in the study.
General disorders Influenza like illness	0.86% 4/463 • up to 6 years All participant who were enrolled in the study.
General disorders Fatigue	0.43% 2/463 • up to 6 years All participant who were enrolled in the study.
Nervous system disorders Headache	0.43% 2/463 • up to 6 years All participant who were enrolled in the study.
Gastrointestinal disorders Diarrhoea	0.22% 1/463 • up to 6 years All participant who were enrolled in the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.22% 1/463 • up to 6 years All participant who were enrolled in the study.
Psychiatric disorders Depression	0.22% 1/463 • up to 6 years All participant who were enrolled in the study.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.22% 1/463 • up to 6 years All participant who were enrolled in the study.
Skin and subcutaneous tissue disorders Drug eruption	0.22% 1/463 • up to 6 years All participant who were enrolled in the study.
Skin and subcutaneous tissue disorders Pruritus	0.22% 1/463 • up to 6 years All participant who were enrolled in the study.
Vascular disorders Syncope	0.22% 1/463 • up to 6 years All participant who were enrolled in the study.

Other adverse events

Other adverse events
Measure	Participants With Hepatitis C n=463 participants at risk All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator's discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician's decision (depending on the participant's weight and genotype). All participants were observed for 12 months.
Blood and lymphatic system disorders Leukopenia	13.8% 64/463 • up to 6 years All participant who were enrolled in the study.
Blood and lymphatic system disorders Anaemia	12.7% 59/463 • up to 6 years All participant who were enrolled in the study.
Blood and lymphatic system disorders Thrombocytopenia	8.6% 40/463 • up to 6 years All participant who were enrolled in the study.
General disorders Fatigue	8.4% 39/463 • up to 6 years All participant who were enrolled in the study.
Psychiatric disorders Depression	5.8% 27/463 • up to 6 years All participant who were enrolled in the study.
Skin and subcutaneous tissue disorders Pruritus	5.6% 26/463 • up to 6 years All participant who were enrolled in the study.

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