Trial Outcomes & Findings for ATHENAS - Retrospective Study of Compliance in Chronic Hepatitis C With Pegylated Interferon Alfa-2b/Ribavirin in Brazil (P05632) (NCT NCT00856024)
NCT ID: NCT00856024
Last Updated: 2015-07-01
Results Overview
The participant was considered compliant if he/she had administered 80% of the doses of pegylated interferon alpha 2b and 80% of the doses of ribavirin that were prescribed by the physician in the first 12 weeks of treatment.
Recruitment status
TERMINATED
Target enrollment
902 participants
Primary outcome timeframe
First 12 weeks of treatment
Results posted on
2015-07-01
Participant Flow
Participant milestones
| Measure |
General Peginterferon + Ribavarin
Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
|
|---|---|
|
Overall Study
STARTED
|
902
|
|
Overall Study
COMPLETED
|
902
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ATHENAS - Retrospective Study of Compliance in Chronic Hepatitis C With Pegylated Interferon Alfa-2b/Ribavirin in Brazil (P05632)
Baseline characteristics by cohort
| Measure |
General Peginterferon + Ribavarin
n=902 Participants
Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
|
|---|---|
|
Age, Continuous
|
49.9 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
367 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
535 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
902 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First 12 weeks of treatmentPopulation: All enrolled participants
The participant was considered compliant if he/she had administered 80% of the doses of pegylated interferon alpha 2b and 80% of the doses of ribavirin that were prescribed by the physician in the first 12 weeks of treatment.
Outcome measures
| Measure |
Naïve Participants
n=669 Participants
Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
|
Re-treatment
n=199 Participants
Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
|
HIV/Hepatitis C Virus (HCV) Co-infected Participants
n=34 Participants
Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
|
|---|---|---|---|
|
Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks
|
98.5 Percent of participants
Interval 97.3 to 99.3
|
98.5 Percent of participants
Interval 95.7 to 99.7
|
100.0 Percent of participants
Interval 89.7 to 100.0
|
SECONDARY outcome
Timeframe: Week 4Population: Number of participants with data
RVR was defined as HCV RNA negative after 4 weeks of treatment.
Outcome measures
| Measure |
Naïve Participants
n=170 Participants
Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
|
Re-treatment
n=48 Participants
Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
|
HIV/Hepatitis C Virus (HCV) Co-infected Participants
n=6 Participants
Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
|
|---|---|---|---|
|
Percent of Participants Who Achieved Rapid Virologic Response (RVR)
|
34.7 Percent of participants
Interval 27.6 to 42.4
|
18.8 Percent of participants
Interval 8.9 to 32.6
|
0.0 Percent of participants
Interval 0.0 to 45.9
|
SECONDARY outcome
Timeframe: Week 12Population: Number of participants with data
EVR was defined as HCV RNA negative after 12 weeks of treatment.
Outcome measures
| Measure |
Naïve Participants
n=118 Participants
Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
|
Re-treatment
n=32 Participants
Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
|
HIV/Hepatitis C Virus (HCV) Co-infected Participants
n=6 Participants
Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
|
|---|---|---|---|
|
Percent of Participants Who Achieved Early Virologic Response (EVR)
|
67.8 Percent of participants
Interval 58.6 to 76.1
|
46.9 Percent of participants
Interval 29.1 to 65.3
|
33.3 Percent of participants
Interval 4.3 to 77.7
|
Adverse Events
General Peginterferon + Ribavarin
Serious events: 11 serious events
Other events: 658 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
General Peginterferon + Ribavarin
n=902 participants at risk
Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.78%
7/902 • Number of events 7
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.55%
5/902 • Number of events 5
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.44%
4/902 • Number of events 4
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.11%
1/902 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
0.11%
1/902 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
0.11%
1/902 • Number of events 1
|
|
Infections and infestations
GASTROENTERITIS
|
0.11%
1/902 • Number of events 1
|
Other adverse events
| Measure |
General Peginterferon + Ribavarin
n=902 participants at risk
Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
22.6%
204/902 • Number of events 205
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
5.2%
47/902 • Number of events 48
|
|
Gastrointestinal disorders
NAUSEA
|
15.5%
140/902 • Number of events 141
|
|
General disorders
ASTHENIA
|
20.0%
180/902 • Number of events 183
|
|
General disorders
FATIGUE
|
13.6%
123/902 • Number of events 124
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
12.9%
116/902 • Number of events 117
|
|
General disorders
IRRITABILITY
|
5.8%
52/902 • Number of events 53
|
|
General disorders
PYREXIA
|
27.8%
251/902 • Number of events 253
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
11.1%
100/902 • Number of events 101
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
14.3%
129/902 • Number of events 132
|
|
Nervous system disorders
HEADACHE
|
20.3%
183/902 • Number of events 186
|
|
Psychiatric disorders
INSOMNIA
|
6.0%
54/902 • Number of events 54
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
6.9%
62/902 • Number of events 62
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The text of the article that will be submitted to the journal shall be defined in common accord between the Investigators and the Sponsor. The principal investigators also agree to not publish and/or present interim results of the study without due written authorization of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER