Trial Outcomes & Findings for A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B (NCT NCT00927082)
NCT ID: NCT00927082
Last Updated: 2016-03-09
Results Overview
HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe). Missing values were counted as non-response.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
383 participants
Primary outcome timeframe
Annually, for up to 5 years
Results posted on
2016-03-09
Participant Flow
The study was conducted from 10 April 2009 to 05 November 2014. A total of 383 participants were recruited from 31 centers across 9 countries (Australia, New Zealand, China, Taiwan, Singapore, Korea, Thailand, Brazil, and Russia).
Participant milestones
| Measure |
PEG-IFN 90mcg 24 Wks
Participants received Pegasys (Pegylated interferon alfa-2a \[PEG-IFN\]) 90 micrograms (mcg) subcutaneously (SC) once a week for 24 weeks in Study WV19432 and entered follow-up (FU) Study MV22430.
|
PEG-IFN 180mcg 24 Wks
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 90mcg 48 Wks
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 48 Wks
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
91
|
87
|
108
|
97
|
|
Overall Study
COMPLETED
|
79
|
77
|
86
|
78
|
|
Overall Study
NOT COMPLETED
|
12
|
10
|
22
|
19
|
Reasons for withdrawal
| Measure |
PEG-IFN 90mcg 24 Wks
Participants received Pegasys (Pegylated interferon alfa-2a \[PEG-IFN\]) 90 micrograms (mcg) subcutaneously (SC) once a week for 24 weeks in Study WV19432 and entered follow-up (FU) Study MV22430.
|
PEG-IFN 180mcg 24 Wks
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 90mcg 48 Wks
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 48 Wks
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
8
|
12
|
16
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
7
|
2
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
|
Overall Study
Screen fail,Participant migrated,Unknown
|
0
|
0
|
2
|
1
|
Baseline Characteristics
A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B
Baseline characteristics by cohort
| Measure |
PEG-IFN 90mcg 24 Wks
n=91 Participants
Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 24 Wks
n=87 Participants
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 90mcg 48 Wks
n=108 Participants
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 48 Wks
n=97 Participants
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
Total
n=383 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.5 years
STANDARD_DEVIATION 9.73 • n=5 Participants
|
34.5 years
STANDARD_DEVIATION 10.54 • n=7 Participants
|
34.3 years
STANDARD_DEVIATION 10.82 • n=5 Participants
|
34.2 years
STANDARD_DEVIATION 10.78 • n=4 Participants
|
33.9 years
STANDARD_DEVIATION 10.49 • n=21 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
125 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
258 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Annually, for up to 5 yearsPopulation: The Per Protocol (PP) population included participants who satisfied key inclusion/exclusion criteria of Study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for Study MV22430. Analysis was performed per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.
HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe). Missing values were counted as non-response.
Outcome measures
| Measure |
PEG-IFN 90mcg 24 Wks
n=93 Participants
Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 24 Wks
n=89 Participants
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 90mcg 48 Wks
n=106 Participants
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 48 Wks
n=95 Participants
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
|---|---|---|---|---|
|
Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.
End of Treatment (EOT)
|
9.7 Percentage of participants
Interval 4.5 to 17.6
|
14.6 Percentage of participants
Interval 8.0 to 23.7
|
19.8 Percentage of participants
Interval 12.7 to 28.7
|
31.6 Percentage of participants
Interval 22.4 to 41.9
|
|
Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.
FU Year 1
|
20.4 Percentage of participants
Interval 12.8 to 30.1
|
31.5 Percentage of participants
Interval 22.0 to 42.2
|
27.4 Percentage of participants
Interval 19.1 to 36.9
|
35.8 Percentage of participants
Interval 26.2 to 46.3
|
|
Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.
FU Year 2
|
26.9 Percentage of participants
Interval 18.2 to 37.1
|
37.1 Percentage of participants
Interval 27.1 to 48.0
|
30.2 Percentage of participants
Interval 21.7 to 39.9
|
47.4 Percentage of participants
Interval 37.0 to 57.9
|
|
Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.
FU Year 3
|
38.7 Percentage of participants
Interval 28.8 to 49.4
|
40.4 Percentage of participants
Interval 30.2 to 51.4
|
34.0 Percentage of participants
Interval 25.0 to 43.8
|
52.6 Percentage of participants
Interval 42.1 to 63.0
|
|
Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.
FU Year 4
|
37.6 Percentage of participants
Interval 27.8 to 48.3
|
44.9 Percentage of participants
Interval 34.4 to 55.9
|
41.5 Percentage of participants
Interval 32.0 to 51.5
|
49.5 Percentage of participants
Interval 39.1 to 59.9
|
|
Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg) Seroconversion.
FU Year 5
|
41.9 Percentage of participants
Interval 31.8 to 52.6
|
44.9 Percentage of participants
Interval 34.4 to 55.9
|
40.6 Percentage of participants
Interval 31.1 to 50.5
|
48.4 Percentage of participants
Interval 38.0 to 58.9
|
PRIMARY outcome
Timeframe: Annually, for up to 5 yearsPopulation: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.
HBsAg loss is defined as the absence of HBsAg (i.e. a negative result for HBsAg). Missing values were counted as non-response.
Outcome measures
| Measure |
PEG-IFN 90mcg 24 Wks
n=93 Participants
Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 24 Wks
n=89 Participants
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 90mcg 48 Wks
n=106 Participants
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 48 Wks
n=95 Participants
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
|---|---|---|---|---|
|
Percentage of Participants With HBsAg Loss
EOT
|
0.0 Percentage
Interval 0.0 to 3.9
|
1.1 Percentage
Interval 0.0 to 6.1
|
1.9 Percentage
Interval 0.2 to 6.6
|
3.2 Percentage
Interval 0.7 to 9.0
|
|
Percentage of Participants With HBsAg Loss
FU Year 1
|
1.1 Percentage
Interval 0.0 to 5.8
|
0.0 Percentage
Interval 0.0 to 4.1
|
0.9 Percentage
Interval 0.0 to 5.1
|
1.1 Percentage
Interval 0.0 to 5.7
|
|
Percentage of Participants With HBsAg Loss
FU Year 2
|
2.2 Percentage
Interval 0.3 to 7.6
|
0.0 Percentage
Interval 0.0 to 4.1
|
1.9 Percentage
Interval 0.2 to 6.6
|
3.2 Percentage
Interval 0.7 to 9.0
|
|
Percentage of Participants With HBsAg Loss
FU Year 3
|
3.2 Percentage
Interval 0.7 to 9.1
|
0.0 Percentage
Interval 0.0 to 4.1
|
1.9 Percentage
Interval 0.2 to 6.6
|
3.2 Percentage
Interval 0.7 to 9.0
|
|
Percentage of Participants With HBsAg Loss
FU Year 4
|
3.2 Percentage
Interval 0.7 to 9.1
|
0.0 Percentage
Interval 0.0 to 4.1
|
2.8 Percentage
Interval 0.6 to 8.0
|
2.1 Percentage
Interval 0.3 to 7.4
|
|
Percentage of Participants With HBsAg Loss
FU Year 5
|
3.2 Percentage
Interval 0.7 to 9.1
|
0.0 Percentage
Interval 0.0 to 4.1
|
2.8 Percentage
Interval 0.6 to 8.0
|
2.1 Percentage
Interval 0.3 to 7.4
|
SECONDARY outcome
Timeframe: Annually, for up to 5 yearsPopulation: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.
HBeAg loss is defined as the absence of HBeAg (i.e. a negative result for HBeAg). Missing values were counted as non-response.
Outcome measures
| Measure |
PEG-IFN 90mcg 24 Wks
n=93 Participants
Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 24 Wks
n=89 Participants
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 90mcg 48 Wks
n=106 Participants
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 48 Wks
n=95 Participants
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
|---|---|---|---|---|
|
Percentage of Participants With HBeAg Loss.
EOT
|
9.7 Percentage of participants
Interval 4.5 to 17.6
|
14.6 Percentage of participants
Interval 8.0 to 23.7
|
19.8 Percentage of participants
Interval 12.7 to 28.7
|
33.7 Percentage of participants
Interval 24.3 to 44.1
|
|
Percentage of Participants With HBeAg Loss.
FU Year 1
|
23.7 Percentage of participants
Interval 15.5 to 33.6
|
31.5 Percentage of participants
Interval 22.0 to 42.2
|
30.2 Percentage of participants
Interval 21.7 to 39.9
|
36.8 Percentage of participants
Interval 27.2 to 47.4
|
|
Percentage of Participants With HBeAg Loss.
FU Year 2
|
30.1 Percentage of participants
Interval 21.0 to 40.5
|
38.2 Percentage of participants
Interval 28.1 to 49.1
|
33.0 Percentage of participants
Interval 24.2 to 42.8
|
48.4 Percentage of participants
Interval 38.0 to 58.9
|
|
Percentage of Participants With HBeAg Loss.
FU Year 3
|
41.9 Percentage of participants
Interval 31.8 to 52.6
|
46.1 Percentage of participants
Interval 35.4 to 57.0
|
38.7 Percentage of participants
Interval 29.4 to 48.6
|
53.7 Percentage of participants
Interval 43.2 to 64.0
|
|
Percentage of Participants With HBeAg Loss.
FU Year 4
|
46.2 Percentage of participants
Interval 35.8 to 56.9
|
49.4 Percentage of participants
Interval 38.7 to 60.2
|
49.1 Percentage of participants
Interval 39.2 to 59.0
|
53.7 Percentage of participants
Interval 43.2 to 64.0
|
|
Percentage of Participants With HBeAg Loss.
FU Year 5
|
50.5 Percentage of participants
Interval 40.0 to 61.1
|
49.4 Percentage of participants
Interval 38.7 to 60.2
|
50.0 Percentage of participants
Interval 40.1 to 59.9
|
51.6 Percentage of participants
Interval 41.1 to 62.0
|
SECONDARY outcome
Timeframe: Annually, for up to 5 yearsPopulation: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.
HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs). Missing values were counted as non-response.
Outcome measures
| Measure |
PEG-IFN 90mcg 24 Wks
n=93 Participants
Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 24 Wks
n=89 Participants
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 90mcg 48 Wks
n=106 Participants
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 48 Wks
n=95 Participants
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
|---|---|---|---|---|
|
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion.
EOT
|
0.0 Percentage of participants
Interval 0.0 to 3.9
|
1.1 Percentage of participants
Interval 0.0 to 6.1
|
1.9 Percentage of participants
Interval 0.2 to 6.6
|
3.2 Percentage of participants
Interval 0.7 to 9.0
|
|
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion.
FU Year 1
|
1.1 Percentage of participants
Interval 0.0 to 5.8
|
0.0 Percentage of participants
Interval 0.0 to 4.1
|
0.9 Percentage of participants
Interval 0.0 to 5.1
|
1.1 Percentage of participants
Interval 0.0 to 5.7
|
|
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion.
FU Year 2
|
2.2 Percentage of participants
Interval 0.3 to 7.6
|
0.0 Percentage of participants
Interval 0.0 to 4.1
|
0.9 Percentage of participants
Interval 0.0 to 5.1
|
3.2 Percentage of participants
Interval 0.7 to 9.0
|
|
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion.
FU Year 3
|
3.2 Percentage of participants
Interval 0.7 to 9.1
|
0.0 Percentage of participants
Interval 0.0 to 4.1
|
0.9 Percentage of participants
Interval 0.0 to 5.1
|
3.2 Percentage of participants
Interval 0.7 to 9.0
|
|
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion.
FU Year 4
|
3.2 Percentage of participants
Interval 0.7 to 9.1
|
0.0 Percentage of participants
Interval 0.0 to 4.1
|
0.9 Percentage of participants
Interval 0.0 to 5.1
|
2.1 Percentage of participants
Interval 0.3 to 7.4
|
|
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion.
FU Year 5
|
3.2 Percentage of participants
Interval 0.7 to 9.1
|
0.0 Percentage of participants
Interval 0.0 to 4.1
|
1.9 Percentage of participants
Interval 0.2 to 6.6
|
2.1 Percentage of participants
Interval 0.3 to 7.4
|
SECONDARY outcome
Timeframe: Annually, for up to 5 yearsPopulation: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.
The presence of anti-HBe is defined as antibody produced against e antigen in HBeAg. Seroconversion from e antigen to e antibody (anti-HBe) is a predictor of long-term clearance of hepatitis B virus (HBV) in participants undergoing antiviral therapy and indicates lower levels of HBV, and therefore lower infectivity. Missing values were counted as non-response.
Outcome measures
| Measure |
PEG-IFN 90mcg 24 Wks
n=93 Participants
Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 24 Wks
n=89 Participants
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 90mcg 48 Wks
n=106 Participants
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 48 Wks
n=95 Participants
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
|---|---|---|---|---|
|
Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe).
FU Year 5
|
43.0 Percentage of participants
Interval 32.8 to 53.7
|
48.3 Percentage of participants
Interval 37.6 to 59.2
|
42.5 Percentage of participants
Interval 32.9 to 52.4
|
50.5 Percentage of participants
Interval 40.1 to 60.9
|
|
Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe).
EOT
|
23.7 Percentage of participants
Interval 15.5 to 33.6
|
27.0 Percentage of participants
Interval 18.1 to 37.4
|
29.2 Percentage of participants
Interval 20.8 to 38.9
|
40.0 Percentage of participants
Interval 30.1 to 50.6
|
|
Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe).
FU Year 1
|
28.0 Percentage of participants
Interval 19.1 to 38.2
|
42.7 Percentage of participants
Interval 32.3 to 53.6
|
28.3 Percentage of participants
Interval 20.0 to 37.9
|
38.9 Percentage of participants
Interval 29.1 to 49.5
|
|
Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe).
FU Year 2
|
31.2 Percentage of participants
Interval 22.0 to 41.6
|
40.4 Percentage of participants
Interval 30.2 to 51.4
|
33.0 Percentage of participants
Interval 24.2 to 42.8
|
50.5 Percentage of participants
Interval 40.1 to 60.9
|
|
Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe).
FU Year 3
|
41.9 Percentage of participants
Interval 31.8 to 52.6
|
42.7 Percentage of participants
Interval 32.3 to 53.6
|
36.8 Percentage of participants
Interval 27.6 to 46.7
|
55.8 Percentage of participants
Interval 45.2 to 66.0
|
|
Percentage of Participants With Presence of Anti-Hepatitis B Envelope Antigen (HBe).
FU Year 4
|
37.6 Percentage of participants
Interval 27.8 to 48.3
|
44.9 Percentage of participants
Interval 34.4 to 55.9
|
41.5 Percentage of participants
Interval 32.0 to 51.5
|
52.6 Percentage of participants
Interval 42.1 to 63.0
|
SECONDARY outcome
Timeframe: Annually, for up to 5 yearsPopulation: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.
The presence of anti-HBs is defined as antibody produced against HBsAg.It is generally interpreted as indicating recovery and immunity from HBV infection. Missing values were counted as non-response.
Outcome measures
| Measure |
PEG-IFN 90mcg 24 Wks
n=93 Participants
Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 24 Wks
n=89 Participants
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 90mcg 48 Wks
n=106 Participants
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 48 Wks
n=95 Participants
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
|---|---|---|---|---|
|
Percentage of Participants With Presence of Anti-HBs
EOT
|
4.3 Percentage of participants
Interval 1.2 to 10.6
|
2.2 Percentage of participants
Interval 0.3 to 7.9
|
11.3 Percentage of participants
Interval 6.0 to 18.9
|
9.5 Percentage of participants
Interval 4.4 to 17.2
|
|
Percentage of Participants With Presence of Anti-HBs
FU Year 1
|
6.5 Percentage of participants
Interval 2.4 to 13.5
|
3.4 Percentage of participants
Interval 0.7 to 9.5
|
7.5 Percentage of participants
Interval 3.3 to 14.3
|
7.4 Percentage of participants
Interval 3.0 to 14.6
|
|
Percentage of Participants With Presence of Anti-HBs
FU Year 2
|
5.4 Percentage of participants
Interval 1.8 to 12.1
|
10.1 Percentage of participants
Interval 4.7 to 18.3
|
6.6 Percentage of participants
Interval 2.7 to 13.1
|
6.3 Percentage of participants
Interval 2.4 to 13.2
|
|
Percentage of Participants With Presence of Anti-HBs
FU Year 3
|
4.3 Percentage of participants
Interval 1.2 to 10.6
|
4.5 Percentage of participants
Interval 1.2 to 11.1
|
7.5 Percentage of participants
Interval 3.3 to 14.3
|
5.3 Percentage of participants
Interval 1.7 to 11.9
|
|
Percentage of Participants With Presence of Anti-HBs
FU Year 4
|
4.3 Percentage of participants
Interval 1.2 to 10.6
|
3.4 Percentage of participants
Interval 0.7 to 9.5
|
4.7 Percentage of participants
Interval 1.5 to 10.7
|
5.3 Percentage of participants
Interval 1.7 to 11.9
|
|
Percentage of Participants With Presence of Anti-HBs
FU Year 5
|
3.2 Percentage of participants
Interval 0.7 to 9.1
|
4.5 Percentage of participants
Interval 1.2 to 11.1
|
5.7 Percentage of participants
Interval 2.1 to 11.9
|
5.3 Percentage of participants
Interval 1.7 to 11.9
|
SECONDARY outcome
Timeframe: Annually, for up to 5 yearsPopulation: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.
Alanine Transaminase is an enzyme found mainly in liver and is measured to check if the liver is damaged or diseased. In case of liver damage or disease, the liver releases ALT into the blood stream and the ALT levels increase. Missing values were counted as non-response.
Outcome measures
| Measure |
PEG-IFN 90mcg 24 Wks
n=93 Participants
Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 24 Wks
n=89 Participants
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 90mcg 48 Wks
n=106 Participants
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 48 Wks
n=95 Participants
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
|---|---|---|---|---|
|
Percentage of Participants With Normalised Alanine Transaminase (ALT)
FU Year 3
|
66.7 Percentage of participants
Interval 56.1 to 76.1
|
70.8 Percentage of participants
Interval 60.2 to 79.9
|
54.7 Percentage of participants
Interval 44.8 to 64.4
|
66.3 Percentage of participants
Interval 55.9 to 75.7
|
|
Percentage of Participants With Normalised Alanine Transaminase (ALT)
EOT
|
28.0 Percentage of participants
Interval 19.1 to 38.2
|
27.0 Percentage of participants
Interval 18.1 to 37.4
|
38.7 Percentage of participants
Interval 29.4 to 48.6
|
49.5 Percentage of participants
Interval 39.1 to 59.9
|
|
Percentage of Participants With Normalised Alanine Transaminase (ALT)
FU Year 1
|
45.2 Percentage of participants
Interval 34.8 to 55.8
|
44.9 Percentage of participants
Interval 34.4 to 55.9
|
49.1 Percentage of participants
Interval 39.2 to 59.0
|
50.5 Percentage of participants
Interval 40.1 to 60.9
|
|
Percentage of Participants With Normalised Alanine Transaminase (ALT)
FU Year 2
|
58.1 Percentage of participants
Interval 47.4 to 68.2
|
60.7 Percentage of participants
Interval 49.7 to 70.9
|
55.7 Percentage of participants
Interval 45.7 to 65.3
|
65.3 Percentage of participants
Interval 54.8 to 74.7
|
|
Percentage of Participants With Normalised Alanine Transaminase (ALT)
FU Year 4
|
67.7 Percentage of participants
Interval 57.3 to 77.1
|
64.0 Percentage of participants
Interval 53.2 to 73.9
|
62.3 Percentage of participants
Interval 52.3 to 71.5
|
63.2 Percentage of participants
Interval 52.6 to 72.8
|
|
Percentage of Participants With Normalised Alanine Transaminase (ALT)
FU Year 5
|
69.9 Percentage of participants
Interval 59.5 to 79.0
|
67.4 Percentage of participants
Interval 56.7 to 77.0
|
56.6 Percentage of participants
Interval 46.6 to 66.2
|
63.2 Percentage of participants
Interval 52.6 to 72.8
|
SECONDARY outcome
Timeframe: Annually, for up to 5 yearsPopulation: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.
The percentage of participants with HBV-DNA suppression \< 20,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.
Outcome measures
| Measure |
PEG-IFN 90mcg 24 Wks
n=93 Participants
Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 24 Wks
n=89 Participants
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 90mcg 48 Wks
n=106 Participants
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 48 Wks
n=95 Participants
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
|---|---|---|---|---|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL).
EOT
|
22.6 Percentage of participants
Interval 14.6 to 32.4
|
33.7 Percentage of participants
Interval 24.0 to 44.5
|
34.0 Percentage of participants
Interval 25.0 to 43.8
|
50.5 Percentage of participants
Interval 40.1 to 60.9
|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL).
FU Year 1
|
33.3 Percentage of participants
Interval 23.9 to 43.9
|
31.5 Percentage of participants
Interval 22.0 to 42.2
|
45.3 Percentage of participants
Interval 35.6 to 55.2
|
40.0 Percentage of participants
Interval 30.1 to 50.6
|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL).
FU Year 2
|
57.0 Percentage of participants
Interval 46.3 to 67.2
|
50.6 Percentage of participants
Interval 39.8 to 61.3
|
58.5 Percentage of participants
Interval 48.5 to 68.0
|
54.7 Percentage of participants
Interval 44.2 to 65.0
|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL).
FU Year 3
|
67.7 Percentage of participants
Interval 57.3 to 77.1
|
61.8 Percentage of participants
Interval 50.9 to 71.9
|
61.3 Percentage of participants
Interval 51.4 to 70.6
|
64.2 Percentage of participants
Interval 53.7 to 73.8
|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL).
FU Year 4
|
69.9 Percentage of participants
Interval 59.5 to 79.0
|
68.5 Percentage of participants
Interval 57.8 to 78.0
|
68.9 Percentage of participants
Interval 59.1 to 77.5
|
64.2 Percentage of participants
Interval 53.7 to 73.8
|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 International Unit/Milliliter (IU/mL).
FU Year 5
|
67.7 Percentage of participants
Interval 57.3 to 77.1
|
70.8 Percentage of participants
Interval 60.2 to 79.9
|
67.0 Percentage of participants
Interval 57.2 to 75.8
|
63.2 Percentage of participants
Interval 52.6 to 72.8
|
SECONDARY outcome
Timeframe: Annually, for up to 5 yearsPopulation: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.
The percentage of participants with HBV-DNA suppression \< 2,000 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.
Outcome measures
| Measure |
PEG-IFN 90mcg 24 Wks
n=93 Participants
Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 24 Wks
n=89 Participants
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 90mcg 48 Wks
n=106 Participants
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 48 Wks
n=95 Participants
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
|---|---|---|---|---|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL)
EOT
|
15.1 Percentage of participants
Interval 8.5 to 24.0
|
21.3 Percentage of participants
Interval 13.4 to 31.3
|
27.4 Percentage of participants
Interval 19.1 to 36.9
|
45.3 Percentage of participants
Interval 35.0 to 55.8
|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL)
FU Year 1
|
20.4 Percentage of participants
Interval 12.8 to 30.1
|
23.6 Percentage of participants
Interval 15.2 to 33.8
|
39.6 Percentage of participants
Interval 30.3 to 49.6
|
31.6 Percentage of participants
Interval 22.4 to 41.9
|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL)
FU Year 2
|
45.2 Percentage of participants
Interval 34.8 to 55.8
|
39.3 Percentage of participants
Interval 29.1 to 50.3
|
50.0 Percentage of participants
Interval 40.1 to 59.9
|
45.3 Percentage of participants
Interval 35.0 to 55.8
|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL)
FU Year 3
|
52.7 Percentage of participants
Interval 42.1 to 63.1
|
52.8 Percentage of participants
Interval 41.9 to 63.5
|
52.8 Percentage of participants
Interval 42.9 to 62.6
|
52.6 Percentage of participants
Interval 42.1 to 63.0
|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL)
FU Year 4
|
59.1 Percentage of participants
Interval 48.5 to 69.2
|
56.2 Percentage of participants
Interval 45.3 to 66.7
|
63.2 Percentage of participants
Interval 53.3 to 72.4
|
54.7 Percentage of participants
Interval 44.2 to 65.0
|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 International Unit/Milliliter (IU/mL)
FU Year 5
|
59.1 Percentage of participants
Interval 48.5 to 69.2
|
61.8 Percentage of participants
Interval 50.9 to 71.9
|
60.4 Percentage of participants
Interval 50.4 to 69.7
|
57.9 Percentage of participants
Interval 47.3 to 68.0
|
SECONDARY outcome
Timeframe: Annually, for up to 5 yearsPopulation: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.
The percentage of participants with HBV-DNA suppression \< 80 IU/mL. HBV DNA is the genetic material that carries the blueprint of the virus. The measure of HBV DNA in blood indicates how rapidly the virus is replicating in liver. Missing values were counted as non-response.
Outcome measures
| Measure |
PEG-IFN 90mcg 24 Wks
n=93 Participants
Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 24 Wks
n=89 Participants
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 90mcg 48 Wks
n=106 Participants
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 48 Wks
n=95 Participants
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
|---|---|---|---|---|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL)
FU Year 2
|
28.0 Percentage of participants
Interval 19.1 to 38.2
|
23.6 Percentage of participants
Interval 15.2 to 33.8
|
36.8 Percentage of participants
Interval 27.6 to 46.7
|
29.5 Percentage of participants
Interval 20.6 to 39.7
|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL)
FU Year 3
|
39.8 Percentage of participants
Interval 29.8 to 50.5
|
30.3 Percentage of participants
Interval 21.0 to 41.0
|
34.9 Percentage of participants
Interval 25.9 to 44.8
|
38.9 Percentage of participants
Interval 29.1 to 49.5
|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL)
EOT
|
5.4 Percentage of participants
Interval 1.8 to 12.1
|
12.4 Percentage of participants
Interval 6.3 to 21.0
|
16.0 Percentage of participants
Interval 9.6 to 24.4
|
32.6 Percentage of participants
Interval 23.4 to 43.0
|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL)
FU Year 1
|
12.9 Percentage of participants
Interval 6.8 to 21.5
|
7.9 Percentage of participants
Interval 3.2 to 15.5
|
17.9 Percentage of participants
Interval 11.2 to 26.6
|
14.7 Percentage of participants
Interval 8.3 to 23.5
|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL)
FU Year 4
|
47.3 Percentage of participants
Interval 36.9 to 57.9
|
38.2 Percentage of participants
Interval 28.1 to 49.1
|
46.2 Percentage of participants
Interval 36.5 to 56.2
|
40.0 Percentage of participants
Interval 30.1 to 50.6
|
|
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 80 International Unit/Milliliter (IU/mL)
FU Year 5
|
39.8 Percentage of participants
Interval 29.8 to 50.5
|
40.4 Percentage of participants
Interval 30.2 to 51.4
|
42.5 Percentage of participants
Interval 32.9 to 52.4
|
38.9 Percentage of participants
Interval 29.1 to 49.5
|
SECONDARY outcome
Timeframe: Annually, for up to 5 yearsPopulation: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.
Quantitative HBsAg assay is a diagnostic test for assessing the amount of the HBsAg in chronic Hepatitis B participants. Missing values were counted as non-response.
Outcome measures
| Measure |
PEG-IFN 90mcg 24 Wks
n=93 Participants
Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 24 Wks
n=89 Participants
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 90mcg 48 Wks
n=106 Participants
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 48 Wks
n=95 Participants
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
|---|---|---|---|---|
|
Quantitative HBsAg
FU Year 3 (n= 83, 82, 91, 85)
|
3.479 log10 IU/mL
Standard Deviation 0.9008
|
3.393 log10 IU/mL
Standard Deviation 0.7095
|
3.339 log10 IU/mL
Standard Deviation 0.8870
|
3.178 log10 IU/mL
Standard Deviation 1.0561
|
|
Quantitative HBsAg
EOT (n= 89, 86, 102, 91)
|
3.541 log10 IU/mL
Standard Deviation 0.9523
|
3.371 log10 IU/mL
Standard Deviation 1.1570
|
3.322 log10 IU/mL
Standard Deviation 1.0875
|
2.949 log10 IU/mL
Standard Deviation 1.3170
|
|
Quantitative HBsAg
FU Year 1 (n= 87, 85, 93, 86)
|
3.495 log10 IU/mL
Standard Deviation 0.9314
|
3.484 log10 IU/mL
Standard Deviation 0.8102
|
3.379 log10 IU/mL
Standard Deviation 0.9076
|
3.453 log10 IU/mL
Standard Deviation 0.9282
|
|
Quantitative HBsAg
FU Year 2 (n= 86, 86, 96, 90)
|
3.478 log10 IU/mL
Standard Deviation 0.9263
|
3.441 log10 IU/mL
Standard Deviation 0.7682
|
3.381 log10 IU/mL
Standard Deviation 0.8898
|
3.318 log10 IU/mL
Standard Deviation 1.0139
|
|
Quantitative HBsAg
FU Year 4 (n= 81, 79, 89, 80)
|
3.456 log10 IU/mL
Standard Deviation 0.9418
|
3.350 log10 IU/mL
Standard Deviation 0.8172
|
3.240 log10 IU/mL
Standard Deviation 0.9143
|
3.135 log10 IU/mL
Standard Deviation 0.9906
|
|
Quantitative HBsAg
FU Year 5 (n= 81, 79, 83, 74)
|
3.391 log10 IU/mL
Standard Deviation 0.8555
|
3.305 log10 IU/mL
Standard Deviation 0.8206
|
3.201 log10 IU/mL
Standard Deviation 0.9099
|
2.932 log10 IU/mL
Standard Deviation 1.1391
|
SECONDARY outcome
Timeframe: Up to 5-year FU periodPopulation: The PP population included participants who satisfied key inclusion and exclusion criteria of study WV19432, received at least 4 doses of PEG-IFN, and provided informed consent for study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants switched treatment groups for analysis.
Participants who required additional treatments specifically to treat CHB, associated laboratory test abnormalities and associated symptoms in this long-term observation in the study were reported. Receipt of such treatment did not require participant withdrawal from further participation.
Outcome measures
| Measure |
PEG-IFN 90mcg 24 Wks
n=93 Participants
Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 24 Wks
n=89 Participants
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 90mcg 48 Wks
n=106 Participants
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 48 Wks
n=95 Participants
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
|---|---|---|---|---|
|
Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
Nucleoside/nucleotide analogues
|
49 Participants
|
40 Participants
|
51 Participants
|
36 Participants
|
|
Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
Antiviral agents
|
9 Participants
|
7 Participants
|
18 Participants
|
9 Participants
|
|
Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
Cytokines
|
2 Participants
|
8 Participants
|
9 Participants
|
9 Participants
|
|
Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
Botanicals
|
4 Participants
|
6 Participants
|
4 Participants
|
9 Participants
|
|
Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
Miscellaneous gastrointestinal agents
|
5 Participants
|
3 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
Miscellaneous drugs
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
Supplements
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
Pharmaceutic aids
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
Immunomodulators
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
Blood products
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
Chelating agents
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
Clotting factors and haemostatics
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
Prostaglandins
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
Vaccines, toxoids and serologic agents
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Received Treatment With Antiviral, Immunomodulatory, Anti-inflammatory or Herbal/Botanical/Other Treatments for Chronic Hepatitis B
Vitamins and minerals
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5-year FU periodPopulation: The safety analysis population included participants who had received at least one dose of study medication in Study WV19432, had at least one visit in study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants in the safety population switched treatment groups.
Clinically significant events were defined as one or more of the following: Hepatocellular carcinoma, hepatic decompensation, CHB-related death, hepatic transplant, marked elevation of serum ALT of \>10 x upper limit of normal (ULN).
Outcome measures
| Measure |
PEG-IFN 90mcg 24 Wks
n=93 Participants
Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 24 Wks
n=89 Participants
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 90mcg 48 Wks
n=106 Participants
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 48 Wks
n=95 Participants
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)
Hepatocellular Carcinoma (No)
|
20 Participants
|
22 Participants
|
22 Participants
|
21 Participants
|
|
Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)
Elevated ALT >10 x ULN (Yes)
|
3 Participants
|
5 Participants
|
9 Participants
|
5 Participants
|
|
Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)
Elevated ALT >10 x ULN (No)
|
89 Participants
|
83 Participants
|
97 Participants
|
90 Participants
|
|
Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)
Elevated ALT >10 x ULN (Missing)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)
Hepatic Decompensation (Yes)
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)
Hepatic Decompensation (No)
|
88 Participants
|
87 Participants
|
105 Participants
|
94 Participants
|
|
Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)
Hepatic Decompensation (Missing)
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)
Hepatocellular Carcinoma (Yes)
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)
Hepatocellular Carcinoma (No assessment performed)
|
71 Participants
|
66 Participants
|
81 Participants
|
74 Participants
|
|
Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)
Hepatocellular Carcinoma (Missing)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)
Hepatic Transplant (No)
|
92 Participants
|
88 Participants
|
106 Participants
|
95 Participants
|
|
Number of Participants With Clinically Significant Events Related to Chronic Hepatitis B (CHB)
Hepatic Transplant (Missing)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 5-year FU periodPopulation: The safety analysis population included participants who had received at least one dose of study medication in Study WV19432, had at least one visit in study MV22430. Analysis was performed as per the treatment received and not the randomized treatment. Four participants in the safety population switched treatment groups.
Marked abnormality of laboratory parameters is defined as the value which is outside the defined reference range of that respective parameter. Roche's following reference ranges for laboratory test parameters were used for the analysis: Hemoglobin (reference range: 110-200 grams/liter\[g/L\]), White blood cells (WBC) (3.0-18.0 \^10\^9/L), Platelets (100-550 \^10\^9/L), Neutrophils (1.50-9.25 \^10\^9/L), Prothrombin time (PT) Normal ratio (n.d.-2.00), Alkaline phosphatase (0-220 units/liter \[U/L\]), Alanine aminotransferase (0-110 U/L), Aspartate transaminase (0-80 U/L), Total bilirubin (0-34 micromole/liter \[umol/L\]), Gamma-glutamyl transpeptidase (GGT) (0-190 U/L), Blood urea nitrogen (BUN) (0.0-14.3 millimole/liter \[mmol/L\]), Creatinine (0-154 umol/L), Total Protein (55-87 g/L), Albumin (30.0-n.d. g/L), Potassium (2.9-5.8 mmol/L), Sodium (130-150 mmol/L), Calcium (2.00-2.90 mmol/L), Uric acid (0-600 umol/L). It includes marked abnormalities observed during Study WV19432 and FU study MV22430
Outcome measures
| Measure |
PEG-IFN 90mcg 24 Wks
n=93 Participants
Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 24 Wks
n=89 Participants
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 90mcg 48 Wks
n=106 Participants
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 48 Wks
n=95 Participants
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
|---|---|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities
Alanine transaminase (High)
|
66 Participants
|
67 Participants
|
74 Participants
|
56 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Aspartate transaminase (High)
|
60 Participants
|
60 Participants
|
60 Participants
|
51 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Albumin (Low)
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Alkaline phosphatase (High)
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
BUN (High)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Calcium (High)
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Calcium (Low)
|
5 Participants
|
5 Participants
|
15 Participants
|
7 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Creatinine (High)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
GGT (High)
|
3 Participants
|
5 Participants
|
7 Participants
|
7 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Hemoglobin (Low)
|
5 Participants
|
6 Participants
|
1 Participants
|
13 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Neutrophils (High)
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Neutrophils (Low)
|
53 Participants
|
57 Participants
|
79 Participants
|
77 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
PT normalized ratio (High)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Platelets (Low)
|
14 Participants
|
23 Participants
|
28 Participants
|
41 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Potassium (High)
|
2 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Potassium (Low)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Prothrombin time (High)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Sodium (High)
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Sodium (Low)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Total bilirubin (High)
|
2 Participants
|
4 Participants
|
8 Participants
|
3 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Total protein (High)
|
3 Participants
|
1 Participants
|
5 Participants
|
6 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Total Protein (Low)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Uric acid (High)
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
White blood cell (Low)
|
27 Participants
|
34 Participants
|
52 Participants
|
65 Participants
|
Adverse Events
PEG-IFN 90mcg 24 Wks
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
PEG-IFN 180mcg 24 Wks
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
PEG-IFN 90mcg 48 Wks
Serious events: 10 serious events
Other events: 8 other events
Deaths: 0 deaths
PEG-IFN 180mcg 48 Wks
Serious events: 6 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG-IFN 90mcg 24 Wks
n=93 participants at risk
Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 24 Wks
n=89 participants at risk
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 90mcg 48 Wks
n=106 participants at risk
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 48 Wks
n=95 participants at risk
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
|---|---|---|---|---|
|
Infections and infestations
Dengue fever
|
1.1%
1/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
1.1%
1/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
2.8%
3/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
0/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.1%
1/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.94%
1/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.1%
1/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.1%
1/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Hepatitis B
|
1.1%
1/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.94%
1/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.1%
1/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.94%
1/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.1%
1/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.1%
1/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.94%
1/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
1.1%
1/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Pregnancy, puerperium and perinatal conditions
Haemorrhage in pregnancy
|
0.00%
0/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.1%
1/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.1%
1/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.94%
1/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.94%
1/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.1%
1/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.1%
1/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Alanine aminotransferase increased
|
1.1%
1/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.1%
1/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.94%
1/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Death
|
0.00%
0/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.94%
1/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.94%
1/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.94%
1/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.1%
1/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
Other adverse events
| Measure |
PEG-IFN 90mcg 24 Wks
n=93 participants at risk
Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 24 Wks
n=89 participants at risk
Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 90mcg 48 Wks
n=106 participants at risk
Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
PEG-IFN 180mcg 48 Wks
n=95 participants at risk
Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
5/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.7%
6/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.8%
4/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
7.4%
7/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
3/93 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
2.2%
2/89 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.8%
4/106 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.3%
5/95 • 5-year FU period
Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 616878333
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