Trial Outcomes & Findings for A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (NCT NCT02167945)
NCT ID: NCT02167945
Last Updated: 2022-07-19
Results Overview
Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
615 participants
Primary outcome timeframe
At Post-Treatment Weeks 52, 104, 156, 208, and 260
Results posted on
2022-07-19
Participant Flow
Safety population: All participants enrolled in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
Participant milestones
| Measure |
ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV)
Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.
|
|---|---|
|
Overall Study
STARTED
|
615
|
|
Overall Study
COMPLETED
|
366
|
|
Overall Study
NOT COMPLETED
|
249
|
Reasons for withdrawal
| Measure |
ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV)
Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
16
|
|
Overall Study
Withdrew Consent
|
42
|
|
Overall Study
Lost to Follow-up
|
122
|
|
Overall Study
COVID-19 logistical restrictions
|
6
|
|
Overall Study
Other, not specified
|
63
|
Baseline Characteristics
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Baseline characteristics by cohort
| Measure |
ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV)
n=615 Participants
Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.
|
|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 10.84 • n=93 Participants
|
|
Sex: Female, Male
Female
|
243 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
372 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
520 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
84 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
3 Participants
n=93 Participants
|
|
HCV Genotype 1 Subtype
GT1b without cirrhosis
|
141 Participants
n=93 Participants
|
|
HCV Genotype 1 Subtype
GT1b with compensated cirrhosis
|
22 Participants
n=93 Participants
|
|
HCV Genotype 1 Subtype
GT1 Non-b without cirrhosis
|
359 Participants
n=93 Participants
|
|
HCV Genotype 1 Subtype
GT1 Non-b with compensated cirrhosis
|
93 Participants
n=93 Participants
|
|
Prior HCV Treatment History
Treatment Naïve
|
437 Participants
n=93 Participants
|
|
Prior HCV Treatment History
Treatment Experienced
|
178 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: At Post-Treatment Weeks 52, 104, 156, 208, and 260Population: Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-II; M14-222; ITT-II) and in companion study M14-423 (TOPAZ-I; NCT02219490; ITT-I) who received at least one dose of study drug
Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
Outcome measures
| Measure |
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12
n=77 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Participants in Studies M14-222 and M14-423 Who Achieved SVR12
n=2134 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Baseline Fibrosis Stage F3
Participants in study M14-222 with a baseline fibrosis stage of F3
|
Baseline Fibrosis Stage F4
Participants in study M14-222 with a baseline fibrosis stage of F4
|
|---|---|---|---|---|
|
All-Cause Death: Time to Event
Kaplan-Meier estimate at PT Week 52
|
8.3 percentage of participants
Interval 3.1 to 21.2
|
0.1 percentage of participants
Interval 0.1 to 0.4
|
—
|
—
|
|
All-Cause Death: Time to Event
Kaplan-Meier estimate at PT Week 104
|
8.3 percentage of participants
Interval 3.1 to 21.2
|
0.7 percentage of participants
Interval 0.4 to 1.1
|
—
|
—
|
|
All-Cause Death: Time to Event
Kaplan-Meier estimate at PT Week 156
|
8.3 percentage of participants
Interval 3.1 to 21.2
|
1.2 percentage of participants
Interval 0.8 to 1.8
|
—
|
—
|
|
All-Cause Death: Time to Event
Kaplan-Meier estimate at PT Week 208
|
8.3 percentage of participants
Interval 3.1 to 21.2
|
1.5 percentage of participants
Interval 1.1 to 2.2
|
—
|
—
|
|
All-Cause Death: Time to Event
Kaplan-Meier estimate at PT Week 260
|
8.3 percentage of participants
Interval 3.1 to 21.2
|
2.0 percentage of participants
Interval 1.5 to 2.8
|
—
|
—
|
PRIMARY outcome
Timeframe: At Post-Treatment Weeks 52, 104, 156, 208, and 260Population: Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-II; M14-222; ITT-II) and in companion study M14-423 (TOPAZ-I; NCT02219490; ITT-I) who received at least one dose of study drug
Time to liver-related death was defined as number of days from the 1st day of study drug dosing for the participant to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver-related death. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver-related death included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
Outcome measures
| Measure |
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12
n=77 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Participants in Studies M14-222 and M14-423 Who Achieved SVR12
n=2134 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Baseline Fibrosis Stage F3
Participants in study M14-222 with a baseline fibrosis stage of F3
|
Baseline Fibrosis Stage F4
Participants in study M14-222 with a baseline fibrosis stage of F4
|
|---|---|---|---|---|
|
Liver-Related Death: Time to Event
Kaplan-Meier estimate at PT Week 260
|
1.4 percentage of participants
Interval 0.2 to 9.6
|
0.1 percentage of participants
Interval 0.1 to 0.4
|
—
|
—
|
|
Liver-Related Death: Time to Event
Kaplan-Meier estimate at PT Week 52
|
1.4 percentage of participants
Interval 0.2 to 9.6
|
0 percentage of participants
Confidence interval is not calculable due to zero events at this visit
|
—
|
—
|
|
Liver-Related Death: Time to Event
Kaplan-Meier estimate at PT Week 104
|
1.4 percentage of participants
Interval 0.2 to 9.6
|
0 percentage of participants
Confidence interval is not calculable due to zero events at this visit
|
—
|
—
|
|
Liver-Related Death: Time to Event
Kaplan-Meier estimate at PT Week 156
|
1.4 percentage of participants
Interval 0.2 to 9.6
|
0.1 percentage of participants
Interval 0.1 to 0.4
|
—
|
—
|
|
Liver-Related Death: Time to Event
Kaplan-Meier estimate at PT Week 208
|
1.4 percentage of participants
Interval 0.2 to 9.6
|
0.1 percentage of participants
Interval 0.1 to 0.4
|
—
|
—
|
PRIMARY outcome
Timeframe: At Post-Treatment Weeks 52, 104, 156, 208, and 260Population: Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-II; M14-222; ITT-II) and in companion study M14-423 (TOPAZ-I; NCT02219490; ITT-I) who received at least one dose of study drug
Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
Outcome measures
| Measure |
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12
n=77 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Participants in Studies M14-222 and M14-423 Who Achieved SVR12
n=2134 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Baseline Fibrosis Stage F3
Participants in study M14-222 with a baseline fibrosis stage of F3
|
Baseline Fibrosis Stage F4
Participants in study M14-222 with a baseline fibrosis stage of F4
|
|---|---|---|---|---|
|
Liver Decompensation: Time to Event
Kaplan-Meier estimate at PT Week 52
|
4.5 percentage of participants
Interval 1.5 to 13.4
|
0.2 percentage of participants
Interval 0.1 to 0.5
|
—
|
—
|
|
Liver Decompensation: Time to Event
Kaplan-Meier estimate at PT Week 104
|
4.5 percentage of participants
Interval 1.5 to 13.4
|
0.2 percentage of participants
Interval 0.1 to 0.5
|
—
|
—
|
|
Liver Decompensation: Time to Event
Kaplan-Meier estimate at PT Week 156
|
4.5 percentage of participants
Interval 1.5 to 13.4
|
0.3 percentage of participants
Interval 0.1 to 0.6
|
—
|
—
|
|
Liver Decompensation: Time to Event
Kaplan-Meier estimate at PT Week 208
|
4.5 percentage of participants
Interval 1.5 to 13.4
|
0.3 percentage of participants
Interval 0.2 to 0.7
|
—
|
—
|
|
Liver Decompensation: Time to Event
Kaplan-Meier estimate at PT Week 260
|
4.5 percentage of participants
Interval 1.5 to 13.4
|
0.5 percentage of participants
Interval 0.2 to 0.9
|
—
|
—
|
PRIMARY outcome
Timeframe: At Post-Treatment Weeks 52, 104, 156, 208, and 260Population: Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-II; M14-222; ITT-II) and in companion study M14-423 (TOPAZ-I; NCT02219490; ITT-I) who received at least one dose of study drug
Time to liver transplantation was defined as number of days from the 1st day of study drug dosing for the participant to date of liver transplantation. All liver transplantation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
Outcome measures
| Measure |
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12
n=77 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Participants in Studies M14-222 and M14-423 Who Achieved SVR12
n=2134 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Baseline Fibrosis Stage F3
Participants in study M14-222 with a baseline fibrosis stage of F3
|
Baseline Fibrosis Stage F4
Participants in study M14-222 with a baseline fibrosis stage of F4
|
|---|---|---|---|---|
|
Liver Transplantation: Time to Event
Kaplan-Meier estimate at PT Week 52
|
0 percentage of participants
Confidence interval is not calculable due to zero events at this visit
|
0 percentage of participants
Confidence interval is not calculable due to zero events at this visit
|
—
|
—
|
|
Liver Transplantation: Time to Event
Kaplan-Meier estimate at PT Week 104
|
0 percentage of participants
Confidence interval is not calculable due to zero events at this visit
|
0 percentage of participants
Confidence interval is not calculable due to zero events at this visit
|
—
|
—
|
|
Liver Transplantation: Time to Event
Kaplan-Meier estimate at PT Week 156
|
0 percentage of participants
Confidence interval is not calculable due to zero events at this visit
|
0.1 percentage of participants
Interval 0.1 to 0.4
|
—
|
—
|
|
Liver Transplantation: Time to Event
Kaplan-Meier estimate at PT Week 208
|
0 percentage of participants
Confidence interval is not calculable due to zero events at this visit
|
0.1 percentage of participants
Interval 0.1 to 0.4
|
—
|
—
|
|
Liver Transplantation: Time to Event
Kaplan-Meier estimate at PT Week 260
|
0 percentage of participants
Confidence interval is not calculable due to zero events at this visit
|
0.2 percentage of participants
Interval 0.1 to 0.5
|
—
|
—
|
PRIMARY outcome
Timeframe: At Post-Treatment Weeks 52, 104, 156, 208, and 260Population: Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-II; M14-222; ITT-II) and in companion study M14-423 (TOPAZ-I; NCT02219490; ITT-I) who received at least one dose of study drug
Time to hepatocellular carcinoma was defined as number of days from the 1st day of study drug dosing for the participant to date of hepatocellular carcinoma. All hepatocellular carcinoma was to be included, whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for hepatocellular carcinoma. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
Outcome measures
| Measure |
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12
n=77 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Participants in Studies M14-222 and M14-423 Who Achieved SVR12
n=2134 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Baseline Fibrosis Stage F3
Participants in study M14-222 with a baseline fibrosis stage of F3
|
Baseline Fibrosis Stage F4
Participants in study M14-222 with a baseline fibrosis stage of F4
|
|---|---|---|---|---|
|
Hepatocellular Carcinoma: Time to Event
Kaplan-Meier estimate at PT Week 52
|
0 percentage of participants
Confidence interval is not calculable due to zero events at this visit
|
0.2 percentage of participants
Interval 0.1 to 0.5
|
—
|
—
|
|
Hepatocellular Carcinoma: Time to Event
Kaplan-Meier estimate at PT Week 104
|
0 percentage of participants
Confidence interval is not calculable due to zero events at this visit
|
0.4 percentage of participants
Interval 0.2 to 0.8
|
—
|
—
|
|
Hepatocellular Carcinoma: Time to Event
Kaplan-Meier estimate at PT Week 156
|
0 percentage of participants
Confidence interval is not calculable due to zero events at this visit
|
0.5 percentage of participants
Interval 0.3 to 1.0
|
—
|
—
|
|
Hepatocellular Carcinoma: Time to Event
Kaplan-Meier estimate at PT Week 208
|
0 percentage of participants
Confidence interval is not calculable due to zero events at this visit
|
0.6 percentage of participants
Interval 0.4 to 1.1
|
—
|
—
|
|
Hepatocellular Carcinoma: Time to Event
Kaplan-Meier estimate at PT Week 260
|
0 percentage of participants
Confidence interval is not calculable due to zero events at this visit
|
0.9 percentage of participants
Interval 0.5 to 1.4
|
—
|
—
|
PRIMARY outcome
Timeframe: At Post-Treatment Weeks 52, 104, 156, 208, and 260Population: Intent-to-treat (ITT) population: all enrolled participants in this study (TOPAZ-II; M14-222; ITT-II) and in companion study M14-423 (TOPAZ-I; NCT02219490; ITT-I) who received at least one dose of study drug
Time to the composite of clinical outcomes is the time to the first occurrence of all-cause death, liver-related death, liver decompensation, liver transplantation, or hepatocellular carcinoma. All first occurrences were to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not experience any of these events, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. Pre-specified analysis included pooled data from this study and from TOPAZ-I; NCT02219490.
Outcome measures
| Measure |
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12
n=77 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Participants in Studies M14-222 and M14-423 Who Achieved SVR12
n=2134 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Baseline Fibrosis Stage F3
Participants in study M14-222 with a baseline fibrosis stage of F3
|
Baseline Fibrosis Stage F4
Participants in study M14-222 with a baseline fibrosis stage of F4
|
|---|---|---|---|---|
|
All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event
Kaplan-Meier estimate at PT Week 52
|
11.4 percentage of participants
Interval 5.2 to 24.2
|
0.5 percentage of participants
Interval 0.3 to 0.9
|
—
|
—
|
|
All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event
Kaplan-Meier estimate at PT Week 104
|
11.4 percentage of participants
Interval 5.2 to 24.2
|
1.2 percentage of participants
Interval 0.8 to 1.8
|
—
|
—
|
|
All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event
Kaplan-Meier estimate at PT Week 156
|
11.4 percentage of participants
Interval 5.2 to 24.2
|
1.9 percentage of participants
Interval 1.4 to 2.6
|
—
|
—
|
|
All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event
Kaplan-Meier estimate at PT Week 208
|
11.4 percentage of participants
Interval 5.2 to 24.2
|
2.3 percentage of participants
Interval 1.7 to 3.1
|
—
|
—
|
|
All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event
Kaplan-Meier estimate at PT Week 260
|
11.4 percentage of participants
Interval 5.2 to 24.2
|
3.2 percentage of participants
Interval 2.5 to 4.1
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 weeks after the last actual dose of study drugPopulation: ITT-II population: all participants enrolled in this study (M14-222; TOPAZ-II) who received at least one dose of study drug. Flanking imputation, where applicable, was used to impute missing data. After applying flanking imputation, if there was no value in the window but there was an HCV RNA value from a local laboratory present, then it was to be imputed into the SVR window. Otherwise, participants with missing data were counted as failures.
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
Outcome measures
| Measure |
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12
n=615 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Participants in Studies M14-222 and M14-423 Who Achieved SVR12
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Baseline Fibrosis Stage F3
Participants in study M14-222 with a baseline fibrosis stage of F3
|
Baseline Fibrosis Stage F4
Participants in study M14-222 with a baseline fibrosis stage of F4
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
|
95.3 percentage of participants
Interval 93.3 to 96.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Post-Treatment Week 12 and Post-Treatment Week 24Population: ITT-II population: all participants enrolled in this study (M14-222; TOPAZ-II) who received at least one dose of study drug and had both baseline and post-treatment data
The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of 4 weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores for each domain and PCS/MCS range from 0-100: higher scores indicate a better state of health. Positive numbers indicate improvement from baseline.
Outcome measures
| Measure |
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12
n=291 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Participants in Studies M14-222 and M14-423 Who Achieved SVR12
n=85 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Baseline Fibrosis Stage F3
n=104 Participants
Participants in study M14-222 with a baseline fibrosis stage of F3
|
Baseline Fibrosis Stage F4
n=106 Participants
Participants in study M14-222 with a baseline fibrosis stage of F4
|
|---|---|---|---|---|
|
Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at Post-Treatment Week 12 and Post-Treatment Week 24
At Post-treatment Week 12
|
1.2 units on a scale
Standard Deviation 6.33
|
0.0 units on a scale
Standard Deviation 6.32
|
1.8 units on a scale
Standard Deviation 7.80
|
1.4 units on a scale
Standard Deviation 7.54
|
|
Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at Post-Treatment Week 12 and Post-Treatment Week 24
At Post-treatment Week 24
|
1.1 units on a scale
Standard Deviation 6.86
|
0.5 units on a scale
Standard Deviation 7.47
|
2.3 units on a scale
Standard Deviation 8.11
|
1.8 units on a scale
Standard Deviation 7.77
|
SECONDARY outcome
Timeframe: From Baseline to Post-Treatment Week 12 and Post-Treatment Week 24Population: ITT-II population: all participants enrolled in this study (M14-222; TOPAZ-II) who received at least one dose of study drug and had both baseline and post-treatment data
The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of 4 weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores for each domain and PCS/MCS range from 0-100: higher scores indicate a better state of health. Positive numbers indicate improvement from baseline.
Outcome measures
| Measure |
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12
n=291 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Participants in Studies M14-222 and M14-423 Who Achieved SVR12
n=85 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Baseline Fibrosis Stage F3
n=104 Participants
Participants in study M14-222 with a baseline fibrosis stage of F3
|
Baseline Fibrosis Stage F4
n=106 Participants
Participants in study M14-222 with a baseline fibrosis stage of F4
|
|---|---|---|---|---|
|
Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Mental Component Summary (MCS) Score at Post-Treatment Week 12 and Post-Treatment Week 24
At Post-treatment Week 12
|
2.7 units on a scale
Standard Deviation 9.77
|
1.0 units on a scale
Standard Deviation 9.05
|
0.9 units on a scale
Standard Deviation 9.64
|
0.3 units on a scale
Standard Deviation 10.62
|
|
Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Mental Component Summary (MCS) Score at Post-Treatment Week 12 and Post-Treatment Week 24
At Post-treatment Week 24
|
3.2 units on a scale
Standard Deviation 9.85
|
1.9 units on a scale
Standard Deviation 7.28
|
1.5 units on a scale
Standard Deviation 10.73
|
0.4 units on a scale
Standard Deviation 10.20
|
SECONDARY outcome
Timeframe: From Baseline to Post-Treatment Week 12 and Post-Treatment Week 24Population: ITT-II population: all participants enrolled in this study (M14-222; TOPAZ-II) who received at least one dose of study drug who had both baseline and post-treatment data.
The FACIT-F is a symptom specific instrument with a focus on measuring fatigue in a variety of chronic diseases or health conditions. It was originally developed from interviews with oncology patients and clinical experts to assess anemia-associated fatigue. Its 13-item-version assesses peripheral, central, or mixed fatigue with a recall period of 7 days and yields a summed total score ranging between 0 and 52. Higher FACIT-F scores indicate a lesser degree of fatigue. Positive numbers indicate improvement from baseline.
Outcome measures
| Measure |
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12
n=292 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Participants in Studies M14-222 and M14-423 Who Achieved SVR12
n=86 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Baseline Fibrosis Stage F3
n=103 Participants
Participants in study M14-222 with a baseline fibrosis stage of F3
|
Baseline Fibrosis Stage F4
n=105 Participants
Participants in study M14-222 with a baseline fibrosis stage of F4
|
|---|---|---|---|---|
|
Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score at Post-Treatment Week 12 and Post-Treatment Week 24
At Post-treatment Week 12
|
3.9 units on a scale
Standard Deviation 9.66
|
2.0 units on a scale
Standard Deviation 9.12
|
2.0 units on a scale
Standard Deviation 8.63
|
3.0 units on a scale
Standard Deviation 9.57
|
|
Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score at Post-Treatment Week 12 and Post-Treatment Week 24
At Post-treatment Week 24
|
3.9 units on a scale
Standard Deviation 10.46
|
3.1 units on a scale
Standard Deviation 6.85
|
2.3 units on a scale
Standard Deviation 9.27
|
2.6 units on a scale
Standard Deviation 10.88
|
SECONDARY outcome
Timeframe: Up to Treatment Week 24Population: Safety population: all participants enrolled in this study (M14-222; TOPAZ-II) who received at least one dose of study drug with available data
Treatment compliance was calculated as the percentage of tablets taken (presumed as \[tablets dispensed-tablets returned\]) relative to the total tablets, respectively, expected to be taken. Study drug interruptions due to an adverse event or other planned interruptions recorded on the electronic case report form (eCRF) were to be subtracted from the duration. For compliance to ribavirin (RBV), RBV dose modifications due to adverse events, toxicity management, or weight changes as recorded on the RBV Dose Modifications eCRF were to be used to modify the total number of tablets that should have been taken. A participant is considered to be compliant if the percentage is between 80% and 120%.
Outcome measures
| Measure |
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12
n=567 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Participants in Studies M14-222 and M14-423 Who Achieved SVR12
n=408 Participants
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
|
Baseline Fibrosis Stage F3
Participants in study M14-222 with a baseline fibrosis stage of F3
|
Baseline Fibrosis Stage F4
Participants in study M14-222 with a baseline fibrosis stage of F4
|
|---|---|---|---|---|
|
Treatment Compliance: Percentage of Tablets Taken Relative to the Total Tablets
|
100.22 percentage of tablets taken
Standard Deviation 22.88
|
99.86 percentage of tablets taken
Standard Deviation 12.40
|
—
|
—
|
Adverse Events
ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV)
Serious events: 25 serious events
Other events: 381 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV)
n=615 participants at risk
Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.
|
|---|---|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Cardiac disorders
PERICARDITIS
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Endocrine disorders
HYPERADRENOCORTICISM
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
General disorders
CHEST PAIN
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Immune system disorders
ALLERGIC OEDEMA
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Infections and infestations
BRONCHITIS
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Infections and infestations
PERITONITIS
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Infections and infestations
PNEUMONIA
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Infections and infestations
PNEUMONIA PNEUMOCOCCAL
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
MULTIPLE FRACTURES
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATOCELLULAR CARCINOMA
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA METASTATIC
|
0.33%
2/615 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Psychiatric disorders
ALCOHOL WITHDRAWAL SYNDROME
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.33%
2/615 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Psychiatric disorders
SCHIZOAFFECTIVE DISORDER
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
|
Vascular disorders
HYPOTENSION
|
0.16%
1/615 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
|
Other adverse events
| Measure |
ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV)
n=615 participants at risk
Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.
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Blood and lymphatic system disorders
ANAEMIA
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5.2%
32/615 • Number of events 32 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
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Gastrointestinal disorders
DIARRHOEA
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8.8%
54/615 • Number of events 59 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
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Gastrointestinal disorders
NAUSEA
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16.1%
99/615 • Number of events 104 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
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Gastrointestinal disorders
VOMITING
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5.0%
31/615 • Number of events 32 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
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General disorders
FATIGUE
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32.2%
198/615 • Number of events 209 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
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Nervous system disorders
DIZZINESS
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6.0%
37/615 • Number of events 38 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
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Nervous system disorders
HEADACHE
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15.9%
98/615 • Number of events 101 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
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Psychiatric disorders
INSOMNIA
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12.7%
78/615 • Number of events 80 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
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Respiratory, thoracic and mediastinal disorders
COUGH
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5.7%
35/615 • Number of events 35 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
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Skin and subcutaneous tissue disorders
PRURITUS
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14.1%
87/615 • Number of events 89 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
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Skin and subcutaneous tissue disorders
RASH
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8.0%
49/615 • Number of events 53 • All-cause mortality is reported from enrollment to the end of study, up to five years of follow-up. Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days after the last study drug administration, up to 213 days. After Post-Treatment Week 4 until the end of the study, only SAE of death was to be collected.
All-cause mortality and adverse events: all participants in this study (M14-222; TOPAZ-II) who received at least one dose of study drug
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER