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 NCT02219490)
NCT ID: NCT02219490
Last Updated: 2023-04-07
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-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1596 participants
Primary outcome timeframe
At Post-Treatment Weeks 52, 104, 156, 208, and 260
Results posted on
2023-04-07
Participant Flow
Safety population: All participants enrolled in this study (M14-423; TOPAZ-I) 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
|
1596
|
|
Overall Study
COMPLETED
|
1258
|
|
Overall Study
NOT COMPLETED
|
338
|
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
|
24
|
|
Overall Study
Withdrew consent
|
96
|
|
Overall Study
Lost to Follow-up
|
126
|
|
Overall Study
COVID-19 infection
|
2
|
|
Overall Study
COVID-19 logistical restrictions
|
33
|
|
Overall Study
Other, not specified
|
57
|
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=1596 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
|
51.2 years
STANDARD_DEVIATION 11.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
800 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
796 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1544 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
2 Participants
n=5 Participants
|
|
HCV Genotype 1 Subtype
GT1b without cirrhosis
|
757 Participants
n=5 Participants
|
|
HCV Genotype 1 Subtype
GT1b with compensated cirrhosis
|
142 Participants
n=5 Participants
|
|
HCV Genotype 1 Subtype
GT1 Non-b without cirrhosis
|
597 Participants
n=5 Participants
|
|
HCV Genotype 1 Subtype
GT1 Non-b with compensated cirrhosis
|
97 Participants
n=5 Participants
|
|
HCV Genotype 1 Subtype
Missing
|
3 Participants
n=5 Participants
|
|
Prior HCV Treatment History
Treatment Naïve
|
782 Participants
n=5 Participants
|
|
Prior HCV Treatment History
Treatment Experienced
|
814 Participants
n=5 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-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) 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-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
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.
|
|---|---|---|
|
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-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug
Time to liver-related death was defined as days from the 1st day of study drug dosing for the subject to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at date of last available assessment. For those with no post-baseline assessment, data was to be censored on 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-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
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.
|
|---|---|---|
|
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
|
|
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
|
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-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) 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-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
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.
|
|---|---|---|
|
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-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug
Time to liver transplantation was defined as days from 1st day of study drug dosing for subject to date of liver transplantation. All liver transplantation was to be included, whether it occurred while the subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, data was to be censored on 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-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
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.
|
|---|---|---|
|
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-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) who received at least one dose of study drug
Time to hepatocellular carcinoma (HCC) was defined as number of days from 1st day of study drug dosing for subject to date of hepatocellular carcinoma. All HCC was to be included, whether it occurred while subject was still taking study drug or had previously discontinued study drug. If the subject 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. 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 HCC. 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-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).
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.
|
|---|---|---|
|
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-I; M14-423; ITT-I) and in companion study M14-422 (TOPAZ-II; NCT02167945; ITT-II) 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-II; NCT02167945.
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.
|
|---|---|---|
|
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: At the final treatment visit and Post-Treatment Weeks 12, 24, 52, 104, 156, 208, and 260Population: ITT-I population: all participants enrolled in this study (M14-423; TOPAZ-I) who received at least one dose of study drug with available data
The FibroScan test is a validated non-invasive test used to assess liver fibrosis in participants with chronic liver disease, and it was performed at study sites where it was available. For participants with Hepatitis C infection, a FibroScan score of 2-7 kPa indicates no liver scarring or mild scarring; a score of 8 or 9 is associated with moderate liver scarring; 9-14 indicates severe liver scarring; and 14 or higher is indicative of advanced liver scarring, cirrhosis. Negative changes from baseline indicate improvement in liver fibrosis.
Outcome measures
| Measure |
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12
n=22 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=1187 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.
|
|---|---|---|
|
Change From Baseline in FibroScan Score by SVR12 Status
At the final treatment visit
|
-2.55 kPa
Standard Deviation 3.282
|
-1.41 kPa
Standard Deviation 4.283
|
|
Change From Baseline in FibroScan Score by SVR12 Status
Post-Treatment Week 12
|
-1.81 kPa
Standard Deviation 2.624
|
-1.76 kPa
Standard Deviation 4.213
|
|
Change From Baseline in FibroScan Score by SVR12 Status
Post-Treatment Week 24
|
-1.26 kPa
Standard Deviation 3.211
|
-1.98 kPa
Standard Deviation 4.363
|
|
Change From Baseline in FibroScan Score by SVR12 Status
Post-Treatment Week 52
|
-0.30 kPa
Standard Deviation 1.986
|
-2.46 kPa
Standard Deviation 4.858
|
|
Change From Baseline in FibroScan Score by SVR12 Status
Post-Treatment Week 104
|
-0.35 kPa
Standard Deviation 3.306
|
-2.80 kPa
Standard Deviation 5.195
|
|
Change From Baseline in FibroScan Score by SVR12 Status
Post-Treatment Week 156
|
-0.37 kPa
Standard Deviation 3.999
|
-2.92 kPa
Standard Deviation 5.249
|
|
Change From Baseline in FibroScan Score by SVR12 Status
Post-Treatment Week 208
|
-0.88 kPa
Standard Deviation 2.445
|
-3.08 kPa
Standard Deviation 5.560
|
|
Change From Baseline in FibroScan Score by SVR12 Status
Post-Treatment Week 260
|
-1.31 kPa
Standard Deviation 3.706
|
-3.08 kPa
Standard Deviation 5.662
|
SECONDARY outcome
Timeframe: 12 weeks after the last actual dose of study drugPopulation: ITT-I population: all participants enrolled in this study (M14-423; TOPAZ-I) who received at least one dose of study drug with available data
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. 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.
Outcome measures
| Measure |
Participants in Studies M14-222 and M14-423 Who Did Not Achieve SVR12
n=1596 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.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
|
97.0 percentage of participants
Interval 96.0 to 97.7
|
—
|
Adverse Events
ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV)
Serious events: 40 serious events
Other events: 805 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
ABT-450/r/ABT-267 Plus ABT-333 With or Without Ribavirin (RBV)
n=1596 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.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Cardiac disorders
PALPITATIONS
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Gastrointestinal disorders
ASCITES
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Gastrointestinal disorders
COLITIS
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Gastrointestinal disorders
DENTAL CARIES
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Gastrointestinal disorders
VARICES OESOPHAGEAL
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
General disorders
DRUG INTERACTION
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
General disorders
OEDEMA PERIPHERAL
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Hepatobiliary disorders
HEPATORENAL SYNDROME
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Infections and infestations
APPENDICITIS
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Infections and infestations
DERMATITIS INFECTED
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Infections and infestations
ERYSIPELAS
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Infections and infestations
INFLUENZA
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Infections and infestations
PERITONITIS BACTERIAL
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Infections and infestations
PNEUMONIA
|
0.13%
2/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Infections and infestations
PYELONEPHRITIS
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATOCELLULAR CARCINOMA
|
0.13%
2/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC NEOPLASM
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAPILLARY THYROID CANCER
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR THROMBOSIS
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Nervous system disorders
DIZZINESS POSTURAL
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Nervous system disorders
PARAESTHESIA
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Nervous system disorders
PSYCHOMOTOR SKILLS IMPAIRED
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Nervous system disorders
SYNCOPE
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Psychiatric disorders
AFFECT LABILITY
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Psychiatric disorders
ANGER
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Psychiatric disorders
INSOMNIA
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Psychiatric disorders
MANIA
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Psychiatric disorders
SCHIZOAFFECTIVE DISORDER
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Renal and urinary disorders
CALCULUS URINARY
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Renal and urinary disorders
RENAL COLIC
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Vascular disorders
HYPERTENSION
|
0.06%
1/1596 • 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 203 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 (M14-423; TOPAZ-I) 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=1596 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.
|
|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
6.5%
103/1596 • Number of events 112 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Gastrointestinal disorders
NAUSEA
|
11.7%
186/1596 • Number of events 200 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
General disorders
ASTHENIA
|
10.3%
165/1596 • Number of events 179 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
General disorders
FATIGUE
|
18.8%
300/1596 • Number of events 331 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Nervous system disorders
HEADACHE
|
18.2%
291/1596 • Number of events 319 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Psychiatric disorders
INSOMNIA
|
11.2%
179/1596 • Number of events 183 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
12.5%
199/1596 • 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 203 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 (M14-423; TOPAZ-I) who received at least one dose of study drug
|
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