Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil (NCT NCT02442271)
NCT ID: NCT02442271
Last Updated: 2017-08-01
Results Overview
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug. Participants with missing data were counted as failures.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
222 participants
Primary outcome timeframe
12 weeks after the last actual dose of study drug
Results posted on
2017-08-01
Participant Flow
Treatment regimen was assigned according to HCV genotype/subtype and cirrhosis status.
Participant milestones
| Measure |
3-DAA ± RBV
3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
|
|---|---|
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Overall Study
STARTED
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222
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Overall Study
COMPLETED
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218
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|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
3-DAA ± RBV
3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
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|---|---|
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Overall Study
Adverse Event
|
1
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Overall Study
Withdrew Consent
|
1
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Overall Study
Lost to Follow-up
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1
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|
Overall Study
Other
|
1
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Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil
Baseline characteristics by cohort
| Measure |
3-DAA ± RBV
n=222 Participants
3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
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|---|---|
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Age, Continuous
|
56.6 years
STANDARD_DEVIATION 10.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
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|
Sex: Female, Male
Male
|
123 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after the last actual dose of study drugPopulation: Intent-to-treat population: all participants who received at least 1 dose of study drug.
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug. Participants with missing data were counted as failures.
Outcome measures
| Measure |
3-DAA ± RBV
n=222 Participants
3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
|
Fibrosis Stage F4
Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
|
Pegylated Interferon (PegIFN)//RBV Partial Responders
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course but failed to achieve HCV RNA undetectable at the end of treatment
|
Pegylated Interferon (PegIFN)/RBV Non-Responders
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and failed to achieve a 1 log10 IU/mL reduction in HCV RNA by Week 4 or a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course.
|
Pegylated Interferon (PegIFN)/RBV Relapser
Participants who had received prior treatment with pegIFN-based therapy for HCV infection who achieved HCV undetectable at end of a prior IFN/RBV or pegIFN/RBV treatment course but HCV RNA was detectable following cessation of therapy
|
Pegylated Interferon (PegIFN)/RBV Breakthrough
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least one documented result of HCV RNA undetectable during a prior IFN/RBV or pegIFN/RBV treatment course
|
IFN Interolerant
Participants who did not meet any of the other definitions of treatment failure and discontinued IFN/RBV or pegIFN/RBV therapy due to IFN intolerability
|
Other
Participants who received IFN treatment, including IFN or pegIFN monotherapy, IFN/RBV, or pegIFN/RBV experienced subjects. Includes subjects who do not have adequate documentation of response.
|
|---|---|---|---|---|---|---|---|---|
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Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
|
96.4 percentage of participants
Interval 93.1 to 98.2
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—
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—
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—
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—
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—
|
—
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—
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SECONDARY outcome
Timeframe: 12 weeks after the last actual dose of study drugPopulation: All participants in the ITT population.
SVR12 was defined as plasma HCV RNA level \<LLOQ\]12 weeks after the last dose of study drug. The percentage of participants achieving SVR12 by fibrosis stage (F3 and F4) are presented. Participants with missing data were counted as failures.
Outcome measures
| Measure |
3-DAA ± RBV
n=89 Participants
3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
|
Fibrosis Stage F4
n=133 Participants
Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
|
Pegylated Interferon (PegIFN)//RBV Partial Responders
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course but failed to achieve HCV RNA undetectable at the end of treatment
|
Pegylated Interferon (PegIFN)/RBV Non-Responders
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and failed to achieve a 1 log10 IU/mL reduction in HCV RNA by Week 4 or a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course.
|
Pegylated Interferon (PegIFN)/RBV Relapser
Participants who had received prior treatment with pegIFN-based therapy for HCV infection who achieved HCV undetectable at end of a prior IFN/RBV or pegIFN/RBV treatment course but HCV RNA was detectable following cessation of therapy
|
Pegylated Interferon (PegIFN)/RBV Breakthrough
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least one documented result of HCV RNA undetectable during a prior IFN/RBV or pegIFN/RBV treatment course
|
IFN Interolerant
Participants who did not meet any of the other definitions of treatment failure and discontinued IFN/RBV or pegIFN/RBV therapy due to IFN intolerability
|
Other
Participants who received IFN treatment, including IFN or pegIFN monotherapy, IFN/RBV, or pegIFN/RBV experienced subjects. Includes subjects who do not have adequate documentation of response.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With SVR12 by Fibrosis Stage
|
96.6 percentage of participants
Interval 90.6 to 98.8
|
96.2 percentage of participants
Interval 91.5 to 98.4
|
—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: 12 weeks after the last actual dose of study drugPopulation: All participants in the ITT population.
SVR12 was defined as HCV RNA level \<LLOQ 12 weeks after the last dose of study drug. Data are presented by prior HCV treatment experience. Data are provided by participants' prior HCV treatment experience at screening. Participants with missing data were counted as failures.
Outcome measures
| Measure |
3-DAA ± RBV
n=102 Participants
3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
|
Fibrosis Stage F4
n=22 Participants
Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
|
Pegylated Interferon (PegIFN)//RBV Partial Responders
n=7 Participants
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course but failed to achieve HCV RNA undetectable at the end of treatment
|
Pegylated Interferon (PegIFN)/RBV Non-Responders
n=26 Participants
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and failed to achieve a 1 log10 IU/mL reduction in HCV RNA by Week 4 or a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course.
|
Pegylated Interferon (PegIFN)/RBV Relapser
n=34 Participants
Participants who had received prior treatment with pegIFN-based therapy for HCV infection who achieved HCV undetectable at end of a prior IFN/RBV or pegIFN/RBV treatment course but HCV RNA was detectable following cessation of therapy
|
Pegylated Interferon (PegIFN)/RBV Breakthrough
n=12 Participants
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least one documented result of HCV RNA undetectable during a prior IFN/RBV or pegIFN/RBV treatment course
|
IFN Interolerant
n=7 Participants
Participants who did not meet any of the other definitions of treatment failure and discontinued IFN/RBV or pegIFN/RBV therapy due to IFN intolerability
|
Other
n=12 Participants
Participants who received IFN treatment, including IFN or pegIFN monotherapy, IFN/RBV, or pegIFN/RBV experienced subjects. Includes subjects who do not have adequate documentation of response.
|
|---|---|---|---|---|---|---|---|---|
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Percentage of Participants With SVR12 by Participant Prior HCV Treatment Experience
|
96.1 percentage of participants
Interval 90.3 to 98.5
|
95.5 percentage of participants
Interval 78.2 to 99.2
|
100 percentage of participants
The number of participants analyzed is \<10
|
100 percentage of participants
Interval 87.1 to 100.0
|
97.1 percentage of participants
Interval 85.1 to 99.5
|
100 percentage of participants
Interval 78.5 to 100.0
|
85.7 percentage of participants
The number of participants analyzed is \<10
|
91.7 percentage of participants
Interval 64.6 to 98.5
|
SECONDARY outcome
Timeframe: 12 weeks after the last actual dose of study drugPopulation: All participants in the ITT population.
SVR12 was defined as HCV RNA level \<LLOQ 12 weeks after the last dose of study drug. Data are presented by prior HCV treatment experience. Data are provided by participants' eligibility for treatment with IFN at screening. Participants with missing data were counted as failures.
Outcome measures
| Measure |
3-DAA ± RBV
n=10 Participants
3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
|
Fibrosis Stage F4
n=92 Participants
Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
|
Pegylated Interferon (PegIFN)//RBV Partial Responders
n=7 Participants
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course but failed to achieve HCV RNA undetectable at the end of treatment
|
Pegylated Interferon (PegIFN)/RBV Non-Responders
n=113 Participants
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and failed to achieve a 1 log10 IU/mL reduction in HCV RNA by Week 4 or a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course.
|
Pegylated Interferon (PegIFN)/RBV Relapser
Participants who had received prior treatment with pegIFN-based therapy for HCV infection who achieved HCV undetectable at end of a prior IFN/RBV or pegIFN/RBV treatment course but HCV RNA was detectable following cessation of therapy
|
Pegylated Interferon (PegIFN)/RBV Breakthrough
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least one documented result of HCV RNA undetectable during a prior IFN/RBV or pegIFN/RBV treatment course
|
IFN Interolerant
Participants who did not meet any of the other definitions of treatment failure and discontinued IFN/RBV or pegIFN/RBV therapy due to IFN intolerability
|
Other
Participants who received IFN treatment, including IFN or pegIFN monotherapy, IFN/RBV, or pegIFN/RBV experienced subjects. Includes subjects who do not have adequate documentation of response.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With SVR12 by Participant Eligibility for Treatment With Interferon (IFN) at Screening
|
90.0 percentage of participants
Interval 59.6 to 98.2
|
96.7 percentage of participants
Interval 90.8 to 98.9
|
85.7 percentage of participants
The number of participants analyzed is \<10
|
97.3 percentage of participants
Interval 92.5 to 99.1
|
—
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—
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—
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—
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SECONDARY outcome
Timeframe: Day 1 (Baseline), 12 weeks after the last actual dose of the study drugPopulation: All participants in the ITT population with evaluable data.
The HCV-PRO has been developed to capture the function and well-being impact of HCV conditions and treatment and contains 16 items important to HCV-infected patients; items were totaled to a summary score. Scores range from 0 to 100. A higher HCV-PRO score indicates a better state of health and a decrease from baseline represents worsening. If a participant answered at least 12 of the 16 items, the missing items were imputed with the mean score of the answered items; if a participant did not answer at least 12 of the items, the total score was considered missing.
Outcome measures
| Measure |
3-DAA ± RBV
n=88 Participants
3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
|
Fibrosis Stage F4
n=130 Participants
Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
|
Pegylated Interferon (PegIFN)//RBV Partial Responders
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course but failed to achieve HCV RNA undetectable at the end of treatment
|
Pegylated Interferon (PegIFN)/RBV Non-Responders
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and failed to achieve a 1 log10 IU/mL reduction in HCV RNA by Week 4 or a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course.
|
Pegylated Interferon (PegIFN)/RBV Relapser
Participants who had received prior treatment with pegIFN-based therapy for HCV infection who achieved HCV undetectable at end of a prior IFN/RBV or pegIFN/RBV treatment course but HCV RNA was detectable following cessation of therapy
|
Pegylated Interferon (PegIFN)/RBV Breakthrough
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least one documented result of HCV RNA undetectable during a prior IFN/RBV or pegIFN/RBV treatment course
|
IFN Interolerant
Participants who did not meet any of the other definitions of treatment failure and discontinued IFN/RBV or pegIFN/RBV therapy due to IFN intolerability
|
Other
Participants who received IFN treatment, including IFN or pegIFN monotherapy, IFN/RBV, or pegIFN/RBV experienced subjects. Includes subjects who do not have adequate documentation of response.
|
|---|---|---|---|---|---|---|---|---|
|
Hepatitis C Virus Patient-Reported Outcomes Instrument (HCV-PRO) Total Score: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
SVR12 Achieved
|
3.8 units on a scale
Standard Deviation 13.25
|
4.2 units on a scale
Standard Deviation 15.72
|
—
|
—
|
—
|
—
|
—
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—
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|
Hepatitis C Virus Patient-Reported Outcomes Instrument (HCV-PRO) Total Score: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
SVR12 Not Achieved
|
0.5 units on a scale
Standard Deviation 10.97
|
0.8 units on a scale
Standard Deviation 10.64
|
—
|
—
|
—
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—
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—
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—
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SECONDARY outcome
Timeframe: Day 1 (Baseline), 12 weeks after the last actual dose of the study drugPopulation: All participants in the ITT population with evaluable data.
The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 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 four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening. If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain. In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing. The SF-36v2 MCS and PCS scores were not computed if any domain
Outcome measures
| Measure |
3-DAA ± RBV
n=87 Participants
3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
|
Fibrosis Stage F4
n=131 Participants
Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
|
Pegylated Interferon (PegIFN)//RBV Partial Responders
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course but failed to achieve HCV RNA undetectable at the end of treatment
|
Pegylated Interferon (PegIFN)/RBV Non-Responders
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and failed to achieve a 1 log10 IU/mL reduction in HCV RNA by Week 4 or a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course.
|
Pegylated Interferon (PegIFN)/RBV Relapser
Participants who had received prior treatment with pegIFN-based therapy for HCV infection who achieved HCV undetectable at end of a prior IFN/RBV or pegIFN/RBV treatment course but HCV RNA was detectable following cessation of therapy
|
Pegylated Interferon (PegIFN)/RBV Breakthrough
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least one documented result of HCV RNA undetectable during a prior IFN/RBV or pegIFN/RBV treatment course
|
IFN Interolerant
Participants who did not meet any of the other definitions of treatment failure and discontinued IFN/RBV or pegIFN/RBV therapy due to IFN intolerability
|
Other
Participants who received IFN treatment, including IFN or pegIFN monotherapy, IFN/RBV, or pegIFN/RBV experienced subjects. Includes subjects who do not have adequate documentation of response.
|
|---|---|---|---|---|---|---|---|---|
|
Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
SVR12 Not Achieved
|
-0.5 units on a scale
Standard Deviation 9.22
|
1.3 units on a scale
Standard Deviation 8.59
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
SVR12 Achieved
|
0.1 units on a scale
Standard Deviation 6.42
|
2.1 units on a scale
Standard Deviation 7.60
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Baseline), 12 weeks after the last actual dose of the study drugPopulation: All participants in the ITT population with evaluable data.
The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 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 four weeks. Domain scores are aggregated into a PCS score and a MCS score. Scores SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening. If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain. In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing. The SF-36v2 MCS and PCS scores were not computed if any domain was missing.
Outcome measures
| Measure |
3-DAA ± RBV
n=87 Participants
3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
|
Fibrosis Stage F4
n=131 Participants
Participants with baseline fibrosis stage F4 (with compensated cirrhosis).
|
Pegylated Interferon (PegIFN)//RBV Partial Responders
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course but failed to achieve HCV RNA undetectable at the end of treatment
|
Pegylated Interferon (PegIFN)/RBV Non-Responders
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and failed to achieve a 1 log10 IU/mL reduction in HCV RNA by Week 4 or a 2 log10 IU/mL reduction in HCV RNA by Week 12 during a prior IFN/RBV or pegIFN/RBV treatment course.
|
Pegylated Interferon (PegIFN)/RBV Relapser
Participants who had received prior treatment with pegIFN-based therapy for HCV infection who achieved HCV undetectable at end of a prior IFN/RBV or pegIFN/RBV treatment course but HCV RNA was detectable following cessation of therapy
|
Pegylated Interferon (PegIFN)/RBV Breakthrough
Participants who had received prior treatment with pegIFN-based therapy for HCV infection and achieved at least one documented result of HCV RNA undetectable during a prior IFN/RBV or pegIFN/RBV treatment course
|
IFN Interolerant
Participants who did not meet any of the other definitions of treatment failure and discontinued IFN/RBV or pegIFN/RBV therapy due to IFN intolerability
|
Other
Participants who received IFN treatment, including IFN or pegIFN monotherapy, IFN/RBV, or pegIFN/RBV experienced subjects. Includes subjects who do not have adequate documentation of response.
|
|---|---|---|---|---|---|---|---|---|
|
(SF-36v2) Mental Component Summary (MCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
SVR12 Not Achieved
|
2.4 units on a scale
Standard Deviation 3.72
|
-0.6 units on a scale
Standard Deviation 8.47
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(SF-36v2) Mental Component Summary (MCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug
SVR12 Achieved
|
2.4 units on a scale
Standard Deviation 11.39
|
2.5 units on a scale
Standard Deviation 9.15
|
—
|
—
|
—
|
—
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—
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—
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Adverse Events
3-DAA ± RBV
Serious events: 6 serious events
Other events: 139 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3-DAA ± RBV
n=222 participants at risk
3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
|
|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
0.45%
1/222 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any AE or SAE with onset or worsening after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
|
0.45%
1/222 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any AE or SAE with onset or worsening after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.45%
1/222 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any AE or SAE with onset or worsening after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Infections and infestations
GASTROENTERITIS
|
0.45%
1/222 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any AE or SAE with onset or worsening after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA METASTATIC
|
0.45%
1/222 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any AE or SAE with onset or worsening after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.45%
1/222 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any AE or SAE with onset or worsening after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.45%
1/222 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any AE or SAE with onset or worsening after the first dose of study drug until 30 days after the last dose of study drug.
|
Other adverse events
| Measure |
3-DAA ± RBV
n=222 participants at risk
3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
7.2%
16/222 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any AE or SAE with onset or worsening after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
DIARRHOEA
|
8.6%
19/222 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any AE or SAE with onset or worsening after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
6.8%
15/222 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any AE or SAE with onset or worsening after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
15.3%
34/222 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any AE or SAE with onset or worsening after the first dose of study drug until 30 days after the last dose of study drug.
|
|
General disorders
ASTHENIA
|
9.0%
20/222 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any AE or SAE with onset or worsening after the first dose of study drug until 30 days after the last dose of study drug.
|
|
General disorders
FATIGUE
|
18.5%
41/222 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any AE or SAE with onset or worsening after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Nervous system disorders
HEADACHE
|
21.6%
48/222 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any AE or SAE with onset or worsening after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Psychiatric disorders
INSOMNIA
|
5.4%
12/222 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any AE or SAE with onset or worsening after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
6.3%
14/222 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any AE or SAE with onset or worsening after the first dose of study drug until 30 days after the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
14.4%
32/222 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 28 weeks).
TEAEs and TESAEs are defined as any AE or SAE with onset or worsening after the first dose of study drug until 30 days after the last dose of study drug.
|
Additional Information
Global Medical Services
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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