Trial Outcomes & Findings for Real World Study: Genotype 1 Chronic Hepatitis C Virus Treatment and Evaluation of Real World SVR and PRO (NCT NCT02461745)
NCT ID: NCT02461745
Last Updated: 2021-01-22
Results Overview
Percentage of study participants achieving sustained virological response (SVR) at Week 12 per protocol among study participants who completed 12-week course of treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
200 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-01-22
Participant Flow
Recruitment period started in June 2015 until October 2016 at four (4) different Kaiser Permanente Southern California medical clinics.
228 study participants screened for the study had 28 days from signing the study consent form to their first dose of study drug to confirm their eligibility to continue with the study. The screening period was also used as a wash-out period for concomitant medications that may interact with the study drug.
Participant milestones
| Measure |
Genotype 1a
Study participants with chronic Hepatitis C Genotype 1a receiving VIEKIRA PAK and Ribavirin for 12 weeks.
|
Genotype 1b
Study participants with chronic Hepatitis C Genotype 1b receiving VIEKIRA PAK for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
70
|
|
Overall Study
COMPLETED
|
116
|
66
|
|
Overall Study
NOT COMPLETED
|
14
|
4
|
Reasons for withdrawal
| Measure |
Genotype 1a
Study participants with chronic Hepatitis C Genotype 1a receiving VIEKIRA PAK and Ribavirin for 12 weeks.
|
Genotype 1b
Study participants with chronic Hepatitis C Genotype 1b receiving VIEKIRA PAK for 12 weeks.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
9
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
Baseline Characteristics
Real World Study: Genotype 1 Chronic Hepatitis C Virus Treatment and Evaluation of Real World SVR and PRO
Baseline characteristics by cohort
| Measure |
Genotype 1a
n=130 Participants
Study participants with chronic Hepatitis C Genotype 1a receiving VIEKIRA PAK and Ribavirin for 12 weeks.
|
Genotype 1b
n=70 Participants
Study participants with chronic Hepatitis C Genotype 1b receiving VIEKIRA PAK for 12 weeks.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.64 years
n=99 Participants
|
60.87 years
n=107 Participants
|
58.12 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
120 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
121 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
177 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
130 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
200 Participants
n=206 Participants
|
|
Baseline HCV RNA
<800,000 IU/mL
|
27 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Baseline HCV RNA
Between 800,000 - 6 million
|
74 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Baseline HCV RNA
>6 million
|
29 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Treatment-experience
Experienced
|
22 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Treatment-experience
Naive
|
108 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPercentage of study participants achieving sustained virological response (SVR) at Week 12 per protocol among study participants who completed 12-week course of treatment.
Outcome measures
| Measure |
Genotype 1a
n=123 Participants
Study participants with chronic Hepatitis C Genotype 1a receiving VIEKIRA PAK and Ribavirin for 12 weeks.
|
Genotype 1b
n=67 Participants
Study participants with chronic Hepatitis C Genotype 1b receiving VIEKIRA PAK for 12 weeks.
|
|---|---|---|
|
Sustained Virological Response (SVR) at Week 12
|
116 Participants
|
66 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPercentage of study participants achieving sustained virological response (SVR) at Week 4 per protocol among subjects who completed 12-week course of treatment in the study.
Outcome measures
| Measure |
Genotype 1a
n=122 Participants
Study participants with chronic Hepatitis C Genotype 1a receiving VIEKIRA PAK and Ribavirin for 12 weeks.
|
Genotype 1b
n=66 Participants
Study participants with chronic Hepatitis C Genotype 1b receiving VIEKIRA PAK for 12 weeks.
|
|---|---|---|
|
Sustained Virological Response (SVR) at Week 4
|
116 Participants
|
65 Participants
|
Adverse Events
Genotype 1a
Serious events: 4 serious events
Other events: 102 other events
Deaths: 0 deaths
Genotype 1b
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Genotype 1a
n=130 participants at risk
Study participants with chronic Hepatitis C Genotype 1a receiving VIEKIRA PAK and Ribavirin for 12 weeks.
|
Genotype 1b
n=70 participants at risk
Study participants with chronic Hepatitis C Genotype 1b receiving VIEKIRA PAK for 12 weeks.
|
|---|---|---|
|
Cardiac disorders
Acute Congestive Heart Failure
|
0.77%
1/130 • Number of events 1 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
0.00%
0/70 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
|
Gastrointestinal disorders
Acute Pancreatitis
|
0.00%
0/130 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
1.4%
1/70 • Number of events 1 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
|
Psychiatric disorders
Acute Psychosis
|
0.77%
1/130 • Number of events 1 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
0.00%
0/70 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
|
Infections and infestations
Cellulitis/ Sepsis
|
0.77%
1/130 • Number of events 1 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
0.00%
0/70 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
|
Nervous system disorders
Guillain Barre Syndrome
|
0.77%
1/130 • Number of events 1 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
0.00%
0/70 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
|
Skin and subcutaneous tissue disorders
Small Cell Carcinoma
|
0.00%
0/130 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
1.4%
1/70 • Number of events 1 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
|
Renal and urinary disorders
Urothelial Carcinoma
|
0.00%
0/130 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
1.4%
1/70 • Number of events 1 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
Other adverse events
| Measure |
Genotype 1a
n=130 participants at risk
Study participants with chronic Hepatitis C Genotype 1a receiving VIEKIRA PAK and Ribavirin for 12 weeks.
|
Genotype 1b
n=70 participants at risk
Study participants with chronic Hepatitis C Genotype 1b receiving VIEKIRA PAK for 12 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fatigue
|
26.9%
35/130 • Number of events 35 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
14.3%
10/70 • Number of events 10 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
|
Gastrointestinal disorders
Nausea
|
15.4%
20/130 • Number of events 20 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
5.7%
4/70 • Number of events 4 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
|
Nervous system disorders
Headache
|
12.3%
16/130 • Number of events 16 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
7.1%
5/70 • Number of events 5 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
|
Nervous system disorders
Insomnia
|
10.0%
13/130 • Number of events 13 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
1.4%
1/70 • Number of events 1 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
5/130 • Number of events 5 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
5.7%
4/70 • Number of events 4 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
7/130 • Number of events 7 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
4.3%
3/70 • Number of events 3 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.6%
6/130 • Number of events 6 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
4.3%
3/70 • Number of events 3 • Adverse events are collected from enrolled study participants during the treatment period (12 weeks) through an additional 12 weeks post treatment. For enrolled study participants that discontinued from the study, adverse events are collected during the treatment period until their last completed study visit.
Adverse events reported in the table below are those that are considered possibly or definitely related to the VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir) and/or RBV (ribavirin tablets). Although adverse events data was collected from all subjects who receive at least one dose of the study drug regardless of their relationship to either VIEKIRA PARK and/or RBV, the analysis of the safety data was focused on those that are treatment-related, which is provided below.
|
Additional Information
Division of Clinical Trials Research
Southern California Permanente Medical Group
Phone: (626) 564-5667
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60