N/A
Completed N=41
Quality of Life Measurement in Treatment Naïve Patients With Hepatitis C Virus (HCV) Genotype 1 (GT1) Suffering From Fatigue and Receiving Ombitasvir, Paritaprevir, and Ritonavir and Dasabuvir (Viekirax®/Exviera®)
Chronic Hepatitis C Virus (HCV)
Source: ClinicalTrials.gov NCT03002818 ↗
Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Change From Baseline at Day 168 in Mean Daytime Physical Activity — -108266; -98373 day-counts — p=0.091
Summary
This is an observational, prospective, open-label, single-arm, multicenter, real-life study designed to observe the impact of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (Viekirax®/Exviera®, 3D regimen) on total daytime physical activity and fatigue in participants with HCV GT1.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at Day 168 in Mean Daytime Physical Activity |
-108266; -98373 | 0.091 |
| SECONDARY Change From Baseline Over Time in Mean Daytime Physical Activity |
26990; 21422; -6448; -13020; -108266; -98373 | 0.461 |
| SECONDARY Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score |
0.69; 0.85; 1.68; 1.76; 2.60; 2.82 | <0.001 sig |
| SECONDARY Change From Baseline Over Time in Sleep Efficiency |
-0.87; -0.44; -0.06; 0.01; 0.61; 0.74 | 0.381 |
| SECONDARY Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population |
0.300; 0.131; -0.022; 0.195 | — |
| SECONDARY Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population |
0.253; 0.386; -0.058; 0.128 | — |
| SECONDARY Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: sdITT Population |
0.228; -0.044; 0.195 | — |
| SECONDARY Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: mITT Population |
0.135; -0.065; 0.169 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-Treatment |
97.6; 97.3; 95.8 | — |
Eligibility Criteria
Inclusion Criteria
- Treatment-naïve participants
- Mono-infected participants with chronic HCV GT1
- Non-cirrhotic participants
- Participants with debilitating fatigue (Fatigue Severity Scale [FSS] greater than or equal to 4)
Exclusion Criteria
- Participants with sources of fatigue other than HCV (especially, severe depression, cancer and hormonal disorders causing clinically significant fatigue)
- Participants with conditions that do not allow to adhere to protocol and use of the device at investigator's discretion
- Participants who are wheelchair dependent
Data sourced from ClinicalTrials.gov (NCT03002818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.