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®)

AbbVie41 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Hepatitis C Virus (HCV)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (5)

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

Inselspital, Universitaetsklin

Bern, Switzerland

Fondazione Epatocentro Ticino

Lugano, Switzerland

Hopital Neuchatelois

Neuchâtel, Switzerland

Outcomes

Primary Outcomes

Change From Baseline at Day 168 in Mean Daytime Physical Activity

Mean daytime physical activity for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link), which measures activity via a 3-axis algorithm. For total daytime physical activity, the measured counts of the activity tracker data minus total sleep counts were used as day-counts. Higher day-counts signify more activity.

Time frame: Baseline, Day 168

Secondary Outcomes

Change From Baseline Over Time in Mean Daytime Physical Activity

Time frame: Baseline, Days 28, 84, 168

Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score

The FSS is a 9-item questionnaire assessing the functional impact of fatigue during the past two weeks on multiple life domains using scales from 1 (strongly disagree) to 7 (strongly agree). The fatigue score is the mean score of the 9 items, with lower scores indicating less fatigue severity. Clinically significant fatigue is usually defined as score equal or above 4. Changes were calculated by the formula "Baseline minus Day 28, Day 84, or Day 168." Therefore the resulting negative values reflect deterioration and resulting positive values reflect improvement.

Time frame: Baseline, Days 28, 84, 168

Change From Baseline Over Time in Sleep Efficiency

Sleep efficiency for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link). Sleep efficiency was defined as the percent of time scored as sleep during the sleep period, from 0% to 100%. Changes were calculated by the formula "Baseline minus Day 28, Day 84, or Day 168." Therefore the resulting negative values reflect deterioration and resulting positive values reflect improvement.

Data from ClinicalTrials.gov

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