Real World Study: Genotype 1 Chronic Hepatitis C Virus Treatment and Evaluation of Real World SVR and PRO

Phase 4

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: ombitasvir, paritaprevir/r, dasabuvir + ribavirin; Drug: ombitasvir, paritaprevir/r, dasabuvir

• Registration Number: NCT02461745
• Lead Sponsor: Kaiser Permanente

Brief Summary

This is a Phase IV, open-label, multi-center study to evaluate the real world sustained virological response rate, subject adherence, and subject reported outcomes during and after treatment of non-cirrhotic genotype 1 chronic hepatitis C subjects aged 18 years and older, with VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir), with or without RBV (ribavirin).

Detailed Description

This is a Phase IV, open-label, multi-center study to evaluate the real world sustained virological response rate, subject adherence, and subject reported outcomes during and after treatment of non-cirrhotic genotype 1 chronic hepatitis C subjects aged 18 years and older, with the AbbVie 3 direct-acting antiviral (3-DAA) regimen of VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir), with or without RBV (ribavirin).

Subjects may be treatment-naïve or treatment experienced with pegylated-interferon based regimens excluding regimens with direct-acting antiviral agents. The study will be conducted at multiple Kaiser Permanente Southern California Medical Centers.

The primary objective of this open label study is to evaluate the rate of sustained virological response rate 12 weeks after completion of treatment (SVR12) with VIEKIRA PAK, with or without ribavirin in a large real world setting.

Study Timeline

• Study First Submitted: 2015-05-31
• Study First Submitted QC: 2015-05-31
• Study Start: 2015-06
• Study First Posted: 2015-06-03
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Results First Submitted: 2018-07-16
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-21
• Last Update Submitted: 2021-01-21
• Results First Posted: 2021-01-22
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Genotype 1a	ombitasvir, paritaprevir/r, dasabuvir + ribavirin	Study participants with chronic Hepatitis C Genotype 1A receiving VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets) and RBV (ribavirin tablets) for 12 weeks.
Genotype 1b	ombitasvir, paritaprevir/r, dasabuvir	Study participants with chronic Hepatitis C Genotype 1B receiving VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets) for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Sustained Virological Response (SVR) at Week 12	12 weeks	Percentage of study participants achieving sustained virological response (SVR) at Week 12 per protocol among study participants who completed 12-week course of treatment.

Secondary Outcome Measures

Name	Time	Method
Sustained Virological Response (SVR) at Week 4	4 weeks	Percentage 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.

Trial Locations

Locations (1)

Kaiser Permanente Medical Center; 🇺🇸 San Marcos, California, United States