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

Hepatitis C, Chronic Clinical Trial

Official title:

A Phase IV, Multisite Study of the Treatment of Chronic Hepatitis C Virus Infection Genotype 1 in a Real World Large Health Maintenance Organization: An Evaluation of Real World Sustained Virological Response and Patient Reported Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461745
• Other study ID #: KPSC IRB 10568
• Status: Completed
• Phase: Phase 4
• Start date: June 2015
• Est. completion date: May 2017

Study information

• Verified date: January 2021
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria

• Male or female at least 18 years of age at time of screening.

• Subject, if female must not use estrogen-containing hormonal contraception including oral, injectable, implantable, patch and ring varieties during study drug treatment

• Subject, if male, who is not surgically sterile and is sexually active with female partner of childbearing potential must agree to practice 2 effective contraceptive methods for study duration

• Subject must have at least one of the following indicators of chronic hepatitis C virus infection prior to study enrollment: Positive anti-HCV antibody or HCV RNA > 10,000 IU/mL at least 6 months before screening, and positive for HCV RNA at the time of screening, or HCV RNA > 10,000 IU/mL at screening and liver biopsy consistent with chronic HCV infection

• Subject has a screening laboratory result indicating HCV genotype 1-infection

Key Exclusion Criteria

• Subject, if female is pregnant or is breastfeeding, of if male, with female partner who is currently pregnant

• Subject has positive test result for hepatitis B surface antigen or confirmed positive anti-HIV antibody test

• Subject received study contraindicated medications prior to study drug administration

• Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inducers of cytochrome P450 2C8 (CYP2C8) or strong inhibitors of CYP2C8 within 2 weeks of the respective medication/supplement prior to initial dose of study drug.

• Clinically significant abnormalities or co-morbidities, other than HCV infection that in opinion of the investigator makes subject unsuitable for this study or drug regimen

• Current enrollment in another interventional clinical study or prior or current use of any investigational or commercially available anti-HCV agents other than interferon or ribavirin including previous exposure to ABT450 (paritaprevir) , ABT-267 (ombitasvir) or ABT-333 (dasabuvir) or receipt of any investigational product within 6 weeks prior to study drug administration

• Prior treatment of chronic HCV infection with a direct acting antiviral agent(s):

telaprevir, boceprevir, sofosbuvir, simeprevir, or other direct acting antiviral

• History of solid organ transplant

• Evidence of cirrhosis

• History of liver decompensation: ascites noted on a physical exam, imaging or other test; variceal bleeding; hepatic encephalopathy

• Confirmed presence of hepatocellular carcinoma indicated on computed tomography, magnetic resonance, or other imaging techniques within 3 months prior to screening

• HCV genotype performed during screening indicates infection with any genotype other than genotype 1

• Recent history of drug or alcohol abuse that could, in the opinion of the investigator, affect adherence to the study protocol

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• ombitasvir, paritaprevir/r, dasabuvir + ribavirin
VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets) + RBV (ribavirin tablets) for 12 weeks
• ombitasvir, paritaprevir/r, dasabuvir
VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets)

Locations

Country	Name	City	State
United States	Kaiser Permanente Medical Center	Irvine	California
United States	Kaiser Permanente Medical Center	Los Angeles	California
United States	Kaiser Permanente Medical Center	San Diego	California
United States	Kaiser Permanente Medical Center	San Marcos	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Virological Response (SVR) at Week 12	Percentage of study participants achieving sustained virological response (SVR) at Week 12 per protocol among study participants who completed 12-week course of treatment.	12 weeks
Secondary	Sustained Virological Response (SVR) at Week 4	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.	4 weeks