Clinical trial NCT02461745: Real World Study: Genotype 1 Chronic Hepatitis C Virus Treatment and Evaluation of Real World SVR and PRO
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Keywords: VIEKIRA PAK
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2015-06-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sustained Virological Response (SVR) at Week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Sustained Virological Response (SVR) at Week 4
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: San Marcos
country: United States
facility: Kaiser Permanente Medical Center
state: California
Study officials:
affiliation: Kaiser Permanente
name: Lisa M Nyberg, MD
role: PRINCIPAL_INVESTIGATOR
References: