A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil

AbbVie222 enrolled

Overview

The purpose of this study is to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with 3 direct-acting antiviral agents (3-DAAs; ombitasvir/paritaprevir/ritonavir and dasabuvir) with or without ribavirin.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

222

Conditions

Chronic Hepatitis C Infection

Interventions

ombitasvir/paritaprevir/ritonavir and dasabuvirDRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

ribavirinDRUG

Tablet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control * Males must be surgically sterile or agree to practice acceptable forms of birth control * Chronic hepatitis C virus (HCV) infection at screening * Fibrosis stage F3 or greater, documented by acceptable tests * Participants with cirrhosis: Absence of hepatocellular carcinoma (HCC) as indicated by acceptable methods Exclusion Criteria: * Women who are pregnant or breastfeeding * Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibody positive (HIV Ab) * Use of contraindicated medications within 2 weeks of dosing * Clinically significant abnormalities or co-morbidities * History of solid organ transplant * Abnormal laboratory tests * Current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification \[\<LLOQ\]) 12 weeks after the last dose of study drug. Participants with missing data were counted as failures.

Time frame: 12 weeks after the last actual dose of study drug

Secondary Outcomes

Percentage of Participants With SVR12 by Fibrosis Stage

SVR12 was defined as plasma HCV RNA level \<LLOQ\]12 weeks after the last dose of study drug. The percentage of participants achieving SVR12 by fibrosis stage (F3 and F4) are presented. Participants with missing data were counted as failures.

Time frame: 12 weeks after the last actual dose of study drug

Percentage of Participants With SVR12 by Participant Prior HCV Treatment Experience

SVR12 was defined as HCV RNA level \<LLOQ 12 weeks after the last dose of study drug. Data are presented by prior HCV treatment experience. Data are provided by participants' prior HCV treatment experience at screening. Participants with missing data were counted as failures.

Time frame: 12 weeks after the last actual dose of study drug

Percentage of Participants With SVR12 by Participant Eligibility for Treatment With Interferon (IFN) at Screening

SVR12 was defined as HCV RNA level \<LLOQ 12 weeks after the last dose of study drug. Data are presented by prior HCV treatment experience. Data are provided by participants' eligibility for treatment with IFN at screening. Participants with missing data were counted as failures.

Time frame: 12 weeks after the last actual dose of study drug

Hepatitis C Virus Patient-Reported Outcomes Instrument (HCV-PRO) Total Score: Change From Baseline to 12 Weeks After the Last Dose of Study Drug

Data from ClinicalTrials.gov

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Short-Form 36 Version 2 Health Survey (SF-36v2) Physical Component Summary (PCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug

The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening. If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain. In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing. The SF-36v2 MCS and PCS scores were not computed if any domain

Time frame: Day 1 (Baseline), 12 weeks after the last actual dose of the study drug

(SF-36v2) Mental Component Summary (MCS) Scores: Change From Baseline to 12 Weeks After the Last Dose of Study Drug

The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a PCS score and a MCS score. Scores SF-36v2 scores range from 1-100: higher scores indicate a better state of health and a decrease from baseline represents worsening. If a participant answered at least 50% of the items in a multi-item scale of the SF-36v2, the missing items were imputed with the average score of the answered items in the same domain. In cases where the participant did not answer at least 50% of the items, the score for that domain was considered missing. The SF-36v2 MCS and PCS scores were not computed if any domain was missing.

Time frame: Day 1 (Baseline), 12 weeks after the last actual dose of the study drug