The purpose of the study is to describe: 1) the clinical profile, past and current management of participants with hepatitis C in Brazil reference centers; 2) the current situation about demographics characteristics, liver disease progression and clinical outcomes in Brazilian Hepatitis C virus (HCV) participants naive, in treatment and previously exposed to antiviral treatment without sustained virological response (SVR).
This is an observational, non-interventional, cross-sectional, multicenter study to describe demographic characteristics, treatment performed and clinical outcomes of Brazilian participants with HCV chronic infection in about 12 Brazilian reference centers. It will expect that approximately 2000 participants will be enrolled in the study. Analysis set will consist of participants with HCV chronic infection who are registered at the Brazilian reference centers and meet all the inclusion criteria and have sufficient information to identify the diagnosis of chronic HCV infection with identification of genotype. The study related data will be collected from the medical records in the predesigned electronic Case Report Form (eCRF).
Study Type
OBSERVATIONAL
Enrollment
1,649
Unnamed facility
Goiânia, Brazil
Unnamed facility
Porto Alegre, Brazil
Unnamed facility
Porto Velho, Brazil
Unnamed facility
Recife, Brazil
Unnamed facility
Number of participants with chronic hepatitis C infection
Data will be collected through medical records of the participants.
Time frame: Day 1
Date of last visit
Time frame: Day 1
Number of Participants with chronic hepatitis C infection Reported Based on City and States
Data will be collected through medical records of the participants.
Time frame: Day 1
Number of Participants with chronic hepatitis C infection Based on precedence
Data will be collected through medical records of the participants.
Time frame: Day 1
Mean Age of Participants with chronic hepatitis C infection
Data will be collected through medical records of the participants.
Time frame: Day 1
Number of Males and Females with chronic hepatitis C infection
Data will be collected through medical records of the participants.
Time frame: Day 1
Number of participants with chronic hepatitis C infection Reported Based on Race
Data will be collected through medical records of the participants.
Time frame: Day 1
Mode of Hepatitis C virus (HCV) transmission
Data will be collected through medical records of the participants. Mode of HCV transmission route (unsafe injections, hemodialysis, infection drug use, blood transfusion, sexual transmission, vertical transmission, unknown, other) will be analysed by number of participants infected with HCV per transmission route.
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Rio Branco, Brazil
Unnamed facility
Rio de Janeiro, Brazil
Unnamed facility
Salvador, Brazil
Unnamed facility
São Paulo, Brazil
Time frame: Day 1
Duration of diagnosis of chronic hepatitis C infection
Data will be collected through medical records of the participants.
Time frame: Day 1
HCV genotype and subtype
Data will be collected through medical records of the participants.
Time frame: Day 1
Liver characteristics: Number of Participants with extra hepatic manifestations
Data will be collected through medical records of the participants. Presence or absence of extra hepatic manifestations (cryoglobulinemia, lymphoma, Sjogren syndrome, glomerulopathy, Porphyria cutanea tarda, liquen planus, diabetes mellitus, thyroiditis, arthralgia).
Time frame: Day 1
Liver characteristics: Number of Participants with presence of comorbidities
Data will be collected through medical records of the participants. Presence of comorbidities (amount of alcohol ingestion, metabolic syndrome, hepatocellular carcinoma, organ transplantation, diabetes, immunodeficiency, renal insufficiency and dialysis, use of drugs) will be collected.
Time frame: Day 1
Liver characteristics: Model for End-Stage Liver Disease (MELD) Score and Child Pugh score
MELD is a scoring system for assessing the severity of chronic liver disease. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).
Time frame: Day 1
Liver characteristics: Number of Participants with Fibrosis based on Fibroscan
Data will be collected through medical records of the participants.
Time frame: Day 1
Number of Participants with Coinfections
Data will be collected through medical records of the participants.
Time frame: Day 1
HCV treatment status on Day 1: Percentage of participants receiving antiviral treatment
Data will be collected through medical records of the participants.
Time frame: Day 1
HCV treatment status on Day 1: Causes of interruption in treatment
Data will be collected through medical records of the participants. Causes of interruption to antiviral therapy will be collected and reported.
Time frame: Day 1
HCV treatment status on Day 1: Number of participants treated without Sustained Virological Response (SVR)
Data will be collected through medical records of the participants.
Time frame: Day 1
Treatment regimen
The drugs used and time of treatment will be collected through medical records of the participants.
Time frame: Day 1
Number of participants with Adverse Events (AEs)
Time frame: Day 1