Laboratory Profile of Hepatitis B and C in Users of a Reference Service

This study has been completed.
Sponsor:
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT00512941
First received: August 6, 2007
Last updated: September 4, 2008
Last verified: September 2008
  Purpose

Chronic hepatitis by the B virus (HBV) and/or by the C virus (HCV) is a major public-health problem since it presents a long phase of clinical latency which makes its early diagnosis difficult and results in the development of a large number of cases to complications such as cirrhosis, hepatic insufficiency and hepatocarcinoma. In Brazil, it is estimated that the number of HBV is two million, of which 72 thousand have been reported. As regards HCV, the ratio is one of three million estimated cases to 52 thousand reports. Learning about the serological profile of the users of a viral hepatitis reference service is fundamental for the planning of diagnostic and caregiving actions; therefore, it is the objective of this study.


Condition
Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted
Hepatitis B, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Laboratory Profile of Hepatitis B and C in Users of a Reference Service

Resource links provided by NLM:


Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Enrollment: 531
Study Start Date: June 2007
Study Completion Date: August 2007
Groups/Cohorts
1
HBV: Carrier
2
HBV: cure
3
HBV: isolate anti-HBc
4
HBV: vaccinated
5
HCV: anti-HCV positive test
6
HBV/HCV co-infection
7
Susceptible individuals

Detailed Description:

Chronic hepatitis by virus B (HVB) and/or by virus C (HVC) is a major public-health problem since it presents a long phase of clinical latency which makes its early diagnosis difficult and results in the development of a large number of cases to complications such as cirrhosis, hepatic insufficiency and hepatocarcinoma. In Brazil, it is estimated that the number of HVB patients is two million, but only 72 thousand have been reported. As regards HVC, the ratio is three million estimated cases to 52 thousand reports. Learning about the serological profile of the users of a viral hepatitis reference service is essential for the planning of diagnostic and therapeutic actions; therefore, it is the objective of this study.

Five hundred and thirty-one HVB and HVC serological profiles of the patients referred to SAE/HD within a period of 18 months (January 2006 to June 2007) were studied by means of retrospective analysis. The patients were classified as: a) HBV: carrier, cure, isolated anti-HBc and vaccinated; b) HVC: reagent anti-HVC; c) HBV/HVC co-infection: AgHBs and reagent anti-HVC; and d) Susceptible: non-reagent serology.

As regards HBV, the following were found from the total number of patients: carriers, 12.6%; cure, 18.9%; isolated anti-HBc, 9.0% and vaccinated, 6.2%. The patients with reagent anti-HVC comprised 31.3% of the total number of individuals. HBV/HCV co-infection was 0.6%. Susceptible individuals comprised 20.5%.

It was concluded that approximately 45% of the referred patients carried chronic infection by B and/or C virus, a condition which requires additional investigation and, in many instances, specific treatment. Strategies for early diagnosis are essential in order to prevent the intrinsic complications of such condition.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with laboratory tests positive for hepatitis B and/or C

Criteria

Inclusion Criteria:

  • Patients with laboratory tests positive for hepatitis B and/or C

Exclusion Criteria:

  • No laboratory tests available
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512941

Locations
Brazil
SAE e Hospital Dia de Aids
Botucatu, Sao Paulo, Brazil, 18618970
SAE e Hospital Dia
Botucatu, Sao Paulo, Brazil, 18618970
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Investigators
Principal Investigator: Alexandre N Barbosa, MD, MSc SAE e Hospital Dia de Aids
  More Information

No publications provided

Responsible Party: Sergio Muller, Faculdade de Medicina de Botucatu - Unesp
ClinicalTrials.gov Identifier: NCT00512941     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-15
Study First Received: August 6, 2007
Last Updated: September 4, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic

ClinicalTrials.gov processed this record on April 17, 2014