Prevalence and Clinical Characterization of Hepatitis D Virus (HDV) Infection Among Sudanese Patients With Hepatitis B Virus

Prevalence and Clinical Characterization of Hepatitis D Virus (HDV) Infection Among Sudanese Patients With Hepatitis B Virus (HBV), A Cross-Sectional Study

Background: Sudan has a high prevalence of hepatitis B surface antigen (HBsAg), exceeding 8%. The prevalence of hepatitis B varies across different regions of Sudan, ranging from 6.8% in central Sudan to as high as 26% in southern Sudan. Hepatitis B virus (HBV) infection can lead to various complications, including cirrhosis, liver failure, and hepatocellular carcinoma (HCC). Hepatitis D virus (HDV) relies on HBV for replication and can accelerate the progression of HBV-related liver diseases, leading to more severe outcomes. This study aims to determine the prevalence of HDV infection among Sudanese patients with HBV-related liver diseases and to investigate the clinical characteristics of patients with HBV/HDV co-infection.

Design/Method: This descriptive cross-sectional hospital-based study was conducted at Ibn Sina Specialized Hospital in Sudan between June and September 2022. Ninety HBV patients aged 16 years and above were included. Patients were interviewed using a structured questionnaire, and medical histories and examinations were recorded. Investigations included liver function tests, abdominal ultrasounds, and ELISA for Ant-HDV-IgG

Study Overview

• Status: Completed
• Conditions: Hepatitis B; Hepatitis D; Viral Hepatitis
• Intervention / Treatment: Diagnostic test: investigations for Hepatitis D virus

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Sudan
  • Khartoum, Sudan, 15004
    • National Center for Gastrointestinal And Liver Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study was conducted between June and September 2022, involving patients aged 16 years and above with hepatitis B virus infection. Patients attending the liver clinic or admitted at Ibn Sina Specialized Hospital were included, while those with HIV and HCV co-infection were excluded.

Description

Inclusion Criteria:

• patients aged 16 years and above
• with hepatitis B virus infection

Exclusion Criteria:

• patients with HIV or HCV co-infection

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the prevalence of hepatitis D infection among Sudanese patients with HBV-related liver diseases.	to ascertain the prevalence of hepatitis D infection among Sudanese patients with HBV-related liver diseases.	June 2022 - September 2022

Collaborators and Investigators

• Sponsor: National Center for Gastroentestinal and Liver Disease

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 10, 2022

Study Registration Dates

• First Submitted: April 7, 2024
• First Submitted That Met QC Criteria: April 7, 2024
• First Posted (Actual): April 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 7, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis D
• Other Study ID Numbers: PrevelanceHDVSudan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No