Current Situation of Health Care in Women With HBV or HCV Infection

A multicenter, retrospective study conducted in male and female population infected with HBV or HCV in east China. HCV part, study will enroll 500 HCV antibody positive and HCV RNA positive patients during 2020.7-2023.12 and then observe the characteristics, duration from diagnosis to treatment, treatment rate and sustained virologic response (SVR12) among eligible female and male patients. HBV part, study will enroll 2000 HBsAg positive patients during 2016.7-2019.12 and then observe the clinical characteristics, natural history, duration from diagnosis to treatment, treatment rate and adherence among eligible female and male patients.

Study Overview

• Status: Not yet recruiting
• Conditions: HBV; HCV

Detailed Description

Some of the sociocultural factors may prevent women infected with HBV or HCV benefiting from quality health care. Limited articles have ever reported the situation of health care in women with viral hepatitis. A previous study found that low HCV knowledge was observed in females, which was related to a lower willingness to be treated for HCV. Besides that, in other disease areas like hypertension, studies found that females have less awareness of their disease but have higher control over it compared with males. These findings might reflect the differences in health literacy levels which might influence disease outcomes, healthcare-seeking and adherence to treatment. This research aims to fill the data gaps of the gender differences in cascade of care in HBV and HCV, to facilitate patient activation, especially for women.

So far, data on the current health care status in HBV-infected women is scarce. With the expansion of treatment indications recommended by China CHB guidelines, more female patients will have the opportunity to gain timely and necessary treatment. This study will analyze the cascade of care by observing the duration from diagnosis to treatment and treatment adherence for women. And this knowledge will serve as a guide for interventions for the management of viral hepatitis, as well as effectively finding and activating patients who meet treatment criteria but are not being treated.

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Honglian Gui; Phone Number: +8613564725017; Email: lillian_ghl@163.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

500 HCV Ab+ and HCV RNA + patients during 2020.7-2023.12 and 2000 HBsAg+ patients during 2016.7-2019.12

Description

Inclusion Criteria:

HBV Cohort -

• ≥18 years old
• serum HBsAg positive for >6 months
• Treatment naïve or,
• Patients who had been previously treated for HBV but discontinued for at least 1 year before enrollment

HCV Cohort -

• ≥18 years old
• HCV-Ab positive
• HCV RNA positive
• Treatment naïve or,
• Patients who had been previously treated for HCV with a regimen containing interferon and not had a sustained virologic response.

Exclusion Criteria:

• HBV/HCV Co-infection
• HIV
• History of hepatic decompensation or hepatocellular carcinoma
• Other carcinoma
• Other severe liver disease
• Severe Comorbidity like cardiovascular disease, diabetes etc.
• Patients who had discontinued previous HCV treatment because of an adverse event.
• Patients who had previously received any nucleotide analogue HCV NS5B inhibitor or any NS5A inhibitor
• Patients who had discontinued previous HBV treatment because of an adverse event.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HBV cohort; 2000 HBsAg positive patients during 2016.7-2019.12
HCV cohort; 500 HCV Ab positive and HCV RNA positive patients during 2020.7-2023.12

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Rate in male in HBV cohort	The treatment rate in male populations who meet treatment criteria recommended by China CHB guideline	from July 2020 to December 2023
Treatment Rate in female in HBV cohort	The treatment rate in female populations who meet treatment criteria recommended by China CHB guideline	from July 2020 to December 2023
Treatment Rate in male in HCV cohort	The treatment rate in male populations who meet treatment criteria recommended by China CHC guideline	from July 2016 to December 2019
Treatment Rate in female in HCV cohort	The treatment rate in female populations who meet treatment criteria recommended by China CHC guideline	from July 2016 to December 2019

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distribution of Income levels among male in HBV cohort	categorize into 3 levels - low income (less than 50,000 CNY/year), medium income (50,000-300,000 CNY/year), high income (more than 300,000 CNY/year), in male populations infected with HBV	from July 2020 to December 2023
Distribution of Income levels among female in HBV cohort	categorize into 3 levels - low income (less than 50,000 CNY/year), medium income (50,000-300,000 CNY/year), high income (more than 300,000 CNY/year), in female populations infected with HBV	from July 2020 to December 2023
Distribution of medical insurance type in male in HCV cohort	categorize into 4 types - employee medical insurance, resident medical insurance, new rural cooperative medical scheme, self-pay, in male populations infected with HCV	from July 2016 to December 2019
Distribution of medical insurance type in female in HCV cohort	categorize into 4 types - employee medical insurance, resident medical insurance, new rural cooperative medical scheme, self-pay, in male populations infected with HCV	from July 2016 to December 2019

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Qing Xie, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 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; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C
• Other Study ID Numbers: IN-US-987-7219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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