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

NCT ID: NCT06579313

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-07-31

Brief Summary

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.

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.

Conditions

HBV; HCV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

HBV cohort

2000 HBsAg positive patients during 2016.7-2019.12

No interventions assigned to this group

HCV cohort

500 HCV Ab positive and HCV RNA positive patients during 2020.7-2023.12

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qing Xie

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Central Contacts

Honglian Gui

Role: CONTACT

lillian_ghl@163.com

+8613564725017

Other Identifiers

IN-US-987-7219

Identifier Type: -

Identifier Source: org_study_id