HBV, HCV
Conditions
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.
Interventions
None listed
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Rate in female in HCV cohort | from July 2016 to December 2019 | The treatment rate in female populations who meet treatment criteria recommended by China CHC guideline |
| Treatment Rate in male in HBV cohort | from July 2020 to December 2023 | The treatment rate in male populations who meet treatment criteria recommended by China CHB guideline |
| Treatment Rate in female in HBV cohort | from July 2020 to December 2023 | The treatment rate in female populations who meet treatment criteria recommended by China CHB guideline |
| Treatment Rate in male in HCV cohort | from July 2016 to December 2019 | The treatment rate in male populations who meet treatment criteria recommended by China CHC guideline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of Income levels among male in HBV cohort | from July 2020 to December 2023 | 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 |
| Distribution of Income levels among female in HBV cohort | from July 2020 to December 2023 | 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 |
| Distribution of medical insurance type in male in HCV cohort | from July 2016 to December 2019 | categorize into 4 types - employee medical insurance, resident medical insurance, new rural cooperative medical scheme, self-pay, in male populations infected with HCV |
| Distribution of medical insurance type in female in HCV cohort | from July 2016 to December 2019 | categorize into 4 types - employee medical insurance, resident medical insurance, new rural cooperative medical scheme, self-pay, in male populations infected with HCV |
Contacts
Primary ContactHonglian Gui
Outcome results
None listed