Clinical trial NCT06579313: Current Situation of Health Care in Women With HBV or HCV Infection
Official title: Current Situation of Health Care in Women With HBV or HCV Infection
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HBV
HCV
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.

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.

Primary outcomes:
measure: Treatment Rate in male in HBV cohort
timeFrame: from July 2020 to December 2023
measure: Treatment Rate in female in HBV cohort
timeFrame: from July 2020 to December 2023
measure: Treatment Rate in male in HCV cohort
timeFrame: from July 2016 to December 2019
measure: Treatment Rate in female in HCV cohort
timeFrame: from July 2016 to December 2019
Secondary outcomes:
measure: Distribution of Income levels among male in HBV cohort
timeFrame: from July 2020 to December 2023
measure: Distribution of Income levels among female in HBV cohort
timeFrame: from July 2020 to December 2023
measure: Distribution of medical insurance type in male in HCV cohort
timeFrame: from July 2016 to December 2019
measure: Distribution of medical insurance type in female in HCV cohort
timeFrame: from July 2016 to December 2019
Other outcomes:
Locations:
Study officials:
affiliation: Ruijin Hospital
name: Qing Xie
role: PRINCIPAL_INVESTIGATOR
References: