Portal hypertension (PH) is one of the key drivers of clinical deteoration in patients with liver cirrhosis. It has been demonstrated that antiviral therapy in patients with chronic hepatitis C infection leads to a decrease of PH and is associated with an improved outcome. Recently, Bulevirtide was approved for the treatment of patients coinfected with hepatitis B (HBV) and chronic hepatitis delta (HDV) infection, which helps to achieve viral supression in these patients. This study investigates the potential effects of viral supression on PH in patients with chronic HBV/HDV infection and liver cirrhosis.
Study Type
OBSERVATIONAL
Enrollment
11
Patients with liver cirrhosis and HBV/HDV coinfection receive Bulevirtide as an antiviral therapy irrespective of the study, this study is observational.
Hannover Medical School
Hanover, Lower Saxony, Germany
Change the degree of portal hypertension after inducing viral suppression via antiviral treatment with Bulevirtide
Change of hepatovenous pressure gradient (HVPG) in mmHg underviral suppression with Bulevirtide in patients with HBV/HDV coinfection and liver cirrhosis. HVPG measurement will be assessed via transjugular HVPG measurement.
Time frame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Change of Quality of life under viral suppression with Bulevirtide
Change of Quality of life is assessed via SF-36 questionnaire.
Time frame: Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment.
Change in minimal hepatic encephalopathy (HE) status under viral suppression
Change in minimal HE status is evaluated via PSE-testing, critical flicker frequency and animal naming test.
Time frame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Change of nutritional status under viral suppression with Bulevirtide
Change of nutritional status will be evaluated via repeated measurement of BMI (in kg/m2), arm circumference and triceps skin fold thickness.
Time frame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Change of physical ability under viral suppression with Bulevirtide
Change of physical ability is assessed via liver-frailty Index.
Time frame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Change of the inflammatory profile under viral suppression with Bulevirtide
Change of the inflammatory profile will be assessed through Cytokines using Bio-Plex Pro Human Cytokine Screening Panel, 48-Plex, Bio-Rad, Olink Target 96 Inflammation and Olink Proteomics.
Time frame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Change in liver stiffness under viral suppression with Bulevirtide
Change in liver stiffness will be assessed via transient elastography.
Time frame: Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment with Bulevirtide.
Clinical endpoints under viral suppression with Bulevirtide
Assessed clinical endpoints are: Resolution of esophageal varices and incidence of esophageal bleeding, hepatic encephalopathy or ascites.
Time frame: Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.