Chronic hepatitis B

Inserm – ANRS

Fabien Zoulim MD, PhD – Hospices Civils de Lyon

Chronic hepatitis B (CHB) is a major public health care issue worldwide and one of the principal causes of chronic liver disease, cirrhosis and hepatocellular carcinoma (HCC). Liver cancer is the third leading cause of cancer deaths globally, with the highest burden of disease found in regions where HBV is endemic.
New treatment options that enhance rates of HBsAg clearance with or without seroconversion are needed. Such treatments will allow patients to discontinue life-long oral antiviral therapy and provide an option for a functional cure with a finite duration of treatment.
The ANRS HB07 IP-cure-B study is a proof of concept Phase II clinical trial in HBeAg negative virally suppressed non-cirrhotic CHB patients. It will explore whether stopping NUC or stopping NUC after SLGN administration can increase the rate of HBsAg decline compared to standard of care CHB treatment. Exploratory analyses will help elucidate whether modifications in the liver immune environment are responsible for HBsAg decline.

Phase II, randomized, multicenter, open-label, exploratory study to examine in virally suppressed, non-cirrhotic HBeAg-negative CHB patients whether stopping NUC or stopping NUC after SLGN administration can increase the rate of HBsAg decline compared to standard of care CHB treatment

To study the virological efficacy, defined as ≥ 1 log10 IU/mL decline in HBsAg at 76 weeks, of both stopping NUC and stopping NUC after SLGN treatment compared to a control arm (NUC taken continuously for 76 weeks) which is defined as the standard of care for CHB treatment in HBeAg negative patients.

Percentage of subjects with ≥ 1.0 log10 IU/mL decline of HBsAg at week 76 compared to baseline

CHB virally suppressed patients

20 participants will receive pre-study NUC for 76 weeks (arm A), 40 participants will receive pre-study NUC for 28 weeks (arm B) and 40 participants will receive pre-study NUC plus Selgantolimod for 28 weeks (arm C)

100 participants

8 highly qualified Liver centres in 4 European countries: France (Lyon, Marseille, Nantes (x2), Paris), Germany (Freiburg), Italy (Milan, Parma) and Spain (Barcelona)

41 months

The IP-Cure-B project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement n°847939

Methodological aspects, trial coordination, data management, statistical analysis, monitoring coordination

https://clinicaltrials.gov/ct2/show/NCT05045261