A MODEL to Explore Clinical Outcomes with High Hepatitis B VIRUS Surface Antigen (HBSAG) Loss Rates in Chronic Hepatitis B (CHB)
Author(s)
Sbarigia U1, Hashim M2, Vincken T3, Heeg B4, Postma M5
1Janssen Pharmaceutica N.V, Beerse, Belgium, 2Ingress Health, Rotterdam, ZH, Netherlands, 3Ingress-health, Rotterdam, ZH, Netherlands, 4Ingress-Health, Rotterdam, ZH, Netherlands, 5University of Groningen, Groningen, Netherlands
OBJECTIVES: Sustained HBsAg loss for more than six months after stopping treatment is a proxy for functional cure (FC) in CHB and, therefore, considered as an ideal endpoint in clinical trials. However, it is rarely achieved with the current standard of care (SoC); Nucleotides Analogues may result in yearly FC of 1.8%. The potential impact of higher FC rates on disease progression is not yet quantified. Therefore, this study aimed to explore long term clinical benefits of higher FC in CHB patients. METHODS: The model structure, clinical inputs, and assumptions were adapted from a cost-effectiveness model published in the UK and used by NICE in CHB health technology assessment. The model included treatment-naïve patients without cirrhosis, both HBeAg-positive, and HBeAg-negative at baseline. We assessed the impact of different FC rates (30%, 40%, and 50%) on the Number Needed to Treat (NNT) to prevent one additional event, i.e. compensated cirrhosis (CC), decompensated cirrhosis (DC), and hepatocellular carcinoma (HCC). RESULTS: The NNTs to prevent one additional case of CC/DC/HCC versus SoC for HBeAg-positive patients were 22/59/34, 17/45/26, and 13/34/21, with yearly FC rates of 30%, 40%, and 50% respectively. For HBeAg-negative patients, the corresponding NNTs were 16/43/33, 12/33/25 and 9/26/19, with yearly FC rates of 30%, 40%, and 50% respectively. CONCLUSIONS: Increasing FC rates would be highly beneficial for CHB patients, further reducing the risk of developing CC, DC, and HCC versus current SoC. Further research is warranted to characterize better the impact of HBsAg loss and FC on liver disease progression, overall survival, and health-related quality of life of CHB patients.
Conference/Value in Health Info
2020-11, ISPOR Europe 2020, Milan, Italy
Value in Health, Volume 23, Issue S2 (December 2020)
Code
PIN52
Topic
Economic Evaluation, Methodological & Statistical Research
Topic Subcategory
Thresholds & Opportunity Cost, Value of Information
Disease
Infectious Disease (non-vaccine)