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The "China Chronic Hepatitis B Clinical Cure (Everest) Project" project is the largest public welfare health poverty alleviation project in China initiated by the China Hepatitis Prevention and Control Foundation, aiming to help more chronic hepatitis B (CHB) patients achieve clinical cure
.
At the upcoming 2022 AASLD Annual Meeting of the American Society for the Study of Liver Diseases (AASLD 2022), the 4-year phased data of this project was announced, and this article collates and reports
.
China Hepatitis B Clinical Cure (Everest) Project 4-year data update (abstract number: 25) study backgroundNucleoside
(acid) analogues (NA) treated with CHB sequentially or with peginterferon α (Peg IFNα)
are effective in improving the functional cure rate [ Hepatitis B surface antigen (HBsAg) clearance]
.
To evaluate the efficacy and safety of large-scale, real-world sequential or additive Peg IFNα treatment, as well as the predictors of HBsAg clearance based on Peg IFNα treatment
.
The "Everest" project is a multicenter, real-world study conducted in China to recruit patients
treated with NA for more than 1 year, HBV DNA < 100 IU/mL, hepatitis B e antigen (HBeAg) negative, and HBsAg ≤ 1500 IU/mL starting in 2018.
Treatment with Peg IFNα is sequentially or added for 48 or 96 weeks
at the discretion of the physician and patient.
The phased analysis included data
from patients who completed 48 weeks of treatment by April 1, 2020.
As
of April 2022, 20,693 patients have enrolled in the program (some have not yet completed treatment), and 3,472 patients have achieved functional cure
.
A total of 5648 patients were included in mITT analysis and 3988 patients were included in PP analysis in the interim analysis
.
In the PP analysis, 81% of patients were male, with a mean age of 40.
9 years and a mean baseline HBsAg level of 380.
6 IU/mL
.
HBsAg clearance at weeks 12, 24, 36 and 48 was 9.
5%, 22.
0%, 29.
0% and 33.
2%,
respectively.
Multivariate analysis showed that age, baseline HBsAg levels, 12- or 24-week HBsAg decline levels, and 12-week acute elevation in alanine aminotransferase (ALT) were predictors of HBsAg clearance at 48 weeks, but a higher correlation between 24-week HBsAg decline levels and HBsAg clearance was higher (Figure 1).
Fig.
1 Predictors
of HBsAg clearance at 48 weeks For patients with a decrease in HBsAg from baseline to 24 weeks>1 log10 IU/ml, the clearance of HBsAg at 48 weeks was 58.
6%, In patients with a decrease in HBsAg at 24 weeks≤ the clearance of HBsAg at 48 weeks was 10.
0% (p<0.
0001).
Patients with higher ALT levels (≥5×ULN) at 12 weeks had higher HBsAg clearance at 48 weeks (46.
3%)
.
A total of 1006 patients (68.
4%, 1006/1470) achieved HBsAg ≤ 100 IU/mL at 48 weeks, and these patients may achieve functional cure
after further extension of Peg IFNα therapy.
The study concludes that
patients with HBeAg-negative CHB treated with NA can achieve a good functional cure
through Peg IFNα-based treatment regimens.
Low baseline HBsAg levels, rapid decline in HBsAg levels at 24 weeks, and elevated ALT at 12 weeks were predictors
of functional cure at 48 weeks.
For patients who do not achieve HBsAg clearance after 48 weeks of treatment, there is still a good chance of functional cure
with long-term treatment.
References: Zhishuo Mo, Dongying Xie, Lei Fu, et al.
Functional cure based on pegylated interferon ɑ-2b therapy in nucleoside analog-suppressed HBeAg negative chronic hepatitis B: a multicenter real-world study (Everest Project in China)-4 years data update.
AASLD 2022.
Abrasts 25.
