What is the efficacy and safety of TAF in the treatment of patients with decompensated chronic hepatitis B cirrhosis? Real-world research

Previous clinical trials and real-world studies have found tenofovir alafenamide (TAF) propofovate (TAF) to show good efficacy and safety in
patients with chronic hepatitis B (CHB).
However, few studies have evaluated the role of
TAF in people with decompensated CHB cirrhosis.

At the 2022 American Association for the Study of Liver Diseases (AASLD 2022), a real-world study conducted by Chinese scholars was announced to evaluate the efficacy and safety
of TAF in the treatment of patients with decompensated CHB cirrhosis.

Efficacy and safety of TAF in patients with decompensated CHB cirrhosis: a real-world study in China

(Abstract Number: 1143)

Research methods

This is a multicenter, retrospective, and prospective study of 100 patients
with decompensated CHB cirrhosis who received real-world treatment with TAF 25 mg once daily.
Follow-up is planned for at least 48 weeks
.
The interim analysis included data
from patients who completed 12 weeks follow-up.

The primary endpoint of the interim analysis was the proportion of patients with undetectable HBV DNA (<20 IU/mL) at week 12 of
treatment.
Other endpoints included normal (40 U/L) rate of alanine aminotransferase (ALT), HBV DNA levels, Child-Turcotte-Pugh (CTP grade), and model for end-stage liver disease (MELD) scores from
baseline.

In addition, the investigators analyzed safety features such as drug-related adverse events (AEs) or serious adverse events (SAEs), clinical outcomes (such as liver transplantation or hepatocellular carcinoma (HCC) or death), renal function, and lipid parameters
.

Study results

This study enrolled 34 patients with decompensated CHB cirrhosis by May 20, 2022 and included them in the interim analysis
.
Among them, 73.
5% (n=25) were male, and the mean age was 52.
03±8.
94 years
.
The average HBV DNA and ALT at baseline were 2.
887 log₁₀IU/mL and 72.
659 U/L
, respectively.
Twenty-five patients (73.
5%) had CTP grade
B or C at baseline.
Eighteen patients completed 12 weeks of follow-up, and 14 patients had HBV DNA test results
.

After 12 weeks of TAF treatment, the proportion of patients with undetectable HBV DNA was 78.
6% (11/14), higher than 59.
4% (19/32) at baseline; The normal rate of ALT was 72.
2% (13/18), higher than the baseline 64.
7% (22/32).

Eleven out of 18 patients had their CTP grade recalculated at week 12, 3 of them changed from CTP C to CTP A (n=1) or CTP B (n=2), 7 patients had the same CTP grade, and only 1 patient progressed from CTP B to CTP C
.
Eleven patients had their MELD scores recalculated at week 12, and all patient scores remained the same
.

No drug-related AEs or SAEs were observed during follow-up, nor were liver transplantation, HCC, or death
observed.
During the 12-week treatment, renal function (eg, serum creatinine (Scr) and β2 microglobulin (β2-MG) levels) and lipids remained stable
.

Conclusion of the study

This analysis showed that TAF was effective in the treatment of patients with decompensated CHB cirrhosis and had good safety characteristics
.

References: Guo F, Ning Z, Wang X, et al.
Effectiveness and safety of tenofovir alafenamide for chronic hepatitis B patients with decompensated cirrhosis: a real-world study in China.
AASLD 2022.
Abrasts 1143.