Recently, the 33rd Annual Meeting of the Asian Pacific Association for the Study of the Liver (APASL 2024) was convened in Kyoto, Japan, at which four research results on Hansoh Pharma's Tenofovir Amibufenamide Tablets, China’s first independently developed oral antiviral drug for hepatitis B, were showcased in the form of oral reports and posters.

At APASL 2024, experts and scholars from around the world were summoned to discuss the most cutting-edge progress in basic and clinical research on liver diseases, and Chinese scholars gave reports on the latest developments in hepatitis B treatments in China.

Four research results on the new generation of tenofovir —Tenofovir Amibufenamide Tablets (TMF, trade name: Hengmu), were released. These included results on TMF in hepatitis B patients with hypoviremia, TMF in newly-treated patients with a high viral load, TMF used in combination treatment with long-acting interferons, and the effects of TMF on lipid metabolism, all of which are a testament to the safety and efficacy of Tenofovir Amibufenamide Tablets in various application scenarios in the real world. Related abstracts from APASL 2024 are as follows:

Abstract 1

Switching to TMF is effective for ETV or TAF monotherapy in patients with hypoviremia

Form: Oral Free Paper; No. O-0142

Author: En-Qiang Chen, West China Hospital, Sichuan University

Method: This is a retrospective study targeting 73 CHB patients from West China Hospital, Sichuan University treated with ETV or TAF monotherapy for more than 1 year, but with serum HBV DNA consistently fluctuating between 20 and 2000IU/mL (hypoviremia). All enrolled patients voluntarily switched to TMF for further antiviral treatment and completed comprehensive examinations at least once every 6 months. The primary outcome measure was the undetectable rate of HBV DNA after 6 and 12 months of TMF treatment.

Result:

●After switching to TMF treatment for 6 months and 12 months, 69.9% (51/73) and 74.0% (54/73) of patients achieved HBV DNA<20 IU/mL, respectively.

●Compared to HBeAg-positive patients, HBeAg-negative patients switching to TMF treatment can achieve a higher proportion of complete virological response (19/33 vs. 32/40, P=0.038; 18/33 vs. 36/40, P<0.001).

●After 12 months of treatment, the abnormal rate of urinary β2 microglobulin was 16.4% (12/73), and the proportion of urinary β2 microglobulin increasing by three times the upper limit of normal value was 6.8%. The proportion of blood phosphorus below the lower limit of normal value is 19.2% (14/73). Although the levels of total cholesterol and low-density lipoprotein cholesterol increased, compared to before treatment, the differences were not statistically significant.

Conclusion: CHB Patients treated with ETV or TAF experience hypoviremia, switching to TMF can help most patients achieve a complete virological response rate, with good patient tolerance.

Abstract 2

48 weeks of initial treatment with TMF versus TAF for patients with CHB: a retrospective study

Form: Poster free paper; No. P-1023

Author: Lu Junfeng, Beijing You’an Hospital, Capital Medical University

Method: Clinical data of high viral load CHB patients who received initial antiviral treatment with TMF (n=58) or TAF (n=32) monotherapy in the outpatient department of Beijing You’an Hospital from March 2022 to June 2022 was collected retrospectively and the efficacy and safety of antiviral therapy for 48 weeks between two groups were compared.

Result:

●Compared with the baseline, the decrease in HBV DNA levels between the TMF group and the TAF group after 4 weeks, 12 weeks, 24 weeks, and 48 weeks of antiviral treatment had no significant statistical difference.

●The HBV DNA clearance rates (<10IU/ml) of the TMF and TAF treatment for 48 week were 41.5% (22/53) and 40.0% (12/30) respectively.

●The baseline median ALT levels in the TMF and TAF treatment groups were 102.0 U/L (56.0 U/L, 210 U/L) and 195.0 U/L (73.5 U/L, 371.0 U/L), respectively (P=0.071). The normalization rates of ALT at 12 weeks, 24weeks and 48 weeks were higher in TMF treatment group than in TAF treatment group

●Compared with baseline, there was no significant statistical difference in serum Cr, eGFR, and lipid levels between the two groups at 24 and 48 weeks (P <0.05).

Conclusion: Both TMF and TAF can achieve good antiviral efficacy and safety in newly treated CHB patients with high viral load.

Abstract 3

Efficacy of TMF combined with Peg-IFN for treatment-naive chronic hepatitis B: a real world study

Form: Poster free paper; No.: P-0121

Author: Jiaquan Huang, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Method: 251 treatment-naive patients with chronic hepatitis B from Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology received NAs and Peg-IFN for at least 24 weeks. The primary endpoint was HBsAg clearance at 24 and 48 weeks to compare the efficacy of different NA+ Peg-IFN regimens.

Result: Among the 251 participants, 60 achieved HBsAg clearance at 24 weeks, and 114 achieved HBsAg clearance at 48 weeks. The type of NA medication did not significantly affect clearance rates at 24 weeks (P=0.315) and 48 weeks (P=0.439) after adjusting for age, gender, and baseline HBsAg levels.

Conclusion: TMF, TDF, and ETV combined with Peg-IFN show comparable efficacy in achieving HBsAg clearance in treatment-naive patients with chronic hepatitis B.

Abstract 4

The effect of Tenofovir Amibufenamide on lipid metabolism

Form: Oral free paper; No. P-0177

Author: En-Qiang Chen, West China Hospital, Sichuan University

Method: 109 CHB patients treated with TMF monotherapy for more than 1 year were screened, and the blood lipid metabolism related indicators were quantitative tested before and after TMF treatment to evaluate the effect of TMF on lipid metabolism. The peripheral blood cholesterol,

triglycerides, high-density lipoprotein(HDL), very low-density lipo-protein(VLDL) and ApoB levels of these patients were within the normal range before receiving TMF treatment.

Result: After more than 1 year of TMF treatment, 28.4% (31/109) of patients had triglyceride levels exceeding the upper limit of normal(ULN), with 67.7% (21/31) of patients having an increase of no more than 30% of ULN ; 15.6% (17/109) of patients had total cholesterol levels exceeding the ULN, with 52.% (9/17) of patients having an increase of no more than 30% of ULN; 11% (12/109) of patients had VLDL levels exceeding the ULN, with 66.6% (8/12) of patients having an increase of no more than 30% of ULN. In this group of cases, 14.7% (16/109) of patients had HDL levels exceeding the ULN. There was no significant difference in the average level of ApoB between before and after TMF treatment, but approximately 11% (12/109) of patients had peripheral blood ApoB slightly exceeding the ULN after 1 year of TMF treatment.

Conclusion: Patients treated with TMF can experience slight abnormalities in some blood lipid indicators, but the clinical significance is not yet clear.