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TAF effective in CHB patients with advanced fibrosis and partial response to NUCs
Researchers in Taiwan recruited 58 patients (median age, 53.5 years; male, n=29) with CHB and advanced fibrosis who were on entecavir (n=41; 70.7 percent), tenofovir disoproxil fumarate (TDF; n=13; 22.4 percent) or other NUCs (n=4; 6.9 percent) and had detectable HBV DNA for >52 weeks. The patients were switched from their original NUCs to TAF 25 mg/day and evaluated for efficacy, safety and metabolic parameters. [Yeh ML, et al, APASL 2023, abstract FP05-23]
At interim analysis, 33 patients had completed 96 weeks of TAF treatment. “TAF effectively suppressed viral replication and prevented progression of fibrosis in CHB patients with advanced fibrosis and partial virologic responses to other NUCs,” the researchers reported.
Median HBV DNA level decreased from a median of 64 IU/mL at baseline to below the lower limit of quantification (<20 IU/mL) in 78.1 percent (n=25/32) of the patients at 96 weeks, while liver stiffness decreased from 8.4 kPa at baseline to 6.2 kPa at 96 weeks. HBV surface antigen titre decreased from 1,914 IU/mL at baseline to 1,467 IU/mL at 96 weeks.
The patients’ body weight increased slightly from 62.9 kg at baseline to 63.1 kg at 96 weeks. For patients with baseline BMI >23.5 kg/m2 and those on prior TDF therapy, corresponding increases in body weight were from 70.8 kg to 74.5 kg and from 62.5 kg to 64.1 kg, respectively. “[Similar] changes in body weight were not observed in patients with baseline BMI <23.5 kg/m2 and those on prior NUCs other than TDF,” the researchers reported.
Controlled attenuation parameter (CAP) score, a measure of steatosis, increased from 242 dB/m at baseline to 257 dB/m at 96 weeks. Among patients with BMI >23.5 kg/m2 and those on prior TDF therapy, corresponding increases in CAP score were from 262 dB/m to 284 dB/m and from 232 dB/m to 246 dB/m, respectively.
Further research is needed on body weight change in patients with high BMI and on liver fat accumulation observed with TAF therapy, the researchers suggested.
Serum creatinine level and estimated glomerular filtration rate remained stable during the 96-week treatment period. Five patients terminated TAF treatment early, including three at weeks 4, 12 and 48 due to personal reasons, while two died due to acute heart attack and necrotizing faciitis. “Only mild adverse events considered unrelated to treatment were observed in the other patients,” the researchers noted.
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