RT Journal Article
SR Electronic
T1 IDDF2024-ABS-0205 Impact of long-term treatment with continuous tenofovir alafenamide (TAF) or after switch from tenofovir disoproxil fumarate (TDF) on hepatocellular carcinoma (HCC) incidence in patients with chronic hepatitis B (CHB)
JF Gut
JO Gut
FD BMJ Publishing Group Ltd and British Society of Gastroenterology
SP A256
OP A257
DO 10.1136/gutjnl-2024-IDDF.189
VO 73
IS Suppl 2
A1 Lim, Young-Suk
A1 Wong, Grace
A1 Ahn, Sang Hoon
A1 Seto, Wai Kay
A1 Agarwal, Kosh
A1 Janssen, Harry
A1 Pan, Calvin
A1 Chuang, Wan Long
A1 Fung, Scott
A1 Shalimar, Dr
A1 Brunetto, Maurizia
A1 Hui, Aric Josun
A1 Chang, Ting-Tsung
A1 Lim, Seng Gee
A1 Abramov, Frida
A1 Flaherty, John
A1 Wang, Hongyuan
A1 Yee, Leland
A1 Kao, Jia-Horng
A1 Marcellin, Patrick
A1 Gane, Edward
A1 Buti, Maria
YR 2024
UL http://gut.bmj.com/content/73/Suppl_2/A256.abstract
AB Background In an integrated analysis of 2 global Phase 3 studies, we evaluated HCC incidence and risk at 8 years in patients treated with TAF and those treated initially with TDF and then switched to TAF for up to 6 years (y).Methods In 2 studies, HBeAg-positive (n=859) and -negative (n=439) patients with HBV DNA ≥20,000 IU/mL and ALT >60 U/L (males) or >38 U/L (females) were randomized to TAF or TDF in a double-blind (DB) phase for up to 3 y, followed by open-label (OL) TAF through Y8. HCC was assessed by local standards of care and by hepatic ultrasonography. Three validated models (REACH-B, aMAP, and mPAGE-B) were utilized to assess HCC risk by initial treatment assignment and collectively. Using the REACH-B model, standard incidence ratios (SIRs) for HCC were calculated.Results Through Y8, HCC was diagnosed in 21/1298 patients (1.6%; TAF 1.4%; TDF→TAF 2.1%; P=0.33)— 11 in DB/10 in OL phase. Eight of 21 HCC cases were in cirrhotic patients. The median time to HCC onset was 729 days (TAF 1291, TDF→TAF 460 days). Advanced age, male, and cirrhosis were more common in HCC vs non-HCC patients (P<0.05). Proportionately, more HCC patients were HBV genotype C (76% vs 47%) and had BL HBV DNA between 6 to ≤ 8 log10IU/mL (57% vs 38%). With treatment over 8y, by REACH-B, HCC incidence was significantly reduced (21 observed vs 74.6 predicted; SIR [95% CI] 0.28; P<0.0001; figure 1). Of patients predicted to be low risk for HCC at BL, nearly all remained low risk at Y8 by aMAP (98%) and mPAGE-B (97%), and substantial proportions estimated to be medium or high risk at BL shifted to lower risk at Y8 (aMAP: 45% and 72%; mPAGE-B: 27% and 51%, respectively).Conclusions CHB patients treated with TAF alone or switched from TDF to TAF for up to 8 y showed a reduced observed vs predicted risk for HCC development.