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)

<h3>Background</h3> 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). <h3>Methods</h3> In 2 studies, HBeAg-positive (n=859) and -negative (n=439) patients with HBV DNA ≥20,000 IU/mL and ALT &gt;60 U/L (males) or &gt;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. <h3>Results</h3> Through Y8, HCC was diagnosed in 21/1298 patients (1.6%; TAF 1.4%; TDF→TAF 2.1%; <i>P</i>=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 (<i>P</i>&lt;0.05). Proportionately, more HCC patients were HBV genotype C (76% vs 47%) and had BL HBV DNA between 6 to ≤ 8 log<sub>10</sub>IU/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; <i>P</i>&lt;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). <h3>Conclusions</h3> 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.

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Published
2024-08-01
DOI
https://doi.org/10.1136/gutjnl-2024-iddf.189
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1
Primary Topic
Hepatitis B Virus Studies
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article
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0.39
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article

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)

Sang Hoon Ahn, Seng Gee Lim, Wan‐Long Chuang, Patrick Marcellin et al.
1 citations
Hepatitis B Virus Studies
0.39
article

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)

Sang Hoon Ahn, Seng Gee Lim, Wan‐Long Chuang, Patrick Marcellin, Leland J. Yee, Grace Wong, Harry L.A. Janssen, Frida Abramov, John F. Flaherty, Marı́a Buti, Jia‐Horng Kao, Scott Fung, Kosh Agarwal, Calvin Q. Pan, S. Shalimar, Maurizia Rossana Brunetto, Young‐Suk Lim, Aric J. Hui, Edward Gane, Ting‐Tsung Chang, Hongyuan Wang, Wai Kay Seto
article en
1 citations

Abstract

<h3>Background</h3> 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). <h3>Methods</h3> In 2 studies, HBeAg-positive (n=859) and -negative (n=439) patients with HBV DNA ≥20,000 IU/mL and ALT &gt;60 U/L (males) or &gt;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. <h3>Results</h3> Through Y8, HCC was diagnosed in 21/1298 patients (1.6%; TAF 1.4%; TDF→TAF 2.1%; <i>P</i>=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 (<i>P</i>&lt;0.05). Proportionately, more HCC patients were HBV genotype C (76% vs 47%) and had BL HBV DNA between 6 to ≤ 8 log<sub>10</sub>IU/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; <i>P</i>&lt;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). <h3>Conclusions</h3> 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.

Ulsan College (KR), University Health Network (CA), Auckland Institute of Studies (NZ), Kaohsiung Medical University (TW), Inserm (FR), National Taiwan University (TW), Chinese University of Hong Kong (HK), University of Toronto (CA), Yonsei University (KR), Université Paris Cité (FR), Hôpital Beaujon (FR), Instituto de Salud Carlos III (ES), Asan Medical Center (KR), Alice Ho Miu Ling Nethersole Hospital (CN), Kaohsiung Medical University Chung-Ho Memorial Hospital (TW), University of Ulsan (KR), Assistance Publique – Hôpitaux de Paris (FR), King's College Hospital NHS Foundation Trust (GB), Vall d'Hebron Hospital Universitari (ES), Gilead Sciences (United States) (US), National University Health System (SG), Toronto Liver Centre (CA), National Cheng Kung University Hospital (TW), Azienda Ospedaliera Universitaria Pisana (IT), New York University (US), All India Institute of Medical Sciences (IN), University of Hong Kong (HK)
Good health and well-being
Openalex Percentile: Top 35%
Hepatitis B Virus Studies
0.39
DOISourceOpenAlex
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