Abstract | BACKGROUND: METHODS: The incidence of HCC in patients treated with TDF was obtained in the pivotal TDF registration studies after 384 weeks of follow-up. The predicted risk of HCC in individual patients was calculated using the Risk Estimation for Hepatocellular Carcinoma in Chronic Hepatitis B (REACH-B) model, which estimates HCC incidence for up to 10 years based on age, sex, alanine aminotransferase level, hepatitis B e antigen status, and HBV- DNA. Standardized incidence ratios (SIRs) were calculated comparing the observed and predicted numbers of HCC cases in the study cohort. RESULTS: Among 634 patients with evaluable baseline biopsies, 152 had cirrhosis (Ishak fibrosis score of 5 or 6) and 482 did not. During the 384 weeks of study, 14 cases of HCC were reported, with 4 occurring within the first year. The incidence of HCC was 0.37% per year in the study as a whole (0.28% among patients without cirrhosis and 0.65% among patients with cirrhosis). Among patients without cirrhosis, the observed incidence of HCC was significantly lower than predicted (SIR, 0.40; 95% confidence interval, 0.199-0.795). The last HCC case in a patient with cirrhosis occurred around week 192 with an SIR of 0.51 (95% confidence interval, 0.231-1.144) reported at week 384. CONCLUSIONS: Based on the REACH-B risk calculator, long-term therapy with TDF was associated with a reduced incidence of HCC among patients without cirrhosis who met treatment criteria.
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Authors | W Ray Kim, Rohit Loomba, Thomas Berg, Raul E Aguilar Schall, Leland J Yee, Phillip V Dinh, John F Flaherty, Eduardo B Martins, Terry M Therneau, Ira Jacobson, Scott Fung, Selim Gurel, Maria Buti, Patrick Marcellin |
Journal | Cancer
(Cancer)
Vol. 121
Issue 20
Pg. 3631-8
(Oct 15 2015)
ISSN: 1097-0142 [Electronic] United States |
PMID | 26177866
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Copyright | © 2015 American Cancer Society. |
Chemical References |
- Antiviral Agents
- Tenofovir
|
Topics |
- Adult
- Antiviral Agents
(administration & dosage, therapeutic use)
- Carcinoma, Hepatocellular
(epidemiology, virology)
- Double-Blind Method
- Drug Administration Schedule
- Female
- Hepatitis B, Chronic
(complications, drug therapy)
- Humans
- Incidence
- Liver Cirrhosis
(complications, epidemiology, virology)
- Liver Neoplasms
(epidemiology, virology)
- Male
- Middle Aged
- Risk Assessment
- Tenofovir
(administration & dosage, therapeutic use)
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