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TDF for 3 Years Reduces Fibrosis Progression in Patients With CHB, HBV DNA > 2000 IU/mL, and Minimally Elevated ALT
Source: 2018 Annual Meeting of the American Association for the Study of Liver Diseases*
Released: November 20, 2018
Multicenter, randomized, triple-blind, placebo-controlled phase IV trial[1,2]
Summary of Key Conclusions
In patients with chronic HBV infection (CHB), HBV DNA > 2000 IU/mL, and minimally elevated ALT at 1-2 x upper limit of normal (ULN), 3 years of tenofovir disoproxil fumarate (TDF) significantly decreased risk of fibrosis progression vs placebo
Fibrosis progression: TDF, 23.1%; placebo, 44.8%
Relative risk (RR) for any increase in Ishak fibrosis: 0.52 (95% CI: 0.31-0.85; P = .01)
TDF associated with significantly lower risk of cirrhosis at Year 3
RR for cirrhosis (Ishak stage 5/6): 0.23 (95% CI: 0.06-0.88; P = .05)
Comparable rates of decrease in inflammatory score between arms (P = .38)
Improved inflammatory score: TDF, n = 34 (52.3%); placebo, n = 29 (43.3%)
1 patient receiving TDF experienced > 30% decrease in estimated glomerular filtration rate (eGFR)
Background
HBV guidelines from American Association for the Study of Liver Diseases (AASLD), European Association for the Study of the Liver (EASL), and Asian Pacific Association for the Study of the Liver (APASL) recommend HBV therapy for patients with CHB based on HBV DNA levels (differing by hepatitis B e antigen [HBeAg] status for AASLD and APASL), ALT levels, and/or liver biopsy results[3-5]
AASLD
HBeAg positive: treat if HBV DNA > 20,000 IU/mL or ALT ≥ 2 x ULN
HBeAg negative: treat if HBV DNA ≥ 2000 IU/mL or ALT ≥ 2 x ULN
EASL, HBeAg positive or negative
Treat if HBV DNA > 20,000 IU/mL or ALT > 2 x ULN
Treat if HBV DNA > 2000 IU/mL and (ALT > ULN and/or moderate necroinflammation/fibrosis)
APASL
HBeAg positive: treat if HBV DNA > 20,000 IU/mL or ALT > 2 x ULN
HBeAg negative: treat if HBV DNA > 2000 IU/mL or ALT > 2 x ULN
Utility of HBV therapy not established in patients with minimally raised ALT > ULN but < 2 x ULN[3]
Current study compared efficacy and safety of TDF vs placebo to prevent disease progression in patients with CHB, HBV DNA > 2000 IU/mL, and ALT 1-2 x ULN[1]
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