IDDF2020-ABS-0061 Impact of treatment with tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) on hepatocellular carcinoma (HCC) incidence in patients with chronic hepatitis B (CHB)

BackgroundPotent antivirals can reduce HCC incidence in CHB. TDF and TAF are first-line treatments, and in Phase 3 studies through 3 years, TAF has shown antiviral efficacy similar to TDF, higher rates of ALT normalization, and no resistance. We evaluated HCC incidence in patients participating in these ongoing studies.MethodsHBeAg-positive (n=1039) and -negative (n=593) patients with HBV DNA 20,000 IU/mL and ALT >60 U/L (males) or >38 U/L (females) were randomized (2:1) to TAF 25 mg QD or TDF 300 mg QD for up to 3 years, followed by open-label TAF through Year 8. Patients with hepatic decompensation, co-infection with HCV/HDV/HIV, or evidence of HCC were excluded. HCC was assessed at 6 monthly intervals by hepatic ultrasonography beginning after Week 96 and by local standards of care. The standardized incidence ratio (SIR) for HCC was calculated for observed cases relative to predicted cases using the REACH-B model.Results1632 patients were followed for up to 4 years; HCC was seen in 16 patients (0.98%; 7 TAF; 9 TDF); median time to onset was 568 days. At baseline HCC patients were older (median age 53 vs 40 y; p