Safety, Pharmacokinetics, and Antiviral Activity of the S-antigen Transport Inhibiting Oligonucleotide Polymers (STOPS) Drug Candidate ALG-010133 in Subjects with Chronic Hepatitis B

evaluated the hazard ratio (HR) of treatment with TDF versus (vs) ETV to reduce HCC risk using a multivariable Cox proportional hazards model.Subgroup analyses for age, sex, HBeAg positivity, cirrhosis status and diabetes status were also conducted.Results: Data from 42, 939 eligible patients (6, 979 TDF and 35, 960 ETV) were included.The treatments were similar in terms of baseline age (TDF: 48.32 years [yrs] vs ETV: 52.26 yrs), sex (female: 38.64% vs 34.13%), follow-up time (3.71 yrs vs 3.97 yrs) and presence of cirrhosis (38.01%vs 33.69%).Patients receiving TDF were associated with a significantly lower risk of developing HCC: adjusted HR (95% confidence interval [CI]) = 0.77 (0.61-0.98), p = 0.03.In all subgroup analyses, TDF showed a lower risk of HCC than ETV (HR <1.0), with the risk difference most pronounced in the HBeAg positive subgroup (Figure ).Figure: Analyses for cumulative incidence of HCC in patients with CHB treated with TDF or ETV *Statistically significant results are in bold.For the '50 years or older' and 'non-diabetic' subgroups, the upper bound of each CI is <1.00, but each has been rounded up to 1.00 when reported to two decimal places.CHB, chronic hepatitis B; CI, confidence interval; ETV, entecavir; HBeAg, hepatitis B e-antigen; HCC, hepatocellular carcinoma; HR, hazard ratio; TDF, tenofovir disoproxil fumarate Conclusion: The risk of developing HCC was significantly lower in CHB patients receiving TDF than ETV.TDF was consistently associated with lower HCC risk across all subgroups, but most notably in HBeAg positive patients.