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Bepirovirsen is a developmental antisense oligonucleotide (ASO) for treatment of chronic hepatitis B virus infection. No pharmacokinetic (PK) studies comparing participants with hepatic impairment (HI) and healthy participants (HPs) have been conducted with ASOs. Given the target patient population, characterization of bepirovirsen PK in HI was imperative. This phase 1, nonrandomized, open‐label study (NCT04971928) evaluated the PKs of a single 300‐mg dose of bepirovirsen in participants with HI and matched HPs, enrolled in 2 parts (Part 1: moderate HI; Part 2: mild HI). If no predefined difference in the area under the concentration‐time curve from time 0 (predose) to infinite time (AUC0‐∞) and maximum observed concentration (Cmax; geometric mean ratio [GMR] 0.5‐1.5) was identified in Part 1, findings were applied to mild HI, eliminating Part 2. Participants were monitored for 50 days post‐treatment and noncompartmental analysis estimated PK parameters. Twenty‐four participants (moderate HI, n = 12; HP, n = 12) received bepirovirsen and completed Part 1. AUC0‐∞ and Cmax were lower in participants with moderate HI (GMR 0.69 and 0.67, respectively) than in HPs, while apparent clearance (CL/F) and apparent terminal phase volume of distribution (Vz/F) were higher (GMR 1.44 and 1.64, respectively), but fell within the predefined thresholds of difference for this study. Part 2 was omitted. Adverse events were mild. Moderate HI did not have a clinically relevant impact on bepirovirsen PK or safety. [ABSTRACT FROM AUTHOR]

Foreign‐born (FB) persons represent a large proportion of adults with chronic hepatitis B (CHB) in Canada due to higher prevalence rates in countries of birth for FB persons. Suboptimal awareness and low rates of hepatitis delta virus (HDV) testing contribute to underdiagnosis and gaps in accurate estimates of Canada HDV prevalence. We aim to provide an assessment of CHB and HDV prevalence in Canada using a comprehensive literature review and meta‐analysis. A comprehensive literature review of articles reporting HBsAg seroprevalence and anti‐HDV prevalence was conducted to calculate country‐specific rates and pooled prevalence of CHB and HDV using meta‐analyses. Country‐specific CHB and HDV rate estimates were combined with number of FB persons in Canada in 2021 from Statistics Canada to estimate total numbers of FB with CHB and HDV, respectively. These estimates were combined with estimates of Canada‐born persons with CHB and HDV to yield the total number of persons with CHB and HDV. In 2021, we estimated 0.550 million (M) (95% CI 0.488–0.615) persons with CHB; 0.344 M (95% CI 0.288–0.401) were FB and 0.206 M (95% CI: 0.200–0.214) were Canada‐born. The weighted average HDV prevalence among FB persons in Canada was 5.19% (17,848 [95% CI 9611–26,052] persons), among whom 50% emigrated from Asia and 31% from Africa. When combined with estimates of Canada‐born persons with HDV, we estimate 35,059 (95% CI: 18,744–52,083) persons with HDV in Canada. In conclusion, we estimate 0.550 M and 35,059 persons living with CHB and HDV, respectively, in Canada in 2021. [ABSTRACT FROM AUTHOR]

Timely antiviral therapy is critical in chronic hepatitis B cirrhosis to prevent further liver complications. Among a national cohort of US Veterans with chronic hepatitis B cirrhosis, only 52% were initiated on antiviral therapy; treatment was significantly lower among patients of non-Asian ethnicity, high-risk alcohol use, and in rural settings. [ABSTRACT FROM AUTHOR]