Bepirovirsen effectiveness and safety in treating chronic hepatitis B infection
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Reviewed by Dat Tien Nguyen, B.A, ScM.
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Posted on November 28th, 2022
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Bepirovirsen is an antiviral agent created by the pharmaceutical company GlaxoSmithKline which is being investigated for its ability to interfere with the replication cycle of the Hepatitis B virus. Being an antisense oligonucleotide, Bepirovirsen works by binding to HBV RNA and negates its interaction with other viral proteins; thus, the agent interferes with the viral life cycle. A previous phase 2a trial has shown that a 4-week therapy results in a substantial drop in hepatitis B surface antigen (HBsAg) level. The same research group had conducted a follow-up study, with a longer surveillance period, and they had recently published their findings.
The phase 2b clinical trial includes 457 participants that had been living with chronic hepatitis B infection for at least 6 months and has an HBsAg level of more than 100 IU per milliliter. The participants were randomly assigned into 4 treatment groups 1) 300 mg of Bepirovirsen for 24 weeks; 2) 300 mg of Bepirovirsen for 12 weeks then 150 mg for 12 weeks; 3) Bepirovirsen for 12 weeks then placebo for 12 weeks; 4) placebo for 12 weeks then Bepirovirsen for 12 weeks. The agent and placebo were administered subcutaneously weekly. After the 24-week of treatment, the groups were subjected to a 24-week long follow-up period, and the study observed that there is a dose-dependent reduction in viral activity. Thus, the study concluded that the 24-week long therapy of Bepirovirsen 300 mg was the most effective at sustainable reduction in the HBsAg and HBV DNA level below the limit of detection/quantification, which is 0.05 IU per milliliter and 20 IU per milliliter respectively. Comparing the frequency of adverse events between the treatment and placebo groups, the study reported that injection-site reactions, pyrexia, and fatigue were more commonly reported by those who have received the Bepirovirsen injection.
The phase 2b clinical trial includes 457 participants that had been living with chronic hepatitis B infection for at least 6 months and has an HBsAg level of more than 100 IU per milliliter. The participants were randomly assigned into 4 treatment groups 1) 300 mg of Bepirovirsen for 24 weeks; 2) 300 mg of Bepirovirsen for 12 weeks then 150 mg for 12 weeks; 3) Bepirovirsen for 12 weeks then placebo for 12 weeks; 4) placebo for 12 weeks then Bepirovirsen for 12 weeks. The agent and placebo were administered subcutaneously weekly. After the 24-week of treatment, the groups were subjected to a 24-week long follow-up period, and the study observed that there is a dose-dependent reduction in viral activity. Thus, the study concluded that the 24-week long therapy of Bepirovirsen 300 mg was the most effective at sustainable reduction in the HBsAg and HBV DNA level below the limit of detection/quantification, which is 0.05 IU per milliliter and 20 IU per milliliter respectively. Comparing the frequency of adverse events between the treatment and placebo groups, the study reported that injection-site reactions, pyrexia, and fatigue were more commonly reported by those who have received the Bepirovirsen injection.