Effects of bepirovirsen on other drugs

“In addition, HIBSAGO did not impact NrtI exposure.” (opens the prescribing information at this quote)CopyFlag

“Based on in vitro study results, HIBSAGO is not a substrate, inducer or inhibitor of major cytochrome P450 (CYP) enzymes, or drug transporters; therefore, clinically relevant pharmacokinetic interactions are not expected.” (opens the prescribing information at this quote)CopyFlag

“The analysis included 186 ETV plasma concentrations from 16 participants treated with bepirovirsen and ETV, 70 TFV plasma concentrations from 6 participants treated with bepirovirsen and TDF, and 70 TFV plasma concentrations from 5 participants treated with bepirovirsen and TAF. As summarized in Table 3, mean ETV and TFV Cmax and AUC values from participants in the B‐Clear study who received coadministration of bepirovirsen and NA (ETV, TDF, or TAF) were consistent with published data without coadministered bepirovirsen.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quoteCopyFlag

“Thus, the analyses reported here showed no potential for DDI between bepirovirsen and ETV or TFV, substantiated by both in vitro assessments and clinical evaluation. Based on the totality of data, bepirovirsen Phase 3 studies were permitted by health authorities to proceed without conducting dedicated DDI studies.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quoteCopyFlag

“Bepirovirsen was not a clinically relevant reversible or time‐dependent inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4/5 or a reversible inhibitor of UGT enzymes.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quoteCopyFlag

“Bepirovirsen was an inducer of CYP3A4 in vitro in 1 of 3 cryopreserved human hepatocyte donors only, with unbound concentration causing half‐maximal induction effect and maximum induction effect values of 13.6 µM and 2.28‐fold, respectively (Table 1). The results of the basic static modeling indicate that bepirovirsen is not considered to be a CYP3A4 inducer of clinical DDI concern.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quoteCopyFlag

“Bepirovirsen inhibited the MRP2 transporter in vitro with an IC50,u of 8.49 µM. Results of the basic static model predicted that bepirovirsen is not a clinically relevant inhibitor of MRP2.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quoteCopyFlag

“The maximum unbound plasma concentration (Cmax), following the therapeutic subcutaneous dose of 300 mg, administered weekly for 24 weeks, was 57 nM.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quoteCopyFlag

“Monitor patients for signs of bleeding and thrombocytopenia if HIBSAGO is taken concomitantly with anticoagulants, antiplatelets, or drugs that decrease platelet count [see Warnings and Precautions (5.2), Adverse Reactions (6.1)].” (opens the prescribing information at this quote)CopyFlag

“Monitor patients for signs of worsening renal function during concomitant administration of HIBSAGO with drugs that may impair renal function. Refer to individual drug information before prescribing [see Warnings and Precautions (5.3), Adverse Reactions (6.1)].” (opens the prescribing information at this quote)CopyFlag

“Concomitant administration of HIBSAGO and peginterferon alfa-2a is not recommended due to the potential for an exacerbated risk of increased ALT, decreased platelet count, and immune-mediated effects.” (opens the prescribing information at this quote)CopyFlag

“HIBSAGO is not recommended in patients with HDV coinfection due to the potential for an exacerbated risk of clinically significant ALT increases.” (opens the prescribing information at this quote)CopyFlag