HEPCLUDEX® (bulevirtide-gmod) for injection, for subcutaneous use: Key Aspects of Chronic Hepatitis Delta and Prescribing Information

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Presented by Robert Gish, MD on August 25, 2026 6:00 PM - 7:00 PM Pacific Time

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IMPORTANT SAFETY INFORMATION  (continued)

Warnings and Precautions

Hypersensitivity Reactions Including Anaphylaxis: Hypersensitivity reactions, including anaphylaxis, have been reported with HEPCLUDEX. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue HEPCLUDEX and initiate appropriate treatment.

Adverse Reactions

Most common adverse reactions (incidence ≥10%; all grades) in HEPCLUDEX clinical trials were injection site reactions, headache, abdominal pain, fatigue and pruritus.

Dosage and Administration

  • Dosage in adults: 8.5 mg once daily administered by subcutaneous injection.
  • HEPCLUDEX should be continued as long as it is associated with a response to treatment. The optimal treatment duration is unknown.
  • In all patients, manage the underlying hepatitis B virus (HBV) infection as clinically appropriate.

Pregnancy and Lactation

  • Pregnancy: There are insufficient data from human pregnancies exposed to HEPCLUDEX to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. 
  • Lactation: There are no data on the presence of HEPCLUDEX in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for HEPCLUDEX and any potential adverse effects on the breastfed child from HEPCLUDEX or from the underlying maternal condition.

Please see full Prescribing Information for HEPCLUDEX, including BOXED WARNING and Instructions for Use.