Hepcludex

Hepcludex is a prescription subcutaneous formulation containing the active ingredient bulevirtide. It is marketed in the European Union as an antiviral entry inhibitor targeting hepatitis B and D viruses. The product is administered by injection and classified as a hepatitis B/HDV entry inhibitor (ATC code J05AX13). It is indicated for hepatitis D virus infection and works by blocking the sodium taurocholate co‑transporting polypeptide (NTCP) receptor on hepatocytes, preventing viral entry.

Hepcludex is prescribed for patients with chronic hepatitis D virus (HDV) infection, often in combination with standard hepatitis B therapy.

- Treatment of chronic HDV infection in adults. - Use as an adjunct to nucleos(t)ide analogues for hepatitis B virus co‑infection. - Management of patients with detectable HDV RNA who have not responded adequately to existing therapies. - Consideration in liver transplant candidates with HDV to reduce viral load pre‑operatively.

The safety profile of Hepcludex includes both frequently observed and less common adverse events.

Common: - Injection site reactions such as pain, redness, or swelling. - Mild headache or fatigue. - Transient elevation of liver enzymes (ALT/AST). - Nausea or mild gastrointestinal discomfort.

Serious: - Severe hypersensitivity reactions, including rash or anaphylaxis. - Significant liver injury manifested by marked ALT/AST increase. - Thrombocytopenia or other hematologic abnormalities.

Clinicians should evaluate several precautionary factors before initiating Hepcludex therapy.

- Assess liver function tests and baseline viral load. - Avoid use in patients with known hypersensitivity to bulevirtide. - Monitor for signs of hepatic decompensation during treatment. - Consider pregnancy status; safety data are limited. - Evaluate renal function, although no dose adjustment is required. - Use caution in patients receiving other hepatotoxic agents. - Educate patients on proper subcutaneous injection technique.

Potential drug interactions with Hepcludex are limited but should be reviewed.

Avoid: - Co‑administration with strong NTCP inhibitors that may reduce bulevirtide efficacy. - Concurrent use of investigational antiviral agents without clinical guidance.

Use with caution: - Combination with nucleos(t)ide analogues for HBV; monitor liver enzymes. - Concurrent hepatotoxic medications such as certain antifungals or antiretrovirals. - Vaccinations administered shortly before or after injection; observe for enhanced local reactions.