HEPCLUDEX® (bulevirtide-gmod) Safety & Tolerability

DEMONSTRATED SAFETY & TOLERABILITY PROFILE¹

Established Safety Profile:  
No Observed Discontinuations From Adverse Reactions¹

Safety and tolerability data through 48 weeks¹

Adverse reactions^a (all grades) reported in ≥10% of participants with chronic HDV infection without cirrhosis or with compensated cirrhosis receiving HEPCLUDEX in Trial MYR301 (Week 48 analysis)¹

Adverse Reaction¹	HEPCLUDEX(n=50)	No Treatment^b(n=51)
Injection site reactions^c	30%	0
Headache	20%	0
Abdominal pain^d	18%	2%
Fatigue	14%	2%
Pruritus	14%	0

Key Trial Data

Based on Week 48 analysis, the most common adverse reactions (all grades) reported in ≥10% of participants were injection site reactions, headache, abdominal pain, fatigue, and pruritus¹

NO PARTICIPANT DISCONTINUED TREATMENT WITH HEPCLUDEX 8.5 mg DUE TO AN ADVERSE REACTION THROUGH WEEK 48¹

A similar safety profile was observed through Week 144 in Trial MYR301 and for participants in the Delayed Treatment arm who switched to treatment with HEPCLUDEX at Week 48 through to Week 144

No Known Drug Interactions¹

No CYP enzyme or transporter-mediated inhibition or induction by HEPCLUDEX is anticipated at clinically relevant concentrations

Due to peptide catabolism of HEPCLUDEX, the drug-drug interaction potential of other drugs to impact HEPCLUDEX pharmacokinetics, via CYP enzymes, is low

Based on the population PK evaluation of drug interactions for bulevirtide, no clinically relevant drug interactions have been observed with PEG-IFNα and TAF or TDF

CYP=cytochrome P450; PEG-IFNα=pegylated interferon-alpha; PK=pharmacokinetic; TAF=tenofovir alafenamide; TDF=tenofovir disoproxil fumarate.

^aFrequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug.¹

^bParticipants who received no HDV treatment in Trial MYR301 for the first 48 weeks.¹

^cGrouped term includes injection site abscess, injection site erythema, injection site reaction, injection site pruritus, injection site swelling, injection site hematoma, injection site rash, injection site dermatitis, and injection site pain.¹

^dGrouped term includes abdominal pain, abdominal pain lower, and abdominal pain upper.¹

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INDICATION¹

HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis.

This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization. An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

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

IMPORTANT SAFETY INFORMATION

BOXED WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS D and B

Severe acute exacerbations of hepatitis D and hepatitis B may occur after HEPCLUDEX is discontinued, especially in patients with cirrhosis, who may be at increased risk of more severe flares or progression to hepatic decompensation. Monitor hepatic function closely with both clinical and laboratory follow-up, including hepatitis B virus (HBV) DNA and hepatitis delta virus (HDV) RNA viral load, for at least six months in patients who discontinue HEPCLUDEX. Resumption of antiviral therapy may be warranted.

Warnings and Precautions

Hypersensitivity Reactions Including Anaphylaxis: Hypersensitivity reactions, including anaphylaxis, have been reported with HEPCLUDEX. If signs or 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.

DEMONSTRATED SAFETY & TOLERABILITY PROFILE1

Established Safety Profile: No Observed Discontinuations From Adverse Reactions1

Safety and tolerability data through 48 weeks1