BULEVIRTIDE-GMOD INJ,LYPHL

Clinical Criteria Summary

Chronic HDV infection in adults without cirrhosis or with compensated cirrhosis
Definition of chronic HDV: Positive serum anti-HDV antibody or HDV RNA detected by PCR at least 6 months before screening plus HDV RNA detected by PCR at screening

Manage and treat the underlying hepatitis B virus (HBV) infection in all patients, as clinically appropriate
Concurrent chronic HBV infection should be appropriately managed with nucleos(t)ide analogs, as clinically indicated

Contraindications: None
Patients with Child-Pugh Class B or C cirrhosis (decompensated cirrhosis) are generally not candidates for bulevirtide-gmod therapy

8.5mg once daily administered by subcutaneous injection
Available as 8.5mg lyophilized powder or cake in a single-dose vial for reconstitution
No dosage adjustment recommended in patients with creatinine clearance (CrCl) ≥15 mL/min; not studied in end-stage renal disease (CrCl <15 mL/min)
No dosage adjustment recommended in patients with mild hepatic impairment (Child-Pugh Class A); not studied in moderate (Class B) or severe (Class C) impairment

Continue treatment as long as it is associated with a response; optimal duration is currently unknown
Monitor hepatic function closely with clinical and laboratory follow-up, including HBV DNA and HDV RNA viral loads, for at least 6 months after discontinuation due to risk of severe acute exacerbation
Resumption of antiviral therapy may be warranted upon post-treatment exacerbation
Immediately discontinue bulevirtide-gmod and initiate appropriate treatment if signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur
Monitor for asymptomatic, dose-dependent increases in total serum bile salt levels (resolves upon discontinuation)

Pregnancy: Insufficient data in humans; animal studies showed no adverse effects on embryofetal development at exposures significantly higher than the recommended human dose
Lactation: Insufficient data in humans; not likely to be secreted in milk due to high protein binding, liver tropism, and high specificity for NTCP

Known hypersensitivity to bulevirtide
CrCl <15 mL/min
Moderate to severe hepatic impairment, defined as Child-Pugh Class B or C
Severe cirrhosis-related thrombocytopenia (e.g., platelet count <60,000 cells/mm3)
Active or suspected malignancy, history of malignancy, or untreated pre-malignancy disorder within the last 5 years (Exceptions: successfully treated carcinoma of the cervix in situ, basal cell or squamous cell carcinoma of the skin)

Care provided by a VA/VA Community Care Infectious Diseases or Gastroenterology provider
Diagnosis of chronic HDV infection established by laboratory testing (Positive serum anti-HDV antibody or detectable HDV RNA for at least 6 months prior to treatment initiation)
Concomitant treatment of underlying HBV infection, as clinically appropriate

ONE of the following must be selected:
Compensated cirrhosis, staged via histology or non-invasive tests (e.g., transient elastography, fibrosis scores, etc.)
Persistently elevated ALT, defined as > 1x ULN but <10x ULN, for at least 3 months