Chronic Hepatitis Delta Virus Infection
Conditions
Brief summary
The goal of this study is to provide access to bulevirtide (BLV (GS-4438), Hepcludex®) to eligible participants with chronic hepatitis delta virus infection (CHD).
Interventions
DRUGBulevirtide
10 mg BLV will be administered via subcutaneous injection
Sponsors
Gilead Sciences
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
Key Inclusion Criteria: * Diagnosed with CHD as confirmed by medical records. * Compensated liver disease with liver cirrhosis (defined by biopsy, Fibroscan, or clinically by the treating physician) and Child-Pugh score ≤ 6. * Positive HDV RNA test within 6 months of initial EAP request (only applicable to patients who have not received treatment with BLV). Key
Exclusion criteria
* Coinfection with hepatitis C virus (HCV) (HCV viremia defined by polymerase chain reaction (PCR)) or uncontrolled HIV infection (CD4 \< 500 cells/mm\^3 and detectable HIV RNA). * Current or previous (within last 3 months from screening) decompensated liver disease, including coagulopathy, hepatic encephalopathy, and esophageal varices hemorrhage. * Significant medical diseases or conditions, that might decrease the benefit-risk ratio of participating in this program to an unacceptable level, as determined by the treating physician. Note: Other protocol defined Inclusion/
Contacts
STUDY_DIRECTORGilead Study Director
Gilead Sciences
Outcome results
None listed