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Label indication 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 [see Clinical Studies (14) ] . An improvement in disease-related clinical outcomes has not been established. FDA label
Also known as Bulevirtide (BLV), Myrcludex B, Hepcludex®
Bulevirtide · 3 trials · 2 indications
Combined response was defined as fulfilment of two conditions simultaneously: Undetectable (\< lower limit of quantification (LLOQ, target not detected)) HDV RNA or decrease by ≥ 2 log10 IU/mL from baseline; and ALT normalization.
SVR24 was defined as undetectable hepatitis delta virus (HDV) RNA (HDV RNA value \< lower limit of quantitation \[LLOQ\] with target not detected) at 24 weeks after the scheduled end of treatment (EOT).
AUCtau is defined as the area under the concentration versus time curve over the dosing interval at steady state at Day 6.
Cmax is defined as the maximum observed concentration of drug at steady state at Day 6.
| Arm | Type | Description |
|---|---|---|
| Delayed Treatment/Bulevirtide 10 mg/day | EXPERIMENTAL | After an observational period of 48 weeks, participants will receive treatment with bulevirtide 10 mg/day subcutaneously (SC) for 96 weeks and will be followed for up to 96 weeks (Up to Week 240). |
| Bulevirtide 2 mg/day | EXPERIMENTAL | Participants will receive bulevirtide 2 mg/day SC for 144 weeks and will be followed for up to 96 weeks (Up to Week 240). |
| Bulevirtide 10 mg/day | EXPERIMENTAL | Participants will receive bulevirtide 10 mg/day SC for 144 weeks and will be followed for up to 96 weeks (Up to Week 240). |
| Pegylated Interferon alfa-2a (PEG-IFN alfa) | ACTIVE_COMPARATOR | Participants will receive PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up. |
| Bulevirtide 2 mg/day + PEG-IFN alfa | EXPERIMENTAL | Participants will receive bulevirtide 2 mg once a day subcutaneously incombination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 2 mg once a day for 48 weeks and additional 48 weeks follow-up. |
| Bulevirtide 10 mg/day + PEG-IFN alfa | EXPERIMENTAL | Participants will receive bulevirtide 10 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 10 mg once a day for 48 weeks and additional 48 weeks follow-up. |
| Bulevirtide 10 mg once a day | EXPERIMENTAL | Participants will receive bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up |
| Group A: BLV 2 mg (Severe RI Group) | EXPERIMENTAL | Participants with severe renal impairment (RI) \[estimated glomerular filtration rate (eGFR) ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] will receive bulevirtide (BLV) 2 mg, administered subcutaneously (SC), once daily (QD), for 6 days. |
| Group A: BLV 2 mg (Matched Control) | EXPERIMENTAL | Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] will receive BLV 2 mg, administered SC, QD, for 6 days. |
| Group B: BLV 10 mg (Severe RI Group) | EXPERIMENTAL | Participants with severe RI \[eGFR ≥ 15 to ≤ 29 mL/min/1.73 m\^2\] will receive BLV 10 mg, administered SC, QD, for 6 days. |
| Group B: BLV 10 mg (Matched Control) | EXPERIMENTAL | Participants with normal renal function (matched control group) \[eGFR ≥ 90 mL/min/1.73 m\^2\] will receive BLV 10 mg, administered SC, QD, for 6 days. |
| Name | Type | Description |
|---|---|---|
| Bulevirtide | DRUG | Administered via SC injections |
| Peginterferon Alfa-2a (PEG-IFN alfa) | DRUG | Administered via subcutaneous injections |
| Bulevirtide (BLV) | DRUG | Administered via subcutaneous (SC) injections |
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Positive serum anti-hepatitis delta virus (HDV) antibody results or polymerase chain reaction (PCR) results for serum/ plasma HDV ribonucleic acid (RNA) for at least 6 months before screening. 3. Positive PCR results for...
Bulevirtide is used for the treatment of chronic hepatitis D infection and chronic hepatitis delta. It is an investigational small molecule developed by Gilead Sciences, Inc. (ticker: GILD) and is currently in Phase 1 clinical development.
Bulevirtide targets SLC10A1, also known as the sodium taurocholate co-transporting polypeptide (NTCP). It acts as an inhibitor of this target. By inhibiting SLC10A1, Bulevirtide blocks the entry of hepatitis D virus into hepatocytes.
Bulevirtide is being developed by Gilead Sciences, Inc., which trades under the ticker symbol GILD. Gilead is responsible for the clinical development of the drug for chronic hepatitis D infection and chronic hepatitis delta.
Bulevirtide is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program includes a completed study in participants with normal and impaired renal function.
Bulevirtide has been studied in three completed clinical trials: NCT05760300, a Phase 1 renal impairment study; NCT03852719, a Phase 3 trial in chronic hepatitis delta; and NCT03852433, a Phase 2 trial combining Bulevirtide with pegylated interferon alfa-2a.
Yes, Bulevirtide is also known as BLV. Bulevirtide (BLV) is the same drug. The abbreviation BLV is sometimes used in scientific literature and clinical trial descriptions to refer to Bulevirtide.