Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bulevirtide · 4 trials · 4 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.
AUCtau was defined as the area under the concentration versus time curve (AUC) over the dosing interval at steady state.
Cmax,ss was defined as the maximum observed concentration of drug at steady state.
| 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. |
| Group A: Bulevirtide (BLV) 2 mg, Moderate Hepatic Impairment | EXPERIMENTAL | Participants with moderate hepatic impairment will receive BLV 2 mg subcutaneous (SC) injection, once daily for 6 days starting on Day 1. |
| Group A: BLV 2 mg, Matched Control | EXPERIMENTAL | Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants will receive BLV 2 mg SC injection once daily for 6 days starting on Day 1. |
| Group B: BLV 2 mg, Severe Hepatic Impairment | EXPERIMENTAL | Participants with severe hepatic impairment will receive BLV 2 mg SC injection, once daily for 6 days starting on Day 1. |
| Group B: BLV 2 mg, Matched Control | EXPERIMENTAL | Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants will receive BLV 2 mg SC injection once daily for 6 days starting on Day 1. |
| Group C: BLV 10 mg, Moderate Hepatic Impairment | EXPERIMENTAL | Participants with moderate hepatic impairment will receive BLV 10 mg SC injection, once daily for 6 days starting on Day 1. |
| Group C: BLV 10 mg, Matched Control | EXPERIMENTAL | Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants will receive BLV 10 mg SC injection once daily for 6 days starting on Day 1. |
| Group D: BLV 10 mg, Severe Hepatic Impairment | EXPERIMENTAL | Participants with severe hepatic impairment will receive BLV 10 mg SC injection, once daily for 6 days starting on Day 1. |
| Group D: BLV 10 mg, Matched Control | EXPERIMENTAL | Control group participants with normal hepatic function matched similar to moderate hepatic impairment participants will receive BLV 10 mg SC injection once daily for 6 days starting on Day 1. |
| 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 an investigational small molecule being developed for chronic hepatitis D infection, also known as chronic hepatitis delta, and for hepatic impairment. It is being studied in patients with chronic hepatitis delta, a serious liver disease caused by the hepatitis D virus.
Bulevirtide is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. Gilead is conducting clinical trials to evaluate the safety and efficacy of Bulevirtide in patients with chronic hepatitis delta.
Bulevirtide is in Phase 1 clinical development. It has completed Phase 1 trials, including studies in participants with normal and impaired renal function and in participants with normal or impaired liver function. Bulevirtide is investigational and has not been approved by regulatory authorities.
Bulevirtide has been studied in four completed clinical trials. NCT03852433 and NCT03852719 assessed efficacy and safety in chronic hepatitis delta, with 175 and 150 participants respectively. NCT05760300 and NCT05765344 were Phase 1 studies in participants with impaired renal or hepatic function.
Bulevirtide is also known by the brand name Hepcludex. It is an investigational small molecule being developed by Gilead Sciences for the treatment of chronic hepatitis delta. The drug targets the sodium taurocholate cotransporting polypeptide (NTCP) receptor to block viral entry into liver cells.