Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Adefovir dipivoxil · 6 trials · 3 indications
Determined by positive hepatitis B serology (tests positive for HBsAg) and HBV DNA viral load (\>40 IU/mL).
| Arm | Type | Description |
|---|---|---|
| Treatment Arm 1 | OTHER | Adefovir dipivoxil 10 mg once daily with tacrolimus or cyclosporine for 14 days |
| ADV plus hepatitis B vaccination | EXPERIMENTAL | Adefovir dipivoxil and hepatitis B vaccination: All subjects will receive adefovir 10mg po daily, or adjusted for renal function and an option for Hepatitis B vaccination, double dose. |
| Treatment Group A | OTHER | ADV (0.14 mg/kg) oral suspension formulation on Day 1 followed by ADV (0.3 mg/kg) oral suspension formulation on Day 8 in 2-6 and 7-11 year old age group |
| Treatment Group B | OTHER | ADV (0.3 mg/kg) oral suspension formulation on Day 1 followed by ADV (0.14 mg/kg) oral suspension formulation on Day 8 in 2-6 and 7-11 year old age group |
| Treatment Group C | OTHER | ADV 10 mg single dose on Day 1 in 12-17 year old age group |
| Name | Type | Description |
|---|---|---|
| Adefovir Dipivoxil | DRUG | Adefovir dipivoxil 10 mg once daily for 14 days co-administered with tacrolimus or cyclosporine |
| Adefovir dipivoxil and hepatitis B vaccination | DRUG | Adefovir 10mg po daily, or adjusted for renal function and option for Hepatitis B vaccination, double dose |
Inclusion Criteria: * 18-65 years of age * Greater than or equal to 6 months post-liver transplantation * Must be on a documented stable total daily dose of tacrolimus or cyclosporine for three months. * Must have calculated creatinine clearance greater than or equal 50 mL/min (Cockcroft-Gault meth...
Adefovir Dipivoxil is an investigational small molecule being developed for HIV infections, Hepatitis B, and Chronic Hepatitis B. It is a nucleotide analog reverse transcriptase inhibitor that has been studied in Phase 3 clinical trials for chronic Hepatitis B. The drug is not approved and remains in clinical development.
Adefovir Dipivoxil targets hepatitis B virus reverse transcriptase, an enzyme essential for viral replication. By inhibiting this enzyme, the drug aims to suppress viral DNA synthesis and reduce hepatitis B viral load in infected patients. This mechanism is relevant to its use in treating chronic Hepatitis B infections.
Adefovir Dipivoxil is developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker GILD. Gilead has conducted multiple clinical trials of this drug for chronic Hepatitis B, including studies in adult and pediatric populations.
Adefovir Dipivoxil has completed Phase 3 clinical trials for chronic Hepatitis B, with three completed trials involving 221 total participants. However, the drug is still investigational and has not received FDA approval. Its development status is not specified beyond these completed trials.
Adefovir Dipivoxil has been studied in completed trials including NCT00071201, a Phase 3 study of a liquid suspension in 48 adults with chronic Hepatitis B, and NCT00095121, a Phase 3 trial in 173 children and adolescents. Additional Phase 1 studies include NCT00645294 and NCT01146808.
Adefovir Dipivoxil is the generic name for the drug also known as Hepsera, which is a brand name used for adefovir dipivoxil. The drug is being developed by Gilead Sciences for chronic Hepatitis B and has been evaluated in clinical trials under the name Adefovir Dipivoxil.