Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tenofovir disoproxil · 1 trial · 1 indication
The number of participants with Hepatitis B Virus (HBV) deoxyribonucleic acid (DNA) \<400 copies/milliliter (mL) at Week 48 in the hepatitis B e antigen (HBeAg)-positive and HBeAg-negative population was assessed. HBeAg is a viral protein that is secreted by hepatitis B-infected cells. It is associated with chronic hepatitis B infections and is used as a marker of active viral disease and a participant's degree of infectiousness. A positive result indicates that the participant has high levels of virus in the blood and greater infectiousness. Usually, a negative result indicates that the participant has lower levels of virus in the blood and is less infectious. A "non-completers equal failures" approach is used for the analysis in ITT population. Only those participants available at the specified time points (represented by n=X in the category titles) were analyzed.
| Arm | Type | Description |
|---|---|---|
| A (TDF tablets) | EXPERIMENTAL | Tenofovir disoproxil fumarate (TDF) tablets |
| B (ADV tablets) | ACTIVE_COMPARATOR | Adefovir dipivoxil (ADV) tablets |
| Name | Type | Description |
|---|---|---|
| Tenofovir disoproxil fumarate (TDF) tablets | DRUG | white, almond-shaped, film-coated tablets containing 300mg of TDF |
| Adefovir dipivoxil (ADV) tablets | DRUG | white to off-white, round, biconvex tablets containing 10mg of ADV |
Inclusion Criteria: * HBeAg positive/negative CHB with blood HBVDNA≥10\^5 copies/mL and elevated ALT * Nucleoside and nucleotide naïve CHB subjects. Previous lamivudine treatment is allowed in less than 10% of the total study population Exclusion Criteria: * subjects with hepatocellular carcinoma...
Tenofovir disoproxil is used for the treatment of hepatitis B. It is a small molecule being developed by GSK plc for this infectious disease indication. The drug is currently in Phase 3 clinical development for hepatitis B.
Tenofovir disoproxil is a nucleotide reverse transcriptase inhibitor that works by blocking the activity of reverse transcriptase, an enzyme essential for viral replication. This mechanism helps suppress hepatitis B virus replication in infected cells.
Tenofovir disoproxil is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's efficacy and safety for the treatment of hepatitis B.
Tenofovir disoproxil is in Phase 3 clinical development for hepatitis B. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being studied in a completed Phase 3 trial to assess its efficacy and safety.
Tenofovir disoproxil has one completed Phase 3 clinical trial registered under NCT01300234. This trial, titled 'Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) 300mg in Chinese Subjects With Chronic Hepatitis B (CHB)', enrolled 512 participants in China. The study was randomized, double-blind, and active-controlled.
Tenofovir disoproxil is the same as tenofovir disoproxil fumarate (TDF). The clinical trial NCT01300234 specifically evaluates tenofovir disoproxil fumarate 300mg, which is the fumarate salt form of tenofovir disoproxil. Both names refer to the same active pharmaceutical ingredient.