Drugs / Adefovir dipivoxil
Adefovir dipivoxil
also known as
ADV · bis-POM PMEA · Preveon · 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine · Adefovir · Hepsera · ADF
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic hepatitis B virus infection 2 milestones | |||||
| Filed | EU (EMA) | Hepsera | chronic hepatitis B virus infection | 2002-03-26 | “Gilead recently filed a New Drug Application (NDA) for adefovir dipivoxil with the U.S. Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) with...” gilead.com ↗ “The approval of Hepsera by the European Commission comes less than a year after Gilead filed its Marketing Authorisation Application with the European authorities” gilead.com ↗ “Also in late March, Gilead announced the submission of a Marketing Authorisation Application (MAA) to the EMEA for adefovir dipivoxil.” gilead.com ↗ |
| Filed | US (FDA) | — | chronic hepatitis B virus infection | 2002-03-21 | “Gilead recently filed a New Drug Application (NDA) for adefovir dipivoxil with the U.S. Food and Drug Administration (FDA).” gilead.com ↗ “the adefovir dipivoxil New Drug Application (NDA), submitted on March 21, 2002.” gilead.com ↗ |
| Withdrawn Indication not stated 4 milestones | |||||
| Withdrawn | EU (EMA) | Hepsera | — | 2022-12-31 | europa.eu ↗ |
| Label expansions (4) | US (FDA) | HEPSERA | — | 2004-08-19 – 2007-12-19 | fda.gov ↗ |
| Approved | EU (EMA) | Hepsera | — | 2003-03-06 | europa.eu ↗ |
| Approved | US (FDA) | HEPSERA | — | 2002-09-20 | fda.gov ↗ |
Trials 45
News releases announcing trial results or a regulatory action · 38
| Date | Issuer | Release |
|---|---|---|
| 2010-08-19 | Gilead Sciences | Regulatory Gilead Sciences Announces Notification of ANDA Filing for Hepsera(R) gilead.com ↗ |
| 2008-12-03 | Gilead Sciences | Results Data Demonstrating Significant Efficacy of Viread(R) in Treating Chronic Hepatitis B Published in New England Journal of Medicine gilead.com ↗
Data also indicate that at week 48, Viread was superior to Hepsera in reducing HBV DNA levels to below 400 copies/mL and was comparable to Hepsera in achieving histological response. |
| 2008-11-01 | Gilead Sciences | Results Gilead Announces Two-Year Data from Pivotal Phase III Studies Evaluating Viread(R) for Chronic Hepatitis B gilead.com ↗
The studies also show that all Hepsera-treated patients whose HBV levels were suppressed at week 48 maintained viral suppression after rolling over to Viread |
| 2007-11-02 | Gilead Sciences | Results Gilead Announces 48-Week Data from Two Pivotal Phase III Studies Evaluating Viread(R) For the Treatment of Chronic Hepatitis B gilead.com ↗
In addition, three percent of Viread patients (n=153) compared to zero percent of Hepsera patients (n=80; p=0.018) experienced "s" antigen (HBsAg) loss, which can indicate that a patient has cleared chronic hepatitis B infection. |
| 2007-06-25 | Gilead Sciences | Results Second Phase III Study Evaluating Gilead's Viread(R) for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint gilead.com ↗
The data show that Viread is non-inferior to the company's once-daily antiviral drug Hepsera(R) (adefovir dipivoxil) among patients with "e" antigen (HBeAg)-positive chronic hepatitis B. |
| 2007-06-06 | Gilead Sciences | Results Phase III Study Evaluating Gilead's Viread(R) for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint gilead.com ↗
The study shows that Viread is non-inferior to the company's once-daily antiviral drug Hepsera(R) (adefovir dipivoxil) among patients with HBeAg-negative/anti-HBe positive (presumed pre-core mutant) chronic HBV infection. |
| 2005-11-14 | Gilead Sciences | Results Five-Year Data Evaluating Long-Term Therapy with Hepsera(R) for Hepatitis B ''e'' Antigen-Negative Chronic Hepatitis B Presented at AASLD Annual Meeting gilead.com ↗
In this analysis, which includes the first prospective set of liver biopsies following five years of oral antiviral therapy, treatment with Hepsera resulted in regression of liver fibrosis in 75 percent of patients. |
| 2005-06-29 | Gilead Sciences | Results Data Evaluating Long-Term Therapy with Hepsera for Hepatitis B ''e'' Antigen-Negative Chronic Hepatitis B Published in the New England Journal of Medicine gilead.com ↗
Continued viral suppression and changes in laboratory markers of liver function were evaluated through three years. |
| 2004-11-02 | Gilead Sciences | Results Gilead Announces Long-Term Safety and Efficacy Data, Through 144 Weeks, for Hepsera in Patients With Chronic Hepatitis B gilead.com ↗
This study suggests that in first-line treatment, Hepsera offers tolerability, continued inhibition of viral replication and normalization of liver enzymes for up to 144 weeks, with an increasing percent of patients achieving HBeAg seroconversion. |
| 2004-04-15 | Gilead Sciences | Results New Data Support Hepsera's Long-Term Efficacy against Chronic Hepatitis B gilead.com ↗
In this study, patients treated with Hepsera showed progressive reductions in serum HBV DNA replication and sustained ALT normalization through 144 weeks of treatment. |
| 2003-10-28 | Gilead Sciences | Results Gilead Announces 144-Week Data of Hepsera in Patients Co-Infected With HIV And Lamivudine-Resistant HBV gilead.com ↗
In this study, co-infected patients who received Hepsera showed sustained suppression of HBV through nearly three years of therapy. |
| 2003-04-09 | Gilead Sciences | Results 96-Week Data Show Hepsera Reduces Liver Damage and Improves Liver Function in More Than 70 Percent of Patients with Hepatitis B ``E'' Antigen-Negative Disease gilead.com ↗
In this study, more than 70 percent of patients treated with Hepsera showed persistent suppression of HBV DNA viral replication, continued histological improvements and sustained improvements in liver function through 96 weeks of treatment. |
| 2003-03-11 | Gilead Sciences | Regulatory Gilead Sciences' Hepatitis B Drug Hepsera Approved for Marketing in European Union gilead.com ↗ |
| 2003-02-27 | Gilead Sciences | Results Results of Two Pivotal Studies of Gilead's Hepsera Published in the New England Journal of Medicine gilead.com ↗
In these studies, Hepsera slowed or even reversed signs of disease progression after a year in most patients, with good tolerability and no incidence of viral resistance. |
| 2002-11-21 | Gilead Sciences | Regulatory European CPMP Gives Positive Opinion On Hepsera, Gilead's Treatment for Chronic Hepatitis B; Recommendation Granted Eight Months After Filing gilead.com ↗ |
| 2002-11-04 | Gilead Sciences | Results New Data Demonstrate Antiviral Activity of Gilead's Hepsera in Patients with Lamivudine-Resistant Chronic Hepatitis B gilead.com ↗ |
| 2002-09-23 | Gilead Sciences | Regulatory FDA Approves Gilead's Hepsera(TM) for the Treatment of Chronic Hepatitis B gilead.com ↗
Gilead Sciences (Nasdaq: GILD) today announced that it received U.S. Food and Drug Administration (FDA) approval on Friday, September 20 for its antiviral agent Hepsera(TM) (adefovir dipivoxil) for the treatment of chronic hepatitis B. |
| 2002-08-06 | Gilead Sciences | Regulatory FDA Advisory Committee Unanimously Supports Approval of Gilead's Adefovir Dipivoxil to Treat Chronic Hepatitis B gilead.com ↗
Advisory committee members unanimously agreed that the adefovir dipivoxil pivotal study data supports the drug's safety and efficacy in patients with chronic hepatitis B. |
| 2002-04-19 | Gilead Sciences | Results Data From Study of Gilead's Adefovir Dipivoxil in Hepatitis B Patients With Lamivudine-Resistant Virus Presented At International Medical Meeting gilead.com ↗
These data indicate that adefovir dipivoxil, whether used alone or in combination with lamivudine, is active against HBV resistance mutations that develop in nearly one third of patients within one year of beginning treatment with lamivudine, |
| 2002-04-18 | Gilead Sciences | Results Gilead Announces Presentation of Data From Phase III Study of Adefovir Dipivoxil in Patients With Precore Mutant Chronic Hepatitis B gilead.com ↗ |
| 2002-04-18 | Gilead Sciences | Results 92-Week Data From Clinical Study of Gilead's Adefovir Dipivoxil in Patients Co-Infected With HIV and Lamivudine-Resistant HBV Presented At International Medical Meeting gilead.com ↗
After 92 weeks of treatment, adefovir dipivoxil was associated with a significant decrease in mean serum HBV DNA levels of 5.13 log10 copies/mL (n=31; p less than 0.001). |
| 2002-03-26 | Gilead Sciences | Regulatory Gilead Submits Marketing Authorisation Application for Adefovir Dipivoxil 10 mg for Treatment of Chronic Hepatitis B; EU Application Follows Submission to FDA gilead.com ↗ |
| 2002-03-21 | Gilead Sciences | Regulatory Gilead Submits New Drug Application to U.S. FDA for Adefovir Dipivoxil 10 mg for the Treatment of Chronic Hepatitis B gilead.com ↗ |
| 2001-11-13 | Gilead Sciences | Results Gilead Announces Data from Studies of Adefovir Dipivoxil in Patients with Lamivudine-Resistant Chronic Hepatitis B Virus Infection gilead.com ↗
In this study, treatment with adefovir dipivoxil 10 mg once daily for 48 weeks resulted in a statistically significant decrease in HBV DNA of 4.6 log10 copies/mL (n=28). |
| 2001-11-12 | Gilead Sciences | Results Gilead Announces Data from Studies of Adefovir Dipivoxil Demonstrating Significant Improved Liver Function and Viral Load Reduction in Patients with Chronic Hepatitis B Virus Infection gilead.com ↗
Additional data presented yesterday at AASLD describe results of long-term treatment with adefovir dipivoxil, including the drug’s effect on HBV DNA suppression, seroconversion and lack of resistance development to treatment with adefovir dipivoxil. |
| 2001-11-09 | Gilead Sciences | Results Gilead Announces Primary Endpoint Met in Phase III Study of Adefovir Dipivoxil 10 mg in Patients with Lamivudine-Resistant Chronic Hepatitis B Infection gilead.com ↗
These early data suggest a potential medical approach to the treatment of lamivudine-resistant HBV, showing that adefovir dipivoxil 10 mg monotherapy reduces viral load in patients who have developed resistance to lamivudine. |
| 2001-09-19 | Gilead Sciences | Results Gilead Sciences Announces Results From Phase III Study of Adefovir Dipivoxil In Precore Mutant Chronic Hepatitis B Virus Infection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced preliminary data from a Phase III clinical trial (Study 438) evaluating the safety and efficacy of adefovir dipivoxil 10 mg once daily as monotherapy compared to placebo in patients infected with precore mutant chronic hepatitis B virus (HBV). |
| 2001-06-22 | Gilead Sciences | Results Gilead Achieves Primary Endpoint in Phase III Study of Adefovir Dipivoxil for Chronic Hepatitis B Virus Infection gilead.com ↗
Results from this intent-to-treat analysis meet the study's primary endpoint of improvement in liver histology at week 48 compared to baseline. |
| 2001-04-23 | Gilead Sciences | Results Gilead Sciences Announces Data from Studies of Adefovir Dipivoxil, Investigational Agent for the Treatment of Chronic Hepatitis B Infection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced data from four studies of adefovir dipivoxil, the company's investigational antiviral agent for the treatment of chronic hepatitis B virus (HBV) infection, at the 36th Annual Meeting of the European Association for the Study of the Liver (EASL) in Prague, The Czech Republic. |
| 2000-12-11 | Gilead Sciences | Regulatory Gilead Sciences Receives Approval to Initiate Clinical Trials in China for Adefovir Dipivoxil, an Investigational Compound for the Treatment of Chronic Hepatitis B Infection gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that it has received approval from the People’s Republic of China State Drug Administration of its clinical trial application for adefovir dipivoxil, the company’s investigational compound for the treatment of patients with chronic hepatitis B virus (HBV) infection. |
| 2000-10-31 | Gilead Sciences | Results Gilead Sciences Announces Preliminary Results from Study of Adefovir Dipivoxil 10 mg for the Treatment of Patients Co-infected with HIV and Chronic Hepatitis B gilead.com ↗
Preliminary results from this 12-month study show that treatment with adefovir dipivoxil 10 mg once daily is associated with a mean decrease in HBV DNA of 3.40 log10 copies/mL at 24 weeks. |
| 2000-04-11 | Gilead Sciences | Results Gilead Presents Preliminary Clinical Data Describing Activity of Adefovir Dipivoxil Against Lamivudine-Resistant Hepatitis B Virus gilead.com ↗
The data suggest that treatment with adefovir dipivoxil was associated with suppression of HBV DNA to undetectable levels in 80 percent of patients who had 12 to 15 months of treatment. |
| 1999-11-01 | Gilead Sciences | Regulatory Gilead Sciences Announces Results of FDA Advisory Panel on Anti-HIV Agent, Adefovir Dipivoxil 60 Mg gilead.com ↗
Following the company's presentation, the Committee recommended that the FDA not approve adefovir dipivoxil 60 mg based on the currently available data. |
| 1999-10-25 | Gilead Sciences | Regulatory Gilead Sciences Completes European Marketing Authorisation Application For Anti-HIV Agent Adefovir Dipivoxil 60 Mg gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Medicines Evaluation Agency (EMEA) has accepted the Company’s Marketing Authorisation Application (MAA) for adefovir dipivoxil 60 mg, an investigational, once-daily, oral nucleotide reverse transcriptase inhibitor intended for the treatment of patients with HIV infection. |
| 1999-04-09 | Gilead Sciences | Results Gilead Presents Preliminary Clinical Data Demonstrating Activity of Adefovir Dipivoxil Against Lamivudine-Resistant Hepatitis B Virus gilead.com ↗
In these preliminary observations, it is particularly encouraging that treatment with adefovir dipivoxil resulted in a rapid virologic response that has been sustainable for more than six months. |
| 1998-09-23 | Gilead Sciences | Results Gilead Sciences Provides Update on PREVEON® Clinical Program for the Treatment of HIV gilead.com ↗
These data demonstrate that PREVEON has durable anti-HIV activity in treatment-experienced patients, including those infected with strains of HIV resistant to most currently approved therapies. |
| 1998-04-28 | Gilead Sciences | Results Gilead Announces Adefovir Dipivoxil Reduces Hepatitis B Levels by More than 99 Percent in Chronically Infected Patients gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) announced today that treatment with adefovir dipivoxil for 12 weeks significantly reduced blood levels of hepatitis B virus (HBV) DNA to an undetectable level in the majority of patients. |
| 1996-09-16 | Gilead Sciences | Results Gilead Sciences Announces Statistically Significant Antiviral Activity Against Hepatitis B Virus gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) announced today Phase I/II data demonstrating that during treatment, GS 840 (adefovir dipivoxil) was well tolerated and resulted in significant and sustained antiviral activity against hepatitis B virus (HBV). |
All press releases naming this drug 50 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 66 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Adefovir dipivoxil | “After 48 weeks of randomised double-blind comparison (trials NCT00117676 and NCT00116805) of tenofovir DF with adefovir dipivoxil, participants (positive or negative for HBeAg)...” PMID 23234725 ↗ Dec 201263“Investigational Product(s) Adefovir dipivoxil 10mg tablets will be supplied by GlaxoSmithKline and presented as a white to off white, round tablets, packaged in the bottle...” NCT01205165 ↗ “This project is a randomized, open-label trial of adefovir dipivoxil (Hepsera) and lamivudine combination therapy versus adefovir dipivoxil (Hepsera) monotherapy.” NCT00230477 ↗ “Adefovir Dipivoxil (12 weeks) + open lable Adefovir Dipivoxil (28 weeks) + Adefovir Dipivoxil (12 weeks) + Open label Adefovir Dipivoxil (52-260weeks)” NCT00857675 ↗ “tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of pre-core mutant chronic hepatitis B” NCT00117676 ↗ “Provide adefovir dipivoxil (Hepsera) 10 mg once daily to patients with chronic hepatitis B virus (HBV) infection” NCT00158704 ↗ “Total treatment period: 12 weeks, followed by 24 weeks of treatment with adefovir dipivoxil 10mg” NCT00895596 ↗ “A.antiviral drugs(Entecavir,Lamivudine,Adefovir dipivoxil,et al)” NCT01844063 ↗ “adefovir dipivoxil 10 mg per day (oral dose)” NCT01718587 ↗ “Adefovir Dipivoxil (ADV)” NCT00316719 ↗ |
| Known as | 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine | “Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients” NCT00002128 ↗1“9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA) (Adefovir Dipivoxil)” NCT00000843 ↗ |
| Known as | Adefovir | “Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations” NCT00002398 ↗1“Adefovir dipivoxil (adefovir)” NCT00371761 ↗ |
| Known as | ADF | “Adefovir Dipivoxil (ADF) at Two Dose Levels” NCT00002184 ↗ |
| Known as | ADV | “The purpose of this study is to see if it is safe and effective to give an experimental anti-HIV drug, adefovir dipivoxil (ADV), in combination with other anti-HIV drugs...” NCT00002426 ↗8“This study will investigate the safety and effectiveness of using adefovir dipivoxil (ADV), pegylated interferon (PEG-INF), and ribavirin (RBV) in patients triple-infected with...” NCT00051077 ↗ “Tenofovir disoproxil fumarate (TDF) and adefovir dipivoxil (ADV) are licensed for the treatment of HIV-1 and HBV infection, respectively, but both have in vivo and in vitro...” PMID 17058225 ↗ Nov 2006 “Patients in studies GS-US-174-0102 (HBeAg-) and GS-US-174-0103 (HBeAg+) were randomized 2:1 to receive TDF or adefovir dipivoxil (ADV) for 48 weeks followed by open-label TDF...” PMID 27658343 ↗ Sep 2016 “tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of pre-core mutant chronic hepatitis B” NCT00117676 ↗ “Arm A: APV plus saquinavir soft gel capsule (SQVsgc) plus abacavir (ABC) plus efavirenz (EFV) plus adefovir (ADV).” NCT00000912 ↗ “Adefovir dipivoxil (ADV) tablets” NCT01300234 ↗ “Adefovir Dipivoxil (ADV)” NCT00316719 ↗ “Adefovir Dipivoxil (ADV)” NCT00095121 ↗ |
| Known as | bis-POM PMEA | “Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients” NCT00002128 ↗5“To evaluate the anti-HIV activity, safety, and tolerance of adefovir dipivoxil ( bis-POM PMEA ) in combination with standard antiretroviral therapy for 48 weeks.” NCT00002161 ↗ “bis-POM PMEA ( adefovir dipivoxil ) versus placebo when administered orally on a daily basis for 2 weeks to HIV-infected patients.” NCT00002346 ↗ “9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA) (Adefovir Dipivoxil)” NCT00000843 ↗ “Preveon (Adefovir Dipivoxil; bis-POM PMEA)” NCT00002234 ↗ “Preveon (Adefovir Dipivoxil; Bis-POM PMEA)” NCT00002419 ↗ |
| Known as | Hepsera | “This project is a randomized, open-label trial of adefovir dipivoxil (Hepsera) and lamivudine combination therapy versus adefovir dipivoxil (Hepsera) monotherapy.” NCT00230477 ↗1“Provide adefovir dipivoxil (Hepsera) 10 mg once daily to patients with chronic hepatitis B virus (HBV) infection” NCT00158704 ↗ |
| Known as | Preveon | “Safety and Effectiveness of Giving Adefovir (Preveon) Plus Other Anti-HIV Drugs to HIV-Infected Patients Who Have Not Responded to Other Anti-HIV Drug Combinations” NCT00002398 ↗2“Preveon (Adefovir Dipivoxil; Bis-POM PMEA)” NCT00002419 ↗ “Preveon (Adefovir Dipivoxil; bis-POM PMEA)” NCT00002234 ↗ |
| Action | Inhibit | “inhibits HBV replication” NCT00023153 ↗ |
| Modality | Small molecule | “Both adefovir dipivoxil and lamivudine are nucleoside analogues approved by the U.S. FDA for the treatment of chronic hepatitis B.” NCT00230477 ↗ |
| Route | Oral | “Oral Antiviral Compound” NCT00000843 ↗ |