Adefovir
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic hepatitis B virus infection 4 milestones | |||||
| Filed | US (FDA) | — | chronic hepatitis B virus infection | — | “In late March, Gilead announced the submission of a New Drug Application (NDA) to the U.S. FDA for marketing approval of adefovir dipivoxil” gilead.com ↗ |
| Filed | EU (EMA) | — | chronic hepatitis B virus infection | — | “Also in late March, Gilead announced the submission of a Marketing Authorisation Application (MAA) to the EMEA for adefovir dipivoxil.” gilead.com ↗ |
| Filed | Japan (PMDA) | Hepsera | chronic hepatitis B virus infection | — | “In February, GSK received marketing approvals for Hepsera in Korea and Taiwan and submitted a Japanese New Drug Application (JNDA) for Hepsera in Japan.” gilead.com ↗ |
| Filed | Other | Hepsera | chronic hepatitis B virus infection | — | “Regulatory filings for the drug also have been completed in Australia, Switzerland, Turkey and Canada” gilead.com ↗ |
| Filed HIV infectious disease 2 milestones | |||||
| Filed | US (FDA) | — | HIV infectious disease | 1999-06-29 | “Gilead submitted a New Drug Application (NDA) for adefovir dipivoxil 60 mg for the potential treatment of HIV infection” gilead.com ↗ |
| Filed | EU (EMA) | — | HIV infectious disease | — | “Gilead filed a Marketing Authorisation Application (MAA) for adefovir dipivoxil for HIV with the European Medicines Evaluation Agency (EMEA)” gilead.com ↗ “in October 1999 filed a marketing application through the centralized procedure of the European Medicines Agency” gilead.com ↗ |
Trials 28
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03801759 | Jul → Sep 2018 | — | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT00002115 | — | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT00002326 | — | HIV infectious disease | Gilead Sciences | Completed | No outcome recorded |
| Phase 25 trials · 1 met primary | ||||||
| Phase 2 | NCT00960518 | Aug 2009 → Aug 2012 | hepatitis B virus infection, hepatocellular carcinoma | Tongji University | Unknown | No outcome recorded |
| Phase 2 | NCT00230490 | Jun 2005 → May 2007 | chronic hepatitis B virus infection | Bausch Health Americas, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT00023309 | Aug 2001 → Apr 2010 | hepatitis B virus infection | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | Met primary |
| Phase 2 | NCT00013702 | Mar 2001 → Feb 2004 | HIV infectious disease, hepatitis B virus infection | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00002219 | — | HIV infectious disease | Gilead Sciences | Unknown | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT00605384 | Aug 2008 → Feb 2009 | chronic hepatitis B virus infection | Bristol-Myers Squibb | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT00496158 | Aug 2007 → ? | chronic hepatitis B virus infection | Pharmasset | Terminated | No outcome recorded |
| Phase 3 | NCT00496002 | Aug 2007 → ? | chronic hepatitis B virus infection | Pharmasset | Terminated | No outcome recorded |
| Phase 417 trials · 2 met primary · 2 missed | ||||||
| Phase 4 | NCT02743260 | Apr 2016 → Dec 2017 | — | University of Cologne | Completed | Met primary |
| Phase 4 | NCT02560649 | May 2015 → Aug 2016 | chronic hepatitis B virus infection | Ruijin Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01928511 | Jan 2014 → Dec 2018 | chronic hepatitis B virus infection | Seng Gee Lim | Completed | Met primary |
| Phase 4 | NCT01834508 | Mar 2013 → Jun 2016 | chronic hepatitis B virus infection | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT01799486 | Feb 2013 | cirrhosis of liver | Lin Bingliang | Unknown | No outcome recorded |
| Phase 4 | NCT01693679 | Sep 2012 → Apr 2014 | cirrhosis of liver | Shao-quan Zhang | Unknown | No outcome recorded |
| Phase 4 | NCT01595633 | Mar 2012 → Feb 2014 | chronic hepatitis B virus infection | Yonsei University | Unknown | No outcome recorded |
| Phase 4 | NCT01263002 | Jun 2010 → Jan 2013 | hepatocellular carcinoma | Bukwang Pharmaceutical | Completed | No outcome recorded |
| Phase 4 | NCT00922207 | May 2010 → Sep 2014 | chronic hepatitis B virus infection | Hoffmann-La Roche | Completed | Missed primary |
| Phase 4 | NCT01086085 | Apr 2010 → Mar 2013 | chronic hepatitis B virus infection | Hoffmann-La Roche | Completed | Missed primary |
| Phase 4 | NCT01088009 | Mar 2010 → Feb 2013 | chronic hepatitis B virus infection | Nanfang Hospital, Southern Medical University | Completed | No outcome recorded |
| Phase 4 | NCT01546116 | Feb 2010 → Feb 2012 | chronic hepatitis B virus infection | Korea University | Completed | No outcome recorded |
| Phase 4 | NCT00986778 | Dec 2009 → Dec 2012 | chronic hepatitis B virus infection | Bristol-Myers Squibb | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT01264133 | Sep 2009 → Jun 2013 | chronic hepatitis B virus infection | Bukwang Pharmaceutical | Terminated | No outcome recorded |
| Phase 4 | NCT00718887 | Jul 2008 → Dec 2009 | chronic hepatitis B virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 4 | NCT00531167 | Apr 2007 → Apr 2011 | chronic hepatitis B virus infection | Korea University | Completed | No outcome recorded |
| Phase 4 | NCT00409019 | ? → Mar 2011 | chronic hepatitis B virus infection | Novartis Pharmaceuticals | Withdrawn | No outcome recorded Stop: Enrollment |
| Comparator or background therapy25 trials | ||||||
| Phase 1 | NCT00513968 Comparator | Jul 2007 → Apr 2010 | chronic hepatitis B virus infection | Genexine, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03491553 Background | Apr 2018 → Mar 2019 | chronic hepatitis B virus infection | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01943799 Background | Sep 2013 → Sep 2014 | chronic hepatitis B virus infection | Gilead Sciences | Completed | Missed primary |
| Phase 2 | NCT01706575 Background | Jan → Sep 2013 | chronic hepatitis B virus infection | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT02366208 Background | May 2011 → Jun 2013 | chronic hepatitis B virus infection | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03236584 Comparator | Sep 2015 → Mar 2018 | — | Uijeongbu St. Mary Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT02366247 Background | Aug 2013 → Dec 2015 | chronic hepatitis B virus infection | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT01192854 Comparator | Feb 2010 → May 2011 | chronic hepatitis B virus infection | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00640588 Comparator | Mar 2008 → Dec 2009 | chronic hepatitis B virus infection | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00410202 Comparator | Mar 2008 → Jan 2011 | chronic hepatitis B virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00096785 Comparator | Dec 2004 → Jan 2006 | hepatitis B virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00065507 Comparator | Aug 2003 → Oct 2008 | chronic hepatitis B virus infection | Bristol-Myers Squibb | Completed | Met primary |
| Phase 4 | NCT03084250 Comparator | Mar 2017 → Apr 2023 | hepatitis B virus infection | Shanghai Nanhui Nanhua Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02482272 Background | May 2015 → Jan 2017 | chronic hepatitis B virus infection | Asan Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01829685 Comparator | Mar 2013 → Jun 2016 | chronic hepatitis B virus infection | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT01732367 Comparator | Nov 2012 → Mar 2016 | chronic hepatitis B virus infection | Keimyung University Dongsan Medical Center | Completed | Met primary |
| Phase 4 | NCT01491295 Comparator | Sep 2012 → Dec 2019 | chronic hepatitis B virus infection | Taipei Veterans General Hospital, Taiwan | Unknown | No outcome recorded |
| Phase 4 | NCT01597934 Comparator | Aug 2012 → May 2014 | chronic hepatitis B virus infection | Yonsei University | Unknown | No outcome recorded |
| Phase 4 | NCT01373684 Comparator | May 2012 → Oct 2019 | chronic hepatitis B virus infection | Foundation for Liver Research | Completed | No outcome recorded |
| Phase 4 | NCT01529255 Comparator | Aug 2011 → Aug 2015 | chronic hepatitis B virus infection | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT01804387 Comparator | May 2011 → Dec 2013 | chronic hepatitis B virus infection | Korea University | Unknown | No outcome recorded |
| Phase 4 | NCT01341743 Comparator | Dec 2010 → Jun 2014 | chronic hepatitis B virus infection | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT01023217 Background | Nov 2009 → Jul 2012 | chronic hepatitis B virus infection | Asan Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00798460 Comparator | Dec 2008 → Jun 2010 | chronic hepatitis B virus infection | Inje University | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01139203 Comparator | Aug 2009 → Dec 2012 | hepatitis B virus infection | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 30
| 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 |
| 2008-04-26 | Bristol-Myers Squibb | Results BARACLUDE® (Entecavir) Treatment Resulted In Greater Viral Load Suppression Compared to Adefovir at 96 Weeks In Antiviral-Naive Adult Chronic Hepatitis B E-Antigen Positive Patients bms.com ↗
Of the 49 patients who remained in the study at 96 weeks, 79 percent (n=23/29) of BARACLUDE-treated patients and 50 percent (n=10/20) of adefovir-treated patients achieved undetectable viral load. |
| 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. |
| 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. |
| 2003-04-09 | 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 ↗
Patients receiving Hepsera alone or in combination with lamivudine experienced statistically significant reductions in both serum hepatitis B virus (HBV) DNA and alanine aminotransferase (ALT, a measure of liver damage), compared with patients who received lamivudine only. |
| 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 ↗ |
| 2001-11-12 | 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. |
| 2000-10-31 | 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. |
| 1999-04-09 | 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. |
| 1998-04-28 | 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 45 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Adefovir | “Patients will be on their existing nucleosid(t)e analogue therapy comprising lamivudine 100mg daily, adefovir 10mg daily, entecavir 0.5mg or 1.0mg daily or tenofovir 300mg...” NCT01928511 ↗52“Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)” NCT01943799 ↗ “Maintaining LAM/LdT+ADV combination Lamivudine 100mg / Telbivudine 600mg +Adefovir 10mg” NCT01597934 ↗ “Nucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir.” NCT01706575 ↗ “Adefovir 10mg QD for 36 months (adjust dosage according to renal function)” NCT01491295 ↗ “if HBV DNA breakthrough, add on oral adefovir 10mg daily” NCT01529255 ↗ “Adefovir (Hepsera®)” NCT03491553 ↗ “Adefovir (Hepsera)” NCT01373684 ↗ |
| Known as | 9-(2-Phosphonylmethoxyethyl)Adenine | “A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.” NCT00002115 ↗1“Combination Zidovudine (AZT) and 9-(2-Phosphonylmethoxyethyl)Adenine (PMEA; Adefovir) Treatment” NCT00002326 ↗ |
| Known as | Adefovir (Hepasera) | “Adefovir (Hepasera)” NCT01546116 ↗ |
| Known as | Adefovir (Hepsera) | “Adefovir (Hepsera)” NCT01373684 ↗1“adefovir (hepsera)” NCT01804387 ↗ |
| Known as | Adefovir dipivoxil | “BACKGROUND: The efficacy of switching to tenofovir disoproxil fumarate (TDF) monotherapy from lamivudine (LAM) plus adefovir dipivoxil (ADV) combination therapy (stable...” PMID 29329305 ↗ Jan 20181“Adefovir(Adefovir dipivoxil)10mg, od, from week -10 to week 48.” NCT00513968 ↗ |
| Known as | Adefovir dipivoxil (Hepsera) | “Adefovir dipivoxil (Hepsera)” NCT01023217 ↗ |
| Known as | ADV | “BACKGROUND: The efficacy of switching to tenofovir disoproxil fumarate (TDF) monotherapy from lamivudine (LAM) plus adefovir dipivoxil (ADV) combination therapy (stable...” PMID 29329305 ↗ Jan 20183“Suboptimal responses to lamivudine or telbivudine plus adefovir (LAM/LdT+ADV) rescue therapy are common in patients with LAM-resistant hepatitis B virus (HBV) infections.” PMID 32460460 ↗ May 2020 “The patients switched therapy to entecavir (ETV) with or without adefovir (ADV) for 104 weeks.” PMID 33500704 ↗ Jan 2021 “Adefovir (ADV)” NCT00065507 ↗ |
| Known as | Hepsera | “Adefovir (Hepsera®)” NCT03491553 ↗ |
| Known as | PMEA | “A Phase I/II Study of the Safety, Tolerance, and Pharmacokinetics of 9-(2-Phosphonylmethoxyethyl)Adenine ( PMEA; Adefovir ) in Patients With Advanced HIV Disease.” NCT00002115 ↗1“Combination Zidovudine (AZT) and 9-(2-Phosphonylmethoxyethyl)Adenine (PMEA; Adefovir) Treatment” NCT00002326 ↗ |
| Action | Inhibit | “Adefovir inhibits HBV by interfering with replication of the virus's genetic material” NCT00013702 ↗ |
| Route | Intravenous | “administered daily by intravenous (IV) and/or subcutaneous (SC) injection” NCT00002115 ↗ |
| Route | Subcutaneous | “administered daily by intravenous (IV) and/or subcutaneous (SC) injection” NCT00002115 ↗ |