CLINICAL TRIALS PROFILE FOR ADEFOVIR DIPIVOXIL

505(b)(2) Clinical Trials for ADEFOVIR DIPIVOXIL

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Bristol-Myers Squibb	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Dupont Applied Biosciences	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination	NCT00002234 ↗	Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients	Completed	Glaxo Wellcome	Phase 2	1969-12-31	The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.

All Clinical Trials for ADEFOVIR DIPIVOXIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000843 ↗	The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To evaluate the single-dose pharmacokinetic profile and acute toxicity of bis-POM PMEA ( adefovir dipivoxil ) in HIV-1 infected children, and to determine whether age-related differences exist. To ascertain dosages that may be suitable for a multiple-dose evaluation in this patient population. Although the oral bioavailability of PMEA ( adefovir ) is low, the prodrug bis-POM PMEA has resulted in increased bioavailability in adult patients in clinical trials. However, the safety and pharmacokinetic patterns of drugs in infants often differ from those of adults and the direction of the variation is not predictable. This study will assess these parameters of bis-POM PMEA in children.
NCT00000885 ↗	Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination With Nucleoside Analogs: A Rollover Study for ACTG 320	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	1969-12-31	Group A: To compare the time to confirmed virologic failure (2 consecutive plasma HIV-RNA concentrations of 500 copies/ml or more) between the treatment arms: abacavir (ABC) or placebo in combination with zidovudine (ZDV), lamivudine (3TC), and indinavir (IDV). To evaluate the safety and tolerability of these treatment arms. [AS PER AMENDMENT 06/16/99: To compare the time to confirmed treatment failure, permanent discontinuation of treatment, or death between the treatment arms.] [AS PER AMENDMENT 12/27/01: Groups B, C, and D completed follow-up on March 4, 1999. Therefore, only information pertinent to Group A is applicable.] Group B: To compare the proportion of patients who achieve plasma HIV-1 RNA concentrations below 500 copies/ml, as assessed by the standard Roche Amplicor assay at Week 16, or to compare the absolute changes in plasma HIV-1 RNA concentrations at Week 16 across the treatment arms: ABC or approved nucleoside analogs and nelfinavir (NFV) or placebo in combination with efavirenz (EFV) and adefovir dipivoxil. To compare the safety and tolerability of these treatment arms. Group C: To monitor plasma HIV-1 RNA trajectory over time and determine the time to a confirmed plasma HIV-1 RNA concentration above 2,000 copies/ml on 2 consecutive determinations for patients treated with ZDV or stavudine (d4T) plus 3TC and IDV. Group D: To evaluate plasma HIV-1 RNA responses at Weeks 16 and 48. To evaluate the safety and tolerability of the treatment arms: ABC, EFV, adefovir dipivoxil, and NFV. This study explores new treatment options for ACTG 320 enrollees (and, if needed, a limited number of non-ACTG 320 volunteers) who have been receiving ZDV (or d4T) plus 3TC and IDV and are currently exhibiting a range of virologic responses. By dividing the study into the corresponding, nonsequential cohorts (Groups A, B, C, D), different approaches to evaluating virologic success, i.e., undetectable plasma HIV-1 RNA levels, and virologic failure, i.e., plasma HIV-1 RNA levels of 500 copies/ml or more [AS PER AMENDMENT 12/27/01: 200 copies/ml or more], are explored while maintaining long-term follow-up of ACTG 320 patients. [AS PER AMENDMENT 12/27/01: Groups B, C, and D completed follow-up on March 4, 1999. Therefore, only information pertinent to Group A is applicable. This study will examine the question of whether intensification of therapy can prolong the virologic benefit in individuals whose plasma HIV-1 RNA concentrations have been below the limits of assay detection on ZDV (or d4T) plus 3TC plus IDV.]
NCT00000892 ↗	A Study of Several Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Used Indinavir	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To compare the proportion of patients whose plasma HIV-1 RNA is below 500 copies/ml after 16 weeks of treatment. To assess the safety, toxicity, and tolerance of each treatment arm. While indinavir is currently the most commonly prescribed protease inhibitor, the optimal therapy for a person on an indinavir-containing regimen who experiences a rebound in viral load or never experiences a decrease in viral load below 500 copies per milliliter is unknown. Current clinical practice for such patients typically involves empiric use of a combination of other protease inhibitors (saquinavir/nelfinavir or saquinavir/ritonavir) and at least 1 other antiretroviral agent to which the patient has had little or no prior exposure. This may involve the use of 1 or more reverse transcriptase inhibitors (RTIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs). This study attempts to formally evaluate some of these options in indinavir-experienced patients.

Clinical Trial Conditions for ADEFOVIR DIPIVOXIL

Condition Name

Condition Name for ADEFOVIR DIPIVOXIL
Intervention	Trials
Chronic Hepatitis B	28
HIV Infections	21
Hepatitis B	17

Condition MeSH

Condition MeSH for ADEFOVIR DIPIVOXIL
Intervention	Trials
Hepatitis B	57
Hepatitis	54
Hepatitis A	49

Clinical Trial Locations for ADEFOVIR DIPIVOXIL

Trials by Country

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Trials by Country for ADEFOVIR DIPIVOXIL
Location	Trials
United States	252
China	59
Canada	13
Korea, Republic of	12
Australia	11

Trials by US State

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−

Trials by US State for ADEFOVIR DIPIVOXIL
Location	Trials
California	25
New York	21
Maryland	18
Massachusetts	13
Texas	13

Clinical Trial Progress for ADEFOVIR DIPIVOXIL

Clinical Trial Phase

Clinical Trial Phase for ADEFOVIR DIPIVOXIL
Clinical Trial Phase	Trials
Phase 4	20
Phase 3	17
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for ADEFOVIR DIPIVOXIL
Clinical Trial Phase	Trials
Completed	58
Unknown status	11
Withdrawn	4

Clinical Trial Sponsors for ADEFOVIR DIPIVOXIL

Sponsor Name

Sponsor Name for ADEFOVIR DIPIVOXIL
Sponsor	Trials
Gilead Sciences	24
GlaxoSmithKline	13
National Institute of Allergy and Infectious Diseases (NIAID)	10

Sponsor Type

Sponsor Type for ADEFOVIR DIPIVOXIL
Sponsor	Trials
Industry	66
Other	42
NIH	11

Adefovir Dipivoxil: Clinical Trials, Market Analysis, and Projections

Introduction to Adefovir Dipivoxil

Adefovir dipivoxil, an acyclic nucleotide analog reverse transcriptase inhibitor (ntRTI), is a crucial drug in the treatment of hepatitis B virus (HBV) infection. Here, we will delve into the clinical trials, market analysis, and future projections for this significant antiviral medication.

Clinical Trials Overview

Phase III Studies

Adefovir dipivoxil has undergone extensive clinical trials to evaluate its safety and efficacy. One of the pivotal Phase III studies, known as Study 438, involved patients with precore mutant chronic HBV infection. This study demonstrated that 64% of patients treated with adefovir dipivoxil 10 mg once daily showed significant improvements in liver histology after 48 weeks, compared to 33% of patients receiving placebo[1].

Another key Phase III trial, Study 437, focused on patients with HBe antigen-positive chronic HBV infection. The results from this study also met the primary and secondary endpoints, further solidifying the efficacy of adefovir dipivoxil[1].

Safety and Resistance Profile

The safety profile of adefovir dipivoxil has been favorable. In Study 438, the discontinuation rate was similar between the treatment and placebo groups, with only 2% of patients discontinuing due to adverse events. No significant renal function abnormalities were observed, and the incidence of grade 3 and 4 laboratory abnormalities and clinical adverse events was similar between the treatment and placebo arms[1].

Preliminary genotypic analyses from these studies showed no adefovir resistance mutations after 48 weeks of treatment, confirming earlier clinical and in vitro studies[1].

Additional Clinical Data

Adefovir dipivoxil has also been studied in various other patient populations, including those with lamivudine-resistant HBV, patients post-liver transplantation, and those co-infected with HIV. These studies presented at the European Association for the Study of the Liver (EASL) further highlighted the drug's efficacy across different patient groups[3].

Market Analysis

Market Size and Growth

The adefovir dipivoxil market is expected to witness considerable growth driven by the significant prevalence of hepatitis B and associated conditions. The market is projected to register a substantial CAGR from 2023 to 2031, with the global market size estimated to increase significantly during this period[2][5].

Market Segmentation

The market is segmented based on application and distribution channel. The primary application is the treatment of hepatitis B, with other applications also being considered. Distribution channels include hospital pharmacies, retail pharmacies, and others[2].

Regional Framework

The market is analyzed across major regions such as North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America. Each region is further sub-segmented by country to provide a detailed overview. The APAC region, particularly countries like China, Korea, Japan, and Taiwan, is expected to play a significant role due to the high prevalence of HBV and the licensing agreement between Gilead and GlaxoSmithKline (GSK) for these territories[2][3].

Market Dynamics

Key drivers of the market include the high prevalence of hepatitis B, strong pipeline candidates, and the need for effective antiviral treatments. However, stringent government regulations are expected to be a restraint on market growth[2].

Market Projections

Future Growth Opportunities

The adefovir dipivoxil market is anticipated to have lucrative growth opportunities due to the rising demand for effective treatments for chronic HBV infection. The licensing agreement between Gilead and GSK will facilitate broader market access, especially in regions with high HBV prevalence[3].

Competitive Landscape

The market includes key players such as Gilead Sciences and GSK, with other companies also focusing on organic and inorganic growth strategies. These strategies include product launches, partnerships, and collaborations, which are expected to expand the business and customer base of market players[2].

Key Takeaways

• Clinical Efficacy: Adefovir dipivoxil has shown significant improvements in liver histology and is effective against various HBV strains, including lamivudine-resistant HBV.
• Safety Profile: The drug has a favorable safety profile with minimal discontinuations and no significant renal function abnormalities.
• Market Growth: The market is expected to grow substantially due to the high prevalence of hepatitis B and the need for effective treatments.
• Regional Impact: The APAC region is expected to be a major contributor to market growth due to licensing agreements and high HBV prevalence.
• Competitive Landscape: Key players are adopting various growth strategies to expand their market presence.

FAQs

What is the primary use of adefovir dipivoxil?

Adefovir dipivoxil is primarily used for the treatment of chronic hepatitis B virus (HBV) infection.

What were the key findings from the Phase III clinical trials of adefovir dipivoxil?

The Phase III trials showed significant improvements in liver histology in patients treated with adefovir dipivoxil compared to placebo, with no observed resistance mutations after 48 weeks of treatment[1].

Which regions are expected to dominate the adefovir dipivoxil market?

The Asia-Pacific region, particularly countries like China, Korea, Japan, and Taiwan, is expected to dominate the market due to high HBV prevalence and licensing agreements[2][3].

What are the main drivers and restraints of the adefovir dipivoxil market?

The main drivers include the high prevalence of hepatitis B and the need for effective antiviral treatments. Stringent government regulations are expected to be a restraint on market growth[2].

Who are the key players in the adefovir dipivoxil market?

Key players include Gilead Sciences and GlaxoSmithKline, with other companies also involved in the market through various growth strategies[2][3].

Sources

1. Gilead Sciences, "Gilead Sciences Announces Results From Phase III Study of Adefovir Dipivoxil in Precore Mutant Chronic Hepatitis B Virus Infection," 2001.
2. The Insight Partners, "Adefovir Dipivoxil Market Key Findings by 2031."
3. Gilead Sciences, "Gilead and GlaxoSmithKline Announce International Licensing Agreement for Investigational Chronic Hepatitis B Drug Adefovir Dipivoxil," 2002.
4. Gilead Sciences, "Gilead Begins Second Pivotal Phase III Trial of Once Daily Oral Hepatitis B Drug Adefovir Dipivoxil 10 mg," 2000.
5. Cognitive Market Research, "Global Adefovir Dipivoxil Market Report 2024 Edition."