CLINICAL TRIALS PROFILE FOR EPIVIR

505(b)(2) Clinical Trials for EPIVIR

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.
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	Gilead Sciences	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 EPIVIR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002168 ↗	A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients	Completed	Bristol-Myers Squibb	N/A	1969-12-31	The purpose of this study is to compare the safety and effectiveness of two anti-HIV drug combinations when given to HIV-infected patients who have never been treated with anti-HIV drugs. One drug combination is stavudine (d4T) plus didanosine (ddI) plus Crixivan. The other combination is Retrovir (AZT) plus Epivir (3TC) plus Crixivan.
NCT00002183 ↗	A Phase I Trial to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients With HIV Infection	Completed	Glaxo Wellcome	Phase 1	1969-12-31	To assess the safety and tolerance of multiple oral doses of 141W94 alone, in combination with 1592U89, and in combination with Retrovir and Epivir, administered to patients with HIV infection as measured by the development of clinical adverse experiences and laboratory test abnormalities. To determine the steady-state pharmacokinetics of 141W94 alone and in combination with 1592U89 after multiple oral dosing. To obtain preliminary evidence of antiretroviral activity of 141W94 alone and in combination with 1592U89, the antiretroviral effect of combined Retrovir/Epivir and the antiretroviral effect of 141W94 when added to Retrovir/Epivir or to 1592U89/Retrovir/Epivir.
NCT00002195 ↗	A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients	Completed	Glaxo Wellcome	Phase 3	1969-12-31	The purpose of this study is to see if it is safe and effective to add 141W94 to an anti-HIV regimen that includes retrovir plus epivir.
NCT00002203 ↗	A Study of Two Anti-HIV Drug Combinations	Completed	Glaxo Wellcome	N/A	1969-12-31	The purpose of this study is to compare the safety and effectiveness of taking lamivudine (3TC) plus zidovudine (ZDV) plus a protease inhibitor (PI) with taking the 3TC/ZDV combination tablet (Combivir) plus a PI. This study also examines how well patients follow the dosing schedules for these drugs. Doctors believe that taking Combivir plus a PI may be as effective as taking 3TC plus ZDV plus a PI.
NCT00002215 ↗	A Randomized, Double-Blind Study of MKC-442 Combined With Viracept in Patients Who Are Epivir + Retrovir Experienced and Are Protease Inhibitor- and Non-Nucleoside Reverse Transcriptase Inhibitor-Naive	Completed	Triangle Pharmaceuticals	N/A	1969-12-31	To compare the proportion of patients whose plasma HIV-1 RNA level falls and remains below the limit of quantification by the Roche Amplicor Monitor (400 copies/ml)[AS PER AMENDMENT 8/4/98: 50 copies/ml] between weeks 0 and 24. To determine the short-term safety and tolerability of MKC-442 plus nelfinavir (Viracept) plus dual nucleoside analogs. To determine the time to viral failure and time to tolerability failure through Week 48 of therapy.
NCT00002233 ↗	A Study of a Combination of Four Drugs in Patients With Recent HIV Infection	Completed	Glaxo Wellcome	Phase 2	1969-12-31	The purpose of this study is to see if it is safe to give a combination of four anti-HIV drugs to patients recently infected with HIV who have never received anti-HIV treatment. The effects of this combination of drugs on the immune system and the level of HIV in the body are studied also. The four-drug combination includes lamivudine, abacavir, amprenavir, and indinavir.

Clinical Trial Conditions for EPIVIR

Condition Name

Condition Name for EPIVIR
Intervention	Trials
HIV INFECTIONS	26
HIV-1 Infection	4
HIV	4
Lipodystrophy	2

Condition MeSH

Condition MeSH for EPIVIR
Intervention	Trials
HIV Infections	31
Acquired Immunodeficiency Syndrome	8
Infections	7
Infection	7

Clinical Trial Locations for EPIVIR

Trials by Country

Trials by Country for EPIVIR
Location	Trials
United States	118
Korea, Republic of	7
Spain	7
India	7
South Africa	6

Trials by US State

Trials by US State for EPIVIR
Location	Trials
New York	12
California	11
Texas	8
Illinois	7
Massachusetts	6

Clinical Trial Progress for EPIVIR

Clinical Trial Phase

Clinical Trial Phase for EPIVIR
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	7
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for EPIVIR
Clinical Trial Phase	Trials
Completed	36
Unknown status	4
Withdrawn	2

Clinical Trial Sponsors for EPIVIR

Sponsor Name

Sponsor Name for EPIVIR
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	8
Glaxo Wellcome	8
Bristol-Myers Squibb	5

Sponsor Type

Sponsor Type for EPIVIR
Sponsor	Trials
Other	37
Industry	27
NIH	17

Clinical Trials Update, Market Analysis, and Projection for EPIVIR (Lamivudine)

Last updated: October 27, 2025

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Introduction

EPIVIR (lamivudine) remains a cornerstone in the management of chronic hepatitis B virus (HBV) infection and HIV/AIDS. As a nucleoside reverse transcriptase inhibitor (NRTI), EPIVIR’s unique pharmacological profile and its longstanding safety record have solidified its place within antiviral treatment regimens. This analysis provides an updated landscape of clinical trials, evaluates current market dynamics, and offers projections for EPIVIR’s future trajectory in global healthcare.

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Clinical Trials Landscape for EPIVIR

Ongoing and Recent Clinical Trials

The clinical development involving EPIVIR predominantly centers on combination therapies, resistance management, and pediatric applications. The recent publication of trials reflects a strategic shift towards exploring its utility alongside novel agents to tackle resistance and improve safety profiles.

1. Combination Therapy Trials
   Several phase III trials, such as NCT03572621 and NCT04536787, examine EPIVIR in combination with tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF). These studies aim to assess synergetic effects, resistance suppression, and safety in both HIV and HBV infections. Results indicate comparable efficacy with potentially fewer adverse events compared to monotherapies, encouraging their integration into guidelines.

2. Pediatric and Special Population Studies
   Trials such as NCT02847389 are evaluating EPIVIR’s safety and efficacy in pediatric cohorts. Data suggest that early intervention with lamivudine in children effectively suppresses viral replication with tolerable safety profiles.

3. Resistance and Long-Term Safety
   A pivotal trial (NCT02518505) tracks resistance development over extended use. Findings reiterate the challenge posed by lamivudine-resistant mutants, notably YMDD variants, emphasizing the importance of combination therapy to mitigate resistance.

Regulatory Status and Approvals

While EPIVIR is approved globally for HIV and HBV, ongoing trials aim to optimize its role amid emerging therapies. Notably, regulatory bodies like the FDA and EMA are attentive to trial outcomes focusing on resistance mitigation and safety in diverse patient populations.

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Market Analysis of EPIVIR

Current Market Position

EPIVIR, first approved in the early 1990s, holds a significant share in antiviral therapy, especially in low- and middle-income countries (LMICs). As a generic drug, its affordability sustains high penetration in resource-constrained settings, maintaining its relevance despite the advent of newer agents.

Market Share & Revenue:
According to industry analyses, EPIVIR's global sales have stabilized, with an estimated annual revenue of approximately $200 million pre-pandemic. Its utilization is chiefly driven by its inclusion in the World Health Organization (WHO) essential medicines list and national treatment guidelines, particularly for HBV suppression.

Generics and Pricing Impact:
Generic manufacturing has driven prices downward, bolstering its accessibility. Major pharmaceutical companies, including Mylan and Cipla, produce cost-effective formulations, feeding into LMIC procurement channels.

Competitive Landscape

The emergence of potent NRTIs like entecavir and tenofovir variants (TAF, TDF) has increased competition, especially in developed markets. These agents offer improved resistance profiles and safety margins, gradually eroding EPIVIR’s market share where newer options are accessible.

Key Competitors:

• ETV (Entecavir)
• TAF (Tenofovir alafenamide)
• TDF (Tenofovir disoproxil fumarate)
• Novel agents in phase II/III trials focusing on HBV cure strategies

Efforts by pharmaceutical companies to position lamivudine as an initial or adjunct therapy in combination regimens underpin a stable niche despite competition.

Market Drivers and Barriers

Drivers:

• Established efficacy and safety
• Cost-effectiveness in LMICs
• Inclusion in global health policies

Barriers:

• Resistance development concerns
• Availability of newer formulations with better safety profiles
• Patent expiration and generic competition reducing margins

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Market Projections

Short-Term Outlook (Next 2-3 Years)

The immediate market outlook remains stable owing to EPIVIR’s entrenched position in HBV and HIV treatment protocols, particularly in resource-limited settings. Growth is anticipated primarily through substitution in high-burden countries where cost remains pivotal.

The integration of EPIVIR into combination regimens with TDF or TAF is likely to enhance its therapeutic profile, extending its relevance. Regulatory approvals expanding its pediatric use and efficacy data in resistant strains will also contribute to maintaining market share.

Medium to Long-Term Outlook (3-10 Years)

As innovative therapies and cure-focused agents emerge, EPIVIR’s market penetration in developed countries may decline. The focus will shift toward salvage therapy or monotherapy in underserved regions lacking access to newer drugs.

The development pipeline, including modified formulations with improved resistance profiles or reduced toxicity, holds potential. If biosimilar versions emerge, pricing could decline further, stimulating usage in LMICs.

The global HBV elimination goal by WHO (2021 roadmap) emphasizes mass treatment strategies, likely sustaining demand for affordable options like EPIVIR in endemic regions.

Emerging Trends Influencing Future Markets

• Combination Regimens: The trend toward fixed-dose combinations (FDCs) incorporating lamivudine with other agents will underpin continued use.
• Resistance Management: Development of resistance-proof therapies may restrict EPIVIR’s role unless combined with agents addressing current resistance pathways.
• Global Health Initiatives: Increased funding and procurement driven by WHO and GAVI will cement its role in public health programs.Potential inclusion in multi-drug regimens aimed at pathways to HBV cure could revive interest.

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Conclusion

EPIVIR remains a vital component for managing HIV and HBV, especially within global health frameworks targeting resource-limited settings. Its clinical landscape is evolving, driven by ongoing trials focusing on combination therapy, resistance management, and pediatric indications. Market dynamics suggest steady demand in the near term, particularly driven by affordability and policy inclusion, but face competition from newer agents with improved safety profiles.

Predictively, EPIVIR’s market share will decline gradually in high-income markets due to therapeutic advancements. However, in LMICs, it will sustain its relevance as a cost-effective antiviral. Strategic positioning through combination regimens and ongoing clinical research will be crucial to prolong its utility.

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Key Takeaways

• Clinical development focuses predominantly on combination therapies and resistance management, with ongoing trials assessing safety in pediatric populations.
• Global market reliance on EPIVIR remains strong, driven by its affordability, WHO recognition, and inclusion in public health strategies.
• Market competition from newer NRTIs like tenofovir alafenamide and entecavir challenges EPIVIR’s dominance, especially in developed countries.
• Projections indicate sustained demand in LMICs over the next decade, with potential expansion through biosimilars and policy initiatives.
• Future success hinges on clinical research advances and strategic collaborations to address resistance issues and improve safety profiles.

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FAQs

1. What are the main uses of EPIVIR today?
EPIVIR is primarily prescribed for chronic hepatitis B infection and HIV/AIDS, often as part of combination antiviral regimens.

2. How does EPIVIR compare to newer drugs like tenofovir?
While effective, lamivudine has a higher propensity for resistance development. Tenofovir formulations (TDF, TAF) offer improved resistance profiles and safety, positioning them as preferred options in many settings.

3. Are there ongoing efforts to improve EPIVIR formulations?
Research is limited primarily to combination therapy optimization and resistance mitigation. New formulations focusing on reducing toxicity or resistance are under exploration but not yet mainstream.

4. What is the outlook for EPIVIR in the context of global HBV elimination initiatives?
Its role remains significant, especially in endemic regions where cost-effective options are essential. Its use in mass treatment initiatives is expected to continue unless superseded by curative therapies.

5. Will resistance development limit EPIVIR’s future use?
Yes. Resistance, especially YMDD mutants, partly restricts its long-term efficacy, underscoring the importance of combination therapy and monitoring. Without strategies to address resistance, its utility could decline.

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References

1. World Health Organization. (2021). Global progress report on HIV, viral hepatitis, and sexually transmitted infections.
2. WHO Model List of Essential Medicines. (2021).
3. ClinicalTrials.gov [https://clinicaltrials.gov].
4. Zhang, H., et al. (2022). Resistance mechanisms of lamivudine in HBV treatment. Journal of Hepatology.
5. MarketWatch. (2023). Antiviral drugs market analysis and forecasts.