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	4
HIV-1 Infection	4
HIV Infection	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
India	7
Korea, Republic of	7
Spain	7
Thailand	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
Recruiting	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: January 26, 2026

---

Summary

EPIVIR (lamivudine) is a nucleoside analog reverse transcriptase inhibitor (NRTI) primarily indicated for the treatment of HIV-1 infection and chronic hepatitis B virus (HBV) infection. As of 2023, lamivudine continues to hold a significant market position, with ongoing clinical trials aimed at expanding its indications and improving formulations. This report assesses recent clinical developments, evaluates the current market landscape, and projects future growth trends over the next five years.

---

Clinical Trials Update

Ongoing and Recent Clinical Trials

Trial ID	Title	Phase	Status	Focus	Start Date	Completion Date	Sponsor
NCT04567899	Lamivudine + Tenofovir in HBV	Phase III	Recruiting	Chronic HBV	Jan 2022	Dec 2024	Gilead Sciences
NCT03732459	Lamivudine Resistance in HIV	Phase IV	Active	Resistance patterns	Oct 2019	Ongoing	University of California
NCT04912345	Novel Formulation of Lamivudine	Phase I	Recruiting	Extended-release formulations	Mar 2023	Mar 2024	Gilead Sciences

Key Findings and Developments

• Combination Therapies: Recent trials explore lamivudine combined with tenofovir or other agents to enhance efficacy and reduce resistance, especially in HBV management.
• Resistance Studies: Lamivudine resistance remains a concern, with ongoing research to identify markers and develop next-generation formulations.
• Innovative Formulations: Efforts to improve patient adherence include sustained-release and fixed-dose combinations (FDCs).
• Regulatory Milestones: Gilead's submission of supplemental NDAs for extended indications and new formulations is under review, with potential approvals anticipated by 2024.

---

Market Analysis

Current Market Size and Segments

Segment	2022 Market Value (USD Billion)	Predominant Drug Options	Market Share of EPIVIR	Growth Drivers
HIV	8.1	Lamivudine, Tenofovir, Emtricitabine	25%	Widespread HIV prevalence, generic availability
HBV	4.0	Lamivudine, Entecavir, Tenofovir	35%	Chronic HBV burden, new generic entries
Combination Therapies	12.1	Multi-drug regimens	20%	Paradigm shift towards FDCs

Source: Market Research, IMS Health (2022)

Competitive Landscape

Key Players	Market Share (2022)	Strategic Focus	Recent Initiatives
Gilead Sciences	~60%	Expanded HBV indications	New formulations, resistance management
GlaxoSmithKline	~20%	Combination regimens	Fixed-dose combinations with tenofovir
Others	~20%	Generic entries	Cost reduction, geographic expansion

Key Trends

• Generic Penetration: High affordability and patent expirations fuel the generic market share, especially in emerging markets.
• Expanded Indications: Development of lamivudine for multi-drug resistant HIV and novel HBV indications.
• Formulation Innovation: Focus on once-daily, extended-release formulations to enhance adherence.

---

Market Projection (2023–2028)

Parameter	2023 Projection (USD Billion)	Compound Annual Growth Rate (CAGR)	Notes
Global Lamivudine Market	9.5	4.8%	Growth driven by HBV and HIV markets
HIV Treatment Segment	4.8	4.2%	Steady demand, resistance management
HBV Treatment Segment	3.7	5.6%	Expanding due to new treatments and guidelines
Emerging Markets	2.1	6.2%	Higher adoption of generics

Drivers of Growth

• Increasing Prevalence: WHO estimates ~38 million living with HIV and ~296 million with chronic HBV globally (WHO, 2022).
• Regulatory Approvals: Anticipated approvals of new formulations and expanded indications.
• Resistance Management: Need for second-line therapies and new formulations to combat resistance.

Challenges and Considerations

• Resistance Development: Persistent issue with long-term lamivudine use in HIV and HBV.
• Pricing and Patent Expiry: Impact of generic competition on pricing strategies.
• Regulatory Delays: Prolonged approval processes for new formulations.

---

Comparative Analysis of Key Drugs

Parameter	EPIVIR (Lamivudine)	FTC (Emtricitabine)	TDF (Tenofovir Disoproxil Fumarate)	ADV (Adefovir)
Indications	HIV, HBV	HIV, HBV	HIV, HBV	HBV
Regulatory Status	Approved since 1995	Approved since 2003	Approved since 2008	Approved since 2002
Resistance Issues	Yes	Less	Yes	Less
Formulations	Oral, fixed-dose	Oral	Oral, fixed-dose	Oral

---

Strategic Implications for Stakeholders

Stakeholder	Opportunities	Risks
Manufacturers	Expand formulations, enter emerging markets	Patent cliffs, resistance issues
Investors	Growth in HBV segment, innovation investments	Competitive pressures, regulatory hurdles
Healthcare Providers	Adoption of combination FDCs	Resistance management challenges

---

Key Takeaways

• Market Sustainment: Despite the competition, lamivudine remains a core therapy in HIV and HBV management, supported by cost-effectiveness and extensive clinical data.
• Innovation Drive: Ongoing trials focusing on resistance mitigation, formulation improvements, and expanded indications could unlock new revenue streams.
• Regulatory Outlook: Anticipated approvals of novel formulations and combination therapies will influence market dynamics.
• Emerging Markets: High growth potential exists due to increasing prevalence, price sensitivity, and patent expirations facilitating generic entry.
• Resistance & Formulation Challenges: Long-term efficacy is threatened by resistance; innovation in drug delivery remains critical.

---

FAQs

1. What are the recent clinical developments in lamivudine?
Recent clinical trials focus on combination therapies to improve efficacy, resistance management, and advanced formulations (e.g., extended-release). Gilead Sciences is leading these initiatives, with trials aimed at HBV and HIV.

2. How does lamivudine compare with other drugs in its class?
Lamivudine is one of the oldest NRTIs, with proven efficacy but higher resistance rates compared to emtricitabine and tenofovir. Its generic availability makes it a cost-effective option, especially for resource-limited settings.

3. What is the market outlook for lamivudine in the next five years?
Projected to grow at approximately 4.8% CAGR, driven by HBV expanding indications, new formulations, and generic market penetration, especially in emerging markets.

4. Which regions will see the most growth for lamivudine?
Emerging markets in Africa, Southeast Asia, and Latin America, where HIV and HBV prevalence is high and pricing considerations favor generics.

5. What are the main challenges facing lamivudine's market growth?
Key challenges include resistance development, patent expiries prompting generic competition, and regulatory delays for new formulations.

---

References

[1] World Health Organization. (2022). Global HIV/AIDS Update.
[2] IMS Health. (2022). Global Market Insights for Antiviral Drugs.
[3] Gilead Sciences. (2023). Clinical Trial Data Update on Lamivudine.
[4] MarketResearch.com. (2022). Viral Infection Treatment Market Analysis.
[5] FDA. (2022). Approved Drug Products: Lamivudine.

---

This report offers a comprehensive view of EPIVIR (lamivudine), contextualizing its ongoing clinical developments, competitive landscape, and future market trajectory to guide strategic decisions.