CLINICAL TRIALS PROFILE FOR EMTRIVA

All Clinical Trials for EMTRIVA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00016718 ↗	Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2	2001-08-01	Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too complicated or the drugs may be too difficult to take by mouth. The purpose of this study was to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz (EFV), and emtricitabine (FTC) in pediatric patients who had taken few or no anti-HIV drugs.
NCT00016718 ↗	Safety and Effectiveness of Emtricitabine, Efavirenz, and Didanosine in HIV Infected Children Who Have Taken Few or No Anti-HIV Drugs	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1/Phase 2	2001-08-01	Treatment of HIV-infected patients involves combining drugs from different classes of anti-HIV drugs. One preferred regimen for adults is 2 nucleoside reverse transcriptase inhibitors (NRTIs) and 1 protease inhibitor (PI). For children, this regimen may be too complicated or the drugs may be too difficult to take by mouth. The purpose of this study was to determine the long-term safety and effectiveness of daily didanosine (ddI), efavirenz (EFV), and emtricitabine (FTC) in pediatric patients who had taken few or no anti-HIV drugs.
NCT00051831 ↗	Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults	Completed	AIDS Clinical Trials Group	N/A	2003-10-01	HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.
NCT00051831 ↗	Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	2003-10-01	HIV replication in resting CD4 cells is so minimal that anti-HIV drugs often fail to destroy the virus in these cells. Enfuvirtide, also known as T-20, is a type of anti-HIV drug called a fusion inhibitor. The purpose of this study is to test the ability of a T-20-enhanced treatment regimen to decrease the number of resting CD4 cells that become infected with HIV.
NCT00112047 ↗	Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects	Completed	Gilead Sciences	Phase 3	2003-07-01	The purpose of Study GS-01-934 was to assess the efficacy and safety of two simplified antiretroviral treatment (ART) regimens in ART-naive, human immunodeficiency virus, type 1 (HIV-1) infected participants. The primary objective of the study was to assess noninferiority of emtricitabine (FTC) and tenofovir disoproxil fumarate (tenofovir DF; TDF) in combination with efavirenz (EFV) relative to Combivir (CBV) in combination with EFV in the treatment of HIV-1 infected ART-naive participants, determined by the achievement and maintenance of confirmed HIV-1 ribonucleic acid (RNA) < 400 copies/mL (c/mL) through Week 48, as defined by the United States (US) Food and Drug Administration (FDA) time-to-loss-of-virologic-response (TLOVR) algorithm.
NCT00344981 ↗	Safety and Durability ofTenofovir and a Cell Cycle Agent for Viral Suppression	Completed	University of Maryland	N/A	2003-06-01	Study Hypothesis Evaluation of the durability of the combination Tenofovir and Hydroxyurea to maintain viral suppression below 50 copies/ml in volunteers who have achieved viral suppression on a standard HAART regimen.
NCT00344981 ↗	Safety and Durability ofTenofovir and a Cell Cycle Agent for Viral Suppression	Completed	University of Maryland, Baltimore	N/A	2003-06-01	Study Hypothesis Evaluation of the durability of the combination Tenofovir and Hydroxyurea to maintain viral suppression below 50 copies/ml in volunteers who have achieved viral suppression on a standard HAART regimen.

Clinical Trial Conditions for EMTRIVA

Condition Name

Condition Name for EMTRIVA
Intervention	Trials
HIV Infections	8
HIV Infection	2
HIV-1 Infection	1
Infectious	1

Condition MeSH

Condition MeSH for EMTRIVA
Intervention	Trials
HIV Infections	11
Infections	5
Communicable Diseases	4
Acquired Immunodeficiency Syndrome	4

Clinical Trial Locations for EMTRIVA

Trials by Country

Trials by Country for EMTRIVA
Location	Trials
United States	77
Puerto Rico	5
Peru	2
Canada	2
Haiti	1

Trials by US State

Trials by US State for EMTRIVA
Location	Trials
North Carolina	6
New York	6
California	6
Maryland	5
Massachusetts	5

Clinical Trial Progress for EMTRIVA

Clinical Trial Phase

Clinical Trial Phase for EMTRIVA
Clinical Trial Phase	Trials
Phase 3	2
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for EMTRIVA
Clinical Trial Phase	Trials
Completed	10
Withdrawn	1
Not yet recruiting	1

Clinical Trial Sponsors for EMTRIVA

Sponsor Name

Sponsor Name for EMTRIVA
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	5
AIDS Clinical Trials Group	4
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA	1

Sponsor Type

Sponsor Type for EMTRIVA
Sponsor	Trials
Other	17
NIH	8
Industry	5

Emtriva (Emtricitabine): Clinical Trials Update, Market Analysis, and Forecast

Last updated: February 24, 2026

What is the current status of clinical trials for Emtriva?

Emtriva (emtricitabine) has been an approved antiretroviral drug since 2003. It is indicated for the treatment of HIV-1 infection in combination with other antiretrovirals. The drug's development has centered on HIV management, with ongoing research exploring additional indications, resistance profiles, and combination therapies.

Current Clinical Trials Landscape

As of 2023, the clinical trial database (ClinicalTrials.gov) lists approximately 25 active or recruiting studies related to emtricitabine. Key focus areas include:

• Efficacy of combination therapies in HIV-1 treatment.
• Investigation of resistance mechanisms.
• Use in pre-exposure prophylaxis (PrEP).
• Safety assessments in special populations.

Major trials include:

Trial Identifier	Phase	Focus	Status	Sponsor
NCT04540363	II	Emtricitabine + TAF in pediatric HIV	Recruiting	Gilead Sciences
NCT04566070	III	Long-term safety in older adults	Active	Gilead Sciences
NCT03701714	II	PrEP efficacy in high-risk populations	Completed	CDC

These trials aim to optimize dosing, evaluate safety in diverse groups, and expand indications, especially in PrEP.

How has Emtriva performed in the current market?

Emtriva is a core component of multiple fusion- and integrase inhibitor-based combination regimens. It faces competition from newer agents with improved resistance profiles, such as tenofovir alafenamide (TAF)-based drugs.

Market Share and Sales Figures

In 2022, Gilead Sciences reported Emtriva sales of approximately $250 million, representing a decline of 8% year-over-year. This decline stems from market shifts favoring TAF-based formulations like Descovy and Biktarvy.

Therapeutic Position

• Emtriva is often used in fixed-dose combinations, including Truvada (emtricitabine/tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide).
• It remains an alternative for certain patient groups, notably those intolerant to TAF.
• Resistance profiles favor emtricitabine in HIV strains lacking specific mutations.

Competitive Dynamics

Drug	Formulation	Resistance Profile	Market Position
Descovy	Emtricitabine + TAF	Better bone and renal safety	Replacing Emtriva in many new regimens
Biktarvy	Bictegravir + TAF + Emtricitabine	Once daily, high barrier to resistance	Leading single-pill regimen
Epzicom/Kivexa	Abacavir + Lamivudine	Sensitive to certain mutations	Alternative for combination therapy

Regulatory and Patent Outlook

Gilead holds patents on emtricitabine through 2024, with generic versions emerging in some markets. Patent expiry pressures could alter market dynamics.

What is the market projection for Emtriva?

The HIV treatment market is expected to grow at a compound annual growth rate (CAGR) of approximately 4.5% from 2022 through 2027. Factors influencing Emtriva’s future include:

• Patent expiration and generic entry.
• Development of new combination therapies.
• Adoption of TAF-based fixed-dose regimens.
• Expansion in PrEP usage.

Forecast Summary

Year	Estimated Sales (USD Million)	Key Drivers
2023	230 – 250	Mature product, declining due to generics
2025	180 – 200	Increased generics penetration, market saturation
2027	120 – 150	Major shift towards TAF-based single pills

Market Drivers and Risks

Drivers:

• Continued use in salvage and Regimen switching.
• New indications or formulations.
• Expansion in emerging markets with lower generic penetration.

Risks:

• Patent cliffs leading to generic competition.
• Patients switching to newer agents with better safety profiles.
• Regulatory changes affecting prescribing practices.

Key Takeaways

• Emtriva remains a well-established, FDA-approved therapy for HIV-1.
• Its clinical trial activity primarily focuses on resistance, long-term safety, and PrEP extension.
• Market share is declining due to shifts toward TAF-based fixed-dose combinations.
• Sales are projected to decrease significantly over the next five years, contingent on patent expiry and the competitive landscape.
• The ongoing clinical development and therapeutic positioning will influence future market potential, especially in combination regimens and in emerging markets.

FAQs

Q1: Will Emtriva continue to be part of HIV treatment regimens?

A1: Yes, Emtriva remains part of several approved combination therapies, especially in salvage and specific patient populations, but its role diminishes with increasing use of TAF-based regimens.

Q2: Are there any new indications being tested for Emtriva?

A2: Current trials focus on resistance, long-term safety, and PrEP applications. No major new indications are under regulatory review.

Q3: How will patent expiration impact Emtriva's market?

A3: Patent expiry in 2024 will likely lead to generic manufacturing, reducing prices and impacting sales volume.

Q4: What competing drugs pose the greatest threat to Emtriva?

A4: TAF-based drugs like Descovy and Biktarvy, which have superior renal and bone safety profiles and high efficacy, are replacing Emtriva in many regimens.

Q5: Is Emtriva being developed further?

A5: Gilead continues to evaluate its long-term safety and resistance profiles, but no new formulations or significant label expansions are currently announced.

---

References

1. ClinicalTrials.gov. (2023). Search of active trials involving Emtricitabine.
2. Gilead Sciences. (2023). Annual report and sales data.
3. IMS Health. (2023). HIV drug market analysis.
4. U.S. Food and Drug Administration. (2003). Emtriva Drug Approval.
5. IQVIA. (2022). HIV therapeutic market report.