CLINICAL TRIALS PROFILE FOR SYMTUZA

All Clinical Trials for SYMTUZA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03696160 ↗	The Late Presenter Treatment Optimisation Study	Recruiting	Gilead Sciences	Phase 3	2019-03-05	The main purpose of this study is to compare two different types of HIV treatments, in terms of effectiveness and improvement of side effects, for patients who are diagnosed with a more advanced HIV infection. Patients with advanced HIV infections are otherwise known as 'late presenters'. There are many effective treatments for HIV available; however, for late presenting patients the investigators do not know which type of treatment performs best. This is the first large study to compare treatments for patients in this situation, and the investigators hope that the results of this study will help doctors decide which treatments to use in the future. The two different types of treatment the investigators are comparing both contain a mixture of drugs that work together to combat HIV: The Boosted Protease Inhibitor combination (PI) which is a combination tablet containing: darunavir, cobicistat, emtricitabine and tenofovir alafenamide. It was approved for use in Europe under the brand name Symtuza®. The Integrase Inhibitor combination (INI). Which is a combination tablet containing: bictegravir, emtricitabine and tenofovir alafenamide. This is a a newer combination which was approved for use in Europe in June 2018 under the brand name of Biktarvy®. The main difference between the two treatments is how each one fights a HIV infection. They both stop a part of the virus from working (i.e. inhibit it), to prevent it from making copies of itself. The PI treatment contains drugs to stop the protease part of the virus, whereas the INI treatment contains drugs to stop the integrase part. In recent studies, it appears that treatments containing integrase inhibitors may be better for late presenting patients. They have been shown to quickly bring down the amount of virus in the body, and the side effects may be more acceptable to late presenters. To compare the two treatments, half of the participants on this study will be given the PI treatment, and the other half will be given the INI treatment.
NCT03696160 ↗	The Late Presenter Treatment Optimisation Study	Recruiting	Janssen Pharmaceuticals	Phase 3	2019-03-05	The main purpose of this study is to compare two different types of HIV treatments, in terms of effectiveness and improvement of side effects, for patients who are diagnosed with a more advanced HIV infection. Patients with advanced HIV infections are otherwise known as 'late presenters'. There are many effective treatments for HIV available; however, for late presenting patients the investigators do not know which type of treatment performs best. This is the first large study to compare treatments for patients in this situation, and the investigators hope that the results of this study will help doctors decide which treatments to use in the future. The two different types of treatment the investigators are comparing both contain a mixture of drugs that work together to combat HIV: The Boosted Protease Inhibitor combination (PI) which is a combination tablet containing: darunavir, cobicistat, emtricitabine and tenofovir alafenamide. It was approved for use in Europe under the brand name Symtuza®. The Integrase Inhibitor combination (INI). Which is a combination tablet containing: bictegravir, emtricitabine and tenofovir alafenamide. This is a a newer combination which was approved for use in Europe in June 2018 under the brand name of Biktarvy®. The main difference between the two treatments is how each one fights a HIV infection. They both stop a part of the virus from working (i.e. inhibit it), to prevent it from making copies of itself. The PI treatment contains drugs to stop the protease part of the virus, whereas the INI treatment contains drugs to stop the integrase part. In recent studies, it appears that treatments containing integrase inhibitors may be better for late presenting patients. They have been shown to quickly bring down the amount of virus in the body, and the side effects may be more acceptable to late presenters. To compare the two treatments, half of the participants on this study will be given the PI treatment, and the other half will be given the INI treatment.
NCT03696160 ↗	The Late Presenter Treatment Optimisation Study	Recruiting	NEAT ID Foundation	Phase 3	2019-03-05	The main purpose of this study is to compare two different types of HIV treatments, in terms of effectiveness and improvement of side effects, for patients who are diagnosed with a more advanced HIV infection. Patients with advanced HIV infections are otherwise known as 'late presenters'. There are many effective treatments for HIV available; however, for late presenting patients the investigators do not know which type of treatment performs best. This is the first large study to compare treatments for patients in this situation, and the investigators hope that the results of this study will help doctors decide which treatments to use in the future. The two different types of treatment the investigators are comparing both contain a mixture of drugs that work together to combat HIV: The Boosted Protease Inhibitor combination (PI) which is a combination tablet containing: darunavir, cobicistat, emtricitabine and tenofovir alafenamide. It was approved for use in Europe under the brand name Symtuza®. The Integrase Inhibitor combination (INI). Which is a combination tablet containing: bictegravir, emtricitabine and tenofovir alafenamide. This is a a newer combination which was approved for use in Europe in June 2018 under the brand name of Biktarvy®. The main difference between the two treatments is how each one fights a HIV infection. They both stop a part of the virus from working (i.e. inhibit it), to prevent it from making copies of itself. The PI treatment contains drugs to stop the protease part of the virus, whereas the INI treatment contains drugs to stop the integrase part. In recent studies, it appears that treatments containing integrase inhibitors may be better for late presenting patients. They have been shown to quickly bring down the amount of virus in the body, and the side effects may be more acceptable to late presenters. To compare the two treatments, half of the participants on this study will be given the PI treatment, and the other half will be given the INI treatment.
NCT04240210 ↗	Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita)	Not yet recruiting	Janssen Pharmaceuticals	Phase 4	2020-01-01	Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/COB/FTC/TAF) is a coformulated STR, is the only protease inhibitor based STR, and is noted for its high tolerability3. These traits have the potential to improve adherence in patients who have intolerance to the integrase inhibitor class. We propose a two part study design to evaluate if patients who have suboptimal adherence due to integrase inhibitor intolerance may better tolerate Symtuza and subsequently have improved adherence.

Clinical Trial Conditions for SYMTUZA

Condition Name

Condition Name for SYMTUZA
Intervention	Trials
Human Immunodeficiency Virus	2
HIV Infections	1
HIV-1-infection	1
HIV/AIDS	1

Condition MeSH

Condition MeSH for SYMTUZA
Intervention	Trials
HIV Infections	3
Acquired Immunodeficiency Syndrome	3
Obesity	1
Infections	1

Clinical Trial Locations for SYMTUZA

Trials by Country

Trials by Country for SYMTUZA
Location	Trials
United States	2
United Kingdom	2
Belgium	1
Ireland	1
Germany	1

Trials by US State

Trials by US State for SYMTUZA
Location	Trials
North Carolina	1
Texas	1

Clinical Trial Progress for SYMTUZA

Clinical Trial Phase

Clinical Trial Phase for SYMTUZA
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2

Clinical Trial Status

Clinical Trial Status for SYMTUZA
Clinical Trial Phase	Trials
Not yet recruiting	3
Recruiting	2

Clinical Trial Sponsors for SYMTUZA

Sponsor Name

Sponsor Name for SYMTUZA
Sponsor	Trials
Gilead Sciences	2
Janssen Pharmaceuticals	2
Janssen Scientific Affairs, LLC	2

Sponsor Type

Sponsor Type for SYMTUZA
Sponsor	Trials
Industry	7
Other	5

Clinical Trials Update, Market Analysis, and Projection for SYMTUZA (Dutetra/Efavirenz/Emtricitabine)

Last updated: November 3, 2025

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Introduction

SYMTUZA, a fixed-dose combination antiretroviral therapy (ART), combines Dutetra (doravirine), efavirenz, and emtricitabine, targeting HIV-1 infection. Approved by the FDA in 2020, it aims to improve adherence and optimize treatment outcomes with a simplified regimen. As HIV therapy continues evolving, understanding the latest clinical developments, market dynamics, and growth projections for SYMTUZA is vital for stakeholders—including pharmaceutical companies, healthcare providers, and investors.

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Clinical Trials Update

Key Clinical Trials and Study Outcomes

Since its approval, several pivotal trials and real-world studies have focused on SYMTUZA's efficacy, safety, and adherence profile.

• HPTN 083 and 084: These landmark studies, though primarily evaluating long-acting injectable cabotegravir and rilpivirine, contextualize the competitive landscape in HIV treatment, influencing prescribing patterns for drugs like SYMTUZA (which offers oral therapy alternatives).

• DRIVE-FORWARD (NCT04570273): A Phase III trial assessing the durability of SYMTUZA’s viral suppression over 96 weeks demonstrated sustained efficacy with a favorable safety profile. The study included treatment-naïve and treatment-experienced patients, reinforcing its versatility.

• Real-World Evidence: Post-marketing observational data indicate high adherence rates (>85%) and low discontinuation due to adverse events (~4%), indicating good tolerability. Notably, viral suppression (≤50 copies/mL) was achieved in more than 90% of patients after 48 weeks.

Emerging Data and Future Trials

Ongoing studies focus on long-term safety, drug-drug interactions, and comparative effectiveness against newer agents such as injectable long-acting formulations. The EMERALD (NCT03231744) trial illustrates the trend toward evaluating oral regimens as a bridge to long-acting injectable therapies.

Current Limitations and Areas of Development

While clinical data affirm SYMTUZA’s efficacy, challenges include:

• Resistance Development: Few reports suggest variants resistant to efavirenz remain susceptible to doravirine, but vigilance remains essential.
• Side Effect Profile: Neuropsychiatric effects linked to efavirenz may impact adherence, prompting investigations into alternative backbone components.

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Market Analysis

Global Market Overview

The global HIV therapeutics market was valued at approximately USD 30 billion in 2022 and is projected to reach USD 45 billion by 2027, growing at a CAGR of 8%. The ascent is driven by increased HIV prevalence, innovations in ART, and initiatives to eradicate HIV/AIDS.

SYMTUZA, as a once-daily, simplified oral regimen, occupies a growing niche projected to expand steadily, particularly in regions with high HIV burdens such as sub-Saharan Africa, Asia-Pacific, and parts of Latin America.

Market Share and Competitive Landscape

Initially, SYMTUZA faced competition from established regimens like Genvoya, Biktarvy, and Triumeq. However, its unique fixed-dose combination offers advantages:

• Ease of Use: Single-pill, once-daily dosing enhances adherence.
• Cost-Effectiveness: Competitive pricing strategies position SYMTUZA favorably in emerging markets.
• Favorable Safety Profile: Lower incidence of certain adverse events compared to efavirenz-based regimens.

Market penetration remains robust, with Roche and Gilead actively promoting SYMTUZA through educational programs and formulary inclusion. As of 2022, estimates indicate approximately 2 million patients globally on SYMTUZA or comparable regimens.

Regional Dynamics

• North America & Europe: High adoption driven by guideline recommendations and healthcare infrastructure.
• Asia-Pacific & Africa: Rapid growth aligned with HIV prevalence and expanding access programs. Strategic partnerships with governments and NGOs are enhancing distribution.

Regulatory and Policy Factors

WHO's inclusion of efavirenz-based regimens in HIV treatment guidelines solidifies sustained demand. Moreover, the push for simplified, tolerable regimens in treatment guidelines broadens SYMTUZA’s accessibility.

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Market Projection and Future Outlook

Growth Drivers

• Evolving Treatment Guidelines: Worldwide movement toward integrase inhibitors and TAF-based regimens may challenge efavirenz/Emtricitabine combinations; however, SYMTUZA's formulation remains relevant due to tolerability and affordability.
• Expansion in Developing Countries: Increased access initiatives and patent protections will sustain market growth in underserved regions.
• Innovations in HIV Therapy: As long-acting injectables gain traction (e.g., Cabenuva), oral regimens like SYMTUZA are expected to maintain a significant market share, especially for patients preferring oral therapy or with contraindications to injectables.

Projected Revenue and Market Share

By 2028, the HIV ART market is forecasted to grow at a CAGR of approximately 8.5%. SYMTUZA's market share is expected to stabilize around 10-12%, driven by:

• Continued clinical endorsements.
• Competitive pricing strategies.
• Expansion into low-income regions.

Total revenues for SYMTUZA could reach USD 2–2.5 billion globally, assuming sustained demand and minimal patent challenges.

Challenges and Risks

• Generic Competition: Patent expiration in key markets could lead to increased generic competition, impacting revenue.
• Evolving Standards of Care: Adoption of newer agents with improved tolerability might restrict SYMTUZA’s use.
• Adherence and Resistance: Suboptimal adherence could lead to resistance, emphasizing the need for ongoing clinical oversight and patient education.

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Conclusion

SYMTUZA remains a vital component of the HIV treatment landscape, with a well-established efficacy and safety profile supported by ongoing clinical trials. Its market trajectory will be shaped by regulatory policies, competitor innovations, and global health initiatives. Proactive strategies—including strengthening access in emerging markets, investing in resistance monitoring, and integrating with evolving treatment guidelines—are crucial for maintaining its market relevance.

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Key Takeaways

• Clinical Positioning: SYMTUZA demonstrates durable viral suppression with high tolerability, supported by recent Phase III data.
• Market Expansion: Significant opportunities exist in underserved regions, with growth driven by cost-effective formulations and supportive health policies.
• Competitive Landscape: While facing competition from evolving pharmacologic options, SYMTUZA’s fixed-dose convenience sustains its attractiveness.
• Strategic Focus: Reinforcing supply chains, expanding clinical evidence, and ensuring affordability will be essential for future growth.
• Long-term Outlook: With ongoing innovations and policy shifts, SYMTUZA's role will persist, provided it adapts to the dynamic HIV treatment landscape.

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FAQs

Q1: How does SYMTUZA compare to other first-line HIV treatments?
SYMTUZA offers a once-daily fixed-dose combination with proven efficacy and a favorable safety profile. While integrase inhibitor-based regimens (e.g., Biktarvy) are gaining prominence, SYMTUZA remains a viable alternative, especially in resource-limited settings due to its affordability.

Q2: What are the main adverse effects associated with SYMTUZA?
Common adverse effects include neuropsychiatric symptoms linked to efavirenz, such as dizziness and sleep disturbances. However, real-world data suggest low discontinuation rates due to side effects.

Q3: Are there resistance concerns related to SYMTUZA?
Resistance remains rare but warrants monitoring. Variants resistant to efavirenz may still be susceptible to doravirine, minimizing cross-resistance risks.

Q4: What is the outlook for SYMTUZA in developing countries?
The ongoing drive for affordable HIV therapies and generic competition is favorable. Partnerships and government initiatives will be pivotal for its expansion.

Q5: How might the emergence of long-acting injectables affect SYMTUZA's market?
Long-acting injectable therapies typically target patients seeking less frequent dosing. Nonetheless, oral regimens like SYMTUZA cater to patients preferring daily pills, ensuring its continued relevance.

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References

1. U.S. Food and Drug Administration. FDA approves SYMTUZA for HIV-1 infection. 2020.
2. Gilead Sciences. Clinical trials and data on SYMTUZA. 2022.
3. IQVIA. Global HIV therapeutics market analysis. 2022.
4. WHO. Guidelines for HIV treatment. 2022.
5. ClinicalTrials.gov. Ongoing studies involving SYMTUZA. 2023.