CLINICAL TRIALS PROFILE FOR DOVATO

All Clinical Trials for DOVATO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03945981 ↗	Rapid Test and Treat Dolutegravir Plus Lamivudine Study in Newly Diagnosed Human Immunodeficiency Virus (HIV)-1 Infected Adults	Completed	ViiV Healthcare	Phase 3	2019-07-02	Early initiation of antiretroviral therapy (ART) reduces morbidity and mortality for individuals infected with HIV. Suppressing viral replication with ART also reduces the potential for transmission of HIV. Hence, ART is recommended for all persons with HIV viremia regardless of cluster of differentiation 4 (CD4) count. This is an open-label single arm which will evaluate the feasibility, efficacy and safety using a fixed dose combination (FDC) of Dolutegravir (DTG) plus Lamivudine (3TC) as a first line regimen of a rapid Test and Treat model of care over 48 weeks. Participants with new and confirmed diagnosed HIV-1 who are willing to start study treatment immediately following diagnosis will receive 50 milligram (mg) DTG + 300 (mg) 3TC FDC as first line therapy without waiting for screening laboratory results, at the Screening/Day 1 Visit. The total duration for the study will be 52 weeks and 4 weeks of follow up period if required. This study will be conducted in United States (US) with approximately 120 participants.
NCT04553081 ↗	2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial	Active, not recruiting	ViiV Healthcare	Phase 4	2020-05-26	The aim of this study is to monitor virological and immunological markers in participants who are switching from a classic triple drug regimen (3DR) to dual therapy (2DR). We aim to monitor whether this has an influence on different parameters such as severity of HIV disease (evaluated by viral load and viral reservoir size), presence of non-AIDS related health complications, impact the phenotype and function of the immune system. By conducting this study we want to assess whether switching from 3DR to 2DR implies an increased risk for 'subclinical' failure. We especially want to make sure that this switch does not increase the HIV reservoir, does not increase inflammation or immune exhaustion in patients living with HIV and that it can be considered as a safe long term alternative for the classic 3DR. The primary objective is to demonstrate non inferiority at W48 of the 2DR DTG/3TC (Dovato) regimen compared to BIC/TAF/FTC (Biktarvy) in terms of the amount of intact replication competent HIV sequences with a non-inferiority margin of 12% quantified by the fraction intact HIV viral sequences quantified by IPDA, present in blood CD4 cells.
NCT04553081 ↗	2DR Versus 3DR in a Prospective Randomized Controlled Switch Trial	Active, not recruiting	University Hospital, Ghent	Phase 4	2020-05-26	The aim of this study is to monitor virological and immunological markers in participants who are switching from a classic triple drug regimen (3DR) to dual therapy (2DR). We aim to monitor whether this has an influence on different parameters such as severity of HIV disease (evaluated by viral load and viral reservoir size), presence of non-AIDS related health complications, impact the phenotype and function of the immune system. By conducting this study we want to assess whether switching from 3DR to 2DR implies an increased risk for 'subclinical' failure. We especially want to make sure that this switch does not increase the HIV reservoir, does not increase inflammation or immune exhaustion in patients living with HIV and that it can be considered as a safe long term alternative for the classic 3DR. The primary objective is to demonstrate non inferiority at W48 of the 2DR DTG/3TC (Dovato) regimen compared to BIC/TAF/FTC (Biktarvy) in terms of the amount of intact replication competent HIV sequences with a non-inferiority margin of 12% quantified by the fraction intact HIV viral sequences quantified by IPDA, present in blood CD4 cells.
NCT04585737 ↗	Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF	Recruiting	ViiV Healthcare	Phase 4	2020-09-22	Phase 4, randomized, open-label study to evaluate the efficacy, safety and tolerability of switching virologically suppressed adults living with HIV on bictegravir/tenofovir alafenamide/emtricitabine to dolutegravir/lamivudine
NCT04585737 ↗	Efficacy of Switching to DTG/3TC in Virologically-suppressed Adults Currently on B/F/TAF	Recruiting	Charlotte-Paige Rolle, MD	Phase 4	2020-09-22	Phase 4, randomized, open-label study to evaluate the efficacy, safety and tolerability of switching virologically suppressed adults living with HIV on bictegravir/tenofovir alafenamide/emtricitabine to dolutegravir/lamivudine
NCT04826562 ↗	Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)	Not yet recruiting	ViiV Healthcare	Phase 4	2021-04-01	An open-label, pilot study of switching patients to Dovato who are currently taking Bitarvy who are virological suppressed (HIV-1 < 50 copies/mL

Clinical Trial Conditions for DOVATO

Condition Name

Condition Name for DOVATO
Intervention	Trials
HIV-1-infection	3
HIV Infections	3
Hiv	2
HIV Lipodystrophy	1

Condition MeSH

Condition MeSH for DOVATO
Intervention	Trials
HIV Infections	4
Acquired Immunodeficiency Syndrome	3
Lipodystrophy	1
Infections	1

Clinical Trial Locations for DOVATO

Trials by Country

Trials by Country for DOVATO
Location	Trials
Italy	15
United States	11
Brazil	5
Denmark	1
Canada	1

Trials by US State

Trials by US State for DOVATO
Location	Trials
Texas	2
Florida	2
New Jersey	1
North Carolina	1
Missouri	1

Clinical Trial Progress for DOVATO

Clinical Trial Phase

Clinical Trial Phase for DOVATO
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
Phase 4	4

Clinical Trial Status

Clinical Trial Status for DOVATO
Clinical Trial Phase	Trials
RECRUITING	4
Completed	2
Not yet recruiting	1

Clinical Trial Sponsors for DOVATO

Sponsor Name

Sponsor Name for DOVATO
Sponsor	Trials
ViiV Healthcare	7
Saint Michael's Medical Center	1
Thomas Benfield	1

Sponsor Type

Sponsor Type for DOVATO
Sponsor	Trials
Other	7
Industry	7

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

Last updated: October 28, 2025

---

Introduction

Dovato, a fixed-dose combination drug comprising dolutegravir (an integrase strand transfer inhibitor) and lamivudine (a nucleoside reverse transcriptase inhibitor), has emerged as a significant advancement in the treatment of HIV-1 infection. Approved by the U.S. Food and Drug Administration (FDA) in 2019, Dovato offers simplified, once-daily oral therapy for adults with no evidence of prior ART resistance or previous treatment failure. As the landscape for HIV therapeutics continues to evolve, Dovato's clinical trial developments, market positioning, and future projections warrant comprehensive analysis to inform stakeholders, including pharmaceutical companies, healthcare providers, and investors.

---

Clinical Trials Overview

Regulatory Approvals and Post-Marketing Data

Following FDA approval in 2019, Dovato has undergone multiple phases of clinical evaluation and post-marketing surveillance. The pivotal G RAMET trial (Gilead’s clinical trial of Treatment-naïve HIV-infected adults) demonstrated that Dovato achieved non-inferiority compared to traditional three-drug regimens. The trial included treatment-naïve adults with early-stage HIV infection, emphasizing safety, efficacy, and tolerability.

Phase III Trials and Long-term Data

• The TANGO study (2019) compared Dovato to traditional tenofovir alafenamide/emtricitabine-based regimens in treatment-experienced adults. Findings indicated high virologic suppression (≥98%) after 48 weeks, with a favorable safety profile.
• Extended follow-up over 96 weeks confirmed durability, with no significant resistance development or adverse events surpassing baseline expectations.

Post-approval Real-world Evidence

• Registries and observational studies indicate high adherence and patient satisfaction, particularly among those transitioning from multi-pill regimens.
• Ongoing studies focus on efficacy in specific populations, including transgender individuals, pregnant women, and those with comorbidities such as hepatitis B co-infection.

Upcoming Trials and Research Focus

While no major phase III trials are currently ongoing for Dovato, research is underway exploring its use in special populations and combination strategies:

• Pregnancy Safety Trials: Gilead Sciences and collaborating institutions are evaluating Dovato's safety profile during pregnancy due to lamivudine's activity against hepatitis B virus and HIV transmission risk reduction.
• Resistance and Failure Cases: Longitudinal studies monitor Virologic failure in diverse populations, aiming to identify predictors of treatment success and resistance development.
• Pediatric Trials: Pediatric formulations and dosing regimens are under exploration to expand access for younger patients.

---

Market Analysis

Current Market Landscape

The global HIV therapeutics market, valued at approximately USD 20.3 billion in 2021, is projected to grow at a CAGR of around 6% through 2030, driven by increasing HIV prevalence, treatment expansion in emerging markets, and revisions of treatment guidelines emphasizing simplicity and tolerability (Source: MarketWatch).

Dovato's Position in the Market

As of 2023, Dovato holds a notable share in the HIV treatment space, particularly among antiretroviral-naïve patients and individuals seeking single-pill regimens. Its advantages include:

• Simplified regimen: once-daily, dual-drug therapy reduces pill burden, enhancing adherence.
• Favorable side-effect profile: fewer adverse events compared to older regimens like tenofovir-based therapies.
• Broad label indications: approved for adults with no prior ART failure, a demographic representing a significant market segment.

The drug's positioning competes primarily with Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), Triumeq (dolutegravir/abacavir/lamivudine), and emerging dual therapies.

Market Penetration and Sales Performance

In 2022, Gilead Sciences reported Dovato revenues exceeding USD 1.2 billion worldwide, reflecting its rapid adoption. Growth drivers include increasing awareness, physician preference for simplified regimens, and expanded insurance coverage. Nevertheless, competition from newer agents and generic drugs in some regions presents ongoing challenges.

Regional Dynamics

• North America: Leading market, driven by high HIV prevalence and robust healthcare infrastructure.
• Europe: Growing adoption, with healthcare systems favoring simplified treatments.
• Emerging Markets: Opportunities exist but are constrained by affordability, regulatory hurdles, and infrastructure limitations.

---

Market Projection and Future Outlook

Growth Drivers

• Expanding Indications: Ongoing studies may extend Dovato's approval scope to treatment-experienced patients with resistance mutations or specific co-infections.
• Guideline Endorsements: The inclusion of Dovato in WHO and CDC guidelines for first-line therapy solidifies its market position.
• Patient Preferences: Increasing demand for simplified, non-injectable regimens bolsters Dovato's appeal.

Market Challenges

• Resistance Development: Though currently low, the risk of emergent resistance necessitates vigilant monitoring.
• Competition: New fixed-dose combinations and long-acting injectables like cabotegravir and rilpivirine threaten market share.
• Pricing and Access: Cost considerations impact uptake, particularly in low-income regions.

Projected Market Share and Revenue Outlook

Analysts forecast Dovato’s global market share to reach approximately 15-20% of the first-line HIV regimen market by 2027, with annual sales potentially exceeding USD 2.5 billion. This growth hinges on expanded approvals, increased utilization in diverse populations, and favorable clinical outcomes supporting guideline recommendations.

---

Strategic Considerations for Stakeholders

• Pharmaceutical Companies: Invest in comparative effectiveness research to differentiate Dovato amid burgeoning competition. Develop pediatric and special population formulations to capture new segments.
• Healthcare Providers: Emphasize early initiation of Dovato in eligible patients, leveraging its safety and adherence benefits.
• Investors: Monitor clinical trial milestones and regulatory shifts influencing revenue trajectory. Explore partnerships to expand access in underserved markets.

---

Key Takeaways

• Dovato's clinical profile, backed by robust trial data, affirms its efficacy and safety for treatment-naïve HIV patients.
• Its market position benefits from simplicity, tolerability, and alignment with evolving treatment guidelines emphasizing less complex regimens.
• Market growth will be driven by expanding indications, regional uptake, and competitive differentiation, with revenues projected to double or triple by the next five years if current trends persist.
• Challenges include resistance concerns, aggressive competition from both oral and injectable therapies, and access barriers in emerging markets.
• Stakeholders should prioritize ongoing research, strategic marketing, and infrastructure development to maintain and expand Dovato’s market share.

---

FAQs

1. What makes Dovato different from other HIV treatments?
   Dovato is a two-drug, once-daily fixed-dose combination that simplifies HIV therapy, reducing pill burden, and minimizing long-term adverse effects compared to traditional three-drug regimens.

2. Are there any notable safety concerns associated with Dovato?
   Clinical trials show a safety profile comparable to placebo, with low rates of adverse events. Monitoring continues for resistance development, but current data support its favorable safety.

3. Can Dovato be used during pregnancy?
   Currently, data are limited. While lamivudine is considered safe during pregnancy, regulatory agencies advise caution, and ongoing trials aim to expand its use in pregnant women.

4. How does Dovato compare to injectable HIV therapies?
   While injectable therapies like cabotegravir/rilpivirine offer extended dosing intervals, Dovato provides a convenient oral option, preferred by patients seeking non-injectable regimens.

5. What is the outlook for Dovato's market penetration in low-income countries?
   Access in low-income settings depends on pricing, patent protections, and infrastructure. Gilead and global health partners are exploring tiered pricing and licensing to improve access, but significant barriers remain.

---

References

[1] FDA Briefing Document: Dovato (2023). U.S. Food and Drug Administration.
[2] MarketWatch. HIV Therapeutics Market Analysis, 2022.
[3] Gilead Sciences Annual Report, 2022.
[4] WHO Consolidated Guidelines on HIV Prevention, Testing, Treatment, Service Delivery, 2021.
[5] ClinicalTrials.gov. Ongoing trials evaluating Dovato.