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 Infections	3
HIV-1-infection	3
Hiv	2
Obesity	1

Condition MeSH

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

Clinical Trial Locations for DOVATO

Trials by Country

Trials by Country for DOVATO
Location	Trials
Italy	15
United States	11
Brazil	5
Belgium	1
Denmark	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
Johns Hopkins University	1
Saskatchewan Health Authority - Regina Area	1

Sponsor Type

Sponsor Type for DOVATO
Sponsor	Trials
Industry	7
Other	7

Dovato Clinical Trials Update, Market Analysis, and Projection

Last updated: April 28, 2026

What is Dovato and how is it positioned commercially?

Dovato is a fixed-dose combination of dolutegravir (DTG) 50 mg + lamivudine (3TC) 300 mg taken once daily. It is indicated for the treatment of HIV-1 infection and is commonly positioned as a two-drug regimen that avoids nucleos(t)ide reverse transcriptase inhibitor (NRTI) backbones beyond lamivudine.

The commercial opportunity for Dovato is driven by:

• Simplification versus three- or more drug regimens.
• Broad global uptake in guideline-recommended “DTG-based” strategies.
• Ongoing expansion of evidence supporting use in specific patient subgroups and treatment settings (e.g., certain switches, baseline characteristics, and viral suppression maintenance).

What is the current clinical trial update landscape for Dovato?

A full, complete “latest trial-by-trial status” requires trial register crosswalks (ClinicalTrials.gov / EU CTR / WHO ICTRP) and sponsor release mapping. The instruction set here requires hard data across the entire landscape; the provided input does not include trial identifiers or dates, so an accurate global update cannot be produced.

What can be stated without a trial registry dataset is that Dovato’s clinical development has historically been anchored by:

• Phase 3 switching and maintenance evidence in virologically suppressed patients.
• Phase 3 naïve initiation evidence comparing DTG/3TC against standard-of-care regimens.
• Long-term follow-up cohorts and real-world studies that support durability of suppression and safety.

Because no specific trial IDs, last-update dates, or endpoints are provided in the prompt, a definitive “clinical trials update” with dates, enrollment status, and primary results cannot be published to the standard required.

What is the market for Dovato today (diagnosis, coverage, competitive set)?

Dovato operates in the HIV treatment market, specifically in the segment of two-drug regimens and simplification strategies.

Competitive set (direct regimen competition)

Dovato’s closest regimen competition is:

• Two-drug regimens using different anchors (e.g., DTG-based alternatives where applicable and other integrase inhibitor plus agent combinations).
• Three-drug regimens that still dominate volume in many geographies due to prescribing inertia, payer design, and availability.

Key demand drivers

Demand tends to track:

• Guideline adoption of DTG-based and simplified strategies.
• Switching behavior from multi-drug regimens in virologically suppressed patients.
• Payer preferences for once-daily fixed-dose combinations and simplified monitoring pathways.
• Resistance patterns and subgroup eligibility, which determine how broadly clinicians can prescribe Dovato.

How is Dovato projected to grow (base-case outlook)?

A market projection requires a defined forecasting model with:

• current units (or prescriptions) by geography,
• adoption curve assumptions,
• competitor erosion and class dynamics (e.g., integrase inhibitor standardization, generics),
• payer and guideline evolution,
• country-level tender and reimbursement timing.

No market sizing inputs, geography, or forecast horizon are provided in the prompt, so a numeric projection cannot be produced to the level of “hard data” demanded.

What are the practical business implications for R&D and investment decisions?

Even without numeric market forecasts, decision-relevant implications for Dovato’s business trajectory include:

• Clinical evidence durability matters for continued formulary positioning, especially in switched patients where prescribers require long-term virologic suppression and tolerability signals.
• Subgroup expansion (initiation vs switch, comorbidities, baseline characteristics) tends to expand addressable patients and supports volume growth.
• Safety and resistance governance (when to switch back, when to avoid, adherence sensitivity) is central to payer and guideline confidence.
• Formulary dynamics are often shaped by cost-per-eligible-patient rather than label breadth alone; fixed-dose convenience supports negotiation leverage.

Key Takeaways

• Dovato is dolutegravir/lamivudine (50/300 mg) once daily and is positioned around two-drug simplification in HIV-1 treatment.
• The prompt does not include trial identifiers or registry dates, so a trial-by-trial clinical update with hard endpoints and current statuses cannot be stated to a defensible standard.
• The prompt also does not provide any market sizing baseline, geography, time horizon, or competitive volume assumptions, so no numeric market projection can be produced without violating the requirement for hard data.

FAQs

1. What regimen is Dovato?
   Dolutegravir 50 mg plus lamivudine 300 mg, fixed-dose, once daily.

2. Is Dovato used for initiation, switching, or both?
   It is used in HIV-1 treatment strategies that include both initiation and switching in appropriate patients, based on label and guideline-based eligibility.

3. What competitor products most affect Dovato uptake?
   Other simplified regimen options (two-drug strategies) and the continuing dominance of standard three-drug regimens.

4. What drives Dovato volume growth in formularies?
   Evidence of durable virologic suppression, tolerability, dosing convenience, and payer economics in eligible subgroups.

5. Why can’t a numeric market forecast be stated here?
   The prompt contains no market baseline units, geography, forecast horizon, or competitor volume assumptions required for a hard-data projection.

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References

[1] US Food and Drug Administration. Dovato (dolutegravir and lamivudine) Prescribing Information. FDA label.