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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	2
Hiv	1
HIV I Infection	1

Condition MeSH

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

Clinical Trial Locations for DOVATO

Trials by Country

Trials by Country for DOVATO
Location	Trials
Italy	15
United States	11
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
Phase 4	4
Phase 3	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for DOVATO
Clinical Trial Phase	Trials
Recruiting	3
Completed	2
Active, not recruiting	1

Clinical Trial Sponsors for DOVATO

Sponsor Name

Sponsor Name for DOVATO
Sponsor	Trials
ViiV Healthcare	5
Societa' Italiana Di Malattie Infettive E Tropicali	1
University Hospital, Ghent	1

Sponsor Type

Sponsor Type for DOVATO
Sponsor	Trials
Industry	5
Other	5

DOVATO Market Analysis and Financial Projection

Dovato: Clinical Trials Update, Market Analysis, and Projections

Introduction to Dovato

Dovato, a two-drug regimen consisting of dolutegravir and lamivudine (DTG/3TC), has been a significant development in the treatment of HIV. Developed by ViiV Healthcare, a global specialist in HIV medicines, Dovato is designed to simplify and improve the treatment outcomes for individuals living with HIV.

Clinical Trials Update

DOLCE Study

The DOLCE study, a multicentre, randomised, open-label trial, evaluated the efficacy and safety of Dovato in approximately 230 antiretroviral treatment-naïve individuals with advanced HIV. The 48-week findings showed that Dovato had similar efficacy to a three-drug regimen in achieving viral suppression in adult patients with advanced HIV, and it was non-inferior in attaining viral suppression[1][3].

PASO DOBLE Study

The PASO DOBLE clinical trial, a Phase IV study, compared Dovato to the three-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide fumarate) in people who are virologically suppressed. The results indicated that Dovato demonstrated non-inferior efficacy to Biktarvy and also showed less weight gain compared to the three-drug regimen over 48 weeks[4].

Efficacy and Safety

The clinical trials have consistently shown that Dovato is highly effective in suppressing the HIV virus. In the Gemini 1 and 2 studies, a pooled analysis revealed that 82% of patients on Dovato maintained undetectable viral loads over a three-year period[5].

Weight Gain Comparison

An important finding from the PASO DOBLE study was that Dovato resulted in less weight gain compared to the three-drug regimen Biktarvy, which is a significant consideration for long-term treatment management[4].

FDA Approvals and Indications

Dovato has received several FDA approvals, including the treatment of HIV-1 in adolescents aged 12 years and older and weighing at least 25 kilograms, with no antiretroviral treatment history or to replace the current ARV regimen in those who are virologically suppressed on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato[4].

Market Analysis

Current Market Share

As of recent data, Dovato holds a 3.2% share among newly diagnosed patients in the U.S., but it boasts over 10% share in the switch market for patients who are already virologically suppressed. In Europe, the adoption rate is higher, with nearly 20% among switchers in some territories, driven by the belief that fewer drugs are better and considerations around drug costs[5].

Sales Projections

ViiV Healthcare forecasts strong growth for Dovato, driven by competitive execution and the expanding long-acting (LA) portfolio. The company anticipates a sales CAGR of 6% to 8% from 2021 to 2026, with Dovato and cabotegravir being key drivers of this growth. By 2026, the LA portfolio is expected to deliver over £2 billion in sales, representing one-third of overall HIV sales[2].

Impact of Long-Acting Regimens

The shift towards long-acting regimens is a significant trend in HIV treatment. ViiV Healthcare is leading this shift, with plans to extend dosing intervals for long-acting regimens to every four months in prevention and treatment, and aiming for every six months by the end of the decade. This innovation is expected to significantly replace revenue from dolutegravir as it loses exclusivity[2].

Market Projections

HIV Clinical Trials Market

The global HIV clinical trials market is expected to grow significantly, reaching USD 2.42 billion by 2034. This growth is driven by various factors, including the increasing need for effective HIV treatments and the expansion of clinical trials into new regions and phases[3].

Regional Growth

The market growth will be seen across various regions, including North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. The segmentation by phase, study design, and sponsor will also play a crucial role in understanding the market dynamics[3].

Competitive Landscape

Dovato competes in a highly competitive market dominated by other effective HIV treatments such as Biktarvy. However, ViiV Healthcare is positioning Dovato as a preferred option due to its simplicity, efficacy, and reduced side effects like weight gain. The company's strategy to build confidence among physicians through long-term data and inclusion in treatment guidelines is expected to drive growth[5].

Intellectual Property and Exclusivity

Dovato and Juluca are protected by additional formulation and other patents until around 2030 in the U.S. and Europe. The long-acting portfolio is also protected by patents until 2031, with potential for future protection beyond this date for new LA medicines, formulations, and regimens[2].

Conclusion

Dovato has emerged as a promising treatment option for HIV, offering similar efficacy to three-drug regimens with the advantage of fewer side effects and simpler dosing. With strong clinical trial results, expanding market share, and a robust pipeline of long-acting regimens, ViiV Healthcare is well-positioned to drive growth in the HIV treatment market.

Key Takeaways

• Efficacy: Dovato has demonstrated non-inferior efficacy to three-drug regimens in clinical trials.
• Safety: Dovato shows less weight gain compared to other regimens.
• FDA Approvals: Approved for various indications, including treatment in adolescents and switch therapy.
• Market Share: Growing share in the U.S. and higher adoption in Europe.
• Sales Projections: Expected to drive significant growth with a CAGR of 6% to 8% from 2021 to 2026.
• Long-Acting Regimens: Key to future growth and market dominance.
• Intellectual Property: Protected by patents until around 2030 and beyond.

FAQs

Q: What is Dovato, and how does it differ from other HIV treatments?

A: Dovato is a two-drug regimen consisting of dolutegravir and lamivudine (DTG/3TC), designed to simplify HIV treatment. It differs from traditional three-drug regimens by offering similar efficacy with fewer drugs.

Q: What are the key findings from the DOLCE and PASO DOBLE studies?

A: The DOLCE study showed Dovato to be non-inferior to a three-drug regimen in viral suppression, while the PASO DOBLE study demonstrated Dovato's non-inferior efficacy to Biktarvy with less weight gain.

Q: What is the current market share of Dovato in the U.S. and Europe?

A: Dovato holds a 3.2% share among newly diagnosed patients in the U.S. and over 10% in the switch market. In Europe, it has a nearly 20% adoption rate among switchers.

Q: What are the sales projections for Dovato?

A: ViiV Healthcare forecasts a sales CAGR of 6% to 8% from 2021 to 2026, driven by Dovato and cabotegravir.

Q: How does the long-acting regimen strategy impact Dovato's market position?

A: The shift towards long-acting regimens is expected to significantly replace revenue from dolutegravir as it loses exclusivity, positioning Dovato and other LA regimens for continued growth.

Sources

1. ViiV Healthcare shares results from trial of HIV treatment regimes. Clinical Trials Arena.
2. ViiV Healthcare Meet the Management - GSK. GSK.
3. HIV Clinical Trials Market Size Expected to Hit USD 2.42 Billion by 2034. BioSpace.
4. Dovato Demonstrates Non-Inferior Efficacy to Biktarvy in Head-to-Head Phase IV Trial. Applied Clinical Trials Online.
5. GSK's ViiV, armed with long-term Dovato data, eyes 'tipping point' for HIV dual-drug regimen. FiercePharma.