CLINICAL TRIALS PROFILE FOR EVOTAZ

All Clinical Trials for EVOTAZ

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02589158 ↗	SSAT067 PK of Atazanavir/Cobicistat and Darunavir/Cobicistat	Completed	Bristol-Myers Squibb	Phase 1	2015-11-01	The purpose of this study is to look at the levels of three HIV medications: atazanavir, darunavir and cobicistat in the blood after drug intake has been stopped, in order to understand how long these drugs persist in the blood. The study will specifically look at blood levels of these three drugs after taking them every day for 10 days. Participants will take Evotaz (atazanavir and cobicistat) on a first stage and Rezolsta (darunavir and cobicistat) on a second stage. If the participants decide to take part, the duration of the study will be up to 33 days plus a screening visit which will take place up to 28 days prior to the start of the study, and a follow up visit, which takes place 7 to 14 days after the last dose of study medication. This study is not randomised which means that all participants will receive all study medications in the same order. The participant and the study doctor will know which study medications the participant is taking at all times during the study.
NCT02589158 ↗	SSAT067 PK of Atazanavir/Cobicistat and Darunavir/Cobicistat	Completed	St Stephens Aids Trust	Phase 1	2015-11-01	The purpose of this study is to look at the levels of three HIV medications: atazanavir, darunavir and cobicistat in the blood after drug intake has been stopped, in order to understand how long these drugs persist in the blood. The study will specifically look at blood levels of these three drugs after taking them every day for 10 days. Participants will take Evotaz (atazanavir and cobicistat) on a first stage and Rezolsta (darunavir and cobicistat) on a second stage. If the participants decide to take part, the duration of the study will be up to 33 days plus a screening visit which will take place up to 28 days prior to the start of the study, and a follow up visit, which takes place 7 to 14 days after the last dose of study medication. This study is not randomised which means that all participants will receive all study medications in the same order. The participant and the study doctor will know which study medications the participant is taking at all times during the study.
NCT02603107 ↗	Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppres	Completed	Gilead Sciences	Phase 3	2015-11-20	The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in HIV-1 infected adults who are virologically suppressed.
NCT02697851 ↗	Pharmacokinetic Effect of Evotaz/Microgynon Co-administration	Terminated	Bristol-Myers Squibb	Phase 1	2016-07-01	This study will investigate the pharmacokinetic of evotaz (atazanavir/cobicistat) and microgynon (ethinylestradiol/levonorgestrel ) when administered alone and together. There will be two study arms, who will take the medications in different orders: GROUP 1: Microgynon 30® for 21 days, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Evotaz® for 14 days GROUP 2: Evotaz® for 14 days followed by 7 days wash-out, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Microgynon 30® for 14 days (participants may chose to complete a 21 day pack). The total duration of the study is 57 days (+screening and follow up visits) and patients will have 3 intensive pharmacokinetic days on days 14, 35 and 56.
NCT02697851 ↗	Pharmacokinetic Effect of Evotaz/Microgynon Co-administration	Terminated	St Stephens Aids Trust	Phase 1	2016-07-01	This study will investigate the pharmacokinetic of evotaz (atazanavir/cobicistat) and microgynon (ethinylestradiol/levonorgestrel ) when administered alone and together. There will be two study arms, who will take the medications in different orders: GROUP 1: Microgynon 30® for 21 days, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Evotaz® for 14 days GROUP 2: Evotaz® for 14 days followed by 7 days wash-out, Followed by Microgynon 30® for 21 days plus Evotaz® for 14 days, Followed by Microgynon 30® for 14 days (participants may chose to complete a 21 day pack). The total duration of the study is 57 days (+screening and follow up visits) and patients will have 3 intensive pharmacokinetic days on days 14, 35 and 56.
NCT04263350 ↗	A Study to Examine the Acceptable Taste and to Estimate the Amount of Atazanavir and Cobicistat in the Body When Taken as a Combination Product Versus When Taken as Separate Products at the Same Time	Not yet recruiting	Bristol-Myers Squibb	Phase 1	2020-02-01	Atazanavir (ATV) and cobicistat (COBI) are approved for use with other drugs for the treatment of HIV-1 (human immunodeficiency virus Type 1) infection in adults. The positive effect of patients taking both these drugs led to the development of a combination tablet (EVOTAZ®), which can help reduce the number of pills a patient has to take and improves their adherence with HIV therapy. This study compares the amount of ATV and COBI in the bodies of healthy adult volunteers when taken as a combination formulation, and when ATV is administered as an oral powder at the same time as COBI administered as an oral tablet. The ATV/COBI combination formulation and ATV powder will be taken with food.

Clinical Trial Conditions for EVOTAZ

Condition Name

Condition Name for EVOTAZ
Intervention	Trials
HIV	2
Healthy Volunteers	1
HIV-1 Infection	1
Healthy Participants	1

Condition MeSH

Condition MeSH for EVOTAZ
Intervention	Trials
Malnutrition	1

Clinical Trial Locations for EVOTAZ

Trials by Country

Trials by Country for EVOTAZ
Location	Trials
United States	25
Australia	3
Canada	3
United Kingdom	3
Italy	2

Trials by US State

Trials by US State for EVOTAZ
Location	Trials
Texas	2
Florida	2
Washington	1
Virginia	1
Tennessee	1

Clinical Trial Progress for EVOTAZ

Clinical Trial Phase

Clinical Trial Phase for EVOTAZ
Clinical Trial Phase	Trials
Phase 3	1
Phase 1	4

Clinical Trial Status

Clinical Trial Status for EVOTAZ
Clinical Trial Phase	Trials
Not yet recruiting	2
Completed	2
Terminated	1

Clinical Trial Sponsors for EVOTAZ

Sponsor Name

Sponsor Name for EVOTAZ
Sponsor	Trials
Bristol-Myers Squibb	4
St Stephens Aids Trust	2
Gilead Sciences	1

Sponsor Type

Sponsor Type for EVOTAZ
Sponsor	Trials
Industry	5
Other	2

EVOTAZ Market Analysis and Financial Projection

Last updated: April 30, 2026

EVOTAZ (atazanavir 300 mg / cobicistat 150 mg) — Clinical Update, Market Dynamics and Revenue Projection

What is EVOTAZ and how is it positioned in the market?

EVOTAZ is a fixed-dose combination antiretroviral therapy (ART) containing:

• Atazanavir 300 mg (HIV-1 protease inhibitor, PI)
• Cobicistat 150 mg (pharmacokinetic enhancer)

It is indicated for:

• HIV-1 infection, in combination with other antiretroviral agents.

EVOTAZ is part of the PI class. In many markets, PI-based regimens have faced structural pressure from the shift to:

• Integrase strand transfer inhibitor (INSTI)-based regimens (including single-tablet regimens and high-efficacy fixed-dose combinations)
• Lower pill burden and higher convenience therapies

This matters for projection because the EVOTAZ revenue base is typically sustained by:

• Durable use in existing patient cohorts
• Line-of-therapy behavior where patients remain on established PI regimens due to tolerability, resistance history, and drug-drug interaction patterns

What is the latest clinical-trials picture for EVOTAZ?

No EVOTAZ-specific late-stage (Phase 3/registrational) readouts that materially change the commercial outlook are confirmed here from the supplied information. A clinical-trials “update” that drives investment conclusions requires trial-level datapoints (enrollment status, endpoints, results, or regulatory actions). Those are not provided in the prompt and cannot be established from the allowed content.

Given EVOTAZ is an established product, the relevant clinical-trial activity that typically moves the needle is:

• New registrational studies (rare for older fixed-dose combinations)
• Pharmacokinetic and interaction studies that support label expansions or new co-therapies
• Real-world switching studies that can affect persistence and churn

A complete, accurate trial update with dates and statuses is not possible without verified trial records and outcomes.

What does the market look like for EVOTAZ: demand drivers and headwinds?

Demand drivers

• Continuing PI utilization in subsets of patients:
  • Those with virologic suppression on established PI regimens
  • Patients with contraindications or intolerance to INSTI backbones
• Drug-drug interaction management:
  • Cobicistat and atazanavir interaction handling can align with certain clinical workflows, especially where clinicians prefer PI-based strategies

Headwinds

• INSTI migration:
  • INSTI-based regimens are now dominant in most formularies and treatment guidelines
• Treatment guideline standardization:
  • Many payers and protocols increasingly favor INSTI-first
• Safety and tolerability considerations:
  • PI class liabilities (class effects) constrain patient switching

How do competitors affect EVOTAZ pricing and share?

EVOTAZ competes indirectly and directly within HIV therapy channels:

• Direct class competition: other boosted PIs (for those selecting PI-based regimens)
• Dominant regimen competition: INSTI-based fixed-dose combinations that displace PI regimens in first-line and switch populations

This competitive structure impacts projection through:

• Lower net new initiations for EVOTAZ
• Higher churn risk toward INSTI regimens
• Margin pressure if pricing dynamics intensify and payer coverage tightens

Market analysis and projection: what to expect for EVOTAZ revenue?

A credible revenue projection requires:

• Historical EVOTAZ revenue/volume by geography
• Pricing trends (list vs net), reimbursement shifts, and tender dynamics
• Share and persistence assumptions
• Loss-of-exclusivity and generics or authorized generics timing
• Regulatory label changes and guideline impacts by line of therapy

None of these quantitative inputs are provided in the prompt, and EVOTAZ forecast models cannot be built without them.

As a result, a complete market analysis and revenue projection for EVOTAZ cannot be produced with the required precision and business decision utility.

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Key data points required for an investable projection (not provided)

EVOTAZ projections typically rely on the following inputs:

• Global sales history (annual revenue and units) across major markets
• Segmenting by geography and line of therapy
• Generic/authorized generic status and effective date impacts
• Payer formulary placement (tier status) over time
• Clinical persistence (time on therapy) and switch rates

These are not included in the supplied information.

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Key Takeaways

• EVOTAZ is a boosted-PI regimen (atazanavir + cobicistat) used for HIV-1 infection as part of combination therapy.
• The commercial environment is structurally pressured by INSTI migration, which reduces net new starts on PI-based regimens over time.
• A complete, accurate clinical-trials update with concrete dates and outcomes is not available from the provided content.
• A revenue projection with defensible assumptions is not possible without historical sales, market share, and competitive and regulatory timing inputs.

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FAQs

1. What is EVOTAZ composed of?
   Atazanavir 300 mg and cobicistat 150 mg.

2. What HIV regimen class is EVOTAZ?
   Boosted protease inhibitor (PI) regimen.

3. What is the main market headwind for EVOTAZ?
   Treatment migration toward INSTI-based regimens and standardized guideline preferences.

4. Does EVOTAZ have registrational trials driving near-term label expansion?
   No validated, trial-level registrational updates can be confirmed from the provided information.

5. Can a precise revenue projection be produced from the prompt?
   No. The forecast requires sales history, pricing/reimbursement dynamics, and competitive and exclusivity timing.

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References

[1] FDA. EVOTAZ Prescribing Information. U.S. Food and Drug Administration.
[2] EMA. EVOTAZ Summary of Product Characteristics (where applicable). European Medicines Agency.