CLINICAL TRIALS PROFILE FOR EVOTAZ

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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.
NCT05236738 ↗	A Study to Compare the Drug Levels of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations and the Coadministration of the Individual Reference Products in Healthy Adults Under Fed Conditions	Not yet recruiting	Bristol-Myers Squibb	Phase 1	2022-02-25	The purpose of this study is to evaluate the drug absorption of atazanavir and cobicistat between the coadministration of the mini-tablet formulations in applesauce or chocolate pudding followed by water and the coadministration of atazanavir oral powder in applesauce and cobicistat oral tablet followed by water in healthy adult participants.

Clinical Trial Conditions for EVOTAZ

Condition Name

Condition Name for EVOTAZ
Intervention	Trials
HIV	2
Healthy Participants	1
Healthy Volunteers	1
HIV-1 Infection	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
Canada	3
United Kingdom	3
Australia	3
Italy	2

Trials by US State

Trials by US State for EVOTAZ
Location	Trials
Florida	2
Texas	2
Kentucky	1
Kansas	1
Illinois	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
Completed	2
Not yet recruiting	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

Last updated: July 30, 2026

EVOTAZ clinical trials update, market analysis and revenue projection (2026)

EVOTAZ (atazanavir + cobicistat) remains a steady HIV-1 regimen in treated populations that seek boosted protease-inhibitor (PI) coverage without nucleoside backbones, but its long-term growth runway is constrained by aging of the cohort, migration to integrase inhibitor (INSTI)-based regimens, and the limited availability of new patient starts in many markets. Public trial reporting is sparse relative to newer HIV pipelines, so near-term commercial outcomes track macro dynamics in treated HIV prevalence, guideline positioning, and payer formulary practices more than new clinical readouts.

What EVOTAZ clinical trial updates exist and what do they show?

Bottom line: Publicly accessible clinical-trial updates for EVOTAZ are limited in volume and largely downstream of regimen evaluation already established for atazanavir/cobicistat. EVOTAZ is not a high-profile source of new registrational data in the current HIV cycle, so updates tend to be label-relevant (drug interaction, renal/hepatic considerations, real-world effectiveness) or modeling of combination regimens rather than new phase 3 endpoints.

Which EVOTAZ trial categories are most active

EVOTAZ’s evidence base typically clusters into:

• Drug-drug interaction studies (DDIs) with common antiretrovirals and concomitant agents, reflecting cobicistat’s CYP3A inhibition.
• Exposure and food-effect pharmacokinetics for dosing and adherence behavior.
• Switching and tolerability studies focused on virologic suppression maintenance in stable patients.
• Real-world observational cohorts tracking retention and discontinuation drivers (GI intolerance, hyperbilirubinemia, lipid changes).

What endpoints matter for EVOTAZ

In HIV treated-patient populations, EVOTAZ performance is usually summarized by:

• HIV-1 RNA suppression rates (time to confirmed virologic response, rates at 48 and 96 weeks in switching cohorts)
• Safety discontinuation linked to:
  • indirect hyperbilirubinemia (atazanavir class effect)
  • grade 3-4 adverse events tied to boosted PI use
• Renal safety proxies, especially because PI regimens remain relevant for patients where certain INSTI options are less preferred.

Does EVOTAZ have ongoing phase 3 registrational work

For business planning, EVOTAZ should be treated as post-registration lifecycle product evidence. Clinical activity that changes revenue is typically:

• new label expansions tied to a distinct patient segment
• new fixed-dose combinations
• new statistically driven non-inferiority claims versus current standard of care

No such large registrational shift is apparent from the standard public clinical-trials footprint used by the market.

What is EVOTAZ market size, revenue trajectory, and adoption trend?

Bottom line: EVOTAZ is a mature HIV product. Market behavior is dominated by continued patient retention among those already on boosted PI regimens and by switching friction, with growth limited by INSTI-first prescribing. Revenue tends to follow:

• treated prevalence trends
• formulary placement and pharmacy benefit management (PBM) decisions
• cohort aging and adherence patterns
• competition from other atazanavir/cobicistat or atazanavir/ritonavir offerings and from INSTI-based fixed doses

Where EVOTAZ sells

EVOTAZ demand concentrates in:

• markets where boosted PIs remain used in treatment-experienced patients after prior regimen history
• formularies that keep EVOTAZ as an option for patients with INSTI intolerance or drug interaction constraints

What drives share vs. alternatives

Key switching alternatives include:

• INSTI-based single-tablet regimens with lower food and DDI burden in typical use cases
• boosted PI comparators (atazanavir/ritonavir or darunavir/ritonavir-based backbones) depending on regional access

EVOTAZ share pressure increases when payers prefer fixed-dose INSTI combinations with broader managed care uptake.

Commercial performance indicators used for projection

For projecting EVOTAZ revenue, the practical indicators are:

• HIV treated population growth in each geography
• fraction of treated patients on boosted PI regimens
• share of atazanavir-containing therapy within boosted PIs
• switching rate away from boosted PIs toward INSTI regimens
• persistence (median time on therapy before discontinuation)
• generic erosion where applicable by market and segment

EVOTAZ’s pricing and volume are sensitive to competitive entry timing and local generics.

When will EVOTAZ exclusivity end and when does EVOTAZ lose exclusivity?

Bottom line: Exclusivity dynamics for EVOTAZ are largely tied to compound and formulation protection around atazanavir and cobicistat combinations, plus any pediatric or additional regulatory exclusivities in specific jurisdictions. For market forecasting, the revenue “risk window” is tied to the earlier expiry among:

• US composition-of-matter and combination claims for atazanavir/cobicistat
• formulation and dosing claims
• regulatory exclusivities in key launch countries

Because EVOTAZ is a mature product, the remaining exclusivity contribution to revenue is typically smaller than historic periods post-launch.

What is the Orange Book status of EVOTAZ in the U.S.?

Bottom line: EVOTAZ’s US market access and generic risk are mediated through FDA Orange Book patent listings for atazanavir + cobicistat combination products. Generic entry risk increases after listed patents expire and after any Paragraph IV events resolve.

A complete Orange Book mapping requires the current FDA Orange Book listing set for the exact dosage form strength (and whether it is still marketed by the NDA holder at full strength), which is not provided here.

How many patents protect EVOTAZ and what patent estate strength matters?

Bottom line: EVOTAZ’s patent estate is expected to be a mix of:

• early-life composition and use claims
• later-life formulation, dosing, and stability claims
• device or manufacturing method claims where applicable

For generic and biosimilar-adjacent risk, the relevant question is not the count, but whether there is at least one enforceable claim that blocks generic combination products in the jurisdictions of interest.

A jurisdiction-by-jurisdiction patent count and enforceability analysis requires a current patent portfolio dataset for EVOTAZ, which is not included in the prompt.

What Paragraph IV challenges affect EVOTAZ and what generic entry risks exist?

Bottom line: EVOTAZ faces generic pressure common to mature HIV combination products. The business risk is driven by:

• whether ANDA filers can design around remaining enforceable patents
• whether Paragraph IV litigations delay launch
• whether settlements impose negotiated “at-risk” or delayed-launch dates

Without a current Paragraph IV litigation docket and ANDA status for EVOTAZ, the only decision-grade guidance is: generic erosion should be treated as an established lifecycle risk, with specific launch timing depending on patent expiry and settlement outcomes.

How does EVOTAZ compare with competing HIV regimens on market and clinical positioning?

Bottom line: EVOTAZ competes primarily with:

• INSTI-based fixed-dose regimens as default first-line choices in many guidelines
• other boosted PI combinations in treatment-experienced or intolerance-driven switching

Competitive positioning vectors

• Efficacy: boosted PI regimens remain effective for suppression maintenance, but INSTI regimens often have superior tolerability profiles.
• Tolerability: atazanavir class effects (bilirubin elevations) can increase discontinuation risk in some cohorts.
• Drug interaction burden: cobicistat’s boosting can complicate concomitant medications; this increases payer scrutiny and patient selection.

Market impact of guideline evolution

Guideline shifts that favor INSTI-first prescribing reduce new patient starts on boosted PI regimens. That compresses volume growth for EVOTAZ even if treated-patient share holds.

What is the clinical and regulatory status of EVOTAZ in 2026?

Bottom line: EVOTAZ is a marketed HIV-1 treatment under established labeling. Regulatory change risk that matters commercially tends to be:

• label narrowing (less likely for a mature product)
• new interaction or safety updates
• pediatric or pregnancy data updates
• REMS-style measures (rare for HIV products)

No new registrational milestone is implied by the product’s lifecycle stage.

EVOTAZ revenue projection: 2026 base case and scenario bands

Bottom line: A defensible revenue model for EVOTAZ should be anchored to treated-patient persistence plus modest share drift against INSTI regimens. Without hard-year-specific revenue history in the prompt, the projection below is structured as a scenario framework suitable for investment and licensing modeling.

Scenario framework (2016-2026 lifecycle logic applied to 2026 outlook)

Assume EVOTAZ revenue in 2026 is driven by:

1. Volume

• Base case: flat-to-slight decline in patients, reflecting attrition to INSTI switches and natural discontinuation
• Bear case: accelerated decline from formulary switches and generic erosion in key markets
• Bull case: stable persistence and protected niche use where INSTI options are limited by interactions or tolerability

2. Price

• Base case: price maintenance offset by modest discounting and rebate compression
• Bear case: stronger generic or payer pressure
• Bull case: fewer erosion events or continued formulary preference

Quantified bands (index-style)

Use an index for planning where EVOTAZ 2025 revenue = 100:

• Bull: 2026 = 104 to 108 (better persistence, limited erosion)
• Base: 2026 = 97 to 103 (moderate cohort shrink, pricing roughly stable)
• Bear: 2026 = 88 to 96 (generic/payer pressure accelerates)

These bands reflect mature-drug dynamics common to boosted PI products facing INSTI-first standard-of-care.

What would move EVOTAZ to the bull side

• limited generic erosion timing in key markets
• payer retention in treatment-experienced subpopulations
• label or evidence changes that expand use beyond niche cohorts

What would move EVOTAZ to the bear side

• earlier-than-expected generic entry in major geographies
• a formulary shift that removes boosted PI options in favor of INSTI fixed-dose regimens
• safety/tolerability-driven switching acceleration in real-world cohorts

What licensing or partnership deals exist for EVOTAZ and how do they affect commercialization?

Bottom line: EVOTAZ commercialization is typically maintained through existing NDA commercialization structures rather than new major partnership-led launches in the current cycle. For business planning, the more relevant deal risk is whether:

• patent licensing supports continued exclusivity posture
• generic settlements affect entry timing
• distribution agreements change rebate dynamics

No deal terms are provided in the prompt, so no specific transaction mapping can be stated.

Key Takeaways

• EVOTAZ remains a mature HIV-1 regimen with limited new registrational clinical trial activity; near-term clinical updates are more likely DDI and real-world persistence than phase 3 breakthroughs.
• Market growth is constrained by INSTI-first guideline evolution, pushing EVOTAZ toward retention-driven rather than acquisition-driven revenue.
• Revenue projection for 2026 should be modeled as flat-to-moderate decline in a base case, with generic and payer formulary shifts driving bear-side downside and persistence plus limited erosion driving bull-side upside.
• Generic entry risk exists as a structural lifecycle factor, but paragraph IV, Orange Book, and patent-claim specifics require current dossier data not included in the prompt.

FAQs

1. Does EVOTAZ still have meaningful demand versus INSTI-based HIV regimens?
2. What patient characteristics most influence EVOTAZ persistence and discontinuation?
3. How do cobicistat drug-drug interactions shape formulary access for EVOTAZ?
4. What is the generic launch risk pathway for atazanavir/cobicistat fixed-dose products?
5. Which geographies typically contribute the most to EVOTAZ-treated patient share?

References

1. FDA Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. ClinicalTrials.gov. EVOTAZ (atazanavir; cobicistat) search results. National Library of Medicine.