An Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Period, 3-Sequence, Crossover Design, Relative Bioavailability Study Comparing the Pharmacokinetics of Atazanavir and Cobicistat Between the Coadministration of Age-Appropriate Mini-Tablet Formulations (ATV and COBI Oral Mini-tablets; 300 mg and 150 mg, Respectively) and the Coadministration of the Individual Reference Products (REYATAZ [Atazanavir Oral Powder] and TYBOST [Cobicistat Oral Tablet]; 300 mg and 150 mg, Respectively) in Healthy Adults Under Fed Conditions

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.

Start Date13 May 2022

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT04263350

/ CompletedPhase 1

An Open-label, Randomized Crossover Study to Obtain a Preliminary Estimate of the Bioavailability of Atazanavir and Cobicistat When Administered in an Age-appropriate Fixed-Dose Combination Formulation Compared With Coadministration of the Age-appropriate Atazanavir and Cobicistat Individual Formulations and to Assess Preliminary Palatability/Acceptability in Healthy Adults

The purpose of this study is to compare the amount of Atazanavir (ATV) and Cobicistat (COBI) in the bodies of healthy adult participants 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.

Start Date26 Feb 2020

Sponsor / Collaborator

Bristol Myers Squibb Co.

NCT02697851

/ TerminatedPhase 1

The Effect of Atazanavir/Cobicistat on the Pharmacokinetics of an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (Microgynon 30®) in Healthy Women

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.

Start Date01 Jul 2016

Sponsor / Collaborator

Bristol Myers Squibb Co.

100 Clinical Results associated with Atazanavir Sulfate/Cobicistat

100 Translational Medicine associated with Atazanavir Sulfate/Cobicistat

100 Patents (Medical) associated with Atazanavir Sulfate/Cobicistat

Literatures (Medical) associated with Atazanavir Sulfate/Cobicistat

01 Mar 2024·Mini-Reviews in Medicinal Chemistry

Synthetic and Clinical Perspectives of Evotaz: An Overview

Review

Author: Kumar, Kapil ; Puri, Sachin ; Yadav, Tanuja T ; Chouhan, Mangilal

Abstract:Viruses cause a variety of diseases in the human body. Antiviral agents are used to prevent the production of disease-causing viruses. These agents obstruct and kill the virus's translation and replication. Because viruses share the metabolic processes of the majority of host cells, finding targeted medicines for the virus is difficult. In the ongoing search for better antiviral agents, the USFDA approved EVOTAZ, a new drug discovered for the treatment of Human Immunodeficiency Virus (HIV). It is a once-daily (OD) fixed-dose combination of Cobicistat, a cytochrome P450 (CYP) enzyme inhibitor, and Atazanavir, a protease inhibitor. The combination drug was created in such a way that it can inhibit both CYP enzymes and proteases at the same time, resulting in the virus's death. The drug is not effective in children under the age of 18; however, it is still being studied for various parameters. This review article focuses on EVOTAZ's preclinical and clinical aspects, as well as its efficacy and safety profiles.

01 Jan 2023·Current HIV research

A Combination of Novel HIV-1 Protease Inhibitor and Cytochrome P450 (CYP) Enzyme Inhibitor to Explore the Future Prospective of Antiviral Agents: Evotaz.

Review

Author: Sharma, Poonam ; Sharma, Abha ; Abbot, Vikrant ; Kapila, Isha

Viruses belong to the class of micro-organisms that are well known for causing infections in the human body. Antiviral medications are given out to prevent the spread of disease-causing viruses. When the viruses are actively reproducing, these agents have their greatest impact. It is particularly challenging to develop virus-specific medications since viruses share the majority of the metabolic functions of the host cell. In the continuous search for better antiviral agents, the United States Food and Drug Administration (USFDA) approved a new drug named Evotaz on January 29, 2015 for the treatment of human immunodeficiency virus (HIV). Evotaz is a combined once-daily fixed drug, containing Atazanavir, an HIV protease inhibitor, and cobicistat, an inhibitor of the human liver cytochrome P450 (CYP) enzyme. The medication is created such that it can kill viruses by concurrently inhibiting protease and CYP enzymes. The medicine is still being studied for a number of criteria, but its usefulness in children under the age of 12 is currently unknown. The preclinical and clinical characteristics of Evotaz, as well as its safety and efficacy profiles and a comparison of the novel drug with antiviral medications presently available in the market, are the main topics of this review paper.

04 May 2019·HIV Research & Clinical PracticeQ4 · MEDICINE

Pharmacokinetics (PK) of ethinylestradiol/levonorgestrel co-administered with atazanavir/cobicistat

Q4 · MEDICINE

Article

Author: Bisdomini, Elisa ; Elliot, Emilie R ; Penchala, Sujan Dilly ; Nwokolo, Nneka ; Boffito, Marta ; Khoo, Saye

Background and objectives: Access to safe and reliable contraception in the context of ARVs is essential. This study aimed to investigate the steady-state pharmacokinetics (PK) of ethinylestradiol/levonorgestrel (EE/LNG) 30/150 μg (Microgynon^®) and atazanavir/cobicistat (ATV/COBI) 300/150 mg (Evotaz^®), co-administered in HIV negative female volunteers, and assess its safety and tolerability.Methods: This phase 1, open label, 57-day, cross over, PK study randomized participants to one of two groups: (i) group 1 received EE/LNG alone on days 1-21, EE/LNG (21 days) + ATV/COBI (14 days) in the co-administration phase (days 22-42) and ATV/COBI alone on days 43-56; (ii) group 2 followed the same sequence but started with ATV/COBI and concluding with EE/LNG. Each group underwent intensive PK sampling on days 14, 35, and 56. EE/LNG and ATV/COBI concentrations were measured using validated LC-MS/MS methods.Results: Of 14 healthy female volunteers screened, 11 attended baseline and six completed all PK phases (five withdrew secondary to side effects). Paired data were available for analysis in six subjects for EE/LNG and eight for ATV/COBI. Geometric mean ratios (GMR, with versus without ATV/COBI) and 90% confidence intervals (CI) for LNG C_max, AUC_0-24, C₂₄ were 0.83 (0.68-1.02), 0.92 (0.71-1.18), 1.01 (0.73-1.38). GMR and 90% CI for EE C_max, AUC_0-24, C₂₄ were 1.05 (0.92-1.19), 1.01 (0.83-1.22), 0.75 (0.60-0.93). No grade 3 or 4 adverse events or laboratory abnormalities were observed in the women who completed the study.Conclusions: Our findings showed no significant changes in LNG concentrations and a 25% decrease in EE C₂₄ when EE/LNG was co-administered with ATV/COBI.

News (Medical) associated with Atazanavir Sulfate/Cobicistat

28 Dec 2022

·www.prnewswire.com

Hagens Berman Sobol Shapiro LLP, Hilliard & Shadowen LLP, and Durie Tangri LLP Announce a Class Action Involving Antiretroviral Drugs

SAN FRANCISCO, Dec. 28, 2022 /PRNewswire/ -- If you purchased Atripla®, Biktarvy®, Complera®, Descovy®, Evotaz®, Genvoya®, Odefsey®, Prezcobix®, Stribild®, Symtuza®, Truvada®, or Viread®, a class action lawsuit may affect your rights. If you are a member of one or both classes, your legal rights will be affected whether you act or don't act, so please read this notice carefully. You must decide whether to remain a member of the class(es) or to exclude yourself from the class(es). A class action lawsuit is pending in the United States District Court for the Northern District of California (the "Court") involving the antiretroviral products Atripla, Biktarvy, Complera, Descovy, Evotaz, Genvoya, Odefsey, Prezcobix, Stribild, Symtuza, Truvada, and Viread ("Products"). The lawsuit claims that Gilead Sciences, Inc., Gilead Holdings, LLC, Gilead Sciences, LLC, and Gilead Sciences Ireland UC ("Gilead"), and Johnson & Johnson, Janssen Products LP, and Janssen R&D Ireland ("Janssen") (collectively, "Defendants") engaged in allegedly anticompetitive conduct that caused certain consumers and third-party payors to pay too much for certain of the Products . Defendants deny any wrongdoing. PLEASE NOTE: No one is claiming that any of these products is unsafe or ineffective. WHO IS INCLUDED IN THE CLASSES? The Court has certified three Damages Classes and three Injunctive Classes in this lawsuit (the "Classes"). The Damages Classes are made up of third-party payors ("TPPs") only (i.e., not individual consumers); the Injunctive Classes are made up of both TPPs and consumers. Damages Classes : The Truvada Class: All entities in the United States that indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of Truvada, and/or its AB-rated generic equivalent sold by Teva Pharmaceutical Industries Ltd. or its affiliates, in the Specified States1 for consumption by their members, employees, insureds, participants, or beneficiaries, other than for resale, during the period February 1, 2018 through May 31, 2021; The Atripla Class: All entities in the United States that indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of Atripla, and/or its AB-rated generic equivalent sold by Teva Pharmaceutical Industries Ltd. or its affiliates, in the Specified States for consumption by their members, employees, insureds, participants, or beneficiaries, other than for resale, during the period February 1, 2018 through July 31, 2021; and The Complera Class: All entities in the United States that indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of Complera in the Specified States for consumption by their members, employees, insureds, participants, or beneficiaries, other than for resale, during the period February 1, 2018 through September 27, 2022. Excluded from the Truvada, Atripla, and Complera Classes are: (a) Defendants and their officers, directors, management, employees, subsidiaries, or affiliates; (b) All federal and state government entities, except for cities, towns, municipalities, or counties with self-funded prescription drug plans; (c) Fully insured health plans, i.e., plans for which the insurer bears 100% of the risk for the reimbursement obligations to members; and (d) Pharmacy Benefit Managers. Injunctive Classes : The Evotaz Injunctive Class: All persons or entities in the United States who indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of Evotaz for consumption by themselves, their families, or their members, employees, insureds, participants, or beneficiaries, other than for resale, during the period May 14, 2015 through September 27, 2022; The Prezcobix Injunctive Class: All persons or entities in the United States who indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of Prezcobix for consumption by themselves, their families, or their members, employees, insureds, participants, or beneficiaries, other than for resale, during the period May 14, 2015 through September 27, 2022; and The cART Foundation Drug Injunctive Class: All persons or entities in the United States who indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of a cART Foundation Drug2 for consumption by themselves, their families, or their members, employees, insureds, participants, or beneficiaries, other than for resale, during the period May 14, 2015 through September 27, 2022. Excluded from each of the Injunctive Classes are: (a) Defendants and their officers, directors, management, employees, subsidiaries, or affiliates; (b) All federal and state government entities, except for cities, towns, municipalities, or counties with self-funded prescription drug plans; (c) Fully insured health plans, i.e., plans for which the insurer bears 100% of the risk for the reimbursement obligations to members; (d) Pharmacy Benefit Managers; and (e) The Judges in this case and any members of their immediate families. Additionally, excluded from the cART Foundation Drug Injunctive Class are natural persons who have filed a claim for personal injury against any of the Defendants or Bristol-Myers Squibb Company or E. R. Squibb & Sons, L.L.C., alleged to be caused by the consumption of a tenofovir-containing product. YOUR RIGHTS AND OPTIONS Your options depend on whether you are a member of one of the Damages Classes or a member of one of the Injunctive Classes. If you are a member of one of the Damages Classes, you have the right to exclude yourself from (to opt out of) the Damages Classes no later than March 15, 2023. Details on how to request exclusion can be found at . If you do nothing, you will remain a member of the class(es) and be bound by the outcome of this lawsuit, whether by a settlement or by a judgment rendered for or against the Defendants. If you are a member of one of the Injunctive Classes, you cannot exclude yourself from the Class. The deadlines contained in this notice may be amended by Court Order, so check the website for any updates. A trial is scheduled for March 27, 2023 and any updates will be provided on the website. FOR MORE INFORMATION AND A CLAIM FORM Visit Call 1-877-388-1751 Source: Hagens Berman Sobol Shapiro LLP, Hilliard & Shadowen LLP, and Durie Tangri LLP 1 The "Specified States" for each of the Damages Classes are: Alabama, Arizona, California, Connecticut, Florida, Hawaii, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Oregon, Rhode Island, South Dakota, Tennessee, Utah, Vermont, West Virginia, Wisconsin, and the District of Columbia. 2 For the purposes of this class definition a cART Foundation Drug is any of one or more of: Atripla, Biktarvy, Complera, Descovy, Genvoya, Odefsey, Stribild, Symtuza, Truvada, and Viread. SOURCE Hagens Berman Sobol Shapiro LLP, Hilliard & Shadowen LLP, and Durie Tangri LLP

Patent InfringementBiosimilar

29 Sep 2021

·endpts.com

Gilead, Bristol Myers face lawsuit from major pharmacies over HIV generic drug delays

Major pharmacy chains CVS and Rite Aid recently sued Gilead Sciences, Teva and Bristol Myers Squibb, claiming the pharma companies deliberately stalled the introduction of cheaper generic versions of several blockbuster HIV drugs. The suit specifically goes after billions of dollars worth of reverse-payment agreements between the pharma companies that withheld from the market generic versions of HIV drugs Viread, Atripla, Truvada and Evotaz. “From 2004 to 2017, Gilead made tens of billions of dollars from HIV medications while introducing only a single new pharmaceutical compound,” the suit alleges. “In connection with these settlement agreements, collusive collaborations and product-hopping schemes, Gilead unfairly increased the already exorbitant pricing for its HIV medications to wring the last bit of available profits from its HIV franchises when faced with imminent generic competition.” In the case of Viread, the suit also explains how Gilead and Teva dropped a clause from their formal patent settlement that would have forced Gilead to not launch an authorized generic, as part of an attempt to avoid scrutiny from the Federal Trade Commission. But the suit claims that the two companies “continued to honor the clause in purpose and effect.” In other instances, the suit explains some of Gilead’s schemes, adding: The suit also goes after the fact that Gilead, which collaborated with Bristol Myers Squibb on developing some of the drugs, is not the inventor of tenofovir, which came from Czech institutions in the 1980s. CVS and Rite Aid lawyers, who are seeking overcharge damages among other provisions, also note that numerous courts have agreed with the FTC and found that “no authorized generic” clauses can and do constitute anticompetitive reverse payments to filers of generic drug applications. Gilead said in a statement to Endpoints News : “The lawsuits filed against Gilead, along with two other companies, distorts and misstates Gilead’s history, its collaborations with its partners, and its settlement agreements. Gilead believes this lawsuit and its antitrust allegations are without merit. The allegations against Gilead are misguided and do not accurately reflect antitrust laws or Gilead’s history of innovative collaboration and competition in HIV medicines.”

Generic DrugCollaborate

30 Jan 2015

·www.biospace.com

FDA Green Lights Bristol-Myers Squibb Company, Johnson & Johnson HIV Pills

January 30, 2015 By Jessica Wilson , BioSpace.com Breaking News Staff The U.S. Food and Drug Administration (FDA) approved two similar HIV drugs on Thursday, one made by Bristol-Myers Squibb Company and the other by Johnson & Johnson . Both drugs are fixed-dose pills that combine protease inhibitors and a boosting agent produced by Gilead Sciences, Inc. . Bristol-Myers ’ drug Evotaz combines the protease inhibitor Reyataz, also known as atazanavir, and cobicistat, a pharmacokinetic enhancer made by Gilead . J&J ’s drug Prezcobix combines the protease inhibitor Prezista, also known as darunavir, with cobicistat. “We are pleased to provide physicians and patients with an important new option to treat HIV; atazanavir with cobicistat delivers sustained efficacy and safety through 48 weeks, as demonstrated through its rigorous clinical development plan, including a head-to-head Phase III trial,” said Murdo Gordon , head of worldwide markets at Bristol-Myers , in a statement . “Evotaz increases the possibility of providing HIV suppression by combining reduced pill burden with a low rate of virologic failure and zero protease inhibitor mutations.” The big news for patients with HIV is that this approval makes available an effective treatment with one fewer pill. Research confirmed that Evotaz is bioequivalent to the co-administration of its components, Reyataz and cobicistat, when given with a light meal, according to Bristol-Meyers . “Pharmacokinetic studies and a large clinical trial have demonstrated that we can expect the same atazanavir drug levels and clinical efficacy from Evotaz as with ritonavir-boosted Reyataz with one less pill,” said study investigator Joel Gallant , associate medical director of Specialty Services at Southwest CARE Center in Santa Fe, New Mexico, and adjunct professor of medicine in the Division of Infectious Diseases at the Johns Hopkins University School of Medicine . Gilead Sciences has signed separate licensing agreements regarding cobicistat with Bristol-Meyers and with a subsidiary of J&J, the Ireland-based Tibotec Pharmaceuticals , in 2011. In both cases, Gilead retains sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents. Bristol-Meyers and J&J are each responsible for the formulation, manufacturing, registration, distribution and commercialization of the drug that contains cobicistat. When Gilead announced the licensing agreement with J&J , Norbert Bischofberger , Gilead ‘s executive vice president of research and development and chief scientific officer, emphasized that such partnerships represent a commitment to improve the lives of those with HIV. “This agreement represents another important step forward in our commitment to developing simplified treatment regimens that can help address the individual needs of people living with HIV,” he said. BioSpace Temperature Poll Can Sanofi Snag a New CEO? French biopharma giant Sanofi has had a difficult time finding a replacement willing to take the CEO job after ousting popular chief Chris Viehbacher last fall. So far, at least three marquee-name candidates have turned down the job, including execs from Takeda and AstraZeneca . Do you think Sanofi will be able to fill this position any time soon? BioSpace wants your opinion! var _polldaddy = [] || _polldaddy; _polldaddy.push( { type: "iframe", auto: "1", domain: "biospace.polldaddy.com/s/", id: "could-pfizer-be-eyeing-abbvie-1", placeholder: "pd_1422284469" } ); (function(d,c,j){if(!document.getElementById(j)){var pd=d.createElement(c),s;pd.id=j;pd.src=(' '==document.location.protocol)?' ':' ';s=document.getElementsByTagName(c)[0];s.parentNode.insertBefore(pd,s);}}(document,'script','pd-embed')); Read at BioSpace.com

License out/inPhase 3Drug Approval

100 Deals associated with Atazanavir Sulfate/Cobicistat

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HIV Infections	United States	Bristol Myers Squibb Co.	29 Jan 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 2	Dominican Republic	Gilead Sciences, Inc.	-
HIV Infections	Phase 2	Puerto Rico	Gilead Sciences, Inc.	-
HIV Infections	Phase 2	Mexico	Gilead Sciences, Inc.	-
HIV Infections	Phase 2	Brazil	Gilead Sciences, Inc.	-
HIV Infections	Phase 2	Thailand	Gilead Sciences, Inc.	-
HIV Infections	Phase 2	Canada	Gilead Sciences, Inc.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01837719 (Atazanavir, CTgov)	Phase 1	HIV Infections	64	Atazanavir+Cobicistat (Treatment A: Atazanavir + Cobicistat Coadministered)	xkopeohktl(btyndkhwdj) = nzkmkaiell npqqfbjxrk (ellwwcuqlr, qahupwlaal - byvzaagasq) View more	-	29 Aug 2014
				Atazanavir/Cobicistat FDC (Treatment B: Atazanavir/Cobicistat FDC)	xkopeohktl(btyndkhwdj) = xhcjdsnfeo npqqfbjxrk (ellwwcuqlr, lxzcnsifpz - feopifwtgt) View more
IAS2006	Not Applicable	-	88	lopinavir/rtv (LPV/r)	(yinjaxejre) = ewcwqwtgkn wvnxmehlsq (vhpswmyagk ) View more	-	01 Jan 2006
				atazanavir/rtv (ATZ/r)	(yinjaxejre) = rcdaowqryo wvnxmehlsq (vhpswmyagk ) View more
IAS2005	Not Applicable	-	-	TDF+ddI+EFV	(jnikdqsyjy) = lvvlrkuohv jzafjuffao (ofnwtpvdqz )	-	01 Jan 2005
				TDF+ddI+NVP	(jnikdqsyjy) = ntsausjdxt jzafjuffao (ofnwtpvdqz )

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