Cobicistat

Overview

Cobicistat, marketed under the name Tybost (formerly GS-9350), indicated for treating infection with human immunodeficiency virus (HIV). Although it does not have any anti-HIV activity, cobicistat acts as a pharmacokinetic enhancer by inhibiting cytochrome P450 3A isoforms (CYP3A) and therefore increases the systemic exposure of coadministered agents that are metabolized by CYP3A enzymes. More specifically, cobicistat is indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection. Increasing systemic exposure of anti-retrovirals (ARVs) without increasing dosage allows for better treatment outcomes and a decreased side effect profile.

Indication

Cobicistat is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection. It is not interchangeable with ritonavir to increase systemic exposure of darunavir 600 mg twice daily, fosamprenavir, saquinavir, or tipranavir due to lack of exposure data. The use of cobicistat is not recommended with darunavir 600 mg twice daily, fosamprenavir, saquinavir or tipranavir. Complex or unknown mechanisms of drug interactions preclude extrapolation of ritonavir drug interactions to certain cobicistat interactions. Cobicistat and ritonavir when administered with either atazanavir or darunavir may result in different drug interactions when used with concomitant medications.

Associated Conditions

Human Immunodeficiency Virus (HIV) Infections
Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
KF2024#1-trial: Esketamine Interaction Study	2024/12/10	NCT06726382	Phase 1	Not yet recruiting	Helsinki University Central Hospital
A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Volunteers.	2024/04/25	NCT06385119	Phase 1	Completed	Fore Biotherapeutics
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments	2024/03/29	NCT06337032	Phase 4	Recruiting	Gilead Sciences
A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML	2023/08/28	NCT06014489	Phase 2	Recruiting	Stichting Hemato-Oncologie voor Volwassenen Nederland
Improving Osimertinib Exposure and Cost-effectiveness Using Pharmacokinetic Boosting With Cobicistat	2023/02/28	NCT05748093	Phase 4	Recruiting	Maastricht University Medical Center
Electrophysiological Effects of Potential QT Prolonging Drugs	2023/02/08	NCT05716854	Phase 1	Completed	Food and Drug Administration (FDA)
A Study of PBI-200 With Ritonavir or Cobicistat in Healthy Volunteers	2023/01/20	NCT05692570	Phase 1	Completed	Pyramid Biosciences
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations	2022/08/17	NCT05503797	Phase 2	Recruiting	Fore Biotherapeutics
A Trial of Cobicistat and Gemcitabine and Nab-Paclitaxel in Patients with Advanced Stage or Metastatic Pancreatic Ductal Adenocarcinoma	2022/08/10	NCT05494866	Phase 1	Terminated	German Cancer Research Center
Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels	2022/07/14	NCT05458102	Phase 1	Terminated	Gilead Sciences

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Symtuza	Janssen Products LP	59676-800	ORAL	150 mg in 1 1	8/18/2023
Stribild	Avera McKennan Hospital	69189-1201	ORAL	150 mg in 1 1	3/20/2017
Stribild	State of Florida DOH Central Pharmacy	53808-0887	ORAL	150 mg in 1 1	3/6/2014
PREZCOBIX	Janssen Products LP	59676-575	ORAL	150 mg in 1 1	8/15/2023
Genvoya	Gilead Sciences, Inc.	61958-1901	ORAL	150 mg in 1 1	1/13/2022
Stribild	Gilead Sciences, Inc.	61958-1201	ORAL	150 mg in 1 1	9/16/2021
Tybost	Gilead Sciences, Inc.	61958-1401	ORAL	150 mg in 1 1	9/15/2021
PREZCOBIX	A-S Medication Solutions	50090-1723	ORAL	150 mg in 1 1	8/15/2023
Stribild Access	Gilead Sciences, Inc.	61958-1202	ORAL	150 mg in 1 1	11/24/2018
EVOTAZ	E.R. Squibb & Sons, L.L.C.	0003-3641	ORAL	150 mg in 1 1	7/31/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Genvoya	Gilead Sciences Ireland UC,IDA Business & Technology Park,Carrigtohill,County Cork,T45 DP77,Ireland	Authorised	11/19/2015
Evotaz	Bristol-Myers Squibb Pharma EEIG,Plaza 254,Blanchardstown Corporate Park 2,Dublin 15,D15 T867,Ireland	Authorised	7/13/2015
Evotaz	Bristol-Myers Squibb Pharma EEIG,Plaza 254,Blanchardstown Corporate Park 2,Dublin 15,D15 T867,Ireland	Authorised	7/13/2015
Rezolsta	Janssen-Cilag International N.V.,Turnhoutseweg 30,Beerse,2340 Antwerp,Belgium	Authorised	11/19/2014
Rezolsta	Janssen-Cilag International N.V.,Turnhoutseweg 30,Beerse,2340 Antwerp,Belgium	Authorised	11/19/2014
Symtuza	Janssen-Cilag International NV,Turnhoutseweg 30,B-2340 Beerse,Belgium	Authorised	9/21/2017
Stribild	Gilead Sciences Ireland UC,IDA Business & Technology Park,Carrigtohill,County Cork,T45 DP77,Ireland	Authorised	5/24/2013
Stribild	Gilead Sciences Ireland UC,IDA Business & Technology Park,Carrigtohill,County Cork,T45 DP77,Ireland	Authorised	5/24/2013
Tybost	Gilead Sciences Ireland UC,Carrigtohill,County Cork T45 DP77,Ireland	Authorised	9/19/2013

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
GENVOYA FILM COATED TABLET 150 MG/150 MG/200 MG/10 MG	Patheon Inc.	SIN15165P	TABLET, FILM COATED	150mg	1/20/2017

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
PREZCOBIX darunavir/cobicistat 800 mg/150 mg film coated tablet bottle	231198	Janssen-Cilag Pty Ltd	Medicine	A	9/24/2015
STRIBILD tenofovir disoproxil fumarate 300mg, emtricitabine 200 mg, elvitegravir 150 mg, cobicistat 150 mg tablet bottle	194081	Gilead Sciences Pty Ltd	Medicine	A	2/22/2013
GENVOYA elvitegravir (150mg), cobicistat (150mg), emtricitabine (200mg) and tenofovir alafenamide (as fumarate) (10mg) fixed dose combination tablets	233398	Gilead Sciences Pty Ltd	Medicine	A	1/15/2016
EVOTAZ atazanavir/cobicistat 300 mg/150 mg film coated tablets bottle	229476	Bristol-Myers Squibb Australia Pty Ltd	Medicine	A	9/23/2015
TYBOST 150 mg cobicistat tablets, bottle	200445	Gilead Sciences Pty Ltd	Medicine	A	10/23/2013
SYMTUZA 800/150/200/10 darunavir/cobicistat/emtricitabine/tenofovir alafenamide 800/150/200/10 mg film-coated tablets	312623	Janssen-Cilag Pty Ltd	Medicine	A	11/22/2019

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
STRIBILD	gilead sciences canada inc	02397137	Tablet - Oral	150 MG	12/20/2012
GENVOYA	gilead sciences canada inc	02449498	Tablet - Oral	150 MG	2/3/2016
SYMTUZA	Janssen Inc	02473720	Tablet - Oral	150 MG	4/25/2018
EVOTAZ	bristol-myers squibb canada	02446731	Tablet - Oral	150 MG	2/11/2016
PREZCOBIX	Janssen Inc	02426501	Tablet - Oral	150 MG	8/28/2014
TYBOST	gilead sciences canada inc	02411423	Tablet - Oral	150 MG	4/10/2015

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
EVOTAZ 300 MG/150 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Bristol-Myers Squibb Pharma Eeig	1151025001	COMPRIMIDO RECUBIERTO CON PELÍCULA	Uso Hospitalario	Commercialized
REZOLSTA 800 MG/150 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Janssen-Cilag International N.V	114967001	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
SYMTUZA 800 MG/150 MG/200 MG/10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Janssen-Cilag International N.V	1171225001	COMPRIMIDO	Diagnóstico Hospitalario	Commercialized
STRIBILD 150MG/150MG/200MG/245MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Gilead Sciences Ireland Unlimited Company	113830001IP	COMPRIMIDO RECUBIERTO CON PELÍCULA	Uso Hospitalario	Not Commercialized
SYMTUZA 800 MG/150 MG/200 MG/10 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Janssen-Cilag International N.V	1171225001IP	COMPRIMIDO	Uso Hospitalario	Not Commercialized
GENVOYA 150mg/150mg/200mg/10mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Gilead Sciences Ireland Unlimited Company	1151061001	COMPRIMIDO RECUBIERTO CON PELÍCULA	Uso Hospitalario	Commercialized
TYBOST 150mg comprimidos recubiertos con pelicula	Gilead Sciences Ireland Unlimited Company	113872001	COMPRIMIDO RECUBIERTO CON PELÍCULA	Uso Hospitalario	Commercialized
STRIBILD 150mg/150mg/200mg/245mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Gilead Sciences Ireland Unlimited Company	113830001	COMPRIMIDO RECUBIERTO CON PELÍCULA	Uso Hospitalario	Commercialized
GENVOYA 150mg/150mg/200mg/10mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Gilead Sciences Ireland Unlimited Company	1151061001IP	COMPRIMIDO RECUBIERTO CON PELÍCULA	Uso Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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