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CLINICAL TRIALS PROFILE FOR TYBOST

All Clinical Trials for Tybost

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02503462 ↗	Effect of Cobicistat Versus Ritonavir Boosting on the Brain Permeation of Darunavir in HIV-infected Individuals	Terminated	University Hospital, Basel, Switzerland	Phase 4	2015-07-01	The purpose of this study is to assess whether a boosting by cobicistat results in similar concentrations of darunavir in the brain compared to a boosting by ritonavir.
NCT02565888 ↗	A Drug-drug Interaction Study Between Daclatasvir and Atazanavir/Ritonavir or Atazanavir/Cobicistat	Completed	Radboud University	Phase 1	2015-11-01	This study aims to provide the evidence that 150mg of cobicistat will have the same effect on the pharmacokinetics of daclatasvir 30mg QD as 100mg of ritonavir, when given together with atazanavir 300mg.
NCT03858491 ↗	Pharmacokinetic Boosting of Osimertinib	Recruiting	The Netherlands Cancer Institute	Early Phase 1	2020-11-01	The main objective of this study is to evaluate if systemic exposure of osimertinib (i.e. AUC) is increased when osimertinib is co-administered with cobicistat in patients with relatively low plasma trough concentration while receiving the standard osimertinib dose.
NCT03858491 ↗	Pharmacokinetic Boosting of Osimertinib	Recruiting	ZonMw: The Netherlands Organisation for Health Research and Development	Early Phase 1	2020-11-01	The main objective of this study is to evaluate if systemic exposure of osimertinib (i.e. AUC) is increased when osimertinib is co-administered with cobicistat in patients with relatively low plasma trough concentration while receiving the standard osimertinib dose.
NCT03858491 ↗	Pharmacokinetic Boosting of Osimertinib	Recruiting	Academisch Ziekenhuis Maastricht	Early Phase 1	2020-11-01	The main objective of this study is to evaluate if systemic exposure of osimertinib (i.e. AUC) is increased when osimertinib is co-administered with cobicistat in patients with relatively low plasma trough concentration while receiving the standard osimertinib dose.
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.
NCT05692570 ↗	A Study of PBI-200 With Ritonavir or Cobicistat in Healthy Volunteers	Completed	Pyramid Biosciences	Phase 1	2022-09-09	This is a drug-drug interaction study in volunteers to evaluate the effect of ritonavir or cobicistat on the pharmacokinetics (PK) of PBI-200.

Clinical Trial Conditions for Tybost

Condition Name

Condition Name for Tybost
Intervention	Trials
Hepatitis C	1
HIV	1
Non Small Cell Lung Cancer	1
Non-small Cell Lung Cancer	1

Condition MeSH

Condition MeSH for Tybost
Intervention	Trials
Carcinoma, Non-Small-Cell Lung	2
Lung Neoplasms	1
Hepatitis C	1
Hepatitis	1

Clinical Trial Locations for Tybost

Trials by Country

Trials by Country for Tybost
Location	Trials
Netherlands	3
United States	2
Switzerland	1

Trials by US State

Trials by US State for Tybost
Location	Trials
Arizona	1
Florida	1

Clinical Trial Progress for Tybost

Clinical Trial Phase

Clinical Trial Phase for Tybost
Clinical Trial Phase	Trials
Phase 4	2
Phase 1	3
Early Phase 1	1

Clinical Trial Status

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

Clinical Trial Sponsors for Tybost

Sponsor Name

Sponsor Name for Tybost
Sponsor	Trials
ZonMw: The Netherlands Organisation for Health Research and Development	1
Academisch Ziekenhuis Maastricht	1
Bristol-Myers Squibb	1

Sponsor Type

Sponsor Type for Tybost
Sponsor	Trials
Other	6
Industry	2

Tybost: Clinical Trials, Market Analysis, and Projections

Introduction to Tybost

Tybost, also known by its active substance cobicistat, is a cytochrome P450 3A (CYP3A) inhibitor used as a pharmacokinetic enhancer in the treatment of HIV-1 infection. It is designed to boost the blood levels of protease inhibitors such as atazanavir and darunavir by suppressing the CYP3A enzyme, which metabolizes these drugs[1][4].

Clinical Trials and Efficacy

Tybost's approval was supported by a pivotal Phase 3 study (Study 114), which demonstrated its non-inferiority to ritonavir when administered with an antiretroviral regimen of atazanavir plus Truvada (emtricitabine and tenofovir disoproxil) in HIV-infected treatment-naïve adults. The study showed that after 48 weeks, around 85% of patients given Tybost had very low levels of HIV-1 RNA (< 50 copies/ml), comparable to the 87% achieved with ritonavir[1][4].

Safety Profile

In clinical trials, Tybost was well tolerated, with most adverse events being mild to moderate. The most common adverse reactions included jaundice, ocular icterus, and nausea. The drug has also been evaluated in adolescents between 12 and 17 years of age, showing similar efficacy and safety profiles[1][4].

Market Analysis

Current Market Position

Tybost is part of Gilead Sciences' portfolio and is used in combination with other antiretroviral medications. It is a component of the once-daily complete single tablet regimen Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil), which was approved for the treatment of HIV-1 infection[1].

Market Trends in HIV Treatment

The HIV treatment market is evolving, with a focus on once-daily dosing and combination therapies to enhance treatment adherence. Tybost plays a crucial role in this landscape by facilitating once-daily dosing of protease inhibitors, which is an important factor in supporting treatment adherence[1].

Projections and Growth Potential

HIV Treatment Market Outlook

The global HIV treatment market is expected to continue growing, driven by advancements in antiretroviral therapies and the need for effective treatment options. While Tybost itself is not a standalone blockbuster, its role as a booster in combination therapies contributes to the overall growth of the HIV treatment market.

Competition and Market Dynamics

Tybost competes with other boosting agents like ritonavir, but its approval and efficacy data have established it as a viable alternative. The market dynamics are influenced by the increasing demand for once-daily dosing regimens and the need for drugs that can be co-administered with various protease inhibitors without significant safety concerns[1][4].

Regulatory Environment

Approval and Authorization

Tybost received marketing authorization from the European Commission in 2013, valid throughout the EU. The approval was based on the efficacy and safety data from clinical trials, which demonstrated that Tybost's benefits outweigh its risks[1][4].

Key Considerations for Healthcare Professionals and Patients

Important Safety Information

Healthcare professionals should be aware that Tybost can decrease estimated creatinine clearance due to the inhibition of tubular secretion of creatinine. This effect should be considered when managing patients, especially those requiring dose adjustments based on creatinine clearance. Additionally, Tybost should not be initiated in patients with creatinine clearance less than 70 ml/min if co-administered agents require dose adjustment based on creatinine clearance[1][4].

Drug Interactions

Tybost must not be taken with certain medicines that affect its metabolism or whose action is affected by Tybost. A full list of restrictions can be found in the package leaflet or by consulting a healthcare professional[1][4].

Conclusion

Tybost is a valuable component in the treatment of HIV-1 infection, offering a new boosting option that facilitates once-daily dosing of protease inhibitors. Its efficacy and safety profile, as demonstrated in clinical trials, make it a significant player in the HIV treatment market.

Key Takeaways

• Efficacy: Tybost is non-inferior to ritonavir in boosting atazanavir and darunavir levels.
• Safety: Well tolerated with common adverse reactions including jaundice, ocular icterus, and nausea.
• Market Position: Part of Gilead Sciences' portfolio and a component of Stribild.
• Regulatory Approval: Authorized by the European Commission in 2013.
• Important Safety Information: Affects creatinine clearance and has specific drug interaction restrictions.

FAQs

What is Tybost used for?

Tybost is used as a pharmacokinetic enhancer to boost the blood levels of protease inhibitors such as atazanavir and darunavir in the treatment of HIV-1 infection.

How does Tybost work?

Tybost works by inhibiting the cytochrome P450 3A (CYP3A) enzyme, which slows down the metabolism of atazanavir and darunavir, allowing these drugs to remain effective for longer periods.

What are the common side effects of Tybost?

Common side effects include jaundice, ocular icterus, and nausea.

Can Tybost be used in adolescents?

Yes, Tybost has been evaluated and is effective in adolescents between 12 and 17 years of age.

What are the key restrictions for using Tybost?

Tybost should not be initiated in patients with creatinine clearance less than 70 ml/min if co-administered agents require dose adjustment based on creatinine clearance, and it must not be taken with certain medicines that affect its metabolism or whose action is affected by Tybost.

Sources

1. European Commission Approves Gilead Sciences' Tybost™, a New Boosting Agent for HIV Therapy - Gilead Sciences
2. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025 - GlobalData
3. U.S. Food and Drug Administration Approves Augtyro (repotrectinib) for the Treatment of Patients with NTRK-Positive Locally Advanced or Metastatic Solid Tumors - Bristol Myers Squibb
4. Tybost | European Medicines Agency (EMA)
5. Sustaining Growth in a Changing Environment - IQVIA Institute