Prezista (Darunavir, TMC114)
| Brand Name: |
Prezista |
| Generic Name: |
darunavir, TMC114 |
| Adult Single Dose: |
Therapy-naive patients: 800 mg (two 400-mg tablets) taken with rionavir 100 mg once a day.
Treatment-experienced patients: Two 300-mg tablets twice daily taken with ritonavir 100-mg twice daily. |
| Food & Liquid Restrictions: |
Take with food. |
| Drug Class: |
PI |
The Basics
- Darunavir (Prezista) (December 20, 2011)
To read PDF, click here.
From AIDS InfoNet
- Patient Information About Prezista (Darunavir, TMC114) (PDF) (December 2011)
From Tibotec Therapeutics
- An Overview of Prezista (Darunavir, TMC114) (November 2, 2011)
From AIDSinfo
- Prezista (March/April 2010)
To read PDF, click here.
In Positively Aware, from Test Positive Aware Network
- Prezista (Darunavir, TMC-114) (September 28, 2007)
Basic information on dosing schedules and side effects.
From U.S. Department of Veterans Affairs
- FAQs About Prezista (Darunavir) From The Body's "Ask the Experts" Forums
From The Body's "Ask the Experts" Forums
- An Interview With Cal Cohen, M.D., a Lead Investigator of the Darunavir (TMC114, Prezista) POWER Trials (June 28, 2006)
Dr. Cohen discusses TMC114's uses, adverse effects and other considerations.
- Prezista Approval (June 23, 2006)
From U.S. Food and Drug Administration
News
- Updated Information About Prezista (Darunavir): Oral Suspension and Labeling Changes (December 20, 2011)
From U.S. Food and Drug Administration
- Gilead and Tibotec Agree on New Single-Tablet Regimen (November 23, 2011)
In Positively Aware, from Test Positive Aware Network
- Gilead and J&J Expand HIV Cocktail Partnership (November 16, 2011)
In CDC HIV/Hepatitis/STD/TB Prevention News Update, from U.S. Centers for Disease Control and Prevention
- Tibotec and Gilead Team Up to Develop Prezista/Cobicistat Combo (July 5, 2011)
From Test Positive Aware Network
- Musty Smell Forces Johnson & Johnson to Recall HIV/AIDS Drug (May 12, 2011)
In Los Angeles Times
- Johnson & Johnson Unit Finds Traces of Fungicide in HIV Drug (May 11, 2011)
In CDC HIV/Hepatitis/STD/TB Prevention News Update, from U.S. Centers for Disease Control and Prevention
- MSF Letter Criticizes Johnson & Johnson for Not Joining Medicines Patent Pool (April 26, 2011)
In Kaiser Daily Global Health Policy Report, from Henry J. Kaiser Family Foundation
- For Some, Taking Prezista Once a Day Is Enough (February 2011)
To read PDF, click here.
In Project Inform Perspective, from Project Inform
- FDA Approves Once-Daily Prezista Dosing for Treatment-Experienced Adults (December 13, 2010)
From U.S. Food and Drug Administration
- National Institutes of Health Donates Protease Inhibitor Patent to UNITAID Medicines Patent Pool (Autumn 2010)
To read PDF, click here.
In TAGline, from Treatment Action Group
- U.S. Food and Drug Administration Approves Labeling Update for Prezista to Include 96-Week Data in HIV-1 Infected Adult Patients (January 28, 2010)
From Tibotec Therapeutics
- Prezista Now Available for Pediatric Patients Six Years of Age and Older as Part of HIV Combination Therapy (February 11, 2009)
From Tibotec Therapeutics
- New 75 mg Prezista Tablet and Corresponding Pediatric Dosing Information Approved (December 18, 2008)
From U.S. Food and Drug Administration
- HIV/AIDS Update - Important information about Prezista (darunavir) (October 22, 2008)
From U.S. Food and Drug Administration
- Updates to Prezista (Darunavir) Tablets Labeling (March 11, 2008)
From U.S. Food and Drug Administration
- "Dear Healthcare Professional" Letter: New Prescribing Information for Prezista (Darunavir) (March 2008)
Labeling has been updated to include warnings regarding hepatotoxicity.
From Tibotec Therapeutics
- New 600-mg Tablet Strength for Prezista (Darunavir) (February 26, 2008)
From U.S. Food and Drug Administration
- A Drug Pricing Victory: Tibotec Prices Prezista at Far Below Cost of Reyataz, Fuzeon (June 30, 2006)
- Tibotec Announces U.S. Expanded Access Program for TMC114 (October 26, 2005)
[Archived Article]
Though not yet FDA approved, TMC114 is now available for some with multidrug resistance.
From Tibotec Therapeutics
- TMC114 Expanded Access Program for People Living With HIV to Begin Enrollment in Autumn of 2005 (June 14, 2005)
[Archived Article]
From Tibotec Therapeutics
Research
 Top 10 HIV/AIDS-Related Clinical Developments of 2011 (December 1, 2011)
From The Body
- Pharmacokinetics of Darunavir and Fosamprenavir in Pregnancy (July/August 2011)
To read PDF, click here.
- Another NRTI-Sparing Regimen Does Well in Treatment-Naive Patients (July 25, 2011)
From aidsmap.com
- Novel Mutations and Shifting Susceptibility to Darunavir and Tipranavir (September 15, 2010)
From National AIDS Treatment Advocacy Project
- Metabolic Marker Changes Similar After 12 Weeks of Darunavir and Atazanavir (July 26, 2010)
From National AIDS Treatment Advocacy Project
- Lessons From GRACE: A U.S. Study Focused on Women Living With HIV (June 2010)
From The Well Project
- Odin -- Darunavir-Ritonavir Once or Twice Daily (March/April 2010)
To read PDF, click here.
In Treatment Update, from Canadian AIDS Treatment Information Exchange
- Monotherapy With Darunavir-Ritonavir -- the Monet Study (March/April 2010)
To read PDF, click here.
In Treatment Update, from Canadian AIDS Treatment Information Exchange
- Surprising Changes in Body Fat With Darunavir Monotherapy (March/April 2010)
To read PDF, click here.
In Treatment Update, from Canadian AIDS Treatment Information Exchange
- Once-Daily Darunavir in Treatment-Experienced Patients (March 8, 2010)
In The 17th Conference on Retroviruses and Opportunistic Infections, from The Body PRO
- Once-Daily Darunavir Effective and Less Toxic Than Twice-Daily in Experienced Patients Without Prior Darunavir Resistance: ODIN (February 18, 2010)
From aidsmap.com
- Prezista Monotherapy May Prove Effective (February 1, 2010)
To read PDF, click here.
In Project Inform Perspective, from Project Inform
- Boosted Darunavir Monotherapy Works Well in Two Studies (July 23, 2009)
Ritonavir-boosted darunavir alone maintains HIV suppression in most patients who achieved an undetectable viral load on combination antiretroviral therapy, according to two studies.
From aidsmap.com
- Darunavir Superior to Lopinavir in 48-Week Study in Treatment-Experienced Patients (July 6, 2007)
From aidsmap.com
- Adding Etravirine to Prezista Improves Anti-HIV Activity, Studies Show (July 6, 2007)
From aidsmap.com
- GRACE Under Pressure (December 2006)
To read PDF, click here.
In TAGline, from Treatment Action Group
- 48-Week TMC114 + Ritonavir Data Set New Bar for Efficacy in Triple-Class-Experienced Patients (August 15, 2006)
In XVI International AIDS Conference
- TMC114 Significantly Outperforms Control Protease Inhibitors in Triple-Class-Experienced Patients, Even in Absence of Enfuvirtide (July 27, 2005)
[Archived Article]
In The 3rd International AIDS Society Conference on HIV Pathogenesis and Treatment
- New Protease Inhibitor TMC-114: Preliminary 24-Week Late Breaker Results of the Phase II Trial (March/April 2005)
[Archived Article]
To read PDF, click here.
In Positively Aware, from Test Positive Aware Network
- TMC-114 Sets a New Standard in Salvage Therapy Trials (February 25, 2005)
[Archived Article]
In The 12th Conference on Retroviruses and Opportunistic Infections, from The Body PRO
- Research Updates on Tipranavir, TMC-114 and TMC-125 (December 2004)
[Archived Article]
A review of the tipranavir RESIST studies, a note on potential tipranavir pricing, and a critical look at two developing rescue drugs.
In TAGline, from Treatment Action Group
- Anti-HIV Therapy Update (July 2004)
[Archived Article]
A quick briefing on tipranavir, TMC-114, capravirine and D-D4FC.
To read PDF, click here.
In Project Inform Perspective, from Project Inform
- Initial Data on TMC114 in Multiple PI-Experienced Patients (July 16, 2003)
[Archived Article]
In The 2nd International AIDS Society Conference on HIV Pathogenesis and Treatment, from The Body PRO
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