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Recent News and Articles on the Keywords: new + prezista + 0.39  Related to the article below (Last Update: 8/5/2008)

IAC: HIV Care Guidelines Expand Treatment Eligibility
MedPage Today, NJ - Aug 3, 2008
3 - About 100000 additional HIV-positive patients in the US would be eligible for initiation of antiretroviral therapy under new treatment guidelines issued ...
Celera Corporation Reports Fourth Quarter and Fiscal 2008 Results
MarketWatch - Jul 23, 2008
Two new drugs, INTELENCE(TM) (etravirine) and PREZISTA(TM) (darunavir) from Tibotec Therapeutics, a division of Ortho Biotech Products, LP, are included in ...CRA - HEL:ATRAV
FDA Clears Newest Version of Celera's HIV-1 Genotyping Software
GenomeWeb News (subscription), NY - Jul 18, 2008
The newest version of the software includes the resistance algorithm for two new anti-HIV drugs, Intelence (etravirine) and Prezista (darunavir). ...
Celera Gets FDA Go-ahead for Updated Version of Genotyping System ... RTT News
FDA Grants Clearance for Celera's ViroSeq(R) HIV-1 Genotyping ... StreetInsider.com (subscription)
all 22 news articles »  CRA - ABT
Illumina, Avantome, Roche, Metabolon, UT Health Science Center ...
Pharmacogenomics Reporter (subscription), NY - Jul 23, 2008
The newest version of the software includes the resistance algorithm for two new anti-HIV drugs, Intelence (etravirine) and Prezista (darunavir). ...ILMN - TSE:RBM - PINK:NPKYF
Source: Google News

[CITATION] US FDA Clears New HIV Protease Inhibitor for Resistant Patients
CME Tracker

Prezista (darunavir, TMC-114) approved; may be important treatment advance. -
JS James - AIDS Treat News, 2006 - aids.org
... Tibotec, a Belgian company that specializes in designing new drug molecules
engineered to prevent resistance, developed Prezista. ...
-

Tibotec Pharmaceuticals' protease inhibitor darunavir [PREZISTA] has received conditional marketing …
I Blog - Inpharma, 2007 - ingentaconnect.com
... Tibotec Pharmaceuticals' protease inhibitor darunavir [PREZISTA] has received
conditional ... Key: - Free content. - New Content. - Subscribed Content. - Free Trial ...

US Prezista label: hepatotoxicity warning added
I Blog - Reactions, 2008 - ingentaconnect.com
... US Prezista label: hepatotoxicity warning added. Source ... Key: - Free Content. - New
Content. - Subscribed Content. - Free Trial Content. Keywords ...

New drug and biological product approvals, 2006. -
K Traynor - American Journal of Health-System Pharmacy, 2007 - pt.wkhealth.com
... not the only infectious organisms to be targeted by new products last ... Tibotec's
anti-HIV medication darunavir, which is marketed as Prezista; telbivudine, or ...
-

New Guidelines on How to Treat HIV -
C Laino, LAM Needed - medscape.com
... Since the last guidelines were published, two new protease inhibitors --
Aptivus and Prezista -- were approved by the FDA. Their ...

Antiviral Briefs -
AE LOW - AIDS Patient Care & STDs, 2006 - liebertonline.com
... Over the summer, the FDA grated marketing approval to Prezista TM , the brand name
for TMC114. The new PI is designed for patients with resistant HIV strains. ...

[PDF] Natural products as sources of new drugs over the last 25 years -
DJ Newman, GM Cragg - J Nat Prod, 2007 - nova-institut.de
Natural Products as Sources of New Drugs over the Last 25 Years ... Results As before,
we have covered only New Chemical Entities (NCEs) in the present analysis. ...
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New and Investigational Antiretrovirals: An Expert Interview With Dr. Cal Cohen -
L In - medscape.com
... the new triple-drug coformulation (Atripla) of efavirenz (Sustiva), tenofovir (Viread),
and emtricitabine (Emtriva), and the new PI darunavir (Prezista). ...
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[CITATION] New and Investigational Antiretrovirals: An Expert Interview With Dr. Cal Cohen
CME Tracker
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Source: Google Scholar
 
 

HIV infection, Prezista, a new protease inhibitor for patients who do not respond to existing drugs, approved

 
 
The FDA ( Food and Drug Administration ) approved Prezista ( Darunavir ), a new drug for adults whose infection with the human immunodeficiency virus ( HIV ) has not responded to treatment with other antiretroviral drugs.

Prezista, a HIV protease inhibitor, is approved to be co-administered with a low-dose of Ritonavir and other active anti-HIV agents.
Ritonavir, a protease inhibitor approved in 1996, slows the breakdown of Prezista in the body thereby increasing the concentration of Prezista.

The accelerated approval is based on evidence from two randomized, controlled studies comparing the safety and effectiveness of a Darunavir -Ritonavir combination with other Ritonavir-boosted protease inhibitor combinations. Patients in both arms of these trials also used other anti-HIV agents ( nucleoside reverse transcriptase inhibitors ) with or without Enfuvirtide ( Fuzeon ), a fusion inhibitor that inhibits the virus from entering the cell.
In these studies, patients on a Darunavir-Ritonavir combination experienced higher rates of reduction of their HIV viral load than patients on other Ritonavir-boosted protease inhibitor combinations.
Seventy percent of treatment-experienced patients achieved a virologic response, improving the treatment outcome, with Darunavir -Ritonavir in combination therapy compared to 21 percent in control group at week 24.

The most common side effects reported by patients on the Darunavir -Ritonavir regimen included diarrhea, nausea, and headache. About seven percent of patients on this combination therapy experienced skin rashes ranging from mild to serious.

The risks and benefits of Darunavir have not been established for adults who have not been previously treated for HIV, or for children.

Prezista and Ritonavir need to be taken with food, and the combination therapy doesn’t have not to be used together with St. John's wort or various other drugs, including certain anticonvulsants, antihistamines, sedatives and a few of the protease inhibitors.

Source: FDA, 2006
 
 
 
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