Quantcast

Subscribe to:
POZ magazine
Newsletters
Join POZ: Facebook MySpace Twitter Pinterest
Tumblr Google+ Flickr Instagram
POZ Personals
Sign In / Join
Username:
Password:
Welcome, Guest. Please login or register.
December 22, 2014, 12:52:40 AM

Login with username, password and session length


Members
Stats
  • Total Posts: 650133
  • Total Topics: 49629
  • Online Today: 177
  • Online Ever: 585
  • (January 07, 2014, 02:31:47 PM)
Users Online
Users: 2
Guests: 147
Total: 149

Welcome


Welcome to the POZ/AIDSmeds Community Forums, a round-the-clock discussion area for people with HIV/AIDS, their friends/family/caregivers, and others concerned about HIV/AIDS.  Click on the links below to browse our various forums; scroll down for a glance at the most recent posts; or join in the conversation yourself by registering on the left side of this page.

Privacy Warning:  Please realize that these forums are open to all, and are fully searchable via Google and other search engines. If you are HIV positive and disclose this in our forums, then it is almost the same thing as telling the whole world (or at least the World Wide Web). If this concerns you, then do not use a username or avatar that are self-identifying in any way. We do not allow the deletion of anything you post in these forums, so think before you post.

  • The information shared in these forums, by moderators and members, is designed to complement, not replace, the relationship between an individual and his/her own physician.

  • All members of these forums are, by default, not considered to be licensed medical providers. If otherwise, users must clearly define themselves as such.

  • Forums members must behave at all times with respect and honesty. Posting guidelines, including time-out and banning policies, have been established by the moderators of these forums. Click here for “Am I Infected?” posting guidelines. Click here for posting guidelines pertaining to all other POZ/AIDSmeds community forums.

  • We ask all forums members to provide references for health/medical/scientific information they provide, when it is not a personal experience being discussed. Please provide hyperlinks with full URLs or full citations of published works not available via the Internet. Additionally, all forums members must post information which are true and correct to their knowledge.

  • Product advertisement—including links; banners; editorial content; and clinical trial, study or survey participation—is strictly prohibited by forums members unless permission has been secured from POZ.

To change forums navigation language settings, click here (members only), Register now

Para cambiar sus preferencias de los foros en español, haz clic aquí (sólo miembros), Regístrate ahora

Finished Reading This? You can collapse this or any other box on this page by clicking the symbol in each box.

Author Topic: FDA approve Prezista (aka darunavir, TMC-114)  (Read 2667 times)

0 Members and 1 Guest are viewing this topic.

Offline newt

  • Member
  • Posts: 3,887
  • the one and original newt
FDA approve Prezista (aka darunavir, TMC-114)
« on: June 25, 2006, 04:02:20 PM »
From the FDA HIV/AIDS email list where you can find the full text & a PDF version.

-----

The Food and Drug Administration today, June 23, 2006, granted accelerated approval for Prezista (darunavir - formerly known as TMC-114), a new drug for treatment experienced adults whose infection with the human
immunodeficiency virus (HIV) is not responding to treatment with other antiretroviral drugs.  Prezista, a protease inhibitor, is indicated to be co-administered with a low-dose of ritonavir, in combination with other
active anti-HIV agents. Ritonavir, which is also a protease inhibitor, slows the metabolism of Prezista, resulting in increased plasma concentrations.

The recommended oral dose of Prezista tablets is 600 mg (two 300 mg tablets) twice daily taken with ritonavir 100 mg twice daily and with food. The type of food does not affect exposure to darunavir.

The accelerated approval is based on evidence from two randomized, controlled studies comparing the safety and effectiveness of a Prezista-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, a fusion inhibitor that inhibits the virus from
entering the cell.  In these studies, patients on a Prezista-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 with PREZISTA/ritonavir in combination therapy compared to 21 percent in control group at week 24.

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

[...]

As a condition of the accelerated approval, the manufacturer is required to conduct post-marketing trials to verify and describe the clinical benefits of Prezista.  In addition, the manufacturer has committed
to conducting other postmarketing studies that  include studies in pediatric populations, studies to better define certain drug-drug interactions, and to evaluate the drug in patients with varying degrees of liver impairment to identify appropriate dosing for this patient population.

Prezista is manufactured for Tibotec, Inc., Division of Ortho Biotech Products, L.P., Raritan, N.J., by JOLL, Gurabo, Puerto Rico.   

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Jeffrey Murray
Division of Antiviral Products
Food and Drug Administration

-----

- matt
« Last Edit: June 25, 2006, 04:03:53 PM by newt »
"The object is to be a well patient, not a good patient"

Offline newt

  • Member
  • Posts: 3,887
  • the one and original newt
Re: FDA approve Prezista (aka darunavir, TMC-114)
« Reply #1 on: June 25, 2006, 04:08:25 PM »
Tim Horn beat me to it in the Living forum, but it's a goodie, and worth having in two places I reckon...

A study by the Univeristy of Liverpool (yes, Ann, the Wizard...) shows TMC-144 does not interact with many drugs.

- matt
"The object is to be a well patient, not a good patient"

 


Terms of Membership for these forums
 

© 2014 Smart + Strong. All Rights Reserved.   terms of use and your privacy
Smart + Strong® is a registered trademark of CDM Publishing, LLC.