Welcome, Guest. Please login or register.
December 07, 2016, 08:30:57 PM

Login with username, password and session length

  • Total Members: 29684
  • Latest: dcx516
  • Total Posts: 704602
  • Total Topics: 56092
  • Online Today: 268
  • Online Ever: 1421
  • (August 13, 2016, 05:18:44 AM)
Users Online


Welcome to the POZ 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 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: Isentress is coming!!!! FDA finds it "Safe and Efficient"...  (Read 1819 times)

0 Members and 1 Guest are viewing this topic.

Offline J220

  • Member
  • Posts: 587
Isentress is coming!!!! FDA finds it "Safe and Efficient"...
« on: September 01, 2007, 11:30:34 PM »
The FDA has posted a paper on their website ( http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4314b1-01-Merck.pdf ) - it's a large PDF file, be advised- in which they conclude that Merck's Isentress (raltegravir):

"All doses used throughout the Phase II and Phase III studies have demonstrated potent efficacy and a favorable safety profile."

This is the key official finding we were waiting for. Now the next step is an official vote within the FDA in October, and if the 'ayes' have it - which seems highly likely- the drug will be approved. This is absolutly great news for everyone, but mainly those who have developed resistance. And even for those of us still on our front line therapies, it is yet more breathing room, knowing that this drug is there should we need it.

For those not familiar with Isentress, here are a few key notes, provided in the FDA's paper:

Fulfills an unmet medical need for a novel anti-retroviral therapy (ART) for patients with multi-drug resistant HIV.

Has significant antiviral activity against multi-drug resistant HIV-1.

Has a broad spectrum of activity and no cross-resistance to currently licensed ARTs.

Has demonstrated rapid, potent, and superior antiretroviral efficacy compared to placebo plus OBT in treatment experienced patients in a comprehensive clinical development program.

Is both efficacious and generally well tolerated in a diverse group of patients representing different genders, races, geographic regions, viral sub-types, and hepatitis B and/or C virus co-infection status.

Has a favorable risk/benefit profile.

There is more info on Merck's website, I am sure, (but I am too lazy to get the exact link right now). But all in all, this is great news. Cheers everybody, J.
« Last Edit: September 01, 2007, 11:32:36 PM by J220 »
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline thunter34

  • Member
  • Posts: 7,361
  • His name is Carl.
Re: Isentress is coming!!!! FDA finds it "Safe and Efficient"...
« Reply #1 on: September 01, 2007, 11:58:27 PM »
Great news.  Thanks for posting.

Cheers back at ya, J!

AIDS isn't for sissies.

Offline powerpuff

  • Member
  • Posts: 138
Re: Isentress is coming!!!! FDA finds it "Safe and Efficient"...
« Reply #2 on: September 08, 2007, 06:39:38 PM »
good hopeful, hope side effects are minimal.


Terms of Membership for these forums

© 2016 Smart + Strong. All Rights Reserved.   terms of use and your privacy
Smart + Strong® is a registered trademark of CDM Publishing, LLC.