Quantcast

Subscribe to:
POZ magazine
E-newsletters
Join POZ: Facebook MySpace Twitter Pinterest
Tumblr Google+ Flickr MySpace
POZ Personals
Sign In / Join
Username:
Password:
Welcome, Guest. Please login or register.
September 19, 2014, 11:55:21 AM

Login with username, password and session length


Members
Stats
  • Total Posts: 639407
  • Total Topics: 48535
  • Online Today: 218
  • Online Ever: 585
  • (January 07, 2014, 02:31:47 PM)
Users Online

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: Aptivus: black box warning update  (Read 2323 times)

0 Members and 1 Guest are viewing this topic.

Offline newt

  • Member
  • Posts: 3,885
  • the one and original newt
Aptivus: black box warning update
« on: July 03, 2006, 04:55:35 PM »
FDA Updates Black Box Warning on Boehringer Ingelheim's Protease Inhibitor Aptivus To Treat Drug-Resistant HIV

In short, the warning is amended to include a caution on use of this drug for people at greater risk  of bleeding after 13 out of 6,840 people on the clinical trials had brain hemorrhages (8 fatal). According to the FDA, many of these people had other medical conditions or were taking other drugs that could have contributed to the bleeding.

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

Offline Cliff

  • Member
  • Posts: 2,645
Re: Aptivus: black box warning update
« Reply #1 on: July 03, 2006, 05:29:22 PM »
This drug has been in clinical studies since 2001 (probably even earlier), I wonder why it takes so long for this sort of potential danger to be exposed (determined) and the public notified?

Offline Tim Horn

  • Member
  • Posts: 799
Re: Aptivus: black box warning update
« Reply #2 on: July 04, 2006, 08:27:02 AM »
Here is a news story I posted on the subject yesterday:

http://www.aidsmeds.com/news/am20060703.html

This drug was only approved a year ago (June 2005).  In turn, the largest clinical trials (including the U.S. and European expanded access program) -- where we learn about a drug's "minutiae," if you will -- have only been closed for a year.  It can definitely take this long to go over all of the safety data and conduct any additional studies -- such as the coagulation test tube studies conducted by Boehringer Ingelhim -- to make sense of any noted adverse events.  The ICH seen in clinical trials of Aptivus actually occurred, on average, a year and a half after Aptivus was started. 

For me, this simply goes to show that even when a drug is approved, there is still quite a bit more to learn about its safety and efficacy in the subsequent months and years of use.  A number of the "Black Box" warnings that have been issued for available antiretroviral drugs were put into place based on observations seen AFTER the completed of clinical trials and the approval of the drug.  This is definitely the case with hepatotoxicity... its definititely the case with things like lactic acidosis... and lipid abnormalities... and diabetes.  Much of what we learned about these side effects -- and how serious they can be -- came from "post-marketing" experience. 

The 14 ICH cases -- out of all participants in clinical trials of Aptivus -- represents an incidence rate of 0.2%.  Apparently, this is not much higher than the incidence rate seen in HIV-positive (or age-matched HIV-negative) people not taking Aptivus.  In turn, there's still a bit more to learn about this potential adverse effect... but, fortunately, some Black Box Warnings (and recommendations) are now in place in an effort to reduce the risk of this happening in people who use Aptivus.

Tim Horn
« Last Edit: July 04, 2006, 09:15:48 AM by Tim Horn »

 


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.