Treatment News : FDA Puts a Hold on Development of ViiV HIV Drug

POZ - Health, Life and HIV
Subscribe to:
POZ magazine
Join POZ: Facebook MySpace Twitter Pinterest
Tumblr Google+ Flickr MySpace
POZ Personals
Sign In / Join

Back to home » Treatment News » February 2011

Most Popular Links
Most Popular Lessons

The HIV Life Cycle


Herpes Simplex Virus

Syphilis & Neurosyphilis

Treatments for Opportunistic Infections (OIs)

What is AIDS & HIV?

Hepatitis & HIV

20 Years Ago In POZ

More Treatment News

Click here for more news

Have news about HIV? Send press releases, news tips and other announcements to


February 10, 2011

FDA Puts a Hold on Development of ViiV HIV Drug

ViiV Healthcare announced that the U.S. Food and Drug Administration (FDA) has placed a hold on the development of a non-nucleoside reverse transcriptase inhibitor (NNRTI) that it was studying, a drug it had licensed from Idenix Pharmaceuticals in 2009.

The reason for the FDA development hold on GSK-2248761 (GSK-761; formerly known as IDX899) involved four reports of seizures as part of a clinical trial involving treatment-experienced patients. “As a result,” the company told HIV treatment activists on February 11, “the responsible course of action is to put the [GSK-761] studies on hold while we gather more information.  The clinical team is now in the process of gathering further information on the cases in order to provide further guidance on next steps with [the drug].”

GSK-761 has been previously studied in several small Phase I and Phase IIa trials, and it was currently in two Phase IIb studies, including the one in which the seizures were reported. In earlier trials, the drug had shown effectiveness at low once-daily doses, and it was active against strains of HIV that are resistant to other NNRTIs.

“Two letters have been sent to the study investigators informing them of the serious adverse events,” explained the company officials. “These letters provide a summary of the adverse events, and guidance that investigators are to contact their patients, inform them of the risk of seizures and bring them in as soon as possible to change their medication from [GSK-761] to a suitable alternative and arrange for follow up care.

 “This does not mean that the overall development program of [GSK-761] has been halted,” the company added.

Search: ViiV Healthcare, Idenix, IDX899, GSK-2248761, GSK-761, FDA, hold, side effects, seizures, NNRTI, non-nucleoside reverse transcriptase inhibitor

Scroll down to comment on this story.


(will display; 2-50 characters)


(will NOT display)


(will display; optional)

Comment (500 characters left):

(Note: The POZ team reviews all comments before they are posted. Please do not include either ":" or "@" in your comment. The opinions expressed by people providing comments are theirs alone. They do not necessarily reflect the opinions of Smart + Strong, which is not responsible for the accuracy of any of the information supplied by people providing comments.)

Comments require captcha.
Please enter this number for verification:

| Posting Rules

Show comments (0 total)

[Go to top]

Facebook Twitter Google+ MySpace YouTube Tumblr Flickr Instagram
Quick Links
Current Issue

HIV Testing
Safer Sex
Find a Date
Newly Diagnosed
HIV 101
Disclosing Your Status
Starting Treatment
Help Paying for Meds
Search for the Cure
POZ Stories
POZ Opinion
POZ Exclusives
Read the Blogs
Visit the Forums
Job Listings
Events Calendar
POZ on Twitter

Ask POZ Pharmacist

Talk to Us
Did you participate in an event for National Black HIV/AIDS Awareness Day 2016?


more surveys
Contact Us
We welcome your comments!
[ about Smart + Strong | about POZ | POZ advisory board | partner links | advertising policy | advertise/contact us | site map]
© 2016 Smart + Strong. All Rights Reserved. Terms of use and Your privacy.
Smart + Strong® is a registered trademark of CDM Publishing, LLC.