Treatment News : Merck’s Victrelis Gets FDA Panel Nod of Approval

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 » April 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


April 27, 2011

Merck’s Victrelis Gets FDA Panel Nod of Approval

Merck announced Wednesday, April 27, that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) unanimously recommended approval of the company’s protease inhibitor Victrelis (boceprevir) for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 infection in combination with current standard therapy.

The committee's recommendation will be considered by the FDA in its review of the New Drug Application for Victrelis. Though the FDA is not bound by the committee's recommendation, the agency often acts on the committee’s advice when reviewing new therapies. Merck anticipates a final announcement from the FDA by mid-May.

The advisory committee panel reviewed the results from the Phase III clinical study program for Victrelis, notably the clinical trials HCV SPRINT-2 and HCV RESPOND-2, which included approximately 1,500 patients with chronic HCV genotype 1 infection—the most common form of the virus in the United States and most difficult to treat. Data discussed involved 1,097 treatment-naïve patients (HCV SPRINT-2) and 403 patients who failed previous therapy (HCV RESPOND-2). HCV SPRINT-2 included a separate analysis of results in African-American patients, a patient population that typically does not respond well to standard therapy.

Results from HCV SPRINT-2 and HCV RESPOND-2 were published in the March 31 issue of the New England Journal of Medicine.

Search: Victrelis, boceprevir, protease inhibitor, hepatitis C, HCV, FDA, approval

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 (3 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.