Treatment News : First-Line Therapy Approval Requested for Prezista

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

Back to home » Treatment News » December 2007

Most Popular Links
Most Popular Lessons

The HIV Life Cycle

Shingles

Herpes Simplex Virus

Syphilis & Neurosyphilis

Treatments for Opportunistic Infections (OIs)

What is AIDS & HIV?

Hepatitis & HIV

15 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 news@poz.com.


emailprint

December 21, 2007

First-Line Therapy Approval Requested for Prezista

Tibotec is seeking expanded approval for Prezista (darunavir) to allow first-time treatment takers to use the protease inhibitor (PI), according to a press release from the company issued earlier today. The request submitted to the U.S. Food and Drug Administration (FDA), in the form of a supplemental new drug application (sNDA), includes 48-week data from the phase III ARTEMIS study comparing Norvir (ritonavir)-boosted Prezista to the popular first-line PI option Kaletra in treatment-naive patients.

Prezista received accelerated approval in June 2006, based on 24-week data from clinical trials involving treatment-experienced patients, to expedite access to the drug for people with drug-resistant virus and few antiretroviral options. The sNDA requests full approval from the FDA for both treatment-experienced and treatment-naive patients. The correct dose in treatment-experienced patients is two 300 mg tablets, plus one 100 mg Norvir capsule, twice a day.

Forty-eight week data from the ARTEMIS study were reported earlier this year. According to Dr. Edwin DeJesus, MD, of the Orlando Immunology Center who presented the preliminary results in September, once-daily dosing of Norvir-boosted Prezista—two 400 mg Prezista tablets plus one 100 mg Norvir capsule—combined with Truvada (tenfovir and emtricitabine) “resulted in excellent virologic and immunologic responses” and that it is “well tolerated with a favorable safety profile.” He added that compared with Kaletra, Prezista combined with Norvir “was non-inferior in the overall population, and superior in patients with high viral loads, with a lower incidence of common GI toxicities and triglyceride elevations.”


Scroll down to comment on this story.



Name:

(will display; 2-50 characters)

Email:

(will NOT display)

City:

(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]


Join POZ Facebook Twitter Google+ MySpace YouTube Tumblr Flickr
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


    Hillcrester
    Ramona
    California


    TanyaB
    Delray Beach
    Florida


    Sexynyrican
    Brooklyn
    New York


    jap022964
    el dorado
    Arkansas
Click here to join POZ Personals!
Ask POZ Pharmacist

Talk to Us
Poll
Do you work with your doc to design your own treatment regimen?
Yes
No

Survey
PrEP Course

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