A Smart + Strong Site
Subscribe to:
E-newsletters
POZ magazine
JOIN AIDSMEDS YouTube

Back to home » Treatment News » Top Stories

Most Popular Stories
An Almost Normal Life Expectancy for People With HIV?
Undetectable Viral Load Essentially Eliminates Transmission Risk in Straight Couples
A 15-Year Jump in Life Expectancy for People With HIV
Misleading News Reports Suggest HIV Cure Is Near
New HIV Drug Class Shows Promise
Gene Therapy Shows Promise in Controlling HIV
Potential Microbicide Tricks HIV Into Sudden Death
What's That Mean?
(just double-click it!)

If you don't understand one of the words in this article, just double-click it. A window will open with a definition from mondofacto's On-line Medical Dictionary. If the double-click feature doesn't work in your browser, you can enter the word below:

Most Popular Lessons
Aging & HIV
The HIV Life Cycle
Shingles
Herpes Simplex Virus
Syphilis & Neurosyphilis
Treatments for Opportunistic Infections (OIs)
What is AIDS & HIV?
More News

Have medical or treatment news about HIV? Send press releases, news tips and other announcements to news@aidsmeds.com.

Click here for more news


emailprint

January 26, 2012

New Gilead GS 7340-Inclusive Fixed-Dose Combo Tablet Trial Announced

Gilead Sciences Inc. (Nasdaq: GILD) today announced the start of a Phase II clinical trial to evaluate a modified version of its experimental “quad” fixed-dose combination (FDC) tablet currently being reviewed by the U.S. Food and Drug Administration, according to a company announcement.

While Gilead’s FDC pill containing the booster cobicistat, the integrase inhibitor elvitegravir, Viread (tenofovir) and Emtriva (emtricitabine) is expected to be approved sometime during the first half of 2012, the company is now exploring the safety and efficacy of a combination tablet containing cobicistat-boosted elivitegravir and emtricitabine, but with GS 7340 instead of Viread.

GS 7340 is a “prodrug” of tenofovir. Prodrugs are typically inactive chemical compounds that turn into an active drug when they interact with the body’s metabolic system. GS 7340’s mechanism of action is the same at tenofovir, but it requires a dose that is 10 times lower than Viread and it provides greater effectiveness. Though Gilead announced in 2004 that it had no interest in further developing the drug, arguing that it “does not believe that GS 7340 has a profile that differentiates it to an extent that supports its continued development,” the company ended up reconsidering the drug’s potential in recent years.

In addition to developing a new FDC quad that includes GS 7340, Gilead is partnering with Janssen Therapeutics to develop a combination tablet containing cobicistat-boosted Prezista (darunavir) plus GS 7340 and Emtriva.

Tenofovir is a potent antiretroviral drug that in its base form is not well absorbed into the blood stream and is quickly eliminated from blood. To overcome this problem, Gilead Sciences made Viread, a prodrug version of tenofovir.

Viread allows for slower elimination of the tenofovir, because it takes a while for the body to transform Viread into tenofovir. That way it can reach and maintain adequate blood levels of the active drug. Unfortunately, boosting the amount of drug in the blood can also increase the amount that gets into the kidneys, which can lead to one of a potentially worrisome side effects—damage to the tubules that help the kidneys filter blood.

In an attempt to overcome this problem, and to increase the potency of the drug, Gilead experimented with stripping away the additional molecules present in Viread. In their place, the company added other molecules—thereby creating a new prodrug—that result in substantial increases of tenofovir inside the cells targeted by HIV, such as CD4 cells, but not in the blood or in organs such as the kidneys. This was accomplished by building a new chemical chain that doesn’t turn into tenofovir until it is transformed by cathepsin A2, which is produced predominately by a white blood cell called a lymphocyte. The end result was GS 7340.

In the Phase II study announced by Gilead, the GS 7340-containing FDC will be compared with Gilead’s Quad FDC, now under FDA review. It is a 48-week randomized, controlled study in which a total of 150 people will receive either novel regimen. About two thirds of the study volunteers will be treated with the GS 7340-containing regimen; the remaining third will receive the Viread-containing FDC tablet.

All study volunteers will need to have HIV that is fully sensitive to both Viread and Emtriva. Earlier use of HIV treatment is now allowed, and kidney function must be normal at the time of enrollment.

Additional information about the study, including enrollment sites, can be found via clinicaltrials.gov.

Search: GS-7340, Gilead, tenofovir, Viread, quad, cobicistat, elvitegravir, clinical trial, phase II, nucleotide analog, NRTI


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 AIDSmeds team reviews all comments before they are posted. Please do not include ":" "@" "<" ">" 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]

Quick Links
AIDSmeds en Español
About HIV and AIDS
Lab Tests
Clinical Trials
HIV Meds
Starting Treatment
Switching Treatment
Drug Resistance
Side Effects
Disclosure
Lipodystrophy
Hepatitis & HIV
Women & Children
Fact Sheets
Treatment News
Community Forums
Blogs
Conference Coverage
Health Services Directory
POZ Magazine


    Hillcrester
    Ramona
    California


    romanticseattle
    Tacoma
    Washington


    Deelight4u
    BROOKLYN
    New York


    josebos
    KISSIMMEE
    Florida
Click here to join POZ Personals!
Conference Coverage

21st Conference on Retroviruses and Opportunistic Infections
(CROI 2014)
Boston, MA
March 3 - 7, 2014


7th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention
(IAS 2013)
Kuala Lumpur, Malaysia
June 30 - July 3, 2013


20th Conference on Retroviruses and Opportunistic Infections
(CROI 2013)
Atlanta, GA
March 3 - 7, 2013


more conference coverage

[ about AIDSmeds | AIDSmeds advisory board | our staff | advertising policy | advertise/contact us]
© 2014 Smart + Strong. All Rights Reserved. Terms of use and Your privacy.
Smart + Strong® is a registered trademark of CDM Publishing, LLC.