Gilead’s Hep C Regimens Progressing Forward | Hepatitis Central

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Gilead’s Hep C Regimens Progressing Forward

The Editors at Hepatitis Central
January 9, 2013

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As one of the frontrunners in interferon-free Hepatitis C drug development, Gilead provides updates on its Phase II and Phase III studies centering around sofosbuvir and GS-5885.

Gilead Provides Update on Hepatitis C Development Programs

— Sustained Virologic Response Achieved with Oral Regimen of Sofosbuvir, GS-5885 and Ribavirin in 9/9 Null Responder Genotype 1 Hepatitis C Patients —

— Second Phase 3 Study Evaluating Fixed-dose Combination of Sofosbuvir and GS-5885 to Begin Later this Month —

FOSTER CITY, Calif.–(BUSINESS WIRE)–Jan. 7, 2013– Gilead Sciences (Nasdaq:GILD) today announced several updates regarding its late-stage pipeline candidates for the treatment of chronic hepatitis C virus (HCV) infection. The company released new results from an arm of the ongoing Phase 2 ELECTRON study examining the nucleotide sofosbuvir and the NS5A inhibitor GS-5885, and provided a progress report on a range of Phase 2 and 3 clinical trials evaluating a once-daily fixed-dose combination tablet of these medicines. These updates will be highlighted today as part of Gilead’s corporate presentation at the 31st Annual J.P. Morgan Healthcare Conference taking place in San Francisco.

“Since the acquisition of Pharmasset only a year ago, we have fully enrolled four Phase 3 studies of sofosbuvir and during the first quarter of this year we will have initiated two Phase 3 studies of the sofosbuvir and GS-5885 fixed-dose combination,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “We are on track to submit the initial regulatory filing for sofosbuvir by mid-2013 and to file for approval of the fixed-dose combination of sofosbuvir and GS-5885 in 2014.”

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HepatitisCentral.com provides information regarding hepatitis and liver disease. Comments are available to the community in order to discuss these topics and obtain answers to questions through community members. The Editors at HepatitisCentral.com will not be responding to questions or comments posed in article comments.

5 Comments

  • Tim says:

    Hello,
    Does anyone know where I can apply for any of the Hep-C Drug Trials? I live in Washington State but am willing to travel anywhere in the U.S. I’m on my last leg here so I need help A.S.A.P. PLEASE!

    • Tom says:

      Tim, I would urge you to consider Dr. Burt Berkson, of Las Cruces,NM. His patient coordinator is at email; becca.berkson@gmail.com, ph# 575-524-3720. The doctor is chief NIH (Nat’l Institutes of Health) investigator for Alpha Lipoic Acid. I have yet to go cuz- NO INS., No $$,etc. you can find him & his work on the web. Good Luck!

  • GS-US-337-0102 says:

    Search http://clinicaltrials.gov/ct2/home, then call hepatologists in your area 🙂

  • X-15 says:

    You can write and ask John J. Jolley, MD, 655 Redwood Hwy Frontage, Suite 375, MV, CA 94941. If he is still involved, there is that, then if not, he might know how to find someone who is.

  • marilyn says:

    if Gilead treatments are with Ribavirin that drug is as bad as Interferon

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