Navigation Links
Second Phase III Study Evaluating Gilead's Viread for the Treatment,of Chronic Hepatitis B Virus Meets Primary Endpoint

the company announced that the first study (Study 102) met its primary 48-week efficacy endpoint showing that Viread is non-inferior to Hepsera among patients with HBeAg-negative/anti-HBe positive (presumed pre-core mutant) chronic hepatitis B.

"The preliminary data observed in both Phase III trials evaluating Viread as a potential treatment option for chronic hepatitis B are very encouraging," said Franck Rousseau, MD, Vice President, Clinical Research, Gilead Sciences. "We look forward to reviewing these data with regulatory authorities and are working quickly to file a New Drug Application in the United States and Marketing Authorisation Application in Europe in the fourth quarter of this year."

The active ingredient in Viread, tenofovir DF, is currently the most prescribed molecule in the United States for combination HIV therapy. Viread received approval as an anti-HIV medication from the U.S. Food and Drug Administration (FDA) in October 2001 and from the European Commission in February 2002. Viread is not approved as a treatment for chronic hepatitis B, and data from this analysis have not been reviewed by the FDA.

Study Design

Study 103 is a multi-center, randomized, double-blind Phase III clinical trial that compares the efficacy, safety and tolerability of Viread and Hepsera over 48 weeks among patients with HBeAg-positive chronic hepatitis B. Two hundred and sixty-six patients were randomized in a 2:1 ratio to receive either Viread (300 mg once daily; n=176) or Hepsera (10 mg once daily; n=90).

About Viread (tenofovir disoproxil fumarate)

In the United States, Viread is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Viread should not be used in combination with the fixed-dose combination products Truvada(R) or Atripla(TM) because they already contain Viread.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported wit
'"/>




Page: 1 2 3 4 5 6

Related medicine technology :

1. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
2. Second Phase III Study Evaluating Gileads Viread for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint
3. Second Successful Quigley QR-443 Study Suggests Method of Action Relevant to Broad Range of Chronic Inflammatory Diseases - Human Study to Follow -
4. NeurogesX Announces Presentation of Positive Phase 3 Clinical Data at the Second International Congress on Neuropathic Pain Meeting (NeuPSIG)
5. Repros Androxal Shows Highly Statistically Significant Positive Effects in Men with Secondary Hypogonadism
6. Pharmions Amrubicin Shows Encouraging Results Compared to Standard of Care in Second Line Treatment of Small Cell Lung Cancer
7. Positive Results for Second-Generation Taxus Liberte Coronary Stent System Highlighted in Journal of American College of Cardiology
8. Kosan Presents Promising Phase 1 Data on Second-Generation Hsp90 Inhibitor, Alvespimycin, Showing Antitumor Activity in Refractory Breast and Ovarian Cancers at ASCO
9. Gilead Announces Achievement of Primary Efficacy Endpoint in Second Phase III Study of Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis
10. Amlodipine and Olmesartan Study Results Released;Late Breaker Presented at American Society of Hypertension Twenty-Second Annual Scientific Meeting (ASH 2007)
11. Amlodipine and Olmesartan Study Results Released; Late Breaker Presented at American Society of Hypertension Twenty-Second Annual Scientific Meeting (ASH 2007)
Post Your Comments:
(Date:6/2/2015)... JERUSALEM , June 2, 2015 ... http://www.oramed.com ), a clinical-stage pharmaceutical company focused on the ... a scientific abstract summarizing studies performed with ORMD-0801, its ... will be presented at the poster sessions in the ... 2015 in Boston . The poster ...
(Date:6/2/2015)... June 2, 2015  PROMETRIKA, LLC, a full-service ... with the addition of pharmacovigilance services for clinical ... in safety data collection and reporting, as our ... professionals, and expert physicians, each with more than ... and monitoring of safety trends. ...
(Date:6/2/2015)... VALLEY FORGE, Pa. , June 2, 2015 /PRNewswire/ ... plans to  build three new distribution centers in ... MN ; and Newburgh, NY ... strengthening the company,s ability to improve product access, increase ... Today,s announcement is part of the company,s ongoing ...
Breaking Medicine Technology:Oramed to Present at the American Diabetes Association 75th Scientific Sessions 2Oramed to Present at the American Diabetes Association 75th Scientific Sessions 3Oramed to Present at the American Diabetes Association 75th Scientific Sessions 4PROMETRIKA Announces the Availability of Pharmacovigilance Services 2AmerisourceBergen to Build Three New Distribution Centers 2
(Date:6/2/2015)... Phoenix, AZ (PRWEB) June 02, 2015 The ... encouraged viewers to watch the station’s 6:00 a.m. Good Morning ... be entered on the station’s Facebook page. , ... other code-entering participants. She plans to apply the monthly ... months. Allen, a stay-at-home mom, expressed her surprise and ...
(Date:6/2/2015)... Ahmedabad, Gujarat, India (PRWEB) June 02, 2015 ... a finalist in the 2015 Microsoft Worldwide Small and ... a global field of top Microsoft partners for demonstrating ... on Microsoft technology. , “This comes as no ... expertise are recognized third year consecutively at worldwide level ...
(Date:6/2/2015)... 02, 2015 Milton Hershey School® graduate ... the 30 members of the Physician Assistant Program’s entering ... He was presented with a white coat, which symbolizes ... are extremely proud of Vincent’s accomplishments both at MHS ... a great example of how a top-notch education can ...
(Date:6/2/2015)... Warwick, RI (PRWEB) June 02, 2015 ... medical equipment distributor, has announced the acquisition of ... medical equipment distributor, effective May 29th, 2015. , With ... February 2015, this latest acquisition joins three premier organizations ... equipment to hospitals and healthcare facilities. By combining forces, ...
(Date:6/2/2015)... 2015 With a dedicated focus to become ... Care has hired Leslie Young as director of human ... initiatives to better understand and respond to the distinct needs ... communities in 13 states across the country. , “As we ... support to our residents, we are making it an equal ...
Breaking Medicine News(10 mins):Health News:Scottsdale Resident Named $12,000 Prize Winner- Arizona Central and KTVK 3TV Phoenix Partner in Mortgage Giveaway Contest 2Health News:Bitscape Infotech recognized as finalist for 2015 Microsoft Worldwide small & midsized cloud solutions award. 2Health News:Bitscape Infotech recognized as finalist for 2015 Microsoft Worldwide small & midsized cloud solutions award. 3Health News:Claflin Medical Equipment (CME) Announces Acquisition of RSI Equipment, Inc. 2Health News:Tutera Senior Living & Health Care Hires HR Pro Leslie Young to Lead New Initiatives to Become Employer of Choice 2Health News:Tutera Senior Living & Health Care Hires HR Pro Leslie Young to Lead New Initiatives to Become Employer of Choice 3Health News:Tutera Senior Living & Health Care Hires HR Pro Leslie Young to Lead New Initiatives to Become Employer of Choice 4
... NORTH ANDOVER, Mass., Nov. 23 This time of year brings lots ... these feelings, both positive and negative, translate into urges to overeat as ... opportunities to do so all season long. , We may ... pie, but how many of us stop there? "That pie often ...
... first time, scientists have demonstrated that stem cells found ... to become specialized cell types, which suggests they may ... and conditions than scientists originally thought. Reporting in ... the research teams of Anthony Atala, M.D., director of ...
... The Institute ... its affiliated campuses in Florida. To locate a campus near you, please visit this webpage: ... ... are well into the third decade of Human Immunodeficiency Virus (HIV) epidemic and yet, with ...
... The Merriman Good Life Foundation ... awareness of the general public to the value of pets visiting residents of nursing homes and ... ... Daisy Project. The Daisy Project is aimed at raising awareness of the general public to ...
... ... Mansion in the exclusive community of Cherry Hills Village, Denver, CO, by Absolute Auction December ... Denver, ... Fentress, located in Cherry Hills Village in Denver, Colo., and you are immediately and keenly ...
... ... dental cleaner powerful enough to kill more than 99% of infection-causing bacteria found on ... ... found that mouthguards used regularly are highly contaminated with bacteria and microorganisms from staph ...
Cached Medicine News:Health News:Tis' the Season to Eat and Eat More! 2Health News:New research shows versatility of amniotic fluid stem cells 2Health News:,The Institute of Women's Health of North America Increases its Outreach by Offering Free and Confidential HIV Testing in Florida, 2Health News:,The Institute of Women's Health of North America Increases its Outreach by Offering Free and Confidential HIV Testing in Florida, 3Health News:,The Institute of Women's Health of North America Increases its Outreach by Offering Free and Confidential HIV Testing in Florida, 4Health News:Daisy Project Seeks To Increase Pet Visitation In Nursing Homes 2Health News:Barbara Fentress, Designer of the Denver International Airport and Convention Center, Offers Her Private Mansion at Absolute Auction 2Health News:DentaSOAK Dental Cleaner Reduces Infection Risk Linked to Mouthguards 2
Form: Cream-colored powder Moisture: 10% Ash: 6.5% Gel Strength (1.5%): 550 950 gm/cm 2 Gel pH (1.5%): 6.0 7.5 Gel Point (1.5%): 34 38C Melting Point (1.5%): 84 88C Application: Bacterial ...
... generation of a hypoxic environment for tissue ... surface-type seal where all portions of the ... steel ring clamp for a reliable air-tight ... and bottom provide minimum gas flow resistance ...
... range of miniTHERM incubators is available, ensuring ... solution for their specific requirements. miniTHERM incubators ... compact and extremely space saving. Their size ... It is possible to stack up to ...
... Steri-Cult has been the leading ... volume cell culture for more ... the name that brought leading ... CO 2 sensors,microprocessor control, ...
Medicine Products: