Gilead-Medivir Hepatitis C Drug Clears Virus in Patients
By Ryan Flinn & Shannon Pettypiece
An automated machine works on purification of a potential hepatitis C virus drug candidate at the Gilead Sciences Inc. lab in Foster City,
California. Photographer: David Paul Morris/Bloomberg
An experimental drug combination from Gilead Sciences Inc. (GILD), Medivir AB (MVIRB) and Johnson & Johnson (JNJ) eradicated the virus that causes hepatitis C in patients with the liver disease in a study.
The trial’s 80 patients, who had tried and failed other medications, took a two-drug mixture of Medivir’s simeprevir and Gilead’s sofosbuvir, according to research presented at the Conference on Retroviruses and Opportunistic Infections today in Atlanta. The patients took the combination for 12 or 24 weeks, with and without the antiviral ribavirin, researchers said.
“We went for the most difficult to cure, with the idea if we could show good efficacy there, it could be assumed the regimen could be efficacious in other patient populations,” Gaston Picchio, hepatitis disease area leader for J&J’s Janssen unit, said in a telephone interview. Medivir, based in Huddinge, Sweden, is working with J&J to develop simeprevir.
The interim results showed that among the 10 patients who had been off the treatment for 12 weeks, all of them still had their virus suppressed.
Gilead, Medivir and J&J are competing with Abbott Laboratories (ABT), Bristol-Myers Squibb Co. (BMY), Merck & Co. (MRK) and Vertex Pharmaceuticals Inc. (VRTX) to develop a new generation of oral hepatitis C treatments. The goal is to eliminate the standard therapy that requires ribavirin and an injection of interferon, an immune-boosting protein that can cause flu-like side effects for as long as 48 weeks.
Hepatitis C affects about 150 million people worldwide, according to the World Health Organization. The new drug regimens in testing are designed to be taken as pills, with shorter treatment durations and fewer side effects.
“Sofosbuvir continues to look like a backbone treatment,” said Brian Skorney, an analyst with Robert W. Baird & Co in a note to clients. “These results support our belief that sofosbuvir’s profile allows it to be combined with virtually any active HCV agent and eliminate the need for interferon and ribavirin.”
Gilead rose 1 percent to $43.87 at the close of trading in New York. The shares of the Foster City, California-based company had gained 87 percent in the past 12 months. Medivir climbed 3.8 percent to 90 kronor.
While Gilead is unlikely to pursue a partnership with Medivir and J&J since the company is developing a combination of its own therapies, doctors may prescribe the pair reported in the study off-label, Brian Abrahams, an analyst with Wells Fargo Securities in New York, said in a note today.
“Of course, this would depend on pricing of the two components and payer acceptability, though with elimination of interferon and possibly ribavirin costs and side effects and substantial sustained virologic responses we believe the would likely be amenable,” Abrahams wrote.
Vertex is also testing an experimental drug, VX-135, with Medivir’s Simeprevir, and today’s clinical trial results could make that combination more likely, if no safety issues emerge, Abrahams said.
To contact the reporters on this story: Ryan Flinn in San Francisco at firstname.lastname@example.org; Shannon Pettypiece in New York at email@example.com
To contact the editor responsible for this story: Reg Gale at firstname.lastname@example.org
Home Drugs Gilead-Medivir Hepatitis C Drug Clears Virus in Patients
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Updated April 15, 2014
Reducing the cost of new hepatitis C drugs
Gilead Sciences reached a deal allowing Doctors Without Borders to procure the company's hepatitis C drug Sovaldi (sofosbuvir) at $900 for a 12-week treatment course, significantly below the price of $84 000 in the US, Bloomberg reported 4-11/Friday. Isabelle Meyer-Andrieux, an adviser at Doctors Without Borders, said the discounted price applies to countries including Kenya, Mozambique, Myanmar and India...... Doctors welcome hepatitis C drug rivals, Gilead still leads-"Competition will drive the price down, but probably not far enough," said Markus Peck-Radosavljevic, professor of medicine in the Medical University of Vienna and secretary-general of EASL.
FDA Sofosbuvir and Ledipasvir Updated
April 7 2014 - Gilead Announced U.S. FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination . In February of this year Gilead filed the NDA for LDV/SOF ,and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of October 10, 2014. Finally on March 27; European Medicines Agency Validated Gilead’s Marketing Application for Ledipasvir/Sofosbuvir.
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Sovaldi is approved in HCV genotypes 1 and 4, treatment-naïve adults in combination with PEG-IFN and ribavirin and the first approved interferon-free treatment regimen for people with HCV genotypes 2 and 3. Overall cure rates are at 80%, response rates and treatment duration varies, depending on genotype, viral and host factors.
Sovaldi (Sofosbuvir) HomepageOLYSIO/simeprevir homepage
Prescribing and patient information, articles and important updates
Johnson & Johnson's protease inhibitor OLYSIO (Simeprevir) is approved for the treatment of HCV genotype 1, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naïve or who have failed previous interferon therapy (pegylated or non‑pegylated) with ribavirin.
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AbbVie is a new, independent biopharmaceutical company composed of Abbott’s former proprietary
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r = ritonavir
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In January 2014 Boehringer Ingelheim announced the development of deleobuvir would not be continued since recent findings from phase III trials did not suggest sufficient efficacy.
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(Sofosbuvir) now Sovaldi
GS-7977 sofosbuvir /GS-5885 ledipasvir,
Sofosbuvir (GS-7977)-Before FDA Approval
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Sofosbuvir/Ledipasvir plus GS-9451
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On The Website - (Sovaldi, formerly GS-7977) and NS5A inhibitor ledipasvir (formerly GS-5885) based combinations, including: Sovaldi and GS-5816 alone without ribavirin
On The Website - Sofosbuvir/Ledipasvir
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**Clinical Trials @ HCV Advocate-Idenix
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Simeprevir now Olysio
Simeprevir now Olysio and Daclatasvir
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Simeprevir (TMC435)-Before FDA Approval
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As a reminder (VX-135) is still on partial clinical hold by the FDA in the U.S.
**Clinical Trials @ HCV Advocate-Vertex
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'Mix-and-match` approach to new hepatitis C drugs
The European Association for the Study of the Liver has issued new guidelines for the treatment of hepatitis C which recommend that wherever possible, patients should be treated with the newest direct-acting antivirals.
EASL is also encouraging European physicians to combine products from different pharmaceutical companies to achieve the most potent interferon-free regimens, often in advance of full phase III trial data, in its new hepatitis C treatment guidelines issued in April at the International Liver Congress in London.
These guidelines recommend that the first-generation protease inhibitors telaprevir or boceprevir should be used for treatment of genotype 1 infection only when newer options are not available. For other genotypes, the combination of pegylated interferon and ribavirin is described as `acceptable` where newer options are not available.
Hepatitis C Options For Therapy
FDA Approved Hepatitis C Treatments
Lucinda K. Porter, RN, the author of "Free from Hepatitis C" has graced the HCV community with a second book "Hepatitis C Treatment One Step at a Time" available now on Amazon.
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