Welcome to HCV Advocate’s hepatitis blog. The intent of this blog is to keep our website audience up-to-date on information about hepatitis and to answer some of our web site and training audience questions. People are encouraged to submit questions and post comments.

For more information on how to use this blog
click here, the HCV drug pipeline click here, and for more information on HCV clinical trials click here

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Alan Franciscus
Editor-in-Chief
HCV Advocate
HBV Advocate

Drugs in Development / Clinical Trials—Updated October 13, 2014

Wednesday, November 26, 2014

Bristol-Myers Squibb Receives Complete Response Letter from U.S. Food and Drug Administration for Daclatasvir, an Investigational Treatment for Hepatitis C

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for daclatasvir, an NS5A complex inhibitor, in combination with other agents for the treatment of hepatitis C (HCV).

The initial daclatasvir NDA submitted to the FDA focused on its use in combination with asunaprevir, an NS3/4A protease inhibitor. Given the withdrawal of asunaprevir by Bristol-Myers Squibb in October, the FDA is requesting additional data for daclatasvir in combination with other antiviral agents for the treatment of HCV. Bristol-Myers Squibb is in discussions with the FDA about the scope of these data.

“Despite the recent advances in the treatment of hepatitis C there remain significant areas of unmet high need in this disease area,” said Francis Cuss, Executive Vice President and Chief Scientific Officer, R&D, Bristol-Myers Squibb. “Our commitment remains to make daclatasvir-based regimens available to help these difficult-to-treat patients achieve cure, and we will continue to collaborate with the FDA to bring daclatasvir to patients in the U.S. as quickly as possible.”

Ongoing Daclatasvir Clinical Development
Bristol-Myers Squibb is dedicated to the ongoing clinical development program for daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet need. The company continues to progress its daclatasvir clinical trial program focused on difficult-to-treat patients, including pre- and post-liver transplant (ALLY-1), HCV patients co-infected with HIV (ALLY-2) and patients with genotype 3 (ALLY-3). The Phase 3 UNITY studies investigating Bristol-Myers Squibb’s investigational all-oral fixed-dose-combination DCV-TRIO regimen (daclatasvir/asunaprevir/beclabuvir) are also ongoing and include study populations of non-cirrhotic naïve, cirrhotic naïve and previously treated patients.

Source: BMS

FDA declines to approve Bristol-Myers hepatitis drug

(Reuters) - Bristol-Myers Squibb Co on Wednesday said U.S. regulators had declined to approve the use of its experimental treatment for hepatitis C, daclatasvir, in combination with other antiviral drugs.

Bristol-Myers said it had initially sought permission from the U.S. Food and Drug Administration to market the drug, a so-called NS5A inhibitor, in combination with asunaprevir, one of the New York-based company's experimental medicines.

But Bristol-Myers abandoned its U.S. marketing application for asunaprevir in October because of potential competition from more potent drugs, leaving the FDA without data to gauge the effectiveness of daclatasvir as part of a combination regimen.

Read more...

Tuesday, November 25, 2014

Hepatitis C Around the World: Hepatitis C in Canada

Be sure to check out our new HCSP fact sheet:  Hepatitis C Around the World: Hepatitis C in Canada, by Cheryl Reitz and C.D. Mazoff.


Israel: Effective drugs for carriers of hepatitis C not included in health basket

The majority of carriers are immigrants from the former Soviet Union

Hepatitis C carriers -- the majority of them immigrants from the former Soviet Union -- are a ticking bomb, as there are drugs that cure the disease but they are not in the basket of health services, according to experts who spoke at the Knesset Immigration and Absorption Committee on Tuesday. There are an estimated 100,000 carriers of hepatitis C who are unaware of their condition. Decades after infection, will trigger cirrhosis and liver cancer in about one-fifth of them.

The session was held to mark Israel Hepatitis Awareness Day. Hepatitis C, very common among baby boomers, immigrants and intravenous drug users, is one of the most dangerous forms of hepatitis as, unlike hepatitis B, there is no vaccine to protect against it. Carrying the virus is very common among people who received blood transfusions before 1992 when donations were tested, FSU immigrants and intravenous drug users. Every year, some 1.4 million people die from the chronic types of hepatitis. In Israel, liver diseases are the 12th most common killers of Israelis, causing three deaths per 100,000 male residents and 1.7 among females.

Committee chairman MK Yoel Razbozov of Yesh Atid, who initiated the session, charged that the Health Ministry lacks exact and current data on the number of Israelis with chronic hepatitis B and C or on the economic costs of the diseases.

Read more...

Australia: What Price a Life? Hepatitis C drug out of reach for millions

More than a decade after the first victories in the battle for affordable HIV drugs, the gulf between the priorities of large pharmaceutical companies and those of governments, affected communities and the general public is again highlighted.

The new treatments for hepatitis C should herald a revolution; a deadly disease can now be cured quickly and painlessly for a few hundred dollars. But unless affordable treatments are made universally available, millions of people in urgent need will be left behind.

Nobody who recognises the human cost of hepatitis C could question the value of these new drugs. But even in wealthy countries such as Australia, we are being forced to question their price tags.

Read more....

Monday, November 24, 2014

Personal Stories about Living with Hepatitis C

Did you know that the HCV Advocate has a whole bunch of personal stories available for you to read to help you and your loved ones along the journey with hepatitis C.  Read about how others have coped with their journeys, their struggles and their successes.

Be sure to check them out at http://hcvadvocate.org/community/stories.asp

The stories are available both to read online as html or to download as pdf's.

New HCSP Fact Series Fact Sheet: Genotype 3, by Alan Franciscus

In the past, HCV genotype 3 was thought to be one of the easiest to cure.  As a result there was little incentive to develop newer therapies especially since there were fewer people with genotype 3 in developed countries.  Now it has turned out that treatment of genotype 3 is the hardest to cure with HCV inhibitor therapy compared to HCV genotypes 1, 2 and 4.  HCV genotype 3 also contributes to the development of steatosis (fatty liver disease) and insulin resistance, both of which can directly influence HCV disease progression including cirrhosis and liver cancer.