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
Drugs in Development / Clinical Trials—Updated August 19, 2014
Monday, September 1, 2014
"Because our study revealed a strong relationship between new infections and injection drug use among youth, we would encourage providers to be on high alert for these risk behaviors in young patients," said senior author Dr. Scott D. Holmberg from the Centers for Disease Control and Prevention in Atlanta, Georgia.
"Assessing their risk can be an important opportunity -- not only for testing but also to provide appropriate therapy or referral to drug-cessation treatment," he told Reuters Health by email.
Sunday, August 31, 2014
For background info see http://hepcbc.ca/contribute-sofosbuvir-ledipasvir-submission-cadth/.
For the actual questionnaire, go to: http://hepcbc.ca/questions-cadth-sofosbuvir-ledipasvir/. DEADLINE: Sunday, October 5th, 2014.
Please tweet, re-tweet, put on Facebook, and forward this information, thanks!
*CADTH = Canadian Agency for Drugs and Technologies in Health, which does government-requested reviews for Health Canada and the Canadian Drug Review process.
Getting a tattoo, a bellybutton ring or even a pedicure can seem a great idea while on holiday, but you may end up bringing home something more sinister than just some body ink or brightly coloured nails.
Experts working in the area of hepatitis B (HBV) and C (HCV) are predicting a jump in the number of people contracting the viruses overseas because of the types of activities Australians are enjoying abroad.
“What we want all Australians to know before they head off on their overseas holiday is that any activity in which the skin is pierced can lead to infection with hepatitis – and, yes, that can include pedicures, tattoos and piercings, and even getting dental work done abroad,” Hepatitis Australia’s CEO Helen Tyrell says.
Saturday, August 30, 2014
Welcoming the EMA's approval of daclatasvir on August 27, 2014, the MSF said that the BMS must rapidly register daclatasvir in those countries with a high burden of hepatitis C, especially in those countries with a high prevalence of genotype 3. It also urged BMS to ensure daclatasvir is affordable in those countries with a high burden of hepatitis C.
Thursday, August 28, 2014
Previously, HCV infections were restricted to humans and chimpanzees, with lab mice, the normal testing subjects for viral research, showing immunity. But a recently published study shows researchers at the Chinese Academy of Sciences (CAS) successfully sustained the virus in a lab mouse for almost two years.
The new breakthrough, conducted by a research team led by Chinese scientists Tang Hong and Chen Xinwen, has been published on the Cell Research website.
Wednesday, August 27, 2014
European Commission Approves Bristol-Myers Squibb’s Daklinza (daclatasvir) Across Multiple Genotypes for the Treatment of Chronic Hepatitis C Infection
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced that the European Commission has approved Daklinza (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults. Daklinza, when used in combination with sofosbuvir, is an all-oral, interferon-free regimen that provided cure rates of up to 100% in clinical trials, including patients with advanced liver disease, genotype 3 and those who have previously failed treatment with protease inhibitors. Daklinza is the first NS5A complex inhibitor approved in the European Union (EU) and will be available for use in combination with other medicinal products, providing a shorter treatment duration (12 or 24 weeks) compared to 48 weeks of treatment with interferon- and ribavirin-based regimens.
Today’s approval allows for the marketing of Daklinza in all 28 Member States of the EU. The marketing authorization for Daklinza follows an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP), a designation that is granted to new medicines of major public health interest.
“HCV is a challenging virus to overcome, requiring multiple modes of attack. With the approval of Daklinza, we have a new class of drug that disrupts the virus in two ways - by inhibiting both viral replication and assembly - and when combined with other compounds often results in cure among even the hardest-to-treat patients,” said Michael P. Manns, MD, Professor and Chairman, Department of Gastroenterology, Hepatology, and Endocrinology, Hannover Medical School, Hannover, Germany.
Of the estimated nine million people living with HCV in the EU, genotype 1 is the most common genotype, though distribution varies across the region. The burden of liver disease and other morbidities from HCV infection is significant in Europe, where HCV accounts for 63% of liver transplants among patients with virus-related liver disease. Patient populations with high unmet needs include those with advanced liver disease, protease inhibitor failure, genotype 3, HIV co-infected patients and those who have undergone liver transplant.
“The eradication of HCV is in sight, and with today’s approval, Daklinza, in combination with other agents, will be an important option to achieve cure across many HCV genotypes and patient types for those in the EU who are in dire need of new treatment choices,” said Emmanuel Blin, Head of Worldwide Commercialization, Bristol-Myers Squibb. “We are proud to have discovered, developed and now brought to market this first-in-class NS5A replication complex inhibitor. We look forward to our continued work with EU health authorities to ensure Daklinza-based regimens are available to patients as quickly as possible.”
The approval of Daklinza is supported by data from multiple studies, including an open-label, randomized study of Daklinza with sofosbuvir in genotypes 1, 2, and 3, including patients with no response to prior therapy with telaprevir or boceprevir and patients with fibrosis. Results showed that a regimen of Daklinza with sofosbuvir achieved SVR12 (sustained virologic response 12 weeks after the end of treatment; a functional cure) in 99% of treatment-naïve patients with HCV genotype 1, 100% of patients with genotype 1 who had failed treatment with either telaprevir or boceprevir, 96% of those with genotype 2 and 89% of those with genotype 3.
In addition, the regimen resulted in low rates of discontinuation (<1%) due to adverse events (AEs). The rate of serious adverse events (SAEs) was low (4.7%). The most common adverse events were fatigue, headache and nausea. Across clinical studies, Daklinza-based regimens have been generally well tolerated with low rates of discontinuation across a range of patients. Ongoing and completed Daklinza studies have included more than 5,500 patients in a variety of all-oral regimens and with the current interferon-based standard of care.
The safety of Daklinza for the treatment of hepatitis C has been demonstrated in diverse patient populations that include elderly patients, patients with advanced liver disease, post-liver transplant recipients and patients co-infected with HIV. No unique safety concerns have been identified in patients who were treated with Daklinza across clinical studies and in the early access program. Several of these studies are ongoing.
Recommended regimens and treatment duration for Daklinza combination therapy include:
|HCV genotype and patient population||Treatment||Duration|
|Genotype 1 or 4 without cirrhosis||
Daklinza + sofosbuvir
Consider prolongation of treatment to 24 weeks for patients with prior treatment including a NS3/4A protease inhibitor (see sections 4.4 and 5.1).
|Genotype 1 or 4 with compensated cirrhosis||Daklinza + sofosbuvir||
Shortening treatment to 12 weeks may be considered for previously untreated patients with cirrhosis and positive prognostic factors such as IL28B CC genotype and/or low baseline viral load.
Consider adding ribavirin for patients with very advanced liver disease or with other negative prognostic factors such as prior treatment experience.
|Genotype 3 with compensated cirrhosis and/or treatment experienced||Daklinza + sofosbuvir + ribavirin||24 weeks|
|Genotype 4||Daklinza + peginterferon alfa + ribavirin||
24 weeks of Daklinza in combination with 24-48 weeks of
peginterferon alfa and ribavirin.
If the patient has HCV RNA undetectable at both treatment weeks 4 and 12, all 3 components of the regimen should be continued for a total duration of 24 weeks. If the patient achieves HCV RNA undetectable, but not at both treatment weeks 4 and 12, Daklinza should be discontinued at 24 weeks and peginterferon alfa and ribavirin continued for a total duration of 48 weeks.
Daklinza monotherapy is not recommended. The Summary of Product Characteristics will be available at www.ema.europa.eu. Commercial availability of Daklinza in the EU will be determined by individual Member States.
About Hepatitis C
Globally, there are 150 million people infected with HCV and of that, an estimated 9 million people are living with hepatitis C in the European Union (EU). Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. Up to 90 percent of those infected with hepatitis C will not spontaneously clear the virus and will become chronically infected. According to the World Health Organization, 20 percent of people with chronic hepatitis C will develop cirrhosis and, of those, about 5 to 7 percent of patients may ultimately die of the consequences of infection.
About Bristol-Myers Squibb’s HCV Portfolio
Bristol-Myers Squibb’s research efforts are focused on advancing late-stage compounds to deliver the most value to patients with hepatitis C. At the core of our pipeline is daclatasvir, a potent pan-genotypic NS5A complex inhibitor (in vitro), which continues to be investigated in multiple treatment regimens and in people with co-morbidities.
Daklinza was recently approved in Japan in combination with Sunvepra (asunaprevir), a NS3/4A protease inhibitor. The Daklinza+Sunvepra Dual Regimen is Japan’s first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic HCV infection, including those with compensated cirrhosis.
Applications for the daclatasvir Dual Regimen are also under review by the U.S. Food and Drug Administration (FDA), which granted priority review status and set a target review date under the Prescription Drug User Fee Act (PDUFA) of November 30, 2014.
In 2014, the FDA granted Bristol-Myers Squibb’s investigational daclatasvir Dual Regimen (daclatasvir + asunaprevir) Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b HCV infection.
In 2013, Bristol-Myers Squibb’s investigational all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325) also received Breakthrough Therapy Designation in the U.S., which helped to expedite the start of the ongoing Phase 3 UNITY Program. Study populations include non-cirrhotic naïve, cirrhotic naïve and previously treated patients. The daclatasvir 3DAA Regimen is being studied as a fixed-dose-combination treatment with twice daily dosing.
Additional studies with daclatasvir in combination with sofosbuvir are being conducted in high unmet need patients, such as pre- and post-transplant patients, HIV/HCV co-infected patients and patients with genotype 3 as part of the ongoing Phase 3 ALLY Program.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
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