HCV Global/USA "Test & Treat"...."Eradication/Access"
Test and treat this silent killer.....Global HCV Access & Eradication....A new battle is looming over access to antiviral medicines in developing countries - this time for treating hepatitis C - more than a decade after a global showdown over the price of AIDS drugs in Africa. Modern pills being launched in western markets could cure the liver-destroying infection in tens of millions of people from China to Congo, or even eradicate the disease entirely...."Liver disease rates will continue to rise, and about 150,000 Americans will die from viral hepatitis in the next decade.".....The CDC's surveillance system covers people who are not homeless or institutionalized, have nothing to fear from the authorities, have access to health care, feel ill when they contract HCV infection and visit a doctor when they feel ill. But HCV disproportionately affects groups for whom those attributes often don't hold true (see 'Hepatitis C is a disease of the marginalized')......Perspective: Test and treat this silent killer
The US government has all but ignored the threat of HCV and is underfunding prevention, treatment and research into the disease (see 'US Response to the HIV and viral hepatitis epidemics')......Hepatitis C, A smouldering public-health crisis, 'Silent Epidemic' in U.S. Needs More Funding: http://www.natap.org/2013/HCV/122713_06.htm
Global epidemiology of hepatitis C virus infection: http://www.natap.org/2013/HCV/122713_06.htm.....
Some 130-200 million people are now estimated to be infected worldwide Nigeria:
40 Million Have Hepatitis Virus and May Not Know, Inaugurates Technical Committee Hepatitis - (12/27/13) ......
China and India together have an estimated 123 million people chronically infected with HBV and 59 million people chronically infected with HCV, accounting for almost 50 percent of all HBV and HCV infections worldwide......"Our analysis identifies Central and East Asia and North Africa/Middle East as regions with high prevalence; South and Southeast Asia, Andean, Central, and Southern Latin America, Australasia, Caribbean, Oceania, and Central, Eastern, and Western Europe, and sub-Saharan Africa as regions with moderate prevalence; and Asia Pacific, Tropical Latin America, and North America as regions with low prevalence in 2005 (Fig. 3). The regions with the highest estimated numbers of people with anti-HCV are South Asia (>50 million), East Asia (>50 million), North Africa / Middle East (>15 million), Southeast Asia (>11 million), and Western Europe (>10 million)
Barriers to HCV Screening/Care among IDUs: "Perceptions of drug users regarding Hepatitis C screening and care: a qualitative study" - (12/27/13)
HCV in China....Extrahepatic Diseases HCV R.E.V.E.A.L. Study in Taiwan
Genotype 1b was the most prevalent at 66.2%
Danoprevir HCV Protease Roche China Deal
Roche at AASLD - (11/26/13)
AASLD: Summary from AASLD 2013 for Hepatitis C Washington 1-5 November 2013 - Written by Jurgen K. Rockstroh M.D., Professor of Medicine University of Bonn, Germany -
AASLD: INTERFERON-FREE TREATMENT WITH FALDAPREVIR, DELEOBUVIR, AND RIBAVIRIN IN SOUND-C3: 95% SVR12 IN HCV GENOTYPE-1b - (11/11/13)
AASLD: Interferon- and Ribavirin-free Regimen of ABT-450/r + ABT-267 in HCV Genotype 1b-infected Treatment-naïve Patients and Prior Null Responders - (11/04/13)
AASLD: All-Oral Combination of Daclatasvir Plus Asunaprevir in Interferon-Ineligible Naïve/Intolerant and Nonresponder Japanese Patients Chronically Infected With HCV Genotype 1b: Results From a Phase 3 Trial - (11/06/13)
GILEAD ANNOUNCES SVR12 RATES FROM THREE PHASE 3 STUDIES EVALUATING A ONCE-DAILY FIXED-DOSE COMBINATION OF SOFOSBUVIR AND LEDIPASVIR FOR GENOTYPE 1 HEPATITIS C PATIENTS - For Immediate Release - (12/18/13)
ABBVIE DEMONSTRATES 96 PERCENT SVR(12) IN ITS PHASE III STUDY OF TREATMENT-EXPERIENCED PATIENTS WITH GENOTYPE 1 HEPATITIS C - (12/18/13)
AbbVie Releases First of Six Phase III Results from Investigational All-Oral, Interferon-Free, 12-week Regimen, Showing 96 Percent SVR12 in Genotype 1 Hepatitis C Patients New to Therapy - (11/18/13)
AASLD: Rapid and Consistent Virologic Responses in a Phase 2 Trial of a New All-Oral Combination of Faldaprevir, Deleobuvir and PPI-668, with and without Ribavirin, in Patients with HCV Genotype-1a Infection - (11/04/13)
AASLD: SVR results of a once-daily regimen of simeprevir (SMV, TMC435) plus sofosbuvir (SOF, GS-7977) with or without ribavirin in cirrhotic and non-cirrhotic HCV genotype 1 treatment-naïve and prior null responder patients: The COSMOS study - (11/05/13)
An all-oral phase IIa study combining Simeprevir, TMC647055 and JNJ56914845 in hepatitis C patients to be initiated - (12/16/13)
Simeprevir Overview: From IFN-Containing to IFN-Free Regimens (12/18/13)
Daclatasvir: Present and Future DAA Combinations (12/18/13)
AASLD: High Efficacy and Safety of the All-Oral Combination Regimen, MK-5172 / MK-8742 ± RBV for 12 Weeks in HCV Genotype 1 Infected Patients: The C- WORTHY Study - (11/05/13)
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AASLD: Gilead at AASLD: Sofosbuvir for GT 3, 2 and 1 - (11/18/13)
AASLD: Gilead at AASLD: 2 - (11/18/13)
AASLD: BMS at AASLD - (11/18/13)
AASLD: Boehringer Ingelheim - (11/18/13)
AASLD: Merck at AASLD - (11/18/13)
AASLD: Janssen at AASLD - (11/18/13)
AASLD: Abbvie at AASLD - (11/18/13)
Daclatasvir backed for compassionate use
Meanwhile, the CHMP also gave a green light to the use of a combination of sofosbuvir with Bristol-Myers Squibb's NS5A inhibitor daclatasvir via a compassionate-use programme.
The decision would make a regimen of daclatasvir and sofosbuvir - with or without ribavirin - available to adults with genotype 1 hepatitis C who are at a high risk of their liver being no longer able to function normally or death within 12 months if left untreated
EASL/2012: Potent Viral Suppression With the All-Oral Combination of Daclatasvir (NS5A Inhibitor) and GS-7977/Sofosbuvir (Nucleotide NS5B Inhibitor), +/- Ribavirin, in Treatment-Naive Patients With Chronic HCV GT1, 2, or 3 (100% SVR gt1, 91% gt2) - (04/19/12)
EASL: Sustained Virologic Response With Daclatasvir Plus Sofosbuvir ± Ribavirin (RBV) in Chronic HCV Genotype (GT) 1-Infected Patients Who Previously Failed Telaprevir (TVR) or Boceprevir (BOC) - (04/27/13)
European Medicines Agency recommends approval of sofosbuvir for the treatment of chronic hepatitis C - (11/25/13)
Daclatasvir Marketing Authorization Application for Treatment of Chronic Hepatitis C Validated for Accelerated Regulatory Review by the European Medicines Agency
· Bristol-Myers Squibb application supports use of daclatasvir in combination with other agents for treating HCV patients with genotypes 1, 2, 3 and 4
· Submission includes EU's first all-oral and ribavirin-free investigational regimen - for use in treatment naïve genotype 1, 2, 3 patients and protease inhibitor treatment failures
· Company is prepared to work with authorities across Europe to help ensure daclatasvir is reimbursed for HCV patients with high unmet needs, if daclatasvir is approved
(PRINCETON, N.J., January 8, 2014) - Bristol-Myers Squibb Company (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated the company's marketing authorization application (MAA) for the use of daclatasvir (DCV), an investigational NS5A complex inhibitor, for the treatment of adults with chronic hepatitis C (HCV) with compensated liver disease, including genotypes 1, 2, 3, and 4. The application seeks the approval of daclatasvir for use in combination with other agents, including sofosbuvir, for the treatment of chronic hepatitis C. The MAA validation marks the start of an accelerated regulatory review process for DCV, which has the potential, when used in combination with other agents, to address a high unmet need in the European Union (EU), where an estimated 9 million people are living with hepatitis C.
"Our extensive clinical trial program has demonstrated that daclatasvir has potential use as a foundational agent for multiple HCV treatment regimens," said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. "If daclatasvir is approved, we would focus on helping to ensure its availability to patients with limited treatment options and would work with EU health authorities to ensure access is achieved as quickly as possible."
In the European Union, the burden of liver disease and other morbidities from HCV infection is significant, with large numbers of patients in urgent need of new treatment options. Because of the progressive nature of HCV, decades may pass before patients become symptomatic. Many of these aging patients develop liver disease, making them more difficult to treat with the current standard of care of interferon plus ribavirin with or without a protease inhibitor. Viral hepatitis has also been cited as a cause for the increase in the incidence of HCC (hepatocellular carcinoma) in Europe.
The EMA submission is supported by data from multiple studies of daclatasvir with other HCV therapies. To date, DCV has been studied in more than 5,500 patients in a variety of all-oral regimens and with the current interferon-based standard of care. In addition to demonstrating pan-genotypic potency in vitro, DCV has shown a low drug-drug interaction profile, supporting its potential use in multiple treatment regimens and in people with co-morbidities. No clinically relevant safety signals have been observed thus far in DCV clinical trials, and DCV has been generally well-tolerated in all investigational regimens and patient types.
The EU submission follows the recent Bristol-Myers Squibb regulatory filing in Japan seeking approval of a DCV-based regimen for the treatment of patients infected with HCV genotype 1b.
About Hepatitis C
Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. An estimated 170 million people worldwide are infected with hepatitis C. Up to 90 percent of those infected with hepatitis C will not 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, up to 25 percent may progress to liver cancer.
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, an investigational NS5A replication complex inhibitor that has been extensively studied as a foundational agent for multiple direct-acting antiviral (DAA) based combination therapies.
DCV is currently being studied in the ongoing Phase III UNITY Program, where it is being investigated as part of an all-oral 3DAA regimen with other Bristol-Myers Squibb investigational agents. Study populations include non-cirrhotic naïve, cirrhotic naïve and previously treated patients. Additional Phase III clinical trials are planned to start in early 2014.
Other compounds in the pipeline include:
· Asunaprevir (ASV) is an investigational NS3 protease inhibitor for hepatitis C which has been studied as a component of DCV-based treatment regimens
· BMS-791325 is a non-nucleoside inhibitor of the NS5B polymerase, currently in Phase III development for hepatitis C as a component of DCV-based treatment regimens
· PegInterferon-Lambda is an investigational type III interferon that has the potential to offer an alternative to alfa-interferon in patients for whom an interferon-based regimen is required or preferred
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.