Updated November 20, 2014 Reducing the cost of new hepatitis C drugs Daclatasvir, Harvoni (ledipasvir/sofosbuvir) and Sovaldi.
An index of articles & research weighing the pros and cons over the high price of hepatitis C drugs. The situation has Medicaid plans and insurers nationwide groping for the right balance. Worldwide patients are unable to afford treatment, while others wait in the wings on coverage.
U.S. FDA Approves Gilead’s Harvoni® (Ledipasvir/Sofosbuvir)
Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
Both drugs in Harvoni interfere with the enzymes needed by HCV to multiply. Sofosbuvir is a previously approved HCV drug marketed under the brand name Sovaldi. Harvoni also contains a new drug called ledipasvir. Continue reading...
Nov 6 FDA approves Medivir's Olysio (simeprevir) in combination with Gilead Sciences' Sovaldi (sofosbuvir)
-Expanded indication includes both treatment-naïve and treatment-experienced adult patients with or without cirrhosis-
Medivir AB (Nasdaq Stockholm:MVIR) announces that the U.S. Food and Drug Administration (FDA) has approved Olysio® (simeprevir) in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C infection in adult patients as part of a combination antiviral treatment regimen
MSF responds to BMS commercial strategy for hepatitis C drug daclatasvir in developing countries
Médecins Sans Frontières (MSF) responds to the news of BMS’s plans on access and licencing for daclatasvir: “Unfortunately, history seems to be repeating itself with BMS, who haven’t learnt from the company’s poor track record responding to the HIV epidemic; it is disappointing that BMS is choosing to lock out millions of people from gaining affordable access to daclatasvir, and will not commit to registering the drug in all countries that have a hepatitis C burden, even those that do not represent a commercial opportunity for BMS.
Comprehensive data investigating HCV interferon-free, ribavirin-free regimens presented at the liver meeting is now available on the website.
Updated daily, categorized by genotype and pharmaceutical company, with links to breaking news, clinical data, commentary and slide-sets from premier Hepatitis C websites.
Bristol-Myers Squibb (BMY) has decided that it will not pursue U.S. Food and Drug Administration (FDA) approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor. September France uses tax to put pressure on hepatitis C drug prices
Daklinza, when used in combination with sofosbuvir, is an all-oral, once daily regimen that yields cure rates of up to 100%
Daklinza + sofosbuvir offers potential cure for a broad range of EU HCV patients, including those with advanced liver disease, genotype 3 and protease inhibitor failures
PBAC decisions – a mixed bag for Australians living with Hepatitis C Hepatitis Australia today welcomed the recommendation to add simeprevir (Olysio) to the Pharmaceutical Benefits Scheme (PBS) for the treatment of genotype 1 chronic hepatitis C. Responding to the PBAC decision to reject an application to subsidise the antiviral medication sofosbuvir (Sovaldi), Ms Tyrrell said “it’s a sad day when access to game-changing therapy is denied. This is a bad outcome for people living with hepatitis C”.
After reviewing the data, though, NICE agrees that Sovaldi is an effective improvement over existing treatments. The Gilead drug, by the way, can cure nine of 10 patients. The decision was likely helped by the lower price tag in the U.K. Gilead is selling its drug for about $56,000, according to a NICE spokesman. “It’s a lot cheaper here,” he tells us.
Vertex’s decision to stop selling Incivek in the United States as of Oct. 16 was conveyed in a Monday letter to health care providers written by Charles Johnson, the company’s vice president of global medical affairs.
Daclatasvir/VX-135 ..Vertex said it will license an experimental hepatitis C drug called VX-135 to Alios BioPharma..As a reminder (VX-135) is still on partial clinical hold by the FDA in the U.S. **Clinical Trials @ HCV Advocate-Vertex
Sovaldi/sofosbuvir Homepage Prescribing and patient information, financial assistance, research and news
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) Homepage
OLYSIO/simeprevir homepage Prescribing and patient information, articles and important updates
& 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
'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.
Click here to order a FREE Home Access Hepatitis C Test Kit
How Soon Should I Get Tested After Exposure ? After the exposure (especially if the blood exposure involved another person known to have the hepatitis C virus), it is recommended that testing for the hepatitis C antibody be performed at 4 to 6 months after the exposure OR that testing for the hepatitis C virus itself (a test often called an HCV PCR or hepatitis C viral load test) be performed 4 to 6 weeks after the potential exposure. These tests are done to determine whether or not hepatitis C infection has occurred as a result of the exposure
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