Oct 2/ FDA Panel Review On For Gilead's Sofosbuvir Despite Government Shutdown
Sept 24/Gilead's (Sofosbuvir) FDA review could be delayed because of government shutdown?
FDA Antiviral Drugs Advisory Committee.
Information On October 25, 2013 Sofosbuvir Review
Information On October 24, 2013 Simeprevir Review
Four Ways that the US Government Shutdown Hurts Patients and Access to Medicines
Published: Oct 07, 2013
World Health Advocacy
Disease Surveillance and Outbreak Monitoring
Due to the furlough of its workers the Centers for Disease Control cannot monitor influenza outbreaks or other disease outbreaks thereby putting the public at risk from the spread of communicable diseases.
Medical Research and Product Approvals
Furloughs at the National Institutes of Health will bring many clinical research projects to a halt. Review panels for cutting edge new drugs for Hepatitis C are scheduled for October but won’t take place if the shut down continues, further delaying access to potentially live changing and life saving new treatments.
New and Generic Drug Registration and Approvals
Although user fees enable the FDA to continue to fund, in the short term, the review and registration of both new drug entities and generic drugs, the shut down prevents the FDA from collecting any user fees. If here is a prolonged shut down drug registrations and approvals will stop.
Any company that requires an FDA inspection before it can re-initiate operations is going to be delayed. In addition more than 70 percent of the active pharmaceutical ingredients used by multi national drug manufacturers are foreign sourced and the impacts of the shut down on port operations good be significant. Current drug shortages will be exacerbated and new drug shortages may soon emerge.
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Sovaldi (Sofosbuvir) Is Now FDA Approved
Hepatitis C- Gilead's Sovaldi (Sofosbuvir) Is Now FDA Approved
Gilead’s Sovaldi™ (Sofosbuvir)
U.S. Patient Assistance Program Gilead is committed to ensuring that people with hepatitis C can access Sovaldi and has launched Support Path™ (www.MySupportPath.com) to provide assistance to patients who are uninsured, underinsured or who need financial assistance to pay for the medicine
Gilead said Friday it would price the drug at $84,000 for one 12-week supply. Patients with a less common subtype of the disease may need to take the drug for 24 weeks, raising the cost to $168,000 for one course of treatment. Drugs already on the market run between $25,000 and $50,000 for a course of treatment.
U.S. Patient Assistance Program
Gilead is committed to ensuring that people with hepatitis C can access Sovaldi and has launched Support Path™ (www.MySupportPath.com) to provide assistance to patients who are uninsured, underinsured or who need financial assistance to pay for the medicine. - See more at: http://hepatitiscnewdrugresearch.com/index.html#sthash.xblNW8ba.dpuf
Sofosbuvir for Hepatitis C: Simpler, Shorter, Safer?
Prescribing and patient information, FDA articles, videos and important updates
Simeprevir Approved In The United States
OLYSIO™ (simeprevir) Receives FDA Approval for Combination Treatment of Chronic Hepatitis C
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.
Simeprevir was approved in Japan this past September , and in Canada on November 20th.
*Updated December 5
HCV Drug Olysio (simeprevir) - The New Kid On The Block
OLYSIO (Simeprevir) Cost? - Janssen has priced Olysio at a wholesale acquisition price of $22,120 per bottle of 28 capsules (150 mg capsules), which is an approximately one-month supply. That's roughly $66,360 for a three-month course.
Lessons Learned - An important lesson we learned from these drugs may serve as a reminder for future DDAs, that is, once telaprevir and boceprevir were used in larger groups of patients, or in "real-life" settings - outside clinical trials, new response rates and adverse effects began to emerge.
Simeprevir drug–drug interactions - Simeprevir has a list of medications that can cause drug–drug interactions Other medications can interfere with the way DDAs are metabolized. The drug–drug interactions can either increase drug concentrations which may cause toxicity and lead to side effects, or decrease drug concentrations leading to a loss of efficacy.
Off Label Use - Simeprevir and Sofosbuvir? - Paul Sax, Editor-in-Chief at NEJM Journal Watch wrote an article this past summer on the possibility of combining simeprevir and sofosbuvir with or without ribavirin, to create an off label interferon-free regimen....
J & J Patient Financial Assistance Program
Important Safety Information
OLYSIO (simeprevir) - Resistant Variant Q80K polymorphism
Olysio-simeprevir/Dosing & Uses, Drug Interactions, Adverse Effects
On November 22nd the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), supported Sovaldi® (sofosbuvir) for the Treatment of Chronic Hepatitis C
The CHMP opinion supports the approval of Sovaldi for the treatment of HCV in combination with other agents. The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union (EU).
For detailed information please download the FDA review package for sofosbuvir and simeprevir.
FDA Updates For Sofosbuvir
FDA Updates For Simeprevir
Quick Links - Hepatitis C Investigational Drugs
News, Research And Clinical Trials
See **Clinical Trials @ HCV Advocate For Enrollment Information
AbbVie is a new, independent biopharmaceutical company composed of Abbott’s former proprietary
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Hepatitis C-New Protease Inhibitor (NS3/4A) Drug Resistance Test
LabCorp has begun offering nationwide its hepatitis C GenoSure NS3/4A assay, which is designed to identify NS3 and NS4A mutations and NS3-associated resistance to a pair of recently approved HCV protease inhibitors.
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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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- New HCV Drugs
- Keeping current on the potential arrival of new improved hepatitis C drugs. As once a hepatitis C patient myself (I successfully treated the virus with standard HCV therapy in 2000) I understand the difficult decisions and overwhelming fear that ensues after being diagnosed with this serious and life-changing disease. This blog serves as a starting point for information on the rapidly evolving number of new agents in development to treat hepatitis C. Tina