News Of The Day
Check Out The Blog For Additional News
Hello folks, I will be busy with my lovely family over the next few weeks. The website and blog will be updated at the end of September.
Gilead Close to Sending $84,000 Drug to Poor Countries
Gilead Sciences Inc. (GILD:US) is close to a pact with generic drugmakers to bring low-cost versions of its $84,000 hepatitis C drug Sovaldi to about 80 developing countries including India, Indonesia, and Pakistan.
The broad licensing deal could be completed as soon as mid-September and would allow the generic manufacturers to produce Sovaldi and an experimental pill that combines Sovaldi with another Gilead hepatitis drug, said Gregg Alton, an executive vice president for Gilead, in a telephone interview...
HCV Newsletters - Update on Hepatitis C:Trials & Treatment and Protesting Gilead
Found In This Months HCV Newsletters:
Great Information: SVR rates according to genotype:
Update on Hepatitis C: Trials & Treatment
Patient Stories - Caring Ambassadors - Listen to audio featuring patient stories.
Research: New Index Helps Predict Course of Early HCV Cirrhosis
Treatment of Chronic Hepatitis C Virus Infection
Of Interest - In The News - We Now Have the Cure for Hepatitis C, but Can We Afford It?
Prickless blood sugar test on horizon for diabetics
NEW YORK (Reuters Health) – Eventually, people with diabetes won’t need to prick their fingers multiple times a day to check their blood sugar levels, if researchers have their way.
Why Is Everybody Picking on Sovaldi?
At Sovaldi’s present price, there is considerable resistance to diagnosing and treating everyone. State Medicaid programs, and likely many private insurers as well, are restricting Sovaldi to patients who have progressed beyond chronic HCV infection into cirrhosis.
Europe: More Direct-Acting Antivirals, More Controversy
Weekend Reading: Evolution of Hepatitis C Virus Treatment
Hepatitis C - New Therapies Are Coming Soon: The Case To Wait
Webcast presented in a trial and jury format, which examines the "Treat Now Or Wait" scenario in patients with HCV. Listen to the judge and expert witnesses discuss new HCV regimens under development with or without ribavirin in this light-hearted innovative presentation.
Bristol-Myers Squibb’s Daklinza (daclatasvir), Approved By European Commission - 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, 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
2014 Hepatitis Newsletters
HCV News Digest
HCV Advocate's own Alan Franciscus will host a; Hepatitis C Training Workshop in Cleveland, OH on September 25, 2014.
Cost - Sovaldi (sofosbuvir)
Updated - Sept 5
Reducing the cost of new hepatitis C drugs
An index of articles pointing the reader to current information and controversy over the high price of Sovaldi.
Bristol-Myers Squibb’s Daklinza (daclatasvir), Approved By European Commission
June 13 2014
U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 1 Chronic Hepatitis C
The AbbVie investigational regimen consists of ABT-450/ritonavir co-formulated with ombitasvir (ABT-267), and dasabuvir (ABT-333) with or without RBV. The combination of three different mechanisms of action interrupts the hepatitis C virus replication process with the goal of optimizing sustained virologic response rates across different patient populations.
April 7 2014
Gilead Announces U.S. FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination
U.S. Food and Drug Administration (FDA) has granted priority review to the company's New Drug Application (NDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults. Gilead filed the NDA for LDV/SOF on February 10, 2014, and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of October 10, 2014. Feb/Gilead Files for U.S. Approval:Ledipasvir/Sofosbuvir Fixed-Dose Combo For Genotype 1 Hepatitis C
European Medicines Agency Validates Gilead’s Marketing Application for Ledipasvir/Sofosbuvir
Advances in the Treatment of Hepatitis C
Sofosbuvir/Ledipasvir based regimens
Sofosbuvir-ledipasvir alone or with ribavirin
December 2013; 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
2013 - Two New Oral Drugs To Treat Hepatitis C Approved
The U.S. Food and Drug Administration approved two new oral drugs in 2013 to treat the hepatitis C virus. Johnson & Johnson's protease inhibitor Simeprevir is approved for the treatment of 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. The second drug is Solvadi (sofosbuvir) a polymerase inhibitor approved for people with genotypes 1 and 4, in combination with interferon and ribavirin and for people with genotypes 2 and 3 with ribavirin alone, making it the first interferon free combination approved to treat HCV. Overall cure rates are at 80%, response rates and treatment duration varies, depending on genotype, viral and host factors.
April 2014 - Watch-Recent FDA approval of sofosbuvir and simeprevir- Implications for current HCV treatment
Will Sofosbuvir and/or Simeprevir Replace the Previous Generation of Antiviral Agents?
Preparing for the uncertain yet inevitable: Off-label combinations of antiviral agents in hepatitis C virus
This article will address anticipated issues regarding off-label use of HCV medications, including the role of the U.S. Food and Drug Administration (FDA), consumer pressure, medical society guidelines, and third-party payers.
Prescribing information, financial assistance, research articles and important updates
Prescribing and patient information, research and news
Chronic hepatitis C: Treat or wait?
A collection of news articles and research weighing the risks and benefits of treating HCV now vs waiting for future therapies.
Clinical Trial Updates
ClinicalTrials.gov:updated in the last 30 days
To learn more about Hepatitis C virus clinical trials or to find out if a study is enrolling patients in your area, please click here.
Everything You Need To Know Before Starting Treatment
Lucinda K. Porter, RN the author of "Free from Hepatitis C"
new book "Hepatitis C Treatment One Step at a Time" is now available on Amazon
Need To Talk To Someone ?
Help is available, recently "Project Inform" announced the launch of a new national helpline, 877-HELP-4-HEP (877-435-7443), run by and for people affected by hepatitis C.
The helpline operates Monday through Friday 9am to 7pm EST. To learn more, visit www.help4hep.org