News Of The Day
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Updated - 2014 Breaking Conference Reports
France uses tax to put pressure on hepatitis C drug prices
Experts warn against use of multi-dose vials in wake of hepatitis C outbreak at colonoscopy clinics
Upcoming/Recruiting HCV Clinical Trials - Sofosbuvir Based Including Ledipasvir/Sofosbuvir
Achillion in prime position to develop its own all-oral hepatitis C treatment
HCV Next: The Challenge Of Treating Genotype 3
For many clinicians, genotype 3 now presents the greatest challenge in the treatment and management of patients with hepatitis C virus
Weekend Reading - Prioritizing Patients for HCV Therapy: The Case for Treating Before Advanced Disease
Nancy Reau, MD., offers commentary on the cost of treating HCV, why patients may wait to start therapy, and liver-related effects (extrahepatic manifestations) seen in certain individuals living with this sometimes life threatening disease
The newest section of the AASLD/IDSA/IAS-USA hepatitis C Guidance, Monitoring Patients Who Are Starting HCV Treatment, Are On Treatment, Or Have Completed Therapy, is now available at www.HCVguidelines.org.
This section provides guidance on monitoring patients with chronic hepatitis C who are starting treatment, are on treatment, or have completed treatment, and is divided into 3 parts: pretreatment and on-treatment monitoring, post-treatment follow-up for persons in whom treatment has failed to clear virus, and post-treatment follow-up for those who achieved a sustained virologic response (SVR; virologic cure)
Access the Guidance through the IAS-USA website.
New DAA Phase 3 Studies for genotype 1 at EASL - in both Treatment-naives, treatment-experienced; simultaneous publications
AASLD/EASL NY HCV Special Conference:
Outcome analysis of ledipasvir/sofosbuvir (LDV/SOF) for the treatment of chronic hepatitis C infected genotype 1 patients in the UK.
CHMP Adopts Positive Opinion for Gilead's Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C Infection in Adults - FOSTER CITY, Calif., Sep 24, 2014 (BUSINESS WIRE) -- Gilead Sciences, Inc. GILD, -1.26% today announced that the company has submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for approval of an investigational 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 genotype 1 hepatitis C virus (HCV) infection in adults. The data submitted in the NDA, which include a Japanese Phase 3 study showing 100 percent SVR12 rates, support the use of LDV/SOF for 12 weeks in treatment-naïve and treatment-experienced patients with chronic genotype 1 HCV infection, including those with cirrhosis. Patients who achieve SVR12 are cured of HCV infection. If approved, LDV/SOF would simplify HCV treatment for genotype 1 patients in Japan to one daily tablet, eliminating the need for interferon and ribavirin (RBV).
Ledipasvir/Sofosbuvir - Gilead Submits NDA to Japan’s PMDA
After Patient's Death, Study Shows HCV Drug Cardiotoxic in 14 of 34 Treated Patients - Now, as part of a retrospective review of the phase 2 study that included the index death, researchers report that 14 of 34 patients treated with BMS-986094 had some evidence of cardiac dysfunction.
Top HCV studies presented at ICAAC
Healio.com/Hepatology has compiled a list of the latest, most relevant research on hepatitis C virus infection presented recently at ICAAC 2014 in Washington, D.C.
Fibrosis Staging by Elastometry and Blood Test in Chronic HCV
Liver International, September 26, 2014
Triple Therapy for Chronic HCV
Journal of Viral Hepatitis, September 26, 2014
Treatment of Hepatitis C Virus Infection: Is It Time for the Internist to Take the Reins?"
FDA Hepatitis Update - OLYSIO (simeprevir) label revisions
Culture Shock: Dropping Out of HCV Therapy
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 30
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