Showing posts with label GS-7977 now sofosbuvir / GS-5885 now ledipasvir. Show all posts
Showing posts with label GS-7977 now sofosbuvir / GS-5885 now ledipasvir. Show all posts

Friday, October 10, 2014

U.S. FDA Approves Gilead’s Harvoni® (Ledipasvir/Sofosbuvir)

U.S. Prescribing Information
Patient Information 

U.S. Food and Drug Administration Approves Gilead’s Harvoni® (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C 

October 10 2014
The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.

Harvoni Product PhotoHarvoni 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.

“With the development and approval of new treatments for hepatitis C virus, we are changing the treatment paradigm for Americans living with the disease,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Until last year, the only available treatments for hepatitis C virus required administration with interferon and ribavirin. Now, patients and health care professionals have multiple treatment options, including a combination pill to help simplify treatment regimens.”

Harvoni is the third drug approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013 and Sovaldi in December 2013.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades.

Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections and liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15-30 percent of these people will go on to develop cirrhosis.

Harvoni’s efficacy was evaluated in three clinical trials enrolling 1,518 participants who had not previously received treatment for their infection (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants with cirrhosis. Participants were randomly assigned to receive Harvoni with or without ribavirin. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response, or SVR), indicating that a participant’s HCV infection has been cured.

In the first trial, comprised of treatment-naive participants, 94 percent of those who received Harvoni for eight weeks and 96 percent of those who received Harvoni for 12 weeks achieved SVR. The second trial showed 99 percent of such participants with and without cirrhosis achieved SVR after 12 weeks. And in the third trial, which examined Harvoni’s efficacy in treatment-experienced participants with and without cirrhosis, 94 percent of those who received Harvoni for 12 weeks and 99 percent of those who received Harvoni for 24 weeks achieved SVR. In all trials, ribavirin did not increase response rates in the participants.

The most common side effects reported in clinical trial participants were fatigue and headache.

Harvoni is the seventh new drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases.

Harvoni was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

Harvoni and Sovaldi are marketed by Gilead, based in Foster City, California. Olysio is marketed by Janssen Pharmaceutical based in Raritan, New Jersey.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Source - FDA

U.S. Food and Drug Administration Approves Gilead’s Harvoni® (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C

-- Harvoni Achieved Cure Rates (SVR12) of 94-99 Percent in Three Phase 3 Studies
-- Shortens Treatment Duration to Just Eight Weeks for Certain Treatment-Naïve Patients
-- Eliminates Need for Interferon and Ribavirin for Patients with Genotype 1 Hepatitis C

FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 10, 2014-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor sofosbuvir, approved under the tradename Sovaldi® in December 2013. Harvoni’s efficacy has been established in patients with chronic hepatitis C virus (HCV) genotype 1 infection, with a treatment duration of eight, 12 or 24 weeks depending on prior treatment history, cirrhosis status and baseline viral load. Eight weeks of treatment with Harvoni can be considered for treatment-naïve patients without cirrhosis who have baseline HCV viral load below 6 million IU/mL.

The FDA granted Harvoni a Priority Review and Breakthrough Therapy designation, which is given to investigational medicines that may offer major advances in treatment over available therapies.
“By providing very high cure rates in as little as eight weeks and completely eliminating the need for interferon and ribavirin, which are challenging to take and tolerate, Harvoni significantly advances treatment for patients with the most common form of hepatitis C in the United States,” said Nezam Afdhal, MD, Director of Hepatology at Beth Israel Deaconess Medical Center, Professor of Medicine at Harvard Medical School and a principal investigator in the Harvoni clinical trials. “For the first time, the vast majority of patients can be cured with a once-daily pill in only eight or 12 weeks.”
Harvoni’s approval is supported by data from three Phase 3 studies, ION-1, ION-2 and ION-3. These studies evaluated eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease. These studies included non-cirrhotic treatment-naïve patients (ION-3), cirrhotic and non-cirrhotic treatment-naïve patients (ION-1) and cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor (ION-2). The primary endpoint for each study was sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12).
Patients who achieve SVR12 are considered cured of HCV. In these studies, ribavirin was not shown to increase response rates. Trial participants in the ribavirin-free arms (n=863) achieved SVR12 rates of 94 to 99 percent.
“Unlike other serious chronic diseases, hepatitis C can be cured and Harvoni offers patients the potential for a cure in as little as eight weeks,” said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. “Gilead is proud to have played a role in developing a once-daily therapy that is safe, simple and well tolerated. We are now working to ensure rapid and broad access to Harvoni.”
Important Safety Information regarding warnings and precautions, adverse reactions and drug interactions is listed below. Zero percent, less than 1 percent and 1 percent of patients treated for eight, 12 and 24 weeks, respectively, discontinued treatment due to adverse events and fewer adverse events were observed in the ribavirin-free arms compared to the ribavirin-containing arms in all ION studies. The most common adverse reactions among patients treated with Harvoni (≥5 percent) were fatigue, headache, nausea, diarrhea and insomnia. For additional study details, and complete dosing information, see the Clinical Studies and Dosage and Administration sections, respectively, of the full Prescribing Information.
U.S. Patient Support Program
To assist eligible hepatitis C patients in the United States with access to Harvoni, Gilead has added the medicine to its Support Path™ ( program. The program consists of an integrated offering of support services for patients and providers, among them:
  • Call center staffed with associates trained to help patients and their providers with insurance-related needs.
  • Education and support, including a 24/7 nursing support service line.
  • The Harvoni and Sovaldi Co-pay Coupon Programs, which provide co-pay assistance for eligible patients with private insurance who need assistance paying for out-of-pocket medication costs. Most patients will pay no more than $5 per co-pay.
  • The Support Path Patient Assistance Program, which will provide Harvoni and Sovaldi at no charge for eligible patients with no other insurance options.
Gilead also provides support to independent non-profit organizations that provide assistance for eligible federally-insured and privately-insured patients who need help covering out-of-pocket medication costs.
To learn more about Support Path for Harvoni or Sovaldi, please visit or call 1-855-769-7284 between 9:00 a.m.8:00 p.m. Eastern, Monday through Friday.
Warnings and Precautions

Risk of Reduced Therapeutic Effect of Harvoni Due to P-gp Inducers: Rifampin and St. John’s wort are not recommended for use with Harvoni as they may significantly decrease ledipasvir and sofosbuvir plasma concentrations.
Related Products Not Recommended: Harvoni is not recommended for use with other products containing sofosbuvir (Sovaldi).
Adverse Reactions
Most common (≥10%, all grades) adverse reactions were fatigue and headache.
Drug Interactions
In addition to rifampin and St. John’s wort, coadministration of Harvoni is also not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of ledipasvir and sofosbuvir, reducing the therapeutic effect of Harvoni.
Coadministration of Harvoni is not recommended with simeprevir due to increased concentrations of ledipasvir and simeprevir. Coadministration is also not recommended with rosuvastatin or co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate due to increased concentrations of rosuvastatin and tenofovir, respectively.
Consult the full Prescribing Information for Harvoni for more information on potentially significant drug interactions, including clinical comments.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.
Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians and patients may not see advantages of Harvoni over other therapies and may therefore be reluctant to prescribe the product, and the risk that private and public payers may be reluctant to provide coverage or reimbursement for the product. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2014, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
U.S. Full Prescribing Information for Harvoni and Sovaldi is available at
Harvoni, Sovaldi and Support Path are trademarks or registered trademarks of Gilead Sciences, Inc., or its related companies.

U.S. FDA approves Gilead's $94,500 hepatitis C drug
By Deena Beasley

Fri Oct 10, 2014 4:36pm EDT

(Reuters) - U.S. regulators on Friday approved a new hepatitis C pill from Gilead Sciences Inc, which said it will charge $94,500 for an improved 12-week course of treatment to rid patients of the liver-destroying viral infection.

The daily pill, to be sold under the brand name Harvoni, combines Gilead's $84,000 pill Sovaldi with another drug, ledipasvir, and eliminates the need for two older, side-effect-laden treatments that needed to be taken along with Sovaldi.

Gilead, which has faced a backlash from health insurers over the high cost of its hepatitis C treatments, said the current regimen of Sovaldi plus the older drugs, interferon and ribavirin, has a cost of $94,726.

The company emphasized that the price of the new drug is less than the current regimen, but insurers and other payers said it is still unsustainable.

"Unfortunately, we believe that the price being demanded is still inappropriately high for a product targeting such a large group of patients," said David Whitrap, spokesman for Express Scripts Holding Co, the largest manager of pharmacy benefit programs in the United States. "New innovations do not always require inappropriate, premium pricing."

Hepatitis C, estimated to infect about 3.2 million Americans, is a viral disease that causes inflammation of the liver that can lead to liver failure.

Gilead said nearly half of patients infected with the most common type of hepatitis C - previously untreated, healthier individuals - can be cured after eight weeks of taking Harvoni, compared with 12 weeks for the current Sovaldi regimen.

The cost of treating those patients with the new pill for eight weeks is $63,000.

Wall Street analysts note that the price of Harvoni is lower than the $130,000 or more now needed to treat certain hepatitis C patients with Sovaldi and Olysio, a newer antiviral drug sold by Johnson & Johnson.

"The price of $94,000 is very attractive," said RBC Capital Markets analyst Michael Yee. "At eight weeks of therapy, the cost is about $63,000, which is 30 percent cheaper than Sovaldi."

Deutsche Bank analyst Robyn Karnauskas said Harvoni's pricing came in slightly below her expectations, but is "rational and strongly supportive of sustained market share."

Bristol-Myers Squibb Co said on Tuesday it is no longer seeking U.S. approval for an oral two-drug combination to treat hepatitis C because of competition from rival drugs.

AbbVie Inc is slated to hear from the FDA later this year on its application to market an all-oral hepatitis C regimen.

"As the additional hepatitis C drugs are approved over the next few months, we're looking forward to driving more competition in this space," Express Scripts said.

Gilead is expected to reap nearly $12 billion in hepatitis C drug sales worldwide in 2014. Sovaldi sales have been unprecedented for any first-year drug. 

Gilead shares closed 2 percent lower at $103.73 on Friday.

 (Additional reporting by Bill Berkrot in New York; editing by Tom Brown and Matthew Lewis)

Sunday, October 5, 2014

Weekend Reading; Friday, anticipated date for FDA decision on Gilead's ledipasvir/price? And our hep hero

Hello everyone, welcome to Weekend Reading, getting ready for Autumn? No doubt you have a few outside chores to finish up, me too.

Annual Meeting of the American Association for the Study of Liver Diseases

Next month the 65th Annual Meeting of the American Association for the Study of Liver Diseases will take place in Boston, the liver meeting will begin on November 7th, and end on November 11th.

Late-breaking abstracts now available

Hep Hero - Fall Newsletters

Lucinda K. Porter, RN

Readers, you are in for treat, Tim Murphy writes about our devoted HCV advocate, Lucinda K. Porter, RN., in his article; Hep Hero, published online at

Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and are the go-to source for educational and social support for people living with hepatitis.
In this months issue
Click here to read digital edition

by Tim Murphy
How one woman overcame hepatitis C and ended up helping others fight it, too.

Eye of the Tiger
by Oriol R. Gutierrez Jr.
The potential for up to millions of Americans to benefit from the new hep C meds makes this one of the most exciting moments in modern medicine.

Sovaldi-Ledipasvir Pill Safe With Major HIV Meds
by Benjamin Ryan
Gilead Sciences’ fixed-dose combination pill of Sovaldi (sofosbuvir) and the investigational ledipasvir, likely to receive FDA approval on October 10, does not significantly interfere with five common HIV antiretrovirals.

'3D' Cures 99% to 100% of Genotype 1b
by Benjamin Ryan
AbbVie’s so-called “3D” combo regimen ditched ribavirin and still cured 99 percent to 100 percent of study participants with genotype 1b of hepatitis C virus (HCV) in two recent Phase III trials.

Daclatasvir and Asunaprevir Cure Up to 87% of 1b
by Benjamin Ryan
Bristol-Myers Squibb's daclatasvir and asunaprevir cured 81 percent to 87 percent of people with genotype 1b of hepatitis C in a recent Phase III trial.

Primary Care Docs Clueless About Hep C Drugs
by Benjamin Ryan
About three out of four primary care physicians (PCPs) are unfamiliar with the new generation of hep C drugs which received U.S. Food and Drug Administration (FDA) approval at the end of 2013.

Hep C Suppression Linked to Major Health Benefits
by Benjamin Ryan
Suppressing the hep C viral load is associated with a diminished risk of liver disease and death.

Curing Hep C Lowers Central Nervous System Fatigue
by Benjamin Ryan
Ridding the body of hep C reduces central fatigue, which is weakness originating in the central nervous system. 

Connect With Us On Twitter and Facebook

The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education.

HCV Advocate News & Pipeline Blog
Click Here

HCV Advocate October Newsletter
Click Here

In This Issue:

Alan Franciscus, Editor-in-Chief
In this month’s column, I will provide a short overview of phase 3 data from sofosbuvir plus ledipasvir. It is important to know, however, that when approved the FDA may add or change the cure rates and add additional warnings or restrictions to the use of the medications based on their review of the clinical trial data. 

Lucinda K. Porter, RN
This month, Lucinda discusses the AASLD and IDSA’s recommendations assigning high treatment priority to those with high risk of HCV transmission. When we reduce HCV transmission, we reduce the prevalence, which benefits us all.

Alan Franciscus, Editor-in-Chief
One of the most important decisions that anyone with hepatitis C (HCV) will make is about HCV treatment. In the past, it has been a difficult decision because of the significant side effects, long treatment duration and modest cure rates. 

Lucinda K. Porter, RN
Lucinda reviews studies on depression and HCV disease progression, mother-to-child transmission, healthcare utilization and racial differences in progression to cirrhosis and HCC. 

Website Plan & Survey Report
Alan Franciscus, Editor-in-Chief

Find out what the results of our recent survey were; what we are going to do about them, and who won the autographed copy of Lucinda's book Hepatitis C One Step at a Time. 

Connect With HCV Advocate


Stay safe, enjoy the weekend

Monday, September 29, 2014

Upcoming/Recruiting HCV Clinical Trials - Sofosbuvir Based Including Ledipasvir/Sofosbuvir

Clinical trials on this page are not a complete list; to learn more about HCV trials or to find out if a study is enrolling patients in your area, please click here. View additional hepatitis trials updated in the last 30 days @

For additional information visit HCV Advocate News and Pipeline for trial updates;

Bristol-Myers Squibb (BMS)
Tibotec / Janssen
**Quick Reference Guide*


Not yet recruiting
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection
Conditions: Chronic Hepatitis C; Genotype 4 Chronic Hepatitis C
Interventions: Drug: Simeprevir; Drug: Sofosbuvir Sofosbuvir/Ribavirin Identifier: NCT02250807
Sponsor: Janssen Infectious Diseases BVBA


Not yet recruiting
Conditions: Genotype 4 Chronic Hepatitis C
Drug: Simeprevir
Drug: Sofosbuvir
Phase 3 Identifier: NCT02256176
Sponsor: Janssen R&D Ireland

Sofosbuvir/Ribavirin - Adolescents and Children
Conditions: Hepatitis C Virus Infection
Drug: SOF
Drug: RBV
Phase 2 Identifier: NCT02175758


Not yet recruiting
DAA-based Therapy for Recently Acquired Hepatitis C II (DAA = Directly Acting Antiviral)
Condition: Hepatitis C
Intervention: Drug: Sofosbuvir and ribavirin Identifier: NCT02156570

Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis
Condition: Hepatitis C Virus Infection
Interventions: Drug: Sofosbuvir; Drug: RBV Identifier: NCT02128542

Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection
Condition: Chronic HCV Infection
Interventions: Drug: Sofosbuvir; Drug: RBV Identifier: NCT02074514


Condition: Hepatitis C Virus Infection
Drug: SOF/GS-5816
Drug: SOF
Drug: RBV
Phase 3 Identifier: NCT02201953

Ledipasvir/Sofosbuvir and Vedroprevir With or Without Ribavirin
Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis
Hepatitis C Virus Infection
Drug: LDV/SOF; Drug: VDV; Drug: RBV Identifier: NCT02226549

Ledipasvir/Sofosbuvir - Adolescents and Children

This study is not yet open for participant recruitment
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination in Adolescents and Children With Chronic HCV-Infection
Condition: Hepatitis C Virus Infection
Phase 2 Identifier: NCT02249182


Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection
Condition: Chronic Hepatitis C
Interventions: Drug: LDV/SOF; Drug: RBV
Phase: Phase 2 Identifier:
Other IDs: NCT02202980

This study is not yet open for participant recruitment
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic HCV Infection
Hepatitis C Virus Infection
Drug: LDV/SOF Identifier: NCT02251717

Ledipasvir/Sofosbuvir Fixed-Dose Combination on Cerebral Metabolism and Neurocognition in Treatment-Naive and Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection
Hepatitis C Virus Infection
Drug: LDV/SOF; Drug: Placebo to match LDV/SOF Identifier: NCT02219685

This study is not yet open for participant recruitment
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination in Adolescents and Children With Chronic HCV-Infection
Hepatitis C Virus Infection
Drug: LDV/SOF Identifier: NCT02249182

Enrolling by invitation
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Subjects With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
HCV Infection
Drug: LDV/SOF; Drug: RBV Identifier: NCT01987453

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders
Chronic HCV Infection
Drug: LDV/SOF; Drug: Sofosbuvir; Drug: Ribavirin Identifier: NCT02120300

HIV Co-infection

Not yet recruiting
Pilot Study to Assess Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-dose Combination in Treatment Experienced Subjects With Hepatitis C Virus (HCV) Genotype 1 - HIV Co-infection
Conditions: Viral Hepatitis C; HIV
Intervention: Drug: Sofosbuvir/Ledipasvir fixed dose Identifier: NCT02125500

HIV Co-infection
Simeprevir and Sofosbuvir

Not yet recruiting
A Study of the Safety and Effectiveness of Simeprevir and Sofosbuvir for Patients With HIV and Hepatitis C
Conditions: Hepatitis C, Chronic; HIV CDC Category A1
Intervention: Drug: Sofosbuvir + Simeprevir Identifier: NCT02206932

Friday, September 26, 2014

CHMP Adopts Positive Opinion for Gilead's Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C Infection in Adults

European CHMP Adopts Positive Opinion for Gilead's Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C Infection in Adults

Date(s): 26-Sep-2014 7:18 AM

FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 26, 2014-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company's Marketing Authorization Application (MAA) for Harvoni®, an investigational once-daily tablet combining the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg, for the treatment of chronic hepatitis C virus (HCV) infection in adults.

The CHMP opinion was adopted following an accelerated review procedure, which is reserved for medicinal products that are expected to be of major public health interest. 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.

The CHMP positive opinion for Harvoni is supported by data from three Phase 3 studies (ION-1, ION-2 and ION-3). These studies evaluated 8, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease. These studies included cirrhotic and non-cirrhotic patients who were new to HCV treatment and those who had failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor. The positive opinion was also supported by preliminary data from the SOLAR-1 trial in decompensated cirrhotic and pre- and post-transplant patients, the ELECTRON-2 trial in genotype 3 patients and phase 2 studies in genotype 4 patients.

Approximately nine million people in Europe are infected with the hepatitis C virus, a major cause of liver cancer and liver transplantation. Genotype 1 is the most prevalent form of HCV in Europe, and accounts for 60 percent of infections worldwide. This is followed by genotypes 2 and 3, while genotypes 4-6 are more prevalent in Asia and Africa.

Sofosbuvir as a single agent was granted marketing authorization in the European Union on January 16, 2014 under the trade name Sovaldi®. Sovaldi is also approved for use in the United States, Canada, Australia, New Zealand, Egypt, Switzerland and Turkey.

Harvoni is an investigational product and its safety and efficacy have not been established in the European Union.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that the MAA may not be approved by the European Commission, and marketing approval, if granted, may have significant limitations on its use. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended June 30, 2014, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Sovaldi and Harvoni are registered trademarks of Gilead Sciences, Inc., or its related companies

For more information on Gilead Sciences, please visit the company's website, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at +1 (650) 574-3000.

Source: Gilead Sciences, Inc.

Gilead Sciences, Inc.
Patrick O'Brien, +1 650-522-1936 (Investors)
Cara Miller, +1 650-522-1616 (Media, U.S.)
Arran Attridge, +44 208 587 2477 (Media, EU)

Ledipasvir/Sofosbuvir - Gilead Submits NDA to Japan’s PMDA

Gilead Submits New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency for Fixed-Dose Combination of Ledipasvir/Sofosbuvir for Chronic Hepatitis C Genotype 1 Infection

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).

Primarily due to HCV, Japan has one of the highest rates of liver cancer of any industrialized country. Of the more than one million people in Japan chronically infected with HCV, 70-80 percent are infected with the genotype 1 strain of the virus.

The NDA is based on data from a Phase 3 clinical trial conducted in Japan (GS-US-337-0113) among 341 treatment-naïve and treatment-experienced genotype 1 patients. In the study, 100 percent (n=83/83) of treatment-naïve and 100 percent (n=88/88) of treatment-experienced patients receiving 12 weeks of LDV/SOF without RBV achieved SVR12. Adverse events observed with LDV/SOF without RBV were generally mild and included nasopharyngitis (28 percent), headache (6 percent) and malaise (5 percent).

The NDA is also supported by SVR12 results from three Phase 3 studies (ION-1, ION-2 and ION-3) evaluating eight, 12 or 24 weeks of LDV/SOF among genotype 1 HCV patients. Trial participants included patients from the United States, Europe and Puerto Rico who were treatment-naïve or who had failed previous treatment, including protease inhibitor-based regimens, and also included patients with compensated cirrhosis. Trial participants in the ribavirin-free arms (n=863) achieved SVR12 rates of 94 to 99 percent.

LDV/SOF is currently under regulatory review in the United States and European Union.

On June 27, 2014 Gilead submitted an NDA to Japan’s PMDA for SOF as a single agent in combination with RBV for the treatment of genotype 2 HCV infection. SOF as a single agent has been approved by regulatory authorities in the United States, European Union, Australia and Canada under the tradename Sovaldi®.

LDV/SOF and SOF are investigational products in Japan and their safety and efficacy have not yet been established.

About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.

Forward-Looking Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from additional clinical trials involving SOF or the LDV/SOF fixed-dose combination. Further, the PMDA and regulatory authorities in the United States and the European Union may not approve the LDV/SOF fixed-dose combination and the PMDA may not approve SOF as a standalone agent in Japan, and any marketing approvals, if granted, may have significant limitations on their use. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2014, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

U.S. full prescribing information for Sovaldi is available at

Sovaldi is a registered trademark of Gilead Sciences, Inc.

For more information on Gilead Sciences, please visit the company’s website at, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Monday, September 15, 2014

ledipasvir/sofosbuvir - Gilead Signs generic licensing agreement for hepatitis C drug

Gilead Announces Generic Licensing Agreements to Increase Access to Hepatitis C Treatments in Developing Countries

Date(s): 15-Sep-2014 6:30 AM

-- Indian companies granted license to produce generic sofosbuvir and investigational single tablet regimen of ledipasvir/sofosbuvir for treatment of chronic hepatitis C --

NEW DELHI--(BUSINESS WIRE)--Sep. 15, 2014-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has signed non-exclusive licensing agreements with seven India-based generic pharmaceutical manufacturers to expand access to its chronic hepatitis C medicines in developing countries. The agreements allow the companies - Cadila Healthcare Ltd.Cipla Ltd.,Hetero Labs Ltd.Mylan Laboratories Ltd.Ranbaxy Laboratories Ltd.Sequent Scientific Ltd. andStrides Arcolab Ltd. - to manufacture sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 91 developing countries

The countries within the agreement account for more than 100 million people living with hepatitis C, representing 54% of the total global infected population.

"Hepatitis C is a significant public health issue worldwide, and Gilead is working to make its chronic hepatitis C medicines accessible to as many patients, in as many places, as quickly as possible. In developing countries, large-volume generic manufacturing and distribution is widely regarded as a key component in expanding access to medicines. These agreements are essential to advancing the goals of our humanitarian program in these countries," commented Gregg H. Alton, Executive Vice President, Corporate and Medical Affairs, Gilead Sciences.
Under the licensing agreements, the Indian companies receive a complete technology transfer of the Gilead manufacturing process to enable them to scale up production as quickly as possible. The licensees also set their own prices for the generic product they produce, paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other essential business activities. The licenses also permit the manufacture of sofosbuvir or ledipasvir in combination with other chronic hepatitis C medicines.

Sofosbuvir was approved under the trade name Sovaldi® by the U.S. Food and Drug Administration(FDA) in December 2013 and by the European Commission in January 2014. The FDA and theEuropean Medicines Agency are currently reviewing the company's applications for a single tablet regimen of ledipasvir/sofosbuvir; it is an investigational agent and its safety and efficacy have not been established.

For a fact sheet on the agreement, visit

Gilead's Approach to Treatment Access in Developing Countries
Gilead makes it a priority to increase access to its medicines for people who can benefit from them, regardless of where they live or their economic means. In developing countries, Gilead's treatment access strategies include tiered pricing, voluntary generic licensing (often in advance of U.S./EU regulatory approval), negotiation with national governments, regional business partnerships, product registration, medical education and partnerships with non-profit organizations. This approach has been successfully applied to Gilead's humanitarian program in HIV over the past ten years, with six million patients now receiving Gilead-based HIV medicines in developing countries.

Thursday, September 4, 2014

HCV Newsletters - Update on Hepatitis C:Trials & Treatment and Protesting Gilead

Update on Hepatitis C: Trials & Treatment and Protesting Gilead

Hello everyone, here we are heading into September, where does the time go?

During the next few weeks I will be busy working on a family project, the kids need nana to babysit, I can't wait! Once I get my short people under control the blog and website should get updated. On second thought, not sure that is likely to happen, if not, see you in a few weeks....

Last month the New York City Hepatitis C Task Force, along with Tracey Swan from the Treatment Action Group (TAG) offered a training seminar to help patients understand more about participating in a clinical trial. The program provided an overview of  new terminology, SVR rates according to genotype using current and future HCV therapies under development.  View the slide presentation, here, highlighting the following:

Update on Hepatitis C: Trials & Treatment
• New terms
• HCV in the US
• Trial participation
• When to treat
• Curing HCV: from interferon to DAAs
• DAAs
• Cure rates, by HCV genotype
• What’s here now, and what’s coming
• Treat now, or wait?
• What matters most?

In case you missed it, TAG's 2014 Pipeline Report is available, here.

Of Interest:
79 Study Locations
Recruiting Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection
Condition: Hepatitis C Virus Infection
Interventions: Drug: SOF/GS-5816; Drug: Placebo to match SOF/GS-5816
Phase: Phase 3
NCT Number: NCT02201940
Other IDs: GS-US-342-1138, 2014-001683-35
Title Acronym: ASTRAL-1

For additional information visit HCV Advocate News and Pipeline for trial updates;

In The News

Gilead to sell pricey hepatitis C drug in poor countries for fraction of U.S. cost
Ron Leuty
Reporter-San Francisco Business Times
Gilead Sciences Inc. will make its pricey hepatitis C drug Sovaldi available in about 80 poorer countries for less than the cost of a single pill in the United States, according to Bloomberg.

Gilead executive vice president Gregg Alton told the news agency that a broad licensing deal with a handful of generic drug makers could be completed by mid-September. After winning regulatory approvals in those countries, Sovaldi then could be sold in India, Indonesia, Pakistan and the other countries for $900 for 12 weeks of therapy....

New hepatitis C drugs could stop an epidemic that now claims more lives in the U.S. than AIDS. An estimated 250,000 New Yorkers are living with hepatitis C, a viral infection that can lead to cirrhosis, liver failure and liver cancer. But hepatitis C can be cured with only a few months of treatment by a combination of drugs that includes Gilead’s Sovaldi as the backbone.

Gilead is selling Sovaldi for $1,000 per pill – a price that is causing treatment rationing, according to advocates. “Public and private payers are restricting access to Sovaldi because of cost, and withholding treatment from people until they have serious liver damage. We don’t force HIV-positive people to wait until they have AIDS before treating them. Should people with hepatitis C go without treatment so Gilead can make more profit?,” asked Michael Tikili of Health GAP, a global treatment access advocacy group.

Today healthcare and labor groups protested Gilead at the Baird Healthcare Conference, a prominent investor meeting, demanding that Gilead immediately reduce the price of Sovaldi, and targeting other companies who will be marketing breakthrough HCV drugs before the end of the year. The coalition includes 1199SEIU United Healthcare Workers East – the largest healthcare union in the nation – ACT UP New York, Health GAP, the Treatment Action Group, and VOCAL New York.

“Healthcare isn’t some wild west gold rush, we’re talking about pricing policies that are directly responsible for people dying,” said Matt Curtis, Policy Director at VOCAL New York, an activist group that represents people living with hepatitis C. “Experts have estimated that 12 weeks of Sovaldi costs well under $200 to produce, but because of Gilead’s greed U.S. states are now adopting treatment guidelines that restrict access. A markup of 40,000% doesn’t reflect ‘value’ as Gilead claims, it’s a conscious decision to prey on people desperate for a cure.”

Helen Schaub, New York State Director of Policy and Legislation for 1199SEIU United Healthcare Workers East, noted the impact on the New York State Medicaid budget. “The members of 1199SEIU United Healthcare Workers East always advocate for the best care for their patients, including the estimated 250,000 New Yorkers infected with Hepatitis C,” said Schaub. “They must have access to the treatment they need, including Sovaldi. But at $84,000 per person, this drug could cost New York State billions of dollars. We cannot let Gilead’s outrageous pricing threaten our Medicaid budget and access to healthcare for the 5.8 million New Yorkers who depend on Medicaid services. Gilead must drop the price now.”

“Gilead has ultimately limited access to life-saving drugs – and their own market – with their disgraceful approach to pricing,” said Tracy Swan, Hepatitis/HIV Project Director with the Treatment Action Group. “We know how much it really costs to produce these drugs at a reasonable profit. Other drug makers have a chance to save their drugs from falling into the poisoned well – if you make them affordable, people won’t die, they will be cured.”

Reducing the cost of new hepatitis C drugs
An index of articles pointing the reader to the current controversy over the high price of Sovaldi.

September Newsletters

Now on with this months edition of HCV Newsletters. Recently, CAP - Caring Ambassadors Program, announced they will be updating part 2; Treatment and Management Approaches, of their popular publication; Hepatitis C Choices Book;2014 5th edition. Check their website for updates, links to each chapter is provided below..... 

If you frequent CAP's website, as I do, you may have noticed the site has a new look, with an impressive amount of information. In addition, through NPR’s StoryCorps visitors can now listen to audio featuring patient stories, including two individuals you may know.

Caring Ambassadors Program
The primary goal of the Caring Ambassadors Program is to help individuals with challenging health conditions to become ambassadors for their own health. We are here to help you—that is now and always will be our singular focus.

In this issue
Review of the Most Relevant Research on Hepatitis C
Literature Review, August 2014

Hepatitis C Choices Book

Table of Contents
Individual chapters are available below in PDF format, or you can download complete book here. (9.23MB) or view the book, here.

PART 1: Information for Everyone with Hepatitis

Chapter 1: How to Use Hepatitis C Choices
Chapter 2: Overview of Hepatitis C, Robert G. Gish, MD
Chapter 3: Alcohol and Hepatitis C , Douglas R. LaBrecque, MD and Lorren Sandt
Chapter 4: Understanding Hepatitis C Disease
Section 1: Liver Disease Progression, Lorren Sandt
Section 2: Promoting Liver Health, Lorren Sandt
Chapter 5: Signs and Symptoms That May Be Associated with Hepatitis C, Tina M. St. John, MD
Chapter 6: Laboratory Tests and Procedures, Tina M. St. John, MD
Chapter 7: The Immune System and Hepatitis C
Section 1: Meet the Immune System, Tina M. St. John, MD
Section 2: Immunology Takes on Hepatitis C, Stewart Cooper, MD

PART 2: Hepatitis C Treatment and Management Approaches

Chapter 8: Western (Allopathic) Medicine
Section 1: Allopathic Hepatitis C Treatment Overview, Douglas R. LaBrecque, MD
Section 2: Initial Treatment Options, Douglas R. LaBrecque, MD
Section 3: Options When Initial Treatment Fails to Clear the Hepatitis C Virus, Gregory T. Everson, MD
Section 4: Future of Allopathic Hepatitis C Treatment, Anthoney Martinez, MD and Robert G. Gish, MD
Chapter 9: Integrative Medicine, Randy J. Horwitz, MD, PhD and Julia Jernberg, MD
Chapter 10: Ayurvedic Medicine, Shri K. Mishra, MD, MS, Bharathi Ravi, BAMS, and Sivaramaprasad Vinjamury, MD
Chapter 11: Chinese Medicine
Section 1: Traditional Chinese Medicine and Hepatitis C, Misha Cohen, OMD, LAc
Section 2: Modern Chinese Medicine Therapeutics for Hepatitis C, Qing Cai Zhang, MD (China), LAc
Chapter 12: Homeopathic Medicine, Sylvia Flesner, ND
Chapter 13: Mind-Body Medicine & Spiritual Healing, Sharon D. Montes, MD
Chapter 14: Naturopathic Medicine, J. Lyn Patrick, ND,
Chapter 15: Nutrition and Hepatitis C, Lark Lands, PhD
Chapter 16: Nutritional Supplementation, Lark Lands, PhD and J. Lyn Patrick, ND
Chapter 17: Products Marketed to People with Hepatitis C, J. Lyn Patrick, ND

PART 3: Other Topics for People Living with Hepatitis C
Chapter 18: Women and Hepatitis C, Norah Terrault, MD and Jessica Irwin, PAC
Chapter 19: Hepatitis C in Children, Aparna Roy, MD, MPH and Kathleen Schwarz, MD
Chapter 20: HIV/HCV Coinfection
Section 1: Overview of HIV/HCV Coinfection, Misha Cohen, OMD, LAc and Tina M. St. John, MD
Section 2: Western (Allopathic) Treatment Options, Tina M. St. John, MD and Misha Cohen, OMD, LAc
Section 3: Alternative Eastern Treatment Options, Misha Cohen, OMD, LAc
Section 4: Naturopathic Treatment Options, J. Lyn Patrick, ND
Chapter 21: Mental Health & Hepatitis C
Section 1: Mental Health & Neurocognitive Issues Associated with Hepatitis C Infection, Julie Nelligan, PhD, David W. Indest, PsyD, and Peter Hauser, MD
Section 2: Mental Health Issues in the Setting of Interferon-Based Therapy, Joyce Seiko Kobayashi, MD
Section 3: Interferon-Based Therapy in Recovery, Amy E. Smith, PAC and Diana L. Sylvestre, MD
Section 4: Psychosocial Issues and HCV, Susan L. Zickmund, PhD
Chapter 22: Military Veterans & Hepatitis C, Terry Baker
Chapter 23: Choosing: My Journey, My Choices, Randy Dietrich
Chapter 24: A Look to the Future, Lorren Sandt

Connect with CAP on Twitter and Facebook

The HCV Advocate newsletter is a valuable resource designed to provide the hepatitis C community with monthly updates on events, clinical research, and education. 

HCV Advocate News & Pipeline Blog
Click Here

September Newsletter

In This Issue:

Alan Franciscus, Editor-in-Chief
The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA/IAS-USA) recently issued revised guidelines. 

HCV Drugs
Alan Franciscus, Editor-in-Chief
This month's column will feature journal articles on two Phase 3 studies of interferon-free therapies as well as a brief overview of HCV drug studies presented at the AIDS 2014 conference held in Melbourne, Australia. 

Lucinda K. Porter, RN
This month Lucinda talks about hepatitis C and chronic kidney disease (CKD)encephalopathy, and the fact that HCV may be directly responsible for renal (kidney) injury.

Lucinda K. Porter, RN
Lucinda reviews studies on the changing burden of hepatitis C virus infection in the United States and research on preventing mortality in cirrhotic and genotype 1 infected individuals. 
Connect With HCV Advocate

Welcome to the new HCV Action website, the home of the UK’s hepatitis C professional community. Browse our tailored resource libraries, view our case study map or find out more information, here.

The HCV Action network brings together health professionals from across the patient pathway, including GPs, specialist nurses, clinicians, drug action teams, public health practitioners, prison healthcare staff and commissioners. We provide resources for commissioners, medical and drug services professionals, promoting good practice in HCV care across the UK.Visit their new website, here.

An Evening with Cathal Smyth
3 Sep 14
Nurses London to Paris hep C cycle
27 Aug 14
How to reduce HCV incidence amongst PWID
27 Aug 14
Key Points: NICE draft recommendation for Sofosbuvir
20 Aug 14

Of Interest
Published Sep 2014 by HCV Action
Format Video
In this good practice film, HCV Action interviews Jayne Wilkie, Hepatitis C Community Nurse, and Dr Diane Exley from the Brownlow Health Practice in Liverpool. Brownlow Health's unique primary care model of testing, diagnosis and treatment for hepatitis C through a Hepatitis C Community Nurse has led to significant positive outcomes locally. In particular, diagnoses have been increased, do not attends reduced, treatment initiations increased, and the burden has been eased on secondary and tertiary services in Liverpool. Jayne and Diane tell HCV Action about why and how the service was established, as well as detailing how it has developed into a highly successful model of how hepatitis C can be managed in a primary care setting.

Published Aug 2014 by Maslaha
The film features Professor Graham Foster (Professor of Hepatology at Queen Mary University of London), Shabana Begum (South Asian Officer at The Hepatitis C Trust), and Imam Yunus Dudhwala (Head of Chaplaincy at Barts Health NHS Trust). It explains why it's so important for the British Pakistani community to understand, prevent and get tested for hepatitis B & C; providing an overview of the viruses, detailing risk factors and providing information on treatment options.

Follow Us On Twitter
Hep is an award-winning print and online brand for people living with and affected by viral hepatitis. Offering unparalleled editorial excellence since 2010, Hep and are the go-to source for educational and social support for people living with hepatitis.

September News
Scottish Harm Reduction Program Scale-up Lowers Hep C Cases
A comprehensive harm reduction program instituted by the Scottish government has sharply reduced hepatitis C rates among injection drug users.

Faster, Easier Cures for Hepatitis C
The Food and Drug Administration (FDA) says hepatitis C can be cured, and today's drug therapies are very effective and easier for patients to take.

Connect With Us On Twitter and Facebook 

Project Inform believes it is possible to create the first generation free of HIV and hepatitis C within the next decade. To achieve that dream, we focus our work in four areas: drug development, bio-medical prevention, education and health care access.

NVHR Fact Sheet: Why Screen for HCV in an Uncertain Treatment Climate
The current challenges in hepatitis C treatment access have caused some medical providers to be hesitant about screening their patients. The National Viral Hepatitis Roundtable (NVHR) has developed this fact sheet explaining why screening is critical even during this uncertain treatment climate. 

Help Lines
HELP-4-HEP (hepatitis C helpline)
Toll-free at 1-877-435-7443 Monday–Friday, 9am–7pm (Eastern Time). 
Learn more.

HIV Health InfoLine
Toll-free at 1-800-822-7422 Monday–Friday, 10am–4pm (Pacific Time), call-back service only. English only. 

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Connect With Us


The following publications have not been published yet, check back for updates. 

The hepc.bull, has been “Canada’s hepatitis C journal” since the late 1990′s and has been published nonstop since 2001. The monthly newsletter contains the latest research results, government policy changes, activities and campaigns you can get involved in, articles by patients and caregivers, and a list of support groups plus other useful links.

September Issue Is Not Yet Published

Stay Connected

The New York City Hepatitis C Task Force is a city-wide network of service providers and advocates concerned with hepatitis C and related issues. The groups come together to learn, share information and resources, network, and identify hepatitis C related needs in the community. Committees form to work on projects in order to meet needs identified by the community. 

News and Updates

As mentioned, view the slide presentation; Update on Hepatitis C: Trials & Treatment 

NYC Viral Hepatitis Monthly E-Newsletter

September Issue Is Not Yet Published

August Newsletter

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Liver Lowdown is the monthly general interest e-newsletter of the American Liver Foundation.

Know Your Dose
Acetaminophen is the most commonly used pain medication in the U.S., but it's also the leading cause of acute liver failure. We've partnered with the Acetaminophen Awareness Coalition to educate the public about safe usage...

Patient Information

July/August 2014 Edition

September Issue Not Yet Published....

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GI & Hepatology News is the official newspaper of the AGA Institute and provides the gastroenterologist with timely and relevant news and commentary about clinical developments and about the impact of health-care policy. The newspaper is led by an internationally renowned board of editors. 

September Newsletter Is Not Yet Published

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Hep C Connections - Website
Our mission is to educate the general public about hepatitis C and to provide resources and support for those affected by the virus. Hep C Connection offers a helpline to answer your questions regarding hepatitis C (HCV). You can expect respect, patience & understanding, in clear, jargon-free language from our staff & volunteers. Call 1-800-522-HEPC (4372) today!

September News Letter Is Not Yet Published

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Healthy You

To Swim or Not to Swim? Safe Swimming Tips for Liver Transplant Recipients 
It’s safe for liver transplant patients to swim in chlorinated pools. In most cases, the ocean is also okay, but patients should avoid swimming in the Chesapeake because the presence of some dangerous bacteria has been found there in recent years. If liver transplant patients experience any kind of abrasion while in the ocean, the abrasion should be thoroughly cleaned with soap and an uncontaminated water source -- not the water they are swimming in -- to minimize the risk of infection.

New research shows that liver injury caused by herbals and dietary supplements increased from 7% to 20% in a U.S. study group over a ten-year period. According to the study published in Hepatology, a journal of the American Association for the Study of Liver Diseases, liver injury caused by non-bodybuilding supplements is most severe, occurring more often in middle-aged women and more frequently resulting in death or the need for transplantation than liver injury from bodybuilding supplements or conventional medications."

Nearly half of all adult Americans consume herbal and dietary supplements with prior reports suggesting that is on the rise. Medical evidence shows that supplements are used more often by women, non-Hispanic whites, those over 40 years of age and those with more advanced education. Data from the National Health and Nutrition Examination Survey (NHANES) III indicate that multivitamins, minerals, calcium and fish oils are the most commonly used supplements.

"While many Americans believe supplements to be safe, government regulations (Dietary Supplement Health and Education Act of 1994) require less safety evidence to market products than what is required for conventional pharmaceuticals" explains lead author Dr. Victor Navarro, from Einstein Medical Center Philadelphia. "With less stringent oversight for herbals and dietary supplements, there is greater potential for harmful consequences including life-threatening conditions."

In response to the need for research in this area, the National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) supported the establishment of the Drug-Induced Liver Injury Network (DILIN) in 2003 to track cases of liver injury caused by medications (excluding acetaminophen (Tylenol®)), herbals, and dietary supplements. Herbals and dietary supplements were identified as the second most common cause of liver injury in the first DILIN report. 

The present study examines hepatotoxicity due to supplements compared to medications, enrolling 839 patients with liver injury from 8 U.S. DILIN referral centers between 2004 and 2013. Liver injury cases included 45 caused by bodybuilding supplements, 85 attributed to non-bodybuilding supplements, and 709 due to medications.

The research team determined that among cases enrolled, liver injuries from herbal and dietary supplements rose to 20% during the study period. While bodybuilding supplements caused prolonged jaundice (median 91 days) in young men, no fatalities or liver transplantations occurred. Death or liver transplantation occurred more frequently among cases of injury from non-bodybuilding supplements, 13%, than from conventional medications, 3%. Liver injury from non-bodybuilding supplements was more common in middle aged women.

Dr. Navarro said, "Our study group is specific to DILIN centers and therefore we cannot conclude that liver injury due to herbals and dietary supplements in on the rise in the U.S. Further population-based study of liver injury due to herbal products and dietary supplements is needed." The authors want to inform the public of potential dangers of using dietary supplements and advise that supplement producers, government agencies, healthcare providers and consumers work together to improve safety.
Source: Wiley

Does Coffee Affect Development of Cholestatic Liver Disorders?
Dr. Kristine Novak
Coffee is considered to be a medically beneficial beverage—consumption has been associated with reductions in metabolic syndrome, cardiovascular disease, and weight gain, as well as total and cause-specific mortality. Furthermore, many studies have reported that coffee consumption reduces the risk of liver diseases such as alcoholic liver disease, cirrhosis, and hepatocellular carcinoma.

Related Link
2014 - Coffee Consumption and Liver Disease

September 04, 201410:10 AM ET
If your eyes feel like a sand dune and your vision improves when you blink, you've probably got dry eye syndrome. This used to be considered a women's thing, caused by hormonal changes at menopause, but thanks to our fondness for staring at screens it's becoming an equal opportunity ailment.

Just For Fun

Liver Disease Quiz: Test Your Medical IQ

Watch: The judge and expert witnesses discuss new HCV regimens under development with or without ribavirin in this light-hearted innovative presentation.

By Lucinda K. Porter, RN
If you are thinking about delaying hepatitis C treatment, consider this: a review of mortality data found that those with hepatitis B or C die an average of 22 to 23 years earlier than those who don't have viral hepatitis...

Looking for Early Signs of Hepatitis C? We Can Help You Know How
Al D. Rodriguez Liver Foundation
If only our livers could complain the way our stomachs grumble when we miss a meal during a hectic day at the office, perhaps many cases of liver cancer could be prevented. But alas, our livers don’t talk to us…. like that anyway

Sharing My Personal Experiences With Hepatitis C Treatment (Part II)
By Andrew Styles
My name is Andrew Styles and I have Hepatitis C. Hepatitis C is a liver infection caused by a virus. Hepatitis means inflammation of the liver, an organ that carries out over 500 functions that keep you healthy. I just successfully completed a new treatment for Hepatitis C (Hep C) and want to inspire others to get tested and treated. I was treated in the past with serious side effects, but this time was different....

***Read Part I of my story at
By Connie
The old adage ‘you are what you eat’ is true. What we eat affects our entire body, especially our liver. The liver is the powerhouse of the body. It is the second largest organ and helps with many vital functions. When our liver is unhealthy, it affects our entire body, even your immune system, which helps you fight disease.....

7 Weeks Post Treatment
By Joe Burke
Fast forwarding 7 years later, and the drug Sovaldi was approved by the FDA in December 2013. By January 21st, 2014 I was on treatment with the new drug, and in just 4 weeks my Hepatitis C was gone! Not only was I a rapid responder to the new drug, but I remained undetected for the duration of my 24 weeks to July 7th...

Lastest Post - July
Finished. The Waiting Begins
By Don
This morning I downed my last $1800 worth of pills, tossed out the empty pill container, and began the worst part. Waiting. The gold standard is a three month test, October 23, if anyone is counting. The silver standard is …


New Index Helps Predict Course of Early HCV Cirrhosis
By Lorraine L. Janeczko September 04, 2014

NEW YORK (Reuters Health) - A genomic signature, combined with bilirubin and platelet tests, can help identify patients with early hepatitis C virus (HCV) cirrhosis who are at high risk for complications, new research suggests.

"This study provides additional evidence that a gene signature . . . can itself predict future clinical events for a patient with HVC-related cirrhosis. It helps predict downstream deterioration in terms of liver failure and deaths from liver failure or risk for hepatocellular carcinoma," said co-senior author Dr. Raymond T. Chung of Harvard Medical School in Boston, in a phone call with Reuters Health.

"The most important aspect of this is really to help stratify or identify patients who may need more intensive follow-up, but also to potentially identify candidates for possible interventions that might help slow the progression of liver disease. Our hope would be to apply this in patients with a longer run-up so they can be identified further in advance and potentially intervened and treated before complications occur," he said.

Could this test replace the MELD the score?

"No," Dr. Chung said. "The MELD score presupposes that these patients already have advanced disease. The MELD in anybody who doesn't have cirrhosis should be in the normal range. It's only when cirrhosis has deteriorated that the MELD score starts to rise. We would intend this index to be used well before one ever had to use a MELD score."

As reported online August 20 in Gut, the components of the new prognostic index are a digital transcript counting assay (NanoString nCounter) consisting of a 186-gene signature, the bilirubin level (>1 mg/dL), and the platelet count (<100,000/mm3).

In an independent training group of 216 Italian patients with HCV cirrhosis followed for a median of 10 years, the prognostic index was associated with hepatic decompensation (hazard ratio=2.71, p=0.003), death (HR=6.00, p<0.001), hepatocellular carcinoma (HR=3.31, p=0.001) and progression of Child-Turcotte-Pugh class (HR=6.70, p<0.001).

The validation group consisted of 145 adults with compensated HCV cirrhosis who had liver biopsies over a 17-year period. Based on the prognostic index, the researchers stratified patients into groups at high-risk (16%), intermediate-risk (42%) or low-risk (42%).

The high-risk group had a significantly increased risk of hepatic decompensation (HR=7.36, p<0.001), death (HR=3.57, p=0.002), liver-related death (HR=6.49, p<0.001) and all liver-related adverse events (HR=4.98, p<0.001).

Co-senior author Dr. Yujin Hoshida of the Icahn School of Medicine at Mount Sinai in New York City wrote in an email, "Our prognostic index was strikingly predictive of a series of hepatitis C cirrhosis complications with hazard ratios as high as 7.36. The magnitude of association is outstanding compared with previously reported molecular prognostic markers (with hazard ratios generally below 2.0). It's kind of surprising that we keep seeing the high prognostic association across multiple patient cohorts and assay platforms."

"The gene signature could be assayed on archived fixed liver biopsy tissues. You could do this by using daily clinical specimens without any special preparation. We have some preliminary data indicating that the gene signature is prognostic also in hepatitis B virus and nonalcoholic steatohepatitis (NASH). We're now analyzing these etiologies and as well as alcohol on a larger scale with National Institutes of Health support," he added.

Several of the authors are named investigators on a pending patent application involving compositions, kits, and methods for detecting, characterizing, preventing, and treating hepatic disorders. NanoString has secured the option to an exclusive worldwide license, but has no role in the current study.

The most cost-effective strategy to determine treatment for patients with hepatitis C virus infection in the United Kingdom was to treat all patients regardless of fibrosis stage, according to new study data. 

Specific serotonin reuptake inhibitors prevent interferon-α–induced depression in patients with Hepatitis C, reports the latest issue of the Clinical Gastroenterology & Hepatology.

Interferon-α (IFN-α)–induced depression is a major complication to treatment of chronic hepatitis C virus (HCV) infection.

Specific serotonin reuptake inhibitors (SSRIs) can be used to treat depression, but it is not clear whether they can prevent depression in patients receiving IFN therapy for chronic HCV infection.

Dr Bing Ruan and colleagues performed a meta-analysis by searching the Cochrane Library, PubMed, and EMBASE databases through 2013 for published results from randomized, placebo-controlled trials evaluating the utility of SSRIs in preventing IFN-induced depression in HCV patients.

The researchers analyzed data from 7 studies with a total of 662 patients.

The incidence of IFN-induced major depression and depression severity were defined as primary outcomes.

Sustained virologic response, completion of antiviral therapy, and tolerability were considered secondary outcomes.

A meta-analysis of IFN-induced major depression revealed that prophylactic SSRIs reduced the risk of depression, compared with placebo.

Proportions of patients achieving a sustained virologic response and completing antiviral therapy were similar between patients given SSRIs and controls.

The team noted that prophylactic SSRIs were tolerated in patients with HCV during treatment.

Dr Ruan's team comments, "On the basis of a meta-analysis of 7 randomized controlled trials, prophylactic administration of SSRIs to patients with HCV significantly lowered the incidence of IFN-induced major depression, compared with placebo, and the SSRIs were well tolerated."
Clin Gastroenterol Hepatol 2014: 12(9): 1452–1460.e3
02 September 2014

Racial Differences in the Progression to Cirrhosis and Hepatocellular Carcinoma in HCV-Infected Veterans....."Hispanics with HCV had a 28 and 61% increased risk of developing both cirrhosis and HCC" 
In this large US cohort of patients with HCV, we found that patients' race/ethnicity was independently associated with the risk of having cirrhosis and HCC recorded during follow-up. Specifically, we found that, compared with NHW patients with HCV, the odds of AAs being less likely to develop cirrhosis and HCC were 0.42 and 0.23, respectively. In contrast, Hispanics with HCV had a 28 and 61% increased risk of developing both cirrhosis and HCC, respectively, compared with NHWs. The effect of race persisted after we adjusted for confounders in the multivariable regression analyses and was consistent across several subgroups based on age, HCV genotype, and diabetes. 

Marijuana use in hepatitis C infection does not affect liver biopsy histology or treatment outcomes.
Marijuana use was not associated with premature interruption of therapy for side effects, the likelihood of completing a full course of therapy or sustained virological response.
CONCLUSION: Marijuana use did not influence biopsy histology or alter key hard outcomes of hepatitis C virus antiviral therapy

Fatigue during treatment for hepatitis C virus: results of self-reported fatigue severity in two Phase IIb studies of simeprevir treatment in patients with hepatitis C virus genotype 1 infection

Next-generation sequencing sheds light on the natural history of hepatitis C infection in patients who fail treatment
In conclusion, deep sequencing technologies are a powerful tool for obtaining a more accurate insight into the dynamics of variants in the HCV quasispecies in human samples. The detection of multiple genotypes that have the potential to emerge following treatment may also have implications in the new era of DAAs when the presence of multiple genotypes and low-level resistance mutations may impact on treatment success.

Liver International, September 5, 2014
These are exciting times in the field of hepatitis C virus (HCV) infection. After many years of ominous predictions, the outlook for HCV-infected patients has improved substantially with the introduction of direct-acting agents.[1,2] However, it is too soon to declare victory. It has even been said that we are only 'at the end of the beginning' of the struggle.[3] There are several remaining obstacles. The purpose of this paper is to enumerate and discuss some of the remaining barriers to effective HCV treatment in the United States, predominantly from an inner city perspective.

SVR Rates: predictors/liver disease stage(cirrhosis) - Abbvie 3D, Gilead's LDV/SOF, JNJ's SIM/SOF 
This report takes a look at cirrhosis as a predictor of SVR response, considering 12 vs 24 weeks, addition or not of Rbv in the SOF/LDV studies, or in SIM/SOF studies although the numbers of patients in the SIM/SOF studies is small.

Clinical evidence and bioinformatics characterization of potential hepatitis C virus resistance pathways for Sofosbuvir
Data suggests that Sofosbuvir (SOF) has a high barrier to resistance; however, low frequency NS5B substitutions associated with treatment failure were identified that may contribute to resistance of this important drug for chronic hepatitis C virus (HCV) infection.

Clinical and Systematic Review
The Rapid Evolution of Treatment Strategies for Hepatitis C
Hepatitis C virus (HCV) treatment took a major step forward at the end of 2013 with the approvals of the second-generation protease inhibitor simeprevir (Olysio) and the nucleotide polymerase inhibitor sofosbuvir (Sovaldi). The interferon-free regimen of sofosbuvir and ribavirin is now available for genotype 2 and 3 patients. This regimen for 12 weeks is highly effective for genotype 2, whereas genotype 3 has proven to be more challenging and requires 24 weeks of therapy. Genotype 1 patients have reduced exposure to peginterferon-α with a 12-week regimen with sofosbuvir and a 24-week regimen with simeprevir. Genotype 4, 5, and 6 patients also respond well to the regimen of sofosbuvir, peginterferon-α, and ribavirin. In another landmark event, the initial approval of sofosbuvir included HCV/HIV-1 coinfected patients. Simeprevir and sofosbuvir also provide a window to the future with sustained virologic response (SVR) rates of >90% for genotype 1 when these agents are combined. Interferon-free regimens for genotype 1 patients have anticipated approvals in late 2014 or early 2015. Clinicians and patients will have the opportunity to discuss and select from current treatment options or await upcoming regimens. These potent new agents provide the tools to cure HCV for many patients.

Of Interest - In The News

We Now Have the Cure for Hepatitis C, but Can We Afford It?
A long, difficult and costly research effort gives doctors a new cure for hepatitis C
Aug 19, 2014 |By Jessica Wapner

A decades-long search for better treatments for a debilitating liver disorder is finally coming to fruition. Later this year the U.S. Food and Drug Administration is expected to approve a new pill that can cure hepatitis C—a chronic infection that afflicts about 170 million people worldwide and annually kills 350,000 people, including 15,000 in the U.S.—faster and with fewer side effects than current remedies.

The breakthrough treatment comes, however, at a price that may place it out of reach for all but the wealthiest or best-insured patients. It will contain two drugs, one of which is already available at $1,000 per dose, or $84,000 for a complete 12-week course. The dual-drug combination will likely cost even more, which has prompted outrage from physicians and patient advocates alike, as well as plans from insurers to ration the combination when it becomes commercially available.

Over the coming months, physicians, patients, economists and insurance companies will no doubt hotly debate whether the treatment is worth the full asking price. There is little doubt, however, that the medication's effectiveness is unprecedented and that its development is a significant achievement. A closer look at the complex chemical problems that needed to be solved to develop the cure shows why.

Fast and Invisible
Cures sometimes result from happy accidents—think penicillin mold growing in an overlooked petri dish. More often they require years of research into what is causing the problem in the first place. Understanding the science behind the new hepatitis C treatment starts with deciphering the meaning of the virus's name.

“Hepatitis” is a general term that refers to severe swelling or inflammation of the liver in response to certain drugs, toxins, excessive alcohol or infections—whether from bacteria or viruses. The letter C refers to the third in a series of viruses that researchers have isolated that specifically target and damage the liver. By the mid-1970s investigators had developed blood tests to identify hepatitis A, which typically spreads when infected individuals improperly handle food or water, and hepatitis B, which is often transmitted during sexual intercourse, the sharing of needles or contact with contaminated blood.

Soon after, researchers realized that a third form of viral hepatitis was silently spreading around the globe and that it was more likely than hepatitis A or B to result in permanent liver damage. By 1989 they had identified the virus that caused the condition. They also determined that the virus's genes mutate very fast—a process that has generated several equally successful varieties, called genotypes, and rendered an effective vaccine impossible to create so far. Hepatitis B virus, in contrast, does not evolve as quickly, and a vaccine against it has been available since the 1980s. Infection with hepatitis A virus, which usually causes symptoms within days, can also be prevented with a vaccine.

Standard treatment for hepatitis C has long been a synthetic, injectable version of interferon, one of the immune system's most powerful proteins, plus the antiviral drug ribavirin. The combination helps 25 to 75 percent of patients, depending on the genotype of the virus. But the side effects, including severe flulike symptoms, fatigue, depression and anemia, are often intolerable. In addition, the virus often becomes resistant to medication, allowing the disease to worsen.

Toward a Cure
Developing effective treatments against the virus required researchers to understand the structure of the various proteins that formed its outer shell, as well as the precise sequence of its genetic material, which is made up of RNA—a process that took the better part of the 1990s and involved researchers working around the globe in government, academia and industry.

With this information in hand, scientists still faced a long and costly phase of trial and error. They chose what looked like a promising target for treatment: an enzyme known as a protease that the virus depends on to make copies of itself. After several false starts, researchers at Vertex Pharmaceuticals, in collaboration with others, developed a protease inhibitor known as telaprevir, while scientists at Schering-Plough (which merged with Merck in 2009), created one called boceprevir. In clinical trials, 60 to 75 percent of patients receiving the standard treatment—ribavirin and interferon—as well as the two new drugs had no detectable signs of the virus in their bloodstream, compared with 44 percent or fewer patients receiving the typical treatment alone.

The FDA approved the new drugs in 2011, but the sense of triumph felt by many in the medical community soon gave way to disappointment. The medications had harsh side effects and worked only for those patients with a particular genetic variant of the virus known as genotype 1, which is the most common type in the U.S. and Canada but rare in many other countries with hepatitis C epidemics. Moreover, the continued need for interferon and ribavirin, with their attendant side effects, was a huge drawback.

As enthusiasm for telaprevir and boceprevir waned, other viral proteins emerged as promising drug targets. What scientists had learned from their earlier research, however, was that inactivating an enzyme or protein was not enough. To stop hepatitis C, any effective drug also had to incorporate itself into the virus's genetic code, where it would need to halt the virus's ability to make new copies of its genes and thus to make new virus. In addition, to avoid potentially debilitating side effects, the medication had to get to the liver quickly and directly, bypassing as many other organs as possible.

A company called Pharmasset had been looking at a group of drugs known as nucleotide analogues, which met some of these criteria, since the mid-2000s. Constructed by stitching molecules that resemble the building blocks of DNA and RNA with a molecule made of phosphorus plus oxygen (known as a phosphate), these compounds inserted themselves into the virus's genes, where they promptly fell apart, interfering with viral replication.

Researchers then ran into a few big biochemical problems. Because the nucleotide analogues were water-soluble, they could not traverse the fatty lining of the intestine (fats and water do not mix) to reach the bloodstream and then the liver. In addition, the phosphate group carried a double negative electrical charge, further restricting its ability to move across the intestine's electrically neutral membrane. Finally, other enzymes in the liver easily dislodged the phosphate group from the nucleotide analogue, rendering the compound ineffective.

Michael Sofia, then at Pharmasset, solved the problems by adding two compounds known as esters to the analogue. This addition both shielded the negative charges and made the drug greasy, enabling it to leave the gut. Once inside liver cells, the enzymes that had initially interfered with the phosphate group hit the ester molecules instead, leaving the active drug free to do its job. The new formulation was named sofosbuvir in Sofia's honor; the company was purchased, in 2011, by Gilead for $11 billion.

In a large study, 295 out of 327 patients treated with sofosbuvir, as well as ribavirin and interferon, showed no signs of the virus in their blood after 12 weeks. In a more advanced trial, 12 weeks of sofosbuvir plus ribavirin yielded the same results as 24 weeks of interferon plus ribavirin: 67 percent of patients had no evidence of the virus in their blood (although side effects such as fever and depression were fewer among patients who did not receive interferon). The FDA approved sofosbuvir in late 2013 as a treatment for hepatitis C in combination with ribavirin.

Still, investigators pushed to make further improvements. During sofosbuvir's development, they had studied other drugs that inhibited different viral proteins and that might eliminate the need for continued use of interferon and ribavirin. So they ran another study of sofosbuvir plus one such complementary drug, daclatasvir, made by Bristol-Myers Squibb. The result: nearly all patients were cured of the disease, with far fewer side effects than before. Since then, Gilead has run three additional studies of sofosbuvir paired with a different drug, ledipasvir. The combination cured at least 94 percent of patients with genotype 1 disease.

It is this combination, mixed in a single daily pill, that industry watchers expect the FDA to approve by October 2014. It heralds a new era of curative treatment for patients with hepatitis C. Similar drugs that work equally well for all genotypes are now in the final stages of clinical development.

Financial Resistance
Because the soon to be released combination pill cures hepatitis in just 12 weeks—eliminating the need for and the expense of treating an otherwise chronic illness—it may end up costing less overall than previous treatments. (Gilead is not expected to announce the retail price of the pill until it receives FDA approval.) Of course, that does not mean that patients will be to afford it.

David Thomas, director of the division of infectious diseases at Johns Hopkins University, considers the price an impediment to health care around the globe, despite the potential savings. Many people in the U.S. with hepatitis C are poor, and several hundred thousand are incarcerated. “Medication that costs more than $100,000 won't make a big impact in prisons in Russia or for drug users in Pakistan,” Thomas says. Within the U.S., copayments may put the treatment out of reach.

The price tag has also struck a nerve among insurers and other third-party payers. “We've never had such a high-cost drug for such a large population,” says Brian Henry, a spokesperson at Express Scripts, which manages benefits for more than 3,500 companies. “Treatment for one hepatitis C patient now can take up a huge portion of a small business's budget for drug spending.”

The manufacturer insists that cost will not prevent access. As it has for its HIV drugs, Gilead plans to provide patient assistance within the U.S., to license the drug (for a fee) to select generic manufacturers outside the U.S., and to lower prices in low- and middle-income countries. In Egypt, which has the world's highest rate of hepatitis C, sofosbuvir costs $300 for a 28-day supply.

At the FDA meeting to review sofosbuvir for approval, Sofia listened to testimony from a patient who had been cured by the new drugs at practically the last minute. “Stories like this,” Sofia says, “put everything one does in perspective.” How many other patients get to tell such stories remains to be seen.
This article was originally published with the title "The Solid-Gold Wonder Drug."

By Jen Christensen, CNN
updated 12:27 PM EDT, Wed September 3, 2014

(CNN) -- Dr. Sean Kumer is actually happy when a call from work wakes him from a deep sleep.

A call means the transplant surgeon at The University of Kansas Hospital can save another life. He worries, though, about possible changes being discussed regarding the way donated organs are distributed; if they go into effect, he may not be able to save so many lives.

"I worry (the possible changes) will harm my patients," Kumer said.

On September 16, the United Network for Organ Sharing, the nonprofit that manages the nation's transplant system, will hold a public hearing to discuss ways to "increase equity" in how organs are assigned to patients across the country. Each organ has a different system for handling its waiting list, and the network has seen a particular problem with donated livers....

Reuters Health Information

Increasing Rates of Acute Hepatitis C Infection Among Young Americans
By Will Boggs MD

September 03, 2014NEW YORK (Reuters Health) - The incidence of acute hepatitis C infection is rising rapidly among Americans aged 30 years and younger, especially those living in non-urban areas, according to U.S. data.

"Because our study revealed a strong relationship between new infections and injection drug use among youth, we would encourage providers to be on high alert for these risk behaviors in young patients," said senior author Dr. Scott D. Holmberg from the Centers for Disease Control and Prevention in Atlanta, Georgia.

"Assessing their risk can be an important opportunity -- not only for testing but also to provide appropriate therapy or referral to drug-cessation treatment," he told Reuters Health by email.
The number of acute cases of hepatitis C virus (HCV) infection had declined rapidly between 1992 and 2003. But since 2006, there has been a resurgence, especially among younger persons who inject drugs.

Between 2006 and 2012, the agency received reports of 7,169 cases of acute hepatitis C. Nearly half of all cases in 2012 involved people aged 30 years and younger, versus only 36% of cases in 2006, the researchers report in Clinical Infectious Diseases, online August 11.

Thirty of 34 states and territories reporting to CDC reported higher incidence of acute HCV in 2012 compared to 2006 among young persons. Fifteen percent of these states had increases between 100% and 199%, and 50% had increases of at least 200%.

In this age group, the incidence of reported acute HCV infection increased 13% per year in non-urban counties and 5% per year in urban counties. The greatest year-to-year increase occurred from 2010 to 2011, when the increase was 38% in non-urban and 85% in urban counties.

Supplemental case follow-up of 1,202 cases in six jurisdictions revealed that 77% of those newly infected had used injected drugs (57% of these shared needles or syringes and 82% shared other drug preparation equipment).

Among those interviewed, 84% reported having ever used drugs, including marijuana (91%), alcohol (83%), prescription opioids (76%), powder cocaine (71%) and heroin (61%). For the 54% who used both heroin and prescription opioids, heroin use followed the use of prescription opioids by an average 2.4 years.

The researchers note that these reports "grossly underestimate HCV incidence in young persons for many reasons, but mainly because most acute infections are asymptomatic and cannot be detected."

"A comprehensive approach is needed to address the increases in HCV infection among young persons," they conclude. "The early abuse of prescription opioids presents an opportunity to mitigate high-risk behaviors. Possible interventions include provider education to reduce opioid misuse, treatment of drug abuse and addiction, national prescription opioid monitoring, and aggressive early education to mitigate evolution to injection drug use."

"Currently, CDC is supporting demonstration projects in two rural and Appalachian settings to conduct outreach to young people who inject drugs," Dr. Holmberg said. "Our goal is to better understand how to identify these at-risk youth, as well as how to test and appropriately treat them."
"While we've recently seen great advances in hepatitis C treatment, including the availability of new treatments, these new therapies only work if people receive them," Dr. Holmberg said. "The potential of these and other advances depends on our ability to get more people screened and into care.""Testing, specifically, is the first critical step to stemming the toll of death and disease from hepatitis C in this nation," he added. "CDC recommends testing for those known to be at high risk, which includes anyone with a history of injection drug use (other key hepatitis C testing recommendations can be found at "

Dr. Brian R. Edlin and Emily Winkelstein from the National Development and Research Institutes in New York, who were not involved in the study, recently published an article on the question of whether hepatitis C can be eradicated in the U.S.

"We're at a watershed in this disease now, with the opportunity to end the hepatitis C epidemic within our grasp, but there's a lot that needs to be done to take advantage of the opportunity," Dr. Edlin told Reuters Health by email. "A potentially fatal, lifelong blood-borne viral disease has gone from incurable to curable, which is a historic event in the history of medicine. But the way things are going, it will just move into the forgotten sectors of society, stay there, and continue to spread, until we make a concerted effort to eradicate it."

"Primary care doctors have a terrific opportunity," Dr. Edlin said. "They see patients before they wind up in the emergency room, or jail, or the morgue. Even better, they can organize outreach to young people at risk. Work with the health department, the police, churches and social services to reach out to young people at risk. As doctors, they have a special credibility that others don't. Express concern. Teach. Counsel. Test. And treat."

Winkelstein added, "While I am not a physician, I have heard countless stories from young people who use drugs who have been treated poorly once drug use is discovered or disclosed. More often than not, young people report that physicians shift their dialogue entirely from whatever brought the young person to the physician to a lecture about cessation of all drug use. As a result, young people either stop seeking medical care or don't disclose important health information to in order to avoid backlash."

"Physicians need to find a way to challenge drug-related stigma rather than reinforce it," Winkelstein said. "They must find ways to treat young people with compassion and empathy regardless of their choices around drug use, and seize the opportunity to build trust, provide meaningful education about ways to reduce their risk of getting or transmitting HCV and treat people who are already infected regardless of ongoing use. Physicians can use treatment as a way to continue engagement with young people and prevent reinfection."

Dr. Benjamin P. Linas from Boston University School of Public Health argued that it will be difficult for doctors to have a big impact because young drug users rarely go to the doctor.

"To really stop this spread of infection, we need to focus on substance abuse treatment," he told Reuters Health by email.

"There is a great deal of discussion about the new HCV meds and how we may be able to use them to eradicate HCV," said Dr. Linas, who was not involved in the study. "Maybe we can -- but treatment as prevention cannot work if kids are relapsing to injection drug use and becoming reinfected."

He added, "As a public health/medical community, we need to expand our thinking about HCV beyond the 'boomers.' It was important and appropriate to begin with the recommendation to screen the birth cohort, but it's time to move to the next phase and realize that if we want to really stop new infections, we need to do the very hard work of identifying and engaging HCV-infected active drug users in care, help them stop their drug use, and treat their HCV."

Clin Infect Dis 2014.

Stanford addiction expert: It’s often a “subtle journey” from prescription-drug use to abuse
By Michelle Brandt on September 2nd, 2014
Here are some frightening facts you might not know: Drug overdose death rates in the United States have more than tripled since 1990, with the majority of drug-related deaths caused by prescription drugs. And as of 2010, about 18 women in the U.S. die every day of a prescription painkiller overdose. Prescription-drug abuse, which we’ve written about extensively here on Scope, is a very real and pressing issue – and it was the focus of a recent Forum on KQED-FM.
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