Hepatitis C 2009 News

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Back to index of news 2008-2001

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July 2009

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Hepatitis C Virus Infection and the Risk of Coronary Disease

Examining Dietary Influences Of Liver Disease

Exercise Helps Patients With Non-Alcoholic Fatty Liver Disease

Liver Transplantation After Drug Induced Acute Liver Failure Examined By Study

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FDA panel backs cut in maximum Tylenol dosage

 

—Liz Highleyman

http://www.hcvadvocate.org/

The pain reliever acetaminophen is generally safe for most people when used as directed, but it can cause life-threatening liver injury if taken at high doses or by individuals at risk for hepatotoxicity.

As acetaminophen toxicity remains one of the leading causes of acute liver failure in the United States—accounting for an estimated 50,000 emergency room visits and 500 deaths annually, according to the American Association for the Study of the Liver—the Food and Drug Administration (FDA) has mandated stronger warnings and stricter regulation of the drug.

Acetaminophen Liver Toxicity
Acetaminophen, like many drugs, is metabolized by the liver. If the normal processing pathway is overwhelmed by a high dose, a different pathway known as the cytochrome P450 system takes over. This leads to production of a metabolite, NAPQI, that is toxic to liver cells.

If acetaminophen toxicity is diagnosed in its early stages—which can be difficult due to nonspecific symptoms and sometimes slow onset—N-acetylcysteine (NAC) can be administered as an antidote; NAC restores the natural antioxidant glutathione, which detoxifies NAPQI. But as liver damage progresses, decompensation may occur, necessitating a liver transplant in the most severe cases.

A significant proportion of acetaminophen-related liver toxicity is due to intentional overdose, typically a suicide attempt. Most cases of serious liver damage occur in people who have taken at least 10-15 grams­—much more than twice the recommended total daily adult dose of 4 grams (4,000 mg).

However, accidental overdoses are also common, accounting for about half of all cases, in part because the drug is present in so many products. In addition to the familiar Tylenol brand, acetaminophen—also known as APAP or paracetamol—is an ingredient in hundreds of prescription painkillers (often combined with narcotics such as hydrocodone or oxycodone) and over-the-counter or OTC products (including many cold, cough, and sinus remedies) (see sidebar for a partial list). This ubiquity increases the likelihood that people will unknowingly mix acetaminophen-containing products, thereby exceeding the maximum recommended dose.

Drinking even a small amount of alcohol while taking acetaminophen—or a few hours before or after doing so—increases the risk of liver toxicity. Research indicates that people with pre-existing liver disease, including chronic viral hepatitis, have an elevated risk of acetaminophen-related hepatotoxicity, although most hepatitis B or C patients with compensated liver disease can safely use the drug at recommended doses. Finally, some individuals are prone to acetaminophen toxicity at or near the recommended amount for unknown reasons, possibly having to do with genetic factors.

Revised Labeling
On April 28, the FDA issued a final rule requiring manufacturers of OTC pain relievers and fever reducers to revise product labeling to include warnings about potential safety risks, including liver damage associated with acetaminophen and gastrointestinal bleeding due to nonsteroidal anti-inflammatory drugs (NSAIDs), which include aspirin and ibuprofen.

“Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches,” Charles Ganley, MD, director of FDA’s Office of Nonprescription Drugs, stated in an agency press release. “However, the risks associated with their use need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk.”

Under the new rules, manufacturers must prominently list all active ingredients in a product both on the external packaging and on the bottle. The label must warn of the risk of severe liver damage with acetaminophen and stomach bleeding with NSAIDs. These changes must be made by April 29, 2010.

The full revised rules, formally titled “Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use”—consisting of 25 pages in the Federal Register—are available online at http://edocket.access.gpo.gov/2009/pdf/E9-9684.pdf.

What Took So Long
Many clinicians and consumer advocates consider the new warning long overdue. FDA advisory panels have recommended a liver toxicity warning for acetaminophen on several occasions (in 1977, 1988, 1993, and most recently 2002) but this was never formally adopted—an outcome some advocates attribute to pharmaceutical industry lobbying. However, in 1998 the agency did require a label warning stating, “If you consume three or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.”

In 2004, the FDA launched a public education campaign about the risks of acetaminophen, but the effort was small and poorly funded. That same year, the agency asked state pharmacy boards to consider requiring stronger labeling on prescription acetaminophen products, but by 2008, none had done so. Some companies voluntarily strengthened their side effects warnings, but not enough to satisfy FDA officials.

In December 2006, the FDA issued proposed labeling requirements for OTC acetaminophen products, and in 2007 the agency’s Center for Drug Evaluation and Research convened a multidisciplinary working group to discuss the issues of acetaminophen-related liver injury and possible prevention measures. This group devised a report with options to be presented for public discussion and comment, which provides the basis for the agency’s latest actions.

Further Steps
On June 29 and 30, after the HCV Advocate went to press, the FDA held a joint meeting of the Drug Safety and Risk Management Advisory Committee, the Anesthetic and Life Support Drugs Advisory Committee, and the Nonprescription Drugs Advisory Committee to discuss the public health problem of liver injury related to acetaminophen in OTC and prescription products and to consider further steps the agency might take to reduce the risk.

“The association between acetaminophen and liver injury is not common knowledge. Consumers are not sufficiently aware that acetaminophen can cause serious liver injury, and their perceptions may be influenced by the marketing of the products,” the FDA wrote in its meeting announcement. “Current labeling on OTC products may be overlooked, as can the patient information provided with dispensed prescriptions. Programs to educate the public about safe use of acetaminophen have been small and encountered a number of obstacles. Advertisements of OTC drugs often emphasize the effectiveness of products, but are not subject to the same requirements to offset such messages by providing warning information as prescription products. Also, acetaminophen is available in retail outlets in large quantities (e.g., 500 tablets per bottle) which may contribute to the perception that the ingredient is unlikely to be harmful.”

Possible measures include lowering the recommended single dose and cumulative daily dose, reducing the amount of acetaminophen in maximum strength tablets and liquid pediatric formulations, removing acetaminophen from combination products, and restricting the number of pills that can be sold at one time. Such a restriction might help reduce intentional overdoses, but likely would not reduce the risk for people who develop liver toxicity at or near the recommended dose. The U.K. instituted acetaminophen pack-size restrictions in 1998, but whether this has decreased deaths due to toxicity remains subject to debate.

Outcomes of the FDA committee meeting will be covered in future issues and on the HCV Advocate web site (www.hcvadvocate.org).

 

Common Products Containing Acetaminophen
(Not a complete list)

Prescription
Darvocet
Esgic
Hydrocet
Lortab
Percocet
Roxicet
Vicodin
Zebutal

OTC
Actifed*
Alka-Seltzer Plus
Anacin*
Comtrex
Contac*
Dimetapp*
Dristan
Excedrin
Midol*
Nyquil
Panadol
Robitussin*
Sinutab*
Sudafed*
TheraFlu
Tylenol

Acetaminophen and Liver Injury: Q & A for Consumers

FDA Takes Action on Acetaminophen

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4th Intrntnl Wrkshp HCV Resist: New HCV Drugs, Special Population (Coinfectio) Access: 4th International Workshop on Hepatitis C, Resistance and New Compounds 25-26 June 2009, Boston, MA U -

Time-Released Interferon Locteron Study Enrollment Completed

4th Intrntnl Wrkshp HCV Resist: FDA Loosens Up HCV Drug Development - HCV Boston Meeting

CDC Researchers Release Latest Hepatitis A, B, and C Statistics

Detectable HCV RNA at Week 8 Is Best Predictor of Relapse in Genotype 1 Hepatitis C Patients Treated with Pegylated Interferon plus Ribavirin

FYI...Artificial Liver For Drug Tests

HCV Advocate Newsletter: July, 2009

Sleep duration is associated with variations in levels of inflammatory markers in women

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June 2009

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Blood Pressure Drug Losartan Associated with Liver Fibrosis Regression in Small Study

Effectiveness of Pegylated Interferon plus Ribavirin for Chronic Hepatitis C Patients with HCV Genotypes 5 or 6

Testosterone Replacement For Men With Low Testosterone Improves Liver Function, Metabolic Syndrome

FDA Alert Warns of Elevated Risk of Death in Liver Transplant Recipients Who Switch to Rapamune (Sirolimus)

Older Genotype 3 Chronic Hepatitis C Patients Do Not Respond as Well to Interferon-based Therapy

Many People with Chronic Hepatitis B and C Do Not Receive Appropriate Treatment

FDA Approves Zoledronic Acid - Reclast(R) - to Prevent Osteoporosis in Postmenopausal Women With Convenient Less Frequent Dosing, Once Every 2 Years

Cancer May Be Stopped In Its Tracks By MicroRNA Replacement Therapy

New Training Module:
Extrahepatic Manifestations of Hepatitis C: Skin Disorders

FDA Warns About Serious Liver Injury Associated With Anti-Thyroid Drug

Download HCV Updates

Ribavirin Prevents Relapse

News Letter June 2009

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Dr. Galati Discussed Hepatitis C Updates

 

http://www.youtube.com/user/TexasLiverdotcom

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HCV Protease Inhibitor Telaprevir Improves Response, Halves Treatment Time For Hepatitis C Patients

Study Finds Noninvasive Blood Test For Liver Fibrosis May Alleviate Need For Liver Biopsies For Some Patients With Chronic Hepatitis C

NEJM Study Points To New Era In Hepatitis C Treatment

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Dr. Kuemmerle, Dr. Emmet Keeffe and Dr. Michael W. Fried discuss study results that show the combination of nitazoxanide, peginterferon alfa-2a, and ribavirin improved percentages of patients with rapid virologic response (RVR) and sustained virologic response (SVR).

Rossignol JF, Elfert A, El–Gohary Y, et al.  Improved Virologic Response in Chronic Hepatitis C 136: 856-862
http://www.gastrojournal.org/article/S0016-5085(08)02051-9/abstract

 

Hepatitis C Warning WXYZ

 

Hyperion Therapeutics Announces Results Of Phase I Study In Patients With Liver Cirrhosis

Pharmasset Initiates Phase 1b Multiple Ascending Dose Clinical Trial of PSI-7851 in Chronic Hepatitis C Patients

Progenics Stops PRO 206 HCV Entry Inhibitor -

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Did You Know?

 

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DDW 2009 Reveals Advances Being Made In The Treatment Of Hepatitis

CDC Updated Viral Hepatitis Surveillance

Liver Disease 'Shrunk' By Blood-pressure Drug

Liver Cancer Rates Triple: Hepatocellular Carcinoma Incidence, Mortality, and Survival Trends in the United States From 1975 to 2005

Retreating chronic hepatitis C with daily interferon alfacon-1/ribavirin after nonresponse to pegylated interferon/ribavirin: DIRECT results -

Valeant Grants Schering-Plough Exclusive Option in Japan for Taribavirin in Exchange for Release of Last Right of Refusal

Causes of Liver Cancer in HCV: Hepatitis C virus-induced hepatocarcinogenesis (HCC)) -

Early EPO Use Increased SVR Rates and Reduced Discontinuation Rate !

New HCV Drug Report: "Using a new palette of treatment options to paint the portrait of cure for patients infected with hepatitis C on our clinical canvas."

EXTENDED TREATMENT DURATION TO 72 Weeks IN CHRONIC HEPATITIS C GENOTYPE 1-INFECTED SLOW RESPONDERS: FINAL RESULTS OF THE SUCCESS STUDY (SUCCESS) -

BI 201335, a potent HCV NS3 protease inhibitor, in treatment-naïve and -experienced chronic HCV genotype-1 infection: genotypic and phenotypic analysis of the NS3 protease domain

Continue reading "Curing Hepatitis C Versus Healing From Hepatitis C"

For HCV-Positive Liver Transplant Recipients, Some Donor Factors Affect Outcomes

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From HCV Advocate DDW 2009

HCV Advocate Newsletter: June, 2009

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From HIVandHepatitis.com

 

Digestive Disease Week

May 30 - June 4, 2009, Chicago, Illinois

Asian-American Chronic Hepatitis C Patients Respond Well to Pegylated Interferon plus Ribavirin
6-12-2009

Asian-Americans Are More Likely to Have Unknown Hepatitis C Virus Transmission Risk Factors

Metabolic Syndrome Is Associated with Increased Risk of Hepatocellular Carcinoma in Chronic Hepatitis C Patients
6-9-2009

Strategies for Managing Acetaminophen-related Liver Disease and Acute Liver Failure
6-5-2009

Vitamin B12 Levels May Help Predict Response to Interferon-based Therapy for Chronic Hepatitis C
6-5-2009

High HBV DNA Level Is the Strongest Predictor of Elevated ALT
6-9-2009

Should Entecavir (Baraclude) and Tenofovir (Viread) Be First-line Treatment for Chronic Hepatitis B?
6-5-2009

Slides and Posters on Entecavir (Baraclude) and Hepatitis B Liver Disease Progression Presented at DDW 2009
6-5-2009

 

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May 2009

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ALT Level Increase Common During HCV Therapy

FDA Will Require Additional Warning Labels for Over-the-Counter Painkillers, Including Tylenol, Aspirin and Ibuprofen

IDEAL Study Shows that Greater Hemoglobin Decline during Treatment with Pegylated Interferon plus Ribavirin Is Associated with Better Response

World Hepatitis Day: Prospects for the Future - Guest blog by Paul Klenerman and colleagues

" An Overview of the HCV Drug Development Process"

 

World Hepatitis Day 2008

'Am I Number 12?

 

 

EASL Analysis, New Oral HCV Drugs What's Expected -

Ask the Experts: The Inactive Carrier State in Chronic HepatitisB Infection

New England Journal of Medicine Publishes Promising Data from PROVE 1 and PROVE 2 Studies of HCV Protease Inhibitor Telaprevir

FDA Approves Dose Adjustments of PegIntron and Rebetol for Certain Patients with Chronic Hepatitis C

Hepatitis C Treatment Is More Successful before Progression to Advanced Liver Damage

Extended 72-week Treatment with Pegylated Interferon plus Ribavirin Did Not Improve Outcomes among Slow Responder Hepatitis C Patients

Researchers Present Data on Investigational Cyclophilin Inhibitors Debio 025 and SCY-635

Phase IIb Trial Will Further Assess Efficacy, Safety And Tolerability Of MK-7009 - For Patients With Chronic Hepatitis C

Patients With Resolved Hepatitis C Likely Still Contagious According To Study

Understanding Your HCV Labs

Infection By Hepatitis C Virus Prevented By Novel Antibody

Hypothyroidism In Women Associated With Liver Cancer

May HepCBC Newsletter 2009

 

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Metabolic Syndrome Hikes Mortality in Hepatitis C

By John Gever, Senior Editor, MedPage Today

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HCV Advocate Newsletter:
May 2009

Cancer Preventive Effect For Statins Indicated By Study

2 Schering HCV Protease Inhibitors; Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis C Patients

Schering-Plough Highlights Hepatitis C Clinical Data Presentations At The European Association For The Study Of The Liver (EASL) Annual Meeting

Non Alcoholic Fatty Liver Disease Is In The Family

Clinical Update - Debio 025 In Hepatitis C

New Non-invasive Liver Fibrosis Index Reduces Need For Biopsies In Children

New England Journal Of Medicine Publishes Landmark Clinical Studies Of The Investigational Hepatitis C Virus Protease Inhibitor Telaprevir

Studies: Drug shows promise against hepatitis C

Interferon-Free Drug Combo Effective Against Hepatitis C

Cleaning Safety for Hepatitis C

FDA Will Require Additional Warning Labels for Over-the-Counter Painkillers, Including Tylenol, Aspirin and Ibuprofen

Downloadable Hepatitis Slidesets Available From CCO

Warning on Hydroxycut Products

May is National Hepatitis Awareness Month

Re-Treatment With Pegasys(R) Provides Hepatitis C Patients With A Second Chance For A Cure, Switzerland, New Study

Summaries For Patients: Re-treating Patients With Chronic Hepatitis C Who Have Not Responded to Peginterferon-2b

Early treatment gives hepatitis C patients the all-clear

Taribavirin vs Ribavirin -

Avila Therapeutics May Have Found “Achilles’ Heel” of Hepatitis C Virus
 

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2009 Annual Meeting of the European Association for the Study of the Liver*

April 22-26, 2009 | Copenhagen, Denmark

*CCO is an independent medical education company that provides state-of-the-art medical information to healthcare professionals through conference coverage and other educational programs.

 

http://www.clinicaloptions.com

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HCV Advocate EASL 2009 Coverage

From NATAP EASL

 

EASL: EFFICACY AND SAFETY OF PEGINTERFERON ALFA-2A 360 �g/WEEK IN COMBINATION WITH RIBAVIRIN IN HEPATITIS C GENOTYPE 1 PATIENTS - IMPACT Of CIRRHOSIS: ANALYSIS FROM THE CHARIOT STUDY - (05/14/09)

EASL: EASL Analysis, New Oral HCV Drugs What's Expected - (05/14/09)

EASL: Histologic Outcomes in Hepatitis C-Infected Patients With Breakthrough or Relapse to Interferon-Based Treatments: there was a positive correclation between viral response and improved fibrosis - (05/13/09)

EASL: BASELINE CHARACTERISTICS AND WEEK 4 RESPONSE AMONG CHRONIC HEPATITIS C PATIENTS INFECTED WITH HCV GENOTYPE 1, 2, 3 OR 4: INTERIM RESULTS OF THE PROPHESYS TRIAL - (05/13/09)

EASL: Identifying Patients Infected With HCV Genotype 1 Who May Benefit From Extended Peginterferon Alfa-2a/Ribavirin Therapy Beyond 48 Weeks - (05/13/09)

EASL: IDENTIFYING PATIENTS WITH A HIGH LIKELIHOOD OF ACHIEVING AN SVR FOLLOWING RE-TREATMENT WITH PEGINTERFERON ALFA-2A (40KD) PLUS RIBAVIRIN: USE OF POSITIVE PROGNOSTIC FACTORS (PPF'S) - (05/12/09)

EASL: Ursodeoxychic Acid Improved NASH, Not So Sure About Rosiglitazone - (05/12/09)

EASL: Single and Multiple-Dose Assessments of the Safety and Pharmacokinetics of SCH 900518 and Its Effect on the Pharmacokinetics of Midazolam in Healthy Subjects - (05/12/09)

EASL: Preclinical Characterization of SCH 900518,A Novel Mechanism-Based Inhibitor of HCV NS3 Protease - (05/12/09)

 EASL: Individualized treatment duration with peginterferon alfa-2b and ribavirin for 24, 30 or 36 weeks in HCV genotype 1-infected patients with undetectable HCV-RNA early during therapy (INDIV-2 study) - (05/12/09)

EASL: A Regional Gastrointestinal Absorption Study of the HCV NS3 Protease Inhibitor SCH 900518 in Healthy Volunteers: "remote-controlled drug delivery device that delivers any form of drug to key regions of the human gastrointestinal (GI) tract." - (05/12/09)

 

EASL: Preclinical Pharmacokinetic and Safety Profile of IDX375, A Novel and Potent Non-Nucleoside HCV Polymerase Inhibitor - (05/11/09)

EASL: Preclinical Profiles of IDX136 and IDX316, Two Novel Macrocyclic HCV Protease Inhibitors - (05/11/09

EASL: IDENTIFICATION AND PROFILE OF POTENT AND SELECTIVE INHIBITORS OF HCV NS5A PROTEIN - (05/11/09)

Phase 2a Study to Evaluate the Safety and Tolerability and Anti-Viral Effect of 4 Doses of a Novel, Controlled-Release Interferon Alfa-2b (LocteronTM) Given Every 2 Weeks for 12 Weeks in Treatment-Naive Patients with Chronic Hepatitis C (Genotype 1) (AASLD 2007) - (05/08/09)

Telaprevir with Peginterferon and Ribavirin for Chronic HCV Genotype 1 Infection...PROVE1 in NEJM 4/2009 - (05/08/09) 

EASL: Albuferon vs Pegasys Genotype 2/3 - (05/07/09)

EASL: Albuferon vs Pegasys Genotype 1 - (05/07/09)

EASL: Co Press Release: Biolex presents Locteron US Phase 2a hepatitis C data at EASL - (05/07/09)

EASL: Identification and Characterization of VCH-222, a Novel Potent and Selective Non-Nucleoside HCV Polymerase Inhibitor - (05/07/09)

EASL: Activity & Genotypic and Phenotypic Analysis of HCV NS5B Variants Selected from Patients Treated with VCH-916 - (05/07/09)

EASL: Randomized Trial Comparing Systemic and Local Reactions to Controlled-release Interferon Alpha2b and Pegylated-interferon Alpha2b in Hepatitis C Patients Who Failed Prior Treatment - (05/07/09)

EASL: Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide with Peginterferon Alfa-2a and Ribavirin in Nonresponders (NR) with Chronic HCV Genotype 1: Week 28 Interim Analysis - (05/07/09)

EASL: Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of Nitazoxanide Plus Peginterferon and Ribavirin in HCV Genotype 1 Naïve Patients: Interim Analysis Shows Increase in EVR - (05/07/09)

EASL: Preclinical Pharmacokinetic and ADME Characterization of VCH-222, a Novel Non-Nucleoside HCV NS5B Polymerase Inhibitor from Vertex/ViroChem - (05/07/09)

EASL: IDX184, A Liver-Targeted Nucleotide HCV Polymerase Inhibitor: Results of a First-in-Man Safety and Pharmacokinetic Study - (05/07/09)

EASL: Antiviral Activity of the Liver-Targeted Nucleotide HCV Polymerase Inhibitor IDX184 Correlates with Trough Serum Levels of the Nucleoside Metabolite in HCV-infected Chimpanzees - (05/07/09)

EASL: Albuferon vs Pegasys Genotype 1 - (05/06/09)

EASL: Pharmacokinetics, Safety and Tolerability of the HCV Polymerase Inhibitor ABT-333 Following Multiple Ascending Doses and Effect of Co-Administration of Ketoconazole in Healthy Subjects - (05/06/09)

EASL: Characterization of Resistance Mutations Selected In Vitro by Non-Nucleoside HCV Polymerase Inhibitors ABT-333 and ABT-072

EASL: Characterization of Resistance Mutations Selected In Vitro by Non-Nucleoside HCV Polymerase Inhibitors ABT-333 and ABT-072 - (05/06/09)

EASL: US Hepatitis C Burden Assessment from a Transmission Model: HCV burden reduced by new HCV drugs - (05/06/09)

EASL: Pharmacokinetics and Tolerability of the HCV Polymerase Inhibitor ABT-333 Following Single Ascending Doses in Healthy Adult Volunteers - (05/06/09)

EASL: Safety, Tolerability and Pharmacokinetics of the HCV Polymerase Inhibitor VCH-222 Following Single Dose Administration in Healthy Volunteers and Antiviral Activity in HCV-infected Individuals - (05/06/09)

EASL: Safety, Tolerability, and Pharmacokinetics of GS-9450 in Healthy Male and Female Volunteers - (05/05/09)

EASL: Abbott/Enanta - Potent HCV Protease Inhibitors with the Potential for Once-daily Dosing and Broad Genotype Coverage - (05/05/09)

EASL: Preclinical Characterization of ABT-072: A Novel Non-Nucleoside HCV Polymerase Inhibitor - (05/05/09)

EASL: Preclinical Potency, Pharmacokinetic and ADME Characterization of ABT-333, A Novel Non-Nucleoside HCV Polymerase Inhibitor - (05/05/09

EASL: 2 Schering HCV Protease Inhibitors; Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis C Patients

EASL: EFFICACY AND SAFETY OF THE CYCLOPHILIN INHIBITOR DEBIO 025 IN COMBINATION WITH PEGYLATED INTERFERON ALPHA-2A AND RIBAVIRIN IN PREVIOUSLY NULL-RESPONDER GENOTYPE 1 HCV PATIENTS

EASL: SAFETY AND ANTIVIRAL ACTIVITY OF SCH 900518 ADMINISTERED AS MONOTHERAPY AND IN COMBINATION WITH PEGINTERFERON ALFA-2B TO NAIVE AND TREATMENT-EXPERIENCED HCV-1 INFECTED PATIENTS

EASL: PegIntron Maintenance Therapy in Cirrhotic (METAVIR F4) HCV Patients Who Failed to Respond to Interferon/Ribavirin (IR) Therapy: Final Results of the EPIC3 Cirrhosis Maintenance Trial

Recombinant (EPO) human erythropoiesis-stimulating agents and mortality in patients with cancer: a meta-analysis of randomised trials

EASL: HCV SPRINT-1: Final Results SVR 24 NS3 Protease Inhibitor Boceprevir plus PegIFN alpha-2b/Ribavirin HCV 1 Treatment Na�ve Patients -

ntiviral Activity and Safety of ITMN-191 (R7227) in Combination with Peginterferon alfa-2a and Ribavirin in Patients with Chronic Hepatitis C Virus

EASL: HCV SPRINT-1: Final Results SVR 24 NS3 Protease Inhibitor Boceprevir plus PegIFN alpha-2b/Ribavirin HCV 1 Treatment Na�ve Patients - (04/30/09)

EASL: Antiviral Activity and Safety of ITMN-191 (R7227) in Combination with Peginterferon alfa-2a and Ribavirin in Patients with Chronic Hepatitis C Virus - (04/29/09)

EASL: Antiviral activity and safety of TMC435 combined with peginterferon a-2a and ribavirin in patients with genotype-1 hepatitis C infection who failed previous IFN-based therapy - (04/29/09)

EASL: Antiviral Activity of Filibuvir in Combination with Pegylated Interferon Alfa-2a and Ribavirin for 28 Days in Treatment-Naive Patients Chronically Infected with HCV Genotype 1 - (04/29/09)

EASL: Subgroup Analysis Confirms Efficacy, Safety of Sorafenib in Patients With Late-Stage Liver Cancer: Presented at EASL - (04/29/09)

EASL: A FIRST CLINICAL TRIAL OF THERAPEUTIC VACCINATION USING NAKED DNA DELIVERED BY IN VIVO ELECTROPORATION SHOWS ANTIVIRAL EFFECTS IN PATIENTS WITH CHRONIC HEPATITIS C - (04/29/09)

EASL: Safety, Tolerability, and Pharmacokinetics after Single and Multiple Doses of MK-3281 in Healthy Subjects - (04/28/09)

EASL: MK-7009 Significantly Improves Rapid Viral Response (RVR) in Combination with Pegylated Interferon Alfa-2a and Ribavirinin Patients with Chronic Hepatitis C (CHC) Genotype 1 Infection - (04/28/09)

EASL: Metabolic Syndrome Hikes Mortality in Hepatitis C - (04/28/09)

EASL: Ground-Breaking Combination of 2 All-Oral Agents Demonstrates Potential as Hepatitis C Treatment Regimen (ITMN-191 protease + R7128 NRTI) - (04/28/09)

EASL: FDA Regulations for HCV Drug Development - are they too Strict? - (04/28/09)

EASL: Can Peginterferon and Ribavirin Be Eliminated from Therapy - (04/28/09)

EASL: Roche and Pharmasset start phase IIb clinical trial of R7128 nucleoside polymerase inhibitor for chronic hepatitis C - (04/28/09)

EASL: OPERA-1 trial (Study TMC435-C201): interim analysis of safety and antiviral activity of TMC435 in treatment-na�ve genotype-1 HCV patients - (04/28/09)

EASL: TELAPREVIR IN HEPATITIS C GENOTYPE-1-INFECTED PATIENTS WITH PRIOR NON-RESPONSE, VIRAL BREAKTHROUGH OR RELAPSE TO PEGINTERFERON-ALFA-2A/B AND RIBAVIRIN THERAPY: SVR RESULTS OF THE PROVE3 STUDY - (04/28/09)

EASL: Potent Antiviral Activity With A Nucleoside Polymerase (R7128) And Protease (R7227/ITMN-191) Inhibitor Combination in HCV Genotype 1: Initial Safety, Pharmacokinetics, And Virologic Results From INFORM-1 - (04/28/09)

EASL: EASL Day 3 Saturday - (04/28/09)

EASL: HCV Protease ITMN-191 + Peg/RBV for 14 Days - safety, antiviral activity - (04/28/09)

EASL: SCH-900518 New Schering Protease Inhibitor Monotherapy & with Peg/RBV 7-14 days - (04/28/09)

EASL: Roche and Pharmasset Initiate Phase IIb Clinical Trial of R7128, Most Advanced Nucleoside Polymerase Inhibitor in Development for Chronic Hepatitis C - (04/28/09)

EASL: Peg-Interferon lambda + Ribavirin 4 Weeks - (04/28/09)

EASL: Telaprevir Effective for Genotype 2 But Not For Genotype 3 - (04/27/09)

EASL: Maintenance Therapy: we don't know if it provides benefit - (04/27/09)

EASL: HIV positive and HIV negative patients have similar survival rates following liver transplant - (04/27/09)

EASL: Anadys shares plunge on hepatitis C drug ANA598 safety concerns - (04/27/09)

EASL: Schering's protease boceprevir phase 2; Schering symposium - (04/27/09)

EASL: Safety, pharmacokinetics and antiviral effect of BI 207127, a novel HCV RNA polymerase inhibitor, after 5 days' oral treatment in patients with chronic hepatitis C - (04/27/09)

EASL: ANA598 Demonstrates Potent Antiviral Activity at all Dose Levels in Completed Phase Ib Study in Hepatitis C Patients - (04/24/09)

EASL: Tibotec HCV Protease TMC435 I Treatment-Naives Genotype 1, Monotherapy & Combination with Peg/RBV - (04/24/09)

EASL: New HCV Drugs II: Schering's protease boceprevir phase 2; Abbott/Enanta HCV Protease Inhibitors; Progenics PRO-206 HCV Entry Inhibitor - (04/24/09)

EASL: Taribavirin vs Ribavirin - (04/24/09)

EASL: New HCV Drugs Today at EASL 1st Day - (04/24/09)

EASL: EASL New HCV Drugs - (04/23/09)

EASL: EPIC Study Shows Maintenance Therapy Provides Benefits -

Low-Dose Naltrexone Eases Pain and Fatigue of Fibromyalgia - (04/22/09)

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April 2009

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 Hepatitis C study shows early treatment works

Interferon-based Therapy for Hepatitis C Improves Fibrosis Even in Individuals without Virological Response

Sustained Response to Interferon-based Therapy Reduces Risk of Diabetes in Hepatitis C Patients

Hepatitis C not a life sentence: doctor

Low-Dose Naltrexone Eases Pain and Fatigue of Fibromyalgia

Re-treatment of Patients With Chronic Hepatitis C Who Do Not Respond to Peginterferon-{alpha}2b

New Gilead HCV Drug GS-9190

What Is Hepatitis? Symptoms, Causes and Treatments

Presidio Pharmaceuticals, Inc. To Present Data On Their Lead Hepatitis C Virus NS5A Inhibitor Program At The EASL Conference

Fatty Liver Disease: The Next Big Thing

Keyhole Surgery Speeds Patient Battle With Cancer - Removing Tumor From Liver And Lower Intestine At The Same Time

Phase I Studies With Hepatitis C Compounds In Healthy Volunteers And Patients: Views From Inside

Man Living With Hepatitis C Tells Medical Marijuana Story

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From HCV Advocate:

HCV Advocate Newsletter April, 2009

HCV SnapShots

SVR - 5 Years Later
Alan Franciscus, Editor-in-Chief

Does the health of the liver improve after someone achieves a sustained virological response?

The article titled "Sexual Transmission of HCV: An Emerging New Consensus?" by Liz Highleyman has generated quite a lot of comments. One in particular we received from a colleague in Canada who has been conducting an ad campaign to raise the awareness of sex and HCV.

Check It Out here

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HEPC Bull Newsletter

April 2009

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Full Story: VA: 3 patients HIV-positive after clinic mistakes

Celsion Receives Orphan Drug Designation for ThermoDox to Treat Primary Liver Cancer -

HEPATITIS TODAY:
A Look Back at the
Advances & Insights in
Chronic Hepatitis B
Management in 2008

Studies of Hepatitis B and C Virus Interaction Produce Conflicting Results

Some Individuals Harbor HBV with Adefovir (Hepsera) and Tenofovir (Viread) Resistance Mutations before They Ever Receive Treatment

Pharmasset Initiates First Clinical Trial of Second-generation HCV Polymerase Inhibitor PSI-7851

Gallstones and Natural Remedies ?

http://www.foxnews.com/

The cyclophilin inhibitor Debio 025 combined with PEG IFN2a significantly reduces viral load in treatment-naive hepatitis C patients: efficacy & safety -

IDUs Risky Behavior: < 32% share syringes/63% have unprotected vaginal sex, CDC Study

Perspective on the Progression of Hepatitis C

Latinos and Chronic Hepatitis C

New from HCV Advocate: "The Ultimate Quiz"

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News Rewind (General Medical Updates)

Salmonella

AASLD Practice Guidelines: Diagnosis, management, and treatment of hepatitis C: An update, pdf attached

New Studies Examine Elimination of Hepatitis B and C

HALT-C Patient Subgroups That Appear To Benefit From Maintenance Therapy -

Idenix Pharmaceuticals To Present At The Canaccord Adams Hepatitis C Conference

The First Research Plan To Reduce The Burden Of Digestive Diseases Released By NIH

Medical College One Of Only Five Sites In US Studying TheraSphere Technology For Secondary Liver Tumors

She tells her story to help others cope

Health insurance and pre-existing conditions

New Action Plan To Reduce Hepatitis In Wales

Smoking with Hepatitis C Raises Liver Cancer Risk

Peginterferon Alfa-2a Plus Ribavirin for the Treatment of Dual Chronic Infection With Hepatitis B and C Viruses

'Every 15th Hepatitis C virus carrier is an Indian'

Tattooing blamed for sharp rise in Hep C rates

International Hepatitis C Conference

EHDRW: Pharmasset Initiates First Time in Human Study of PSI-7851 for the Treatment of Hepatitis C (HCV) -

New Drugs

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Written by Mark Mascolini (04/01/09)

Pharmasset Initiates First Time in Human Study of PSI-7851 for the Treatment of Hepatitis C (HCV)

Natural History of Steatosis in Patients with Chronic Hepatitis C

Use of New Drugs in the Treatment of Chronic Hepatitis B

Anadys Pharmaceuticals to Present at the CanAccord Adams Hepatitis C Conference

Health under cover

Hepatitis C and HIV

TV news on organ donation says little about need, how to become a donor

Fibrosis Improves with Interferon Treatment

Long-Term Outcomes

HCC Despite Sustained Response

Treatment for HCV/HBV Coinfection

New insights into how brain responds to viral infection

Health Care Fraud

http://www.foxnews.com/

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March 2009

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HCV Vaccine Development

Pegylated Interferon Monotherapy for Treatment of Chronic Hepatitis B

ImQuest Identifies First Non-nucleoside Inhibitors of Hepatitis B Virus

Studies Shed More Light on Acute Hepatitis C among HIV Positive Men in the U.S. and Europe

TMC435 HCV Protease Inhibitor Safety/antiviral activity OPERA Study doses 25 & 75 mg once daily -

Screening for Acute Hepatitis C Virus Infection (AHCV) among At-Risk Patients in an HIV Clinic -

Safety and antiviral activity of TMC435 (TMC435350) in treatment-na�ve genotype 1 HCV-infected patients Study TMC435-C201

Variables Impacting Treatment and Prognosis in Young Patients(under Age 40) who Develop Hepatitis B Virus-Associated Hepatocellular Carcinoma; Implications for Management of an Unscreened Population

Hepatitis B and Hepatitis C in 2009: Review Article

Nitazoxanide Added to Treatment of Hepatitis C Genotype 4 Improves Outcome

Treatment for Hepatitis B: When to Start, What to Use, and When to Stop

Chronic Hepatitis B Patients May Need to Begin Liver Cancer Screening at a Younger Age than Currently Recommended

HCV Reinfection and Superinfection Are Common among Injection Drug Users

Many Asian-American Primary Care Providers Do Not Screen their Asian-American Patients Who Are at Risk for Chronic Hepatitis B

Tenofovir (Viread) during Pregnancy: Findings from the Antiretroviral Pregnancy Registry

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March News

Hepatitis Journal Review, March 2009, by Liz Highleyman

Racial Differences in Response to Interferon-Based Antiviral Therapy for Hepatitis C Virus Infection: A Hardwiring Issue? EDITORIAL COMMENTARY

Early Changes in Hepatitis C Virus (HCV) Levels in Response to Peginterferon and Ribavirin Treatment in Patients with Chronic HCV Genotype 1 Infection

HALT-C in the final analysis: A molehill out of a mountain - does peginterferon maintenance therapy work?

Development Of Liver Cancer Prevented By Long-Term L-Carnitine Supplementation

BioMosaics' Glypican-3 Antibody (clone 1G12) Validated At PhenoPath Laboratories For Immunohistochemical Detection Of Liver Cancer

Aethlon Medical Announces Data Supported Strategy To Increase Hepatitis-C (HCV) Cure Rates

Searching for a Cure-All

Male Sexual Function During Hepatitis C Treatment

Smoking is associated with steatosis and severe fibrosis in chronic hepatitis C but not B

Review Finds Albumin Interferon for Chronic Hepatitis C Is Effective and Well-tolerated; Phase 3 Results Show Non-inferiority to Pegylated Interferon

Vertex Pharmaceuticals Announces Acceptance of Telaprevir and VCH-222 Abstracts for Presentation at EASL Annual Meeting

Positive Hepatitis Results Denied By VA

Ultimate Response To Therapy In Chronic Hepatitis C Predicted By 2-Day Results

Potential Target For Cancer, Wound Healing And Fibrosis Discovered

Inhibiting the Hepatitis C Virus

U.S. Liver Cancer Rate Triples, but Survival Improves

Stimulus Help with COBRA Premiums

New Study Finds Daily Drinking Rather Than Binge Drinking Is Biggest Risk Factor In Serious Liver Disease

CANADA: "3,000 Warned of HIV Risk at Tattoo Shop"

March 2009 News Letter

Hepatitis A, B, C'S

Digestive and liver diseases: no joking matter

FDA Approves New Indication for PegIntron plus Ribavirin for Certain Patients Who Failed Prior Hepatitis C Treatment

Bidding for HCV NNRTI ANA598

Identification Of Key Molecules That Inhibit Viral Production May Aid In The Development Of Anti-Hepatitis C Virus Drugs

Clinical, virologic, histologic, and biochemical outcomes after successful HCV therapy: A 5-year follow-up of 150 patients - "No patient had conclusive evidence of virologic relapse" -

Human Genome Sciences Announces Results in Second of Two Phase 3 Trials of Albuferon(R) in Chronic Hepatitis C -

How Inflammatory Disease Causes Fatigue

Q&A: could I catch hepatitis C?

Updated:
Hepatitis C Basics

The Role Of The Omentum In Regenerating The Liver

Stalling Hepatitis C In-Between Health Coverage

Toray Developing Pegylated Interferon Beta for HCV

esearch/msg13411.html"> Transient elastography and other noninvasive tests to assess hepatic fibrosis in patients with viral hepatitis

Liver fibrosis staging with contrast-enhanced ultrasonography: prospective multicenter study compared with METAVIR scoring

Hepatitis C Drug Trial Results Not Good Enough For Investors

Fighting Hepatitis To Tackle Liver Cancer - Survey Reveals National Deficiencies Which Make EU Action Critical

Continuous antiretroviral therapy improves survival in HIV/hepatitis C co-infected patients with liver cirrhosis

Combination therapy eases fibromyalgia symptoms

Proteomics Prove Accurate In Identifying Liver Cancer

Rates of Liver Cancer are Rising, but Survival is Increasing

Vertex Pharmaceuticals Strengthens HCV Drug Development Portfolio, Adds Novel Polymerase Inhibitors to Shape New Combinations with Telaprevir

Vertex Acquires VCH-222 and VCH-759, Two Experimental Oral HCV Polymerase Inhibitors

Merck Will Buy Schering-Plough for $41.1 Billion

HCV Advocate Newsletter:
March, 2009

Alcohol, Hepatitis C: Dangerous Cocktail

HCV SnapShots

HealthWise: HCV Treatment and Sexual Dysfunction

Liver Tumors Associated With Metabolic Syndrome Differ From Other Tumors

HCV NNRTI ANA598 News Update: Anadys Keeps Surging, as Hepatitis C Drug Data Trickles In -

8 Promising Hepatitis C Drugs

Study may lead to new tests for liver toxicity

HCV-Infected Individuals at Increased Risk for Immune Thrombocytopenia Purpura and Autoimmune Hemolytic Anemia

When Acute Hepatitis Develops Into Chronic Hepatitis

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Feb 2009

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