Hepatitis C New Drug Research And Liver Health

CDC- wants all baby boomers to get tested for hepatitis C.

18 May 2012 23:01:11 GMT

In The News

May 18
U.S. health officials want all baby boomers to get tested for hepatitis C.
The Centers for Disease Control and Prevention on Friday released draft recommendations calling for all baby boomers
to get a one-time blood test for the liver disease. That's everyone born from 1945 to 1965.

All baby boomers should get hepatitis C test -CDC
Fri May 18, 2012 1:14pm EDT
Reuters) - All baby boomers should be tested at
least once for the liver-destroying hepatitis C virus, according to proposed guidelines from U.S. health officials released on Friday.The often-undiagnosed virus is transmitted through contaminated blood. While infection rates have dropped dramatically since the early 1990s - due in part to
the introduction of blood and organ screening - many older adults are still at risk, according to the U.S. Centers for Disease Control and Prevention, which released the draft guidelines..Continue Reading @Reuters .

Surveillance of Patients at Risk for HCC Paltry, at 6%
by Christina Frangou
San Francisco�For patients at highest risk for
hepatocellular carcinoma (HCC), the careful surveillance that can lead to early diagnosis is simply not happening, according to a recent study (Singal AG et al. J Gen Intern Med 2012 Jan 4 [Epub ahead of print]).

Studies Illustrate Role of HCV Infection as Risk Factor for HCC
Researchers Stress Importance of Early Detection of HCV

Expert Reviews Diagnostic Imaging for HCC
Increased Sensitivity of Imaging Exams Could Help Improve Surveillance

HCV Weekly Rewind Of Hepatitis C News and Research
This weeks review of HCV headlines and lastest research for the week of May 14, including updates as the day progresses.

Incivek Rash Reports: What HIV/Hepatitis C-Coinfected People Need to Know

18 May 2012 02:25:49 GMT

Rashes have been seen for many years now in hepatitis C (HCV) therapy, ever since we started widely using ribavirin after finding that it increased HCV cure rates. Ribavirin can cause speckled rash all over the body. (Peg-interferon can cause rash too, but it is usually just seen at the injection sites.) It turns out that Incivek (telaprevir), one of the HCV protease inhibitors approved last year, is also associated with rash. When Incivek was presented at the U.S. Food and Drug Administration meetings for drug approval, this rash problem was discussed in great detail.

Milk Thistle Does Not Alter Disease Activity in Hepatitis C Patients

16 May 2012 12:35:21 GMT

San Francisco�One of the first rigorous trials to test the popular herbal extract milk thistle (silymarin) has shown that this treatment does not relieve symptoms or slow disease progression in patients with hepatitis C who are nonresponsive to interferon (IFN). “We must conclude that oral silymarin, given in higher than customary doses, did not significantly alter biochemical or virologic disease activity in hepatitis C patients previously treated with interferon-based regimens,� said lead author Michael W. Fried, MD, professor of medicine and director of hepatology, University of North Carolina, Chapel Hill. Dr. Fried presented the study at The Liver Meeting 2011.

Achillion ACH-3102 announced the receipt of a Fast Track designation

15 May 2012 16:36:37 GMT

ACH-3102 Receives Fast Track Designation From the FDA for the Treatment of Chronic Hepatitis C
Fast Track designation was requested for ACH 3102 for its potential to provide Improved safety as compared to the current standard of care; Potential for development in a once daily interferon-free fixed dose combination; Potent antiviral activity in vitro against HCV genotypes 1 through 6; and Low potential for drug-drug interactions and therefore greater potential to treat HCV patients with comorbidities, co-infected with HIV, or pre- or post-liver transplantation.

Will Interferon-Free Hepatitis C Regimens Prevail?

12 May 2012 22:01:44 GMT

May Updates
This month a special supplementary issue of Gastroenterology with full text viral hepatitis review articles and commentaries are available through open access.

A Few Topics Include;
Maximizing Opportunities and Avoiding Mistakes in Triple
Therapy for Hepatitis C Virus
Recently developed drugs and innovative strategies for the treatment of chronic infection with genotype 1 hepatitis C virus (HCV) have become the standard of care. The protease inhibitors telaprevir (Incivek) and boceprevir (Victrelis) are the first...

Will Interferon-Free Regimens Prevail?
Many promising small molecule inhibitors directed against hepatitis C virus (HCV) proteins (direct-acting antiviral [DAA] agents) and compounds targeting host cell factors (host-targeting agents [HTAs]) are currently in the drug development and...

Click here for the index and links to all open access articles.....

News Of The Day-Interferons and hepatitis C virus

10 May 2012 21:38:57 GMT

In The News
May 10
Interferons and hepatitis C virus
Interferons are not only important for the initial host response to HCV, but remain key components of the immune response during the chronic phase of hepatitis C which lasts decades and can lead to cirrhosis and hepatocellular carcinoma.

April HEPATOLOGY Podcast
Dr. Jasmohan Bajaj on a new, cost-effective standard for diagnosis and treatment of drivers with minimal hepatic encephalopathy.

New challenges in viral hepatitis

9 May 2012 02:35:26 GMT

In The News
May 9
New challenges in viral hepatitis
Although liver inflammation or �hepatitis� can be caused by many infectious and non-infectious conditions, there are at least five viruses for which hepatitis is the primary (or only) clinical manifestation and are thus named: hepatitis A virus (HAV),hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D (or delta) virus (HDV) and hepatitis E virus (HEV).

New Drugs Require New Terms for HCV Virologic
Response

Risk of Liver-Related Deaths Twice as High With Chronic Hep B Versus Hep C
by Tim Horn
In a cohort of men who have sex with men, most of whom were living with HIV, those who were coinfected with chronic hepatitis B virus (HBV) were twice as likely to
die of liver disease compared with those chronically infected with hepatitis C virus (HCV), according to a new report published online of print by Clinical Infectious Diseases...

Clinical Trial-Peg/Ribavirin,Telaprevir in Hepatitis C-Orthotopic Liver Transplant Recipients

8 May 2012 04:05:47 GMT

Clinical Trial-Peg/Ribavirin, Telaprevir in Hepatitis C-Orthotopic Liver Transplant Recipients

Pegylated Interferon, Ribavirin, Telaprevir in Hepatitis C Virus Infection in Orthotopic Liver Transplant Recipients
This study is currently recruiting participants.
Verified May 2012 by University of Chicago
First Received on April 27, 2012.Last Updated on May 2,
2012

Sponsor:University of Chicago
Information provided by (Responsible Party):Helen Te, University of Chicago
ClinicalTrials.gov Identifier:NCT01592006

Click here for more info

Durability of Sustained Response Shown in Paediatric Patients With Chronic

8 May 2012 03:12:52 GMT

Although chronic hepatitis C (CHC) is often benign in young children, the occurrence of fibrosis increases with age and duration of the disease.[4] Thus, effective treatment of children with CHC may reduce the progression of liver disease in young adulthood.[5] Studies using interferon (both nonpegylated and pegylated) plus ribavirin for 48 or 52 weeks in children and adolescents with CHC have yielded sustained virologic response (SVR) rates of 46�65%.[6�11] However, the long-term safety of interferon (both nonpegylated and pegylated) plus ribavirin and durability of the virologic response in children are unknown and are essential outcome measures.

New In May- Relevant research on hepatitis C

2 May 2012 22:43:47 GMT

This months HCV research contains updates from the "Digital Liver Disease Journal" an official digital educational resource from the American Association for the Study of Liver Diseases. Also check out the May review of abstracts from Pubmed provided by Hep C Challenge

Click Here To Begin

�

Hepatitis C - Side effects-direct-acting antivirals

2 May 2012 04:43:33 GMT

MAY 2012
Interferon - Hepatitis C Drug Can Cause Depression

New From-The "Digital Liver Disease Journal"an official digital educational resource from the American Association for the Study of Liver Diseases....

Management of adverse events during the treatment of chronic hepatitis C infection (pages 54�57)
Abstract
Watch the interview with the authors
Watch the video presentation of this article

April 2012
Updated information on drug interactions between Victrelis
(boceprevir) and certain boosted HIV protease inhibitor drugs

Telaprevir May Cause Severe Cutaneous Eruptions NEW YORK
(Reuters Health)

Hepatitis C drug alisporivir is effective, but pancreatitis a concern

EASL-Alisporivir: Pancreatitis Forces Halt to HCV Drug Trial

Summary Of The 47th European Association for the Study of the Liver EASL

EASL: Telaprevir and Boceprevir Effective but Cause Serious Side Effects in Patients With Cirrhosis

EASL-Telaprevir and boceprevir show high rate of serious side-effects in hepatitis C patients with urgent need of treatment
A real-world study of new hepatitis C protease inhibitors in the group of patients who have been told they should not wait for newer, experimental antivirals has shown a much higher rate of serious adverse events and treatment
discontinuations than in clinical trials, Dr Christophe H�zode reported on behalf of the French Compassionate Use of Protease Inhibitors in Cirrhotics cohort study at the 2012 International Liver Congress in Barcelona on Thursday.

More News on Drug Interactions With New HCV Drugs -- This Time With Daclatasvir

Advances in HCV Treatment -Comparison of Telaprevir and Boceprevir

30 Apr 2012 21:37:03 GMT

In The News
April 30

Hepatitis C Virus Therapeutics: At the End of the Beginning
Most management decisions were relatively simple, and most patients could be followed primarily by nurse practitioners and physician assistants The field of HCV therapeutics is moving rapidly and much remains to be learned; thus, firm predictions are inherently risky. It is likely, however, that for the foreseeable future, management decisions will require much more thought than they did in the “easy� days of interferon alfa�based regimens.

Advances in the treatment of hepatitis C virus infection.
Thomas DL. Antivir Med. 2012 Apr;20(1):5-10.
The addition of a protease inhibitor (PI) to what has been the standard HCV therapy of peginterferon alfa and ribavirin dramatically improves sustained virologic response rates in treatment-naive patients with genotype 1 infection.
Similar results have been observed in some treatment-experienced patients in whom prior peginterferon alfa/ribavirin therapy has failed. The use of these new agents has also permitted response-guided therapy, wherein early sustained virologic response to treatment allows for a shortened treatment duration.
However, these new PIs add cost and adverse effects to HCV therapy. Boceprevir is associated with increased risk of anemia and dysgeusia, and telaprevir is associated with increased risk of anemia and skin and gastrointestinal adverse effects. Early studies indicate that the addition of PIs results in high response rates in patients with HCV/HIV coinfection. Other studies suggest that combinations of PIs and other direct-acting antivirals may ultimately permit cure when used in interferon sparing regimens....

Learning / Practising Medicine in theChanging World

EASL: Closing Summary by Jean-Michel Pawlotsky: New HCV Drug Development, Goodbye Interferon?

27 Apr 2012 07:06:07 GMT

EASL Updates @ NATAP

Hepatitis C News and Research Updates

26 Apr 2012 22:05:34 GMT

Updates:
BMS-650032 (Asunaprevir)-BMS-790052 (Daclatasvir)

Danoprevir -RG7227 is second generation protease inhibitor

GS-7977 formally PSI-7977
EASL-Gilead's GS-7977 and Bristol-Myers Squibbs' daclatasvIr.
GS-7977 in combination with PEG-IFN and ribavirin
GS-7977 Plus Ribavirin

GS-5885 is a novel NS5A inhibitor

Boehringer Ingelheim -BI 201335

Vertex-Telaprevir with VX-222

EASL 2012-Updated April 26
Summary Of The 47th European Association for the Study of the Liver EASL
The promise of all oral hepatitis C drug regimens were the highlight of the liver conference this year. For the hepatitis C patient the drug developments in Interferon-free regimes will become the long awaited revolution in HCV treatment.........

U.S.: do not mix Merck hepatitis pill with HIV drugs

26 Apr 2012 21:39:58 GMT

(Reuters) - U.S. drug regulators are changing the label for Merck & Co Inc's recently approved Victrelis treatment for hepatitis C to show it should not be taken with some widely used HIV medicines.

Updated-Side effects-direct-acting antivirals for hepatitis C

25 Apr 2012 05:14:39 GMT

Side effects-direct-acting antivirals

Telaprevir May Cause Severe Cutaneous Eruptions NEW YORK (Reuters Health)

Hepatitis C drug alisporivir is effective, but pancreatitis a concern

EASL-Alisporivir: Pancreatitis Forces Halt to HCV Drug Trial

EASL: Telaprevir and Boceprevir Effective but Cause Serious Side Effects in Patients With Cirrhosis

EASL-Telaprevir and boceprevir show high rate of serious side-effects in hepatitis C patients with urgent need of treatment

Click Here For Updates

EASL 2012-Summary Of The 47th European Association for the Study of the Liver

24 Apr 2012 02:52:28 GMT

The promise of all oral hepatitis C drug regimens were the highlight of the liver conference this year. For the hepatitis C patient the drug developments in Interferon-free regimes will become the long awaited revolution in HCV treatment.

Friday Wrap-2012 EASL Headlines for April 18-20

21 Apr 2012 00:33:44 GMT

Greetings,
Here's this weeks round-up of the European Association for the Study of the Liver (EASL) taking place in Barcelona, Spain.
Offered on the blog are links to this weeks interim results on new and experimental hepatitis C drugs.
Click here for a collection of headlines,slides,data of the meeting, and here for EASL updates throughout the day.

EASL:NEW DATA SUGGESTS INTERFERON-FREE THERAPY AROUND THE CORNER

19 Apr 2012 00:59:27 GMT

The 47th European Association for the Study of the Liver
EASL - 2012

**Click Here To View All Updates

NEW DATA SUGGESTS INTERFERON-FREE THERAPY AROUND THE CORNER FOR HCV PATIENTS

Further data shows PegIFN-?�s comparable efficacy but better safety profile than PegIFN-a

Barcelona, Spain, 19 April 2012 /PRNewswire/ � New data presented at the International Liver Congress™ 2012 shows consolidation of the interferon-free (IFN) revolution in HCV treatment. The much anticipated data from a number of clinical trials 1,2,3,4,5,6 confirm that combinations of antivirals offer the hope of shorter, more effective treatment with fewer side effects.

The following new studies cover the treatment of HCV patients with genotypes (GT) 1, 2 or 3, who were administered ribavirin (RBV) - without IFN - and either one or two other drugs: direct-acting antivirals HCV nucleotide analogues, HCV protease inhibitors, non-nucleoside RNA polymerase inhibitors � or host-targeting antivirals cyclophilin A inhibitor.

PROTON & ELECTRON
�Lawitz E, et al �PSI-7977 PROTON and ELECTRON: 100% concordance of SVR4 with SVR24 in HCV GT1, GT2, & GT3� and the related abstract Gane EJ, et al �ELECTRON: once daily PSI-7977 plus RBV in HCV GT1/2/3�.
�In Lawitz E, et al, 100% of HCV GT2 or 3 patients (10) achieved SVR4 after treatment with PSI-7977 and RBV. In Gane EJ, et al, of nine HCV GT1 prior null-responders treated with PSI-7977 and RBV for 12 weeks, 7 had undetectable levels of HCV RNA by week 2.

SOUND-C2
�Zeuzem S, et al �SVR4 and SVR12 with an INTERFERON-FREE regimen of BI201335 and BI207127, +/- RIBAVIRIN, in treatment-na�ve patients with chronic genotype-1 HCV infection: interim results of SOUND-C2�.
�Treatment-na�ve GT1 HCV patients treated with a regimen of BI201335, BI207127 and RBV achieved 60% SVR12 after 16 weeks of treatment and up to 70% SVR4 after treatment with a lower BI207127 dose (600mg BID) for 28 weeks.

VITAL-1
�Pawlotsky J-M, et al �ALISPORIVIR plus RIBAVIRIN is highly effective as INTERFERON-FREE or INTERFERON-ADD-ON regimen in previously untreated HCV-GT2 or GT3 patients: SVR12 results from VITAL-1 phase 2b study� and the related abstract Alberti A, et al �ALISPORIVIR (ALV) plus PEG-INTERFERON/RIBAVIRIN (PR) in HCV G1 treatment-experienced patients achieves primary endpoint with superior efficacy at treatment week 12 compared to retreatment with PR�.
�In Pawlotsky J-M, et al, 88% of treatment-na�ve HCV GT2 or 3 patients achieved SVR 12 after treatment with Alisporivir and RBV. In Alberti A, et al, 70% of null non-responders achieved cEVR when treated with Alisporivir, IFN and RBV.

AI444040
�Sulkowski M, et al �Potent viral suppression with all-oral combination of DACLATASVIR (ns5a inhibitor) and GS-7977 (ns5b inhibitor), +/-RIBAVIRIN, in treatment-na�ve patients with chronic HCV GT1, 2, or 3�
�Treatment-na�ve HCV GT1, 2, and 3 patients given an IFN- and RBV-free once-daily combination of DACLATASVIR and GS-7977 for 24 weeks achieved high rates of early virologic response (HCV RNA detectable at week 4 but undetectable at week 12 EVR) by mITT analysis: 97% EVR in GT1, 90% in GT2 and 3.

The combination of PegIFN-a and ribavirin (RBV) is the current standard of care for chronic HCV7, but is associated with a number of side effects � including flu-like symptoms, psychiatric manifestations, autoimmune reactions, and hematologic toxicities.8,9 Between 20-40% of patients require a dose reduction or temporary interruption in their PegIFN-a and ribavirin (RBV) treatment10 and in 10-14% of patients, side effects are so severe that treatment must be discontinued.8,9

However, studies have shown that achieving a virologic response in chronic HCV is much more dependent on the dose of IFN-a11/PegIFN-a12,13,14 than RBV15,16,17,11,18. As such, PegIFN-a free therapy is highly anticipated by healthcare professionals and patients alike.

EASL�s Secretary General Professor Mark Thursz commented on the exciting new data being showcased at the congress: “In the future, patients can look forward to all oral treatment regimens with high success rates and low side effects. Furthermore, there is a large cohort of patients with more advanced liver disease who will now be able to access treatment that was previously impossible due to the side effects of Interferon-alpha. Over the last five years we have seen an evolution in HCV treatment, with direct antivirals used in combination with Pegylated Interferon and Ribavirin. Interferon-free regimes truly represent a revolution in treatment.�

Separate data presented at the congress may provide a further option. New results from a phase IIb study show a different form of interferon pegylated Interferon-lambda (PegIFN-?) � administered with RBV for 24 weeks in HCV GT2 & 3 patients gives comparable SVR24 (undetectable HCV RNA levels 24 weeks after treatment) to PegIFN-a-2a and RBV, but with fewer side effects (musculoskeletal and flu-like symptoms, hematologic toxicity) and dose modifications for PegIFN or RBV.

EASL�s Secretary General Professor Mark Thursz commented: “It remains possible that a number of patients will still need interferon based therapy for their HCV infection. Interferon-lambda, with a better side effect profile, looks like an excellent option in this group of patients, who are likely to have more advanced disease.�

Updates-TMC435 and aclatasvir (BMS-790052)

18 Apr 2012 19:52:36 GMT

New on the blog in Multimedia/Videos
Podcast
The Race To Create The Best Antiviral Drugs - "Today, people with Hepatitis C can get interferon treatment, but it doesn't work all that well. It has some benefit, but not as much as Eleanor Fish would like," says Zimmer. "So she has been essentially tweaking the interferon molecule to make it more effective, to make it last longer, to make it safe and to make it cheap. Because what she wants to do is deploy interferon all over the world where there isn't fancy

Video
Douglas Dieterich, M.D., a leading expert on hepatitis C, speaks about contracting hepatitis C as a medical student and his life's goal of fighting the disease once he was cured.

EASL-INCIVO® (Telaprevir) SVR Rates Unaffected by Ribavirin Dose Reduction in Treatment Na�ve and Previously Treated Patients With Genotype-1 Chronic HCV
View All EASL Updates Here

Vertex to Begin Enrollment in a Phase 2 Study of its Most Advanced All-Oral Regimen

In the coming weeks, Vertex will begin enrollment in a Phase 2b study evaluating combination regimens of INCIVEK, VX-222 and ribavirin. The study will evaluate total treatment durations as short as 12 weeks in people with genotype 1 (1a and 1b) hepatitis C who are new to treatment and will not use response-guided treatment criteria. If successful, Vertex plans to submit a New Drug Application (NDA) to the FDA for its first all-oral regimen as early as the end of 2014...Read More Here

Medivir said. Medivir announces TMC435 in an expanded clinical collaboration
18-Apr-12
Expanded clinical study program evaluating a combination of TMC435 and aclatasvir (BMS-790052)
TMC435 and BMS-986094 (formerly INX-189), two direct-acting antivirals in combination, will be evaluated in clinical trial
Continue Reading...

BMS-650032 (Asunaprevir) BMS-790052 (Daclatasvir)-A revolution in HCV treatment with direct-acting antivirals: from non response to eradication
Both daclatasvir and asunaprevir produce marked declines in HCV RNA levels in patients with HCV genotype 1 infection [9-10] and administration of the two drugs in combination did not produce a clinically meaningful pharmacokinetic
interaction [11].

April 16-Update-Hepatitis-Multimedia/Videos

17 Apr 2012 02:20:16 GMT

New on the blog
Multimedia/Videos
1-Determinants of Serum Alpha-Fetoprotein levels in Hepatitis C�Infected Patients
2-The Health Report - Causes of cancer
3-Combating Hepatitis C
4-Hepatitis C Could You Have It ?

Prevalence of fibromyalgia among patients with chronic hepatitis C infection: relationship to viral

15 Apr 2012 05:02:23 GMT

We determined the prevalence of fibromyalgia syndrome (FMS) in a cohort of subjects with chronic hepatitis C virus (HCV), and the relationship to subject demographics, viral characteristics, and quality of life.

Taking Your Hepatitis C Triple Therapy 1-page handouts

13 Apr 2012 00:33:55 GMT

VA-Taking Your Hepatitis C Triple Therapy 1-page handouts
One-page printable handouts for providers to give to patients
who are taking one of the new hepatitis C drugs--boceprevir or telaprevir--with
tips on how and when to take the medications, and what to do if you miss a dose.
Boceprevir handout
Telaprevir handout
VA National Hepatitis C Resource Centers

EASL Brief Preview, liver conference next week in Barcelona: interferon-free therapies

13 Apr 2012 00:27:05 GMT

The annual European liver meeting EASL, European Association for the Study of the Liver, starts April 18 where there will be new data on numerous oral HCV drugs in various stages of development and on new interferon-free oral HCV drug therapies

EASL-Where Do I Find 2012 Abstracts And Meeting News

6 Apr 2012 23:27:06 GMT

The 47th European Association for the Study of the Liver
EASL - 2012
**Click Here To View Blog Updates

The meeting begins on April 18 but the public can view abstracts ahead of time by clicking here. To view only posters/abstracts click here. If this is your first time checking out the EASL click here for a few links and tips on searching for abstracts.

Meeting Summary Coming Soon

Hepatitis C News Of The Day

3 Apr 2012 22:11:59 GMT

Hepatitis C Newsletter @ HCV Advocate

Drugs in Development: Update, by Alan Franciscus, Editor-in-Chief � read about the latest developments in the HCV drug pipeline including GS-7977, VX-222 and HIV/HCV coinfection studies on telaprevir and boceprevir.

From The Body

Hepatitis C Experimental Drug Daclatasvir:Drug Interactions With HIV Medications

Check out additional news at Hepatitis C New Drug Research...