Here's a "HCV Weekly Rewind" of news stories in progress during the week of April 2nd. Click here to view previous "HCV Weekly Rewind" articles.
First up is the European Association for the Study of the Liver (EASL), which is an exciting time for hepatitis C patients. The meeting will give us interim results on new and experimental HCV drugs currently in clinical trials.
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.
Journalist Adam Feuerstein who writes for investors at (TheStreet) has given a summary of a few drugs -winners or losers ?, to watch during the meeting. Although, you may not be an investor the information is easy to digest and worth a look see. Below are a few highlights from his April 4th article titled :Winners, Losers From EASL Hep C Data Dump, which can be found here or better yet click here to read future and current articles from Mr. Feuerstien.
Excerpt :Winners, Losers From EASL Hep C Data Dump
Abbott: Today's results come from a phase II study of its own all-oral Hep C regimen consisting of protease inhibitor ABT-450, a ritonavir booster and the non-nuke polymerase inhibitor ABT-333. The study enrolled treatment naive genotype 1 patients as well as treatment-experienced non-responders. Patients were treated for 12 weeks.
In the treatment-naive patients, SVR12 or hepatitis C "cure" rates were 93% and 95% for the low- and high-dose arms, respectively. These are some of the strongest cure rates seen for new hepatitis C therapies, particularly for regimens that exclude injectable interferon. The high cure rates are even more impressive given that a majority of the patients enrolled were diagnosed with the more difficult-to-treat genotype 1A subtype.
In patients who failed to respond to previous treatment, the Abbott all-oral regimen resulted in a cure rate of 47%.
One looming concern about the Abbott hepatitis C regimen is convenience. As formulated now, patients must take one pill once per day and another two pills twice per day. For a relatively short treatment duration of 12 weeks, remembering to take a total of five pills per day may not be a problem, unless competing companies develop equally effective and simpler therapies.
Idenix: A Roche study combining the nucleoside polymerase inhibitor mericitabine, a protease inhibitor danoprevir and ribavirin proved to be relatively unsuccessful, with a cure rate of 41% overall (71% in genotype 1b patients and just 26% in the harder-to-treat genotype 1a patients.)
This study has nothing to with Idenix except that the company's own nucleoside polymerase inhibitor IDX184 is perceived by some investors to be similar to that of Roche's mericitabine. This raises concerns that any future combination regimen pairing IDX184 with a protease inhibitor may result in similarly poor cure rates.
Idenix CEO Ron Renaud calls comparisons between IDX184 and mericitabine "ridiculous," adding that data already presented shows '184 to be more like GS-7977 than mericitabine. "Comparing '184 to mericitabine, I don't know where that comes from," says Renaud. "It's just conjecture and assumptions being made by some… All we can do is continue to generate good data. We remain as optimistic about '184 as we've ever been." Hepatitis C data not yet released by EASL but expected at the meeting:
Gilead Sciences: Data from two separate but similar studies (ELECTRON and QUANTUM), both involving the two-drug combination of GS-7977 plus ribavirin in treatment-naive genotype 1 patients.
Gilead has said results from the QUANTUM study could be announced in a press release early in the second quarter i.e. before the start of the EASL meeting. Investors are sure to scour the EASL web site Thursday for any early patient data that may give a hint about the later '7977 results. Much is riding on the outcomes from these treatment-naive patient studies because '7977's potency was cast in doubt due to poor results in so-called "null responder" patients.
Bristol-Myers Squibb: Interim results from a phase II study combining Bristol's NS5a inhibitor daclatasvir (BMS-52) with Gilead's GS-7977 in genotypes 1, 2, and 3 is the most highly anticipated data presentation at the EASL meeting this year. The study is important because it will be one of the first glimpses at the Hep C-killing potency of these two classes of direct-acting antivirals combined into a single, all-oral therapy.
If this study is successful, Bristol is expected to swap out GS-7977 for its newly acquired nuke INX-189, gained from the Inhibitex acquisition. Gilead may also capitalize on the study by combining GS-7977 with its own NS5a inhibitor.
--Written by Adam Feuerstein in Boston, continue reading here.
This Weeks Articles
Abbott In The Headlines
In hepatitis C: Curing the incurable
However, ACSH’s Dr. Josh Bloom predicted last year that the Holy Grail of hepatitis C therapy — curing the disease without the use of interferon — might be discovered by Abbott Laboratories. And a new study suggests that this now could be the case. According to recent research, hepatitis C patients who had never before received treatment and were given Abbott’s latest four-drug cocktail showed an astounding 95 percent cure rate. In more difficult cases, where patients had already tried and failed other therapies (and were generally regarded as untreatable), 47 percent were cured. Best of all, this novel drug combination does not include interferon — the first time this has been possible....
1. Abbott hepatitis drug 93% effective in small study - chicagotribune.com
2. Abbott hepatitis C combo impressive in small study - chicagotribune.com
3. Abbott wows the crowd with promising Phase II hep C data - FierceBiotech
4. Abbott Hepatitis C Therapy Works After Other Drugs Fail - Bloomberg
5. More than 90% cured in small hep. C study | Health & Fitness | Life | Toronto Sun
6. Winners, Losers From EASL Hep C Data Dump - TheStreet
7. Abbott To Present Positive Phase 2 Results From Multiple Interferon-Free Studies Of Combination Regimens For The Treatment Of Hepatitis C
8. Abbott To Present Phase2 Result From InterferonFree Studies For Treatment Of HCV
9. Abbott Laboratories Rises To Record High On Hepatitis Drug Study | Biotech/pharma | Minyanville.com
10. Abbott Hepatitis C Therapy Works After Other Drugs Fail
11. CORRECT: Abbott Drugs Suppress Hepatitis C Virus In 2 Mid-Stage Studies
12. Abbott's Hep-C Pressures All Hep-C Rivals (ABT, RIGL, GILD, VRTX, IDIX) - 24/7 Wall St.
13. Abbott Drugs Suppress Hepatitis C Virus in Studies - WSJ.com
14. 2nd UPDATE: Abbott Drugs Suppress Hepatitis C Virus In 2 Studies - WSJ.com
Articles Worth A Click
Chinese Teen Trades His Kidney for iPhone and iPad
A surgeon and four people in southern China have been charged with intentional injury in the case of a 17-year-old boy who sold a kidney for an illegal transplant operation so he could buy an iPhone and an iPad, according to the state news agency on Friday.....
Lab Notes: HCV Vaccine on the Horizon
Researchers have identified a possible new target for the development of a vaccine against the hepatitis C virus (HCV).
Such a vaccine -- which could help control the growing global problem of HCV infection – has been difficult to come by because the virus's constant mutations have thwarted previous attempts to attack it.
Mansun Law, PhD, of the Scripps Research Institute, and colleagues identified a site on the viral envelope involved in fusing the virus to target cells that remains relatively stable, even among divergent strains. Using a technique called exhaustive panning, the researchers identified 73 new antibodies in patients with HCV infection that had neutralizing activity at that site.
One -- AR4A -- stood out from the rest, showing broad neutralizing ability for all 22 HCV strains tested in the lab. The antibody also protected mice from infection with two widely different strains of HCV.
The findings were reported in the Proceedings of the National Academy of Sciences.
-- T.N.
CDC nutrition report: Vitamin D status is public health problem
The Centers for Disease Control and Prevention (CDC) just released their Second National Report on Biochemical Indicators of Diet and Nutrition, reporting the nutritional status of various nutrients in the United States population...
Hepatitis C infections now twice as likely in HIV+ gay men as in injecting drug users, Swiss study finds
The annual incidence of hepatitis C infection in gay men with HIV is now nearly twice that seen in HIV-positive injecting drug users, according to a Swiss study.
Hepatitis C infections started increasing substantially from 2005 onwards, the study finds, and there is an accelerating trend, with a particularly large increase in infections in the last year.
The Swiss HIV Cohort Study (SHCS) of the largest and most complete cohorts of HIV patients in the world; it includes the majority of HIV-positive people in Switzerland. Annual tests for hepatitis C became routine in 1998...
Salmonella Outbreak Infections Rise
By THOMAS M. BURTON
The number of people infected in a multistate salmonella outbreak has reached 100, but federal officials said Friday that they haven't conclusively identified the cause.
The Centers for Disease Control in Atlanta said 10 people have been hospitalized and that no deaths have occurred. The illnesses in 19 states plus the District of Columbia mostly involved people who had recently eaten sushi, sashimi or related types of foods, the CDC said.
But health officials in New York state said it is too soon to peg sushi as the culprit, because not all of the 23 people there who became infected had eaten such raw-fish products. The illnesses involved an unusual strain of the bacteria, known as salmonella Bareilly....
Hepatitis C poses a silent crisis
ALBANY — A dozen women from health clinics, local hospitals and government agencies met in the basement of the Albany County Health Department on Thursday morning to talk about a crisis they say is spreading silently through the region: hepatitis C....
Surveyed U.S. Physicians Who Prescribe Vertex's Incivek More Often Than Merck/Roche's Victrelis Perceive Incivek as Offering a Short, Simple and Highly Efficacious Treatment Option
The High Efficacy of Incivek-Based Triple Therapy is the Most Important Driver of Formulary Inclusion and Favorable Tier Placement of Incivek in Commercial Health Plans, According to a New Report from Decision Resources...
Scripps scientists to develop new HCV screening tools
MDBR Staff Writer
Published 05 April 2012
The National Institutes of Health, an agency of the US Department of Health and Human Services, has funded over $1m to The Scripps Research Institute.
Under the three-year study, Scripps' researchers will develop new screening tools to identify compounds that disable a protein essential to hepatitis C virus (HCV) replication.
Scripps Florida associate professor and study principal investigator Timothy Tellinghuisen said the new research is focused on a potent enzyme, NS2 protease which is necessary for productive infections that produce new viruses and spread the infection among cells.
"The new grant will help us develop potential chemical tools to look at the role of NS2 in HCV biology because we really don't know how the protein works," Tellinghuisen added.
"Our overall goal is to turn our small-scale NS2 assay into an assay appropriate for high-throughput small-molecule screening."
According to recent studies, NS2 protease may be involved in altering gene expression in the host cell and in helping the virus defend against apoptosis or programmed cell death, in addition to the direct roles for the protein in viral replication and particle assembly.
Physician assistant receives 'letter of concern' after medication causes liver damage in patient
According to the letter, a patient suffered from psoriasis and Reid’s former supervising physician prescribed methotrexate, a drug that goes by the brand name Trexall and is commonly used to treat the skin disease.
The letter does not name the patient or the former supervising physician.
The patient’s initial treatment course included frequent liver function testing to monitor for possible liver damage while taking the drug.
The letter said Reid assumed the care of the patient and continued the patient on the same drug. But the patient’s records do not indicate Reid reviewed and considered ongoing liver function testing, the letter said.
Subsequently, the patient developed unrecognized nonalcoholic cirrhosis of the liver, “presumably through longterm use of improperly monitored methotrexate,” the letter said.....
Industry Voices: The Fibrosis Stampede
Fibrosis is wound repair gone bad. It's the process that erodes our organs, slowly and inexorably, in response to a lifetime of injury and insult. Fibrosis burns out the kidneys of diabetics, condemning patients to a punishing regime of dialysis. It turns the livers of hepatitis C patients crusty and cirrhotic, making liver transplant the only way out....
Hepatitis C assay important in patient diagnosis
The new Roche Elecsys anti-HCV II assay can play an effective part in this strategy, as it is used to demonstrate the presence of antibodies against HCV during acute and chronic stages of disease, and after a passed infection.
Due to the high rate of asymptomatic infections, clinical diagnosis of hepatitis C is difficult and screening assays are of major importance.
The Roche Elecsys anti-HCV II assay provides 100% clinical sensitivity for all known genotypes, leading to early detection of infection and patient-oriented decision making...
Hepatitis C Experimental Drug Daclatasvir:Drug Interactions With HIV Medications
Daclatasvir was studied along with asunaprevir (an HCV protease inhibitor in development) in a small study of HCV-monoinfected patients who previously didn't respond to PEG interferon plus ribavirin. In results presented at CROI 2012, the use of "quad" (four-drug) therapy consisting of daclatasvir plus asunaprevir plus PEG intereferon plus ribavirin led to cures for 9 of 10 patients. In addition, 4 of 11 patients who only got the two new HCV drugs (i.e., not PEG interferon or ribavirin) were cured of their HCV infection. Although this is a small study to “test out the waters,” these are pretty amazing results. Much larger trials are now planned in HCV-monoinfected patients......
EASL
EASL: ACH-1625 -Watch Achillion Pharmaceutical for Upcoming Phase IIa Data
Achillion’s pipeline also includes one preclinical-stage drug being developed for bacterial infections, although the bulk of the company’s resources are being spent on HCV (hepatitis C virus). Achillion have five separate HCV drugs in various stages of development, most notable is ACH-1625 which is classified as a protease inhibitor...
EASL2012-New Hepatitis C Data from Boehringer Ingelheim to be Presented
New data from Boehringer Ingelheim's hepatitis C virus (HCV) clinical development program, HCVerso™, have been accepted for presentation at the International Liver Congress™ 2012, the 47th Annual Meeting of the European Association for the Study of the Liver (EASL), taking place April 18 – 22 in Barcelona, Spain. Data from SOUND-C2, a Phase 2b trial evaluating an investigational interferon-free HCV treatment, have been selected for inclusion in official EASL press office activities...
EASL 2012-Merck Presents New Data Analyses for VICTRELIS™ (boceprevir)
Presented for the first time as part of a late-breaker poster session will be results from a randomized trial comparing ribavirin dose reduction and use of erythropoietin as methods of anemia management in previously untreated adult patients with chronic HCV genotype 1 receiving VICTRELIS plus peginterferon alfa and ribavirin (P/R)...
Interim results also will be presented from the PROVIDE study, an ongoing, open-label, single-arm, multicenter rollover study for patients who participated in the P/R control arms of the Phase II and Phase III studies for VICTRELIS and failed to achieve SVR. These interim results will report sustained virologic response (SVR) rates in prior P/R treatment failures after retreatment with VICTRELIS and P/R, including those patients who met the traditional definition of null response (less than a 2 log10 HCV-RNA decline at treatment week 12)...
EASL 2012-List Of Bristol-Myers Squibb Abstracts
20 abstracts on the Company’s research in liver disease have been accepted for presentation at The International Liver CongressTM 2012, the 47th annual meeting of the European Association for the Study of the Liver (EASL), in Barcelona, April 18 – 22. Bristol-Myers Squibb is studying a portfolio of compounds that has the potential to address unmet medical needs for patients with liver disease, including the investigational compounds daclatasvir, asunaprevir, Lambda, BMS-791325, and BMS-986094 (INX-189) for hepatitis C (HCV); brivanib for hepatocellular carcinoma (HCC); and BARACLUDE®(entecavir). BARACLUDE is currently indicated for the treatment of chronic hepatitis B (CHB) in adults with evidence of active viral replication and either evidence of persistent elevations in aminotransferases (ALT or AST), or histologically active disease...
EASL 2012-List Of Vertex Abstracts
Vertex will present data on INCIVEK® (telaprevir) tablets, approved for the treatment of hepatitis C, and one of its hepatitis C medicines in development, the non-nucleoside polymerase inhibitor VX-222, at the 47th Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, April 18 to 22, 2012...
EASL-April 2012 Revised Clinical Practice Guidelines on the Management of Chronic Hepatitis B
April 2012, EASL's revised CPGs on the Management of Chronic Hepatitis B (originally released in October 2008) now include; modified indications for liver biopsy and treatment for HBeAg-negative patients, new stopping rules for pegylated interferon-alfa therapy, amended recommendations for patients with partial virological response at 12 months of therapy with entecavir (ETV) or tenofovir (TDF), a replacement of the add-on strategy for resistance (better focus on lamivudine resistance) - replaced by a switch strategy, recommendations for less frequent HBV DNA testing under ETV or TDF, and more detailed recommendations for specific subgroups (particularly for HBV & pregnancy and for HBV & immunosuppression)....
HCV Resources-Important Updates
New Videos at the Liver Learning Portal AASLD
The Liver Meeting® 2011 Educational Webcast of selected sessions
If you haven't yet explored the "LiverLearning" section available @ the AASLD web site you're missing out on the November meeting webcasts, video podcasts, abstracts and more. Free registration is required, it's quick and painless folks, start the process by clicking Here.
New @ Liver Learning
Mechanisms of HCV DAA Resistance: A Primer
by Jean-Michel Pawlotsky 2012-03-16
Mechanisms and Management of Drug Side Effects, Toxicity and Drug Interactions
by Stefan Zeuzem 2012-03-16
Trials of HCV Protease Inhibitors in Treatment Experienced Patients
by Norah Terrault 2012-03-16
Treatment Rationale for 2012 / Guidelines for Practice
by Michael Fried 2012-03-17
coming soon!
View all updates here
Newsletters
On Monday HCV Advocate published this months newsletter.
HCV Advocate
- In This Issue:
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.
HealthWise: Laughing with Liver
Disease, by Lucinda K. Porter, RN- this is Lucinda’s annual
Disease, by Lucinda K. Porter, RN- this is Lucinda’s annual
April Fools HealthWise. See what tickles your funny bone.
HCV Snapshots Lucinda K. Porter, RN discusses the on-going issue of coffee and the liver, the use of erythropoietin, and transmission of HCV in the health care industry.
Disability & Benefits: Maintaining Your Disability Claim in the Internet Age, by Jacques Chambers, CLU – a must read article—most people have some type of personal information on the internet. Read about the potential harmful effects of social media on disability.
Topics
-Boceprevir (Merck's Victrelis™) treatment will be covered
by PharmaCare in certain cases
-Answers from PharmaCare
-Research News
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