Friday, February 24, 2012

HCV News Ticker - Friday Round-Up

Good Afternoon Folks,
As the week comes to a close, I celebrate the national focus placed on hepatitis C this week. The last few days of awareness was first generated  when research resulted in the devastating headlines that "Hepatitis C Now Kills More Americans Than HIV "

The research has given rise to many new articles on HCV, thank goodness. The CDC took part in the Q&A article @ Time Healthland discussing risk, transmission and treatment.
Healthland spoke with Dr. John Ward, who heads the CDC’s effort to fight hepatitis C, about who is at risk of infection, how the disease is really spread and why it’s important to know your hepatitis C status now.

The author Lucinda K. Porter, RN, may sound familiar to the HCV community, she has written for HCV Advocate since 1998. Over the years, many HCV patients have gained invaluable information by reading Ms. Porters HealthWise columns published in the sites monthly newsletters. This December the authors new book "Free from Hepatitis C: Your Complete Guide to Healing Hepatitis C" was published. The book is a must read for the newly diagnosed, or anyone living with hepatitis C. I am honored to point my readers to a new review of Ms. Porters book at Xpress Reviews, please check out the review here, and if interested click here to order "Free from Hepatitis C: Your Complete Guide to Healing Hepatitis C." priced at $11.77.

Most Popular Articles On The Blog And Website This Week  



In The News

Hepatitis C, a leading killer, is frequently undiagnosed but often curable

February 24, 2012
By Jeffrey Norris

(Medical Xpress) -- Hepatitis C virus — not AIDS-causing HIV — is the leading chronic virus infection leading to death in the United States, and its victims most often are baby boomers. More than half who are infected do not know it.

Researchers from the U.S. Centers for Disease Control and Prevention (CDC) found in a study published in the February 21 issue of the Annals of Internal Medicine that C had overtaken HIV as a cause of death in the by 2007.

Deaths in the United States due to HIV infection have been steadily decreasing, and  dropped below 13,000 in 2007, while deaths from hepatitis C infection have been steadily increasing, first surpassing 15,000 per year in 2007.

The good news, according to UCSF liver specialist Alex Monto, MD, is that there has been progress in fighting both diseases, and the kinds of drug combination strategies that have done so much to transform HIV infection from a death sentence to a manageable disease are poised to further boost cure rates for those infected with hepatitis C.

“We know that not enough people with risk factors get tested,” Monto says. “There are a lot of people walking around with hepatitis C who don’t know it.”
Monto directs the liver clinic at the UCSF-affiliated San Francisco Veteran’s Affairs Medical Center, one of four hepatitis C centers nationally within the VA system. Like boomers, veterans are disproportionately affected by hepatitis C. The VA cares for 165,000 patients who are chronically infected with the virus.

Three Million in U.S. Diagnosed with Hep C
Chronic Hepatitis C has been diagnosed in about three million people in the United States. It often causes no symptoms, and many who have been infected for years or even decades may remain unaware of it until symptoms finally appear. The ultimate cause of death attributable to chronic infection is cirrhosis or liver cancer, although the disease progresses to cirrhosis in fewer than half of cases. There is no vaccine.

“The main risk factor in the United States is past injection-drug use,” Monto says. “The others most at risk are those who received blood transfusions before 1992,” Monto says, referring to the year when high-quality screening of the blood supply was implemented.

Compared to HIV or hepatitis B, the risk of hepatitis C being transmitted by sex is low, Monto says, but among men who have sex with men there has been an increase in reports of the virus being sexually transmitted, more so among those who are infected with HIV.

“Anybody with a history of ever being exposed to injection drugs or who received a transfusion before the blood supply was screened should be tested,” Monto says. “That’s not controversial at all. What has been controversial is whether or not all baby boomers should be screened.”

Another study in this week’s edition of the journal suggests that a one-time blood test ordered by primary care providers to screen for antibodies to hepatitis C in those born between 1945 and 1965 would be cost effective — costing $2,874 for each chronically infected patient identified — and would lead to the identification of more than 800,000 previously undiagnosed cases.
Those who are chronically infected may be able to reduce the likelihood of disease progression by avoiding alcohol, by maintaining a healthy weight, and by being vaccinated against hepatitis A and hepatitis B, Monto says.

Treatment Often Cures Hepatitis C
About four out of five who are infected do not rid themselves of the virus without treatment. For about a decade the standard treatment was a combination of two drugs — pegylated interferon given once per week by subcutaneous injection, and daily ribavirin pills, with treatment lasting from six to 11 months. This treatment represented a vast improvement — offering cure rates of 40 percent to 50 percent in most patients, according to Monto.
Within the past year two new drugs of a type known as protease inhibitors have become available. These are valuable for the 75 percent of U.S. hepatitis C patients infected with a form of the virus called genotype 1. With the protease inhibitors added to the mix, the duration of treatment may be shorter, and the cure rate has increased to about 70 percent in patients who have not previously been treated, Monto says. A cure may be less likely for those who have been previously treated, depending on how they responded to earlier treatment.

“New therapies are clearly getting better, and there are probably 25 to 30 new drugs in the pipeline, with many coming out in the next few years,” Monto says. “There are going to be drugs that are better than the ones we have so far.” Several UCSF researchers, including Monto, are helping to evaluate new drugs in clinical trials. UCSF researchers also are investigating the role of the immune system in hepatitis C and hepatitis B infection.

Not to Be Confused with Hepatitis B
Hepatitis B chronically infects about half as many as in the United States, and hits those of Asian descent especially hard — they account for half of hepatitis B infections. Hepatitis B is responsible for about 1,800 deaths yearly in the United States.

Despite the similar names, the two viruses are not closely related. Hepatitis B is spread much more easily through sexual intercourse, and passes from mother to newborn child much more easily. In most adults who become infected the immune system successfully controls infection. Only about five percent of adults exposed to hepatitis B become chronically infected, according to Monto.

There are vaccines for hepatitis B. A UCSF laboratory team led by William Rutter, PhD, now professor emeritus, first demonstrated that an uncontaminated source of material for a hepatitis B vaccine could be obtained by mass-producing viral proteins in genetically engineered, laboratory-grown yeast. This was the groundwork leading to the first marketed genetically engineered vaccine, made by Chiron, a company co-founded by Rutter.
Provided by University of California, San Francisco (news : web)

Big Pharma

Idenix Pharmaceuticals Reports Fourth Quarter and Year End 2011 Financial Results and Provides Pipeline Update

CAMBRIDGE, Mass., Feb. 23, 2012 /PRNewswire/ -- Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported unaudited financial results for the fourth quarter and year ended December 31, 2011 as well as the advancement of its hepatitis C virus (HCV) development pipeline. 

Operational Highlights
IDX184 Program

The Company's lead program, IDX184, is a pan-genotypic oral nucleotide polymerase inhibitor for the treatment of HCV. In July 2011, Idenix initiated enrollment of treatment-naive HCV-infected patients into a 12-week phase IIb clinical trial of IDX184 in combination with pegylated interferon and ribavirin. In January 2012, the Company reported an interim analysis from this study of the first 31 patients who completed 28 days of treatment demonstrating favorable safety and antiviral activity. At 12 weeks, the Complete Early Virologic Response (cEVR < 25 IU/mL) was 93% for the 100 mg IDX184 arm (n=15) and 81% for the 50 mg IDX184 arm (n=16) of the study (intent-to-treat analysis). The side effect profile of the combined therapy has remained consistent with the known safety profile for pegylated interferon and ribavirin.

In February 2012, the U.S. Food and Drug Administration removed the partial clinical hold on IDX184 after review of the interim phase IIb data and the independent Data Safety Monitoring Board's recommendation to continue the study. The Company has now begun enrollment of an additional 30 patients under expanded enrollment criteria in the ongoing phase IIb clinical trial. Additionally, the Company anticipates implementing a broad phase IIb program with IDX184, focusing on the evaluation of interferon-free direct-acting antiviral (DAA) combination regimens, in the coming months.

IDX719 Program

In January 2012, the Company initiated a phase I clinical study of IDX719, its NS5A inhibitor candidate. The first part of the study is evaluating the safety, pharmacokinetics and food effect of IDX719 in 48 healthy volunteers at single doses ranging from 5 to 100 mg. Dosing up to 50 mg has been completed in healthy volunteers and to date IDX719 has been well tolerated. A cohort of eight HCV genotype 1-infected patients received single doses of IDX719 of either 1, 5, 10 or 25 mg (2 patients per dose). Mean maximal viral load reductions were 1.9 log(10), 2.6 log(10), 3.3 log(10) and 3.7 log(10), respectively. A 3-day proof-of-concept segment of the study in treatment-naive genotype 1 HCV-infected patients is expected to begin in the second quarter of 2012 with additional cohorts of genotype 2, 3, or 4 HCV-infected patients to be added during the study.

Nucleotide Discovery Program

In January 2012, Idenix selected two nucleotide inhibitors, IDX19368 and IDX19370, as potential clinical candidates from its novel nucleotide prodrug discovery program. IDX19368 has demonstrated strong potency in preclinical studies and as a result the Company has chosen IDX19368 as its lead candidate and expects to submit an investigational new drug application (IND) for IDX19368 in mid-2012. The Company continues to identify new promising compounds and evaluate multiple candidates for further development from this discovery program.

"Our focus for 2012 will be to build on the progress we made last year through the continued advancement of our pipeline of novel HCV drug candidates," said Ron Renaud, Idenix's President and Chief Executive Officer. "Now that the partial clinical hold has been removed for IDX184, we will be able to explore the full potential of this promising nucleotide polymerase inhibitor in combination with other DAAs in a broad phase IIb program. The early results are promising for IDX719, our NS5A inhibitor, in HCV patients and we look forward to completing the phase I clinical trial, as well as initiating a phase I study for our next-generation nucleotide inhibitor, IDX19368. We believe that the potent and pan-genotypic profiles of our drug candidates support their potential role in future HCV combination regimens."

Vertex Stays in HepC Game, as All-Oral Combo Passes Small Study
Source Xconomy 

Vertex Pharmaceuticals, some investors theorized in recent months, was about to be left in the dust by other companies with more effective drugs in development against hepatitis C. Today, Vertex released some clinical trial data which just might make some folks wait a minute before declaring this story to be “Game Over.”

The Cambridge, MA-based biotech company (NASDAQ: VRTX) today released some preliminary results from a study of 46 hepatitis C patients who got a combination of three oral pills—Vertex’s telaprevir (Incivek), its experimental drug VX-222, and standard ribavirin as their first form of treatment. The study found that 83 percent (38 of 46 patients) had undetectable amounts of the liver-damaging virus after 12 weeks of therapy on the three-pill combo regimen. While patients aren’t considered cured until 24 weeks have passed with undetectable amounts of the virus in the blood, past studies have shown that 12-week measurements are typically predictive of what researchers can expect to see at 24 weeks.

Shares of Vertex climbed 3.4 percent, to $38.90, in mid-day trading after the news.
The results are a small feather in Vertex’s cap, as it seeks to hold onto its market leadership position in hepatitis C, and improve upon the standard of care by eliminating the standard injectable interferon that causes flu-like side effects. Vertex won FDA approval last May for its market-leading protease inhibitor, telaprevir, which, when given with interferon and ribavirin, doubled the cure rate to about 80 percent of patients new to therapy. But competition in the field is fierce, as various companies are researching antiviral cocktails that include not just protease inhibitors, but also nucleotide polymerase inhibitors, and non-nucleotide polymerase inhibitors that attack the virus from different angles, and seek to raise the cure rate to near 100 percent, while getting rid of the dreaded interferon.

Gilead Sciences paid $11 billion last November to acquire Pharmasset and its portfolio of nucleotide
polymerase inhibitors that seek to establish a new standard of care, and Bristol-Myers Squibb countered in January with a $2.5 billion takeover of Inhibitex. But just six days ago, Gilead stock tumbled when it released preliminary data from a study that said six of eight patients who hadn’t responded to prior therapy, and then took its nucleotide polymerase inhibitor (GS-7977) along with ribavirin, ended up having relapses. That finding put a dent in the thesis that the Gilead drug would work on its own against virtually all genotypes of hepatitis C patients, even in tough patients who failed on prior therapies. Essentially, it created an opening for Vertex and other companies, as Gilead said in a statement that “additional direct acting antivirals may be necessary,” for the toughest patients to treat.

It’s too soon to say if Vertex’s combo will end up being the answer to Gilead, but if Vertex can follow through on this latest finding, and turn in an application for FDA approval of the new all-oral regimen by year-end 2014 or early 2015, that “would keep Vertex competitive in the emerging all-oral space for HCV,” said Jason Kantor, an analyst with RBC Capital Markets, in a note to clients today. He added a caveat that “the sustained viral response (SVR) data presented, however, is only from a small and select portion of the total patients treated, and future updates will be key to determining the real efficacy of this regimen.”

Side effects of the drug were mostly mild, and there were no cases of moderate to severe rash that has been seen in other studies of Vertex’s telaprevir when given in combination with interferon and ribavirin. Two patients with the genotype 1b form of the virus dropped out of the study because of adverse events, Vertex said. More data from this study, called Zenith, has been submitted for detailed presentation at a medical meeting in the first half of 2012, Vertex said.

Based on the encouraging antiviral response rates seen so far, Vertex plans to run a bigger Phase 2b study of this all-oral regimen of telaprevir, VX-222, and ribavirin among patients with the most common genotypes of the disease (1a and 1b), and who are new to treatment. That trial would be designed to lay the groundwork for a pivotal, Phase 3 trial that could serve as the basis for an FDA application for marketing, Vertex said.

Besides this combo, Vertex is testing other all-oral combinations, through molecules it obtained in a collaboration with South San Francisco-based Alios Biopharma. For more of the background on that deal and its strategic importance to Vertex’s position in the hepatitis C market, see this feature story from last month.

Luke Timmerman is the National Biotech Editor of Xconomy, and the Editor of Xconomy Seattle. E-mail him at or follow him on Twitter at

Review Article
Full Text-Download PDF, or view HTML 

Context: HCV infection is strongly associated with development of insulin resistance and type-2 diabetes, however molecular mechanism of these associations is not known. The aim of this review was to conduct a comprehensive literature search to understand the nature of the association between hepatitis C virus (HCV) infection and insulin resistance (IR). We also explored the role of HCV core protein and NS5a in modulating the course of the insulin-signaling pathway.

Evidence Acquisitions: We searched Directory of Open Access Journals (DOAJ) Google Scholar, Pubmed (NLM), LISTA (EBSCO), Web of Science (TS and PakMediNet).

Results: Emerging evidence suggests an association between HCV infection and carotid/coronary vascular disease. IR appears to be a dominant underlying cause of accelerated atherosclerosis in patients with chronic hepatitis C (CHC). HCV can induce IR directly through the stimulation of SOCS3 and PPA2, and both of these molecules have been shown to inhibit interferon-α signaling. Improvement of insulin sensitivity may increase the response rate to antiviral treatment and prevent IR complications, including vascular diseases. The results of several clinical trials that have used insulin sensitizers (metformin and PPAR-γ agonists) have been inconclusive.

Conclusions: Beside the association between HCV and IR, the published data also have showed the possible association of HCV core and NS5A protein with IR. 

Full Text-Download PDF, or view HTML 

Liver Cancer

Chemotherapy Beads Used To Fight Cancer
By: Ellie Merritt |
There's a procedure many have never heard of but is being used to treat certain cancers with great success, especially liver cancer.

It's called transarterial chemoembolization and is often referred to as "chemo beads." It is a minimally invasive procedure that injects chemotherapy drugs directly into the blood vessel feeding the tumor.

It's called transarterial chemoembolization and is often referred to as "chemo beads." It is a minimally invasive procedure that injects chemotherapy drugs directly into the blood vessel feeding the tumor.
Continue Reading Here

Elsewhere On The Internet

Featuring Experts@ WebMD
Melissa Palmer, MD
Melissa Palmer, MD is medical director of hepatology at NYU Hepatology Associates Plainview and is clinical professor of medicine at NYU. She graduated from Columbia University with a BA and was trained in hepatology (as well as medical school) at the Mount Sinai School of Medicine in New York City. Dr. Palmer is Board Certified in Gastroenterology and in Internal Medicine.
Palmer runs the popular liver web site

Recent Posts Answered By Melissa Palmer, MD @ WebMD® Hepatitis Community

No comments:

Post a Comment