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Welcome to HCV Advocate’s hepatitis blog. The intent of this blog is to keep our website audience up-to-date
on information
about hepatitis and to answer some of our web site and training audience questions.
People are encouraged to submit questions
and post comments.

Be sure to check out our other blog: Hepatitis & Tattoos

Alan Franciscus
Editor-inChief
HCV Advocate
HBV Advocate


Friday, March 30, 2012

Increasing Routine Viral Hepatitis Testing

The Viral Hepatitis Action Plan spells out the importance of identifying persons infected with viral hepatitis early in the course of their disease as an important component of national efforts to improve diagnosis, care and treatment to prevent liver disease and liver cancer.  As awareness of viral hepatitis increases and treatment options become more effective and better tolerated, it is vital that we implement best practices to improve the frequency, availability, and acceptability of viral hepatitis testing.

To inform and advance these efforts, my office hosted a day-long consultation last month. Sharing their perspectives with us were representatives from state and local health departments, community health centers, drug treatment and correctional health programs, local and national advocacy organizations, the American Association for the Study of Liver Disease, the National Medical Association and other partners. Also participating in the discussion were experts from various federal agencies including the Centers for Disease Control, Agency for Healthcare Research and Quality, Centers for Medicaid and Medicare Services, HRSA’s Bureau of Primary Health Care and HIV/AIDS Bureau, Indian Health Service, National Institutes of Health, Office of Minority Health, and Substance Abuse and Mental Health Services Administration, as well as Federal Bureau of Prisons and the Department of Veterans Affairs.

Hepatitis C Review - Acetaminophen -Tylenol

You may recall in 2011 Johnson & Johnson reduced the maximum daily dose of its Extra Strength Tylenol pain reliever, lowering the risk of accidental overdose from the drugs active ingredient acetaminophen.

Today on the blog those label changes are highlighted with the hepatitis C patient in mind.

Read More...

Hepatitis C Information and Support Group with Book Signing

Lucinda Porter, RN, author of Free from Hepatitis C, will be at the Hepatitis C Information and Support Group in Redwood City, CA on Thurs, April 19. Ms. Porter is a nurse who has hepatitis C a recognized hepatitis C authority and patient advocate. She will be talking about hepatitis C, following with a book signing.

Sequoia Health and Wellness Center, 749 Brewster Avenue,Redwood City, 3rd Thursday of the month, 7-8:30 PM. Free, open to all. For more information, call (650) 367-5998

Read More...

Thursday, March 29, 2012

HIV, Hepatitis C rapid testing now in D.C.

A D.C. pharmacy has become the first in the nation to screen for HIV and Hepatitis C with a new rapid test—providing results in the time it takes to drink a cup of coffee.

D.C. pharmacy first to offer HIV, Hepatitis C rapid testing
The Ora-Quick HIV test is the first of its kind to detect the virus through an oral swab. The Hepatitis C test was just approved by the FDA—both give results in 20 minutes. D.C.’s Bio Scrip pharmacy is the only place in the country where you'll find a pharmacist offering both tests

Read More...

Wednesday, March 28, 2012

Video- Featuring Hepatitis C Advocate Shari Foster

Featured in this video from YNN news in Rochester NY is Shari Foster a respected HCV advocate and old friend. Ms. Foster is the President & Chief Executive Officer of Status C Unknown, Inc. The non-profit organization was founded in response to the overwhelming need for hepatitis c public education in New York. Status C Unknown is dedicated to dispelling myths regarding this disease and providing support, testing and education to all communities.

I met Shari over ten years ago online supporting friends who were living with hepatitis C. Years later I had the privilege of meeting Shari in person at a mutual friends home here in Michigan. Our friend was in end-stage liver disease and passed away soon after, it was a difficult time for all of us. Before undergoing standard HCV therapy Shari was listed for a transplant. Please take time to read the article accompanying the video written by Marcie Fraser, here.

Read More...

Hepatitis B program helps cut infant infections

A program to prevent chronic hepatitis B infection in newborns seems to be working, according to a new study from researchers at the Centers for Disease Control and Prevention.

They found that more babies exposed to hepatitis B through their moms have gotten vaccinated right away, and fewer have ended up with chronic infections, since the program started in 1990.

Read More...

Antiretroviral rollout provides a model for efforts to expand hepatitis C treatment and care in resource-limited settings

The rollout of antiretroviral therapy in resource-limited settings provides a model for efforts to increase access to hepatitis C treatment and care in similar settings, investigators argue in the online edition of Clinical Infectious Diseases.

“Expanding access to hepatitis treatment in resource-limited settings will require a dedicated effort to overcome practical and political challenges,” comment the authors. “Perhaps the most important lesson from the scaling up of ART [antiretroviral therapy] during the last decade is that this will not happen without clear political commitment, and the engagement of civil society to hold policy makers and drug manufacturers to account.”

Read More...

VICTRELIS™ Now Available for Eligible Patients in British Columbia

BC PharmaCare recently announced the reimbursement of VICTRELIS™ (boceprevir) for eligible British Columbians living with chronic hepatitis C.

Boceprevir is a first-in-class oral hepatitis C virus (HCV) protease inhibitor for the treatment of chronic hepatitis C genotype 1 infection. It is to be used in combination with peginterferon alpha and ribavirin (peg/riba) in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous therapy.1 When added to peg/riba, boceprevir can significantly increase a patient's chance of clearing the virus from the body.2,3 The treatment was authorized for use in Canada in July 2011.

Read More...

CROI 2012: Two hepatitis C drugs greatly increase HCV cure rates in co-infected people

In 2011, two protease inhibitors for treating hepatitis C (HCV) came to market: Incivek (telaprevir) and Victrelis (boceprevir).  They were approved only for mono-infected individuals, or those with HCV only. However, between one-quarter and one-third of people living with HIV also have hepatitis, and knowing how well both drugs perform in co-infected people is urgently needed.

The results from two co-infection studies were presented in March at the Conference on Retroviruses and Opportunistic Infections (CROI) held in Seattle.  Both looked at the undetectable HCV viral loads at 12 weeks after people had ended their 48 weeks of Incivek or Victrelis treatments (plus standard treatment drugs). This time point is important as it helps predict the “viral cure” of HCV, or undetectable HCV viral load at week 24 after the end of HCV treatment.

Read More...

Screening for hepatitis C in jail

Every day thousands of Americans with treatable physical or mental health problems are locked up in jails and other secure facilities. Work by Theodore Hammett and others makes clear that a surprisingly large fraction of Americans living with HIV, tuberculosis, and a variety of psychiatric disorders pass through the correctional system every year. All too often, men and women with these disorders pass through criminal justice facilities relatively quickly, their illnesses undetected and thus unaddressed.

Hepatitis C is a particularly prevalent and serious condition, which infects a huge fraction of injection drug users. In an important JAMA commentary this week (in print, but apparently not yet posted on the web), Anne Spaulding and David Thomas note that between 29 and 43 percent of all Americans infected with this disease are estimated to pass through the criminal justice system every year. Hundreds of thousands of inmates have no idea that they are infected. That’s just a huge missed opportunity.

Read More...

Monday, March 26, 2012

Scots hepatitis campaign praised in European study

A Scots campaign to deal with hepatitis C has been praised in a European health study.

The government invested £43m to improve testing, treatment, care and prevention of the disease in 2006.

Read Now...

Chlamydia, Hepatitis C lead diseases reported by Ross health district

CHILLICOTHE -- Hepatitis C and chlamydia still are the highest reported communicable diseases in Ross County, but health officials said the county remains below the state average.

In its recently released annual report, The Ross County Health District reported 119 cases of Hepatitis C -- a viral disease that leads to swelling of the liver -- and 181 cases of chlamydia -- a sexually transmitted disease -- in 2011.

Read More...

New manual provides guidance in addressing viral hepatitis in people with substance use disorders

Addressing Viral Hepatitis in People With Substance Use Disorders is a new manual developed to provide behavioral health care programs offering substance abuse treatment services information to better address the needs of clients who have viral hepatitis. The manual was developed by the Substance Abuse and Mental Health Services Administration (SAMHSA).

The manual is one of the latest in the Treatment Improvement Protocol (TIP) series. TIPs are best-practice guidelines developed by SAMHSA to help provide state-of-the-art information to behavioral health care providers about effective treatment approaches.

This TIP is organized into two parts:

  • Part 1. Addressing Viral Hepatitis in People With Substance Use Disorders
  • Part 2. Addressing Viral Hepatitis in People With Substance Use Disorders: A Review of the Literature

Part 1 is for counselors and administrators of behavioral health programs providing substance abuse treatment. It comprises seven chapters and emphasizes steps substance abuse treatment counselors and administrators can take to educate clients, prevent new hepatitis infections, and help clients who have viral hepatitis recover from their substance use disorders. Information is provided at a basic level so that it can be understood by readers without medical training.

Part 2 is an online literature review for clinical supervisors, program administrators, and counselors interested in reviewing the medical literature on which this TIP is based. The literature review, available at http://www.kap.samhsa.gov, will be updated every 6 months for 5 years following publication of this TIP.

TIP 53: Addressing Viral Hepatitis in People With Substance Use Disorders is available on the Web at: http://kap.samhsa.gov/products/manuals/tips/pdf/TIP53.pdf
Printed copies may be obtained free of charge by contacting SAMHSA’s Health Information Network by ordering online at http://kap.samhsa.gov/products/manuals/tips/numerical.htm or by calling at 1-877-SAMHSA-7 (1-877-726-4727). Request inventory number (SMA) 11-4656. For related publications and information, visit http://www.samhsa.gov/.

SAMHSA is a public health agency within the Department of Health and Human Services. Its mission is to reduce the impact of substance abuse and mental illness on America’s communities.

Thursday, March 22, 2012

Liver Cancer Patients Less Likely to Die on Wait List than Candidates without Carcinomas

Experts Call for Evaluation of Current Criteria for Allocating Organs for Transplantation

New research shows increasing disparity in mortality among candidates with and without hepatocellular carcinoma (HCC) who are on the waiting list for liver transplantation. The study available in the April issue of Liver Transplantation, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases, found that liver cancer patients are less likely to die on the wait list than non-HCC candidates, prompting transplantation specialists to suggest a reevaluation of current allotment criteria for those with HCC.

In 2002, the United Network for Organ Sharing (UNOS) implemented the Model for End Stage Liver Disease (MELD) scoring system to prioritize candidates on the waiting list for liver transplantation in the U.S. While MELD accurately predicts 90-day waitlist mortality, there are some candidates with extensive disease symptoms, such as those with HCC, who need additional prioritizing criteria to assess clinical risk. These candidates receive MELD exception points, of which HCC patients on the wait list could gain 22 points based on increased mortality risk, meaning HCC patients may be transplanted before other patients at greater risk of death.

“With the scarcity of available livers for transplantation, it is vital that allocation criteria ensure those candidates at greatest mortality risk are first to receive a life-saving organ,” said Dr. David Goldberg with the University of Pennsylvania and lead author of the current study. “Our study investigated appropriate designation of exception points for transplant candidates with HCC, comparing mortality risk to those with similar MELD scores, but without liver cancer.”

The team analyzed data from the Organ Procurement and Transplantation Network (OPTN) UNOS database, including candidates eighteen years of age and older who were on the waiting list for liver transplantation between January 2005 and May 2009. The HCC group was comprised of 6,246 candidates who received exception points for stage two (T2) liver cancer. These candidates were more likely to be older, male and Caucasian or Asian compared to those without liver cancer. In the non-HCC cohort, candidates were categorized by MELD score with 2,564 candidates with a score of 21-23; 4,655 with 24-26; and 2,737 with MELD 27-29.

Analysis shows that within 90 days of listing 4.2% of HCC candidates were removed from the wait list for death or clinical deterioration compared to 11% of non-HCC candidates with MELD scores 21-23. For HCC candidates with 25 exception points (3-6 months wait-time) versus non-HCC candidates with MELD scores 24-26, close to 5% and 17% were removed from the waiting list, respectively. Of the HCC candidates with 28 exception points (6-9 months wait-time) 3% were removed for death or clinical deterioration compared to 24% of non-HCC candidates with MELD scores of 27-29.

Researchers determined that over time the risk of waitlist mortality or clinical decline was unchanged for HCC candidates, but increased significantly for non-HCC candidates. Dr. Goldberg concludes, “Our data suggest HCC candidates have substantially lower odds of waitlist removal for death or deterioration than non-HCC candidates, and strongly indicates that exception points currently allotted for HCC should be lowered.”

In a related editorial also published this month in Liver Transplantation , Dr. Patrick Northup from the University of Virginia agrees and writes, “The Goldberg et al. study adds strength to the argument that the ‘sickest first’ policy may not be well served by the current allocation methods for HCC under the MELD system.” He proposes that the transplantation community strive to develop a more fluid allocation system that is responsive to new medical evidence. “The allocation system should be managed as a whole, rather than as isolated pieces, to ensure patients on the waitlist are prioritized based on the desire to minimize waitlist mortality.”

This study and editorial is published in Liver Transplantation. Media wishing to receive a PDF of the articles may contact healthnews@wiley.com.

Full citations: “Increasing Disparity in Waitlist Mortality Rates with Increased MELD Scores for Candidates with versus without Hepatocellular Carcinoma.” David Goldberg, Benjamin French, Peter Abt, Sandy Feng, Andrew M. Cameron. Liver Transplantation ; (DOI: 10.1002/lt.23394) Published online: January 23, 2012; Print Issue Date: April 2012.
http://onlinelibrary.wiley.com/doi/10.1002/lt.23394/abstract.

Editorial: “HCC and MELD Exceptions: The More We Understand, The More Challenging the Allocation Gets.” Patrick G. Northup and Carl L. Berg. Liver Transplantation ; (DOI: 10.1002/lt.23409) Published online: Februar 10, 2012; Print Issue Date: April 2012.
http://onlinelibrary.wiley.com/doi/10.1002/lt.23409/abstract.

Author Contact: To arrange an interview with Dr. Goldberg, please contact Katie Delach with PENN Medicine at katie.delach@uphs.upenn.edu or 215-349-5964. Media wishing to speak with Dr. Northup may contact Jason Ellis with the University of Virginia at jasonellis@virginia.edu or 434-924-5679.

About the Journal 
Liver Transplantation. is published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society. Since the first application of liver transplantation in a clinical situation was reported more than twenty years ago, there has been a great deal of growth in this field and more is anticipated. As an official publication of the AALSD and the ILTS, Liver Transplantation. delivers current, peer-reviewed articles on surgical techniques, clinical investigations and drug research — the information necessary to keep abreast of this evolving specialty. For more information, please visit Liver Transplantation.

About Wiley-Blackwell
Wiley-Blackwell is the international scientific, technical, medical, and scholarly publishing business of John Wiley & Sons, with strengths in every major academic and professional field and partnerships with many of the world’s leading societies. Wiley-Blackwell publishes nearly 1,500 peer-reviewed journals and 1,500+ new books annually in print and online, as well as databases, major reference works and laboratory protocols. For more information, please visit www.wileyblackwell.com or our new online platform, Wiley Online Library (wileyonlinelibrary.com), one of the world’s most extensive multidisciplinary collections of online resources, covering life, health, social and physical sciences, and humanities.

Liver disease deaths jump 25% in England: study

LONDON — Deaths from liver disease have risen 25 percent in England in less than a decade, mainly due to increased alcohol consumption, a study revealed on Thursday.

Alcohol-related liver disease in Britain, notorious for its binge-drinking culture, accounted for over a third (37 percent) of the deaths, according to the National End of Life Care Intelligence Network report.

Read More...

Wednesday, March 21, 2012

Action Alert - Act Now: End Federal Funding Ban on Syringe Exchange Programs

As we told you back in December, House Republicans turned their backs on sound science when they reintroduced and passed legislation reinstating the ban on federal funding for syringe exchange programs (SEP). Today, HRC is joining with our partners in the HIV/AIDS community in a National Call to Action on Syringe Exchange.

Injection drug use (IDU) has directly and indirectly accounted for 36 percent of AIDS cases in the U.S. and 68 percent of current hepatitis C infections. By providing clean, sterile syringes in exchange for used ones, SEPs directly reduce the transmission of HIV, hepatitis, and other blood-borne infections frequently spread through sharing syringes. These programs are often one of a wide range of social services offered by organizations along with HIV testing and education, rehabilitation, and treatment for drug addiction. In 2008, the Centers for Disease Control and Prevention concluded that the incidence of HIV among intravenous drug users had decreased by 80 percent in the U.S. over a 20 year period in part due to SEPs. Currently, more than 32 states and the District of Columbia operate SEPs.

In 2009, understanding the importance of this scientifically-proven prevention tool, lawmakers removed the funding ban. But last year, ideology prevailed over science, and the fight against HIV/AIDS took a small step backward. President Obama - who has made strides to end the HIV/AIDS epidemic by announcing and implementing a prevention-based National HIV/AIDS Strategy - included lifting the federal funding ban among his FY 2013 budget priorities.

Help us lift the ban! Call your Senators today and urge them to support scientifically-based prevention programs, and to lift the ban on federal funding for syringe exchange programs. Senators can be reached through the Capitol Switchboard at (202) 224-3121 . Tell the operator your state and you will be directed accordingly.

HRC Political Intern Andrew Zapfel contributed to this post.

Marker of Active Hep B Infection Declines in Those Coinfected with HIV, Treated with Tenofovir

Prolonged therapy with antiretroviral regimens containing tenofovir is associated with a decline in hepatitis B surface antigen (HBsAg) levels in people coinfected with HIV and hepatitis B virus (HBV), according to a report presented by Dutch researchers at the 19th Conference on Retroviruses and Opportunistic Infections on Tuesday, March 6, in Seattle.

Loss of HBsAg is the ultimate chronic HBV infection treatment goal, as it signals that the immune system has ramped up and gained control of HBV replication. Among people with chronic HBV infection who experience a spontaneous loss in HBsAg, rates of cirrhosis and liver cancer are significantly lower than those who remain positive for the antigen, considered to be one of the most important markers of active infection.

Read more....

Tuesday, March 20, 2012

Top court rules against two diagnostic patents

The justices unanimously overturned on Tuesday a ruling by a U.S. appeals court that allowed the patents for Nestle SA unit Prometheus, the high court saying companies could not patent observations about a natural phenomenon.

The patent challenge, brought by a unit of the Mayo Clinic, had been closely watched because it could affect the burgeoning field of personalized medicine, which can also involve determining whether a patient is genetically susceptible to a disease or which patient would respond best to which treatment.

Read more.....

Monday, March 19, 2012

Discovery Provides Blueprint for New Drugs That Can Inhibit Hepatitis C Virus

ScienceDaily (Mar. 19, 2012) — Chemists at the University of California, San Diego have produced the first high resolution structure of a molecule that when attached to the genetic material of the hepatitis C virus prevents it from reproducing.

The structure of the molecule, which was published in a paper in this week's early online edition of the journal Proceedings of the National Academy of Sciences, provides a detailed blueprint for the design of drugs that can inhibit the replication of the hepatitis C virus, which proliferates by hijacking the cellular machinery in humans to manufacture duplicate viral particles.

Read more....

877-HELP-4-HEP; a Peer Advocacy Success Story

877-HELP-4-HEP; a Peer Advocacy Success Story

San Francisco, CA, March 19, 2012 --(PR.com)-- The first week of February brought both good news and bad news to Mary*. She learned that her husband was an early responder to the powerful triple drug cocktail for hepatitis C. She also found out that their family’s state-sponsored health insurance coverage was going to be terminated.

Several months ago, Mary had called 877-HELP-4-HEP (877-435-7443). Many conversations with peer counselors helped her husband prepare to start treatment at the beginning of the year and provided much needed emotional support for the family.

One counseling conversation raised a flag. A few short weeks after her husband started treatment; Mary mentioned that she got a part-time job to help buy groceries for their family of five. Her HELP-4-HEP counselor was on the alert. What Mary did not consider was that her extra wages might alter her family eligibility for state-sponsored insurance at a very inopportune time.

Mary’s counseling team began reviewing options to avoid disruptions to treatment. When her “bad news” came, it was met with an action plan. Mary’s husband will continue under the care of his current treating physician, receive medications at no cost through patient assistance programs, and get the tests necessary to monitor his progress at a discount.

“This story could have had another ending. It was the proactive work of a group of HELP-4-HEP counselors who made the difference for this family,” said peer counselor, Sue Simon from Hepatitis C Association.

HELP-4-HEP is a project of The Support Partnership which includes HealthPro (formerly Hep-C ALERT), FL; Hepatitis C Association, NJ; Hepatitis Education Project, WA; Hep C Connection, CO; and Project Inform, CA. The helpline operates Monday through Friday, 9:00am to 7:00pm EST. To learn more, visit www.help4hep.org or email info@help4hep.org.

877-HELP-4-HEP peer counselors are available to help your patients too. Palm cards are now available to distribute. Please email your organization’s contact name, site name, address, phone number, and the number of cards desired.

* Name changed.
Contact Information
The Support Partnership
Andi Thomas
 954-692-0450

www.help4hep.org
Denny Simon
908-812-2488     
      

Needle exchange program is a health care necessity

Australia has more than 1000 new HIV infections a year. For the sake of future generations of Australians we should be doing everything we can to reduce the number of new HIV infections. In several countries, HIV epidemics starting among prison inmates sharing injecting equipment have sparked severe epidemics in the general community. Australia also has about 10,000 new hepatitis C infections a year. The overwhelming majority of old and new hepatitis C infections occur among people who inject drugs.

Many new hepatitis C infections occur inside prisons. Hepatitis C is a time bomb ticking for the Australian health care system. A good measure of a country's fairness is how it respects the human rights of its most disadvantaged populations. Prisoners are among our most disadvantaged. Professor Jon Stanhope (''Rights exist behind the wire'', March 13, p15) is right to emphasise the need to respect the human rights of prisoners. Australian governments have a responsibility to minimise the number of new HIV and hepatitis C infections. Who runs the Alexander Maconochie Centre? The government or the CPSU?

Sunday, March 18, 2012

CROI: HIV/HCV Coinfection News from CROI 2012 [VIDEO]

Hepatitis C was a major topic at the 19th Conference on Retroviruses and Opportunistic Infections (CROI 2012) last week in Seattle. Liz Highleyman from HIVandHepatitis.com spoke with Douglas Dieterich and Kenneth Sherman about advances in the field, with a focus on HIV/HCV coinfected patients.

The attention this year was apt, since an estimated one-third of people with HIV are coinfected with hepatitis C virus (HCV). Dieterich and Mark Sulkowski presented the first data on sustained virological response (SVR) using the recently approved HCV protease inhibitors boceprevir (Victrelis) and telaprevir (Incivek) plus pegylated interferon/ribavirin in HIV/HCV coinfected patients.

Watch the video.....

Saturday, March 17, 2012

City hitting hepatitis C

The Bloomberg administration is launching a campaign to prevent the spread of the deadly hepatitis C virus, The Post has learned.

The Check Hep C initiative targets high-risk populations in Harlem, the South Bronx, central Brooklyn and parts of Staten Island and Queens.

Treating HIV During Pregnancy Also Lowers Risk of Transmitting Hep C to Baby

For women living with HIV and hepatitis C virus (HCV) coinfection, using HIV antiretroviral (ARV) therapy during pregnancy may lower the risk of transmitting both viruses to their infants, according to encouraging new data presented Tuesday, March 6, at the 19th Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.

Most research on mother-to-child transmission (MTCT) of hepatitis C was done before there was widespread access to combination ARV therapy among pregnant women living with HIV and HCV. In earlier years of the HIV pandemic, up to 19 percent of babies born to mothers living with HIV/HCV coinfection acquired HCV, versus 2 to 5 percent of babies born to mothers with HCV alone. Although combination ARV treatment has been proved to reduce MTCT of HIV, little has been known about the effects of modern-day HIV treatment combinations on MTCT of HCV.

Read more.....

Friday, March 16, 2012

BCRX challenges Biota patent, claims its hepatitis C compound was first

The experimental hepatitis C treatment that BioCryst Pharmaceuticals (NASDAQ:BCRX) wants to take into clinical trials this year has run into an unexpected hitch: a patent for the compound was awarded to another pharmaceutical company.

Biota was granted the patent in “an apparent error,” BioCryst said in a March 12 securities filing. The Feb. 21 patent awarded to Biota covers the molecular structure for the hepatitis C drug that the Australian company is developing. Rob Bennett, BioCryst’s executive director for investor relations and communications, said both companies claim the same molecular structure in their patent applications. But Durham, North Carolina-based BioCryst believes it was the first to invent that molecular structure.

Read more.....

NICE recommends Incivo for hepatitis C

NICE is recommending Janssen’s hepatitis C pill Incivo for funding on the NHS in England.

The watchdog is recommending Incivo (telaprevir), in combination with Roche’s Pegasus (peginterferon alfa) and Copegus (ribavirin), as an option for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease.

Janssen’s rival drug Victrelis (boceprevir), made by Merck, also received a speedy review by NICE last week, and has been recommended for funding for the same licence.

Read more.....

Thursday, March 15, 2012

Liver Transplant Program at Methodist Specialty and Transplant Hospital Recognized as Best in the Nation

The Liver Transplant Program at Methodist Specialty and Transplant Hospital (MSTH), a campus of Methodist Hospital, has been recognized as the best liver transplant program in the country, based on data recently released by the Scientific Registry for Transplant Patients.

The MSTH program has the best one-year patient survival rate in the United States among patients with the most seriously advanced liver disease, according to data from the Organ Procurement and Transplant Network (OPTN)/SRTS Annual Data Report. The ranking is based on comparisons of programs performing 10 or more transplants annually.

Read more here:

County Campaigns for Hepatitis B Prevention

The preventable disease goes undetected in two-thirds of the Asian population.

More than 600 people gathered at Dynasty Restaurant Friday night to kick off the "Hep B Free: Santa Clara County" campaign, but guest count pales in comparison to the 1.4 million people in the U.S. who live with chronic hepatitis B virus.

Nationwide, chronic hepatitis B causes up to 80 percent of all liver cancer cases. Its numbers are especially concerning in the Asian population, where about 48,000 Asian Santa Clara County residents are inflicted with the disease.

Read more....

Broader screening for hepatitis C would be cost effective, study suggests

Linking those infected with care is key to reducing related mortality and morbidity

Broader screening to identify people infected with hepatitis C virus (HCV) would likely be cost effective, according to a new report published in Clinical Infectious Diseases and available online (http://cid.oxfordjournals.org/content/early/2012/02/27/cid.cis011.abstract). Significantly reducing HCV-related mortality and morbidity, however, will require a coordinated effort that emphasizes not only increased testing but also linking those infected with the treatment they need.

The HCV epidemic peaked many years ago, but roughly 4 million U.S. residents still suffer the consequences of chronic hepatitis C. A growing proportion of those infected now has advanced disease, including cirrhosis of the liver and liver cancer. Deaths from chronic infection have doubled over the last decade and are expected to more than double again by 2030.

Read more....

Wednesday, March 14, 2012

Updated Hepatitis C Evaluation and Treatment Guidelines from Bureau of Prisons

The Bureau of Prisons has finalized, posted and sent their new hepatitis C evaluation and treatment guidelines out to correctional facilities. You can download your copy of these updated guidelines which include treatment with the new direct acting antiviral agents here:
http://www.bop.gov/news/PDFs/hepatitis_c.pdf

Okairos announces initiation of Phase I/II clinical trial for potential first-in-class hepatitis C vaccine

Basel, Switzerland – 14 March 2012 – Okairos today announced the initiation of a Phase I/II clinical
trial evaluating its vaccine against the hepatitis C virus (HCV). This is the first multi-center, double
blinded, randomized, placebo-controlled trial of a vaccine to prevent HCV infection, and represents a
major milestone in the collaboration between Okairos and the National Institute of Allergy and
Infectious Diseases (NIAID), which is part of the US National Institutes of Health (NIH). The NIHfunded
trial will be conducted by co-principal investigators from Johns Hopkins University and the
University of California San Francisco (UCSF).

The trial follows promising Phase I results that were recently published in Science Translational
Medicine, showing that the vaccine had a good safety profile, was well tolerated, and that it stimulated
a highly potent T-cell response in healthy volunteers. This Phase I/II trial will provide the opportunity
to demonstrate the potential effectiveness of such an approach in protecting against chronic HCV
infection, the leading cause of liver cancer.

Dr Riccardo Cortese, Chief Executive Officer of Okairos, said: “This news represents many years of
work in developing our technology platform and proving its utility in early clinical studies in HCV and
other areas. We are very pleased to be part of this productive collaboration and look forward to
initiating additional clinical programs from our platform in the near future.”

The trial will enroll 350 subjects and will begin with an interim Phase I analysis of safety and
immunogenicity data in a subset of them. The primary endpoints of the overall study will measure the
incidence of chronic HCV infection, as well as the safety and tolerability of the vaccine.

Dr Alfredo Nicosia, Chief Scientific Officer of Okairos, explained: “The history of vaccine research has
primarily focused on stimulating antibody responses. We’ve unlocked the door to stimulating robust
T-cell responses and will leverage this technology to combat important diseases such as HCV,
respiratory syncytial virus (RSV) and influenza.”


Read complete release here.....

Tuesday, March 13, 2012

Hepatitis C Infection Increasing Among Adolescents, Young Adults

ATLANTA – The incidence of hepatitis C infection is increasing among adolescents and young adults in Pennsylvania, just as it has in other areas in the United States, according to surveillance data for 2003 through 2010. 

During that 7-year period, the number of reports of newly recognized confirmed or probable cases of hepatitis C past or present infection among those aged 15-34 years increased from 1,384 to 2,393, representing a near doubling of the rate of cases (from 43 to 72) per 100,000 population, Dr. Sameh W. Boktor reported in a poster at the International Conference on Emerging Infectious Diseases. 

Read more.....

Phase 3 Data on HEPLISAV(TM) in Adults Aged 40-70 Published in VACCINE

BERKELEY, CA, Mar 13, 2012 (MARKETWIRE via COMTEX) -- Dynavax Technologies Corporation DVAX +3.37% announced today that results of an early Phase 3 trial (HBV-04) of HEPLISAV(TM) investigational hepatitis B vaccine were published online in the journal VACCINE. The article concludes that HEPLISAV was well-tolerated and demonstrated superior and more durable seroprotection earlier than the licensed comparator hepatitis B vaccine. 

The article, entitled "Demonstration of Safety and Enhanced Seroprotection Against Hepatitis B with Investigational HBsAg-1018 ISS Vaccine Compared to a Licensed Hepatitis B Vaccine" by first author Benjamin Sablan, describes the results from a Phase 3 clinical trial of HEPLISAV conducted in Asia. The trial compared the safety and immunogenicity of HEPLISAV with Engerix-B(R) in 412 adults 40-70 years of age. The seroprotection rate at one month after the second dose in the HEPLISAV group was 97% versus 24% in the Engerix-B group (p < 0.0001). At one month after the third dose, the seroprotection rates were 100% for HEPLISAV and 73% for Engerix-B (p < 0.0001). Seroprotection rates at one year after the first dose were 100% for HEPLISAV and 69% for Engerix-B (p < 0.0001). 



Medivir announces new studies in phase III program for TMC435

· Study in previous non-responder Hepatitis C genotype-1 infected patients
· Study in Hepatitis C genotype-4 infected patients


Huddinge, Sweden – MedivirAB (OMX: MVIR) a research based specialty pharmaceutical company focused on infectious diseases announces that its oral, once daily investigational protease inhibitor TMC435, developed by Janssen Pharmaceuticals for the treatment of Hepatitis C virus (HCV), has commenced patient dosing and started screening in two new phase III clinical trials, HPC3001 and HPC3011, respectively.

HPC3001
HPC3001 is a phase III efficacy, safety and tolerability study comparing TMC435 versus telaprevir, each in combination with Pegylated Interferon α-2a (PegINF) and ribavirin (RBV), in hepatitis C genotype-1 infected patients who were null or partial responders to prior PegINF/RBV therapy. The study which is a randomized, double-blind, double-dummy, two-arm study is targeted to enroll 744 patients.

The aim of the study is to demonstrate the efficacy of TMC435 based therapy compared to the approved telaprevir regimen in this difficult to treat population.

Patients will receive TMC435 150 mg once daily or telaprevir 750 mg administered every eight hours (q8h) in combination with PegINF/RBV for 12 weeks followed by 36 weeks of PegIFN/RBV alone. The primary endpoint of the study is sustained virological response at 12 weeks (SVR12).

HPC3011
HPC3011 is an open label, single arm phase III trial to explore the efficacy, safety and tolerability of TMC435 150 mg once daily, in combination with PegIFN/RBV in 100 treatment naïve or treatment experienced, Hepatitis C genotype-4 infected patients.

Current standard of care treatment for chronic HCV genotype-4 infection consists of 48 weeks of PegIFN/RBV with a large proportion of patients do not achieve SVR with this treatment regimen.

All subjects will receive 12 weeks triple therapy of TMC435 150 mg once daily and PegIFN/RBV, followed by PegIFN/RBV alone. The duration of total treatment is response guided in treatment naïve and prior relapser subjects and patients are eligible to stop all treatment at week 24 if predefined response-guided criteria are met. Subjects with cirrhosis will receive 48 weeks of therapy, irrespective of on-treatment virologic response and treatment history. The primary endpoint in the study is SVR12.

TMC435 - Ongoing global phase III program in brief:
· TMC435-C208 or QUEST-1 in 375 treatment-naïve genotype-1 patients
· TMC435-C216 or QUEST-2 in 375 treatment-naïve genotype-1 patients
· TMC435-C3007 or PROMISE in 375 genotype-1 patients who have relapsed after prior interferon-based treatment
· Phase III program in Japan, includes 417 genotype-1 treatment naïve and treatment experienced patients

Charlotte Edenius, Executive VP Research and Development, of Medivir commented,
"We are extremely pleased to expand the phase III program with these two new trials as we continue development of TMC435 for broad patient populations. The 744 patient HPC3001 study is aimed at further confirming the positive findings of the ASPIRE phase IIb trial in genotype-1 non-responder patient populations and in the HPC3011 study, the genotype-4 activity of TMC435 is being investigated.”

For more information about Medivir, please contact:
Medivir Mobil:             +46 708 537 292      
Rein Piir, EVP Corporate Affairs & IR
M:Communications Medivir@mcomgroup.com
Europe: Mary-Jane Elliott, Amber Bielecka, Hollie Vile             +44(0)20 7920 2330      

About TMC435
TMC435 is an investigational HCV protease inhibitor in late phase III clinical development. It is an efficacious, safe and well-tolerated once-daily (q.d.) drug jointly developed by Janssen Pharmaceuticals to treat chronic hepatitis C virus infections.

TMC435 is in phase III clinical development in combination with PegIFN/RBV but is also being evaluated with Direct-acting Antiviral (DAA) agents in interferon-free combinations both with and without ribavirin (RBV).

For additional information please visit www.medivir.com and www.clinicaltrials.gov

In June 2011, Medivir acquired the specialty pharmaceutical company BioPhausia to ensure timely commercialisation of TMC435 in the Nordic markets, once approved.

Medivir’s first product, the unique cold sore product Xerese®/Xerclear®, was launched on the US market in 2011. Xerese®/Xerclear®, which has been approved in both the US and Europe, is being launched in collaboration with GlaxoSmithKline to be sold OTC in Europe, Japan and Russia. Rights in North America, Canada and Mexico were sold to Meda AB in June 2011. Medivir has retained the Rx rights for Xerclear® in Sweden and Finland.

For more information about Medivir, please visit the Company’s website: www.medivir.com

Read complete press release here

Monday, March 12, 2012

Familiarity With Drugs Helps a Group Speak for Users

The San Francisco Drug Users’ Union, has more on its mind than simply turning on, tuning in and dropping out. The union is one of several groups in the United States and Canada that advocate for the rights of drug users, following the lead of older European drug user organizations. Their goals are often varied, but carry a common refrain: to represent the political interests — and practical needs — of chronic drug abusers, a sometimes grim agenda that includes everything from providing clean needles to finding safe places to nod out.

In San Francisco, the drug union received its first grant in 2009, Mr. Jackson said, and got more help in December 2010 from the city’s Hepatitis C Task Force, which advocated for a pilot “supervised injection facility” for intravenous drug users because they often contract hepatitis by using dirty needles. No such facility exists in the United States — a so-called safe injection site in Vancouver, British Columbia, has been considered a success there — and it has become a central goal of the San Francisco union.


Read more....

Sunday, March 11, 2012

New Hep C meds may override watchful waiting for patients with no symptoms

What should we advise patients with HCV who feel perfectly well? Of course, patients should make the call after they have been informed of the risks and benefits of treatment. In my experience, after this discussion, none of these patients wants to proceed. Hopefully, I am meeting my obligation to present the issues to them fairly. I am certainly aware of my bias, and do my best to compartmentalize it.

I think that there has been a rush to treatment with these patients. Academic centers tend to be more enthusiastic about racing for the HCV cure with toxic medicines, although in fairness, their HCV population is very different from mine. Their patients are much more ill, so the risk/benefit analysis of treatmentmay calculate out differently. Nevertheless, academicians in writing and on the speaking circuit tend to extol the virtue of treatment, which they regard as the default response. Watchful waiting just doesn’t have the red meat appeal for liver gurus. They argue that eradicating the virus will prevent the dire consequences I listed at the top of this post. However, when there was only treatment available 20 years ago -injectable interferon - academics were gaga over this it, which had a full page of side effects and was effective in less than 20% of patients treated. I’m amazed that interferon slid by the FDA. Now,HCV can be cured in a majority of patients, according to data from two drugs approved in 2011 to treat the disease, although there remains substantial toxicity from the medications.

Read more....

Saturday, March 10, 2012

Hep B Free Philadelphia Launches “B A Hero” Photo Scavenger Hunt Contest in the City of Brotherly Love

Citywide and Community-Owned Education Campaign Led by the Hepatitis B Foundation Offers Photo Contest and Prizes

Philadelphia, PA, March 10, 2012 --(PR.com)-- Beginning on Mar. 19, 2012, Hep B Free Philadelphia, a citywide and community-owned education campaign led by the Hepatitis B Foundation, will launch its “B A Hero” Photo Scavenger Hunt to help save lives and stop hepatitis B. The contest is just what it sounds like – individuals living and working in the Philadelphia area will have the opportunity to win prizes by going to locations throughout the city, accomplishing tasks, helping to spread awareness about hepatitis B and taking photos that are creative and prove to be popular on Facebook.

To participate, individuals of at least 18 years of age or having legal guardian consent can register by emailing their full name, email address and the names of up to two additional teammates to scavengerhunt@hepb.org or by visiting the official contest page at http://bfreephilly.org/scavengerhunt. Contest participants will then choose which one of the two contest weeks in which they would like to partake: Mar. 19–25, 2012 or Mar. 26–Apr. 1, 2012. Scavenger hunt individuals and teams will then receive branded t-shirts and a list of sites to visit and tasks to complete from Hep B Free Philadelphia. Sites should be visited, and tasks completed and captured by digital photography while the contestants wear the Hep B Free Philadelphia-issued t-shirts. All photos should be submitted to ScavengerHunt@hepb.org before the close of the contest week.

Read more.....

Friday, March 9, 2012

Court revives suit over NY prison medical care

March 9 (Reuters) - A federal appeals court on Friday revived a lawsuit by a former inmate against the New York State Department of Correctional Services for allegedly failing to provide timely medical treatment.
The U.S. Court of Appeals for the 2nd Circuit found that the district court judge was too quick to dismiss Robert Hilton's suit against the prison system and that the former inmate's claims deserved more attention.

While incarcerated in New York prison, Hilton had requested antiretroviral drugs to treat his Hepatitis C, a potentially fatal liver disease. The Department of Corrections refused, requiring Hilton, a former drug user, to first complete a substance abuse program. Because Hilton's sentence was shorter than the program, he was not eligible for treatment.

Read more...

Merck's hepatitis C drug wins UK cost endorsement

(Reuters) - U.S. drugmaker Merck & Co's new hepatitis C drug Victrelis was recommended for use within Britain's state health service on Friday, despite its hefty price tag.

The National Institute for Health and Clinical Excellence, which often spurns expensive new medicines on cost grounds, said significant improvements seen with Victrelis made it a cost-effective option.

Read more...

Hepatitis C test helps curb Egypt epidemic

CAIRO: About 10 million hepatitis C (HCV) patients live in Egypt, giving Egypt the distinction of having the highest prevalence of hepatitis C in the world. According to a recent study published in the Proceedings of the National Academy of Science, the blood-borne pathogen infects almost 500,000 people in the country each year. According to the World Health Organization, the strong homogeneity of HCV subtypes found in Egypt (HCV4a) suggests an epidemic spread of HCV in the country.

In response to this rapidly spreading virus, an American University in Cairo (AUC) research team at the Yousef Jameel Science and Technology Research Center, led by Hassan Azzazy, professor of chemistry, has designed a novel test capable of detecting all genotypes of HCV in less than one hour, instead of days, and at one-tenth of the cost of traditional tests.

Read more....

Thursday, March 8, 2012

ACTION ALERT URGE YOUR MEMBERS OF CONGRESS TO ENSURE OUR NATION IS PROPERLY FUNDING VIRAL HEPATITIS PROGRAMS

Representatives Michael Honda (D-CA), Hank Johnson (D-GA) and Judy Chu (D-CA) have sent a “Dear Colleague” letter to every Member of the House asking them to sign on asking the House Appropriations Committee to support increased funding for the Division of Viral Hepatitis at the Centers for Disease Control and Prevention (CDC).

We need your help in raising awareness among Members of Congress about viral hepatitis and asking their support for increased funding for viral hepatitis activities at the federal level.  The more Members of Congress that sign on to this letter, the greater the likelihood the Appropriators will include additional funding in FY2013.

Viral hepatitis impacts over 5.3 million people nationwide. With a lack of a comprehensive surveillance system, these estimates are likely only the tip of the iceberg and 75% of those infected do not know their status. Even with these daunting figures, the CDC only receives $29.7 million in federal funding dedicated to fund viral hepatitis activities.  Members of Congress need to know that viral hepatitis is a concern in their district, that their constituents are being affected and that this is an issue they need to care about. We need you to tell your story and ask your elected representatives to sign on by March 15, 2012.


Instructions:

Please call your Representative’s Washington, DC office and ask to speak with the staff person who handles health issues.  You can call your Representative at 202.225.3121. You will get the Capitol switchboard.  Ask to be connected to your Representative’s office.  If you don’t know who your Representative is, you can go online to www.house.gov to determine your Member of Congress.

Whether you speak to this person directly or leave a message, tell them:

My name is ____________ and I live in City/State/Zip. I am writing to urge Representative ________________ to sign on to a Dear Colleague funding letter supporting increased funding for viral hepatitis prevention at the Centers for Disease Control and Prevention.  The funding letter is being circulated by Reps. Mike Honda, Hank Johnson and Judy Chu.  [Include brief details on the impact of viral hepatitis on yourself or describe your organization].

There are over 5.3 million Americans impacted by viral hepatitis but the only dedicated federal funding stream provides a mere $29.8 million through CDC.  This is insufficient to provide the most basic public health services such as education, counseling, testing, or medical management for people living with or at risk of viral hepatitis.

I urge Representative ___________ to sign on to Mr. Honda’s Appropriations Letter.

If you need assistance or want to talk through the process please contact Oscar Mairena or Daniel Raymond.

Thanks for taking the time to make these important phone calls!


Oscar Mairena
Senior Associate, Viral Hepatitis/Policy and Legislative Affairs
National Alliance of State & Territorial AIDS Directors (NASTAD)
444 North Capitol Street NW, Suite 339
Washington, DC  20001
Phone: (202) 434.8058      Fax: (202) 434.8092
omairena@NASTAD.org     www.NASTAD.org  

National Consumer Protection Week and FDA’s Fight Against Health Fraud Scam

This week, FDA joins 29 other government agencies and a host of private groups to highlight National Consumer Protection Week, an annual event for consumers to learn how to protect their privacy, manage money and debt, avoid identity theft, and prevent frauds and scams. And, helping protect consumers against health fraud or scams is where the FDA plays a role.

For the FDA, banishing fraudulent remedies has been a top focus since the agency was created—and that was back in the early 1900′s, when consumer protection involved protecting consumers from peddlers of snake oil and “miracle” elixirs.

Read more...

Wednesday, March 7, 2012

Results from Investigational Studies with VICTRELIS™ (boceprevir) Presented at the Conference on Retroviruses and Opportunistic Infections to Understand Potential Use in Patients Coinfected with Chronic Hepatitis C and HIV-1

SEATTLE, March 6, 2012 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from two different investigational studies conducted to better understand the potential use of VICTRELIS™ (boceprevir), the company’s oral HCV NS3/4A protease inhibitor, in treating patients coinfected with chronic hepatitis C virus (HCV) and HIV-1. These data are being presented for the first time today at the 19th Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.

Results were presented from a 12-week post treatment interim analysis of a Phase IIb clinical study evaluating the investigational use of VICTRELIS in combination with peginterferon alfa-2b and ribavirin for the treatment of chronic HCV genotype 1 infection in adult patients coinfected with HIV-1 (n=100). In the study, a higher percentage of patients receiving VICTRELIS in combination with peginterferon alfa-2b and ribavirin had undetectable hepatitis C virus (HCV-RNA) 12 weeks after treatment ended (sustained virologic response-12 or SVR-12) than patients receiving peginterferon alfa-2b and ribavirin alone.

Additionally, Merck announced results as part of a late-breaker poster session [Poster #771] from a pharmacokinetic study evaluating drug interactions between VICTRELIS and ritonavir-boosted HIV protease inhibitors in 39 healthy volunteers. In this study, concomitant administration of VICTRELIS with ritonavir (Norvir®) in combination with atazanavir (Reyataz®) or darunavir (Prezista®), or with lopinavir/ritonavir (Kaletra®) resulted in reduced exposures of the HIV medicines and VICTRELIS. These drug interactions may be clinically significant for patients infected with both chronic HCV and HIV by potentially reducing the effectiveness of these medicines when co-administered. Merck does not recommend the co-administration of VICTRELIS and ritonavir-boosted HIV protease inhibitors.

"In light of the differing results in these data sets, Merck recognizes it is important to continue to study VICTRELIS in combination therapy in this difficult-to-treat patient population," said Eliav Barr, M.D., vice president, Project Leadership and Management, Infectious Diseases, Merck Research Laboratories. "Our collaborative studies with the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) and the AIDS Clinical Trial Group (ACTG), which is funded by the U.S. National Institute of Allergy and Infectious Diseases, will provide greater insight into the potential role of VICTRELIS in treating patients with chronic HCV genotype 1 infection who are coinfected with HIV-1."

*Action Alert* Call your member of Congress today about the CDC Hepatitis C Screening Guidelines!

Dear Viral Hepatitis Advocate:
Congressman Hank Johnson, one of our strongest champions for viral hepatitis screening, care and treatment, is asking his colleagues to sign onto a letter to the CDC asking for the speedy release of new screening guidelines for the Hepatitis C virus.  The proposed age-based screening guidelines will identify many more Americans with Hepatitis C and enable them to access care and treatment, thereby reducing deaths and health care costs. 

We urge you to help Congressman Johnson by calling YOUR  member of Congress today to ask him or her to sign on to the letter (below and attached).  You can reach your Representative by calling the Capitol Switchboard at 1-202-224-3121 or google their website for a direct office number.  Sign on to the letter closes on Thursday, COB, so please call today! 


Here’s a sample call script:

“My name is ____________ , I live in (city, state), and I care about viral hepatitis. Hepatitis is a serious health problem in the U.S., in my District, and is a very important issue to me. I urge Representative _____________ to show leadership in the fight against hepatitis and liver cancer by signing Congressman Hank Johnson’s Congressional sign on letter to the CDC regarding hepatitis C screening guidelines.



If there is time, tell them why this issue is important to you. You will probably only have time for 2-3 sentences. Members of Congress and their staff pay attention to their constituents. They need to hear how viral hepatitis affects you, the people you care for, your friends, family, and co-workers. Our lawmakers are unaware of viral hepatitis and how it impacts people in their Districts so they really need to hear from you!
Begin forwarded letter:

Dr. Thomas R. Frieden
Director
Centers for Disease Control and Prevention
1600 Clifton Road
Atlanta, GA 30333

RE: Release of Screening Guidelines for Hepatitis C

Dear Director Frieden:

We are writing to express our full support for the timely release of the Centers for Disease Control and Prevention’s (“CDC”) revised screening guidelines for the Hepatitis C virus (“HCV”).  In particular, we urge the CDC to adopt new guidelines that would recommend a one-time screening for all Americans born between 1945 and 1965, the “baby boomer generation.”  Existing risk-based screening is not effectively targeting a patient population where baby boomers account for 80 percent of all Americans infected with chronic HCV.[1]

HCV infection is the most common long-term blood-borne infection in the United States.[2]  There are four million Americans currently infected with HCV, but 75% of these individuals are unaware of their condition.[3]  Additionally, the incidences of chronic infection are disproportionately higher in minority populations.  For example, HCV is twice as prevalent among African Americans as among Caucasians.[4]
Chronic HCV can result in long-term health problems, and is the leading cause of liver cancer and the most common reason for liver transplantation in the United States.[5]  Despite new treatment options that can cure the disease, the mortality rate associated with HCV has now surpassed HIV/AIDS with 15, 106 deaths attributable to the virus in 2007 alone.[6]
These are devastating numbers and that is why it is so important for the CDC to take action and release new age-based screening guidelines that will more effectively address this serious issue.  Age-based screening may help to identify these HCV-infected patients prior to the onset of liver failure or liver cancer, allowing them to be adequately monitored and potentially treated.[7]  Furthermore, by increasing efforts to detect HCV infection, screening may assist in reducing further transmission of the virus.

Recent studies offer evidence that this is sound public policy that will also save lives.  An article in The Annals of Internal Medicine, authored by the CDC, provides a glimpse into the type of effect new guidelines could have.  The article found that compared with the status quo, age-based screening would identify 808,580 additional cases of chronic HCV infection and, when followed by treatment, would reduce the number of deaths by 121,000.  If implemented, this could be a transformative development given the study’s other finding that deaths from HCV are forecasted to increase to 35,000 annually by 2030.[8]

A similar peer-reviewed article on the cost-effectiveness of age-based screening was recently published in Hepatology.  The study’s authors found that compared to the current strategy of risk-based screening, birth cohort screening followed by treatment reduced deaths by 78,000 compared to risk-based screening at a cost of $37,700 per quality-adjusted life year (QALY) gained.  The study also found that birth cohort screening resulted in 84,000 fewer cases of cirrhosis, 46,000 fewer cases of liver cancer, and 10,000 fewer liver transplants.[9]

Deaths attributable to HCV are increasing, leading to a sense of urgency around the need to take action.  We believe that the lessons from the HIV epidemic are applicable to combating HCV, that hepatitis C deaths can be prevented through promoting testing, early diagnosis & linkage to care.  The CDC is to be commended for identifying the magnitude of the problem, but it is now imperative that it take further steps towards helping the millions of patients unaware of their condition to get screened and linked to care.

New CDC draft guidelines could offer an effective approach to reaching populations where the disease is most prevalent.  We once again offer our full support for new HCV age-based screening guidelines, and urge the CDC to finalize their recommendations as soon as possible.

Sincerely,


Cc: The Honorable Kathleen Sebelius, Secretary, Department of Health and Human Services
Cc: Dr. Howard Koh, Assistant Secretary for Health, Department of Health and Human Services




Martha Saly
Director
National Viral Hepatitis Roundtable
Phone: 707-242-3333
Cell: 707-480-0596


The National Viral Hepatitis Roundtable is a coalition of public, private and voluntary organizations dedicated to reducing the incidence of infection, morbidity and mortality from viral hepatitis in the United States. NVHR is a project of the Task Force for Global Health (www.taskforce.org).


[1] “Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C,” at 1. Institute of Medicine, July 27, 2011
[2] McHutchison, J.G. & Bacon, B.R. Chronic hepatitis C: an age wave of disease burden. Am J Manag Care 11, S286-295; quiz S307-211 (2005).
[3] CDC, FAQs for Health Professionals, http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm
[4] Armstrong GL, et al. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med. 2006;144(10):705-714; 3.
[5] CDC, Hepatitis C FAQs for the Public, http://www.cdc.gov/hepatitis/c/cfaq.htm
[6] “The Growing Burden of Mortality Associated with Viral Hepatitis in the United States, 1999-2007,” S.D. Holmberg, K.N. Ly., et.al, AASLD Abstract, November 5-8, 2011.
[7] Srocynski G, Esteban E, Conrads-Frank A, Schwarzer R, et. al. Long-term effectiveness and cost-effectiveness of screening for Hepatitis C virus infection. European Journal of Public Health, Vol. 19, No. 3, 245-253. February 2009.
[8] “The Cost Effectiveness of Birth-Cohort Screening for Hepatitis C Antibody in US Primary Care Settings,” D. Rein, B. Smith, et. al, The Annals of Internal Medicine, February 2012.
[9] “An Economic Model of Birth Cohort Screening for the Hepatitis C Virus,” L. McGarry, V. Pawar, et. al, Hepatology, at 2. Pre-publication December 2011 available online at http://onlinelibrary.wiley.com/journal/10.1002/%28ISSN%291527-3350.

National Day of Action for Syringe Exchange

When: Wednesday, March 21

Where: all across the country!

Why: No more federal dollars for syringe exchange: that was the message from Congress less than 3 months ago. The funding ban is back, and the timing couldn't be worse -- with tight state budgets, and signs that many painkiller users are injecting or switching to heroin, our syringe exchange programs need more support than ever. We are pulling out all the stops this time to demand that Congress and the federal government set politics aside, but we need your help.

On March 21, we're going to make out voices heard around the country. Local meetings with US Senators, media events to highlight issues, and a National Call-in Day sponsored by a dozen organizations will amplify our voices.

To learn more, sign up, and find out the seven different ways you can become involved, go to: https://www.facebook.com/events/329668350416789/

The 8th way you can get involved: please distribute this email widely.  

Oscar Mairena
Senior Associate, Viral Hepatitis/Policy and Legislative Affairs
National Alliance of State & Territorial AIDS Directors (NASTAD)
444 North Capitol Street NW, Suite 339
Washington, DC  20001
Phone: (202) 434.8058      Fax: (202) 434.8092

HCV vaccine – it’s coming in big steps

In the UK alone, 500 000 people are infected with Hepatitis C virus (HCV) and still, most of the patients are not diagnosed. Therefore, HCV infection is a major cause of liver transplantation there. A few years ago, scientists have found monoclonal antibodies which gave hope for the acquisition of an effective vaccine. Now, the first results of the testing of vaccines based on adenoviral vectors have occurred. 

180 million people worldwide is infected with Hepatitis C virus. Infection leads to the development of liver cancer and is the main cause of transplantation of this organ in the United Kingdom and the United States. Viral hepatitis treatment is expensive and effective only in half of the patients. Among not treated patients or not responding to the treatment, liver cirrhosis may develop, causing the need for transplantation.


Read More...

Tuesday, March 6, 2012

Scientists Develop Better Test for Identifying Hepatitis Type

Madison, Wisconsin - Hepatitis C virus (HCV) comes in many types and subtypes, and knowing these specifics helps determine how long a patient should be treated, doses and types of medication needed and how well the patient will do on treatment.

Scientists in the Molecular Diagnostics Laboratory at UW Hospital and Clinics are now providing doctors and patients much more information about virus type and subtype than before. No other hospital or laboratory in the country routinely offers this level of detail.

"We hope this new information will help clinicians make better judgments about the best course of treatment for each patient," says Dr. William Rehrauer, head of the Molecular Diagnostics Laboratory and assistant professor of pathology and laboratory medicine at UW School of Medicine and Public Health (SMPH).

Read more....

Prison dispatch: Hepatitis epidemic could become costly

A fellow inmate recently informed me he will be undergoing interferon anti-viral treatment. He’s been diagnosed with state 3 Hepatitis C. This admission precipitated a discussion about what treatments were available here, and to prisoners in general, how long they lasted and how difficult it was to get them. I, for one, am keenly interested in this subject because, like many people of my generation, I have also been diagnosed with Hepatitis C.


A recent newspaper article by Bloomberg News revealed that during the past decade, deaths from Hepatitis C have surpassed those from HIV in people born between 1946 and 1964: the Baby-Boom generation. From 1999 to 2007, researchers found that 15,000 deaths occurred due to Hepatitis C, while 13,000 resulted from HIV related illnesses during the same period. “Seventy-five percent of the mortality is in this age group,” stated John Ward, director of the Centers for Disease Control and Prevention’s hepatitis division. “Injection drug use was frequent in this age group, and even one-time exposure to injection drug use carries a high risk.” Records indicate that as many as 170 million people around the world are chronically infected with the Hepatitis C virus.

Read more.....

Data from Phase 2 Study of an INCIVEK® Combination Regimen Showed 74% of People Co-Infected with Hepatitis C and HIV Had Undetectable Hepatitis C Virus 12 Weeks After Treatment Ended (SVR12)

- INCIVEK was well tolerated with commonly used Atripla- and Reyataz-based HIV treatment regimens, and no patients experienced HIV breakthrough -
- Enrollment is ongoing in Phase 3 study evaluating 24- and 48-week treatment durations in people who are co-infected -
 
SEATTLE--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced interim results from an ongoing Phase 2 study designed to evaluate the safety and tolerability of INCIVEK® (telaprevir) tablets in combination with pegylated-interferon and ribavirin in people who are co-infected with genotype 1 hepatitis C virus and human immunodeficiency virus (HIV). Data showed 74 percent (28/38) of patients who were treated with INCIVEK (in-SEE-veck) combination therapy had undetectable hepatitis C virus (HCV RNA) 12 weeks after the end of all study treatment (SVR12) compared to 45 percent (10/22) who were treated with pegylated-interferon and ribavirin alone.

INCIVEK was well tolerated with commonly used Atripla®- and Reyataz®-based HIV treatment regimens. Changes in CD4 counts were similar between the treatment groups and no HIV viral load breakthroughs were observed in either treatment group during the study. The most common adverse events in the INCIVEK arms of the study were fatigue, pruritis (itching), headache, nausea and rash. No cases of severe rash were reported and there were no discontinuations due to rash. Interim results from this study are being presented at the Conference on Retroviruses and Opportunistic Infections (CROI), March 5 to 8, 2012 in Seattle.

"Hepatitis C generally progresses faster, leads to more long-term liver complications and has been harder to cure among people who also have HIV," said Robert Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical Officer at Vertex. "These new INCIVEK data are important as we work toward our goal of helping cure more people with hepatitis C. We're actively enrolling co-infected patients in a Phase 3 study and expect that data from this study will be included in a submission for a supplemental approval of INCIVEK."

The Phase 2 study includes two parts: Part A is evaluating people who are not currently being treated with antiretroviral therapy (ART) for HIV infection and Part B is evaluating those who are taking an Atripla- or Reyataz-based regimen for HIV. This study enrolled patients who were new to hepatitis C treatment (treatment naïve). Patients who were randomized to receive INCIVEK were treated with 12 weeks of INCIVEK, pegylated-interferon and ribavirin, followed by 36 weeks of pegylated-interferon and ribavirin alone. Interim data also showed that 68 percent (26/38) of patients treated with INCIVEK combination therapy in this study had a rapid viral response (RVR, undetectable hepatitis C virus at week 4 of treatment) compared to none (0/22) of the patients who received pegylated-interferon and ribavirin alone.

"There is a great need for treatments that are well tolerated and offer co-infected patients a better chance at a cure for hepatitis C while maintaining suppression of their HIV," said Douglas Dieterich, M.D., Professor of Medicine in the Division of Liver Diseases, Mount Sinai School of Medicine, New York City. "It's very encouraging that nearly three out of four people had undetectable hepatitis C virus 12 weeks after stopping INCIVEK combination therapy and that their HIV medicines continued to work during treatment."

Interim Study Results
Sixty-two people 18 and older were enrolled in this Phase 2 study and 60 received at least one dose of study drug. This analysis was conducted 12 weeks after patients completed all treatment. The ART regimens evaluated in this study were selected based on current HIV treatment guidelines from the U.S. Department of Health and Human Services, International AIDS Society and drug-drug interaction studies of INCIVEK with commonly used ART medicines.
 
Interim Intent To Treat Analysis of Study #110
 
 
Part A
(No ART)
 
Part B
Atripla®-based regimen
 
Part B
Reyataz®-based regimen
  Total
 
INCIVEK-
based Arm+
 
Control
Arm++
 
INCIVEK-
based Arm+
 
Control
Arm++
 
INCIVEK-
based Arm+
 
Control
Arm++
 
INCIVEK-
based Arm+
 
Control
Arm++
RVR*  
71% (5/7)
 
0% (0/6)
  75% (12/16)   0% (0/8)   60% (9/15)   0% (0/8)   68% (26/38)   0% (0/22)
eRVR**   57% (4/7)  
0% (0/6)
  75% (12/16)   0% (0/8)   47% (7/15)   0% (0/8)   61% (23/38)   0% (0/22)
SVR12  
71% (5/7)
 
33% (2/6)
 
69% (11/16)
 
50% (4/8)
 
80% (12/15)
 
50% (4/8)
 
74% (28/38)
 
45% (10/22)
             
Atripla-based regimen (efavirenz, tenofovir disoproxil fumarate and emtricitabine): INCIVEK was dosed at 1,125 mg, every 8 hours (q8h).
 
Reyataz-based regimen (ritonavir-boosted atazanavir, tenofovir disoproxil fumarate and emtricitabine or lamivudine): INCIVEK was dosed at 750 mg, every 8 hours (q8h).
 
*RVR: Rapid Viral Response; undetectable HCV RNA at week 4.
**eRVR: extended Rapid Viral Response; undetectable HCV RNA at weeks 4 and 12.
 
+12 weeks of INCIVEK, Pegasys® (PEG, pegylated-interferon alfa-2a) and Copegus® (RBV, ribavirin) followed by 36 weeks of only PEG and RBV.
++48 weeks of PEG and RBV only for hepatitis C treatment.
 
The majority of adverse events in this study were mild or moderate. Adverse events that occurred more frequently in the INCIVEK arms compared to placebo (≥10 percent difference) were pruritis (itching), headache, nausea, rash, fever, and depression. Three patients, all in Arm B, discontinued all study treatment due to adverse events (one each due to gall stones, hemolytic anemia and nausea/vomiting).

About this Phase 2 Study
Vertex and its collaborator Janssen conducted extensive drug-drug interaction studies with INCIVEK and commonly used HIV medicines prior to initiating a development program in people co-infected with hepatitis C (HCV) and HIV. This Phase 2 study is a two-part (A and B), randomized, double-blind, placebo-controlled, parallel group, multi-center study in people chronically infected with both HCV and HIV who were new to HCV treatment. The primary endpoint of the study is to evaluate the safety and tolerability of INCIVEK combination therapy in people co-infected with HCV and HIV. A secondary endpoint is to evaluate rates of sustained viral response (SVR) 12 and 24 weeks after the end of treatment. The study is being conducted by Vertex in collaboration with Janssen.

Phase 3 Study Actively Enrolling
Enrollment is ongoing in a Phase 3 study evaluating 24- and 48-week response-guided regimens of INCIVEK combination therapy in people co-infected with HCV and HIV. Patients who are either new to treatment for HCV, or who had relapsed after at least one prior course of therapy with pegylated-interferon and ribavirin alone, will receive 24 or 48 weeks of INCIVEK combination treatment, based on their antiviral response. Patients who had not responded to a prior course of treatment (partial responders and nulls) will receive 48 weeks of INCIVEK combination treatment. A similar study is also being initiated by Janssen in its territories.

Data from In Vitro Evaluation of INCIVEK and HIV Protease Inhibitors
Also being presented at CROI this week are data from an in vitro evaluation of the anti-HIV activity of four HIV protease inhibitors (amprenavir, darunavir, lopinavir and atazanavir) in combination with INCIVEK. In the study, no antagonistic effects on the antiviral activity were observed when INCIVEK was used in combination with amprenavir, darunavir, and lopinavir, and slight antagonistic effects were observed on the antiviral activity of atazanavir.

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