Thursday, July 26, 2012

HCV Weekly Rewind:Gilead Begins Single Pill Hepatitis C Study For 2014 Approval

Hello folks,
Welcome to HCV rewind, a weekly digest of news, research and a look at today's headlines.

This week we've been given a glimpse into research on liver cancer, HCV drugs in development (Gilead single pill study), disease progression, disease mortality, diabetes, and news coming from the International AIDS Conference. Also in the media, the number of states linked to the suspect in hepatitis C outbreak at Exeter hospital continues to rise. Last but not least, the US district court in Washington DC, rules a controversial stem cell therapy offered at US clinics should be regulated.

We begin with a disturbing, but significant hepatitis C study published in the Journal of Infectious Diseases. According to the paper the overall mortality from liver related disease and non-liver conditions - including some cancers- was found to be significantly increased in people with chronic hepatitis C.  The Full text is available to the public through open access, and includes an accompanying editorial.

In The News

Hepatitis C may increase deaths from both liver-related and other diseases
In a long-term study of people infected with the hepatitis C virus (HCV), researchers found increased deaths from both liver-related and non-liver related diseases in patients with active infections who had not cleared their infection.

The study, published in the Journal of Infectious Diseases and available online, found increased mortality in patients with chronic HCV infection—that is, with detectable levels of HCV genetic material, or RNA, in their blood—suggesting that chronic HCV infections, even in people who have no symptoms, can lead to increased mortality from liver disease or a variety of other causes. The findings highlight the importance of people getting tested for HCV antibodies and for active HCV infection—and of evaluating patients for antiviral treatment when they are found to have an active HCV infection, even when they feel well.

HCV infects more than 170 million people globally and has been shown to cause such liver diseases as cirrhosis and hepatocellular carcinoma. Many infected patients have no symptoms and are not aware of infection until after irreversible liver disease has occurred. In addition, several diseases not related to the liver have been linked to HCV. However, nearly two-thirds of patients can be cured of their HCV infection with currently available antiviral therapy.

Chien-Jen Chen, ScD, and researchers from the Genomic Research Center in Taipei, Taiwan, enrolled more than 23,000 adults in Taiwan in their study and followed them from 1991 to 2008. Blood samples were collected at study entry and at follow-up health examinations. Researchers found increased mortality from liver- and non-liver-related diseases—including cancers of the esophagus, prostate, and thyroid, as well as circulatory and renal diseases—among those infected with HCV. Mortality was higher in HCV-infected participants with detectable serum levels of HCV RNA, indicating they had active infections; subjects with previous infections who only had HCV antibodies, but not HCV RNA, in their blood did not have increased mortality on follow-up.

According to Dr. Chen, "The findings implied that the serum HCV RNA level is an important marker for clinical decisions in the management of HCV-infected patients." Dr. Chen suggested that HCV-infected patients may benefit from treatment with antiviral and immunomodulating agents to promote viral clearance.

The investigators concluded that their findings have significant implications for clinical practice and public health—namely, that individuals seropositive for HCV RNA should be followed intensively and urged to be evaluated for antiviral therapy. In addition, they noted, testing to determine serum HCV RNA level by a sensitive assay is essential for clinical management of HCV-infected patients.

Dr. Chen and his colleagues cautioned that some non-liver-related diseases are too rare to accurately determine their risk in connection with HCV infection. They suggested that a collaborative study with a large sample size would be needed in order to further investigate the full spectrum of diseases associated with HCV.

In an accompanying editorial, Kenrad E. Nelson, MD, of Johns Hopkins University in Baltimore, noted that overall mortality was significantly increased from liver-related and other causes compared to uninfected patients from the same communities in the study. The findings indicate that, although some who are infected with HCV can cure their infection without treatment, most people who are infected and who have no symptoms develop chronic infections and are at increased risk of death from HCV, Dr. Nelson said.

Many patients with HCV infection go undiagnosed, and among those whose infection is detected, "few are medically evaluated and effectively treated," Dr. Nelson added. Although treatment for HCV infection is improving dramatically, he noted, a significant reduction in HCV-related mortality will require that screening measures are greatly expanded.

Fast Facts:
  1. Overall mortality in patients infected with hepatitis C virus (HCV) was significantly increased from both liver-related and other diseases compared to uninfected patients from the same communities.
  2. Compared to people who had never been infected with HCV, mortality was higher in HCV-infected patients with detectable levels of HCV RNA in their blood on follow-up, but not in patients with inactive infections—those who were positive for HCV antibodies but whose blood was free of HCV RNA.
  3. Diseases not related to the liver that were observed in this study included cancers of the esophagus, prostate, and thyroid, and circulatory and renal diseases.
  4. Most people with chronic HCV infection don't know they are infected because the infection is often without symptoms. However, chronic HCV can be curable with treatment, so people should be screened and considered for treatment if they have chronic HCV infection.
Liz Highleyman, Editor-in-Chief and Publisher at HIV and Hepatitis, examines the study results in detail:

Hepatitis C Raises Risk of Both Liver-Related and Non-Liver Deaths
CONCORD, N.H. (AP) — A dozen hospitals in seven states are scrambling to identify people who might have been infected with hepatitis C by a traveling medical technician who was charged a week ago with causing an outbreak in New Hampshire. 
With details of David Kwiatkowski's resume still emerging, a hospital official in Arizona said he had been fired from her facility in April 2010, after he was found unresponsive in a men's locker room with syringes and needles. Kwiatkowski was treated at the hospital, and tests showed he had cocaine and marijuana in his system, said Monica Bowman, chief executive officer of the Arizona Heart Hospital... 
In Michigan, officials at Oakwood Annapolis Hospital in Wayne noted that there was no indication that Kwiatkowski had hepatitis C when he was employed there from January to September 2007, and that he passed at least two drug tests during that time. State health officials said they are still looking into other locations where Kwiatkowski worked and what steps, if any, they need to take.... 
Twenty-five former patients at St. Francis Hospital in Poughkeepsie, N.Y., where Kwiatkowski worked for three months in late 2007 and early 2008, have been asked to get tested. In Kansas, state health officials are sending letters to about 460 patients who were treated at the cardiac catheterization lab at Hays Medical Center from May 24, 2010, to Sept. 22, 2010. The state also is setting up an informational website, and the hospital has set up a telephone hotline... 
In Maryland, hundreds of patients are being contacted by the four hospitals where Kwiatkowski worked between May 2008 and March 2010. None of the four, which include The Johns Hopkins Hospital and a Veterans Affairs hospital in Baltimore, reported that Kwiatkowski was fired or that his behavior raised red flags... 
At Houston Medical Center in Warner Robins, Ga., CEO Cary Martin the identification process hasn't been completed yet. Kwiatkowski worked in the cardiac cath lab there from October 2010 to March 2011 but did not have access to the hospital's medication system, he said.... 
Continue reading at Bloomberg

Contributing to this report were Associated Press writers Felicia Fonseca and Paul Davenport in Arizona, Kate Brumback in Atlanta, Ben Nuckols in Washington, David Runk in Detroit, John Hanna in Topeka, Kan., and JoAnn Loviglio in Philadelphia.

Video - Jul. 26, 2012
US Attorney: Hepatitis C Case 'Unprecedented'
A federal prosecutor said Tuesday he expects to bring more charges against a traveling medical technician accused of infecting 30 patients with hepatitis C in New Hampshire.(/AP)..

Learning About HCV

This week Clinical Care Options released "part one" of an online quiz containing 35 questions on treating hepatitis C, answered by nine world-renowned hepatology experts, to review the quiz and links, click here. When CCO goes live with part two and three, I'll be sure to post a link.

July Issue Of CDL

Digital Liver Disease Journal - "Clinical Liver Disease" Third Issue Is Out

07/2012 Digital Liver Disease Journal: HCV In Children, After Liver Transplantation, Cirrhosis, HIV, and More
The journal is an official digital educational resource from the American Association for the Study of Liver Diseases.

Visitors are able to view videos, full data, and download files in either HTML or PDF formats

Disease Progression In hepatitis C

NIH scientists identify likely predictors of hepatitis C severity
Scientists at the National Institutes of Health have identified several factors in people infected with the hepatitis C virus that may predict whether the unusually rapid progression of disease from initial infection to severe liver conditions, such as cirrhosis, will occur. Knowing whether a patient's condition is likely to deteriorate quickly could help physicians decide on the best course of treatment.
Continue reading...


Gilead Begins Single Pill Hepatitis C Study For 2014 Approval

By Michelle Fay Cortez and Ryan Flinn on July 27, 2012

Gilead Sciences Inc. (GILD) said it plans to start a combination study of two drugs in a single pill to treat hepatitis C by the end of the year, putting it on track to request U.S. regulatory approval for the medicine in 2014.
Gilead, which spent $10.8 billion to acquire one of the medicines, GS-7977, plans to combine it with another, GS-5855, in a trial of 800 patients starting in the fourth-quarter, said Norbert Bischofberger, chief medical officer of the Foster City, California-based company, in a conference call yesterday. If the combination is effective, the company could apply for regulatory approval in the middle of 2014, Bischofberger said.
Gilead is among several drugmakers racing to develop new hepatitis C treatments that act more quickly with fewer side effects than the current standard of care. The goal is to provide doctors and patients with simpler, more effective treatments, Bischofberger said.
The company aims for a therapy that “will clearly be a one pill, once daily, maybe a 12 week course,” for patients with all different types of hepatitis C, Bischofberger said. “That’s our goal. We are very close.”
Continue reading @ Bloomberg

Gilead Sciences' Stock Rises on Prospects for Hepatitis C Pill
By Brett Chase Jul 27, 2012 12:15 pm

Some analysts say Gilead is now clearly in the lead for a better hepatitis drug.

MINYANVILLE ORIGINAL Shares of Gilead Sciences rose as much as 6% Friday on sentiment, once again, that the biotech company is in the lead position for a better hepatitis C treatment.

Gilead is performing multiple studies to test an experimental drug, but the trial that is possibly the most intriguing looks at a combination therapy that rolls two medicines into a single pill. Gilead hopes to advance tests of its lead hepatitis drug GS-7977 in a combination with another company medicine, GS-5885. Wall Street analysts and investors are excited about the potential for this combination as a highly effective, safe, single pill. If all goes well in studies, the company may apply for US approval by 2014.

“This probably puts them in the lead,” ISI Group analyst Mark Schoenebaum says.

Hepatitis C is a liver-wasting virus that affects millions of people. Gilead is in a highly competitive race for a better hepatitis treatment with rivals such as Bristol-Myers Squibb (BMY), Abbott Laboratories (ABT), Merck (MRK), Vertex Pharmaceuticals (VRTX), Idenix Pharmaceuticals (IDIX), and Roche (RHHBY).

Shares of Gilead were up 5% to $54.41 in late-morning trading. The stock is up 33% this year.

Pressure is on the company to prove that its almost $11 billion acquisition of Pharmasset will pan out. Gilead acquired GS-7977 in that takeover, which was completed earlier this year. (See Gilead Plans $11 Billion Takeover of Pharmasset to Gain Hepatitis Drugs.)

The company is likely to apply for US approval of GS-7977 next year. But the combo pill with the two drugs signals potential for an even more superior treatment compared with the current standard of care. Currently, medicines are taken with an injection of interferon, an immune booster that can have nasty side effects. The goal of all the next-generation hepatitis drug programs is to develop a treatment that doesn’t require interferon. A single pill to treat the virus would be a real breakthrough.

“It’s the ultimate frontier in (hepatitis) therapy,” Gilead’s chief scientific officer Norbert Bischofberger told investors on a conference call late-day Thursday. “That’s what we want to pursue.”

Bristol-Myers CEO Lamberto Andreotti has said Gilead should test GS-7977 with his company’s drug, daclatasvir. Like GS-5885, daclastasvir is among a class of drugs called NS5A inhibitors. GS-7977 is known as a nucleotide polymerase inhibitor.

Gilead execs say they want to go forward with their own drug rather than testing with Bristol-Myers.

Gilead Sciences Management Discusses Q2 2012 Results - Earnings Call Transcript
Before we begin our formal remarks, we want to remind you that we will be making forward-looking statements that contains certain assumptions, risks and uncertainties that are beyond our control. 
These risks include the possibility that our actual financial results may differ materially from the revised guidance we are presenting today. 
The possibility of unfavorable results from our clinical studies, including those evaluating the GS 7977, and GS 5885 in various patient populations and the possibility that we may be unable to compete our clinical studies and regulatory filings or obtain regulatory approvals in currently anticipated timelines. 
A description of these risks can be found at our latest SEC disclosure documents in our recent press releases. Gilead does not undertake any obligation to update these forward-looking statements made during this call.
Continue reading @ Seeking Alpha

Related@ Gilead Sciences-Second Quarter 2012 Financial Results
FDA grants fast track designation for Idenix HCV therapy
The US Food and Drug Administration (FDA) has granted fast track designation for Idenix Pharmaceuticals' IDX719 to treat chronic hepatitis C infection (HCV).

IDX719 is an NS5A inhibitor that demonstrated pan-genotypic activity in a recent proof-of-concept clinical trial in genotypes 1-4, treatment-naive HCV patients.

Idenix president and chief executive officer Ron Renaud said the receipt of fast track designation from the FDA for IDX719 reflects the critical need for new treatment regimens to address HCV infection.

"As previously reported, we are on track to initiate a phase II combination study of IDX719 with IDX184, our other lead HCV product candidate, by the end of this year," Renaud added.

The fast track program allows a company to file a new drug application on a rolling basis, which permits the FDA to review the filing as it is received, rather than waiting for the entire submission prior to commencing the review process.

Related- IDX719-Idenix hepatitis C drug Receives Fast Track Designation

Idenix: New HCV Treatment Could Be A Game Changer

July 24 - Investing Commentary

Author's Profile

Idenix Pharma (IDIX): New HCV Treatment Could Be A Game Changer

The company's candidate IDX184 is the principle value driver at this point. Although IDX184 is considered to be less potent than the leading HCV nuclear clinical candidate (Gilead Sciences' GS-7977), the available data suggest that IDX184 would be successfully developed, thereby unlocking significant value in Idenix shares...
"While the wholly-owned key asset IDX184 is not a best-in-class nucleotide ("nuc") polymerase inhibitor, we think its high barrier to resistance will confer value in alternative DAA combos, with data in 2013 driving estimates higher and solidifying its scarcity among late-stage nucs," UBS analyst Matthew Roden wrote in a note to clients...
Idenix has the only unencumbered nuc in late-stage clinical development, as well as IDX719, a potentially best-in-class pan-genotypic NS5a inhibitor in phase-1 trials as well. IDX719 targets the HCV non-structural 5A (NS5A) protein presents a second clinical stage asset, and could be differentiated among the NS5a class in terms of potency and pan-genotypic activity.
The company has also planned to begin trials with a combination of IDX 719 and IDX 184 towards the end of this year. "Given the potential for both classes to become backbone therapies in HCV (and potentially form an all-IDIX pan-genotypic combo), we believe the Idenix pipeline has considerable scarcity value, and will attract large pharma or biotech partners," the analyst noted. In addition, Idenix holds significant intellectual property in nuc chemistry, and may have rights to other nucs in HCV.....
Continue Reading....

Related - Published July 14 at
IDX184-Idenix Pharmaceuticals Lagging Behind In Breakthrough Hepatitis C Drug Development

GSK wins FDA priority review for Promacta supplemental new drug application to treat thrombocytopenia in adult patients with chronic hepatitis C virus infection

July 26

GlaxoSmithKline (GSK), Ligand Pharmaceuticals' partner, has gained FDA priority review status for the supplemental new drug application for Promacta to treat thrombocytopenia in adult patients with chronic hepatitis C virus infection.

Eltrombopag, known by the brand name Promacta in the US and Revolade in the European Union and other countries, is indicated for thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia.

The risks associated with Promacta include hepatotoxicity, bone marrow reticulin formation and risk for bone marrow fibrosis, thrombotic/thromboembolic complications, hematologic malignancies, and cataracts

A priority review designation is given to drugs that are considered to offer major advances in treatment or provide a treatment where no adequate therapy exists, if approved.

Under the Prescription Drugs User Fee Act, the goal for completing a priority review is six months.

Ligand is a biopharmaceutical company with a business model that is based upon the concept of developing or acquiring royalty revenue generating assets and coupling them to a lean corporate cost structure.

Liver Cancer

Medscape published data on the importance of early diagnoses of HCC, and the excellent survival rate for patients who underwent curative treatments. View Full Text @ Medscape, or click here to read only the discussion/conclusion.

Survey: Surgeons Play to Strengths in Early Hepatocellular Cancer
Therapy for early HCC with well-compensated cirrhosis is controversial; there is little agreement on when resection, transplantation, or radiofrequency ablation becomes the best approach. Choice of therapy for early HCC often depends on the surgeon’s repertoire of techniques and the therapeutic services the hospital offers, based on the findings of a web-based survey of centers that had at least five HCC cases per year..Continue reading..

Liver Cancer - Clinical Trials

Jennerex begins Phase 2 HCC trial of JX-594
PBR Staff Writer Published 26 July 2012
Jennerex has treated the first patient in a Phase 2 clinical trial of intravenous treatment with JX-594 for patients with advanced hepatocellular carcinoma (HCC) who have not received treatment with sorafeni.

The multinational, single-arm, open-label study of JX-594 is administered weekly by intravenous infusions in sorafenib-naive patients with advanced HCC. The trial will be conducted in South Korea, US and Europe.

The radiographic response rate based on modified RECIST and modified Choi criteria is the primary objective of the study and the patients will subsequently be followed for progression-free survival and overall survival.

Jennerex research and development president and chief medical officer David Kirn said unlike other treatments in the class, JX-594 can be administered intravenously, and it has the ability to target tumors systemically and, therefore, has the potential to impact both metastatic and primary tumors.

"In our previously reported randomized Phase 2 dose-ranging study in HCC with intratumoral delivery, we showed a statistically significant benefit in overall survival in the high dose group, which we believe was due, in large part, to the systemic delivery of JX-594 at that dose level," Kirn added.


Combination of Tarceva, Nexavar fails to meet main goal of Phase III liver cancer study
Bayer, Onyx Pharmaceuticals and Astellas announced Monday that a late-stage trial investigating the combination of Tarceva (erlotinib) and Nexavar (sorafenib) failed to meet the main goal of a late-stage trial in patients with unresectable hepatocellular carcinoma (HCC).

Hepatocellular carcinoma - Brivanib Phase III Does Not Meet Overall Survival Primary Endpoint
Bristol-Myers Squibb Company today reported the result of the phase III BRISK-FL clinical trial of the investigational agent brivanib versus sorafenib as first-line treatment in patients with advanced hepatocellular carcinoma (HCC; liver cancer). The study did not meet its primary overall survival objective based upon a non-inferiority statistical design

Worth A Click

For the savvy HCV patient who strives to stay abreast of the latest research, Healio offers news and education in the field of gastroenterology, hepatology, infectious disease and more.  The site alleviates the daunting task of breaking down either full text articles or abstracts found in medical journals online by publishing the same research in easy to comprehend articles. Here are a few articles offered at Healio this week.

July 25-26, 2012
Chronic HCV can increase mortality risk from hepatic, extrahepatic diseases
Liver transplant may be an option for some patients with unresectable HCC
Patients with HCV may not benefit from HAV vaccination

**After visiting the site a few times free registration is required
Hepatitis C Drug Development Goes from Pony Ride to Rocket Launch
The in depth report includes the following topics; HCV drug resistance, DAA drug-drug interactions, nucleosides and nucleotide polymerase inhibitors, HCV protease inhibitors, the next generation of drugs, HCV quad therapy, treating genotypes 1-4, SVR-4 ,SVR-12, interferon free therapy and much more....
Click here to read the article....

HCV Awareness

Just In July 27-
ALF- New HCV Website and Adds HCV Specialist To HelpLine

World Hepatitis Day
On 28 July 2012 people around the world will come together to mark World Hepatitis Day and raise awareness of viral hepatitis. Coordinated by the World Hepatitis Alliance since 2007, World Hepatitis Day was officially recognised by the World Health Organization on May 2010 and it’s now one of only four disease related official days.

Hepatitis kills around one million people every year. Millions more suffer immediate sickness or long-term ill health. World Hepatitis Day provides an opportunity to recognise viral hepatitis as a major global health problem in order to advance prevention and control.

Hepatitis C: A “silent killer”
Encourage patients to get tested for World Hepatitis Day, July 28

The liver disease hepatitis C is a major health issue in the United States—as much as 5 million Americans have hepatitis C, approximately four times the amount of people with HIV. It’s the leading cause of liver cancer and the most common reason for liver transplantation in the country. What’s more surprising is that 75% of people with hepatitis C don’t know it yet.

Hepatitis C has been called a “silent epidemic” in a Department of Health & Human Services report because it often has no symptoms and can go decades without detection. In the meantime, serious liver damage or even liver cancer may occur.

Recent CDC studies have reported that deaths from hepatitis C are on the rise. In 2007, there were more than 15,000 deaths in the United States from hepatitis C, surpassing the 13,000 deaths from HIV/AIDS in the same year.

People born from 1945 through 1965 have a greater prevalence of hepatitis C than the general population. In fact, 82% of people with the disease in the country are members of the baby boomer generation, and 73% of the deaths from hepatitis C occur in this group.

Those at increased risk for hepatitis C include people who had blood transfusions before 1992, people with tattoos, people who used I.V. drugs even once, and those who work in a health care setting. Certain populations, including African Americans and Hispanics, are also affected by hepatitis C at a significantly higher rate than the general population.

The good news is that for many patients, hepatitis C can be cured, unlike other chronic diseases such as hepatitis B and HIV/AIDS.

Screening for hepatitis C is not currently part of routine testing. Many patients who think they have been tested have not. CDC recently released draft guidelines recommending that all baby boomers have a simple, one-time antibody test to screen for hepatitis C. According to a CDC-sponsored study, such age-based screening could identify more than 800,000 additional cases of chronic hepatitis C infection and, when followed by treatment, could reduce the number of deaths by an additional 121,000 over risk-based screening.

Posted by Alex Egerváry
July 26, 2012
Read more here....

UK - Hepatitis C hospital cases soar
A Health Protection Agency (HPA) annual report into the infectious disease revealed an increase in hospital admissions and deaths for End Stage Liver Disease (ESLD) and liver cancer - both of which are related to hepatitis C.

In 2010 there were 1,979 hospital admissions, compared with 612 in 1998, while deaths have risen from 98 in 1996 to 323 in 2010.

In 2011, 9,908 new diagnoses of hepatitis C were reported to the HPA in England, up from 7,892 cases in 2010, however the HPA said the rise is thought to be due to changes in laboratory reporting.
The report, Hepatitis C in the UK, looks at the future burden of hepatitis C-related infections and national progress in tackling the infection. It was produced to coincide with World Hepatitis Day on July 28.

Dr Helen Harris, a hepatitis expert at the HPA, said: "Many of the 216,000 people who are chronically infected with the virus are unaware of their infection. Therefore, it is vital that we continue to monitor the true burden of infection to help focus public health action on getting these people diagnosed and into treatment.

"Although our latest report shows that we are having a number of successes in our fight against hepatitis C, many people continue to become seriously ill from this preventable infection, which is usually treatable if caught early enough.

"We must therefore redouble our efforts and continue to develop new schemes to raise awareness in at-risk communities and ensure that individuals who may have been exposed to the virus are tested, diagnosed and treated early, before they become seriously ill."

Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV). The virus causes inflammation of the liver and, when left untreated, can result in chronic liver disease, liver failure, or death. Because the liver is able to work even when damaged, many people are unaware they have the disease at first because they have no symptoms. It is only when the liver becomes seriously damaged that symptoms occur and people report to their doctor.

Charles Gore, chief executive of The Hepatitis C Trust, said: "Hepatitis is closer than you think In the UK, a 'see no evil, hear no evil, speak no evil' attitude prevails and many people are needlessly dying. We simply must increase testing."

Bristol-Myers Squibb Foundation Marks World Hepatitis Day 2012 with New Grants Focused on Hepatitis B and Hepatitis C Patient Empowerment in China and India
Foundation's Delivering Hope(TM) program wins Asia's Best CSR Practices Award
NEW YORK, Jul 26, 2012 (BUSINESS WIRE) -- The Bristol-Myers Squibb Foundation has awarded four new grants totaling US $1.69 million to improve prevention, care and support of hepatitis B (HBV) and hepatitis C (HCV) in China and India as part of its Delivering Hope(TM) program. The grants, announced to coincide with World Hepatitis Day on July 28, support initiatives to empower hepatitis patients to take an active role in disease management and advocacy. This focus on patient empowerment recognizes the significant health disparities that exist in these countries but also the progress that has been made to address them through disease awareness efforts and education targeted to the health care community.
Continue reading @ Bristol-Myers Squibb

Health Check: Hepatitis C testing

By: Barbara Morse Silva | NBC 10

WHO-Prevent hepatitis C: Avoid unsafe injections , use of illicit drugs, tattoos, piercings, acupuncture performed with contaminated equipment
Hepatitis C is a contagious liver disease that results from infection with the hepatitis C virus. It can range in severity from a mild illness lasting a few weeks to a serious, lifelong illness.
The hepatitis C virus is usually spread when blood from an infected person enters the body of a susceptible person. It is among the most common viruses that infect the liver.
Every year, 3–4 million people are infected with the hepatitis C virus. About 150 million people are chronically infected and at risk of developing liver cirrhosis and/or liver cancer. More than 350 000 people die from hepatitis C-related liver diseases every year.

Related-WHO: Four ways to reduce hepatitis infections in people who inject drugs


Two More Men with HIV now Virus-Free. Is This a Cure?
Two men unlucky enough to get both HIV and cancer have been seemingly cleared of the virus, raising hope that science may yet find a way to cure for the infection that causes AIDS, 30 years into the epidemic....

Study finds gaps in services for heterosexual men with HIV 
July 27- Study finds heterosexual men feel existing HIV-related programs and services don't meet their needs and are geared primarily or exclusively toward gay men and heterosexual women who are living with the virus...

XIX International AIDS Conference
22-27 July 2012 Washington D.C., USA

View Conference Coverage @ NATAP and HIV and Hepatitis

Conference website
The entire AIDS 2012 programme is available online through the Programme-at-a-Glance (PAG). Links to abstracts, slide sets with audio, rapporteur reports and e-posters will be added as they are available.

Source: DGDispatch @ Doctors Guide

Low-Level Viraemia on Antiretroviral Therapy Should Not Be Sole Indicator of Virologic Failure: Presented at AIDS 2012
Kidney Function Declines With Use of Tenofovir Plus Protease Inhibitors as Treatment for HIV: Presented at AIDS 2012

Gilead HIV drug as good as Merck's Isentress: study
Gilead Sciences Inc said its elvitegravir, a component of the company's important four-drug Quad HIV treatment currently awaiting an approval decision, demonstrated similar efficacy and tolerability to Isentress in difficult-to-treat patients...Continue reading...

Stem Cells

The US district court in Washington DC, rules a controversial stem cell therapy offered at clinics should be regulated...

Ruling frees FDA to crack down on stem cell clinics

Excerpt -  New Scientist

Peter Aldhous, San Francisco bureau chief
It's official: stem cells are drugs. At least, that's the opinion of the US district court in Washington DC, which has ruled that the Food and Drug Administration (FDA) has the authority to regulate clinics offering controversial stem cell therapies...
Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice - not regulated by the US government. But if the cells are subjected to more than "minimal manipulation", the FDA maintains that the therapy becomes a "drug", which must be specifically approved for use...
Full Article at New Scientist

Read more @ New Scientist , Scope, Nature and Knoepfler Lab Stem Cell Blog.


FDA staff say Roche drug helped diabetics see

A U.S. Food and Drug Administration advisory panel recommended Roche Holding AG's Lucentis eye drug for treatment of diabetic macular edema, a leading cause of vision loss among working-age people.

The FDA advisory committee of outside experts on Thursday recommended both 0.3 milligram and 0.5 milligram doses of the drug after reviewing clinical research showing it clearly helps diabetic patients who suffer from the vision-robbing condition.

However, some panel members expressed concern about evidence linking higher doses of the drug to adverse events including death....Continue reading..

Healthy You

Coffee: The Original Wonder Drug?

Medscape Features A Slideshow On The Benifits Of Coffee, published July 24, 2012
The best part of waking reducing your risk of neurodegeneration. And depression, and cancer, and cardiovascular disease... It's becoming increasingly clear that coffee is more than just a morning routine. The body of data suggesting that the world's most widely used stimulant is beneficial in a variety of mental and medical conditions is growing at a staggering rate. A recent study published in the New England Journal of Medicine found that coffee consumption lowered all-cause mortality by over 10% at 13-year follow-up.[1] Based primarily on recent Medscape Medical News coverage, the following slideshow reviews the potential medical and psychiatric benefits of coffee consumption.

Liver Disease
The liver might help break down coffee, but coffee might protect the liver (in some cases). Evidence suggests that coffee consumption slows disease progression in patients with alcoholic cirrhosis and hepatitis C and reduces the risk of developing hepatocellular carcinoma.[30-33] A 2012 study reported that coffee intake is associated with a lower risk for nonalcoholic fatty liver disease (NAFLD),[34] while other recent work found that coffee protects against liver fibrosis in those with already established NAFLD.
Click here to view the slide presentation

Minority Women: Latinas' Cirrhosis and Liver Disease Rates High
July 26
In the United States, the most common causes of cirrhosis are drinking too much alcohol and hepatitis. Although Latinas have lower rates of alcohol use than other groups of women, they still have high rates of cirrhosis. This may be explained, in part, by nonalcoholic fatty liver disease (NAFLD), which is common in Latinos and can cause cirrhosis. NAFLD is a buildup of fat in the liver in people who drink little or no alcohol. Ethnicity may play a role in the tendency of Latinos to develop NALFD. This group also has high rates of obesity and diabetes, which are among the risk factors for NAFLD.
Continue reading.....

Health Care Reform

How will the Affordable Care Act affect your health care?
The ACA also puts strong patient protections into place and provides tools to help citizens understand their health care options. Many protections and reforms have already been put into place. Most of the large coverage expansions will take place in 2014.

The law is generally meant to ensure that many more Americans will be able to have secure and affordable health insurance. It will also mean that people will have clearer information about their insurance choices, and insurance companies will be held more accountable for delivering quality health care.

As soon as the ACA was signed into law, people who oppose it started to challenge the law in the courts and through media. One of the lawsuits made its way to the Supreme Court and in late June 2012, the Court delivered its decision.

The Supreme Court decision
The Supreme Court reviewed the ACA and upheld most parts of it. The part that requires all Americans to get health insurance (called individual mandate) was found to be constitutional. However, the court found that the penalty for not having insurance must be imposed as a tax.
Before the ACA was signed into law, insurance companies could deny coverage to someone on the basis of pre-existing conditions like HIV or hepatitis C and gender. They could also raise premiums based on age and where someone lives. Now, because the individual mandate was upheld, these types of insurance discrimination are no longer in danger of being stripped from the law.
The Supreme Court also upheld the Medicaid expansion part of the ACA. This will provide federal funding to help states expand their Medicaid programs to serve all adults under 138% of the federal poverty level (FPL), or about $15,000 per year for one person.

However, the Supreme Court did not uphold the part that says Congress could withhold funding if states refuse to expand their Medicaid programs. Although it doesn’t make sense for a state to refuse these large amounts of funding (100% in the first three years), unfortunately several governors have already said they will not expand their Medicaid programs.

The problem with this is that about half of all people who would get new coverage under health care reform (including people with HIV) will rely on Medicaid. If a state refuses this federal funding, its low-income individuals would continue to be unable to access health insurance coverage, which is exactly what health care reform is trying to address.

The Supreme Court decision and people with HIV
The decision to uphold the individual mandate is a victory for people living with HIV and others who have been shut out of the health insurance market. The ban on insurance discrimination against adults with pre-existing conditions will begin in 2014. This means that people living with HIV and/or hepatitis C will be able to get affordable, quality health care and specialized treatment.
As for Medicaid, the good news is that many states will expand their programs, allowing people with HIV to get Medicaid coverage sooner. (Currently, most people have to become disabled to use it.) The bad news is that people with HIV who live in states that don’t expand their Medicaid will continue to be unable to afford health insurance and forced to rely on insufficient health care services. Estimates indicate that 50–70% of uninsured people with HIV will depend on Medicaid expansion and will continue to get suboptimal or no health care without those services.
Currently, only about half of Americans with HIV regularly see their doctors and only 1 out of 4 are taking HIV medications. Medicaid expansion would allow low-income people with HIV to find the quality health coverage they need in order to ensure continuous care. Research shows that early access to treatment gives people the opportunity to stay healthier and reduce the likelihood of transmitting HIV to others.

What to expect as we move towards 2014
Learning about these changes in health care programs may seem overwhelming to you. And rightly so. Changes will differ quite a bit state by state, and much of how your health care will look is being decided at the state level. Health care providers, advocacy organizations, and even state and local governments are all struggling to prepare for these transitions in HIV care.
We are all in this learning process together. We can assume that there will be hiccups along the way. Below are links to two different timelines of the changes that we can expect. It will also be important to check at your state level for the timeline in your own state.

Keep in mind these are beneficial changes
Although these changes can be difficult to understand, the ACA will solve many issues that people living with HIV currently face. People with incomes above 138% FPL (about $15,000 per year) who have had problems getting insurance will be able to purchase it through a new market place called an Exchange.

The Exchange will be a place where people can compare plans and choose the one that is best for them. If an individual’s income is below 400% FPL (about $44,500 per year), they will receive financial help from the federal government to buy their insurance.

People with incomes below 138% FPL will be eligible for Medicaid. For the first time everyone will be eligible regardless of disability status. Also people will be allowed to have a savings account of any amount and still qualify. As of now, it is unclear what will happen if there are states that do not choose to expand their programs.

It is very important to note that health care reform does nothing to help people with HIV who are undocumented. It does not end the five-year Medicaid waiting period for most new immigrants. However, new immigrants will be able to purchase insurance coverage in the Exchanges. We will all have to continue advocating for quality care for immigrants living with HIV in the US.

We don’t expect these transitions to occur without any problems. And we all have a lot of work to do to ensure that implementation of the ACA meets the needs of people with HIV. Despite these expected challenges, health care for people with HIV will be strengthened after full implementation of health care reform.

How can I begin to prepare for changes?
Here is a list of things you can do to start to prepare for changes over the next couple of years:

  • Begin to educate yourself about where you currently get your health care coverage.
  • Find out if you will experience any changes in coverage; many will not but many others will.
  • Begin to educate yourself about the insurance coverage you think you will gain. People with HIV have been historically shut out of health care coverage and have much to learn about these new systems.
  • Stay involved with the implementation of health care reform by joining and the monthly webinars offered there.
  • Begin to find out if there is anyone planning for changes for people with HIV at your local or state level. Check your local HIV planning council or contact local, regional or state HIV agencies.
  • Keep talking to your provider, clinic and/or doctor about their plans for health care reform.
  • Stay involved in what is going on. If you come across an unfavorable change in your care or notice something that could use improvement, contact organizations or officials to make your voice heard.
What resources can I refer to?
Learn More @ Project Inform

Off Topic

'Cannibal' bath salt drugs as 'addictive as cocaine'
Wednesday Jul 25 2012
The former legal high mephedrone, also known as meow meow, is as ‘addictive as cocaine’ reported the Mail. The effects of the drug, which the paper says has been blamed for a series of ‘cannibal attacks’ have recently been studied in mice…Continue reading..

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