July 22, 2010

NVHR Responds to New York Times Article on Hepatitis C Testing

WASHINGTON, July 22 /PRNewswire-USNewswire/ -- In response to today's New York Times article, "Hope against Hepatitis C," Andrew Muir, M.D., M.H.S., Director, Gastroenterology/Hepatology Research, Duke Clinical Research Institute and Steering Committee Member of the National Viral Hepatitis Roundtable (NVHR) released the following statement:

"Today's New York Times article details potential promising new drug therapies that could significantly improve the way we treat individuals infected with hepatitis C. Regrettably, the article suggests that expanded screening for hepatitis C may not be warranted. This approach is wrong and contrary to the direction in which we should and must move our health care system, particularly through improved access to care under health care reform. More than 5 million Americans are estimated to be infected with viral hepatitis B or C – and most are unaware they are infected as there are often few symptoms. Our health care system misses most infected individuals, who only learn that they have hepatitis C once they have progressed to liver cancer, cirrhosis, or liver failure. At that juncture, treatment options are limited and success rates are lower.

"Precisely because we do not know which individuals with hepatitis C will advance to these terrible diseases, it is critical that our public health infrastructure be modernized to achieve early detection of new infections and also to screen for individuals within specific risk groups, such as baby boomers and disproportionately affected populations. Once individuals are aware of their status, they will be empowered with this information, not only to make treatment choices, but also lifestyle choices to decrease their likelihood of disease progression and not to spread this infectious disease to others. In our current health care system, there are far too few options for diagnosis, care, and treatment. Unless or until the health care system provides access to all persons in need of hepatitis C treatment, it is important for the pharmaceutical industry to provide comprehensive compassionate care programs for those who are un/under insured.

"We can't prevent or treat what we don't know, which is why screening is critical. Access to screening would capture more infected individuals who can respond favorably to early intervention, reduce transmission, avoid needless medical expenses, and ultimately save thousands of lives annually."

NVHR is a coalition of more than 150 public, private, and voluntary organizations dedicated to reducing the incidence of infection, morbidity, and mortality from chronic viral hepatitis that afflicts more than 5 million Americans. www.nvhr.org

SOURCE National Viral Hepatitis Roundtable

RELATED LINKS
http://www.nvhr.org/

Source

Effects of Milk Thistle Extract on the Hepatitis C Virus Lifecycle

® 2004 Horticopia, Inc.
Photography by Robert E. Lyons

A laboratory study suggests that silymarin—an extract from the milk thistle plant—has multiple effects against the lifecycle of the hepatitis C virus. Hepatitis C is a chronic (long lasting) disease that primarily affects the liver and is often difficult to cure. The laboratory study examined the antiviral properties and mechanisms of silymarin on cultured (grown in a lab) human liver cells infected with the virus. The study, funded in part by NCCAM, was published in the journal Hepatology.

The researchers grew human liver cells and infected them in vitro with the hepatitis C virus. The cells were then exposed to either standard hepatitis C drug treatment or to a diluted dose of silymarin. By analyzing the interactions between silymarin and the virus, the researchers observed that silymarin prevented the entry and fusion of the hepatitis C virus into the target liver cells. They also found that silymarin inhibited the ability of the virus to produce RNA (a chemical that plays an important role in protein synthesis and other chemical activities of the cell), interfering with a portion of the virus's lifecycle. When measured against untreated cells, silymarin also significantly decreased viral load (the amount of virus in the cells), although to a lesser degree than treatment with interferon did. The researchers also found that silymarin prevented the cell-to-cell spread of the virus.

These findings build on previous research of silymarin's antiviral and anti-inflammatory properties and provide more information about the potential mechanisms involved in silymarin's antiviral actions. Further research, particularly in clinical trials, is needed to determine if silymarin could be a safe and effective supplement for treating hepatitis C in humans.

Reference
Wagoner J, Negash A, Kane OJ, et al. Multiple effects of silymarin on the hepatitis C virus lifecycle. Hepatology. 2010;51(6):1912–1921.

Additional Resources
CAM and Hepatitis C: A Focus on Herbal Supplements
Milk Thistle
 
Source

Vertex: A New Era In HCV Drug Development

by: Jason Chew
July 19, 2010 
 
Pegylated interferon plus ribavirin is the current standard of care for HCV treatment. However, it is a 48-week treatment and is only effective in about 50% of patients. On top of that, patients must deal with the inconvenience of injections and side effects that include fatigue, depression, anemia and rash.

Now a new generation of so-called “direct acting” antivirals is expected to change the way HCV is treated, lead by the protease inhibitor teleprevir from Vertex (VRTX). In a Phase III trial, it was shown that a short 12-week treatment of teleprevir on top of Peg-interferon plus ribavirin resulted in a cure rate of 75% compared to just 44% with Peg-interferon plus ribavirin alone for 48 weeks. In the most likely scenario, teleprevir will reach the market toward the end of 2011, with a similar drug from Schering-Plough (SGP), boceprevir, following soon after.

The World Health Organization estimates 200 million people worldwide are infected with HCV, with an additional 3 to 4 million contracting the disease each year. The global market for HCV treatment is currently around $2 to $3 billion. With the advent of new available treatments, this market is expected to increase to more than $8 billion by 2016.

Teleprevir and boceprevir are only the first in a long list of novel HCV treatments moving through the pipeline. There are now four main classes of direct acting oral antivirals in clinical trials:

NS3/4A protease inhibitors- these are the most advanced agents; Teleprevir is among them

Non-nucleoside NS5B polymerase inhibitors- many are in development

Nucleoside NS5B polymerase inhibitors- these are showing a great deal of promise

NS5A inhibitors- most recently developed

The market for these novel medicines is still in its infancy, with no drugs so far approved by the FDA, yet there are no fewer than 14 companies working on these four classes of HCV treatments.

Companies with market caps ranging from less than $100 million to greater than $100 billion are involved in this work.

To divine the future of HCV drug development, it may be intuitive to look at the history of HIV drugs. Both HCV and HIV are RNA viruses, and some of the most effective early drugs to treat HIV were protease inhibitors. Over time, new classes of drugs were developed that were more potent and had fewer side effects. Scientists found that combinations of multiple drugs taken together worked the best; HIV became highly treatable even though no cure was found. Single pills containing a cocktail of antiviral drugs became the standard of care. Importantly, the current leader in the HIV market was not among the first entrants, it usurped the throne by developing a superior treatment.

Now as teleprevir heads towards market, drug makers are already at work on combinations of direct acting drugs. None of the compounds in development today work as monotherapies. The first generation of these combination drugs are protease inhibitor plus non-nucleoside NS5B polymerase inhibitor or protease inhibitor plus nucleoside NS5B polymerase inhibitor. The former of these is slightly more advanced in the clinic. The ultimate goal is to find a combination of oral drugs, which will eradicate the virus without the need for the addition of Peg-interferon plus ribavirin.

With four drug classes, the number of drug combinations is quite large. It is expected that similar to HIV treatment, these drug combos will consist of from two to four different compounds. Certain combinations of three drugs have now been shown to be synergistic together. It is not necessary that each of the drugs in the combo come from a different drug class. For instance, multiple polymerase inhibitors, each attacking different sites on the polymerase, can be used together, allowing for an even greater diversity of drug combinations.

In my opinion, it is almost a certainty that neither of the first two protease inhibitors will reign as standard of care in HCV treatment for very long. They have a significant head start on other compounds, but both have similar weaknesses. Neither can be taken once-daily, and resistant strains have already been identified for both compounds. Early stage protease inhibitors are now being developed that are more potent against the NS3/4A protease by greater than 100 fold, may have the potential for once-daily dosing, and have been shown to be active against HCV strains resistant to teleprevir and boceprevir. It is also thought that nucleoside polymerase inhibitors may have an advantage over other compound classes due to the high barrier it presents to the creation of resistant viral strains.

With the rapid advances in drug development, some predict treatment time may be reduced to as short as six weeks. The HCV space will be fascinating to watch in the coming years as new treatments become approved.

Source

A Letter to Patients with Chronic Illness

By: Dr. Rob
July 20, 2010

Note: The following post from my blog had an incredible response in the chronic pain community and across the web. Clearly this is a very important issue and this letter touched a nerve that has largely been ignored.

Dear Patients:

You have it very hard, much harder than most people understand. Having sat for 16 years listening to the stories, seeing the tiredness in your eyes, hearing you try to describe the indescribable, I have come to understand that I too can’t understand what your lives are like. How do you answer the question, “how do you feel?” when you’ve forgotten what “normal” feels like? How do you deal with all of the people who think you are exaggerating your pain, your emotions, your fatigue? How do you decide when to believe them or when to trust your own body? How do you cope with living a life that won’t let you forget about your frailty, your limits, your mortality?

I can’t imagine.

But I do bring something to the table that you may not know. I do have information that you can’t really understand because of your unique perspective, your battered world. There is something that you need to understand that, while it won’t undo your pain, make your fatigue go away, or lift your emotions, it will help you. It’s information without which you bring yourself more pain than you need suffer; it’s a truth that is a key to getting the help you need much easier than you have in the past. It may not seem important, but trust me, it is.

You scare doctors.

No, I am not talking about the fear of disease, pain, or death. I am not talking about doctors being afraid of the limits of their knowledge. I am talking about your understanding of a fact that everyone else seems to miss, a fact that many doctors hide from: we are normal, fallible people who happen to doctor for a job. We are not special. In fact, many of us are very insecure, wanting to feel the affirmation of people who get better, hearing the praise of those we help. We want to cure disease, to save lives, to be the helping hand, the right person in the right place at the right time.

But chronic unsolvable disease stands square in our way. You don’t get better, and it makes many of us frustrated, and it makes some of us mad at you. We don’t want to face things we can’t fix because it shows our limits. We want the miraculous, and you deny us that chance.

And since this is the perspective you have when you see doctors, your view of them is quite different. You see us getting frustrated. You see us when we feel like giving up. When we take care of you, we have to leave behind the illusion of control, of power over disease. We get angry, feel insecure, and want to move on to a patient who we can fix, save, or impress. You are the rock that proves how easily the ship can be sunk. So your view of doctors is quite different.

Then there is the fact that you also possess something that is usually our domain: knowledge. You know more about your disease than many of us do – most of us do. Your MS, rheumatoid arthritis, end-stage kidney disease, Cushing’s disease, bipolar disorder, chronic pain disorder, brittle diabetes, or disabling psychiatric disorder – your defining pain -- is something most of us don’t regularly encounter. It’s something most of us try to avoid. So you possess deep understanding of something that many doctors don’t possess. Even doctors who specialize in your disorder don’t share the kind of knowledge you can only get through living with a disease. It’s like a parent’s knowledge of their child versus that of a pediatrician. They may have breadth of knowledge, but you have depth of knowledge that no doctor can possess.

So when you approach a doctor – especially one you’ve never met before – you come with a knowledge of your disease that they don’t have, and a knowledge of the doctor’s limitations that few other patients have. You see why you scare doctors? It’s not your fault that you do, but ignoring this fact will limit the help you can only get from them. I know this because, just like you know your disease better than any doctor, I know what being a doctor feels like more than any patient could ever understand. You encounter doctors intermittently (more than you wish, perhaps); I live as a doctor continuously.

So let me be so bold as to give you advice on dealing with doctors. There are some things you can do to make things easier, and others that can sabotage any hope of a good relationship:

1. Don’t come on too strong – yes, you have to advocate for yourself, but remember that doctors are used to being in control. All of the other patients come into the room with immediate respect, but your understanding has torn down the doctor-god illusion. That’s a good thing in the long-run, but few doctors want to be greeted with that reality from the start. Your goal with any doctor is to build a partnership of trust that goes both ways, and coming on too strong at the start can hurt your chances of ever having that.

2. Show respect – I say this one carefully, because there are certainly some doctors who don’t treat patients with respect – especially ones like you with chronic disease. These doctors should be avoided. But most of us are not like that; we really want to help people and try to treat them well. But we have worked very hard to earn our position; it was not bestowed by fiat or family tree. Just as you want to be listened to, so do we.

3. Keep your eggs in only a few baskets – find a good primary care doctor and a couple of specialists you trust. Don’t expect a new doctor to figure things out quickly. It takes me years of repeated visits to really understand many of my chronic disease patients. The best care happens when a doctor understands the patient and the patient understands the doctor. This can only happen over time. Heck, I struggle even seeing the chronically sick patients for other doctors in my practice. There is something very powerful in having understanding built over time.

4. Use the ER only when absolutely needed – Emergency Room physicians will always struggle with you. Just expect that. Their job is to decide if you need to be hospitalized, if you need emergency treatment, or if you can go home. They might not fix your pain, and certainly won’t try to fully understand you. That’s not their job. They went into their specialty to fix problems quickly and move on, not manage chronic disease. The same goes for any doctor you see for a short time: they will try to get done with you as quickly as possible.

5. Don’t avoid doctors – one of the most frustrating things for me is when a complicated patient comes in after a long absence with a huge list of problems they want me to address. I can’t work that way, and I don’t think many doctors can. Each visit should address only a few problems at a time, otherwise things get confused and more mistakes are made. It’s OK to keep a list of your own problems so things don’t get left out – I actually like getting those lists, as long as people don’t expect me to handle all of the problems. It helps me to prioritize with them.

6. Don’t put up with the jerks – unless you have no choice (in the ER, for example), you should keep looking until you find the right doctor(s) for you. Some docs are not cut out for chronic disease, while some of us like the long-term relationship. Don’t feel you have to put up with docs who don’t listen or minimize your problems. At the minimum, you should be able to find a doctor who doesn’t totally suck.

7. Forgive us – Sometimes I forget about important things in my patients’ lives. Sometimes I don’t know you’ve had surgery or that your sister comes to see me as well. Sometimes I avoid people because I don’t want to admit my limitations. Be patient with me – I usually know when I’ve messed up, and if you know me well I don’t mind being reminded. Well, maybe I mind it a little.

You know better than anyone that we docs are just people – with all the stupidity, inconsistency, and fallibility that goes with that – who happen to doctor for a living. I hope this helps, and I really hope you get the help you need. It does suck that you have your problem; I just hope this perhaps decreases that suckishness a little bit.

Sincerely,
Dr. Rob

Source
 
Dr. Alexander J. Thompson discusses his manuscript "Interleukin-28B Polymorphism Improves Viral Kinetics and Is the Strongest Pretreatment Predictor of Sustained Virologic Response in Genotype 1 Hepatitis C Virus
 
Gastroenterology

Volume 139, Issue 1 , Pages 120-129.e18, July 2010
 
Alexander J. Thompson, Andrew J. Muir, Mark S. Sulkowski, Dongliang Ge, Jacques Fellay, Kevin V. Shianna, Thomas Urban, Nezam H. Afdhal, Ira M. Jacobson, Rafael Esteban, Fred Poordad, Eric J. Lawitz, Jonathan McCone, Mitchell L. Shiffman, Greg W. Galler, William M. Lee, Robert Reindollar, John W. King, Paul Y. Kwo, Reem H. Ghalib, Bradley Freilich, Lisa M. Nyberg, Stefan Zeuzem, Thierry Poynard, David M. Vock, Karen S. Pieper, Keyur Patel, Hans L. Tillmann, Stephanie Noviello, Kenneth Koury, Lisa D. Pedicone, Clifford A. Brass, Janice K. Albrecht, David B. Goldstein, John G. McHutchison

Received 31 December 2009; accepted 8 April 2010. published online 19 April 2010.

Background & Aims

We recently identified a polymorphism upstream of interleukin (IL)-28B to be associated with a 2-fold difference in sustained virologic response (SVR) rates to pegylated interferon-alfa and ribavirin therapy in a large cohort of treatment-naive, adherent patients with chronic hepatitis C virus genotype 1 (HCV-1) infection. We sought to confirm the polymorphism's clinical relevance by intention-to-treat analysis evaluating on-treatment virologic response and SVR.

Methods

HCV-1 patients were genotyped as CC, CT, or TT at the polymorphic site, rs12979860. Viral kinetics and rates of rapid virologic response (RVR, week 4), complete early virologic response (week 12), and SVR were compared by IL-28B type in 3 self-reported ethnic groups: Caucasians (n = 1171), African Americans (n = 300), and Hispanics (n = 116).

Results

In Caucasians, the CC IL-28B type was associated with improved early viral kinetics and greater likelihood of RVR (28% vs 5% and 5%; P < .0001), complete early virologic response (87% vs 38% and 28%; P < .0001), and SVR (69% vs 33% and 27%; P < .0001) compared with CT and TT. A similar association occurred within African Americans and Hispanics. In a multivariable regression model, CC IL-28B type was the strongest pretreatment predictor of SVR (odds ratio, 5.2; 95% confidence interval, 4.1–6.7). RVR was a strong predictor of SVR regardless of IL-28B type. In non-RVR patients, the CC IL-28B type was associated with a higher rate of SVR (Caucasians, 66% vs 31% and 24%; P < .0001).

Conclusions

In treatment-naive HCV-1 patients treated with pegylated interferon and ribavirin, a polymorphism upstream of IL-28B is associated with increased on-treatment and sustained virologic response and effectively predicts treatment outcome.

Keywords: Genetics, IL-28B, Interferon-Lambda, Peg-Interferon-Alfa

Abbreviations used in this paper: ALT, alanine aminotransferase, BMI, body mass index, cEVR, complete early virologic response, CI, confidence interval, EVR, early virologic response, HCV, hepatitis C virus, HCV-1, hepatitis C virus genotype 1, IL, interleukin, ITT, intention-to-treat, pegIFN, pegylated-interferon, RBV, ribavirin, RVR, rapid virologic response, SNP, single nucleotide polymorphism, SVR, sustained virologic response

Source

Misuse of anesthesia could cause hepatitis virus transmission

Public release date: 22-Jul-2010

Contact: Alissa J. Cruz
media@gastro.org
301-272-1603
American Gastroenterological Association

Study findings and recent potential virus exposures reiterate importance of proper sterilization

Hepatitis B virus (HBV) and hepatitis C virus (HCV) can be transmitted during intravenous (IV) administration of anesthesia, according to a new study in Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute. In this study, doctors found that anesthesia contamination — not endoscopy contamination — was the cause of infection.

Efforts are needed to better educate the health-care community on the importance of strict adherence to sterile techniques when using any form of anesthesia. The study findings highlight the fact that many instances of health care-related HBV and HCV virus transmission probably go undetected. The true magnitude of this problem is therefore unknown.

Doctors investigated an outbreak of acute HBV and HCV infections among patients who received anesthesia during endoscopy procedures from the same anesthesiologist in two different gastroenterology clinics. They identified six cases of outbreak-associated HCV infection and six cases of outbreak-associated HBV infection in one clinic; one outbreak-associated HCV infection was identified in a second clinic. All affected patients in both clinics received propofol from this anesthesiologist, who inappropriately used a single-use vial of propofol for multiple patients. Reuse of syringes to re-dose patients, with resulting contamination of medication vials used for subsequent patients, likely resulted in viral transmission.

These findings are consistent with other investigations of HBV and HCV infection in health-care settings: contamination of anesthesia or other IV medications was far more likely to be responsible for transmission of HBV or HCV than the equipment used in the patients' medical procedures.

The doctors' study results increase concerns regarding infection control practices and use of shared medication vials for anesthesia administration to multiple patients, especially in outpatient settings where infection control oversight is limited and procedures such as endoscopies are increasingly performed. Physicians diagnosing patients with acute viral hepatitis should report these cases to their local health department and carefully consider the role of health-care exposures, especially among those who do not report traditional risk factors for infection.

Together, increased education and policies limiting use of medication vials to single patients for IV anesthesia should reduce the risk for health care-associated HBV and HCV transmission.

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To learn more about hepatitis, visit the patient center on the AGA Web site at http://www.gastro.org/patient-center.

About the AGA Institute

The American Gastroenterological Association is the trusted voice of the GI community. Founded in 1897, the AGA has grown to include 17,000 members from around the globe who are involved in all aspects of the science, practice and advancement of gastroenterology. The AGA Institute administers the practice, research and educational programs of the organization. http://www.gastro.org/.

About Gastroenterology

Gastroenterology, the official journal of the AGA Institute, is the most prominent scientific journal in the specialty and is in the top 1 percent of indexed medical journals internationally. The journal publishes clinical and basic science studies of all aspects of the digestive system, including the liver and pancreas, as well as nutrition. The journal is abstracted and indexed in Biological Abstracts, CABS, Chemical Abstracts, Current Contents, Excerpta Medica, Index Medicus, Nutrition Abstracts and Science Citation Index. For more information, visit http://www.gastrojournal.org/.

Source
Liz Highleyman

Published: 22 July 2010

HIV-positive people co-infected with hepatitis C virus (HCV) may be more likely to develop osteoporosis (porous bones) and sustain fractures than individuals with either virus alone, according to a US study presented this week at the Eighteenth International AIDS Conference in Vienna.

Roger Bedimo, from the Veterans Administration North Texas Healthcare System, looked at osteoporotic fractures, or breaks in the wrist, vertebrae or hip due to loss of bone mineral density.

Numerous studies have found lower than average bone density and higher risk of osteoporosis amongst people with HIV, although there remains controversy about whether this is attributable to the virus itself, antiretroviral drugs, or other factors.

Bone loss may be related to toxic damage to the bones or to metabolic changes that produce an imbalance in natural bone turnover, so that old bone material is reabsorbed faster than new bone can be produced to replace it.

Approximately one-third of HIV-positive people are co-infected with chronic hepatitis C, which is also linked to low bone mineral density and increased risk of fractures. Bone loss is a growing concern as this population ages. Bedimo pointed out that, while women are more likely to sustain fragility fractures, men are more likely to die from fracture-related complications.

Using ICD9 diagnostic codes in medical records, the researchers retrospectively identified all patients in the Veterans Affairs' Clinical Case Registry who were diagnosed with HIV between 1988 and 2009 and subsequently sustained osteoporotic fractures.

The analysis included 56,660 HIV-positive people. Almost all were men, the average age was 45 years and one-third were co-infected with hepatitis C. About two-thirds had taken antiretroviral therapy (ART), for an average duration of about four years. Participants were followed for just over five years on average, for a total 305,237 person-years of observation.

The investigators compared fracture rates between people with HIV alone and those with HIV/HCV co-infection. They then looked at the influence of other factors linked to bone loss including age, race/ethnicity, body weight, ART use, diabetes, chronic kidney disease, and smoking.

Bedimo acknowledged that they could not reliably estimate nutrition status or alcohol or drug use based on medical records, but these would be important risk factors to consider.

During the observation period, 951 people sustained at least one osteoporotic fracture. Most fractures (451) affected the wrist, followed by 308 broken hips and 106 vertebra fractures.

The fracture rate for people with HIV alone was 2.54 per 1000 person-years, rising to 3.25 per 1000 person-years amongst HIV/HCV co-infected participants. Looking only at data from the combination ART era (1996 to 2009), the corresponding rates were 2.86 and 4.06 per 1000 person-years, respectively.

Using these numbers, the researchers then calculated the impact of co-infection and the other confounding factors on fracture risk.

Whilst 51% of people who sustained fractures were HIV/HCV co-infected, this fell to 31% amongst fracture-free individuals. Both single-factor and multivariate analysis found co-existing HCV infection to be a significant independent predictor of osteoporotic fractures, with hazard ratios of 1.27 and 1.43, respectively. In other words, co-infection was associated with a 27 to 43% increase in risk.

In accordance with prior research, people of African descent were significantly less likely to sustain fractures, whilst older age, low body mass index, and tobacco use were linked to significantly higher risk. Bedimo explained that the apparent reduction in wrist fractures at the oldest ages was likely to be attributable to a reduction in strenuous activities that can lead to trauma.

In this study, however, chronic kidney disease and diabetes were not significant predictors of fracture risk after adjusting for other factors. Use of antiretroviral therapy was found to be protective. During the ART era, sustaining an osteoporotic fracture increased the risk of death by 77%.

These findings led Bedimo and colleagues to conclude that HCV co-infection is a significant risk factor for osteoporotic fractures in HIV-positive people, and that fractures appear to be increasing amongst HIV/HCV co-infected people during the ART era.

One limitation of this study is that the researchers only looked at fractures and did not take into account measures of bone mineral density, which could reveal bone loss at earlier stages.

During the discussion after the presentation, co-infection researcher Juan Macias suggested that HCV probably does not directly cause bone changes, but chronic hepatitis C can lead to liver cirrhosis, a known risk factor for bone damage.

Reference

Bedimo R et al. HCV co-infection is associated with a high risk of osteoporotic fractures among HIV-infected patients. Eighteenth International AIDS Conference, Vienna, abstract TUAB0104, 2010.

Source

Also See: HIV/HCV Coinfection Further Increases Risk of Bone Fractures
Public release date: 22-Jul-2010

Contact: Michael Kessler
mkessler@ya.com
34-655-792-699
International AIDS Society

First Lady Sandra Roelofs, Deputy Chairman of Parliament George Tsereteli and Minister of Labor, Health and Social Affairs Irakli Giorgobiani show support for evidence-based drug policy

22 July 2010 [Vienna, Austria] – Sandra Roelofs, First Lady of Georgia; George Tsereteli, Georgia's Deputy Chairman of Parliament; and Irakli Giorgobiani, Georgia's Vice Minister of Labour, Health and Social Affairs, today signed the Vienna Declaration, the official declaration of the XVIII International AIDS conference (AIDS 2010) in Vienna, Austria.

The Vienna Declaration (http://www.viennadeclaration.com/) is a scientific statement seeking to improve community health and safety by calling for the incorporation of scientific evidence into illicit drug policies. More than 12,580 people – including Nobel laureates and leaders in science, medicine and public policy – have signed the declaration since it was launched three weeks ago. The Declaration was published in the Lancet medical journal to coincide with AIDS 2010.

"Georgia supports evidence- based policy in our efforts to protect community health and safety," said Roelofs, the wife of Mikheil Saakashvili, President of Georgia. "Our signatures on the Vienna Declaration reinforce our recognition that harm reduction can provide numerous benefits and highlights the need to design policies that align with emerging science."

Georgia is moving forward with activities that are intended to ensure safer and healthier communities across the country by taking action in three priority areas: prevention, treatment and enforcement.

"The health of Georgians is paramount and therefore we are looking at many ways to improve the well-being of all of our citizens, including those facing challenges such as substance use and HIV," said Giorgobiani.

Added Tsereteli: "We believe a scientific approach to drug policy is the way forward. We will move in support of evidence-based research and policy to optimize investments in public health, improve existing policies, and adopt much more effective and relevant legislation."

In some areas of rapid HIV spread, such as Eastern Europe and Central Asia, injecting drug use is the primary cause of new HIV infections. In some countries, people who use drugs are threatened with arrest, incarceration and worse, and therefore are reluctant to access the necessary public health services.

"Misguided drug policies fuel the AIDS epidemic and result in violence, increased crime rates and destabilization of entire states – yet there is no evidence that they have reduced rates of drug use or drug supply," said AIDS 2010 Chair Dr. Julio Montaner, President of the IAS and Director of the BC Centre for Excellence in HIV/AIDS. "I welcome the endorsement of the Vienna Declaration from these Georgian leaders; it provides great hope for the future in an area of the world being devastated by the HIV and AIDS epidemic."

In much of the world, the current approach to drug policy is ineffective because it neglects proven and evidence-based interventions, while pouring a massive amount of public funds and human resources into expensive and futile enforcement measures. Legal barriers to scientifically proven prevention services such as needle programmes and opioid substitution therapy (OST) mean hundreds of thousands of people become infected with HIV and Hepatitis C (HCV) every year. In some areas of the world, the criminalization of people who inject drugs has also resulted in record incarceration rates placing a massive burden on taxpayers. An emphasis on criminalization produces a cycle of disease transmission, breaking homes and destroying livelihoods.

"Georgia is at risk of rising HIV rates due to epidemics in neighboring countries and a high rate of injection drug use, so it is gratifying to see this type of leadership and deep support for evidence-based policy-making in this area," said Dr. Evan Wood, the chair of the Vienna Declaration writing committee and founder of the International Centre for Science in Drug Policy (ICSDP).

The Vienna Declaration calls on governments and international organizations to take a number of steps, including:

•undertake a transparent review the effectiveness of current drug policies;

•implement and evaluate a science-based public health approach to address the harms stemming from illicit drug use;

•scale up evidence-based drug dependence treatment options;

•abolish ineffective compulsory drug treatment centres that violate the Universal Declaration of Human Rights; and

•unequivocally endorse and scale up funding for the drug treatment and harm reduction measures endorsed by the World Health Organization (WHO) and the United Nations.

The declaration also calls for the meaningful involvement of people who use drugs in developing, monitoring and implementing services and policies that affect their lives.

The Vienna Declaration is one step in pushing for support of science-based approaches to dealing with illicit drugs. The signature-gathering process aims to galvanise scientists and others working in illicit drug policy and place real and sustained pressure on policymakers to meaningfully consider the scientific evidence regarding the limited beneficial impact and negative unintended consequences of conventional illicit drug policies.

The impact of the Vienna Declaration will be measured over the coming years, and progress reports on the adoption of evidence-based policies will be presented at subsequent International AIDS Conferences. The adoption of the Vienna Declaration's recommendations among high-level policymakers at the local, national, and international levels will also be tracked by the International Centre for Science in Drug Policy.

The Vienna Declaration was drafted by an international team of scientists and other experts. It was initiated by the IAS, the International Centre for Science in Drug Policy (ICSDP), and the BC Centre for Excellence in HIV/AIDS based in Vancouver, British Columbia.

Those wishing to sign on may visit http://www.viennadeclaration.com/, where the full text of the declaration, along with a list of authors, is available. The two-page declaration references 28 reports, describing the scientific evidence documenting the effectiveness of public health approaches to drug policy and the negative consequences of approaches that criminalize drug users.

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BC Centre for Excellence in HIV/AIDS

The BC Centre for Excellence in HIV/AIDS (BC-CfE) is Canada's largest HIV/AIDS research, treatment and education facility. The BC-CfE is based at St Paul's Hospital, Providence Health Care, a teaching hospital of the University of British Columbia. The BC-CfE is dedicated to improving the health of British Columbians with HIV through developing, monitoring and disseminating comprehensive research and treatment programs for HIV and related diseases.

International Centre for Science in Drug Policy

ICSDP aims to be a primary source for rigorous scientific evidence on illicit drug policy in order to benefit policymakers, law enforcement, and affected communities. To this end, the ICSDP conducts original scientific research in the form of systematic reviews, evidence-based drug policy guidelines, and research collaborations with leading scientists and institutions across diverse continents and disciplines.

MEDIA CONTACTS:

Michael Kessler
Media Consultant, AIDS 2010
Email: mkessler@ya.com
Tel: +34 655 792 699

Mahafrine Petigara
Edelman
Email: mahafrine.petigara@edelman.com
Tel: +1 604 623 3007, ext. 297

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President Asif Ali Zardari of Pakistan signs up as organ donor

22 July 2010

Islamabad -- President Asif Ali Zardari of Pakistan today signals top-level personal support for a new national organ transplantation service by signing an organ donor card to bequeath his organs upon his death. The signing will take place at a ceremony at Bilawal House, Karachi.

The new service is based on donations from deceased donors. It prohibits commercial transplantation and outlaws the organ trade.

“Pakistan has taken an important step in passing this new law to regulate organ transplantation, and is setting an excellent example to other countries,” said Dr Hussein A. Gezairy, WHO Regional Director for the Eastern Mediterranean. “The commercialization of organ transplantation is unethical, inequitable and unhealthy – both for vendors and recipients.”

Kidney transplantation took off in Pakistan in the late 1980s. To begin with, most transplanted kidneys were donated by family members but by the late 1990s, the majority of kidneys were bought from individuals from villages located around major cities. By 2003, most kidney transplants were undertaken in private hospitals in the cities of Punjab.

In 2005 (the last year for which figures are available), 1500 commercial transplantations were conducted openly in Pakistan.

An article published online in the journal Clinical Transplantation on 6 July 2010 by a group of researchers from Skopje, Macedonia, describes 36 patients who travelled from the Balkans to buy kidneys in Pakistan. Following operations in Lahore and Rawalpindi, seven patients died, while many others suffered serious complications such as infected wounds, renal artery thrombosis, active hepatitis C, steroid diabetes and acute myocardial infarctions. [1]

Meanwhile, many people who have sold a kidney say that their health has suffered as a result, citing general overall weakness and an inability to work long hours.

Organ transplantation is the only viable treatment for a range of fatal and non-fatal diseases affecting the heart, liver or lungs. Although patients with terminal renal diseases can be treated through other renal replacement therapies (notably dialysis), kidney transplantation is generally accepted as the best treatment both for quality of life and cost effectiveness. Kidney transplantation is by far the most frequently carried out form of transplantation globally.

Worldwide, approximately 100 900 solid organ transplants were performed in 2008 (based on information from the 104 countries in which 99% of the world’s organ transplants take place). Kidney transplants made up the majority of all transplants (69 300), followed by liver (5330), heart (5330) and lung (3330) transplants.

Demand for organs outstrips supply in almost every country of the world. WHO estimates that less than one tenth of estimated global needs in organ transplantation are currently met. This results in offers of incentives for donation, profiteering and exploitation of the disadvantaged.

In 1987, the World Health Assembly noted that the commercialization of organ transplantation contravenes the Universal Declaration of Human Rights and the spirit of the WHO Constitution. WHO subsequently developed a unified legal instrument to regulate transplantation, which led to the approval of a set of Guiding Principles at the World Health Assembly in 1991. The Guiding Principles emphasize voluntary donation and non-commercialization of human organs. In May 2010, the sixty-third World Health Assembly adopted a further resolution (WHA63.22) endorsing an updated set of Guiding Principles on Human Cell, Tissue and Organ Transplantation. The resolution highlights the social risks associated with trafficking in human materials, and the need for public support to stamp out the trade and increase donations from deceased donors.

Meanwhile, in March 2010, the Third Global Consultation on Organ Donation and Transplantation agreed to aim for self-sufficiency by scaling up preventive measures (such as healthy lifestyle campaigns) to reduce the numbers of people needing organ transplants, and to encourage people to do what President Zardari is doing today: demonstrating a commitment to the community by bequeathing his organs for use by others after his death. Ensuring adequate local supply of voluntarily donated organs is critical to eliminating commercial trade and “transplant tourism”.

For more information:

Sarah Russell, WHO headquarters
russellsa@who.int, +41 22 791 5412

Mona Yassin, WHO Regional Office for the Eastern Mediterranean
yassinm@emro.who.int, +202 22765020

[1] Ivanovski N, Masin J, Rambabova-Busljetic I, Pusevski V, Dohcev S, Ivanovski O, Popov Z. The outcome of commercial kidney transplant tourism in Pakistan.
Clin Transplant 2010 DOI: 10.1111/j.1399-0012.2010.01299.x.
© 2010 John Wiley & Sons A/S

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press release

July 22, 2010, 7:04 a.m. EDT

ACH-2928 Demonstrates Excellent Potency Against HCV RNA Replication, Holds Potential for Combination Therapy

NEW HAVEN, Conn., Jul 22, 2010 (GlobeNewswire via COMTEX) -- Achillion Pharmaceuticals, Inc. /quotes/comstock/15*!achn (ACHN 2.40, -0.02, -0.83%) , a leader in the discovery and development of treatments for the most challenging infectious diseases, today announced the nomination of a lead clinical candidate in its fourth proprietary program against hepatitis C virus (HCV) infection. The candidate, ACH-2928, is an NS5A inhibitor that in preclinical studies has demonstrated excellent potency against HCV RNA replication, as well as good pharmacokinetic and safety profiles.

"The overall profile of ACH-2928 demonstrates that it is highly active and retains potency against HCV genotypes 1a and 1b, as well as across other genotypes. The compound's high potency, in the picomolar range, and its favorable pharmacokinetic properties strongly suggest once-daily dosing," said Milind S. Deshpande, Ph.D., Executive Vice President and Chief Scientific Officer of Achillion. "Importantly, we believe ACH-2928 is highly effective in combination with NS3 protease inhibitors, NS5B polymerase inhibitors, interferon and ribavirin."

Michael D. Kishbauch, Achillion's President and CEO, stated, "The nomination of this novel NS5A clinical candidate is both exciting and significant. The treatment paradigm for HCV is moving toward combination therapies, and we are now poised to pursue our own combination therapies, putting ACH-2928 together with our highly potent protease inhibitors, ACH-1625 and ACH-2684. The development of our fourth proprietary HCV program underscores the depth of our robust drug discovery expertise in this important therapeutic area. We have initiated IND-enabling testing of ACH-2928, and plan to initiate combination treatment in 2011."

"The nomination of ACH-2928 is further evidence of our expertise in HCV drug discovery and structure-based design. We continue to build discrete intellectual property estates to which we retain all commercial rights," concluded Kishbauch.

About HCV

The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide and The American Association of Liver Disease estimates that up to 80% of individuals become chronically infected following exposure to the virus. If left untreated, chronic hepatitis can lead to permanent liver damage, which can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile and injectable route of administration.

About Achillion Pharmaceuticals

Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease -- hepatitis C, resistant bacterial infections and HIV. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including statements with respect to the potency, safety and other characteristics of our drug candidates, which may not be duplicated in future preclinical studies or in future clinical studies, if any; Achillion's expectations regarding the timing of other preclinical and clinical trials. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: uncertainties relating to results of clinical trials, unexpected regulatory actions or delays, and Achillion's ability to obtain additional funding required to conduct its research, development and commercialization activities. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2009.

All forward-looking statements reflect Achillion's expectations only as of the date of this release and should not be relied upon as reflecting Achillion's views, expectations or beliefs at any date subsequent to the date of this release. Achillion anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Achillion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. ACHN-G

This news release was distributed by GlobeNewswire, http://www.globenewswire.com/

SOURCE: Achillion Pharmaceuticals, Inc.

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In Afflicted, a Doctor Finds Her Following

Peter DaSilva for The New York Times
Dr. Diana L. Sylvestre at the Oasis treatment clinic in Oakland, Calif.

By ANDREW POLLACK
Published: July 21, 2010
 
OAKLAND, Calif. — Betty Stevenson used heroin for many years and spent seven years in prison for forgery. She finally cleaned up, only to discover that she been infected with hepatitis C from contaminated needles and had serious liver disease.

Ms. Stevenson was successfully treated by Dr. Diana Sylvestre, the founder and lone physician at a clinic here set in a former factory near a blighted neighborhood known as Ghost Town.

“By the time I got here and to Dr. Sylvestre, I was dead, I had no hope,” said Ms. Stevenson, 68, who is now raising three great-grandsons. “She literally saved my life.”

Dr. Sylvestre has earned avid devotion from many of the several hundred addicts and former addicts, ex-convicts, poor and uninsured whom she has treated for hepatitis C. Getting such patients help is a challenge that, if not met, could thwart the success of new hepatitis C drugs aimed at subduing the virus.

“People will use a lot of excuses not to treat patients with hepatitis C,” Dr. Sylvestre said.

An uninsured man, who would give only his first name, Dash, showed up recently at the clinic’s weekly hepatitis meeting saying that he had tried for a year to get treatment, only to be referred from place to place and turned down by the county hospital.

A graduate of Harvard Medical School, Dr. Sylvestre was doing genetic research in New York when, in 1995, she moved west with her husband, who had taken a job at a Bay Area biotechnology company. Needing a job, she took one doing entrance examinations at a drug addiction treatment center.

She found it odd that most patients had signs of liver damage. “It finally dawned on me that all of my patients had hepatitis C,” she said.

In 1998, she started the nonprofit Oasis clinic, whose name stands for Organization to Achieve Solutions in Substance-Abuse. She began visiting methadone clinics, urging people to be tested for hepatitis C.

In one study Dr. Sylvestre enrolled 188 drug addicts to see if she could first treat their addiction then their hepatitis C. Some 65 made it through the addiction treatment and were then offered treatment for hepatitis C. Of those, 55 tried and 23 were cured.

Lorinda Willens is trying to curb her drinking so that Dr. Sylvestre will treat her hepatitis. Ms. Willens and her husband, Donald, began using heroin at music clubs in the 1970s. They quit 20 years ago, but Mr. Willens died from hepatitis in 2006 after treatment failed.

Having promised her husband that she would never use drugs again, Ms. Willens instead began drinking heavily to cope with her sorrow, which further damaged her liver.

“I want to get it done,” Ms. Willens said of hepatitis treatment. “I’m starting to get cirrhosis.”

Besides treating patients, Dr. Sylvestre is an activist fighting for more government resources. Her patients have joined her at some rallies.

“They don’t think we can organize because we are all a bunch of junkies,” said one patient, Lisa Roellig.

The patients must be restrained in pressing their case, however, because many have criminal records. “If they get arrested,” Dr. Sylvestre said, “they might not come out again.”

Source

A Food-Related Method For The Diagnosis Of Hepatic Steatosis

Article Date: 22 Jul 2010 - 0:00 PDT

A multidisciplinary research team from the Instituto Biodonostia made up by digestologists, epidemiologists and researchers of the Experimental Unit evaluated the use of a method so far employed in the food industry to improve the diagnosis of hepatic steatosis. Fatty liver is one of the most frequent liver diseases and it is promoted by obesity and diabetes.

Up to now, fat determination in the liver involved histology (study of liver tissues), and four severity degrees were subjectively identified. The Biodonostia research team has evaluated the suitability of the Soxtec method, commonly used for lipid determination in different foods, to quantify liver fat in mice in which hepatic steatosis was promoted.

The study shows that there is a good correlation between the histological and the Soxtec methods; the latter allows objective fat determination using a non-invasive method - nuclear magnetic resonance.

After getting positive results in research animals, the study currently involves patients operated on for liver diseases.

Source:
Irati Kortabitarte
Elhuyar Fundazioa

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