The story of one million lives lost

Source: Fri, 26 Jul 2013 08:15 AM

Author: Ding-Shinn Chen, CEVHAP

On Sunday advocates, patients, clinicians and a growing number of government representatives will come together in support of World Hepatitis Day, an annual event endorsed by the World Health Organization (WHO) that aims to raise awareness of viral hepatitis among at-risk groups.

The need for raising awareness of viral hepatitis is immense. Indeed, although the transmission of viruses that cause hepatitis is preventable, we now know that the number of people dying globally every year from these viruses has increased from approximately 986,000 in 1990 to more than 1.4 million people today. This is a similar number of people that die each year as a result of HIV/AIDS.

The situation is graver in the Asia Pacific region, where the data shows that 70 percent of all worldwide deaths related to viral hepatitis occur. That means that in Asia, one million people die needlessly every year and on average one person dies every 30 seconds. These figures - from the Global Burden of Disease Study (GBDS) by the University of Washington’s Institute for Health Metrics and Evaluation - were presented for the first time in Asia in June 2013, at the Liver Week conference of the Asian Pacific Association for the Study of the Liver (APASL).

An important part of a worldwide movement to halt this death toll, World Hepatitis Day aims to raise awareness of how hepatitis is transmitted and to prevent the many millions of new infections that occur each year. The event addresses the abysmally low awareness levels that surround these diseases, which mean that in the case of South East Asia around 65 percent of people living with chronic hepatitis B, and 75 percent with hepatitis C, are unaware they are infected.

The significant number of undiagnosed people explains why - despite the existence of an effective vaccine for hepatitis B and treatments for chronic hepatitis C that could save millions of lives - the number of people dying from viral hepatitis continues to rise. Fundamentally, a large proportion of people are diagnosed late - once they start to have symptoms and become ill. It is only then, when their infection has led to liver cirrhosis or liver cancer, that they discover the infection they have carried, usually for many years. Unfortunately, by the later stages of the disease, treatment options are more limited.

Viral hepatitis represents one of the world’s greatest threats to health, and yet these diseases remain low on the global and Asia health priority list, falling way behind other diseases such as HIV, tuberculosis (TB) and malaria. These new figures reveal the increasing threat posed by viral hepatitis to the Asia Pacific region and are symptomatic of the poor understanding and lack of political commitment that has typically surrounded these diseases in many countries.

In defence of government policymakers, however, there has been a distinct lack of categorical evidence needed to guide policy development and justify the required investments. We now have the evidence we need to prove that viral hepatitis is an urgent public health priority in Asia. On World Hepatitis Day, the Coalition to Eradicate Viral Hepatitis in Asia Pacific (CEVHAP) is urging governments to embrace the blueprint contained in the WHO’s new Global Framework for Action.

The WHO’s framework was first launched on World Hepatitis Day 2012 and, recognising that each country will face a different set of challenges, provides a guide for governments to develop their own nationally-coordinated action plans to tackle viral hepatitis. The WHO framework represents a comprehensive strategic policy approach, and over the last year, many of our members have held encouraging discussions with ministries of health across the region, a number of which have expressed interest in strengthening their country’s response to viral hepatitis.

The success in implementing the framework within countries requires, however, the realisation that many countries, particularly in the Asia Pacific region, are resource-constrained and that funding issues present a significant barrier to their ability to implement lasting measures to reduce the burden of disease. The recent formation of WHO’s Global Hepatitis Network provides governments with access to the expertise needed to translate this framework into national action plans and public policy, but its work will require funding, and many governments will need support to build capacity and mobilise resources.

In the past, we have seen what can be achieved when governments, the medical community, donor organisations and civil society come together in a collective response to spur change and secure funding through the global response provided by UNAIDS, the Stop TB Partnership and Rollback Malaria Partnership. Viral hepatitis lacks a major international funding structure to resource the change that is needed to implement the framework within individual countries. On World Hepatitis Day, our members will ask governments to embrace the WHO’s new global framework and CEVHAP will offer our support, but we need international commitment.

In Asia Pacific, World Hepatitis Day is a story of one million lives lost every year, but it simply does not need to be that way. We can save lives if all people who are touched by viral hepatitis work together, but our human resources alone are not enough. Development agencies, governments and donor bodies must also come to the table and designate viral hepatitis as a funding priority if we are to reverse the escalating impact of these silent but destructive diseases.

Ding-Shinn Chen is the chairman of the Coalition to Eradicate Viral Hepatitis in Asia Pacific (CEVHAP).

Any views expressed in this article are those of the author and not of Thomson Reuters Foundation.

Source

Don’t use used syringes

By Dr Arshad Altaf Published: July 28, 2013

According to the World Hepatitis Alliance, which is commemorating the World Hepatitis Day on July 28, there are 500 million people worldwide infected with hepatitis B or C, a number which is much higher than those suffering from HIV or any cancer. Pakistan is among those countries, which has one of the highest rates of hepatitis B and C infections. A national study in 2007 estimated that there are 12 million Pakistanis infected with these two life-threatening infections. The nationwide prevalence of hepatitis B is 2.5 per cent and that of hepatitis C is 4.9 per cent. Both these infections can be life-threatening and even if the treatment is provided free, it is a complicated and lengthy process with a varying success rate and has some very serious side-effects. While there are multiple causes of transmission of hepatitis B and C, ranging from unsafe blood transfusion, use of unsterilised surgical equipment, unsafe dental procedures, ear piercing or tattooing and shaving by barbers, the most established risk based on epidemiological research is unsafe injection practices by healthcare providers.

The World Health Organisation defines a safe injection as one that does not harm the recipient or the provider and does not result in waste that is dangerous to the community. Unfortunately in Pakistan, unsafe injection practices are very common and MBBS doctors, as well as untrained ones (quacks), prescribe unnecessary injections to patients. Another dangerous aspect is the reuse of single-use disposable syringe for economic reasons. Often the patient is so poor that she/he cannot afford to pay extra or the practitioner has a package deal in which some cheap medicines and an injection is part of the prescription. The reuse of disposable syringes still happens in Pakistan in this day and age, and is an intentional practice on part of the provider. The Safepoint Trust describes this practice in the following manner: “Syringe reuse is quite literally murder on a global scale.”

The Sindh government is sensitised on the issue and has been cognisant of this life-threatening practice. The Sindh cabinet approved the draft and the Sindh Assembly passed the Sindh Regulation and Control of Disposable Syringe Bill, 2010 on January 12, 2011. It has also become an Act of the Legislature of Sindh. The full Act is available at the official website of the Sindh Assembly. This action on part of the previous government must be appreciated as to the best of our knowledge, no other province has gone through this exercise.

The main clause of this Act under the heading of “Restriction” states that “no person shall manufacture, sell or use disposable syringes other that auto lock, auto destruct or auto break for injection, drawing of blood and other purposes.”  Under the heading of “Offence and Penalty”, it states that all directors, managers, secretaries or agents shall follow this Act, and those contravening will be punished with imprisonment for a term that may extend to two years or a fine which may extend to Rs500,000 or with both.

The key reason to pass this bill was to control the reuse of single-use disposable syringes, which as mentioned earlier, has been strongly associated with the spread of hepatitis B and C infections. Unfortunately, there are areas which still need improvement.

For the ease of readers, it should be clarified what an auto disable (AD) is. It is a type of syringe that was specifically developed to restrict the reuse on part of the providers. The syringe has a mechanism, which if used correctly, can make it difficult to reuse it after a single use. At the end of the procedure i.e., after administering an injection, a small force is applied on the plunger and there is a click sound, which practically locks the plunger, making the syringe hard to reuse. In many developed countries, the use of AD syringes is mandatory by law in healthcare settings.

Now coming to the gaps in the Act. The first major weakness is its lack of implementation. To the best of my knowledge, majority of public sector hospitals are still using and tendering conventional disposable syringes. It is safe to assume that medical superintendents or purchase departments are violating the law and can easily go to jail or be liable to huge fines. Most of these persons are probably not even aware of the Act.

The other problem in this Act pertains to the selling and manufacturing of AD syringes. Even though it states that no person shall manufacture or sell syringes other than AD, the Act has overlooked a very important condition, which is that the syringe has to conform to the standard set by the International Organisation for Standardisation Standard (ISO) 7886-4. Accordingly, the manufacturer of the syringe should also comply with the ISO Quality Systems Standards for Medical Devices Manufacturing ISO 13485. The language of this Act is such that at the moment, any supplier or manufacturer can provide any type of AD syringe and no one can legally question its quality or standard of manufacturing.

As an injection safety advocate and researcher, a major gap that I see in this Act is that it does not address the intentional reuse of syringes by healthcare providers. As mentioned earlier, this practice is still around and must be addressed in the form of a law. Prior to devolution, a team, of which I was a part, and other highly trained public health professionals, worked on several drafts of a similar kind of legislation. Even though it got stuck in the government’s bureaucratic system, it properly addressed this practice in detail. The poor and uneducated patient is often unaware of this kind of practice and rarely asks the provider if the syringe is new and opened from a sealed packet. No legislation is available in the province or at the national level, which addresses this issue.

In the end, to reiterate, it must be mentioned that this Act has some serious weaknesses in it. While it was being compiled, technical and public health experts should have been consulted. Making amendments in an existing legislation is a formidable task, knowing the political culture and wranglings that go around in the provincial legislature. Who will take the lead, who will revise it and who will improve it, remains a question for all concerned. One practical way is to form a provincial health promotion legislation committee, which should comprise relevant members of the provincial assembly, as well as public health professionals. They can work collectively to address weaknesses and gaps, and make improvement in this Act, which I am sure, was passed with all good intentions.

Published in The Express Tribune, July 28^th, 2013

Source

Unnecessary injecting of medicines is still a major public health challenge globally

Tropical Medicine & International Health

Early View (Online Version of Record published before inclusion in an issue)

Editorial

C. Gore¹, J. V. Lazarus^2,*, R. J. J. Peck¹, I. Sperle², K. Safreed-Harmon²

Article first published online: 23 JUL 2013

DOI: 10.1111/tmi.12151

© 2013 John Wiley & Sons Ltd

Keywords: hepatitis; injecting practices; public health; World Health Organization

In 2012, we sought responses from all 194 World Health Organization (WHO) Member States for the WHO/World Hepatitis Alliance Global Hepatitis Survey (World Health Organization 2013). While the full survey results will be released on 28 July 2013, World Hepatitis Day, we feel that it is imperative to draw attention to one finding with potentially far-reaching public health implications. Only 7 of 126 Member States that responded to the survey were able to provide data for the following question: ‘What are your government's official estimates of the number and percentage of unnecessary injections administered annually in healthcare settings?’ Another 6 respondents skipped the question, and 113 – almost 90% – answered ‘do not know’.

It is dismaying to learn that such a large number of countries do not appear to have these data available in light of what has been documented regarding injection overuse in developing countries. Much of the evidence is from the 1980s and 1990s, but more recent studies in China and Egypt found unnecessary health facility injection rates of 57% and 95%, respectively (Yan et al. 2006; Bodenschatz et al. 2009). A 2006 Pakistani study estimated that 94% of therapeutic injections nationally are unnecessary (Altaf et al. 2009). A 1999 review article summarising earlier evidence noted levels of unnecessary injections ranging from 70% to 99% in various patient populations in India, Indonesia, the Russian Federation and Tanzania (Simonsen et al. 2006).

The findings from the recent global hepatitis survey are a stark reminder of the persistence of this danger. In our survey, the three highest national estimates for the proportion of unnecessary injections were 68% (Mongolia), 50% (Cambodia) and 20% (Pakistan). These figures, coupled with the absence of data from many other countries, raise the question of whether progress is being made on reducing unnecessary injections, which WHO identifies as a key strategy for reducing injection-associated disease transmission (World Health Organization 2010).

Simonsen et al. (1999) define an unnecessary injection as ‘one where oral alternatives are available, where the injected substance is inappropriate or harmful or where the symptoms or diagnosis do not warrant treatment by injection’. The literature on this phenomenon indicates that a complex array of factors may influence the decision-making of both patients and healthcare providers. Providers may recommend injections and patients may welcome them because of widespread misconceptions about injected medications being stronger or more effective than other types of treatment (Safe Injection Global Network 1999). Even providers who know otherwise may feel pressured by patients to administer injections (Kotwal 2005; Safe Injection Global Network 2011) – and may be concerned that withholding injections will undermine their professional credibility (Kotwal 2005; Chowdhury et al. 2011). Furthermore, it has been suggested that some providers may be motivated to administer injections because of the profitability of this practice (Safe Injection Global Network 2011).

We contacted the five Member States with national estimates of unnecessary injection levels of 5% or higher to obtain more information about why unnecessary injections occur. Three of them – Cuba, Mongolia and Pakistan – responded to this request, while two – Cambodia and Guyana – did not. (The two other Member States that reported national estimates of unnecessary injection levels were Denmark and Tonga, both of which indicated that no unnecessary injections take place).

Respondents were given several possible reasons for the occurrence of unnecessary injections and were asked to choose ‘yes’, ‘no’ or ‘do not know’ for each one. All three countries indicated that healthcare workers believe injections to be more effective. Two indicated that patients prefer injections rather than oral medication. One indicated that oral equivalents are unavailable, although the other two indicated that this is not a reason for why unnecessary injections occur. Additionally, one country selected each of the following as a reason: healthcare workers believe that patients expect injections; healthcare workers are paid more for injections; and better adherence can be achieved through the use of injectable medicine as opposed to the oral equivalent. The survey also asked for examples of ‘a drug that is typically injected when a cheaper oral equivalent is also available’. Responses included antibiotics, diclofenac and vitamins.

It is our hope that the global hepatitis survey findings about unnecessary injection rates and follow-up survey findings will rekindle interest in a problem that may be causing widespread unnecessary suffering. In 2008, an estimated 14% of HIV infections were attributable to unsafe injections, as were 25% of hepatitis B infections, 8% of hepatitis C infections and 7% of infections with bacteraemia. These estimates collectively represented 28 million disability-adjusted life years (DALYs) (Safe Injection Global Network). Therefore, if even one tenth of unsafe injections globally in 2008 were cases in which the injection was not warranted, this would translate into a disease burden of 2.8 million DALYs attributable to unnecessary injections.

In actuality, it appears that estimating the global disease burden attributable to unnecessary injections would be a difficult task if at least 119 countries do not have national estimates for unnecessary injections. The lack of data gives rise to the first of four recommendations regarding how to reduce unnecessary injections. Tracking the incidence of unnecessary injections – understood as providing an injection when an oral equivalent is available – at the country level is essential for determining the magnitude of the problem and measuring progress on the response. Governments are urged to incorporate this metric into ongoing health system monitoring, including tracking it as a mode of transmission for all bloodborne viruses.

Our second recommendation calls for a more concerted global effort to reduce unnecessary injections. This issue is already on the agenda of the Safe Injection Global Network (SIGN), which since its inception in 1999 has provided leadership in the campaign to reduce unsafe injections. Given that SIGN and WHO now have a toolkit and other resources in place to help countries address the general problem of unsafe injections (Safe Injection Global Network), it is logical to focus more on increasing awareness of the contribution of unnecessary injections to disease transmission. Furthermore, the toolkit might be expanded with tools such as a global guidance document that informs decision-making around whether injections are warranted and identifies commonly injected medicines that should be replaced with oral equivalents. The latter might require WHO to carry out a review of the evidence regarding oral versus injectable drugs. Guidance is also needed on how to stage information, education and communication interventions to change perceptions among both health providers and the general public in regard to the role of injections in health care.

As for our two other recommendations, an informative body of evidence provides insight into the behavioural, economic and structural drivers of unnecessary injecting in healthcare settings, but the majority of these studies are more than a decade old. Health systems in many countries have undergone extensive changes in recent years, and research is needed to illuminate the dynamics behind current injecting practices. Finally, with the intensification of efforts to reduce unnecessary injections, research will also be needed to measure progress and to refine interventions, with particular attention given to how interventions should be adapted to address different drivers of the problem in different countries and cultures.

WHO research indicates that interventions to reduce unnecessary injections are cost-effective, as are interventions combining these activities with efforts to also reduce unsafe injections (World Health Organization 2003). WHO, SIGN and government authorities must work in collaboration with medical associations, nursing associations and civil society partners such as patient advocacy groups to take stock of this problem and develop country-specific strategies for its resolution. The WHO Director-General's upcoming injection safety initiative has the potential to serve as the backbone of this effort by increasing the global focus on unnecessary injections. Strong leadership on this issue is a moral imperative: it is simply unacceptable for the provision of medical treatment to be a pathway for large-scale disease transmission, suffering and death.

References

Altaf A, Janjua NZ & Hutin Y (2006) The cost of unsafe injections in Pakistan and challenges for prevention program. Journal of the College of Physicians and Surgeons Pakistan 16, 622–4.

Bodenschatz C, Talaat M, Kandeel A, Lohiniva AL, Radwan E & Mahoney F (2009) Injection prescribing patterns in public health care facilities in Egypt. East Mediterranean Health Journal 15, 1440–8.

Chowdhury AK, Roy T, Faroque AB et al. (2011) A comprehensive situation assessment of injection practices in primary health care hospitals in Bangladesh. BMC Public Health 11, 779. doi: 10.1186/1471-2458-11-779.

Kotwal A. (2005) Innovation, diffusion and safety of a medical technology: a review of the literature on injection practices. Social Science and Medicine 60, 1133–47.

Safe Injection Global Network (2011) Advocacy Booklet. http://www.who.int/injection_safety/sign/sign_advocacy_booklet.pdf.

Safe Injection Global Network. Report of the SIGN2010 meeting. http://www.who.int/injection_safety/toolbox/sign2010_meeting.pdf.

Simonsen L, Kane A, Lloyd J, Zaffran M & Kane M (1999) Unsafe injections in the developing world and transmission of bloodborne pathogens: a review. Bulletin of the World Health Organization 77, 789–800.

World Health Organization (2003) Managing an injection safety policy. http://www.who.int/injection_safety/toolbox/en/ManagingInjectionSafety.pdf

World Health Organization (2010) WHO best practices for injections and related procedures toolkit. http://whqlibdoc.who.int/publications/2010/9789241599252_eng.pdf

World Health Organization (2013) Global Policy Report on the Prevention and Control of Viral Hepatitis in WHO Member States Geneva.

Yan Y, Zhang G, Chen Y, Zhang A, Guan Y & Ao H (2006) Study on the injection practices of health facilities in Jingzhou district, Hubei, China. Indian Journal of Medical Sciences 60, 407–16.

Source

World Hepatitis Day: 28 July 2103

26/07/2013

The European Medicines Agency supports World Hepatitis Day, which is taking place on Sunday 28 July 2013.

World Hepatitis Day is held every year on 28 July to provide international focus for patient groups and people living with hepatitis B and C. It aims to raise awareness and influence change in disease prevention and access to testing and treatment.

The World Hepatitis Alliance first launched World Hepatitis Day in 2008. The Alliance is a non-governmental organisation that represents hepatitis B and hepatitis C patient groups from around the world. The World Hepatitis Day is organised in partnership with the World Health Organisation (WHO).

Hepatitis B and C are caused by viruses that infect liver cells. Both diseases can lead to inflammation, scarring and cancer of the liver if left untreated. Viral hepatitis affects 500 million people worldwide and kills 1.4 million people every year.

The European Commission has authorised eight medicines for the treatment of chronic (long-term) hepatitis B and eight medicines for chronic hepatitis C on the recommendation of the Agency's Committee for Medicinal Products for Human Use (CHMP).

Among the medicines for hepatitis C recently authorised, two medicines in a new class called protease inhibitors attack the hepatitis C virus directly, in contrast to older medicines which work by stimulating the immune system to attack the virus.

The European Commission has also authorised ten vaccines for protection against hepatitis B infection for use in the European Union (EU).

The CHMP is currently evaluating the benefits and risks of a new vaccine for the protection against hepatitis B infection and two antivirals, a protease inhibitor and a polymerase inhibitor, for the treatment of chronic hepatitis C.

The Agency also publishes guidelines for pharmaceutical companies, describing how they should design and carry out studies of medicines for the treatment of hepatitis B and C. The Agency released a draft guideline on the clinical evaluation of medicinal products for the treatment of chronic hepatitis C in 2011 and a draft guideline on the clinical investigation of hepatitis-B immunoglobulins in 2012 for six-month public consultations. Comments received on these draft documents are currently under review.

Source

Prevention and Management of Hepatitis C Virus Infection Among People Who Inject Drugs: Moving the Agenda Forward

Provided by NATAP

All PDFs attached

Clinical Infectious Diseases
Volume 57 suppl 2 August 15, 2013

- Moving the Agenda Forward: The Prevention and Management of Hepatitis C Virus Infection Among People Who Inject Drugs
Jason Grebely, Philip Bruggmann, Markus Backmund, and Gregory J. Dore
Moving the Agenda Forward: The Prevention and Management of Hepatitis C Virus Infection Among People Who Inject Drugs

- Injection Drug Use and Hepatitis C Virus Infection in Young Adult Injectors: Using Evidence to Inform Comprehensive Prevention
Kimberly Page, Meghan D. Morris, Judith A. Hahn, Lisa Maher, and Maria Prins
Injection Drug Use and Hepatitis C Virus Infection in Young Adult Injectors: Using Evidence to Inform Comprehensive Prevention

- Combination Interventions to Prevent HCV Transmission Among People Who Inject Drugs: Modeling the Impact of Antiviral Treatment, Needle and Syringe Programs, and Opiate Substitution Therapy
Natasha K. Martin, Matthew Hickman, Sharon J. Hutchinson, David J. Goldberg, and Peter Vickerman
Combination Interventions to Prevent HCV Transmission Among People Who Inject Drugs: Modeling the Impact of Antiviral Treatment, Needle and Syringe Programs, and Opiate Substitution Therapy

- Hepatitis C Virus Vaccines Among People Who Inject Drugs
Andrea L. Cox and David L. Thomas
Hepatitis C Virus Vaccines Among People Who Inject Drugs

- Understanding Barriers to Hepatitis C Virus Care and Stigmatization From a Social Perspective
Carla Treloar, Jake Rance, and Markus Backmund
Understanding Barriers to Hepatitis C Virus Care and Stigmatization From a Social Perspective

- Models of Care for the Management of Hepatitis C Virus Among People Who Inject Drugs: One Size Does Not Fit All
Philip Bruggmann and Alain H. Litwin
Models of Care for the Management of Hepatitis C Virus Among People Who Inject Drugs: One Size Does Not Fit All

- Assessment and Treatment of Hepatitis C Virus Infection Among People Who Inject Drugs in the Opioid Substitution Setting: ETHOS Study
Maryam Alavi, Jason Grebely, Michelle Micallef,, Adrian J. Dunlop,, Annie C. Balcomb, Carolyn A. Day, Carla Treloar, Nicky Bath, Paul S. Haber, Gregory J. Dore, and on behalf of the Enhancing Treatment for Hepatitis C in Opioid Substitution Settings (ETHOS) Study Group
Assessment and Treatment of Hepatitis C Virus Infection Among People Who Inject Drugs in the Opioid Substitution Setting: ETHOS Study

- Enhancing Assessment and Treatment of Hepatitis C in the Custodial Setting Jeffrey J. Post, Amber Arain, and Andrew R. Lloyd
Enhancing Assessment and Treatment of Hepatitis C in the Custodial Setting

- Peer Support Models for People With a History of Injecting Drug Use Undertaking Assessment and Treatment for Hepatitis C Virus Infection
Sione Crawford and Nicky Bath
Peer Support Models for People With a History of Injecting Drug Use Undertaking Assessment and Treatment for Hepatitis C Virus Infection

- Treatment of Hepatitis C Virus Infection Among People Who Are Actively Injecting Drugs: A Systematic Review and Meta-analysis
Esther J. Aspinall, Stephen Corson, Joseph S. Doyle, Jason Grebely, Sharon J. Hutchinson, Gregory J. Dore, David J. Goldberg, and Margaret E. Hellard
Treatment of Hepatitis C Virus Infection Among People Who Are Actively Injecting Drugs: A Systematic Review and Meta-analysis

- Directly Observed Pegylated Interferon Plus Self-Administered Ribavirin for the Treatment of Hepatitis C Virus Infection in People Actively Using Drugs: A Randomized Controlled Trial
Robert J. Hilsden, Gisela Macphail, Jason Grebely, Brian Conway, and Samuel S. Lee
Directly Observed Pegylated Interferon Plus Self- Administered Ribavirin for the Treatment of Hepatitis C Virus Infection in People Actively Using Drugs: A Randomized Controlled Trial

- Psychoeducation Improves Hepatitis C Virus Treatment During Opioid Substitution Therapy: A Controlled, Prospective Multicenter Trial
Jens Reimer, Christiane Sybille Schmidt, Bernd Schulte, Dirk Gansefort, Jorg Golz, Guido Gerken, Norbert Scherbaum, Uwe Verthein, and Markus Backmund
Psychoeducation Improves Hepatitis C Virus Treatment During Opioid Substitution Therapy: A Controlled, Prospective Multicenter Trial

- Hepatitis C Virus Reinfection Following Treatment Among People Who Use Drugs
Bart P. Grady, Janke Schinkel, Xiomara V. Thomas, and Olav Dalgard
Hepatitis C Virus Reinfection Following Treatment Among People Who Use Drugs

- Management of Mental Health Problems Prior to and During Treatment of Hepatitis C Virus Infection in Patients With Drug Addiction
Martin Schaefer, Rahul Sarkar, and Crisanto Diez-Quevedo
Management of Mental Health Problems Prior to and During Treatment of Hepatitis C Virus Infection in Patients With Drug Addiction

- Drug-Drug Interactions in the Treatment of HCV Among People Who Inject Drugs Stefan Mauss and Hartwig Klinker
Drug-Drug Interactions in the Treatment of HCVAmong People Who Inject Drugs

- Recommendations for the Management of Hepatitis C Virus Infection Among People Who Inject Drugs
Recommendations for the Management of Hepatitis C Virus Infection Among People Who Inject Drugs

Geert Robaeys, Jason Grebely, Stefan Mauss, Philip Bruggmann, Joseph Moussalli, Andrea De Gottardi, Tracy Swan, Amber Arain, Achim Kautz, Heino Stover, Heiner Wedemeyer, Martin Schaefer, Lynn Taylor, Markus Backmund, Olav Dalgard, Maria Prins, Gregory J. Dore, and on behalf of the International Network on Hepatitis in Substance Users

Source

T-Cells May Show HCV Exposure in Healthcare Workers With Negative Antibodies

Reuters Health Information

Jul 15, 2013

By Robert Goodier

NEW YORK (Reuters Health) Jul 15 - Measuring T-cell responses reveals exposure to hepatitis C in healthcare workers who test negative for antibodies against the virus, a new study has found.

T-cell proliferation assays may be a more sensitive test, the results suggest. But the low-level exposures that the assays can detect are highly unlikely to be a health risk for the patient or for others, according to experts who spoke to Reuters Health.

Rather, the results suggest that T-cell assays should be included in surveillance studies that monitor exposure to hepatitis C, said Dr. Barbara Rehermann, Chief of the Immunology Section of the Liver Diseases branch of the National Institute of Diabetes and Digestive and Kidney Diseases in Bethesda, Maryland, in email to Reuters Health.

Dr. Rehermann and her team published their research online June 28 in the Journal of Infectious Diseases.

They performed T-cell assays on samples from 72 healthcare workers who had been in contact with a source of the virus, most of them through an accidental stick by a contaminated needle. During six months of follow-up, none of the workers tested positive for a chronic hepatitis C infection, but nearly half had evidence of an immune response to the virus, denoted by white blood cells, not by antibodies.

"Part of the interest of this study is we're learning more about how our bodies control viruses and how quickly we're able to respond to them," said Dr. Henry Bodenheimer at Beth Israel Medical Center in New York City, who was not involved in the research.

"It seems that very low level infection can be controlled by our immune systems. That's new information. Much of the time people have relied on antibodies. Studying T-cells is a more difficult, but a novel approach," Dr. Bodenheimer told Reuters Health.

The findings may lead to new approaches to vaccine development or treatments that stimulate the immune response to fight hepatitis infection, Dr. Bodenheimer said.

But, he added, this study does not suggest that testing methods should be changed. Antibody tests can detect chronic infection, but there is no evidence that the infection detected by T-cell assays was transmissible or linked to long-term consequences in the healthcare workers, Dr. Bodenheimer pointed out.

Past studies have offered a range of estimates of the risk of transmission of the virus to exposed healthcare workers, from 0 to 10.3%, with an average of 0.5%, according to a 2005 report in Clinical Infectious Diseases (see http://bit.ly/15g4une). The reason for that variation is not clear, however.

In this new study, assays of peripheral blood mononuclear cells in proliferation found hepatitis C-specific T-cell responses in 30 out of 63 participants tested, or 48%.

Interferon-gamma enzyme assays found at least two hepatitis-specific responses in 26 out of 62 participants tested, or 42%.

Fifty-three subjects underwent both tests. Thirteen (24%) responded to both, 21 (40%) did not respond to either, and 19 (36%) responded to one but not the other.

Those who were exposed to the virus after high-risk, rather than low-risk, needle sticks had higher proliferative T-cell responses.

"Whether these T-cell responses reflect protective immunity or whether they are downstream events of protective innate immune responses or abortive replication of defective viral genomes requires further studies in suitable models," Dr. Rehermann and her team write.

In the general population, the Centers for Disease Control and Prevention now recommends that all Baby Boomers, those born from 1945 to 1965, be tested for hepatitis C.

SOURCE: http://bit.ly/15g7cZW

J Infect Dis 2013.

Source

Fever After Interferon Injection for HCV Predicts Treatment Success

Reuters Health Information

Jul 25, 2013

By Will Boggs, MD

NEW YORK (Reuters Health) Jul 25 - Patients with chronic hepatitis C virus (HCV) who become febrile after peginterferon alfa-2a (PEG-IFN) injection are more likely to have a virological response than those who don't, a retrospective study suggests.

"Many patients find it difficult to complete interferon-based regimens because of the side-effects," Dr. Yaron Rotman from National Institutes of Health, Bethesda, Maryland told Reuters Health by email. "Clinicians can use our findings as a tool to encourage patients who suffer from side effects, to let them know that these actually suggest they are responding, and to help convince them to persist and maintain their compliance and adherence to treatment."

Fever commonly follows PEG-IFN injection, but the factors that predict the magnitude of this febrile response and its association with the antiviral efficacy of PEG-IFN are unknown.

To explore this issue, Dr. Rotman and colleagues reviewed data from a prospective trial of 60 treatment-naive adults with chronic HCV.

Most (57%) were infected with genotype 1, and their average age was 52 years.

As reported online July 11th in the Journal of Hepatology, oral temperature rose above 38.0 C in 20 patients (33%) at a median of 12.5 hours after injection.

The maximum temperature increase correlated strongly with the first phase virological decline, with a 0.49 C increase for each 1 log10 decline in viral levels.

Temperature increases did not differ significantly by gender. The link between temperature increase and virological decline also didn't differ by gender, nor by the presence or absence of cirrhosis or the viral genotype.

The maximum temperature change was higher for patients with the IL28B-related SNP rs12979860 CC genotype, and the correlation of maximum temperature increase with virological decline was limited to patients with the CC genotype.

Despite the link of temperature change with virological response, maximum temperature change did not predict either rapid or sustained virological response very well, and it was only a weak predictor of early virological response.

"Since the spike of fever is independent of virological predictors of response, it could potentially serve in the research setting as a tool to tease out host interferon-responsiveness from viral- and liver-related factors," the researchers say.

"The clinical importance of the study is in the novel appreciation that medication side-effects are closely linked to its efficacy," Dr. Rotman said.

"Of course," he continued, "the interferon-induced fever is not causing viral clearance, and we are not claiming that, but its occurrence early on (in the first 24 hours) can give patients and their doctors an inclination that the drug is actually doing its job."

Dr. Hans Van Vlierberghe from Ghent University Hospital in Belgium, who has published work on chronic HCV treatment, told Reuters Health by email, "This is a very nice and elegant study, monitoring temperature after peginterferon administration and linking the rise in temperature to response. However, treatment of hepatitis C is evolving more and more to an interferon-free combination schedule, making the observation by the authors less and less relevant."

Dr. Rotman added, "I would have to credit the first author, Hwalih Han, BSN, BS, the research nurse specialist, who has done a significant amount of the work on this study under my mentorship. Research nurses are not typically involved in the analysis and writing of clinical trial manuscripts; our work shows how physicians and nurses can work in synergy not only in clinical care, but also in research, especially in areas that straddle both disciplines."

SOURCE: http://bit.ly/172Njoy

J Hepatol 2013.

Source

Marijuana May Not Exacerbate Liver Disease in At-Risk Patients

Reuters Health Information

Jul 25, 2013

By Rob Goodier

NEW YORK (Reuters Health) Jul 25 - Marijuana smoking doesn't appear to accelerate liver disease progression in HIV patients with hepatitis C coinfection, a new prospective study from Canada has found.

"Based on previous studies, physicians have counseled patients that marijuana is harmful to their livers," Dr. Marina Klein, of McGill University Health Centre in Montreal, told Reuters Health by email.

"The results of our study suggest that physicians can reassure their patients that marijuana use, while it may have other deleterious effects, likely will not make their liver disease progress more rapidly," said Dr. Klein, who led the study, published online June 28 in Clinical Infectious Diseases.

Patients in Canada can apply for permission to use marijuana for medicinal purposes. The United States has conflicting marijuana laws. The federal government outlaws it, but 18 states allow for medicinal use, including two, Colorado and Washington, that also allow for recreational use.

The researchers followed up with 690 patients at 17 Canadian HIV clinics for an average of 2.7 years. The patients had HIV-hepatitis C coinfection at baseline, but did not have significant liver fibrosis (aspartate aminotransferase-to-platelet ratio (APRI) < 1.5).

At baseline, more than half of the patients said they had smoked marijuana in the past six months (median, seven joints per week) and 40% of those did so daily. A similar proportion said they used the drug for symptom relief.

In the course of the study, 19% of the patients reached an APRI score of 1.5, and 15% percent progressed to a score of 2. Eight patients, representing 1.2% of the study group, developed cirrhosis and 11, or 1.6%, developed end-stage liver disease (ESLD).

On multivariate analysis, there was no link between marijuana smoking and progression to liver disease based on the APRI score.

The researchers did find an association between marijuana use and progression to a clinical diagnosis of cirrhosis, with a hazard ratio of 1.33 per 10 additional joints per week. But when they reevaluated the findings using a lagged model of marijuana exposure, the association became statistically insignificant.

The lagged model measured marijuana use six to 12 months before the period during which liver disease developed, while the main model measured marijuana use during the same time that liver disease was diagnosed.

"The idea, really, was to make sure that smoking started before the participants got a liver problem and using the exposure and outcome at the same interval doesn't allow that (e.g. patients may have simply increased their use because they had symptoms of a disease that was already present). When we did this, it no longer looks as though marijuana is associated with any of the outcomes we investigated," Dr. Klein said.

That bias may explain some of the associations found between marijuana use and liver disease in past studies, she added.

SOURCE: http://bit.ly/12LdD5o

Clin Infect Dis 2013.

Source

Proclamation -- World Hepatitis Day, 2013

The White House

Office of the Press Secretary

For Immediate Release

July 25, 2013

WORLD HEPATITIS DAY, 2013

- - - - - - -

BY THE PRESIDENT OF THE UNITED STATES OF AMERICA

A PROCLAMATION

Each year, we mark World Hepatitis Day to bring attention to a disease that afflicts one in twelve people worldwide. Viral hepatitis is a major cause of liver cancer and cirrhosis in the United States, leading to approximately 18,000 American deaths every year. Outcomes can significantly improve with treatment, but because viral hepatitis can be present without symptoms for decades, most infected Americans do not know they have it. Today, we raise awareness about preventing and treating viral hepatitis, and we renew our commitment to combat this disease in all its forms.

Public awareness is key to halting the spread of viral hepatitis. All types of this disease pose serious health threats, and both hepatitis B and C can become chronic infections that lead to liver cancer and liver disease. Vaccines for hepatitis A and B are crucial to preventing new cases, and they are recommended for all children, as well as adults at an elevated risk of infection. There is no vaccine against hepatitis C, but through early detection and treatment, it is possible to reduce the risk of transmission, avert the worst complications, and in many cases even cure the infection.

Anyone can contract hepatitis, but in the United States it disproportionately affects the African American, Hispanic, and Asian American and Pacific Islander communities, and people born between 1945 and 1965. Injection drug users of all ages are also at increased risk. My Administration is working to raise awareness among communities hardest hit by viral hepatitis, organizing campaigns to prevent new infections, and promoting testing and treatment.

My Administration also continues to work with our partners across the Federal Government, in States, communities, and the public and nonprofit sectors to implement programs like the Healthy People 2020 initiative and the Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis. This ambitious plan aims to reduce the number of new hepatitis C cases by 25 percent, eliminate mother-to-child transmission of hepatitis B, and significantly increase the proportion of people who know of their hepatitis B and C infections. In addition, the Affordable Care Act requires health insurance plans to cover, without co-pays, hepatitis A and B vaccines as recommended for children and adults at elevated risk for infection, as well as hepatitis B screenings for pregnant women at their first prenatal visit. After June 2014, new health plans must cover screening, without co-pays, for hepatitis C virus infection in persons at high risk for infection. Plans must also cover one-time screening for hepatitis C infection for adults born between 1945 and 1965.

Viral hepatitis is a silent epidemic, and we can only defeat it if we break that silence. Now is the time to learn the risk factors for hepatitis, talk to family, friends, and neighbors who may be at risk, and to speak with healthcare providers about strategies for staying healthy. On World Hepatitis Day, let each of us lend our support to those living with hepatitis and do our part to bring this epidemic to an end.

NOW, THEREFORE, I, BARACK OBAMA, President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim July 28, 2013, as World Hepatitis Day. I encourage citizens, Government agencies, nonprofit organizations, and communities across the Nation to join in activities that will increase awareness about hepatitis and what we can do to prevent it.

IN WITNESS WHEREOF, I have hereunto set my hand this twenty-fifth day of July, in the year of our Lord two thousand thirteen, and of the Independence of the United States of America the two hundred and thirty-eighth.

BARACK OBAMA

Source

Hepatitis C: 6 Prevention Strategies That Work

Medscape Medical News

Ricki Lewis, PhD

Jul 26, 2013

Hepatitis C virus (HCV) infection is on the rise, particularly among young white adults living in rural and suburban areas who abuse intravenous opiate drugs. A review article published in a special supplement to Clinical Infectious Diseases, coinciding with World Hepatitis Week, discusses 6 ways to combat the spread of HCV in this group.

HCV incidence is increasing among those aged 15 to 30 years who inject drugs, according to the US Department of Health and Human Services. HCV is 10 times as infectious as HIV and surpassed HIV in number of deaths in the United States in 2007. Nearly 4 million people in the United States have chronic HCV infection.

For 16 years, Kimberly Page, PhD, MPH, from the University of California, San Francisco, and colleagues have conducted the "U Find Out," or UFO, Study with injection-drug users. The program is modeled on clean syringe programs, but with greater emphasis on social issues that fuel drug abuse and on integrating multiple approaches to combat HCV infection. Data from the ongoing prospective study show that the interventions used can reduce the risk of seroconversion.

In addition, the investigators note that more than 31,000 young adults who inject drugs of abuse will become infected with HCV in the United States each year. "Although there is evidence that HCV incidence has declined in recent decades, if the number of young injectors increases, as the [Centers for Disease Control and Prevention] suggests is occurring in the United States, these gains could be lost. Ongoing and targeted surveillance efforts to enumerate the population at risk and assess the burden of infection are essential steps in targeting and implementing effective HCV prevention in this group," the authors write.

Therefore, they recommend 6 comprehensive measures to prevent the spread of hepatitis C:

1. Reducing risk from shared ancillary drug preparation equipment, such as containers, rinse water, and filters. The researchers estimate that paying attention to the ancillaries as well as shared syringes could prevent at least 25% of seroconversions. The availability of single-use supplies could lower risk.

2. Using a new rapid test at point of care that offers results in 20 minutes can detect infection before seroconversion and, combined with counseling, can help to stem transmission.

3. Addressing social and relational contexts of injecting can encourage uninfected individuals to take precautions when injecting drugs with infected sex partners.

4. Encouraging "taking a break" from injecting drugs because HCV cannot be transmitted without this behavior. In past studies, the investigators discovered that the more often drug abusers attempted to quit, the more likely they were to eventually succeed.

5. Developing models to guide delivery of new prevention strategies, including already-available approaches such as increasing syringe availability and future strategies such as direct-acting antivirals that can be used prophylactically, as well as vaccines.

6. Combining interventions in synergistic ways, such as needle exchange and methadone maintenance programs.

"With ongoing and expanding transmission of HCV, there is little doubt that there is a need to implement what is in the prevention 'toolbox,' as well as add to it," they write. "Expanding HCV prevention and reaching the new generation of young injectors will require dedicated advocacy, pragmatism, and persistence to enable access to all of these technologies."

The work was supported by the National Institute on Drug Abuse. The Kirby Institute is funded by the Australian Government Department of Health and Ageing. One coauthor is also supported by a National Health and Medical Research Council Senior Research Fellowship. The other authors have disclosed no relevant financial relationships.

Clin Infect Dis. 2013;57:S32-S38. Abstract

Source

Also See:

1. Miriam researcher helps develop global hepatitis C recommendations for injection-drug users
2. Six Recommended Measures to Prevent Hepatitis C for Young Injection-Drug Users
3. Moving the Agenda Forward: The Prevention and Management of Hepatitis C Virus Infection Among People Who Inject Drugs

New focus to combat rising liver disease

Friday, 26 July 2013

University of Adelaide researchers are investigating how the liver responds to hepatitis C virus (HCV) and why some people can control the virus while others can't. The aim is to find better therapies to combat hepatitis C and associated liver disease.

Speaking ahead of World Hepatitis Day (Sunday 28 July), Head of the Hepatitis C Virus Research Laboratory Associate Professor Michael Beard says the burden of disease from the hepatitis C virus is rapidly escalating.

"A large number of people were infected with HCV in the 1970s and 1980s before isolation of the virus in 1989, and we're now seeing those people emerging with liver disease," says Associate Professor Beard. "Unfortunately, liver cancer as a result of HCV infection is on the rise and is expected to double by 2020."

HCV is blood-borne and contracted primarily through injecting drug use and, before bloodbank screening for HCV started in 1990, through blood-transfusion. Unchecked hepatitis C can lead to chronic disease and liver cancer and there are currently more than 220,000 Australians living with chronic hepatitis C.

A unique feature of infection with HCV is that about 75% of individuals develop a chronic infection while 25% spontaneously clear the virus.

"We hope to understand why some people can combat the virus without drugs and why others can't," says Associate Professor Beard. "We'll be looking at how the liver cells respond to HCV infection to see how genes are being regulated and how this, in turn, impacts virus replication and liver disease."

"If we can better understand this process, we will be able to use this information to help develop a vaccine or improved antiviral drugs." Vaccines exist for hepatitis A and B, but not for hepatitis C.

The Adelaide researchers will be using live imaging of the virus in cultured liver cells to investigate the interactions between the liver cell and the virus in real time.

"Up until now, we've only been able to look at virus infection in a particular snap-shot in time. Now we can look at the dynamics between the cell and the virus, within a living cell," Associate Professor Beard says.

"We're also investigating how some of the emerging new classes of antiviral drugs work and what their mode of action is. This will help develop the next generation of antiviral drugs against HCV."

The research is funded by the National Health and Medical Research Council (NHMRC) under a $5.5 million program grant with University of Sydney and University of NSW, starting in 2014.

Associate Professor Beard is also convenor of the 20th International Symposium on Hepatitis C Virus and Related Viruses which meets in Melbourne in October and will discuss the latest knowledge in hepatitis therapies and disease.

Source

FDA puts ‘partial hold’ on Vertex study

By Robert Weisman | Globe Staff  July 25, 2013

Federal regulators have put a “partial clinical hold” on a mid-stage study of an experimental oral drug developed by Vertex Pharmaceuticals Inc. to treat hepatitis C.

The move will prevent the Cambridge company from giving clinical trial patients 200 milligram doses of the pill, which would be used in combination with other oral therapies to treat the virus.

Vertex already has an oral hepatitis C treatment on the market, but it is used in combination with an injectable drug.

A Vertex spokesman, Zach Barber, said that the Food and Drug Administration ordered the hold after three patients in a European trial showed elevated liver enzymes — a potential marker of liver damage — when taking 400 milligram doses.

The US trial was designed to use only 100 milligram and 200 milligram dosing levels, he said. Vertex will continue with its 100 milligram dosing.

“The FDA has requested data from us, and we’ll be providing that data on an ongoing basis” to gauge the effect of the drug candidate on patients, Barber said. “Hepatitis C remains an important part of our business and with multiple ongoing studies of [the experimental pill], our strategy is unchanged.”

Robert Weisman can be reached at weisman@globe.com. Follow him on Twitter @GlobeRobW.

Source

Also See: Vertex Provides Update on Ongoing All-Oral Studies of VX-135 in Hepatitis C

Leading Liver and ID Experts to Develop Hepatitis C Practice Recommendations

Provided by Infection Control Today

Recognizing the rapid development of hepatitis C medications coupled with increasing numbers of people being identified with hepatitis C virus (HCV) infection, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) are collaborating to develop clinical recommendations for the management of hepatitis C. 

New medications approved by the Food and Drug Administration in recent  years have increased HCV cure rates, and several additional medications are expected to be approved  in the next three to five years. At the same time, new HCV testing guidelines are expected to increase the number of patients diagnosed with hepatitis C, many of whom currently are HCV-infected but unaware of their status. Ensuring that patients receive the new, effective treatment will be critical in increasing cure rates for hepatitis C.

“We can finally say that cure of HCV infection has become a real possibility for the majority of individuals infected with this deadly virus,” says Gary Davis, MD, of AASLD.
“Members of AASLD and IDSA are committed to ensuring that patient care keeps pace with rapidly advancing science,” said David Relman, MD, president of IDSA. “This effort is an important step toward advancing that goal and comes at an important time as we all work to raise awareness of hepatitis virus infections on World Hepatitis Day on July 28.”

Through this collaboration, the societies will review current treatment recommendations and use evidence-based, consensus guidance to develop updated recommendations for managing patients. Recommendations will be updated regularly and made available online. “A web-based system of new recommendations coupled with a published annual update will afford the greatest opportunity for both rapid and comprehensive output,” says Donald M. Jensen, MD, of AASLD.

Hepatitis C is a liver disease resulting from chronic infection with the hepatitis C virus (HCV).  It is estimated that between 3 million and 4 million Americans are infected with HCV and have chronic liver disease as a result. Because symptoms of HCV infection may not appear for many years, more than 70 percent are unaware they are infected.

Earlier this year, the Centers for Disease Control and Prevention recommended an age-based screening strategy consisting of a one-time test for HCV for those at highest risk, including everyone born between 1945 and 1965. This recommendation was endorsed by the U.S. Preventive Services Task Force in June 2013. The broader testing recommendations likely will detect a substantial number of people who are unaware they are infected.

According to a July 10, 2013 article published in the Journal of The American Medical Association (JAMA), deaths from liver disease increased from 1990 to 2010. HCV is the most likely cause of the emergence of liver disease as a growing threat to Americans. Early testing enables people who are infected to receive treatment as soon as possible, and prevent progression to more serious disease, such as cirrhosis and liver cancer.

Currently available drugs and the next generation of direct-acting antivirals that will likely be available later this year offer the potential to treat and cure most patients with HCV infection. Therefore, up-to-date recommendations for the medical management of these patients and their treatment are critically important.

Source

Human stem cell-derived hepatocytes regenerate liver function

Public release date: 26-Jul-2013
Contact: Vicki Cohn
vcohn@liebertpub.com
914-740-2100 x2156
Mary Ann Liebert, Inc./Genetic Engineering News

And extend survival in mice with hepatic failure

New Rochelle, NY, July 26, 2013 -- Researchers have generated functional hepatocytes from human stem cells, transplanted them into mice with acute liver injury, and shown the ability of these stem-cell derived human liver cells to function normally and increase survival of the treated animals. This promising advance in the development of cell-based therapies to treat liver failure resulting from injury or disease relied on the development of scalable, reproducible methods to produce stem cell-derived hepatocytes in bioreactors, as described in an article in Stem Cells and Development, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available free on the Stem Cells and Development website.

Massoud Vosough and coauthors demonstrate a large-scale, integrated manufacturing strategy for generating functional hepatocytes in a single suspension culture grown in a scalable stirred bioreactor. In the article "Generation of Functional Hepatocyte-Like Cells from Human Pluripotent Stem Cells in a Scalable Suspension Culture" the authors describe the method used for scale-up, differentiation of the pluripotent stem cells into liver cells, and characterization and purification of the hepatocytes based on their physiological properties and the expression of liver cell biomarkers.

David C. Hay, MRC Centre for Regenerative Medicine, University of Edinburgh, U.K., comments on the importance of Vosough et al.'s contribution to the scientific literature in his editorial in Stem Cells and Development entitled "Rapid and Scalable Human Stem Cell Differentiation: Now in 3D." The researchers "developed a system for mass manufacture of stem cell derived hepatocytes in numbers that would be useful for clinical application," creating possibilities for future "immune matched cell based therapies," says Hay. Such approaches could be used to correct mutated genes in stem cell populations prior to differentiation and transplantation, he adds.

"The elephant in the room for stem cell therapy rarely even acknowledged let alone addressed in the literature is that of scalable production of cells for translational application," says Editor-in-Chief Graham C. Parker, PhD, research professor, Carman and Ann Adams Department of Pediatrics, Wayne State University School of Medicine. "Baharvand's groups' landmark publication not only demonstrates but exquisitely describes the methodology required to scale up stem cell populations for clinical application with a rigor to satisfy necessary manufacturing standards."

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About the Journal

Stem Cells and Development is an authoritative peer-reviewed journal published 24 times per year in print and online. The Journal is dedicated to communication and objective analysis of developments in the biology, characteristics, and therapeutic utility of stem cells, especially those of the hematopoietic system. Complete tables of content and a free sample issue may be viewed on the Stem Cells and Development website.

About the Publisher

Mary Ann Liebert, Inc., publishers is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Cellular Reprogramming, Tissue Engineering, and Human Gene Therapy. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 70 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., publishers website.

Mary Ann Liebert, Inc. 140 Huguenot St., New Rochelle, NY 10801-5215 Phone: (914) 740-2100 (800) M-LIEBERT Fax: (914) 740-2101 http://www.liebertpub.com

Source

World Hepatitis Day: When in Doubt Get Tested

July 24, 2013

The following statement was issued by the BCCDC and BC Centre of Excellence for HIVAIDS to mark World Hepatitis Day, July 28.

By Dr. Mel Krajden and Dr. Julio Montaner

Hepatitis is a frequent headline-maker in media, and creates lots of online chat in blogs, tweets and posts. No wonder, given that this liver disease is potentially life-threatening. Despite all this attention, getting people tested and treated is still a challenge for public health practitioners.

As we acknowledge the annual World Hepatitis Day on July 28, the number of infections is still of concern.  One in 12 people worldwide has liver disease, and greater than three per cent, or more than 120,000 people in BC are hepatitis B and/or C-infected.

Enormous strides in hepatitis B prevention have been made in the province through the use of publically-funded vaccinations covering all children. However, hepatitis C is a different story.

There is so far no vaccine for this silent killer, which can lay dormant for decades, often only showing symptoms when much damage is done. Two thirds of all cases are “baby boomers” born between 1945 and 1965 - people who should be in their peak earning and family-raising years. Instead, many of their years are spent with increasing disabilities because of this disease.

The earlier hepatitis C is detected the sooner it can be treated and the greater the likelihood of recovery. Treatment is the start of the healing journey which for many can lead back to full, productive lives.

In March of this year, the provincial government announced $1.5 million in one-time funding to the St. Paul’s Hospital Foundation to explore ways to better address both hepatitis B and C epidemics in BC. In collaboration with the foundation, we’ll be talking with interested individuals and organizations from across BC, including healthcare providers, liver specialists, regional health authorities and the new First Nations’ health authority, community groups, and non-government organizations to develop options  for improving the provincial response to viral hepatitis. 

It is important that health professionals continue to emphasize that people need to be tested for hepatitis B and C so that those diagnosed can be engaged in care and treatment.

Work at the BC Centre for Excellence in HIV/AIDS has taught us some very important lessons. For HIV, “treatment as prevention” improves the health of those already infected with HIV, while simultaneously reducing the risk of HIV transmission others. This model can be adopted for hepatitis.

Applied to hepatitis C this approach could simultaneously prevent liver disease and avert further transmission of the disease, multiplying the beneficial impact of treatment.

In order to stem the hepatitis virus in BC we need to unite the voices of affected communities, health professionals, and community leaders, and transform knowledge into action.

-30-

Dr. Mel Krajden is the medical head, Hepatitis, BCCDC.  Dr. Julio Montaner is the director of the BC Centre for Excellence in HIV/AIDS.
Media Contacts:
Patrick Blennerhassett
Provincial Health Services Authority
Patrick.Blennerhassett@phsa.ca
604-675-7416
Media pager: 604-871-5699

Kevin Hollett
BC Centre for Excellence in HIV/AIDS
Phone: 604-682-2344 ext. 66536
Mobile: 778-848-3420
khollett@cfenet.ubc.ca

Source

World Hepatitis Day Statement

News Release

FOR IMMEDIATE RELEASE
July 26, 2013

Contact: HHS Press Office
(202) 690-6343

World Hepatitis Day Statement

by HHS Secretary Kathleen Sebelius and HHS Assistant Secretary for Health Dr. Howard Koh

On World Hepatitis Day, we reaffirm our commitment to combating the “silent epidemic” of viral hepatitis.

Globally, one in 12 people has chronic hepatitis B or C infection. About 1 million people die each year from chronic viral hepatitis. Viral hepatitis is the leading cause of liver cancer in the United States and worldwide. And while it is the most common blood-borne infection and a leading infectious cause of death, claiming the lives of some 15,000 Americans each year, viral hepatitis often remains unrecognized as a public health priority.

Thanks to advances in science and policy, we have made progress with combating this silent epidemic. Hepatitis B and C are both preventable – there is a vaccine for hepatitis B and effective treatments. Hepatitis C is curable for many people, and, with the rapidly improving treatment landscape, we have hope for a higher cure rate in the near future.

The Department of Health and Human Services (HHS) recently announced it will renew its landmark Viral Hepatitis Action Plan for 2014-2016 to strengthen existing strategies to prevent new cases. The new plan will help ensure that people who are already infected receive testing and linkage to care and treatment. The Affordable Care Act, by requiring health plans to offer certain free preventive services, also provides tremendous opportunities to expand access to viral hepatitis testing, care, and treatment services.

Early detection and treatment of chronic hepatitis B and C can reduce disease progression, limit transmission to others, and prevent serious liver disease. The Centers for Disease Control and Prevention and the U.S. Preventive Services Task Force recommend that adults born between 1945 and 1965 be tested for Hepatitis C.

Talk with your doctor about whether you should be tested for hepatitis B or C. You can also take an online risk assessment at http://www.cdc.gov/hepatitis/riskassessment.

Don’t let hepatitis be a silent killer any longer.

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Note: All HHS news releases, fact sheets and other press materials are available at http://www.hhs.gov/news.

Like HHS on Facebook, follow HHS on Twitter @HHSgov, and sign up for HHS Email Updates.

Follow HHS Secretary Kathleen Sebelius on Twitter @Sebelius .

Last revised: July 26, 2013

Source

Futility, discontinuation of HCV therapy more common in practice than clinical trials

Provided by Healio

Belperio PS. Clin Gastroenterol Hepatol. 2013;11:1021-1027.

July 26, 2013

Patients with hepatitis C treated with direct-acting antivirals in routine practice were more likely to experience early discontinuation or futility than those treated in clinical trials in a recent study.

Researchers evaluated data from veterans with chronic HCV genotype 1 treated with pegylated interferon and ribavirin with either boceprevir (n=661) or telaprevir (n=198) before January 2012. Patient data was collected from the Veterans Affairs’ Clinical Case Registry. HCV RNA levels were measured at 4, 8, 12 and 24 weeks of treatment.

Among treatment-naive, noncirrhotic participants, more patients in the boceprevir group had undetectable HCV RNA levels at 24 weeks (74% of cases vs. 60% of telaprevir recipients; P=.03). Early response occurred at similar rates among prior null or partial responders, relapsers and cirrhotic patients, though undetectable RNA at 24 weeks was more common among treatment-naive patients in the boceprevir group (71% vs. 58%; P=.02).

At 24 weeks, treatment discontinuation and futility had occurred in 30% and 14%, respectively, of the boceprevir group and 34% and 17%, respectively, of the telaprevir group. Multivariate analysis indicated that prior null response (OR=2.98; 95% CI, 1.73-5.13) and diabetes (OR=1.49; 95% CI, 1.01-2.21) were predictive of treatment failure among boceprevir recipients. In the telaprevir group, diabetes was predictive of failure (OR=2.15; 95% CI, 1.11-4.17) and prior relapse was associated with reduced failure risk (OR=0.18; 95% CI, 0.06-0.57).

“In routine medical practice, treatment with boceprevir- or telaprevir-based antiviral therapy had better early results than previously observed with pegylated interferon/ribavirin alone, but results [were] not quite as good as seen in the clinical trials,” researcher Lisa I. Backus, MD, PhD, national clinical manager of clinical case registries for the Office of Public Health/Population Health in Palo Alto, Calif., told Healio.com. “In particular, in routine medical practice, more patients discontinue treatment early than in clinical trials.” She said the lower early response rates observed among prior null responders suggest a need for patients and providers to make very considered treatment decisions.

Disclosure: The researchers report no relevant financial disclosures.

Source

At the Forefront of Hepatitis Testing, Abbott Recognizes World Hepatitis Day

With ongoing advances in hepatitis diagnosis and monitoring, Abbott has been a leader in developing and improving tests for hepatitis for more than 40 years. On July 28 - World Hepatitis Day - Abbott joins with organizations around the world to help increase awareness of viral hepatitis and related diseases.

According to the World Health Organization (WHO), more than 390 million people are living with chronic hepatitis.Of those, an estimated 150 million people are chronically infected with hepatitis C, a virus transmitted through contact with the blood of an infected person.¹ Unfortunately, because approximately 80 percent of people do not exhibit any symptoms following initial infection, many people with hepatitis C virus (HCV) do not know they are infected.² If left untreated, HCV can result in serious long-term health problems such as liver damage and cirrhosis; it is also a leading cause of liver cancer.³ The good news is that with early detection and treatment, hepatitis C can be completely cured.

For decades, Abbott has worked to develop products to detect and manage hepatitis. In addition to our comprehensive array of tests for hepatitis A and B, today Abbott offers the following tests to diagnose and monitor the hepatitis C virus across the spectrum of patient care:

• The ABBOTT PRISM HCV test is used in the blood screening environment and helps prevent the transmission of hepatitis C virus to recipients of blood, blood products, tissue and organs.
• The ARCHITECT Anti-HCV test helps doctors diagnose hepatitis C by detecting antibodies to the virus in people with signs and symptoms of infection as well as in people who may be at risk for hepatitis C.
• Once a person is diagnosed with hepatitis C, Abbott’s RealTime HCV Genotype II test, the first and currently only FDA-approved hepatitis C genotyping test, helps physicians find out what type or strain of hepatitis C is present. This enables physicians to create the most effective course of treatment for each patient.
• Throughout treatment, Abbott’s RealTime HCV-Viral Load test is an important tool for monitoring the amount of virus in a patient’s blood and helps physicians understand if the patient is responding to antiviral therapy.

For people infected with hepatitis C, the World Health Organization recommends⁴:

• Education and counseling options for care and treatment;
• Immunization with the hepatitis A and B vaccines to prevent coinfection from these hepatitis viruses to protect their liver;
• Early and appropriate medical management including antiviral therapy if appropriate; and
• Regular monitoring for early diagnosis of chronic liver disease.

For more information:

• Click here to learn more about hepatitis C, testing for the disease, and who is at risk [infographic]
• Click here for a video about Abbott’s commitment to hepatitis
• Click here to read about Abbott’s recently FDA-approved hepatitis C genotyping test
• Click here to learn about World Hepatitis Day on the World Health Organization (WHO) website

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References

1 World Health Organization. Hepatitis C Fact Sheet, No. 164. July 2012.

2 World Health Organization. Hepatitis C Fact Sheet, No. 164. July 2012.

3 Centers for Disease Control and Prevention. Travelers’ Health, Map 3-05: Prevalence of Chronic Hepatitis C Infection. July 2011.

4 World Health Organization Hepatitis C Fact Sheet, No. 164, July 2013.

Source

Global policy report on the prevention and control of viral hepatitis

in WHO Member States

Authors:
World Health Organization

Publication details

Number of pages: 220
Publication date: July 2013
Languages: English
ISBN: 978 92 4 156463 2

Downloads

Global policy report on the prevention and control of viral hepatitis
July 2013

The periodic evaluation of implementation of the WHO strategy requires an initial baseline survey of all Member States. In mid-2012, WHO, in collaboration with the World Hepatitis Alliance, conducted such a survey, asking Member States to provide information relating to the four axes of the WHO strategy. In particular, Member States were asked whether key prevention and control activities are being conducted. This report presents the results.

The first chapter provides an introduction to viral hepatitis and to the global response to this group of diseases. The second chapter provides a global overview of the survey findings. Chapters three through eight present findings from the six WHO regions, including summaries of data from all responding countries. Additional survey data, study methodology information and the survey instrument can be found in Annexes A–E.

Source

Citations Highlight Promising New Drugs for Hepatitis C Infection

July 2013

by David W. Sharp

The U.S. Centers for Disease Control and Prevention has recently revised its guidance on testing for infection with hepatitis C virus (HCV). Testing for anti-HCV, recommended for known at-risk groups for the past 15 years (and, in 2012, suggested as routine in the birth cohort 1945-65, the so-called “baby boomers”) does not distinguish between past and ongoing infection. The latest guidance includes tests for HCV RNA; these tests do make the distinction. Another reason for the revision is “significant advances in the development of antiviral agents with improved efficacy against HCV” (MMWR 62[18]: 357-61, 2013). Drawing on exclusive citation data from Thomson Reuters Web of Science, a new Top Ten list, with papers #4 and #8, provides the opportunity for an update on those agents.

What’s Hot in Medicine

Rank	Paper	Citations This Period (Nov-Dec 12)	Rank Last Period (Sep-Oct 12)
1	R. Siegel, et al., “The impact of eliminating socioeconomic and racial disparities on premature cancer deaths,” CA-A Cancer J., 61(4): 212-36, Jul-Aug 2011. [American Cancer Soc., Atlanta, GA]	149	1
2	P.B Chapman, et al., “Improved survival with vemurafenib in melanoma with BRAF V600E mutation,” New Engl. J. Med., 364(26): 2507-16,  30 June 2011. [26 institutions worldwide]	121	2
3	M.R. Patel, et al., “Rivaroxaban versus warfarin in nonvalvular atrial fibrillation,” New Engl. Med., 365(10): 883-91, 8 September 2011. [12 institutions worldwide]	77	4
4	F. Poordad, et al., “Boceprevir for untreated chronic HCV genotype 1 infection,” New Engl. J. Med., 364(13): 1195-1206, 31 March 2011. [12 institutions worldwide]	74	9
5	C.R. Smith, et al., “Transcatheter versus surgical aortic-valve replacement in high-risk patients,” New Engl. J. Med., 364(23): 2187-98, 9 June 2011. [12 institutions worldwide]	67	10
6	C.B. Granger, et al., “Apixaban versus warfarin in patients with atrial fibrillation,” New Engl. J. Med., 365(11): 981-92, 15 September 2011. [26 institutions worldwide]	61	7
7	M. Gerlinger, et al., “Intratumor heterogeneity and branched evolution revealed by multiregion sequencing,” New Engl. J. Med., 366(10): 883-92, 8 March 2012. [7 institutions worldwide]	60	+
8	I.M. Jacobson, et al., “Telaprevir for previously untreated chronic hepatitis C virus infection,” New Engl. J. Med., 364(25): 2405-16, 23 June 2011. [22 institutions worldwide]	59	+
9	M.S. Cohen, et al., “Prevention of HIV-1 infection with early antiretroviral therapy,” New Engl. J. Med., 365(6): 493-505, 11 August 2011. [27 institutions worldwide]	57	3
10	E. Scallan, et al., “Foodborne illness acquired in the United States—Major pathogens,” Emerging Infectious Dis., 17(1): 7-15, January 2011. [Ctrs. Disease Control, Atlanta, Ga.]	55	+
SOURCE: Thomson Reuters Web of Science NB. Only papers indexed by Thomson Reuters since January 2011 are tracked. The “+” sign indicates that the paper was not ranked in the Top Ten during the last period. In the event that two or more papers collected the same number of citations in the most recent bimonthly period, total citations to date determine the rankings

HCV infection is a serious public-health issue. World Health Organization global estimates include 150 million people with chronic HCV infection and 350,000 deaths from HCV-related liver disease and 3 to 4 million new infections annually. Many cases remain undiagnosed; there is currently no vaccine; and available treatments are not ideal. The six known HCV genotypes can respond differently; a mainstay of therapy has been interferon, a tricky drug to manage; and about 60% of patients with HCV genotype 1 infection are not cured by up to 48 weeks of interferon plus ribavirin (J.G. McHutchison et al,  New Engl. J. Med., 361[6]: 580-93, 2009). When ScienceWatch last covered the therapeutic options, the best on offer seemed to be a combination of polyethyleneglycolated interferon (PEG interferon) and the antiviral agent ribavirin. The picture has recently been changing, and rapidly, with the development of compounds that act more directly on HCV. The two current front-runners in terms of both clinical trial activity and publications and citations are boceprevir and telaprevir (#4 and #8, respectively), still given in combination with the former dual therapy, but there is huge interest in second-generation candidates (vaniprevir, sofosbuvir and MK-5172, to name but a few).

INTERFERON IN RETREAT?

There is not yet much long-term clinical experience with any of these new drugs, and issues such as resistance, adverse reactions, and differing response rates for different HCV genotypes will require close attention. However, sustained virologic responses (SVR) are now being reported in 90% or more of patients treated with direct-acting antivirals, and there is the welcome possibility of interferon-free regimens. A New England Journal of Medicine editorial in May of this year, accompanying papers reporting four trials of sofosbuvir, foresaw an imminent radical change in clinical practice, noting that“interferon is in retreat,” although the interferonologist (a reference to the very specialized handling needed for this agent) is not yet down and out (J.P.H. Drenth, New Engl. .J Med., 368[20]: 1931-21, 2013). Other observers, meanwhile, see “the nail in the coffin for HCV” (M.P. Mans., M. Cornberg,, Lancet Infect. Dis., 13[5]: 378-79), or speak of at least interferon-sparing regimens (G. Dusheiko, T. Burney, in a commentary on a phase-2 trial of sofosbuvir published in mid-June [Lancet, 381(9883): 2063-5, 2013). ScienceWatchreaders will want to share this optimism, but while we wait for more evidence on the newest drugs let us focus on the two first-generation agents, both of which have been the subject of large numbers of papers and have been attracting high citation rates in the first half of 2013.

EFFICACY IN THE UNTREATED

The trial on patients with previously untreated HCV infection (#4) should be considered in parallel with the companion paper on the use of boceprevir in those previously treated (B.R. Bacon, et al,. New Engl. J. Med., 364[13]: 1207-17, 2011; 46 citations this period). With interferon/ribavirin as the standard-of-care control, SVR rates were 21% in previously treated patients and 23% and 40% in black and non-black controls who had not been treated before, compared with the much higher responses found when boceprevir was added of around 60% in treated and untreated depending on the drug regimen used (but lower in blacks). Clinical trials with telaprevir have followed a similar pattern and have similar success in terms of SVR data, and again it is the study in untreated patients (#8) that has been receiving the greater number of citations; the findings from the companion trial here were published in 2010 (J.G. McHutchison, et al., New Engl. J. Med., 362[14]: 1292-303, 2010; a report now too “old” for Hot Papers coverage but cited more than 260 times to date). These findings and others (e.g., S. Zeuzem, et al., New Engl. J. Med., 364[25]: 2417-28, 2011; 37 cites this period) certainly are encouraging, but clinicians may be holding back in the expectation of something even better. In the 12 months following the U.S. Food and Drug Administration’s licensing of these two drugs, only 18.7% of HCV patients were on them, perhaps because of “concerns about side effects and recognition that more effective medications could be available in the future” (E.Y. Chen, et al., Clin. Gastroenterol. Hepatol. April 16, 2013; doi 10.1016/j.cgh.2013.03.032).

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A former deputy editor of The Lancet, David W. Sharp, M.A. (Cambridge), is a freelance writer living in Minchinhampton, Gloucestershire, UK.

The data and citation records included in this report are from Thomson Reuters Web of KnowledgeSM. Web of KnowledgeSM is a registered trademark of Thomson Reuters. All rights reserved.

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