Hep C Drugmakers' Best Outcome

By Brian Orelli, PhD, The Motley Fool Posted 8:47PM 03/16/12

Treating hepatitis C is a losing proposition. Unlike treatments for chronic diseases -- high blood pressure or diabetes, for instance -- if a hepatitis C drug does its job, the patient is cured. It's a one-and-done treatment. Since the hepatitis C epidemic peaked many years ago, hepatitis C drugmakers need to find a new source of patients.

A report published in Clinical Infectious Diseases might have the solution: people who are already infected, but don't know it yet.

Current guidelines recommend testing only people who have identified risk factors such as drug use, blood transfusions before blood-bank testing began in 1992, or unexplained liver-function abnormalities, for example -- but that misses a substantial number of infected individuals. Estimates vary, but somewhere between 50% and 75% of people infected with hepatitis C don't know it.

Most probably have the risk factors, but they're unwilling to admit to the drug use, especially if it was years ago, or have forgotten about the blood infusion. Or the doctors aren't asking the right questions to identify the risk factors -- it's a touchy subject, you know.

The solution: Test everyone. You'll get a lot of negative results -- less than 2% of the population is infected -- but you'll catch those who might not have been diagnosed before they progress to serious liver problems.

The researchers plugged everything from costs to cure rates to likelihood of progression of liver disease and a lot of additional parameters into one giant formula and concluded that it would be cost-effective to screen everyone between the age of 20 and 69. Hepatitis C leads to liver cancer and other complications, and eliminating the cost of a liver transplant -- a quarter-of-a-million-dollar procedure -- can make up for a lot of $20 tests.

Sounds good, in theory

One journal article isn't going to change public policy; that will require a recommendation from the Centers for Disease Control and Prevention, which is a slow and methodical process.

If the CDC does institute universal testing for adults, hepatitis C test makers would certainly benefit. Just keep in mind that there's substantial competition out there: Abbott Labs (NYS: ABT) , Roche, Siemens, and OraSure Technologies (NAS: OSUR) all sell hepatitis C tests. They don't disclose margins on individual tests, but considering the number of players involved, I'd have to guess they aren't great.

Drugmakers developing hepatitis C treatments will be the real beneficiaries if more people are diagnosed. With the cost of treatment in the $80,000 range, each new patient is quite valuable.

That is, if they're treated

As the authors of the paper point out, screening is cost-effective -- and makes drugmakers money -- only if the patients who test positive are actually treated. Hepatitis C is a chronic infection that takes years to do any real damage in patients. Unlike cancer, where there's an immediate need for treatment, hepatitis C patients can take their time.

That could mean patients are lost to follow-up. It could also mean patients wait until drugs go off patent and there are cheap generics available before taking the drugs.

Identifying more patients is good, but they're not going to be moneymakers without the help of doctors.

Something companies can control

The cure rate of hepatitis C drugs is one of the factors that determine whether testing is worth the effort. If there were no way to treat patients, identifying infected patients would be only marginally useful.

As it is, Vertex Pharmaceuticals' (NAS: VRTX) Incivek has increased the standard of care substantially. Roche's Pegasys and Merck's (NYS: MRK) Pegintron cure about half of the patients, while adding Incivek increases that to around 70%.

As Gilead Sciences (NAS: GILD) , Abbott, and others develop better drugs, and we get closer to 100% cure rates, the benefit of testing will increase. It would be nice to have the patients waiting when the second-round of oral medications are approved, but drugmakers might have to get the drugs approved first and then show that identifying additional patients is beneficial.

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Model: Broad HCV Testing Cost-Effective

By Michael Smith, North American Correspondent, MedPage Today

Published: March 16, 2012

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.

Broader screening for hepatitis C would be cost-effective but would not by itself markedly reduce morbidity and mortality from the virus, researchers reported.

A detailed mathematical model of the U.S. hepatitis C epidemic showed that testing most adults once would be more cost-effective than the current practice of only testing people with risk factors such as injection drug use, according to Phillip Coffin, MD, and colleagues at the University of Washington in Seattle.

In a scenario with optimal referral, treatment, and cure rates, they reported, screening 60% of the general population averted an additional 7.1% of liver-related deaths, compared with risk-factor screening, they wrote online in Clinical Infectious Diseases.

But screening is only the first step, the researchers argued -- it would have to be followed by measures to ensure patients obtained treatment.

The study is the second in recent weeks to suggest that broader screening for the virus would be a cost-effective approach.

In February 2011, researchers led by David Rein, PhD, of the social science research organization NORC at the University of Chicago in Atlanta, reported that testing all adults born from 1945 to 1965 would be more cost-effective than the current risk-factor approach.

Coffin and colleagues said the conclusions of the two studies are "similar," despite differences in methods. Their own analysis of treating just the 1945-to-1965 birth cohort also showed cost-effectiveness, they reported.

The epidemic of hepatitis C transmission peaked decades ago, but about four million people in the U.S. are currently infected with the virus and up to 75% of those don't know they have the disease, the researchers noted.

Current incidence is low but chronic infection now results in more deaths annually than HIV. In the absence of treatment, Coffin and colleagues noted, chronic infection is predicted to lead to almost 300,000 deaths from 2020 to 2029.

"The stealth epidemic of hepatitis C has finally matured, leaving a narrow window of opportunity to find those with advancing disease, connect them with care, and prevent the tragic and costly consequences of liver cancer and end-stage liver disease," Coffin said in a statement.

To see how best to find those with disease, he and colleagues used statistical modeling techniques, comparing the current risk-factor screening with broader approaches.

They reported that one-time screening of adults ages 20 through 69 would have an incremental cost per quality-adjusted life year gained (ICER) of $7,900.

The cost-effectiveness ratio for screening by birth year was actually better -- with an ICER of $4,200, compared with risk-factor screening -- if parameters such as cost, clinician uptake, and median age of diagnoses were the same.

But the impact of screening alone on liver-related deaths was not great -- about a 1% reduction for every 15% of the population screened, Coffin and colleagues reported.

Those figures could be improved, they found, with better linkage to care and treatment outcomes.

"We need a large-scale, coordinated effort to identify people with this infection and make sure they get the care they need," Coffin said.

Indeed, better screening strategies will only be of use "if efforts are implemented to increase acceptability of screening by patients and clinicians and (to) improve linkage to care," argued Sylvie Deuffic-Burban, PhD, of Université Lille Nord de France in Lille, France, and Yazdan Yazdanpanah, MD, PhD, of Hôpital Bichat Claude Bernard in Paris.

In an accompanying editorial commentary, they note that one-time screening might be preferred, because it could be done at the same time as universal HIV testing, which is now recommended both in the U.S. and France.

But they cautioned that another aspect of the analysis remains to be done -- which approach would have the least impact on overall health budgets?

"Such an analysis, which may favor one-time screening of high-risk birth cohorts because it targets a smaller number of patients, will provide additional information for decision-making in a context in which financial resources are scarce," they wrote.

The research had support from the National Institute of Allergy and Infectious Diseases and the National Center for Research Resources.

Coffin did not report any relevant conflicts.

Editorialist Deuffic-Burban reported financial links with Roche, Janssen Pharmaceuticals, Schering-Plough, Merck, and GlaxoSmithKline. Co-author Yazdanpanah reported financial links with Abbott, Bristol-Myers Squibb, Gilead, Merck, Roche, Tibotec, and ViiV Healthcare.

Primary source: Clinical Infectious Diseases
Source reference:
Coffin PO, et al "Cost-effectiveness and population outcomes of general population screening for hepatitis C" Clin Inf Dis 2012; DOI: 10.1093/cid/cis011.

Additional source: Clinical Infectious Diseases
Source reference:
Deuffic-Burban S, Yazdanpanah Y "It is time to change the paradigm for hepatitis C virus testing" Clin Inf Dis 2012; DOI: 10.1093/cid/cis047.

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NICE Publishes Final Draft Guidance on telaprevir for Chronic Hepatitis C

Healthcare guidance body NICE has today (16 March) issued final draft guidance recommending telaprevir (Incivo, Janssen Cilag), in combination with peginterferon alfa and ribavirin, as an option for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease [1].

Hepatitis C is a blood-borne virus that predominantly infects the cells of the liver. Transmission is by contact with infected blood primarily as a result of exposure through the skin to contaminated blood (for example, through intravenous drug use). The virus can cause inflammation of, and sometimes significant damage to, the liver and affect its ability to perform its many, varied and essential functions. A hepatits C infection can be categorised into 2 stages, firstly an acute infection (the first 6 months following initial infection) and secondly a chronic infection.

Figures from 2009 suggest that around 146,000 people were chronically infected with the hepatitis C virus. Genotype 1 is the most common subtype of hepatitis C in England and Wales - affecting 40-50% of people with hepatitis - and the most resistant to treatment. Poor diagnosis and compliance rates and a high annual incidence of new infection mean that CHC presents a major public health challenge, despite the availability of treatments that provide the opportunity to address this challenge.

The primary aims of treatment are to clear the virus from the blood to prevent progression of liver disease, and to prevent the transmission of the hepatitis C virus. Current NICE guidance [2] recommends pegylated interferon and ribavirin combination therapy for people with genotype 1 chronic hepatitis C.

Telaprevir inhibits the activity of the NS3/4A serine protease. Activity of this protease is essential for viral replication and may be partially responsible for the ability of the hepatitis C virus to evade clearance by the host immune system. The drug is administered orally. The final draft guidance for telaprevir recommends the drug as an option for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease who are previously untreated or in whom previous treatment with peginterferon alfa and ribavirin has failed, including people whose condition has relapsed, partially responded or did not respond.

Commenting on the draft recommendations, Meindert Boysen, Programme Director Technology Appraisals at NICE, said: "Chronic hepatitis C can have a significant impact on a person's quality of life, particularly when if it progresses to the fibrosis and cirrhosis stage. Fear of transmitting the disease is also a concern, particularly for women of child-bearing age for whom there is a risk of transmitting the disease to their unborn child. The Committee heard that the current treatment regimen for chronic hepatitis C is often lengthy and that the side effects of treatment themselves can have a significant impact on daily life.

"The significant improvement in sustained virological response rates seen with telaprevir plus peginterferon alfa and ribavirin compared to peginterferon alfa and ribavirin alone, and its potential for shortening the treatment time from the full 48 week course needed for a virological response therefore represents a major benefit for people with chronic hepatitis C. The Committee also acknowledged the significant public health impact that a sustained virological response can have in reducing transmission of the hepatitis C virus to uninfected people. We are pleased to be able to recommend teleprevir as a cost effective use of NHS resources, alongside boceprevir for which positive draft guidance was published last week."

The draft guidance is now with consultees, who have the opportunity to appeal against it. NICE has not yet issued final guidance to the NHS.

Ends

Notes to Editors
References and explanation of terms
[1] Chronic hepatitis C infection causes initial inflammation of the liver that progresses through to gradual scarring (fibrosis) and then hardening of liver tissue (cirrhosis). Cirrhosis commonly occurs in two stages, compensated and decompensated. In the first stage of cirrhosis, the liver can compensate for the damage and still has the ability to function normally. When extensive damage occurs and the liver can no longer function normally, decompensation occurs.

[2] NICE has published the following related guidance on hepatitis C:

•Peginterferon alfa and ribavirin for the treatment of chronic hepatitis C (part review of NICE technology appraisal guidance 75 and 106). NICE technology appraisal guidance 200 (2010).
•Peginterferon alfa and ribavirin for the treatment of mild chronic hepatitis C. NICE technology appraisal guidance 106 (2006).
•Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C. NICE technology appraisal guidance 75 (2004).
About the draft guidance
1. Approximately 15% of those infected with hepatitis C virus will naturally clear the virus from their body and experience no long-term effects from the infection. However, for the remaining 85% a chronic infection will develop. 80%(68) of those who develop a chronic infection will remain stable but the remaining 20% (17) will go on to develop liver cirrhosis, of whom 25% (4) will either progress to hepatocellular carcinoma, require a liver transplant, or die.

2. Figures from 2009 suggest that around 250,000 people were infected with the hepatitis C virus, of whom 146,000 were chronically infected. Hepatitis C is more common in men and in people aged 25-44 years. In England, prevalence studies suggest that people of South Asian family origin are at an increased risk of having hepatitis C infection.

3. In 2008, the Department of Health estimated that 68,000 patients with hepatitis C infection had been diagnosed and 4,800 had been treated.

4. The aims of treatment are:

•To eradicate the hepatitis C virus in the individual
•To prevent progression of liver disease and development of liver cancer
•To prevent transmission of hepatitis C virus
5. The Committee accepted that the most plausible ICERs for telaprevir plus peginterferon alfa and ribavirin compared with peginterferon alfa and ribavirin alone were £18,000 and £10,000 per QALY gained for the previously untreated and previously treated patients.

6. Telaprevir is priced at priced at £1866.50 for a 1-week, 42-tablet pack (excluding VAT; ‘Monthly Index of Medical Specialities' [MIMS] January 2012). This equates to a maximum of £22,398 for a 12-week course of therapy. Costs may vary in different settings because of negotiated procurement discounts.

7. NICE is also appraising boceprevir (Victrelis, Merck Sharp & Dohme) for this indication.

8. The SMC has published guidance on telaprevir for this condition: www.scottishmedicines.org.uk/SMC_Advice/Advice/742_11_telaprevir_Incivo_experienced_patients/telaprevir_Incivo and www.scottishmedicines.org.uk/SMC_Advice/Advice/743_11_telaprevir_Incivo_naive_patients/telaprevir_Incivo

About NICE
The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health

NICE produces guidance in three areas of health:

•public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
•health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
•clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.
NICE produces standards for patient care:

•quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
•Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients
NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.

This page was last updated: 13 March 2012

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CROI 2012: Treating HIV During Pregnancy Also Lowers Risk of Transmitting Hep C to Baby

March 16, 2012

by Tim Horn

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

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

Continue Reading …

Hepatitis C Incidence Increasing in Younger People

From Medscape Medical News

Emma Hitt, PhD

March 16, 2012 — Pennsylvania is reporting an increased incidence of hepatitis C infections in people 15 to 34 years of age, according to results presented at the International Conference on Emerging Infectious Diseases 2012, held in Atlanta, Georgia.

Sameh Boktor, MD, adult viral hepatitis prevention coordinator at the Bureau of Epidemiology, Pennsylvania Department of Health, in Harrisburg, presented the findings.

"This has major consequences for the control of this disease, and has implications for the long-term treatment of infected individuals," Dr. Boktor and colleagues say.

"Our findings are similar to those recently reported from Massachusetts and elsewhere," they add.

"Clinicians need to consider hepatitis C in their younger patients, especially those engaging in behaviors such as IV drug use," Dr. Boktor told Medscape Medical News.

To assess the incidence of hepatitis C, the researchers reviewed Pennsylvania's hepatitis C surveillance data from 2003 (the first full year of reportable data) to 2010. They compared age-specific rates of reported cases over time.

The number of newly confirmed or probable hepatitis C cases in people 15 to 34 years of age increased from 1384 in 2003 to 2393 in 2010 (from 43 to 72 cases per 100,000 people).

In addition, the proportion of cases in males in the that age group rose from 50% in 2003 to 63% in 2010.

In contrast, rates of newly reported cases in all age groups decreased from 85 to 72 cases per 100,000 from 2003 to 2010. In those 45 to 64 years of age, cases decreased from 185 to 142 per 100,000 during the same time period.

"The change in rates between 2003 and 2010 appears largest in some rural areas of Pennsylvania rather than in the 2 large urban centers," Dr. Boktor and colleagues point out.

According to Dr. Boktor, hepatitis C is considered a problem of middle age, owing to exposures that happened well in the past, particularly among those 45 to 64 years of age (the baby boomers).

"Many in the clinical and public health communities are unaware that there appears to be a new wave of hepatitis C among adolescents and young adults emerging, especially in those engaged in high-risk behaviors such as IV drug use," he said.

"Since this infection is becoming increasingly treatable, testing for hepatitis C is a very important step to ensure proper care, avoid long-term complications, and hopefully reduce the potential for subsequent transmission of the virus," he added.

Independent commentator John Bartlett, MD, professor of medicine in the division of infectious diseases at the Johns Hopkins University School of Medicine in Baltimore, Maryland, noted that "there really is not a good explanation for these findings."

"The greatest risk by far is injection drug use; it is unclear from the report if this was shown," Dr. Bartlett told Medscape Medical News. He added that hepatitis C can be transmitted by sex and tattooing, although neither transmit the infection very efficiently and probably can not explain the increase.

According to the Centers for Disease Control and Prevention, approximately 3.2 million people are chronically infected with hepatitis C, making it the most common blood-borne infection in the United States. Overall, the incidence of acute hepatitis C has declined from just under 2.50 cases per 100,000 in 1992 to about 0.25 cases per 100,000 in 2003 in the United States, with the incidence remaining stable after that.

This study was not commercially funded. The researchers and Dr. Bartlett have disclosed no relevant financial relationships.

International Conference on Emerging Infectious Diseases (ICEID) 2012: Board 75. Presented March 14, 2012.

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CEVHAP hosts agenda-setting meet on hepatitis policy

16 - 31 March 2012

While, it has taken far too long to get viral hepatitis the attention it deserves, global experts cautiously hope that with successful partnerships and learning from the HIV/AIDS experience, the Asia-Pacific region can be an example to the rest of the world in controlling viral hepatitis, reports Viveka Roychowdhury

The spread of viral hepatitis got special attention at this year's Conference of the Asia Pacific Association for the Study of the Liver (APASL) which was held in February in Taiwan. Even though viral hepatitis, especially B and C, affect approximately 340 million people across the Asia-Pacific region, most governments do not have a public health policy in place to tackle this disease. This is in sharp contrast to the efforts of HIV/AIDS advocacy, which over the last three decades, has helped to shape public health policy.

Hoping to adopt and adapt key learnings from HIV/AIDS experience, The Coalition to Eradicate Viral Hepatitis in Asia Pacific (CEVHAP), organised the 'CEVHAP Symposium: Better health through better public policies—What Viral Hepatitis can learn from the HIV experience', on the last day of APASL. The purpose of the Symposium was to identify advocacy models that might be effectively adapted within the Asia Pacific region to lobby governments to improve public health policies to cope with the threat of viral hepatitis.

Such efforts seem long overdue. In fact it was as late as May 2010, that the World Health Assembly ratified a resolution on viral hepatitis (WHA63 R18), which for the first time recognised the full scale of the challenge and finally put viral hepatitis on the global healthcare agenda, alongside HIV/AIDS, TB and malaria. The strategy provided a framework for national governments to respond to the challenge of viral hepatitis within their own borders but also as part of a cohesive approach to tackle the disease across regions. This was followed by the World Health Organization (WHO) issuing its Global Hepatitis Strategy which combines a wide range of its products to assist countries in the development of national responses to viral hepatitis.

The CEVHAP Symposium attracted leaders from the global and Asia Pacific viral hepatitis community as well as WHO regional experts. Giving the welcome address, PASL Jia-Horng Kao, President of A2012 and Professor and Director, Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine highlighted the fact that viral hepatitis is considered endemic in some parts of the Asia-Pacific region and hoped that the takeaways from the CEVHAP Symposium would assist policy makers to tackle the situation.

Prof Ding-Shinn Chen, Immediate Past Dean of the National Taiwan University College of Medicine and Chair of CEVHAP, then kicked off the Symposium, with an overview of CEVHAP's goal to be the “bridge between the medical and scientific community as well as other stakeholders.” While he admitted that the ultimate goal to eradicate hepatitis would take many years, even generations to achieve, he stressed that the short term goal is to focus on improving public health policies to reduce the health, social and economic burden of viral hepatitis in the Asia-Pacific region. He emphasised the power of collaborative partnerships, the importance of keeping patients at the centre of advocacy and ended his presentation by speculating on what would be the catalyst for mobilising a movement behind viral hepatitis.

Lessons learnt

Giving the keynote address, titled 'Learning from the Past', David L Thomas, MD, Director of the Division of Infectious Diseases, Johns Hopkins School of Medicine stressed that the viewpoint has to shift from the individual to the population. While the first lesson, is that hepatitis treatment saves lives, but unlike ARVs, this is not yet the case at the population level. Lesson two followed that improved efficacy means improved urgency, but not necessarily effectiveness. Lesson three was about reap what you sow, in terms of the impact on public health being directly in proportion to resources devoted. So while the massive resources devoted to HIV/AIDS (through PEPFAR, etc.) saw a reduction in mortality due to HIV/AIDS, the same is not the case with viral hepatitis because the political will is absent, as are the celebrities endorsing and supporting advocacy movements.

Thomas' fourth lesson is that there is more to the disease than the virus, as borne out by the fact that a study showed that there was markedly lower survival for HIV/HCV co-infected persons in Denmark during highly active anti-retroviral therapy, from 2000-2005. The fifth and final lesson is that prevention is better than treatment. He pointed out that the annual incidence of liver cancer in children in Taiwan was markedly reduced by HBV vaccination. Elimination is of course, the best form of prevention, with small pox being the best example.

Looking ahead Thomas said, controlling chronic hepatitis in the population requires more work on improving safety and efficacy of treatments, expanding testing and treatment access, educating to expand political and societal commitment. Preventing new infections, together with curing existing infections will ultimately lead to the elimination of hepatitis.

Successful collaborations

The next two speakers, Ali Sulaiman, Lecturer in Internal Medicine, Department of Medicine University of Indonesia and Benjamin Cowie, WHO Regional Reference Laboratory for Hepatitis B, VIDRL Board of Directors, Australasian Society for HIV Medicine were a classic example of the importance of leveraging partnerships and collaborations in containing diseases like HIV/AIDS in the past and now viral hepatitis. Developing countries like Sulaiman's home country Indonesia, bear the greatest disease burden and challenges due to viral hepatitis. For instance, Sulaiman said that only five per cent of hepatitis cases have access to medicine, clearly pointing to barriers that go beyond the clinic. But hopefully this will change. Sulaiman pointed out that while his government spearheaded the celebration of viral hepatitis day in the past two years, the backbone of such programmes is medicine access programmes.

Cowie spoke about translating the Australasian Society for HIV Medicine's (ASHM's) learnings from HIV to hepatitis, pointing out that while there is increasing evidence for HBV antiviral therapy as a cancer prevention strategy, antiviral effect on disease progression is reduced when resistance develops. Therefore partnerships with clinicians like ASHM's preceptorship programme, imparting primary care management of HCV for Indonesian primary care doctors and internists, are crucial. Cowie expressed the hope that maybe the Asia-Pacific region can be an example to the rest of the world in controlling viral hepatitis.

There is no doubt of the patient's role as an important stakeholder and even catalyst to policy change, hence patient advocacy groups (PAGs) have a very crucial role. Speaking about the development of PAGs in viral hepatitis, Charles Gore, President, World Hepatitis Alliance, himself a patient of hepatitis C and cirrhosis, spoke about the need to raise viral hepatitis up the agenda and the role conferences like APASL and associations like CEVHAP need to play to build up the patient voice in the Asia-Pacific region.

The WHO viral hepatitis strategy

Professor Stephen Locarnini, Head, WHO Regional Reference Laboratory for hepatitis B, Victorian Infectious Diseases Reference Laboratory, Melbourne, Australia and Joint Secretary, CEVHAP outlined the four key priorities of the WHO Viral Hepatitis Strategy. Partnership, mobilisation and communication come first, followed by collection of data to help shape for policy and action. Prevention of transmission forms the third axis followed by screening, care and treatment.

Locarnini cautioned that there were many challenges, not least the need to fully staff the WHO HQ team as well as fully fund the 2012-2013 work plan. Operationalising the global hepatitis network, translating the HQ strategy at the regional level, contributing to country strategy and technical support as well as finally producing results and actually impacting viral hepatitis are the many challenges in the path ahead.

Speaking as the co-founder of CEVHAP, he summarised its work since its inception, saying that it has established a solid base, with strong membership and a unique position. Current and planned projects can provide strong data and evidence to influence policy but will require strong follow-up on the ground. Therefore he stressed that it is imperative that CEVHAP works closely with other groups at global, regional and national levels to share data and best practices and maximise impact

The Symposium concluded with a panel discussion, chaired by Locarnini, with the panellists (Gore, Rosmawati Mohamed, University of Malaya, Kuala Lumpur, Henry Lik-Yuen Chan, The Chinese University of Hong Kong and Jack Wallace, La Trobe University, Melbourne) giving their views on what the viral hepatitis sector needed to catalyse a movement.

viveka.r@expressindia.com

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The great doctors on a mission

By Dr. Saif Ur Rehman - Mar 16th, 2012

Today, about 500 million people worldwide – one in 12 – are infected with chronic viral hepatitis B or C. Pakistan is currently home to around 15 to 18 million patients suffering from Hepatitis B and C.One out of every 10 Pakistanis suffers from either Hepatitis B or C. Unsafe drinking water, unscreened blood transfusions and used syringes have made Hepatitis one of Pakistan’s greatest health concerns. Current estimated prevalence of Hepatitis B is 3-4% and Hepatitis C is 5-6%. Though, there are many different causative agents of Hepatitis, but Hepatitis B, C and D are lethal, which if not cured in time; can be fatal.

Alarming rise in hepatitis cases in Pakistan, made the big wigs of the country to pay heed and address this issue. And this way, The first phase of the Prime minister’s programme for Hepatitis prevention and Control was launched in August 2005, this programme (2005-10) was launched to decrease substantially the prevalence, morbidity and mortality. The projected cost of the first phase of programme was Rs. 2.594 billion. Official statistics shows that there was substantial reduction in prevalence, morbidity and mortality due to viral hepatitis infections in the general population, up to 50% reduction in number of new cases; aimed by 2010.

After successful completion of of the first phase, federal government allocated Rs14 billion for the second phase of the project which started in November 2010 and will end in 2015. Second phase of this programme has five components, including programme management and surveillance, case management and care, prevention; training, education and awareness, and research and publication.

The establishment of Centre for Liver Diseases and Liver Transplant at PIMS is a step forward towards the achievement of this objective. Establishment of Centre for Liver Diseases and Liver Transplant at PIMS for treatment of hepatitis patients was announced by the Prime Minister on 4th November 2010 on the occasion of launching ceremony of second phase of Prime Minister’s programme for hepatitis prevention and control. On April 18, 2011, Prime Minister Syed Yusuf Raza Gilani directed the Ministry of Health to ensure operationalization of the 1st “Liver Diseases and Transplant Centre” in Pakistan by the end of May 2011.

He desired that the 1st liver transplant operation be conducted in the centre in June 2011. The Prime Minister issued the above directions during a presentation made by the Ministry of Health here at the Prime Minister’s House on the establishment of the first Liver Diseases and Transplant Centre at the Pakistan Institute of Medical Sciences (PIMS), Islamabad. The Prime Minister directed that the centre for liver diseases and liver transplant (LDLT), PIMS, must have the state of art medical facilities which should essentially meet the international standards. He further directed the Ministry of Health that the best professionals should be hired for this medical facility (LDLT) to provide quality health care to the hepatitis patients. The Prime Minister directed that the poor and needy patients suffering from hepatitis should be given free treatment at (LDLT).

In order to identify the genuine needy and deserving, he said that a board be constituted with eminent individuals from various fields including professionals. The establishment of the centre for Liver Diseases and liver Transplant (LDLT), is a landmark project of the present government having local/indigenous expertise to manage the centre and perform the liver transplant surgeries.
Initially 200 million rupees grant was released to further this objective and there were also directions to set up a separate building for centre for liver diseases and liver transplant (LDLT) within the PIMS premises.

Afterwards another grant of 99 million rupees was issued. But some questions arise that why still there is no separate building for this objective? Why there is non- serious attitude on the part of administration? Why employees of LDLT are deprived of their salaries despite that existing employees are punctual, hard working and they are doing their best for this project as per available place and facilities by administration…! Which forces are hell bent on to fail this project of Prime minister? Is Al-Qaeda active or Al-Faeda is playing its role to make prime minister’s program a great blunder? A billion dollar question; where did the money go? and last but not the least, what about the ultimate goal that is liver transplant? To unearth the answers of these questions, we have to go back in may 2011, this is the month in which we were called for our written tests and interviews and all the inductions were made on merit contrary to the wishes and pressure of the administration of PIMS, because the top management wanted their people to be recruited but their proposal was turned down. Since then to date we are being punished, our sole crime is that we were inducted on merit; we are deprived of our salaries.

But still we are determined to render our services for the national cause, we all employees are working day in day out to make this project successful. World’s most difficult task is to work without pay for a long time. But we have made history our dedication to the national cause is matchless. At the moment treatment of Liver diseases is underway at PIMS Hospital providing indoor and outdoor treatment
including the provision of equipment, drugs and minor surgeries. Hepatitis B and C patients are provided complete set of third generation Hepatitis drugs.

I bet, take any sort of work, even a daily wager will not come to his work next day if he is not paid his wage at the end of day. Lets move little ahead, if salaries of employees of any private or government institution do not meet their demands they go on strike, refuse to work and shut their offices. They do not care for losses to national exchequer and plight of common people due to their strikes. We have recent so many practical examples of such incidents, don’t go away, just take the example of our own community of doctors. Over rise of salaries issue there were back to back strikes. But we have made the history, we have never ever gone on a single minute of token strike over deprivation of our salaries, which is our due and fundamental right too. Because we are thinking bigger, we prefer national interest to our due.

I would like to pay rich tribute to my all colleagues who are most revered, honest, sagacious and dedicated to the national cause and we all have strictly followed the Hippocratic oath. We believe that our profession and our hippocratic oath is based on strong spirit of dedication to patients. Even we can risk our lives for to save patients’ lives. I would like to share basis of hippocratic oath which entails breath taking fact in terms of Greek mythology, it is as following “Apollo, the god of healing, fell in love with a human, Coronis. In his absence, Apollo sent a white crow to look after her.

When the crow informed Apollo that Coronis loved another man, Apollo’s rage turned the crow black. To avenge her brother, Apollo’s sister shot Coronis with an arrow and, as she lay dying , Coronis told Apollo that she was bearing his child. Although Apollo could not save Coronis, he rescued the unborn child, Asclepius. Hygieia, the goddess of health, and Panacea, the goddess of cures, are the daughters of Asclepius.

According to legend, Hippocrates was a descendant of one of Asclepius’ sons”. This is the basis of hippocratic oath and each and every doctor is bound to follow it. To work without pay is a great deal indeed. But we have worked and we will keep on working. Fact is that we are on mission, we are focusing to eradicate hepatitis from the country and provide state of the art medical facilities to patients. Prime Minister Yousaf Raza Gilani who wanted to provide a liver transplant facility in the capital so those patients needing this costly procedure would not need to go abroad.

This is our beloved homeland and it is the duty of each and every pillar of the state to go with national interest. Would that PIMS administration were sincere! My humble request to Prime minister of Pakistan and all top officials of peoples government and Chief Justice of Pakistan is that kindly look into this matter before it is too late.

Bloggers Intro

Dr. Saif Ur Rehman is a medical hepatologist and working in center for liver diseases & liver transplant PIMS, Islamabad.

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Experts recommend large-scale hepatitis C testing initiatives

Updated: 2012-03-14 16:14:18 CST

Broader efforts to make lab testing for hepatitis C available to more individuals could be a cost-effective method of controlling the spread of the infection, according to a new report published in the journal Clinical Infectious Diseases.

The University of Washington researchers who wrote the paper said that current testing programs evaluate an individual's risk factors for hepatitis infection. However, this kind of approach has failed to identify at least half of those infected with the disease.

The healthcare costs assocaited with treating new infections and the complications associated with the virus are high. The researchers suggested providing all adults between the ages of 20 and 69 with at least one lab test for hepatitis C could be a more cost-effective approach to dealing with the problem.

"Hepatitis C is a lot like HIV. The U.S. took a long time to come to the conclusion that we needed to really emphasize testing and efforts to link people to care. Hepatitis C is the same," said Phillip Coffin, the lead author of the paper. "We need a large scale, coordinated effort to identify people with this infection and make sure they get the care they need."

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J&J’s Hepatitis C Drug Wins U.K. Cost Agency’s Backing

By Makiko Kitamura on March 15, 2012

Johnson & Johnson (JNJ)’s Incivo won the backing of the U.K.’s health-cost regulator in a draft recommendation for the treatment of hepatitis C.

The medicine, also known as telaprevir or Incivek, is a cost-effective option for chronically infected hepatitis C patients when used with older drugs peginterferon alfa and ribavirin, the National Institute for Health and Clinical Excellence said today in a statement. The agency advises the state-run National Health Service on which products represent value for money.

Hepatitis C affects as many as 170 million people globally, putting them at risk of developing liver cancer, according to the World Health Organization. The disease is most commonly transmitted through contaminated blood transfusions, organ transplants, contaminated syringes and needle-injected drug use, according to the WHO.

“The significant improvement in sustained virological response rates seen with telaprevir plus peginterferon alfa and ribavirin compared to peginterferon alfa and ribavirin alone, and its potential for shortening the treatment time from the full 48-week course needed for a virological response, therefore represents a major benefit for people with chronic hepatitis C,” Meindert Boysen, program director of technology appraisals at NICE, said in the statement.

About 146,000 people in England and Wales were chronically infected with hepatitis C in 2009, according to NICE. The draft recommendation applies to patients with genotype 1, which is found in as many as half of hepatitis C patients and is the most resistant to treatment, NICE said.

The agency also recommended Merck & Co. (MRK)’s Victrelis treatment for hepatitis C for the same use as telaprevir last week.

To contact the reporter on this story: Makiko Kitamura in London at mkitamura1@bloomberg.net 

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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Texts Can Help HIV Patients Stay on Therapy

By Michael Smith, North American Correspondent, MedPage Today

Published: March 15, 2012

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco

Text messages sent by cell phone can help HIV patients stay on their medications, according to a Cochrane review.

High-quality evidence from two randomized controlled trials conducted in Kenya suggests text messaging reduced the risk of non-adherence by 22%, according to Tara Horvath, MA, of the University of California San Francisco, and colleagues.

And there is also good evidence that the text messaging was associated with lower viral load, Horvath and colleagues found in a Cochrane Systematic Review.

"Clinics and hospitals should consider using weekly text messaging as a way to ensure HIV patients stick to their antiretroviral therapy regimens," Horvath said in a statement.

"With the expansion of mobile phone networks worldwide, particularly in regions that are new to these technologies, text messaging interventions for HIV are rapidly becoming more feasible," Horvath said.

The researchers said the studies, conducted in adults, found a clear benefit, and urged that studies be conducted in other populations, especially adolescents.

Her group also argued that, contrary to the usual progression of randomized trials, studies should be conducted in the developed world, where adherence is also a problem.

Horvath and colleagues noted that some 34 million people are living with HIV/AIDS, and many of them on highly active anti-retroviral therapy. But the therapy can fail, they noted, if the drugs are not taken as prescribed, leading to the need to switch regimens and also potentially to drug resistance.

"Mobile phone text-messaging has the potential to help promote adherence," they argued.

To find out if it does, they conducted a systematic review of the HIV/AIDS literature, finding two randomized controlled trials that compared mobile text messaging with a control condition.

One year-long trial in adults compared brief weekly text messages against standard care.

Those in the intervention arm received a message of "Mambo?," which means "How are you?" in Kiswahili, and were asked to reply within 48 hours.

A negative response was met with a direct phone call to obtains details and arrange for care.

The primary outcomes were self-reported adherence to medication -- defined as taking more than 95% of prescribed doses in the previous 30 days, assessed at six months and again at 12 months -- and suppression of HIV viral load at 12 months, defined as fewer than 400 copies of HIV RNA per microliter of plasma.

The other trial compared standard care with short daily, long daily, short weekly and long weekly messages, again among adult patients. The short message said simply: "This is your reminder." The long message said:

"This is your reminder. Be strong and courageous. We care about you."

The primary endpoint was risk of non-adherence, defined as fewer than 90% of doses during each of four 12-week analysis periods.

Horvath and colleagues found that in the first trial, comparing only short weekly messages to standard care, those getting the text messages were 23% less likely to be non-adherent at 12 months. The relative risk was 0.77 (95% CI 0.63 to 0.93). They were also less likely to have virologic failure (RR 0.83 at 12 months, 95% CI from 0.69 to 0.99).

In the second trial, the length of the messages did not affect adherence. Patients who got weekly messages were 21% less likely to be non-adherent (RR 0.79, 95% CI 0.64 to 0.99).

On the other hand, compared with standard care, any daily messaging did not reduce the risk for non-adherence.

But in a meta-analysis of both trials, any weekly text-messaging was associated with a lower risk of non-adherence (RR 0.78, 95% CI 0.68 to 0.89).

As well, the effect of short weekly messaging remained significant (RR 0.77, 95% CI 0.67 to 0.89), Horvath and colleagues reported.

The study was supported by the University of California San Francisco. The authors did not report any potential conflicts.

Primary source: Cochrane Database of Systematic Reviews
Source reference:
Horvath T, at al. "Mobile phone text messaging for promoting adherence to antiretroviral therapy in patients with HIV infection" Cochrane Database of Systematic Reviews 2012; 3: CD009756.

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