Are Patients Receiving the Latest Anti-HCV Drugs?

Provided by the AGA Journals Blog

Posted on July 22, 2013 by Kristine Novak, PhD, Science Editor

Less than 20% of patients infected with the most common Hepatitis C virus (HCV) genotype receive the latest drugs approved by the US Food and Drug Administration (FDA), according to the August issue of Clinical Gastroenterology and Hepatology. This low percentage could result from concerns of side effects or patient hopes that more effective medications will soon become available.

The anti-HCV drugs boceprevir and telaprevir, approved by the FDA in May 2011, were found to be highly effective in phase 3 clinical trials. When one of these drugs is given in combination with pegylated interferon and ribavirin (triple therapy), rates of sustained virologic response are 70%–80% in patients with HCV genotype 1 infection. Furthermore, these drugs have been reported to reduce mortality from liver diseases, including hepatocellular carcinoma, hepatocellular failure, and complications of portal hypertension.

Emerson Chen et al. investigated how many patients with HCV genotype 1 infection actually started this treatment regimen within the 12 months after their FDA approval.

They found that only 18.7% of patients seen at hepatology practices in Dallas and Miami from June 2011 through February 2012 began the triple therapy–about the same percentage as those receiving dual therapy (with only pegylated interferon and ribavirin) before boceprevir and telaprevir were approved. So, rates of treatment with triple therapy have not increased beyond levels seen in the prior decade with dual therapy, despite the proven efficacy of the new agents.

In analyzing patients’ charts, Chen et al. found that the reasons patients were not given the triple therapy included contraindications (in 50.5%, including non-hepatic disorders, decompensated liver disease, and adverse events during prior treatment), patient choice (22.5%), and less-advanced liver disease (17.4%).

Among the patients who did receive triple therapy, 15% discontinued prematurely because of serious adverse events such as anemia, dehydration, and rash.

Treatment experience and the extent of liver fibrosis seemed to be the most important determinants for initiation of triple therapy.

Patients who had HCV relapse after previous treatments are prime candidates for triple therapy, compared with prior non-responders and treatment-naive patients. Chen et al. found that patients with stage 3−4 fibrosis were also considered prime candidates for triple therapy—they have the highest risk for disease progression and development of liver-related complications.

The factors that affected initiation of triple therapy in this study were similar to those for dual therapy before 2011. Although race, marital status, and insurance were previously reported to be important, these associations were not observed by Chen et al.

The authors propose that the disappointingly low use of the new therapies, even after a decade without novel medications, could result from the continued requirement for interferon, the safety profile of the new drugs, low predicted rates of response for patients that did not respond to previous therapy, and hopes that interferon-free regimens could be around the corner.

Expanding HCV screening to people born between 1945 and 1965—the age group in whom up to 75% of HCV-related deaths occur—could increase the number of treatment-naive patients seeking HCV therapy.

Read the article online.
Chen EY, Sclair SN, Czul F, et al. A small percentage of patients with hepatitis c receive triple therapy with boceprevir or telaprevir. Clin Gastroenterol Hepatol 2013;11:1014-1020.e2.

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African Experts Join Forces with MSD to Battle Hepatitis

July 23, 2013 at 15:34

Posted by Marc Mcilhone

Conférence Internationale sur les Hépatites states: Hepatitis B and C remain under-diagnosed and under-reported in Africa

From July 20 to 22, the Initiative Panafricaine de Lutte Contre les Hepatites (IPLH) held the conference “Consensus De Dakar”, for the Francophone Africa region in Dakar, Senegal.  During the meeting the experts agreed on a consensus to drive prevention, awareness, research and management of hepatitis through national action plans in participating countries. Experts including clinicians, physicians, patient groups and policy makers formulated a unified call for action towards shaping effective hepatitis policy.  Among the participating countries from Francophone Africa were Algeria, Benin, Burkina Faso, Burundi, Cameroon, Central Africa, Congo, Democratic Republic of Congo, Ivory Coast, Gabon, Guinea, Madagascar, Mali, Morocco, Mauritania, Niger, Rwanda, Senegal, Chad, Togo and Tunisia. This group was joined by representatives from the English Africa initiative “Hepatitis in Africa – Call for Action”.

Hepatitis – a burden to society

Hepatitis B and C are among the most serious infectious disease challenges impacting individuals, families and society today. Both viral hepatitis B and C are the leading cause of chronic liver disease in the world (1). This is of particular importance in Africa where a fifth of the population are chronic hepatitis carriers and liver cancer is the leading cause of death from cancer in men. Commonly striking men in the 30-45 age group and with virtually 100 percent mortality, the economic impact of liver cancer and thus hepatitis is enormous (2) (3).

Despite the health and economic impact of viral hepatitis, hepatitis B and C remain under-diagnosed and under-reported in Africa. Unlike HIV, which has had enormous resources expended for its management, funds for battling hepatitis infection are limited and lack community advocacy and awareness. As grass roots support is missing, populations most affected by hepatitis B and C, which are typically hard to reach and disenfranchised, don’t receive needed services.

Experts across Africa join forces to battle hepatitis

In order to meet these and other challenges, the IPLH has initiated the “Consensus De Dakar”. This second IPLH meeting leveraged on the ground experience gained since the first Dakar meeting in 2011. In order to increase the impact of these efforts across the African continent, IPLH has joined hands with the Focus Scientific Research Center (FSRC), a physician-led team of researchers and MSD, a global healthcare leader, who have sparked an initiative to create awareness about hepatitis in the English speaking countries of Africa. This initiative called “Hepatitis in Africa – Call for Action” was launched in Lagos, Nigeria on June 18 with the intention of raising disease awareness among the relevant stakeholders in the region.

Prof. Aminata Sall Diallo, executive director of “Le Programme National de Lutte contre les Hépatites” (PNLH) and Coordinator of IPLH stated: “By developing strategies for data harmonisation, shared resources, and by bringing together research expertise across all of Africa, we can effectively assess the burden of hepatitis B and C, learn more about the risk factors and improve efforts in diagnosis, management and prevention. The event in Dakar will set the roadmap to action against hepatitis with the involvement of local, regional and international stakeholders.”

Henrik Secher, managing director and vice president, MSD Africa, added:  “We support the efforts of governments and healthcare professionals in Africa to prevent transmission and improve detection of hepatitis. MSD’s engagement in this initiative is part of our commitment to discover, develop and deliver medicines to help prevent and treat viral hepatitis.”

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Research: Some African American liver recipients fare better with organ from black donor

BY LAURA RICKS

Special to The Advocate

July 23, 2013

Black patients with Hepatitis C who receive liver transplants fare better if they received the organ from black donors, new research from Tulane University and the University of California at San Francisco has found.

Dr. Nathan Shores, assistant professor of clinical medicine at Tulane School of Medicine, and other researchers followed 1,766 black patients with Hepatitis C who received liver transplants over a seven-year period. In a break from previous findings, the team found that transplants proved more successful if the donors were black as well.

The benefits were so significant that researchers found matching race in these particular cases mitigated the affect of age, allowing doctors more leeway in using organs from older donors. Both results could have significant ramifications for black liver patients and the organ donation community.

“This inverts a landmark 2006 study that said organs from African-Americans did less well in recipients than those from young Caucasians,” said Shores, whose study will soon be published in Hepatology. “This study shows that they do quite well in certain patients and sends a positive message to everyone. If people realize their organ donation can make a difference for their friends and neighbors, the people in their church and their community, they know they can make a real difference, especially in a place like New Orleans.”

According to Shores, black Americans have a 58 percent higher likelihood of contracting Hepatitis C than white Americans. Although those black Americans with chronic Hepatitis C have relatively better outcomes than patients from other races prior to needing a transplant – a fact that Shores said is not completely understood – they suffer higher rates of liver transplant failure than other racial and ethnic groups.

“Hep C is a huge problem in New Orleans,” said Shores, who also is medical director of liver transplantation at Tulane Medical Center. “More African-Americans suffer from it, as do those in (other) large Southern cities, so all those rates come together to make our rate higher than the national rate.”

While surgeons often prefer to use organs from younger donors, this study’s findings showed that black patients requiring a liver transplant will do better with an organ from a donor of the same race, up to age 60, Shores said.

The study therefore suggests that the current Donor Risk Index used to predict transplant failure be replaced in these cases by a model incorporating race and age, among other standard characteristics. Currently, race and ethnicity are not factors considered when matching organs, though certain blood types and tissue factors are recognized as being more common among certain groups.

“The liver is a big complex organ. It’s almost like an extension of bone marrow with lots of white cells and we don’t really understand it.” Shores said. “If we could figure out why this works, it could help us study the affect of medications and more. And I think this can help lead us on the path to more individualized care, which is the future of medicine.”

In Louisiana, African-Americans make up a disproportionate share of the people waiting for an organ, according to the Louisiana Organ Procurement Agency (LOPA), the agency designated by the federal government to maintain the Louisiana Donor Registry and recover organs and tissues for transplant. More than 1,000 African Americans in the state were waiting for an organ as of June 5.

Although people of most races and ethnic groups donate in proportion to their representation in the population nationwide, that isn’t the case in Louisiana. Twenty-five percent of African-Americans have registered with the Office Of Motor Vehicles to be organ donors while representing 32 percent of the population.

“Minority populations make up the majority of the Louisiana wait list,” said Kristen Heintz, LOPA public relations director. “There’s a great need for people to donate from those communities. That’s why it’s so important for people who wish to donate their organs to discuss it with their families and make their desires known.”

Sometimes misconceptions about organ donation hold people back from making the decision to donate.

“One of the most common myths we hear is that people think a health care provider won’t go all out to save someone’s life if they think that person is an organ donor,” Heintz said. “That’s simply not true. Health care providers take an oath to save lives and have no idea whether or not most patients have decided to be organ donors. The providers only call us when they have exhausted every option, and it’s then we look to see if the patient is in the registry.”

In addition, on a practical note, Heintz said a person who has not been given the proper care would be more likely to have organs that suffered during treatment, which then make those organs less viable for transplant.

While there are approximately 40,000 deaths a year in Louisiana, LOPA approaches less than 300 families a year about donating a loved one’s organs. “Last year about 160 people actually became donors. More families said ‘yes,’ but some people were too sick or too unstable and that prevented them from donating. It’s actually very rare, less than one percent on average, that someone can become an organ donor,” she said. “It really is an honor.”

Heintz also wants people to know that organ donation is not the quick process often portrayed on television. “Donation is usually a 24-to-36 hour process and, until the donation is complete, it can be taxing for families. They should know it takes a little bit of time,” she said.

Though organs often go to the sickest person on the list nationally, there is a limited time that an organ can go without oxygen and blood, creating restrictions on travel.

Therefore, Heintz says about 70 to 75 percent of organs donated in Louisiana stay here, helping fellow Louisiana patients.

To become an organ donor, sign your donor card on your Louisiana driver’s license. You can also become an organ donor online by completing the registry form at www.donatelifela.org or through LOPA at www.lopa.org. Be sure to discuss your decision to donate your organs and/or tissues with your friends and family beforehand so there will be no confusion at the time of death.

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Hepatitis C virus reinfection among prisoners with sustained virological response after treatment for chronic hepatitis C

J Hepatol. 2013 Jul;59(1):45-51. doi: 10.1016/j.jhep.2013.03.008. Epub 2013 Mar 22.

Marco A, Esteban JI, Solé C, da Silva A, Ortiz J, Roget M, Sarriera C, Teixidó N, Guerrero RA, Caylà JA.

Health Services of Barcelona Men's Penitentiary Centre, Barcelona, Spain. Electronic address: andres.marco.m@gmail.com.

Abstract

BACKGROUND & AIMS: We estimated HCV reinfection rate and its associated risk factors in inmates with chronic hepatitis C who had achieved sustained virological response (SVR) after completing combination therapy while in prison.

METHODS: Individuals who had achieved an SVR after treatment provided from January 2003 to December 2009 at four prisons in Catalonia, had been tested annually for HCV RNA and were in prison during 2010, were invited to complete a questionnaire regarding risk factors for reinfection. Incidence rate was calculated as 100 person-years of follow-up. Risk factors potentially associated with reinfection were evaluated by bivariate log-rank test and multivariate Cox regression analysis.

RESULTS: One hundred and nineteen subjects who had achieved an SVR agreed to participate. 98% were male, with a median age of 33.3±6.3years and 81% had a history of injection drug use (IDU). After a mean follow-up of 1.4years, HCV reinfection was identified in nine former IDUs, seven with HCV genotype switch, for an overall reinfection rate of 5.27 cases per 100 person-years. Reinfection incidence was significantly higher among active drug users (HR=12.47; 95% CI: 2.90-53.71), HIV co-infected (HR=9.95; 95% CI: 1.73-57.34), and those engaging in more than one risk behaviors after treatment (HR=7.47; 95% CI: 1.19-46.89).

CONCLUSIONS: HCV reinfection among inmates after successful treatment is high especially in those with ongoing IDU. Preventative interventions at diagnosis and during and after HCV treatment should be strongly reinforced.

Copyright © 2013 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

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HCV disease burden greatest among baby boomer veterans

Provided by Healio

Backus LI. JAMA Intern Med. 2013;doi:10.1001/jamainternmed.2013.8133.

July 15, 2013

Veterans born between 1945 and 1965 have a much greater prevalence of anti-HCV and HCV infection compared with other birth cohorts, according to recent results.

In a retrospective cohort study, researchers evaluated data from 5,415,084 veterans who made one or more outpatient visits to VA clinics during 2011, including 2,889,385 who underwent hepatitis C screening. Screening was performed in 40.6% of those born before 1945, 63.5% of those born between 1945 and 1965 and 57% of those born after 1965.

Overall, 6.2% of the cohort had HCV, with variance according to age: 1.7% of those born before 1945 and 1.1% of those born after 1965 had HCV infection, compared with 10.3% of those born between 1945 and 1965. Investigators noted that infection prevalence peaked during 1954, occurring among 18.4% of patients born that year.

HCV was more common among men than women (6.5% vs. 2.8%). Comparisons across races/ethnic groups indicated the highest HCV prevalence among blacks (12.3%), Hispanics (6.7%) and American Indians/Alaskan natives (6.6%). Patients born between 1945 and 1965 had the greatest HCV prevalence across both sexes and all evaluated races/ethnic groups, with the highest rates among men observed in blacks (18.2%) and the lowest among Asians (3.5%).

Anti-HCV was observed in 8.4% of the cohort, and varied similarly by birth cohort, sex and race/ethnicity as HCV infection. Participants born between 1945 and 1965 had the highest anti-HCV prevalence (13.5% vs. 2.9% before 1945 and 1.8% after 1965).

“This high HCV infection prevalence in the 1945-1965 birth cohort substantiates the disproportionate disease burden that underpins the CDC recommendation for birth cohort screening and supports the birth cohort emphasis,” the researchers wrote. “The observed high HCV infection prevalence — relative to prior VA estimates and general population estimates — serves as a reminder of the greater HCV disease burden in the veteran population.

“Full adoption of birth cohort screening may reveal substantial numbers of veterans with previously unknown HCV infection.”

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NICE draft guidance recommends drugs to treat chronic hepatitis C in children and young people

In draft guidance published today NICE recommends peginterferon alfa in combination with ribavirin as an option for treating chronic hepatitis C in children and young people.

Hepatitis C is a blood-borne virus that infects the liver. Children and young people get the disease primarily from their mothers at birth. If the virus is not cleared from the body, either naturally or through drugs to treat it, an acute infection (defined as the first six months following initial infection) can progress to chronic hepatitis C (long term infection, lasting more than six months). Chronic hepatitis C infection increases the risk of scarring of the liver (fibrosis and cirrhosis), liver failure and liver cancer. Peginterferon alfa-2a (Pegasys, Roche Products) and peginterferon alfa-2b (ViraferonPeg, Merck Sharp and Dohme (MSD)), in combination with ribavirin are the only treatments currently licensed in the UK for the treatment of chronic hepatitis C in children and adolescents.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “Hepatitis C is a potentially debilitating condition, and although it rarely causes serious liver damage in children, if left untreated there is a high risk that it will cause liver cirrhosis and eventual liver failure many years down the line. The independent Appraisal Committee concluded that treatment with peginterferon alfa and ribavirin can decrease the hepatitis C virus to undetectable levels, effectively providing the equivalent of a cure for the disease. By widening access to these drugs this guidance will give clinicians and people living with hepatitis C more treatment options. Early successful treatment is also likely to lessen the social stigma that can be associated with hepatitis C infection later in life.”

Until final guidance is issued to the NHS, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.

Ends

Notes to Editors

About the draft guidance

1. The draft guidance will be available from 00:01hrs on Thursday 18 June
2. Estimates from the Health Protection Agency in 2011 indicate that 26 people aged 1 year or less and 21 people between the ages of 1 and 14 years were newly diagnosed with HCV in England in 2010. Estimates for chronic infection in children and young people are not available.
3. The Assessment Group calculated that, based on an average age of 11 years, a body weight of 35.5 kg and a body surface area of 1.19 m², a 24-week course of peginterferon alfa-2a and ribavirin costs approximately £3700 while a 48-week course of treatment costs approximately £7400.
4. A 24-week course of peginterferon alfa-2b and ribavirin oral solution costs approximately £4000, while a 48-week course of treatment costs approximately £8100.
5. Ribavirin is manufactured by Roche Products (Copegus) and MSD (Rebetol). Each product is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with peginterferon alfa or interferon alfa. The marketing authorisation for Copegus does not include specific recommendations for use in children. Copegus should be administered only in combination with the interferon products made by Roche Products (peginterferon alfa-2a or interferon alfa-2a). Rebetol (MSD) is available as an oral solution and 200 mg hard capsules and has a UK marketing authorisation for children and adolescents aged 3 years and older in combination only with MSD products peginterferon alfa-2b or interferon alfa-2b.
6. The cost effectiveness results suggested that peginterferon alfa-2a and peginterferon alfa-2b (each in combination with ribavirin were more effective and less costly than best supportive care.
7. The comparison between peginterferon alfa-2a and peginterferon alfa-2b was not robust enough for the Committee to recommend one treatment over the other.
8. NICE technology appraisals apply across the NHS in England and Wales.

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health. Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012). Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provideare value for money, in order to reduce inequalities and variation. Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services. Follow us on Twitter: @NICEcomms

This page was last updated: 17 July 2013

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Study shows HBV co-infections can predict prognosis

Hepatitis B

Provided by Vaccine News Daily

Published on July 19, 2013 by Daniel Kamin

A group of scientists detailed the role of chronic hepatitis B co-infection in carcinogenesis of hepatitis C in a recent study published by PLOS ONE,.

A study was done on 115 liver tissues taken from the noncancerous parts of removed hepatitis C associated hepatocellular carcinoma. These samples were then given a virological analysis.

The results showed that occult and overt hepatitis B co-infection served as independent predictors for postoperative survival in HCV-associated HCC.

HCC is responsible for over 90 percent of liver malignancies and is the fifth most common solid cancer, as well as the third leading cause of cancer-related death. Around 75 percent of all HCCs are caused by HBV and HCV infections.

In the study, the clinical records of 342 HCC patients who had liver tumors removed from July 1998 to Aug 2001 were analyzed. Of the 342 patients, 115 tested positive for antibody HCV.

The results first showed that there was no significant difference between men and women in regards to HCV-associated HCC. Out of the 342 patients, 35 had overt HBVCI and 16 had detectable intrahepatic HBV DNA. This helped to show that occult, rather than overt, HBVCI led to a shorter postoperative disease-free survival in patients with HCV-associated HCC.

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Medical Virology of Hepatitis B: how it began and where we are now?

Published on: 2013-07-20

Infection with hepatitis B virus (HBV) may lead to acute or chronic hepatitis. HBV infections were previously much more frequent but there are still 240 million chronic HBV carriers today and ca.

620,000 die per year from the late sequelae liver cirrhosis or hepatocellular carcinoma. Hepatitis B was recognized as a disease in ancient times, but its etiologic agent was only recently identified.

The first clue in unraveling this mystery was the discovery of an enigmatic serum protein named Australia antigen 50 years ago by Baruch Blumberg. Some years later this was recognized to be the HBV surface antigen (HBsAg).

Detection of HBsAg allowed for the first time screening of inapparently infected blood donors for a dangerous pathogen. The need to diagnose clinically silent HBV infections was a strong driving force in the development of modern virus diagnostics.

HBsAg was the first infection marker to be assayed with a highly sensitive radio immune assay. HBV itself was among the first viruses to be detected by assay of its DNA genome and IgM antibodies against the HBV core antigen were the first to be selectively detected by the anti-mu capture assay.

The cloning and sequencing of the HBV genome in 1978 paved the way to understand the viral life cycle, and allowed development of efficient vaccines and drugs. Today's hepatitis B vaccine was the first vaccine produced by gene technology.

Among the problems that still remain today are the inability to achieve a complete cure of chronic HBV infections, the recognition of occult HBV infections, their potential reactivation and the incomplete protection against escape mutants and heterologous HBV genotypes by HBV vaccines.

Author: Wolfram H Gerlich
Credits/Source: Virology Journal 2013, 10:239

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Top foods to keep your liver healthy

Pavitra Sampath, Jul 19, 2013 at 10:20 AM

The liver is one of the most important organs of the body. One of its most important functions involves breaking  down and disposing of toxic substances. In such a case if the released toxins are not expelled properly due to the inefficiency of the liver they are simply reabsorbed. These toxins can later lead to various severe complications including cancer. (Read: Why is the liver so important? )

There are certain vegetables that contain ingredients which help the liver secrete greater concentrations of important enzymes; in turn, these enzymes help to excrete potential carcinogens from the body.

What you should eat:

• Broccoli, onion and garlic are believed to provide sulfur to the body. Sulphur, helps  enhance the detoxifying reactions in the liver, and carry out processes that prevent its damage.
• Beetroot contains pectin which is very useful in flushing out the toxins from the liver, and does not allow them to be reabsorbed.
• Cabbage is known for its high levels of sodium, which help in proper disposal and detoxification of the liver.
• Carrots are rich in Niacin and beta carotene, they are great for the eyes and liver. The niacin helps the liver properly break down substances to release toxins, keeping it healthy and avoiding re-absorption of harmful substances.

What you should avoid:

• Highly processed foods with a large number of additives
• Food that is rich in hydrogenated oil
• Food with high content of fructose corn syrup, artificial sweetening agents
• Alcohol

So the next time you reach out for that bag of chips or that extra peg over the weekend, think again.

Read: Top 6 natural remedies to keep your liver healthy

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No link between neutropenia, infection during interferon-based therapy in HIV/HCV coinfection

Provided by Healio

Serrano-Villar S. Clin Infect Dis. 2013;57:458-464.

July 19, 2013

Patients with HIV and HCV who experience neutropenia during therapy with pegylated interferon and ribavirin are no more likely to develop infection than those who do not, according to recent results.

In a prospective cohort study, researchers evaluated 418 patients coinfected with HIV and chronic HCV who received treatment with peginterferon and ribavirin between 2000 and 2012. All patients either received 180 mcg weekly peginterferon alfa-2a or 1.5 mcg/kg peginterferon alfa-2b subcutaneously, along with weight-adjusted oral ribavirin. Infections requiring treatment discontinuation or hospitalization, or resulting in death, were classified as serious.

Infection occurred in 149 cases across 123 patients, for a rate of 3.8 infections per 100 person-weeks of treatment. Forty-seven percent of these were minor and involved the upper respiratory tract. Other common infections included skin and soft tissue (16%), ears/eyes/nose/throat (15%) and the GI tract (9%). No variables evaluated via multivariate analysis, including age, sex, AIDS status, cirrhosis, neutrophil count, use of antiretroviral therapy, CD4 count of the type of interferon treatment received, were significantly associated with infection risk.

Moderate neutropenia (fewer than 1,500 cells/mcL) occurred in 64.6% of cases, while 8.4% experienced severe neutropenia (fewer than 500 cells/mcL). More patients with neutropenia developed infection compared with those without neutropenia, but the difference was not significant (34.3% of severe cases and 32.5% of moderate cases vs. 22.5%; P=.067 for trend).

Serious infection occurred in 4.8% of cases. Prevalence of serious infection was numerically but not significantly greater among patients with severe neutropenia compared with nonsevere or no neutropenia (8.6% vs. 4.8% and 3.6%, respectively; P=.281 for trend). Multivariate analysis did not indicate a significant association between neutropenia and risk for serious infection.

“We … analyzed associated risk factors for infections complications during [peginterferon/ribavirin] treatment in the largest cohort of HIV/HCV coinfected subjects to date,” the researchers wrote. “Our results support previous data showing a lack of association with different risk factors, including neutropenia, and provide new insight by showing no relationship between severe neutropenia and the development of serious infections.”

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HCV decline associated with needle and syringe programs

Provided by Healio

Iversen J. Am J Public Health. 2013;103:1436-1444.

July 18, 2013

There was a significant reduction in hepatitis C incidence in Australia among injection drug users who attended needle and syringe programs, according to data published in the American Journal of Public Health.

“The decline in new cases of hepatitis C among people who inject drugs coincided with the expansion of programs like opioid substitution therapy and needle and syringe programs, which aim to minimize the spread of bloodborne viruses,” Jenny Iversen, a PhD candidate at the Kirby Institute at the University of New South Wales in Sydney, said in a press release. “We also found that fewer young people are starting to inject drugs and that the types of drugs people are injecting have changed, which may have contributed to a decline in the number of people contracting the virus.”

Iversen and colleagues conducted a passive retrospective study that included a cohort of 724 injection drug users who tested negative for HCV antibodies. The participants had been part of the annual Australian Needle and Syringe Programs Survey and had completed the survey for consecutive years or with only a 1-year gap from 1995 to 2010.

Among the 724 participants, 180 had HCV seroconversions, for a pooled incidence density of 17 per 100 person-years (95% CI, 14.68-19.66). The incidence density varied each year, peaking at 30.8 per 100 person-years in 2003 (95% CI, 21.3-44.6), then declining to 4 per 100 person-years in 2009 (95% CI, 1.3-12.3). In a multivariable analysis, independent predictors of HCV seroconversion included imprisonment in the previous 12 months, daily or more frequent injection, residence in mainland eastern Australia and injection of cocaine, heroin or other drugs, compared with injection of methamphetamine.

“These results demonstrate the value of ongoing investment in Australia’s internationally recognized system for the surveillance of HIV and hepatitis C among people who inject drugs,” Lisa Maher, PhD, head of the viral hepatitis epidemiology and prevention program at Kirby Institute, said in a press release. “This is the first time in the world this method has been used to estimate hepatitis C incidence and the first report of incidence in a national sample of people who inject drugs. It allows us to assess the uptake and impact of prevention and treatment interventions in this group.”

Disclosure: Iversen and Maher report no relevant financial disclosures.

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The Burden of Liver Disease Increases

ALEXANDRIA, Va., July 15, 2013 /PRNewswire/ -- According to a July 10, 2013 article published in the JAMA Journal of The American Medical Association, deaths from liver disease increased from 1990 to 2010. Liver disease also rose as a contributor to premature mortality. 

Cirrhosis -- damaged liver tissue and the loss of liver function due to a variety of liver diseases -- has risen substantially from the 14^th most frequent cause of death in 1990 to the 8^th most frequent cause of death in 2010. In the same time period, liver cancer went from the 39^th to the 30^th most frequent cause of death in the US. The prognosis of liver cancer is particularly poor with the medical community's limited ability to treat patients with liver cancer, with death most often occurring within six months. 

The most common causes of both cirrhosis and liver cancer are viral hepatitis, alcoholism, and obesity-related fatty liver disease. However, it is hepatitis C that is the most likely cause of the emergence of liver disease as a growing threat to American lives.

In May 2011, the Department of Health and Human Services released an action plan for the prevention, care, and treatment of viral hepatitis. Earlier this year, the Centers for Disease Control and Prevention recommended an age-based screening strategy that required a one-time test for hepatitis C for everyone born between 1945 and 1965. In June 2013, the US Preventive Services Task Force endorsed that recommendation by giving the one-time test of baby-boomers a "B" rating, which allows for payment by Medicare and private insurers for testing with no copayment by patients.

The American Association for the Study of Liver Diseases (AASLD) is a medical subspecialty society representing clinicians and researchers in liver disease. The work of our members has been at the forefront of liver transplantation and has laid the foundation for the development of drugs used to treat patients with viral hepatitis. The most recent generation of drugs approved by the FDA has been proven to cure hepatitis C.

Refinements in how those drugs are used will increase cure rates for hepatitis C, and we anticipate the FDA to approve numerous new drugs over the next three to five years that will provide more hope for patients with hepatitis C. The ability of a patient to be tested and treated for hepatitis C at the earliest possible date allows him or her to get treated and avoid the hepatitis C's progression to liver cancer.

Liver transplantation is expensive, the treatment for hepatitis C is both difficult and expensive, there is still a shortage of livers available for the number of patients waiting on the transplant list, and there are still too many Americans unaware of their hepatitis status -- 75 percent of the estimated 3 million US citizens with hepatitis C. However, policies and plans from the federal government linked to medical breakthroughs from the research community are creating the potential of a brighter future for patients with liver disease even as the burden of liver disease grows.

AASLD is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease. AASLD was founded in 1950 by a small group of leading liver specialists and has grown to an international society responsible for all aspects of hepatology.

Press releases and additional information about AASLD are available online at www.aasld.org.

Media Contact: Gregory Bologna
703/299-9766
gbologna@aasld.org

This release was issued through The Xpress Press News Service, merging e-mail and satellite distribution technologies to reach business analysts and media outlets worldwide. For more information, visit http://www.XpressPress.com.

SOURCE American Association for the Study of Liver Diseases (AASLD)

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http://www.aasld.org

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Plenty Of Room For Everyone In The Race To FDA Approval For New Hepatitis C Therapies

Jul 23 2013, 12:32 by: Three Knights Capital  |  includes: ABBV, BMY, ENTA, GILD, JNJ

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours

Business relationship disclosure: Disclaimer and Conflicts: Please read the Three Knights Capital (the publisher of this article) blanket disclaimer as it relates to all of our published articles and postings on Seeking Alpha ("SA") and as it relates to this article. Our disclaimer provides information, among other things, regarding, conflicts of interest that we may have. A link to the Three Knights Capital disclaimer is located on our SA profile page. We strongly urge you to read the disclaimer carefully.

The United States Preventive Services Task Force, or USPSTF, reversed its stance late on June 25 to conclude that all baby boomers - those people born between 1945 and 1965 - should be tested for hepatitis C. The USPSTF is an influential medical guidelines organization that advises Congress and, as its website reads, "makes recommendations about the effectiveness of specific preventive care services for patients without related signs or symptoms."

The recommendation of the USPSTF could lead to health insurance companies having to pay for screening under the revamped U.S. healthcare laws that start next year. It also could also lead to a lot more diagnoses of hepatitis C infections and a boon in sales for pharmaceutical companies. According to the Centers for Disease Control and Prevention, about 3.2 million Americans have the chronic version of the hepatitis C virus (HCV). Worldwide, it's estimated that more than 150 million people are infected with HCV, according to the World Health Organization.

HCV is a viral infection that can lead to swelling of the liver, cirrhosis, the need for transplant, and possibly even liver cancer. Today's standard of care is the injectable interferon, which is well documented to cause flu-like side effects. Because of the side effects and the method of delivery, new therapies that treat HCV more quickly are in great demand. Demand and potentially changing guidelines have planted several companies firmly on investors' radar.

A definite leader in the treatment of HCV is Gilead Sciences, Inc. (NASDAQ: GILD), with shares rising about 45 percent in 2013 as optimism for its oral HCV medication, sofosbuvir, are soaring. The drug is meant for use in combination with pegylated interferon and/or ribavirin, and represents what most consider the next generation of HPV therapies as an all-oral regime. Gilead's interferon-free ELECTRON trial of sofosbuvir demonstrated a strong response rate in patients with HCV genotypes 2 and 3 treated only with sofosbuvir and ribavirin.

Gilead, the world's biggest maker of HIV drugs, diversified into the HCV market by snagging the promising drug - and two other HCV drug candidates - in its $11.1-billion acquisition of Pharmasset, Inc. in November 2011. On June 10, the U.S. Food and Drug Administration granted Gilead priority review, following completion of Phase III clinical trials for the drug. Gilead is hoping for approval no later than early in December this year. S&P Capital IQ maintains a 5-STAR "Strong Buy" recommendation for Gilead.

Gilead may be leading the pack, but it is not alone in a race that will likely deliver billions of dollars in sales to the first to market. AbbVie (NYSE: ABBV) is nipping at Gilead's heels with its own all-oral, interferon-free treatment for HCV, with and without ribavirin. Much like sofosbuvir, AbbVie's HCV protease inhibitor ABT-450, in combination with other AbbVie drugs, produced strong response rates of greater than 90 percent in only a few months. ABT-450 was developed in a joint effort with Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA).

AbbVie's drugs, ABT-450/r, ABT-267 and ABT-333, have received the vaunted "Breakthrough Therapy" designation from the FDA. A "Breakthrough Therapy" designation from the FDA, a relatively new category from the FDA (initiated in 2012), is meant to expedite the regulatory process for drug candidates that may meet great areas of unmet medical need. To date, the FDA has received over 60 applications for "Breakthrough Therapy" designation, but only 15 have been awarded, with AbbVie commanding three of them with its HCV treatments.

Shares of ABBV have also lofted higher, rising about 27 percent in 2013, on bets that they can catch Gilead in the quest for FDA approval to market a new HCV treatment. The Breakthrough designation gives AbbVie an outside shot, but Gilead appears to still be out front in a very close contest.

Even if one or both win the thumbs-up from the FDA, there are a host of other companies running the regulatory gamut with HCV drugs that can certainly still benefit in the future. It's also notable that both AbbVie's and Gilead's treatments would likely include ribavirin, a drug that many patients have difficulty tolerating. Bristol-Myers Squibb (NYSE: BMY), developing a ribavirin- and interferon-free treatment, is certainly in the hunt. BMS already has Baraclude approved for the treatment of chronic hepatitis B and several ongoing clinical trials testing its antiviral cocktails. In May, the company completed a Phase III trial of BMS-790052 and BMS-650032 in Japanese HCV patients. Japan has recently unveiled plans under Prime Minister Shinzo Abe that are meant to raise the number of clinical applications by consolidating management of research money. To that end, it will be interesting to see where BMS goes with this research moving forward.

Shares of BMY have risen about 23 percent so far in 2013.

Johnson & Johnson's (NYSE: JNJ) oral HCV drug, simeprevir, received priority review from the FDA in May and has also delivered very promising clinical data. It's noteworthy that research has been conducted combining simeprevir with Gilead's sofosbuvir with compelling results. That's another point in recognizing that there can be more than one blockbuster drug in the massive HCV industry. Several of the drugs in development could eventually receive FDA approval and potentially be used together to treat patients.

Shares of JNJ are up about 29 percent in 2013.

This also means considering medical device manufacturers in the HCV business. Late in June, Aethlon Medical, Inc. (AEMD.OB), a maker of medical devices targeting unmet medical needs in cancer, infectious disease and more, got the green light from the FDA to commence a clinical trial evaluating its Hemopurifier® in end-stage renal disease patients (ESRD) infected with HCV.

The Hemopurifier is a first-in-class "blood filter" that targets the rapid elimination of infectious disease and cancer glycophathogens, removing the pathogen from the bloodstream. It allows for extracorporeal therapeutic delivery on standard CRRT and dialysis equipment currently used in hospitals and clinics globally. Specific to HCV, the Hemopurifier potentially could be used as an adjuvant to any type of therapy, whether it is interferon-based or the aforementioned oral antiviral regimes. Further, for patients that develop a drug resistance to any or all HCV treatments, the Hemopurifier could work independently to reduce viral load.

Trials conducted in India showed the Hemopurifier to be well tolerated in naïve HIV and HCV-infected ESRD patients while reducing viral loads in excess of 50 percent in both disease conditions. Follow-on studies in non-ESRD HCV patients treated with the Hemopurifier and interferon demonstrated an undetectable viral load in as little as seven days in genotype-1 patients, the hardest-to-treat patient population.

Successful completion of the 10-patient clinical trial could pave the way to a pivotal trial necessary for marketing clearance of the Hemopurifier as a new HCV treatment.

Shares of AEMD.OB are ahead 71 percent so far in 2013.

There has certainly been no shortage of buzz surrounding potential "cures" for hepatitis C, qualified by no detectable HCV viral load. Investors have been jumping into the companies mentioned based upon the lucrative revenue stream potential that surrounds the disease, helping drive valuations for each upward. Regardless of who garners approval from the FDA first, each company is bringing something substantial to the table that could provide an invaluable benefit to patients, giving each one significant headroom for growth.

Source

Splitting Donated Livers Shown to be Safe, Allowing Doctors to Save Two Lives from Single Organ

Donor organ allocation policy could be changed to nearly eliminate waitlist mortality for children —without additional risk to adult recipients.

BOSTON, July 17, 2013 /PRNewswire-USNewswire/ -- Split liver transplantation carries no increased risk of failure in either recipient, allowing surgeons to safely save two lives from a single donated organ (graft), according to new research from Boston Children's Hospital published online in the Journal of the American College of Surgeons. 

Due to their regenerative nature, livers donated by a deceased adult or adolescent can be surgically split into two unequally sized portions; the smaller segment is allocated to a young child awaiting transplant and the larger portion to an adult.

"Infants waiting for a donor liver have the highest waitlist mortality of all liver transplant candidates, and dozens of children die each year waiting for size-appropriate organs to become available," says Heung Bae Kim, MD, director of Boston Children's Hospital's Pediatric Transplant Center and lead author on the study. "If we can increase the number of split livers to just 200 a year, which would still affect less than four percent of the total number of livers transplanted each year, it would save virtually every small child waiting for a new liver."

Based on his recent findings, (which includes research on how well children function with split livers) Kim is advocating for changes in how donor livers are allocated—automatically placing infants and small children at the top of the liver waitlist, thereby giving pediatric transplant surgeons the option to split the first graft to become available. Once the liver has been split, the smaller portion is transplanted into a child and the larger portion is transplanted into the next appropriate adult on the list.

Analyzing United Network for Organ Sharing (UNOS) records, Boston Children's researchers looked at data compiled over a fifteen year period (1995-2010), studying the graft survival rates of 62,190 first-time adult deceased-donor liver transplant recipients, 889 of whom received partial grafts from a split liver transplant. The research shows that from 2002 forward the vast majority of adults who received a split graft experienced a risk of graft failure comparable to those who received a whole graft.

"After an extensive review of the data, it's clear that in the current era, with the exception of a small, very sick population of patients, adults who receive a split graft can expect to fare as well as those who received a whole organ," says Ryan Cauley, MD, MPH, first author on the paper. "Because risks once associated with this technique are now negligible, if a center has a patient waiting for a liver and it has access to a split graft, there's no reason not to accept it."

In addition to saving young patients, Kim's proposed amendments to the allocation process could take place without sweeping change, affecting only an extremely small portion of available grafts. "There are around 500 to 600 pediatric liver transplants done each year in the United States, with split liver transplant only accounting for 120 of the total number," Kim says. "By splitting just 80 more livers a year, it would make grafts available to virtually every small child on the waitlist. Given the current national debate on maximizing access to organs for children, it's my hope that implementing changes that would benefit children without harming adults would be considered favorably."

Boston Children's Hospital is home to the world's largest research enterprise based at a pediatric medical center, where its discoveries have benefited both children and adults since 1869. More than 1,100 scientists, including seven members of the National Academy of Sciences, 13 members of the Institute of Medicine and 14 members of the Howard Hughes Medical Institute comprise Boston Children's research community. Founded as a 20-bed hospital for children, Boston Children's today is a 395 bed comprehensive center for pediatric and adolescent health care grounded in the values of excellence in patient care and sensitivity to the complex needs and diversity of children and families. Boston Children's also is the primary pediatric teaching affiliate of Harvard Medical School. For more information about research and clinical innovation at Boston Children's, visit: http://vectorblog.org.

Contact:
Erin Tornatore
617-919-3110
erin.tornatore@childrens.harvard.edu

SOURCE Boston Children's Hospital

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

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Hepatitis is a silent epidemic that kills two people per minute throughout the world

PAHO/WHO urges everyone to become better informed about hepatitis, to get screened for the disease and to seek treatment, if needed

Washington, D.C., 23 July 2013 (PAHO/WHO) - Viral hepatitis affects some 424 million people throughout the world, killing 1.4 million per year as a result of complications such as acute liver failure, cirrhosis, or liver cancer. The disease is sometimes called a "silent epidemic" because most people who are infected are unaware of their status.

The theme of this year's World Hepatitis Day, July 28, is "This is the hepatitis. Know It. Confront it."  This year the Pan American Health Organization/World Health Organization (PAHO/WHO) is marking the day by calling on everyone to become better informed about hepatitis, to get screened for the disease and to seek treatment, if needed.

"People know very little about hepatitis, its potential severity, and its serious consequences for health and quality of life," said PAHO Director Carissa F. Etienne. "We therefore need to intensify our information, education and communication initiatives around this disease and take action to promote prevention and early detection so people can get the treatment they need."

Hepatitis is an inflammation of the liver generally caused by a viral infection. Five principal types of hepatitis virus are known: A, B, C, D and E, which can be transmitted through a variety of routes including unprotected sexual intercourse, unsafe injecting and piercing practices and through contaminated water or food. These cause infection and severe and chronic inflammation of the liver, which in turn can lead to cirrhosis and liver cancer. In the Americas, between 8 million and 11 million people suffer from chronic hepatitis B infection, and 7 million have chronic hepatitis C.

This disease puts a heavy burden on health-care systems because of the high cost of treatment. In many countries it is the main cause for liver transplants.

The fact that most people do not have symptoms-and tend not to have them for decades until they develop chronic liver disease-has contributed to the problem of poor diagnosis and inadequate treatment.

"The number of deaths throughout the world each year from causes associated with hepatitis is about equal to the number of traffic deaths, that is, more than two deaths every minute," said Rafael Mazin, PAHO/WHO senior advisor on HIV, sexually transmitted diseases, and hepatitis.

Hepatitis can be controlled with simple measures such as good hygiene, avoiding consumption of contaminated food and water, getting vaccinated for hepatitis B, practicing safe sex, and not sharing injection or piercing equipment.

PAHO/WHO has been collaborating with its Member States on strategies to prevent and control viral hepatitis. All the countries of Latin America and the Caribbean have officially introduced the hepatitis B vaccine into their child immunization programs, and more than 99% of donated blood units are screened for hepatitis B and C viruses

The Pan American Health Organization is also promoting hepatitis B vaccination of health workers and the expanded use of sterilized, disposable injecting, cutting and piercing tools and instruments to prevent cross infections (this includes needles used both in health facilities and in cosmetic procedures, such as tattooing).

WHO to launch global policy report

WHO will launch a new global policy report on prevention and control of viral hepatitis on July 24. The report presents the results of a survey examining the response of WHO Member States to the disease and provides information from 27 countries in the Americas.

The report's launch will take place at 6.30am (Washington DC time) at WHO headquarters in Geneva, Switzerland. Health authorities from Brazil will participate in the event and describe their country's efforts to increase access to treatment for hepatitis. Join the launch live via webinar. The report and other information can be found on the web.

PAHO is the oldest international public health organization in the world. It works with its Member States to improve the health and the quality of life of the people of the Americas. It also serves as the Regional Office for the Americas of WHO.

More information on hepatitis:

• Fact sheet
• Frequently asked questions
• Infographic
• WHO Global policy report on the prevention and control of viral hepatitis in WHO Member States

Links:

• PAHO/Hepatitis
• WHO/World Hepatitis Day
• World Hepatitis Alliance

Last Updated on Tuesday, 23 July 2013 13:52

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How to Save $200 Billion and Cure Hepatitis C

Peter Kolchinsky 7/22/13

Wall Street is buzzing with anticipation about the first new all-oral drugs for hepatitis C approaching the market. The high rate of HCV infection and dissatisfaction with current treatments have created a potential multi-billion dollar bonanza for drug companies. It’s estimated that Gilead, the frontrunner in this race, will charge as much as $90,000 per patient. With roughly 3 million infected patients currently in the U.S., that’s about $270 billion to cure everyone.

Is this necessary? Or even advisable? Particularly in the case of hepatitis C, payers, physicians, and patients can collaborate to extract huge price concessions from pharmaceutical companies, netting more than $200 billion in savings. All they have to do is acknowledge that sometimes “good enough” is better than “best.” I’m wagering they will, and that’s why my firm, RA Capital, has invested in Achillion Pharmaceuticals, which we believe will compete quite aggressively and effectively on price once they launch their HCV therapy in 2016.

Price competition is going to play a bigger and bigger role in containing healthcare cost, and HCV treatment is one area where such competition won’t have to come at the expense of patient welfare.

An estimated 150 million people are infected with hepatitis C worldwide. All current treatment regimens require long-term, weekly interferon injections with significant side effects. Many patients can’t tolerate those or just don’t want to bother with them. Because the disease progresses slowly, patients can and do wait for years for better treatment choices. Hence the mounting anticipation for the all-oral treatments.

Clearly, being first to market will be a plus. Both Gilead and AbbVie are likely to get approvals around the same time towards the fall of 2014. Gilead’s treatment also appears to deliver the highest cure rate (about 95 percent) and will comprise just a single pill daily for eight to twelve weeks. Abbvie’s regimen has a similar cure rate but requires taking a number of pills twice a day. By 2016, several other all-oral treatments are expected to be approved, including one from Bristol-Myers Squibb and another from Achillion, a small biotech.

Analysts are buzzing about the various characteristics of the new drugs and trying to determine which company has the advantage. All of these combo drug regimens are expected to provide cure rates of 85 percent or better, but there are slight differences in their side-effect profiles, pills per day, treatment duration and cure rates. By most accounts, Gilead offers the “best” treatment and is therefore expected to both charge top dollar and win a majority market share. Its stock has more than doubled in the last year to a $90 billion valuation on high expectations for hepatitis C drug sales.

In business-as-usual mode, U.S. payers would just throw open their wallets and pay whatever it costs to provide the “best” therapy to all the patients who could benefit. But once they start receiving the bills, payers and providers may begin singing a different tune.

Certainly, some patients with advanced disease will immediately require treatment with the “best” drug available. But many patients are still in the early stages of Hepatitis C and will feel no sense of urgency. With at least four competitive “good-enough” all-oral regimens on the market by 2016, payers could negotiate dramatically reduced prices, awarding the lowest bidder the privilege of selling the first line treatment. The small percent of patients who fail that regimen could then cycle onto the best and presumably most expensive one.

This approach is extremely simple and convenient for patients, compared to today’s regimens that can take up to a year and require injections with many side effects. Indeed, this is similar to the way doctors usually prescribe antibiotics, moving to the more expensive options only after the cheaper ones have been exhausted.

After all, every one of these drugs represents a huge improvement over current therapy. They are all “good enough” to cure most patients. And, assuming that the first-line drug could be negotiated down to as low as $10,000, each patient who responds to the cheapest drug (most will) would save the system as much as $80,000 compared to using the best drug first. By our calculations, the cumulative savings nationwide would be as much as $200 billion in the U.S. alone over the next decade. Similar savings await other nations.

Certainly companies deserve to be rewarded for tremendous breakthroughs like the new hepatitis C drugs. And many on Wall Street are incredulous that drug companies will lower their prices. Indeed, large pharmaceuticals companies don’t have a strong track record of offering deep discounts even in the face of significant competition. For example, there are many drugs approved for multiple sclerosis yet the prices for these only go up each year.

But hepatitis C is a big market and a certain type of company could still do quite well charging even $10,000 per patient. The 3 million patients in the U.S. alone could net $30 billion of sales, which might be modest for Gilead shareholders but would be a windfall for a company as small as Achillion, whose market capitalization is less than 1 percent of Gilead’s valuation. So even if having Gilead, AbbVie, and Bristol-Myers on the market is not enough to spark a price war by 2015, payers will likely get a discounted offer they can’t refuse from Achillion in early 2016.

To some, the idea of using merely “good enough” drugs will seem offensive. It’s a point of pride for Americans that patients come first and doctors have the freedom to prescribe the best regardless of cost. Even if this American healthcare fantasy were true, when the most expensive route to a cure is merely more convenient than the least expensive drug regimen, are those extra billions of dollars worth it? My bet is that private and public insurers will both be taking a much closer look at scenarios like this one, cutting wherever they can reap huge savings without harming patients.

Besides, if $90,000 were offered directly to patients, what would they chose? My guess is that most would buy the cheaper drugs, get cured for less, and put the massive savings towards countless other necessities.

If only reimbursement worked that way.

Hepatitis C has proven to be surprisingly easy to cure and we will soon see multiple “good enough” drugs on the market, which makes it easy for payers and providers to negotiate down prices on behalf of patients, employers, and taxpayers. Just as oncologists have started to push back against high drug prices, others will begin taking a stance against exorbitant spending, especially for mere convenience.

After all, our definition of “best” has left us with the priciest healthcare system in the world, but not always the best outcomes. HCV treatment is one textbook example of how mindlessly sticking to our old ways will have spectacularly expensive consequences.

Source

World Hepatitis Day 2013: Know it, Confront it

The Lancet Global Health, Early Online Publication, 22 July 2013

doi:10.1016/S2214-109X(13)70038-X Cite or Link Using DOI

Copyright © 2013 2013 Lazarus et al. Open Access article distributed under the terms of CC BY World Hepatitis Alliance Published by Elsevier Ltd. All rights reserved.

Jeffrey V Lazarus a, Charles Gore b, Tim Nguyen c, Kelly Safreed-Harmon a, Ida Sperle a, Raquel JJ Peck b, Hande Harmanci c, Stefan Wiktor c

Viral hepatitis has not received the level of attention that it warrants. However, the global picture began to change in May, 2010, when the World Health Assembly adopted its first resolution on viral hepatitis.1

Recent data clearly show the magnitude of the challenge. Hepatitis A and E together caused more than 34 million cases of illness in 2005.2 According to Global Burden of Disease3 estimates, 1·3 million deaths occurred in 2010 from diseases related to hepatitis B and C. To put this finding into context, malaria and HIV caused about 1·2 million and 1·5 million deaths in 2010, respectively.3 Much of the suffering caused by hepatitis is unnecessary. Safe and effective vaccines for hepatitis A and B are available. Hepatitis C is curable, and hepatitis B treatable. Improvements in sanitation, hygiene, and blood and injection safety can reduce the spread of viral hepatitis and many other diseases.

In 2012 WHO, in collaboration with the World Hepatitis Alliance, did the first worldwide survey to investigate how governments are addressing viral hepatitis.4 The findings will be released on July 28, 2013—World Hepatitis Day.1 126 of WHO's 194 member states submitted answers to the survey—a response rate of 64·9%. Slightly more than a third of the countries reported the existence of a national hepatitis strategy or plan. Less than half of respondents reported holding events for World Hepatitis Day 2012, and less than a third had funded any other type of hepatitis public awareness campaign in recent months. The survey also asked questions about surveillance, disease prevention measures, and policies and practices for screening, care, and treatment.4

The findings provide a crucial baseline against which progress can be measured in coming years. We hope that the report will also stimulate dialogue with respect to the roles of all stakeholders in forging a cohesive and effective response to viral hepatitis. For example, civil society organisations can help to strengthen and call attention to governmental responses to hepatitis, in line with their involvement in many other pressing health issues. The relatively high response rate for the survey is an affirmation of the global community's concern about viral hepatitis.

However, low response rates from the WHO African Region and Western Pacific Region suggest that some of those member states do not see viral hepatitis as a priority disease. Further, the fact that so few survey respondents reported having a national strategy or plan for viral hepatitis is alarming. Such documents provide foundations for strong national leadership to address the complex array of issues to improve prevention, treatment, and care.

Another component of an effective public health response is to raise awareness of hepatitis among the general public, policy makers, and health-care workers. Governments should commemorate World Hepatitis Day and promote other awareness-raising activities. The World Hepatitis Alliance has adopted the three wise monkeys motif (figure) for World Hepatitis Day to call attention to the widespread public ignorance surrounding viral hepatitis, which will not end unless policy makers show better leadership on this issue. The World Hepatitis Day slogan is: “This is hepatitis…Know it. Confront it.” We invite readers to ask themselves why, given its burden, viral hepatitis is absent from major global health initiatives.

Figure Full-size image (76K) World Hepatitis Alliance

The three wise monkeys call attention to how people block out the reality of viral hepatitis

TN, HH, and SW are staff members of WHO. The authors alone are responsible for the views expressed in this publication, and they do not necessarily represent the decisions or policies of WHO. We declare that we have no conflicts of interest.

References

1 WHO. Sixty-third World Health Assembly. WHA63.18 Viral hepatitis. Geneva: World Health Organization, 2010.

2 WHO. Prevention and control of viral hepatitis infection: framework for global action. Geneva: World Health Organization, 2012.

3 Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380: 2095-2128. Summary | Full Text | PDF(1201KB) | CrossRef | PubMed

4 WHO. Global report on the prevention and control of viral hepatitis in WHO member states. http://apps.who.int/iris/bitstream/10665/85397/1/9789241564632_eng.pdf. (available July 22, 2013).

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a Copenhagen HIV Programme, Copenhagen University, Copenhagen, DK-2100, Denmark

b World Hepatitis Alliance, London, UK

c World Health Organization, Geneva, Switzerland

Source

Sixth Annual World Hepatitis Day Takes Place on July 28

BOSTON, Mass.—Sunday, July 28 will mark the sixth annual World Hepatitis Day sponsored by the World Hepatitis Alliance in collaboration with the World Health Organization.

Local, national, and international organizations will hold events this week to raise awareness of viral hepatitis. AIDS Action Committee of Massachusetts will offer confidential information, referrals, and support about hepatitis from 9 a.m.-8 p.m. Monday through Thursday and from 9am-5pm on Friday. Call 800-235-2331 or email hotline@aac.org for more information.

“People can live with hepatitis for a decade or more before learning they have the disease, which greatly complicates their eventual treatment and increases the costs of care,” said Rebecca Haag, President & CEO of AIDS Action Committee of Massachusetts, a convening member of the Massachusetts Viral Hepatitis Coalition. “If we don’t slow the infection rate and improve treatment outcomes, the state’s costs for treating people with hepatitis—which is often called the ‘silent epidemic’ because people can live with hepatitis for more than a decade without symptoms—will continue to increase. One of the first things we need to do is to raise awareness of what viral hepatitis is and the devastating impact it is having on the public’s health.” 

“People can live with hepatitis for a decade or more before learning they have the disease, which greatly complicates their eventual treatment and increases the costs of care,” said Rebecca Haag, President & CEO of AIDS Action Committee.

A new report released this year by the State Healthcare Access Research Project (SHARP) and prepared by The Center for Health Law and Policy Innovation of Harvard Law School, the Treatment Access Expansion Project, and the Massachusetts Viral Hepatitis Coalition found the average age of death between 1992 and 2009 of those in Massachusetts who had been previously diagnosed with hepatitis C was 53 with the cause of death being either hepatitis C or other causes. Seventy-three percent died within five years of receiving their diagnosis of hepatitis C. During the same period, the average age of death from all causes of those who were not infected with hepatitis C was 75. The report concludes that “many people with [hepatitis C] may be getting diagnosed and entering care late in their illness.”

Facts About Viral Hepatitis

• Viral hepatitis causes inflammation of the liver which can lead to cirrhosis and increased risk of liver cancer.
• There are an estimated 110,000 people living with viral hepatitis in Massachusetts today with between 7,000 to 10,000 new diagnoses annually.
• 14 percent of those living with HIV/AIDS are co-infected with hepatitis C.
• Viral hepatitis is spread in the same manner as HIV, but is much more highly infectious and easily transmitted from one person to another.
• Between 2002 and 2009, the rate of infection among teens and young adults age 15-24 increased 74%, largely driven by the shared use of injection drug equipment.
• In 2008, the number of US deaths attributed to hepatitis (15,768) surpassed, for the first time, the number of deaths due to HIV/AIDS (11,924).

AIDS Action provides on-going outreach, education, and prevention services to those living with viral hepatitis and at risk of contracting hepatitis C in several critical ways:

• Running a monthly support group for people living with hepatitis C
• Providing easy access to PharmaHealth, a hepatitis C specialty pharmacy located in our Jamaica Plain office;
• Providing one-on-one education at our drop-in centers in Jamaica Plain, Cambridge, and Lynn to those at-risk and infected with hepatitis C;
• Operating two needle and sterile injection equipment exchanges, one in Boston and one in Cambridge;
• Making information about hepatitis freely available to providers, researchers, policy analysts, lawmakers, and the general public via the Health Library and a telephone hotline (888-443-HEPC (4372);
• Referring those newly diagnosed with hepatitis C to medical care and providing the support necessary to keep them connected with care
• Advocating for increased public funding to conduct outreach, education, and prevention to those vulnerable to infection with viral hepatitis, and encouraging those born between 1945 and 1965 to get tested for hepatitis C;
• Convening the Massachusetts Viral Hepatitis Coalition

About AIDS Action Committee of Massachusetts

AIDS Action Committee of Massachusetts is the state’s leading provider of prevention and wellness services for people vulnerable to HIV infection. It provides services to one in six people in Massachusetts living with an HIV diagnosis. These services include HIV counseling and testing; needle exchange; mental health counseling; housing assistance; and legal services. AIDS Action works to prevent new HIV infections, support those affected by HIV, and tackle the root causes of HIV/AIDS by educating the public and health professionals about HIV prevention and care; and advocating for fair and effective HIV/AIDS policy at the city, state, and federal levels. Founded in 1983, AIDS Action Committee of Massachusetts is New England’s first and largest AIDS service organization. Learn more at www.aac.org.

[From a News Release]

Source

World Hepatitis Day, 28 July 2013

This is hepatitis. Know it. Confront it

Every year on 28 July, WHO and partners mark World Hepatitis Day to increase the awareness and understanding of viral hepatitis and the diseases that it causes.

Hepatitis viruses A, B, C, D and E can cause acute and chronic infection and inflammation of the liver that can lead to cirrhosis and liver cancer. These viruses constitute a major global health risk with around 240 million people being chronically infected with hepatitis B and around 150 million people chronically infected with hepatitis C.

For 2013, the overall theme continues to be "This is hepatitis. Know it. Confront it." The campaign emphasizes the fact that hepatitis remains largely unknown as a health threat in much of the world.

Goal: moving from awareness to commitment and action to address the "silent epidemic" of viral hepatitis

Millions of people are living with viral hepatitis and millions more are at risk of becoming infected. Most people with chronic infection with hepatitis B or C are unaware that they continue to carry the virus. They are therefore at high risk of developing severe chronic liver disease and can unknowingly transmit the virus to other people. Approximately one million people die each year from causes related to viral hepatitis, most commonly cirrhosis and liver cancer.

World Hepatitis Day provides an opportunity to focus on specific actions, such as:

• strengthening prevention, screening and control of viral hepatitis and its related diseases;
• increasing hepatitis B vaccine coverage and integration of the vaccine into national immunization programmes;
• coordinating a global response to viral hepatitis.

Although the burden of disease related to hepatitis infection is very high, in most countries, the problem has not been addressed in a comprehensive way for many reasons. These include the fact that most people do not develop any symptoms when they become infected and that they remain free of symptoms often for decades until they develop chronic liver disease. This has largely resulted in "the silent epidemic" we are experiencing today.

Viral hepatitis also places a heavy burden on the health-care system because of the high costs of treatment of liver cancer and liver failure from cirrhosis. In many countries, liver failure from viral hepatitis is the leading reason for liver transplants. Such end-stage treatments are expensive, easily costing up to hundreds of thousands of dollars per person.

The date of 28 July was chosen for World Hepatitis Day in honour of the birthday of Nobel Laureate Professor Baruch Samuel Blumberg, discoverer of the hepatitis B virus.

Related links

• Fact sheets on hepatitis
• WHO's work on hepatitis
• More on hepatitis

Source