End this neglect of viral hepatitis

Viral hepatitis is a major cause of global mortality, yet the MDGs don't mention it at all. Photograph: Graham Turner for the Guardian

With mortality rates comparable to HIV/Aids, TB and malaria, is it time the global health community addressed viral hepatitis with the urgency it needs?

Charles Gore

Guardian Professional, Friday 9 August 2013 06.02 EDT

In December 2012 the global burden of disease project released its mortality data for 2010. It reported that viral hepatitis caused 1,445,000 deaths. This compares with 1,465,000 from HIV/Aids, 1,196,000 from TB and 1,169,000 from malaria. And this is not some new phenomenon suddenly emerging from nowhere.

Viral hepatitis mortality in 1990 was just under 1m. Given those figures and the relative profile and priority of the diseases, it is clear that a major cause of global mortality has been consistently overlooked and neglected. For example, hepatitis does not feature in the MDGs, despite its prevalence in many developing countries in Asia and Africa. Nor are treatment and prevention programmes financed though the global fund.

Before people living with hepatitis took action in 2008 there was not a single person in the WHO with 'hepatitis' in their job title. How was that possible in the face of such a global burden?

There has been some recent progress in persuading governments to develop national hepatitis strategies, andadopting the 2010 WHO resolution.

Prior to 2008 no-one had looked at viral hepatitis, not least because the viruses that cause it are different, making messaging complex, and because they cut across many parts of a health ministry; for example immunisation, HIV, food and water safety, blood safety, injection safety and cancer. Yet in a world increasingly sceptical of vertical programmes, this is an advantage because a comprehensive hepatitis policy looks much more like a programme to strengthen the whole health system. Equally, because most of these areas will have their own programmes, any hepatitis programme will need to be integrated, leveraging existing infrastructure.

A WHO global policy report on prevention and control of viral hepatitis in member states, published on 28 July, over half the countries that reported having a national hepatitis strategy said it was integrated into other areas.

This is particularly pertinent in the case of HIV where there are overlapping populations and risk factors. On top of that, about 10% of those with HIV also have chronic hepatitis B and 3 to 4m (10-15%) with hepatitis C. What is the point of investing billions of dollars to prevent people dying of HIV/Aids only to let them die of liver disease? Hepatitis co-infection is now part of Unitaid's 2013-16 strategic plan.

The historic neglect of viral hepatitis was also the key reason that the 2010 resolution was adopted. Although there were only six official WHO days at the time, there are so many semi-official ones like World Cancer Day that there was initial reluctance to adopt World Hepatitis Day. However, countries were persuaded that viral hepatitis was an exceptional case as in no other area was the difference between the size of the problem (enormous) and the level of awareness (negligible) so great.

However, since the adoption of the resolution in 2010 the global health landscape has shifted and this has required hepatitis advocacy to move too. Just as hepatitis was getting recognition as the fourth major communicable disease, attention started to focus on non-communicable diseases.

But this too is an opportunity: viral hepatitis is responsible for 78% of primary liver cancer and liver cancer is globally the fifth most important cause of cancer mortality in men (first in Africa) and sixth in women (third in Africa) so hepatitis prevention and control is also a significant contributor to cancer and hence non-communicable disease prevention and control.

Advocacy is working and viral hepatitis is on the agenda for the world health assembly in 2014. A new, far stronger resolution is likely. But one of the biggest challenges lies just ahead. The post-2015 sustainable development goals are under discussion. If HIV/Aids, TB and malaria are included, for example as indicators in the health goal, but viral hepatitis is not, it will be a huge setback.

The omission of viral hepatitis from all major global health initiatives to date has massively impeded the flow of resources. Getting hepatitis into the post-2015 goals should be easy if HIV/Aids is there – indeed advocating for hepatitis generally should be easy – because the new global burden of disease numbers speak for themselves. But it isn't. Too much of health prioritisation is decided by what one might call fashion and so often fashion is about timing. Hepatitis has never been in fashion. Maybe finally the time is right.

Charles Gore is the president of World Hepatitis Alliance. He tweets at @Hep_Alliance

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Joan Block of Hepatitis B Foundation Honored by Viral Hepatitis Action Coalition of CDC Foundation

Release Date: 2013-08-08
Category: Medicine

Bucks County executive honored for national advocacy on behalf of healthcare workers and medical students fighting against discrimination

FOR IMMEDIATE RELEASE / PRURGENT

On July 25, World Hepatitis Day, the Viral Hepatitis Action Coalition of the Centers for Disease Control (CDC) Foundation honored Joan M. Block, RN, BSN, executive director of the Hepatitis B Foundation for bringing incidents of discrimination of hepatitis B-infected healthcare workers and medical students to the attention of the U.S. government. Also honored was Anna S. Lok, M.D., F.R.C.P., director of Clinical Hepatology at the University of Michigan Health System, with whom Block has worked for many years in counseling HBV-infected students, and together they approached the CDC’s Division of Viral Hepatitis (DVH) for help. As a result of their combined efforts, hepatitis B is now an officially recognized disability protected under the Americans with Disabilities Act.

“With the help of many people and organizations such as the Department of Justice, we are very pleased that hepatitis B is now a recognized disability. It is important that healthcare providers and medical students who have been diagnosed with hepatitis B do not face discrimination,” said Block. “As we continue to devote time and research to combating this disease, it is wonderful to receive recognition for our strides. I accept the award on behalf of the Hepatitis B Foundation and the people we serve.”

Established by Joan and her husband Timothy M. Block, Ph.D., along with Paul and Jan Witte in 1991, the Hepatitis B Foundation is the only national nonprofit organization solely dedicated to finding a cure for hepatitis B. In 1992, they sought the help of Dr. Baruch Blumberg, who won the Nobel Prize for his discovery of the hepatitis B virus, and with his active support, the Foundation grew from a grassroots effort into a national nonprofit research and disease advocacy organization with a global reach. Today, it funds one of the largest concentrations of hepatitis B scientists in the world and reaches millions of people in more than 180 countries each year.

As a nurse, Block has always been committed to caring for patients and making sure that the healthcare system worked to their benefit. Today, her commitment extends to creating and leading the hepatitis B Foundation’s outreach, public health and national advocacy programs to help improve the lives of those affected by the disease worldwide. Dr. Timothy Block leads the Foundation’s research institute that is searching for a cure and developing early detection biomarkers for cirrhosis and liver cancer.

Block serves on the boards of the Hepatitis B Foundation, Institute for Hepatitis and Virus Research and the Medical Advisory Boards of Parents of Kids with Infectious Diseases and HIV Project Prevent. She is co-founder and co-chair of Hep B United, a national coalition; member of the National Hepatitis B Task Force, Hepatitis B Expert Panel of the Office of Minority Health and National Viral Hepatitis Roundtable. She has served as a national board member of the American Liver Foundation. Her clinical experiences encompass pediatric oncology, adult cardiac care and nursing education.

Hepatitis B is the most common serious liver infection and the primary cause of liver cancer worldwide. Two billion people have been infected with the hepatitis B virus (one out of three) and 400 million are chronically infected. Each year, 1 million people die prematurely from hepatitis B-related liver disease and liver cancer. In the U.S., an estimated 2 million Americans are chronically infected with hepatitis B – that is one in 20. The good news is that hepatitis B is preventable and treatable. However, for the 400 million people living with chronic hepatitis B infections, there is still no complete cure.

About the Hepatitis B Foundation: Located in Doylestown, Pa., the Hepatitis B Foundation is the only national nonprofit organization solely dedicated to finding a cure for hepatitis B and improving the quality of life for those affected worldwide through research, education and patient advocacy. To learn more, go to www.hepb.org, read the blog at http://wp.hepb.org, follow the Foundation on Twitter @HepBFoundation and Facebook at www.facebook.com/hepbfoundation or call (215) 489-4900.

Contact Info
Rose Strong
2 Hidden Lane
Doylestown, PA 18901
Phone: 215-340-0480
Website: http://www.furiarubel.com

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HCV viremic, aviremic individuals at risk for CKD

Provided by Healio

Lucas GM. J Infect Dis. 2013;doi:10.1093/infdis/jit373.

August 8, 2013

Among people with HIV, those who were viremic and aviremic for hepatitis C were at increased risk for chronic kidney disease, compared with patients who were seronegative for the virus, researchers from Johns Hopkins University have found.

“Approximately 20% of individuals who are infected with HCV clear the viremia, although the rate of HCV clearance is lower in HIV-infected persons,” the researchers wrote in the Journal of Infectious Diseases. “To explore the contribution of persistent HCV viremia on CKD risk, we compared CKD incidence in a large cohort of HIV-infected subjects in North America according to HCV exposure status.”

The study included 52,602 HCV seronegative individuals, 9,508 individuals with detectable HCV viremia (viremic) and 913 individuals who were HCV seropositive with undetectable viremia (aviremic). All were part of the North American AIDS Cohort Collaboration on Research and Design.

HCV viremic individuals were at increased risk for stage 3 CKD (adjusted HR=1.36; 95% CI, 1.26-1.46) stage 5 CKD (aHR=1.95; 95% CI, 1.64-2.31) and progressive CKD (aHR=1.31; 95% CI 1.19-1.44) compared with HCV seronegative individuals. HCV aviremic individuals also were at increased risk for stage 3 CKD (aHR=1.19; 95% CI, 0.98-1.45), stage 5 CKD (aHR=1.69; 95% CI, 1.07=2.65) and progressive CKD (aHR=1.31; 95% CI, 1.02-1.68). The risk was similar for both HCV viremic and aviremic individuals.

“The mechanism behind increased CKD risk in HCV aviremic subjects is unclear, but may include confounding effects from drug use, poorer control of HIV infection, lower socioeconomic status, or other unidentified factors,” the researchers wrote.

Disclosure: The researchers report no relevant financial disclosures.

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Fight for C Hepatitis treatment in full force

By Irma Kakhurashvili

8.08.2013

It is several kilometers from Tbilisi to Gori. Gori is a small city where activists fighting Hepatitis C. Among the activists there are representatives of several non-governmental organizations that are part of the Georgian Harm Reduction Network, as well as representatives of Medecins du Monde – France Representation in Georgia and Open Society Georgia Foundation. I am together with them as well, wearing a yellow T-shirt with “C Does Not Wait” in big letters and this is the bitter reality. Several of my friends as well as up to 200,000 citizens of Georgia are suffering from Hepatitis C. They do not have much time left if they do not undergo timely treatment.

Compared to many other countries in the world, Hepatitis C treatment in Georgia is very expensive. For the majority it is unaffordable. Reducing artificially increased prices on medicines – this is one of the main messages of our action, which should be voiced during the two-day tour of the international week for fighting Hepatitis C.

After Gori, the wave of yellow T-shirts will arrive in Kutaisi and Zugdidi and end on Batumi Boulevard with a concert.

There is the hope that the problem of hepatitis C treatment will be resolved in the nearest future. Starting from autumn 2013, the Ministry of Corrections will launch the Program of Prevention, Diagnostics and Treatment of Hepatitis C for the first time. Eighteen percent of deaths in prisons are due to cirrhosis caused by Hepatitis C. 6 million Gel are needed for implementation of this program.

Until 2016 the program will expand and ensure universal accessibility of treatment for everyone, including my friends who had been trying to interest Georgian politicians in the issue with the help of foreign donors for years.

It seems that their goal has almost been achieved – the government realizes its political obligation on treatment of the patients. Now the most important thing is to conduct successful dialogue with the pharmaceutical companies and reduce the prices for treatment.

Close-up of the challenge

According to the World Health Organization, 180 million people all over the world, which makes-up 3 percent of the entire population of the earth, are infected with C Hepatitis. Every year 1.5 million people die of B or C Hepatitis. The number of hepatitis patients is 10 times greater than HIV/AIDS patients. And the majority of them do not know about the disease.

In Eastern Europe and Central Asia, Georgia has the highest rate of hepatitis C and the lowest accessibility for treatment.

Out of the six genotypes of hepatitis C, the first three are spread in Georgia. During the second and third genotypes, after six months of treatment, there is a 60-80 percent probability of recovery. As for the first genotype, after a year of treatment, there is a 40-50 percent probability of recovery.

Diagnosis of hepatitis C in Georgia costs 1,600 Gel, a 48 week course of treatment costs up to 27,000 Gel. Until now, only 2,000 people have managed to receive treatment with their own funds. The Georgian government induced by civil society and groups of patients is holding negotiations with monopolist pharmaceutical companies producing interferon – Merck and Roche.

State office representatives said that prices on medicines should be reduced at least four times from what it is now. According to the Ministry of Health data, currently 47,500 patients need urgent treatment. Based on preliminary calculations, the cost of treating these patients is 98 million Gel.

Recently, loud demonstrations were held at the representations of Merck and Roche pharmaceutical companies in Georgia. Before that roundtables were arranged. Activists say that these companies should not put the lives of people behind commercial profits, especially in a country where “there is a catastrophic situation with regards to Hepatitis C.”

Members attending the event in Gori think that despite the fact that there is the political will, it is necessary for civil society to realize the problem of Hepatitis C. Involvement of civil society in advocating the issue is of great importance.

Activists visiting Gori were joined by local NGOs and residents. The small action in front of the City Hall ended peacefully and the action members left for Kutaisi where another action will take place in front of the parliament, attracting the attention of Kutaisi media.

Zugdidi showed solidarity to the activists fighting against Hepatitis C. A thematic flash-mob is held there demanding accessibility of treatment. People take interest in informational booklets distributed by the activists. The situation in the region in terms of spreading Hepatitis is quite hard.

On the next day, the activists move to the rainy streets of Batumi and divided in groups hold mini informational campaigns in crowded places– cafes, cinemas, shops, beauty salons etc. I enroll in the action so actively that I almost forget my professional duties.

Despite bad weather, Batumi residents and guests of Adjara gather in the boulevard at Alphabet Tower to hold a free concert within the frames of the “C Does Not Wait” campaign. The concert has many listeners. Now more people know what Hepatitis C is and the scale of the epidemic in the country.

Editor’s note: This article has been produced within the frames of the European Union funded project: “Harm Reduction - an oppression or the evidence based interventions: promoting empowerment, awareness and informed policy responses in Georgia” implemented by the Georgian Harm Reduction Network. The project is co-financed by Medecins du Monde- France Representation in Georgia. The contents of the article are the sole responsibility of the author and can under no circumstances be regarded as reflecting the position of the European Union.

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Multiple Tactics Needed to Combat Hepatitis C in Young Drug Users

Provided by Pharmacy Times

Aimee Simone, Assistant Editor

Published Online: Wednesday, August 7, 2013

With hepatitis C infections on the rise among young injection drug users, researchers have recommended a range of promising prevention tactics.

The number of young adults infected with the hepatitis C virus (HCV) is on the rise, and researchers estimate that more than 31,000 young injection drug users could become infected each year in the United States. To help reduce the rate of HCV infection in young drug users, the authors of a new review suggest 6 strategies to prevent the spread of the virus.

The recommendations, published in an August 15, 2013, supplement to Clinical Infectious Diseases, are based primarily on evidence from the large, ongoing “U Find Out” (UFO) study. The study, which began in 2000, enrolls HCV-negative injection drug users younger than 30 in San Francisco, California, and keeps track of the rate of new infections. This data, coupled with results of additional studies, has helped researchers identify a range of promising HCV prevention tactics.

The first suggestion focuses on the reduction of shared drug equipment. A meta-analysis of 21 studies found that the risk of contracting HCV from shared use of drug preparation containers, filters, and rinse water was similar to the risk of infection associated with sharing syringes. If drug preparation equipment sharing were eliminated, the results indicated, a large portion of HCV infections could be prevented. The authors of the current review note that education, training, and increasing the availability of single-use supplies are necessary to prevent new HCV infections.

Although little research has been done to evaluate the efficacy of safety education in injectors, the review authors next suggest that testing and counseling populations at risk for HCV may reduce risky behavior as well as the spread of the virus. In the UFO study, researchers found that drug injectors reduced their alcohol intake and used less non-injection drugs within 6 months of receiving HCV-positive test results, indicating that testing may reduce risky behaviors. The authors are optimistic that the availability of rapid HCV point-of-care tests, recently approved by the FDA, may increase rates of HCV testing, diagnosing, and treatment.

The third tactic recommended by the authors is to develop intervention strategies at a relationship level, as drug use is often a social activity. The UFO study indicates that injectors in sexual relationships with other injectors are more likely to share needles with their partners and, therefore, are at heightened risk of HCV infection. Given the results of a recent study that showed that couple-based testing and counseling effectively reduced risky behaviors in injectors, the authors note that researchers should assess the impact of these interventions on HCV outcomes.

The reviewers next recommend an increase in injection cessation interventions. Evidence from the UFO study suggests that even temporary injection cessation helps prevent HCV infections. The authors note that encouraging injectors to quit, even after multiple failed attempts, may prevent the spread of HCV infections and increase the number of users who quit permanently.

The fifth strategy, based on mathematical models, is to increase needle distribution, expand HCV treatment, and continue to research and develop vaccines against HCV. Researchers modeled the effects of syringe availability on HIV and HCV prevalence among drug injectors in Australia and estimated that increasing the number of needles distributed each year in the United States from 30 million to 60 million could potentially cut the number of new HCV infections in half.

Finally, the authors suggest the adoption of programs combining multiple prevention strategies. The results of a study conducted in the United Kingdom suggested that high coverage of opioid substitution treatment combined with syringe distribution programs could reduce the risk of new HCV infections by up to 80%. Combined prevention methods were also shown to be significantly more effective in reducing HCV rates than a single method in 2 separate studies.

Although the authors have identified strategies they believe will help reduce the spread of HCV, they note that political backing and additional resources will be needed to implement these tactics and to overcome the many obstacles to reducing the infection rate in young injectors.

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First Patient Treated with Civacir® after Hepatitis C Induced Liver Transplantation in Biotest's Phase III Clinical Trial

PRESS RELEASE

Aug. 7, 2013, 10:18 a.m. EDT

- 50% of liver transplantations are due to hepatitis C infection - High unmet medical need: Prevention of hepatitis C virus recurrence in liver transplant - Civacir has received an Orphan Drug designation in both the US and the EU

BOCA RATON, Fla. and DREIEICH, Germany, Aug. 7, 2013 /PRNewswire via COMTEX/ -- Biotest AG has achieved another milestone in the development of intravenous hyperimmune globulins. After treatment with virostatics over several weeks, the first patient underwent liver transplantation and subsequently was treated with the Civacir in the Phase III clinical trial. Civacir, a 10 % hepatitis C hyperimmune globulin developed and produced at Biotest Pharmaceuticals Corporation, a wholly owned subsidiary of Biotest AG, is being used in a clinical trial in North America in patients undergoing liver transplantation as a consequence of Hepatitis C infection.

End-stage liver disease due to hepatitis C virus (HCV) is a common indication for liver transplantation. However, newly transplanted livers are rapidly infected by any HCV viruses which are still circulating in the patient's body, resulting in a reinfection rate of around 80 % within 4 weeks after transplantation. Currently, there is no approved treatment available to prevent recurrence of the HCV virus after surgery since current antiviral regimens cannot be safely used after surgery due to toxicities, tolerability issues and drug-drug interactions within the first months after transplantation. Approximately 30% of these patients require a second liver transplant within 5 years.

The aim of this Phase III clinical trial (Study 988) is to evaluate the efficacy and safety as well as the pharmacokinetics of the agent in the HCV transplant population. Study 988 is being conducted at sites in the US and Canada, with a total of up to 90 patients to be enrolled.

Market exclusivity for 7 and 10 years after approval in the US and EU, respectively, is ensured by the Orphan Drug designation.

About Biotest AGBiotest is a provider of pharmaceutical and biotherapeutic drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialized primarily in the areas of application of clinical immunology, hematology and intensive medicine. In its Plasma Protein portfolio Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and hematopoietic systems. Biotest also researches into the clinical development of monoclonal antibodies, including in the indications of rheumatoid arthritis and cancer of plasma cells. Biotest has more than 1.600 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

About Biotest Pharmaceuticals CorporationBiotest Pharmaceuticals Corporation, a wholly owned subsidiary of Biotest AG, researches, develops and manufactures biotherapeutic products with a specialization in immunology and hematology. BPC is a leader in the collection of source plasma and is currently involved in the development of plasma protein products and various hyperimmune (IG) products. The Company owns and manages twelve plasmapherisis centers across the United States and a state-of-the-art manufacturing facility in Boca Raton, Florida. The Company employs more than 700 people in the U.S.

DisclaimerThis document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

SOURCE Biotest Pharmaceuticals Corporation

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Benitec's hepatitis C therapeutic selected for oral presentation at AASLD conference and TT 034 program

Sydney Australia, 5 August 2013: Benitec Biopharma Limited (ASX Code: BLT), today announced that its ddRNAi-based gene silencing program for hepatitis C (HCV) has been selected for an oral presentation at the November 2013 meeting of the American Association for the Study of Liver Disorders (AASLD) being held in Washington DC. This meeting, The Liver Meeting®, is a pre-eminent worldwide conference for researchers working in the area of liver diseases.

In the session featuring "New Agents for HCV Therapeutics", Benitec has been selected to provide an oral presentation on TT-034, its novel gene silencing therapeutic. TT-034, which is expected to enter a first-in-man Phase I/II clinical trial later this year, has the potential to be a one-shot cure for chronic HCV.

The company's Senior Vice President R&D, Dr. David Suhy, who will deliver the presentation, commented: "We are excited to be selected for an oral presentation at this prestigious meeting. This is a strong indication that our program is of significant interest to the liver disease community."

Benitec also announces that the US Food and Drug Administration (FDA) has advised the company that it does not see the need for a final pre-investigational new drug (IND) meeting for the TT-034 program, allowing the Company to finalise its IND. Clinical trials are able to commence 30 days after the application is filed with, and subsequently accepted, by the FDA.

For more information please contact: Dr Peter French | Chief Executive Officer Phone: +61 (02) 9555 6986
pfrench@benitec.com | www.benitec.com

About TT-034: TT-034 is a potentially transformative therapeutic that is intended to provide a "one-shot-cure" for hepatitis C with a single injection. Preclinical studies have shown that the vector used to deliver TT-034 specifically targets liver cells where it transfects almost every cell without causing toxic effects. TT-034 is designed to prevent development of viral resistance (a major problem for most hepatitis C drugs) by simultaneously silencing three separate highly conserved regions on the virus genome. Studies have demonstrated that a single treatment of TT-034 is active out to 180 days (the duration of the studies).

About Benitec Biopharma Limited: Benitec Biopharma Limited is an ASX-listed biotechnology company (ASX Code: BLT) based in Sydney, Australia. The company has a pipeline of in-house and partnered therapeutic programs based on its patented gene-silencing technology, ddRNAi. Benitec is developing treatments for chronic and life- threatening human conditions such as hepatitis C, hepatitis B, wet age-related macular degeneration, cancer- associated pain, drug resistant lung cancer and oculopharyngeal muscular dystrophy based on this technology. In addition, Benitec has licensed ddRNAi technology to other biopharmaceutical companies who are progressing their programs towards the clinic for applications including HIV/AIDS, retinitis pigmentosa and Huntington's disease. For more information on Benitec refer to the Company's website at www.benitec.com.

Source: Benitec Biopharma Limited

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Three-Quarters of HCV Patients Who Have Previously Failed Treatment and Two-Thirds of Treatment-Naive HCV Patients are Unlikely to Initiate Treatment with a Currently Available Regimen Within the Next Year

A Recent Audit of Patient Records Finds That Physicians are Foregoing Treatment of Their HCV Patients Until New Agents Become Available, According to a New Report from BioTrends Research Group

EXTON, Pa., Aug. 6, 2013 /PRNewswire/ -- BioTrends Research Group, one of the world's leading research and advisory firms for specialized biopharmaceutical issues, finds that three-quarters of patients who have failed prior regimens, regardless of genotype, are not likely to re-treat their chronic hepatitis C virus (HCV) infection with a currently available regimen within the next year. Managing physicians cite that over half will forego re-treatment in the next year because they are waiting for new products currently in development to become available. 

(Logo: http://photos.prnewswire.com/prnh/20130103/MM36805LOGO)

The ChartTrends^®: Hepatitis C Virus (US) report also finds that two-thirds of treatment-naive patients, regardless of genotype, are not likely to initiate treatment with a currently available regimen within the next year.  The most common reason for genotype 1 treatment-naive patients to forego treatment, according to their managing physicians, is because they are waiting for interferon-free products in development to become available, while mild progression of disease and/or little to no liver involvement are contributing factors for delaying treatment among genotype 2/3 treatment-naive patients.

"Although many patients are waiting to treat their HCV infection, one-quarter of the patients who have previously failed treatment and one-third of treatment-naive patients are likely to begin treatment within the next year with a currently available regimen," said BioTrends Research Group Associate Director Lynn Price. "Among patients who are likely to initiate treatment in the next year, 54 to 64 percent are expected to initiate a triple therapy regimen with Vertex's Incivek, while only 16 to 26 percent are estimated likely to be treated/re-treated with a regimen containing Merck's Victrelis."

The recently published report also finds that the vast majority of genotype 1 patients currently on active triple therapy, regardless of the protease inhibitor brand, have achieved early and rapid virological responses since beginning their treatment. Furthermore, nearly 80 percent of genotype 1 patients who have recently completed triple therapy, regardless of the protease inhibitor brand, have achieved a sustained virological response, four to five months post-completion of their regimen.  

ChartTrends^®: Hepatitis C Virus (US) is a quantitative publication based on patient audit data collected from 1,053 HCV patient charts provided by 100 gastroenterologists, 50 hepatologists and 50 infectious disease specialists in March - April 2013 in the United States. The report includes analysis of genotype 1 and genotype 2/3 patients, as well as three patient subgroups: currently treated/recently completed treatment, treatment-naive and prior-treatment failures. Through an in-depth review of patient charts, the report provides insight into how patient demographics, comorbidities and risk factors and lab values influence treatment decisions and brand selection.  

About BioTrends Research Group
BioTrends Research Group provides syndicated and custom primary market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets. For information on BioTrends publications and research capabilities, please contact us at www.bio-trends.com. BioTrends is a Decision Resources Group company.

About Decision Resources Group
Decision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources Group at www.DecisionResourcesGroup.com.

All company, brand, or product names contained in this document may be trademarks of their respective holders.

For more information, contact:

Decision Resources Group
Christopher Comfort
781-993-2597
ccomfort@dresources.com

SOURCE BioTrends Research Group

RELATED LINKS

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Prediction of Treatment Efficacy and Telaprevir-Resistant Variants after Triple Therapy in Patients Infected with HCV Genotype 1

J Clin Microbiol. 2013 Jun 19. [Epub ahead of print]

Akuta N, Suzuki F, Fukushima T, Kawamura Y, Sezaki H, Suzuki Y, Hosaka T, Kobayashi M, Hara T, Kobayashi M, Saitoh S, Arase Y, Ikeda K, Kumada H.

Department of Hepatology, Toranomon Hospital, and Okinaka Memorial Institute for Medical Research, Tokyo, Japan.

Abstract

It is often difficult to predict the response to telaprevir/peginterferon (PEG-IFN)/ribavirin therapy and appearance of telaprevir-resistant variants. The present study determined the predictive factors of sustained virological response (SVR) to 12- or 24-week triple therapy (T12PR12 or T12PR24) in 194 Japanese patients infected with hepatitis C virus (HCV) genotype 1b. The study also evaluated whether ultra-deep sequencing technology can predict the emergence of resistant variants at baseline. Analysis of data of the entire group indicated that SVR was achieved by 78% of the patients. Multivariate analysis identified IL28B rs8099917 (genotype TT), substitution of aa70 (Arg70), response to prior treatment (naive or relapse), PEG-IFN dose (≥1.3 μg/kg), and treatment regimen (T12PR24) as significant determinants of SVR. Among patients of the T12PR24 group, 92% with genotype TT achieved SVR, irrespective of substitution of aa70. In patients with genotype non-TT, SVR was 76% for those of Arg70; while only 14% of patients with genotype non-TT, Gln70(His70) and non-response to ribavirin combination therapy achieved SVR. Ultra-deep sequencing was conducted in 17 patients who did not achieve SVR to determine the emergence of resistant variants during therapy. De novo resistant variants were detected in 16 of 17 patients (94%), regardless of variants frequencies at baseline. In conclusion, the results indicated that the response to triple therapy could be predicted by the combination of host, viral, and treatment factors, and that it is difficult to predict at baseline the emergence of telaprevir-resistant variants during triple therapy, even with the use of ultra-deep sequencing.

PMID: 23784126 [PubMed - as supplied by publisher]

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Discrepancy found between HCV surveillance systems

Provided by Healio

Hart-Malloy R. Am J Public Health. 2013;103:1402-1405.

August 5, 2013

Recent data suggest a discrepancy between hepatitis C seroprevalence and the number of people reported in hepatitis registries in individual states, according to researchers from the New York State Department of Health.

“Our results suggest that existing surveillance systems are inadequate for establishing disease burden and resource needs,” the researchers wrote in the American Journal of Public Health. “These findings support the growing advocacy for strengthening existing HCV surveillance systems in the United States.”

The researchers used data from the ongoing National Health and Nutrition Examination Survey to determine the estimated HCV seroprevalence for New Yorkers aged at least 20 years. They then used data from registries of hepatitis surveillance systems in the state.

The national data suggest that the prevalence of HCV seropositivity in New York in 2008 was approximately 1.95%. However, the surveillance data among the same population suggested a prevalence of 0.98%, which is nearly half the estimate from the NHANES data.

“Surveillance systems may not capture cases because of undiagnosed infection, diagnoses that are not reported by providers or insufficient follow-up of reported information to establish infection status,” the researchers wrote. “Future studies at the state and national level to identify cases no captured in surveillance are needed to better define screening needs and surveillance infrastructure improvements that would give more accurate estimates of disease burden.”

Disclosure: The researchers report no relevant financial disclosures.

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Turmeric curcumin inhibits entry of all hepatitis C virus genotypes into human liver cells

Gut doi:10.1136/gutjnl-2012-304299

Viral hepatitis

Original article

Anggakusuma1, Che C Colpitts2, Luis M Schang2, Heni Rachmawati3, Anne Frentzen1, Stephanie Pfaender1, Patrick Behrendt1,5, Richard J P Brown1, Dorothea Bankwitz1, Joerg Steinmann4, Michael Ott5,6, Philip Meuleman7, Charles M Rice8, Alexander Ploss8,9, Thomas Pietschmann1, Eike Steinmann1

+ Author Affiliations

Received 10 December 2012, Revised 11 July 2013, Accepted 11 July 2013, Published Online First 31 July 2013

Abstract

Objective Hepatitis C virus (HCV) infection causes severe liver disease and affects more than 160 million individuals worldwide. People undergoing liver organ transplantation face universal re-infection of the graft. Therefore, affordable antiviral strategies targeting the early stages of infection are urgently needed to prevent the recurrence of HCV infection. The aim of the study was to determine the potency of turmeric curcumin as an HCV entry inhibitor.

Design The antiviral activity of curcumin and its derivatives was evaluated using HCV pseudo-particles (HCVpp) and cell-culture-derived HCV (HCVcc) in hepatoma cell lines and primary human hepatocytes. The mechanism of action was dissected using R18-labelled virions and a membrane fluidity assay.

Results Curcumin treatment had no effect on HCV RNA replication or viral assembly/release. However, co-incubation of HCV with curcumin potently inhibited entry of all major HCV genotypes. Similar antiviral activities were also exerted by other curcumin derivatives but not by tetrahydrocurcumin, suggesting the importance of α,β-unsaturated ketone groups for the antiviral activity. Expression levels of known HCV receptors were unaltered, while pretreating the virus with the compound reduced viral infectivity without viral lysis. Membrane fluidity experiments indicated that curcumin affected the fluidity of the HCV envelope resulting in impairment of viral binding and fusion. Curcumin has also been found to inhibit cell-to-cell transmission and to be effective in combination with other antiviral agents.

Conclusions Turmeric curcumin inhibits HCV entry independently of the genotype and in primary human hepatocytes by affecting membrane fluidity thereby impairing virus binding and fusion.

Source

The effects of female sex, viral genotype, and IL28B genotype on spontaneous clearance of acute hepatitis C Virus infection

Hepatology

Accepted Article (Accepted, unedited articles published online and citable. The final edited and typeset version of record will appear in future.)

Viral Hepatitis

Jason Grebely^1,*, Kimberly Page², Rachel Sacks-Davis^3,4, Maarten Schim van der Loeff^5,6, Thomas M. Rice², Julie Bruneau⁷, Meghan D. Morris², Behzad Hajarizadeh¹, Janaki Amin¹, Andrea L. Cox⁸, Arthur Y. Kim⁹, Barbara H. McGovern^10,11, Janke Schinkel¹², Jacob George¹³, Naglaa H. Shoukry⁷, Georg M. Lauer⁹, Lisa Maher¹, Andrew R. Lloyd¹⁴, Margaret Hellard^3,4, Gregory J. Dore¹, Maria Prins^5,6, the InC³ Study Group

DOI: 10.1002/hep.26639

© 2013 by the American Association for the Study of Liver Diseases

Publication History

Accepted manuscript online: 2 AUG 2013 05:29AM EST, Manuscript Accepted: 16 JUL 2013, Manuscript Revised: 23 MAY 2013, Manuscript Received: 19 APR 2013

Abstract

Keywords: injection drug use; hepatitis C virus; HIV; incident infection; longitudinal studies

Although 20%-40% of persons with acute hepatitis C virus (HCV) infection demonstrate spontaneous clearance, the time course and factors associated with clearance remain poorly understood. We investigated the time to spontaneous clearance and predictors among participants with acute HCV using Cox's proportional hazards analyses. Data for this analysis were drawn from an international collaboration of nine prospective cohorts evaluating outcomes after acute HCV infection. Among 632 participants with acute HCV, 35% were female, 82% were Caucasian, 49% had interleukin-28 (IL28)B CC genotype (rs12979860), 96% had injected drugs ever, 47% were infected with HCV genotype 1, and 5% had human immunodeficiency virus (HIV) coinfection. Twenty-eight percent were HCV antibody negative/RNA positive at the time of acute HCV detection (early acute HCV). During follow-up, spontaneous clearance occurred in 173 of 632, and at 1 year after infection, 25% (95% confidence interval [CI]: 21, 29) had cleared virus. Among those with clearance, the median time to clearance was 16.5 weeks (IQR: 10.5, 33.4), with 34%, 67%, and 83% demonstrating clearance at 3, 6, and 12 months. Adjusting for age, factors independently associated with time to spontaneous clearance included female sex (adjusted hazards ratio [AHR]: 2.16; 95% CI: 1.48, 3.18), IL28B CC genotype (versus CT/TT; AHR, 2.26; 95% CI: 1.52, 3.34), and HCV genotype 1 (versus non-genotype 1; AHR: 1.56; 95% CI: 1.06, 2.30). The effect of IL28B genotype and HCV genotype on spontaneous clearance was greater among females, compared to males. Conclusions: Female sex, favorable IL28B genotype, and HCV genotype 1 are independent predictors of spontaneous clearance. Further research is required to elucidate the observed sex-based differences in HCV control. (Hepatology 2013;)

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