Hepatitis C, A Global Issue: Access to Care and New Therapeutic and Preventive Approaches in Resource-Constrained Areas

Maud Lemoine, MD, PhD1 Mark Thursz, MD, PhD1

1Hepatology & Gastroenterology Section, Imperial College, London, United Kingdom

Semin Liver Dis 2014;34:89–97.

Address for correspondence Mark Thursz, MD, PhD, Hepatology & Gastroenterology Section, Imperial College, Norfolk Place, London W2 1NY, United Kingdom (e-mail: m.thursz@imperial.ac.uk).

Abstract

With the advent of all oral direct-acting antiviral drugs with a broad range of genotypic activity and a low incidence of side effects, we are entering an exciting new era in the therapeutics of hepatitis C virus (HCV). However, it is not yet clear who will benefit from these innovations: Will the advantages be limited to HCV patients in industrialized nations or could the whole community of HCV-infected individuals be given access to treatment? As the majority of people infected with HCV live in resource-limited settings it is important to overcome the barriers that restrict access to treatment in these areas. Drug costs, public and professional education, simplified diagnostics, and political imperative all need to be addressed before the majority of HCV-infected individuals can benefit from the new generation of HCV antivirals.

Hepatitis C virus (HCV) infection is prevalent in every country where it has been sought making it a global health problem with an estimated prevalence of over 184 million people worldwide.1 However, the prevalence rates of infection are highly heterogeneous with a disproportionate burden of infection in countries with limited health care resources. In addition to heterogeneity in the prevalence of infection there is also heterogeneity in the distribution of viral genotypes; in most developed countries genotypes 1 and 3 dominate whereas genotypes 4, 5, and 6 aremore common in countries with limited healthcare resources.2

Over the past 15 years HCV genotype 1 has been regarded as themost difficult to treat, requiring 48 weeks of pegylated interferon and ribavirin (PegIFN/RBV) and achieving sustained virological response (SVR) rates of only 45%. However, the development of new direct-acting antivirals (DAAs) which are frequently targeted at genotype 1 have made this genotype easier to treat. New IFN-free DAA combinations have also significantly improved SVR rates in HCV genotype 2 and 4 infected patients. However, results are still unsatisfactory in genotype 3 and data in genotypes 5 and 6 are limited.

There are important differences in the dominant routes of transmission between geographical regionswith intravenous drug use being the most common route of transmission in Europe, North America, and Australasia and iatrogenic transmission being more important in most resource-limited settings.3 Preventive strategies are essential to the control of the HCV epidemic, but the variation in routes of transmission will require a tailored approach to infection control according to the local population needs. The priority in resource-limited countries will be control of transmission in health care facilities whereas the priority in affluent countries will be the interruption of transmission among people who inject drugs (PWID).

Although there is significant variation between countries in the routes of transmission, prevalence and burden of disease there is consistency in resource-limited settings for the poor access to treatment.

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Hepatitis C prevention and treatment for substance users in the UnitedStates: acknowledging the elephant in the room

International Journal of Drug Policy 15 (2004) 81–91

Commentary

Brian R. Edlin

Center for the Study of Hepatitis C, Weill Medical College of Cornell University, New York, NY, USA

Received 20 March 2002; received in revised form 3 October 2003; accepted 9 October 2003

Like many countries, the United States faces a major epi-demic of hepatitis C virus (HCV) infection. Nearly 3 millionAmericans are estimated to be infected with HCV (Alteret al., 1999),and some 35,000 new infections are believed tooccur annually (Williams, 1999).The virus causes chronicinfection in about 85% of those infected, and among thosechronically infected, cirrhosis may eventually develop infrom 5 to 20% (Freeman et al., 2001;Liang, Rehermann,Seeff, & Hoofnagle, 2000).HCV infection is thought to re-sult in 8000–10,000 deaths annually. It is already the mostcommon cause of chronic liver disease and the most com-mon reason for liver transplantation in the United States,and morbidity and mortality from HCV infection are risingand are expected to continue rising in the coming decades(Armstrong, Alter, McQuillan, & Margolis, 2000).

In the United States, as in many other developed coun-tries, injection drug users (IDUs) constitute the largest groupof persons infected with HCV, and most new infectionsoccur in IDUs. Injection drug use predominates as a modeof transmission in most countries where the endemicity of HCV is low. There are probably a million or more currentIDUs with HCV infection in the U.S.; of the estimated1.2–1.3 million current IDUs in the U.S. (Normand, Vlahov,& Moses, 1995), some 80–90% have been infected withHCV (Lorvick, Kral, Seal, Gee, & Edlin, 2001;Thomaset al., 1995),although recent studies have shown that preva-lence rates in young IDUs and recent initiates are now muchlower (Garfein et al., 1998;Hahn, Page-Shafer, Lum, Ochoa,& Moss, 2001;Thorpe, Ouellet, Levy, Williams,&Monterroso, 2000).The incidence of new infections amongIDUs is also quite high, however, generally ranging from10 to 20% per year in the U.S. (Garfein et al., 1998; Haganet al., 1999, 2001; Hahn et al., 2001; Thorpe et al., 2000).

The situation is similar in other developed countries (Crofts,Jolley, Kaldor, van Beek, & Wodak, 1997;Patrick et al.,2001;Van Ameijden, Van den Hoek, Mientjes, & Coutinho,1993;van Beek, Dwyer, Dore, Luo, & Kaldor, 1998).Moreover, initiation of heroin use and injection drug use isincreasing among young people (CDC, 2001a).Controllingthe HCV epidemic, therefore, will require developing, test-ing, and implementing prevention and treatment strategiesthat will be effective for persons who inject drugs. Fortu-nately, substantial research and clinical experience exists inthe prevention and management of chronic viral infectionsamong IDUs, particularly because of the HIV epidemic.Learning from this experience will be critical for efforts tocontrol HCV

The public health response to the HCV epidemic in theU.S. to date has, unfortunately, fallen short of what is neededto stop the epidemic. Until recently, official documents pro-duced by the U.S. Public Health Service about its responseto the HCV epidemic were silent on most of the interven-tions described in this article (CDC, 1998; CDC, 2001b;NIH, 1997a).In 2002, NIH issued an updated ConsensusStatement on the Management of Hepatitis C that took asubstantially more comprehensive approach to the problem(NIH, 2002).This statement challenges the medical, scien-tific, and public health communities to address numerousproblems that remain unsolved and continue to contribute tothe HCV epidemic.

Preventing morbidity and mortality from HCV can bedivided into primary, secondary, and tertiary prevention(Table 1).This paper summarises recommendations for ef-fective prevention in each of these categories, and discussessome of the barriers that have hampered their implementa-tion.

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

Clin Infect Dis. (2013) 57 (suppl 2): S29-S31. doi: 10.1093/cid/cit264

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

Jason Grebely1, Philip Bruggmann2, Markus Backmund3,4, and Gregory J. Dore1

+ Author Affiliations

The majority of hepatitis C virus (HCV) occurs among people who inject drugs (PWID) [1], and the burden of HCV-related liver disease is still increasing [2]. HCV treatment is safe and effective among PWID [3], and international guidelines encourage HCV treatment in this group [4, 5], but HCV treatment uptake remains low among PWID [6, 7], mainly due to patient-, practitioner- and systems-related barriers to care. However, strategies have emerged to improve the prevention and management of HCV infection among PWID.

To foster the dissemination of knowledge in the field of viral hepatitis among PWID, the International Network on Hepatitis in Substance Users (INHSU) was established. INHSU established the International Symposium on Hepatitis in Substance Users (held every 2 years), focused on the management of viral hepatitis among PWID, specifically HCV infection. The first symposium was held in Zurich, Switzerland, in 2009 and the second was held in Brussels, Belgium, in 2011. The symposium is attended by researchers, practitioners, and community members and includes sessions on the epidemiology and natural history of viral hepatitis, clinical applications of basic science research, management of medical comorbidities and social science– and community-based perspectives. At the meeting in 2011, a panel of international experts was assembled in collaboration with the European Liver Patients Association to develop the first international recommendations for the management of HCV among PWID. This supplement presents original research from the most recent meeting, highlights recent advances in the field, and presents recommendations for the clinical management of HCV infection among PWID.

HCV PREVENTION AMONG PWID

It is estimated that 10 million PWID were HCV antibody positive in 2010, with a global HCV prevalence of 67% among PWID [8]. HCV incidence also remains high among PWID [9].

In the first article of this supplement, Page et al review and highlight the challenges of behavioral interventions for HCV prevention [9]. The authors demonstrate that harm-reduction programs successful in preventing human immunodeficiency virus (HIV) infection among PWID have been less effective for preventing HCV infection and that combined strategies are likely required [9]. Martin et al use mathematical modeling to project the impact of combining opiate substitution treatment (OST), high-coverage needle and syringe programs (NSPs), and HCV treatment on HCV prevalence and incidence among PWID [10]. Data from their study suggest that large reductions (>45%) in HCV chronic prevalence over 10 years requires HCV antiviral treatment, with the scale-up of combined interventions, including OST and NSPs, substantially reducing the treatment rate required to achieve specific HCV prevalence reductions. An alternative way of preventing HCV infection would be through the availability of an HCV vaccine. Cox and Thomas highlight the need for an HCV vaccine for PWID, demonstrate that protective immunity against persistent HCV infection is possible, and summarize recent advancements in HCV vaccine research, including recent phase 1/2 trials of an HCV candidate vaccine among PWID [11].

ENHANCING HCV ASSESSMENT AMONG PWID

Although HCV treatment is successful among PWID [3], assessment and uptake remain low [6, 7]. Understanding the barriers and facilitators of HCV care is critical in the design of strategies and programs for effectively increasing the proportion of PWID assessed and treated for HCV.

In this supplement, Treloar et al discuss barriers to HCV care and stigmatization, considering components required for the design programs to effectively engage PWID in HCV care [12]. Bruggmann et al review the spectrum of HCV care models among PWID, highlighting that “one size does not fit all” and that when barriers are systematically addressed within a supportive environment, HCV assessment and treatment among PWID can be very successful [13]. This is consistent with data from Alavi et al from the Enhancing Treatment for Hepatitis C in Opioid Substitution Settings (ETHOS) Study, demonstrating that when HCV nursing and specialist support are integrated into existing OST or community health clinics, a high proportion of PWID with chronic HCV assessed by a nurse can be engaged in HCV care [14]. Another setting with opportunity for expanding HCV assessment and treatment is prisons. Post et al review the considerable burden of HCV in prisons, highlight potential challenges, and illustrate programs that have successfully integrated HCV screening, assessment, and treatment for prisoners with HCV [15]. One important consideration as we move forward with the development of new models of care is the involvement of the affected community. In this supplement, Crawford et al review different peer support models [16] and highlight the importance of involving community-based groups early into the design and implementation of these programs to achieve the greatest opportunity for engagement by PWID.

ENHANCING HCV TREATMENT AMONG PWID

It has been clearly demonstrated that PWID can be successfully treated [3]. However, the populations studied are often heterogeneous (combination of current and former PWID) and there are few data on HCV treatment outcomes among active PWID. Further, few prospective trials have evaluated strategies to enhance adherence and response to treatment among PWID.

In a systematic review and meta-analysis of treatment for HCV infection among active PWID, Aspinall et al demonstrate an overall sustained virologic response (SVR) of 56% [17]. This is the first systematic review of HCV treatment among those with ongoing drug use at the time of treatment and illustrates that active PWID can respond favorably to therapy. In the first randomized controlled trial performed to date among active drug users, Hilsden et al randomized participants to immediate vs delayed HCV treatment [18]. They demonstrate that directly observed pegylated interferon and self-administrated ribavirin can lead to a high proportion of patients with SVR among active drug users, but suggest that delaying treatment may compromise subsequent engagement in HCV treatment [18]. Last, in the largest trial reported to date among people with chronic HCV infection receiving OST, Reimer et al demonstrate that an intervention based on psychoeducation may enhance adherence to HCV treatment and reduce dropouts, particularly among people with longer treatment durations (those with genotypes 1/4) or those with mental health comorbidities [19].

MANAGING HCV TREATMENT AMONG PWID

Until recently, HCV treatment guidelines (and many practitioners) excluded PWID from consideration, citing concerns about adherence, increased susceptibility to side effects and reinfection. Issues of HIV infection and management of multiple drug interactions (both prescribed and nonprescribed drug use) complicate HCV management in this population. However, until recently there have been no recommendations for the management of HCV among PWID.

Grady et al demonstrate that the rate of reinfection reported to date has been low (1%–5% per year), which does not support decisions to withhold HCV treatment in this group based on concerns of reinfection [20]. Schaefer et al focus on another common barrier to HCV treatment assessment, namely, mental health issues [21]. They review the available evidence in this area, providing practical information for practitioners interested in managing HCV among PWID. Taylor et al summarize the data to date on management of HCV/HIV coinfection, including recent data investigating new direct-acting antivirals and studies of PWID with HCV/HIV coinfection [22]. Mauss et al focus on the problem of drug–drug interactions, which are an issue among PWID, given the potential for HCV direct-acting antivirals to interact with drugs used to treat HIV coinfection, OST (eg, methadone and buprenorphine), and nonprescription drugs [23].

The supplement is concluded with recommendations for the management of HCV infection among PWID [24]. This is meant to supplement existing international guidelines for HCV treatment, focusing on specific issues encountered among PWID. These guidelines should serve as an evidence-based tool for practitioners managing HCV among PWID.

FUTURE PERSPECTIVES

High rates of HCV infection still occur among PWID. Research is needed to evaluate the efficacy of combined HCV prevention approaches (such as HCV treatment as prevention, OST, NSPs, and vaccines). In addition to primary prevention, efforts must be expanded to prevent advanced liver disease due to chronic HCV. HCV treatment can reduce morbidity and mortality, but HCV assessment and treatment remains low among PWID. The availability of simple, well-tolerated, and highly effective interferon-free direct-acting antivirals will facilitate engagement among PWID, but research on strategies to enhance HCV screening and assessment is still needed. The evaluation of strategies to enhance adherence and therapy outcomes (eg, directly observed therapy, medication reminders, adherence education, peer support) should also be a research priority.

Research in this area needs to move beyond small, single-center, retrospective studies demonstrating that HCV treatment among PWID is feasible. Larger, prospective clinical trials run through international clinical networks are required to more rapidly evaluate potential treatment strategies. One such trial, ACTIVATE (A Collaborative Trial in Injectors of Individualized Treatment for Genotype 2/3), is a phase 4, open-label, multicenter, international trial of response-guided treatment with directly observed pegylated interferon alfa 2b and self-administered ribavirin for patients with chronic HCV genotype 2 or 3 infection and ongoing injection drug use. It is the first attempt to establish a clinical network and may be a step in the right direction. Further evidence-based research focused on strategies for enhanced HCV prevention, screening, assessment, and treatment among PWID will be required to reduce the HCV-related burden that still exists globally.

Notes

Financial support. INHSU receives support from Merck, Janssen, Abbvie, Gilead, Roche, and Orasure. J. G. is supported through a National Health and Medical Research Council Career Development Fellowship. G. D. is supported through a National Health and Medical Research Council Practitioner Fellowship.

Supplement sponsorship. This article was published as part of a supplement entitled “Prevention and Management of Hepatitis C Virus Among People Who Inject Drugs: Moving the Agenda Forward,” sponsored by an unrestricted grant from the International Network on Hepatitis in Substance Users (INHSU), The Kirby Institute (University of New South Wales), Abbvie, Gilead Sciences, Janssen-Cilag, and Merck.

Potential conflicts of interest. All authors: No reported conflicts.

All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

© The Author 2013. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail:

journals.permissions@oup.com.

References

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The silent pandemic: Tackling hepatitis C with policy innovation

Report by the Economist Intelligence Unit supported by Janssen

Governments across the world will have to face up to the challenges posed by the hepatitis C (HCV) pandemic or experience spiralling healthcare costs, says the Economist Intelligence Unit in its report The silent pandemic: Tackling hepatitis C with policy innovation.

The report, made possible as a result of an educational grant from Janssen, challenges countries to use co-ordinated strategies to tackle HCV but warns that this will not be easy because few countries understand the magnitude of the disease. The report finds that in the European Union, only the Netherlands has the kind of epidemiological data robust enough to inform policy.

What the report highlights is that because levels of awareness are so low, many people only receive an HCV diagnosis when diagnosed with its end-stage conditions such as cirrhosis or liver cancer. Poor healthcare practices, such as failing to screen donated blood and the use of unsterilised medical equipment, are the cause of millions of cases in the developing world.

The report concludes that countries need to improve the data they have in order to introduce a comprehensive approach to tackling HCV. This will include raising awareness about the disease, taking preventative measures, especially within health services, and making a real effort to reach vulnerable patient groups with available treatments treatments before end-stage conditions develop.

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Screening Events Promote Hepatitis Testing and Prevention during National Hepatitis Awareness

Hepatitis B and C are the greatest causes of liver cancer in America, but can be prevented or treated;
Screening events and PSAs being coordinated in New York City, San Francisco and Los Angeles

May 14, 2013 12:15 PM Eastern Daylight Time

SAN FRANCISCO & LOS ANGELES & NEW YORK--(BUSINESS WIRE)--During National Hepatitis Awareness Month this May, Hep B Free San Francisco, Asian Week Foundation, and National Viral Hepatitis Roundtable are helping to coordinate hepatitis screenings and a new public service announcement to highlight prevention of hepatitis B and C (HBV/HCV) disease, which together cause almost all liver cancers worldwide.ⁱ Screening events featured in the PSA are being held in three of the largest metro areas affected by viral hepatitis: New York, NY, Los Angeles, CA, and San Francisco, CA.

“We are excited to see this first-ever national collaboration with local communities, healthcare groups and the media to promote testing for viral hepatitis and the prevention of liver disease in our communities”

Viral hepatitis is a leading infectious cause of death in the U.S. To combat the epidemic, the U.S. Department of Health and Human Services created an Action Plan in 2011 for the Prevention, Care and Treatment of Viral Hepatitis. The launch of Hepatitis Awareness Month, observed in May, National Hepatitis Testing Day, observed May 19, and National Hispanic Hepatitis Awareness Day, observed on May 15, have resulted in a growing number of events being organized by local communities in cities around the country to highlight hepatitis prevention.

This year, events in New York City will start on Tuesday, May 14 with a press conference on the steps of City Hall organized by National Hispanic Hepatitis Awareness Day, the New York Hep C Task Force and the New York Hep B Coalition. Los Angeles will hold a media event and community rally on Friday May 17 organized by Hep B Free Los Angeles and the Hep C Task Force of Los Angeles. San Francisco will hold a large pubic screening event and press conference on Saturday May 18 organized by San Francisco Hep B Free and the San Francisco Hep C Task Force. Other events will also be taking place throughout the country in observance of the awareness and testing days.

The televised awareness commercials will air from May 8 to May 19 in the New York, Los Angeles and San Francisco media markets. The commercials feature a call for hepatitis testing as a way to prevent liver cancer and include a unique URL for each city that links to local hepatitis resources and screening events.

“We are excited to see this first-ever national collaboration with local communities, healthcare groups and the media to promote testing for viral hepatitis and the prevention of liver disease in our communities,” said Ted Fang, Executive Director of AsianWeek Foundation. AsianWeek Foundation and SF Hep B Free spearheaded the three-city coordination and worked with the National Viral Hepatitis Roundtable to develop the television awareness commercials.

“This is a wonderful multi-faceted approach for educating the public about the need for viral hepatitis testing,” said Martha Saly, Executive Director of National Viral Hepatitis Roundtable. “We are proud to be part of this coalition and building private/public partnerships to end viral hepatitis liver disease in America.”

“Far too many Americans – approximately four million -- are infected with hepatitis B or hepatitis C, and the majority of those individuals don’t know it,” said Howard K. Koh, M.D., M.P.H., Assistant Secretary for Health, U.S. Department of Health and Human Services. “The HHS National Viral Hepatitis Action Plan promotes prevention, screening, care and treatment to tackle this silent epidemic.”

The majority of liver cancers in the world are attributable to chronic infections of HBV and/or HCV. Primary prevention of HBV infection includes vaccination. HCV infection is potentially preventable through public health measures, including screenings.ⁱⁱ Many will die from liver cancer if they do not receive the proper care. Several minorities are disproportionately impacted by hepatitis. For example, Hepatitis B is the greatest health disparity for both African immigrants and Asian Americans affecting approximately 10% of both groups.

In 2012, approximately 4,300 Hispanics will be diagnosed with liver cancer, and about 2,700 will die from the disease. Liver cancer incidence rates in the US are about twice as high in Hispanics as in non-Hispanic whites.ⁱⁱ

About Hepatitis C Virus (HCV)

Hepatitis C virus (HCV) is the most common chronic blood-borne viral infection and the most common cause of chronic liver disease in the United States. An estimated 3.2 million Americans are infected with HCV, and are at risk for developing cirrhosis and liver cancer. Most persons who have HCV are not aware they are infected, and most with acute infection (60%-70%) show no symptoms. Approximately three of four infected persons were baby-boomers, born between 1945-1965. HCV is responsible for more than 15,000 deaths in the United States every year. In Los Angeles County, an estimated 180,000 persons are infected with HCV, and rates of HCV infection in the general population are estimated at 1.8%, 3.2% among persons born 1945-1965, and as high as 67.8% among injection drug users.

There is currently no vaccine to protect against Hepatitis C infection.

HCV is transmitted by exposure to infected blood. Sexual transmission is possible, but not common. It is most common among people who have injected drugs at some point during their lives. People who have received blood transfusions or organ transplants before widespread screening of the blood supply began in 1992 are also at risk. Others at risk include children born to HCV-positive women, sexual partners of persons with HCV and health care or emergency workers. To prevent HCV infection, only sterile needles and equipment should be used, and personal items, such as toothbrushes, razors or nail clippers should not be shared.

Among HIV-affected persons, one in four are infected with HCV; liver disease is a leading cause of death for persons with HCV. Co-infection rates with HCV are believed to be as high as 40%. An estimated 60-90% of people who contracted HIV from injection drug use also are infected with HCV.

About Hepatitis B Virus (HBV)

The Hepatitis B Virus (HBV), which attacks the liver, is 100 times more infectious than HIV/AIDS. HBV can cause lifelong (chronic) infection, cirrhosis (scarring) of the liver, liver cancer/failure, and death. The U.S. Centers for Disease Control and Prevention (CDC) recommends routine screening and vaccination for HBV in all individuals from high prevalence regions, including Asia, Africa, and parts of South America. Screening can prevent HBV transmission, suffering, and death.

Of the 800,000 to 1.4 million with chronic hepatitis B in United States, and 25% will die of HBV-related liver diseases if not treated. Liver cancer is one of the most common cancers in AAPIs in California. Among men, it is the most common cancer in Cambodians and Laotians, 2^nd most common in Vietnamese, 4^th in Chinese, Filipino and Native Hawaiians, and 5^th in Koreans and Pacific Islanders. Among women, liver cancer is the 5^th most common cancer in Cambodians, Laotians and Vietnamese, and is also common in other AAPI women. In the U.S., AAPIs have the highest rate of liver cancer of any racial/ethnic group. Also, 80% of the HBV perinatal caseload in California, and within Los Angeles County, are AAPI women and household contacts. HBV is one of the greatest health disparities between AAPIs and the general US population (which has less than 1% prevalence of chronic HBV infection).

ⁱ American Cancer Society: http://www.cancer.org/acs/groups/cid/documents/webcontent/003114-pdf.pdf
ⁱⁱ American Cancer Society: http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-034778.pdf

Contacts

Hep B Free San Francisco
Genevieve Jopanda, 415-913-0217
genevieve@sfhepbfree.org

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Data to Guide the "Test and Treat Era" of Hepatitis C: CDC Editorial

Download the PDF here

Gastroenterology October 2012

JOHN W. WARD
Division of Viral Hepatitis
Centers for Disease Control and Prevention
Atlanta, Georgia

DAVID B. REIN
NORC at the University of Chicago
Chicago, Illinois

BRYCE D. SMITH
Division of Viral Hepatitis
Centers for Disease Control and Prevention
Atlanta, Georgia

"HCV morbidity and mortality are increasing, and these increases can be curbed by expanded access to HCV testing and a growing array of effective HCV therapies. This era of effective therapy for HCV creates opportunities for health leaders worldwide to identify and implement new strategies that increase the number of HCV-infected persons who are aware of their infection and who receive effective treatment.......potential impact of HCV therapy in curbing the expected increases in HCV-related cirrhosis and mortality......a greater payoff in disease averted and lives saved when improvements in HCV therapy are accompanied by expanded access to HCV testing, care, and treatment.........4 most recently published models of HCV disease in the United States, each of which demonstrates how the implementation of new testing strategies and/or treatments can cost-effectively diminish the accelerating public health impact of HCV infections acquired decades in the past.12, 13, 14, 15

from Jules of NATAP: in NYC we are now implemented in what I call the model for the "HCV Urban Plan", the HCV Ryan White Care Act". It is a $2 million 1-year demonstration project whose model includes a seamless 'soup to nuts' continuum of services required to address this epidemic in urban small & large cities in the USA or anywhere in the USA, whose model can be duplicated with changes based on local culture in any city globally. The model provides a total-city community inclusive response/mobilization including the Department of Health & community groups & care clinics. There are 6 major key program components: large-scale awareness project, rapid HCV testing, well defined & trained patient navigators, community-based & university clinics, support services for patients, clinics & project, and weekly web-based treatment & care education by a leading local & global hepatologist(s) for clinicians, which will expand treater pool. This project focuses on the most marginalized patient populations in inner city NY due to limited funding but can & should be expanded to all populations which can be accomplished with large scale awareness projects. I designed the original model & raised the funds, the NYC DOH is implementing the project with 8 test sites, 7 patient navigators, 6 community-based clinics. Two HCV databases are collecting medical & demographic data, which could lead to joined databases globally or throughout the USA if this project were duplicated, and multiple professional evaluations are being conducted. The key of this project is that it at-once mobilizes & creates an excitement for a city's community, both public & private, as it has in NYC. Separate isolated screening projects NOT joined together in one joint citywide project cannot accomplish this & will be self-defeating. The NYC project creates a safe environment for the most vulnerable patient populations, evaluations so far report this. Initial cuts of data collected are impressive.

Health leaders around the world are facing critical questions regarding how to combat a rising tide of hepatitis C virus (HCV)-associated liver disease. Worldwide, an estimated 130-170 million persons are living with chronic HCV infection, and HCV causes 1 in 4 cases of cirrhosis and 170,000 deaths per year.1 Persons living with HCV are often unaware they are infected, reflecting the relatively asymptomatic nature of HCV infection until late in the course of disease and the often decades-long latency between acquisition of HCV and the development of end-stage liver disease and death. Many HCV-infected persons were infected decades ago, before the discovery of the virus in the late 1980s and the advent of blood bank screening and other prevention measures. As time passes and HCV has a longer opportunity to cause progressive liver damage, the number of HCV-infected persons developing end-stage liver disease (hepatocellular carcinoma and liver cirrhosis) is increasing at an accelerating rate.2 For example, in the United States, the number of persons dying from HCV-associated conditions recently surpassed the number of deaths from HIV/AIDS. The US Centers for Disease Control and Prevention (CDC) estimate that HCV-related cirrhosis and morbidity will continue to increase year over year into the next decade and beyond.3, 4

Fortunately, health officials are not empty handed in facing this looming crisis. A growing arsenal of direct-acting antiviral agents can clear HCV from the body (ie, achieve virologic cure). The addition of 1 of 2 commercially available protease inhibitors to treatment regimens can increase rates of sustained virologic response (ie, viral eradication after completion of treatment) to 63%-75%.5, 6 Other compounds under study in clinical trials may increase rates of viral eradication even further.7 Achieving a sustained virologic response is important, because persons successfully clearing virus after HCV therapy have lower rates of hepatocellular carcinoma and all-cause mortality.8, 9

The opportunity created by these new therapies is compromised by the lack of quality information that can be used to target case identification and treatment efforts. Insufficient public health surveillance systems that track HCV disease, mortality, and access to testing and medical care hinder health leaders from recognizing the growing threat of chronic hepatitis C and the potential benefits that accompany HCV testing, care, and treatment.10 Seeking to fill this information gap, Deuffic-Burban et al brings together data from 6 European countries to model trends in HCV-related cirrhosis and mortality and to identify the potential impact of new HCV therapies on these trends.11

To estimate the country-specific impact of treatment on the incidence of cirrhosis and mortality for the 6 European nations over the past 10 years and in the 10 years to follow, the authors make several assumptions and use a complex simulation model. Despite its complexity, at the core, this model forecasts a future of increasing HCV morbidity and mortality for these countries while demonstrating the promise of enhanced HCV screening and new therapies in limiting the impact of HCV infection. The model in the Deuffic-Burban et al paper mirrors the 4 most recently published models of HCV disease in the United States, each of which demonstrates how the implementation of new testing strategies and/or treatments can cost-effectively diminish the accelerating public health impact of HCV infections acquired decades in the past.12, 13, 14, 15

Much of the complexity and assumptions of the Deuffic-Burban et al model were associated with the authors' objective to obtain country-specific estimates for each of the 6 nations. The authors found a range of possible impacts of HCV infection and new treatments over the coming decades, which varied based on differences in local epidemiology, HCV genotypes, and national health systems. Although the authors made a laudable effort to synthesize a wide range of data from a variety of sources, additional primary data on HCV are badly needed.

Several limitations are noted by the authors, including assumptions about past disease incidence, techniques to recreate treatment rates from pharmaceutical sales data, and the use of expert opinion in the place of observational data. These limitations point to a larger truth: When compared with other chronic, progressive diseases, there is much to be learned about HCV epidemiology, the rate of progression to end-stage liver disease, and the relative risk of liver cancer and liver failure depending on achievable sustained virologic response rates.

Despite these limitations, the authors' estimations provide data in ≥3 key areas. First, as with forecasts for the United States, all of these countries (with the exception of Italy) can expect increases in HCV-related cirrhosis into the next decade and, for Spain and the United Kingdom, likely beyond. For some countries, these trends signal a need for immediate action. In Belgium, France, and Germany, the epidemics of HCV-related disease are expected to peak within 10 years, leaving little time to expand capacity for HCV testing, care, and treatment.

Second, the Deuffic-Burban et al model also demonstrates the potential impact of HCV therapy in curbing the expected increases in HCV-related cirrhosis and mortality. Assuming no changes in screening or treatment practices in the next 10 years, the authors estimate HCV treatment-related reductions in cirrhosis and mortality by 21% and 12%, respectively. However, the projected declines were not uniform. For example, the authors forecast the greatest impact of HCV therapy for France (39% reduction in cirrhosis, 26% decreases in mortality), where the authors estimate a larger proportion of HCV-infected persons are tested and receive treatment.

Finally, the model of Deuffic-Burban et al also suggests a greater payoff in disease averted and lives saved when improvements in HCV therapy are accompanied by expanded access to HCV testing, care, and treatment. Although the data are sparse, the author's estimate that with the exception of France, ≤50% of HCV-infected persons have been tested. The authors demonstrate that increases in HCV testing and treatment could result in an additional 26% reduction in cirrhosis cases and 20% reduction in deaths averted among persons living with hepatitis C.

With the availability of effective HCV therapies, countries can use data and models, like those employed by Deuffic-Burban et al, to reconsider and realign their prevention priorities. In the United States, where an estimated 45%-85% of HCV-infected persons are unaware of their infection,16 national priorities for HCV prevention are being transformed to help identify HCV-infected persons and link them with care and treatment. Specifically, the CDC recently expanded its HCV testing guidelines to recommend a 1-time HCV test for all persons born in and between 1945 and 1965, reflecting the high HCV prevalence (5-fold greater than other adults in the United States), burden of HCV infection and mortality (approximately 75% of all HCV infections for both) among persons in this population.16 With full implementation of this strategy, CDC estimates that 800,000 persons currently unaware of their HCV infection will be identified. Moreover, when persons found to be HCV infected are linked to appropriate care and direct-acting antiviral agents treatment, >120,000 HCV-related deaths will be averted. With forecasted estimates and additional primary data points, other countries can examine their existing HCV testing policies and design new approaches tailored for their own epidemiologic characteristics of infection, resulting in greater reductions in HCV morbidity and mortality trends.

The health impact of expanded HCV testing can only be achieved when persons found to be infected with HCV receive appropriate care and treatment. Thus, regardless of country, policies must be accompanied by resources for a comprehensive set of implementation activities (eg, community education, provider training, laboratory quality assurance, and antiviral therapy). National plans can bring together different health sectors to improve HCV prevention by ensuring that more persons receive testing and recommended care and treatment services.17 Recognizing the need for such policies, the US Department of Health and Human Services published a viral hepatitis action plan in 2011 that outlines explicit steps for improving HCV testing, care, and treatment.18

The limitations in the Deuffic-Burban et al model highlight the need for better primary data to inform decision making for health policies to prevent HCV and reduce HCV-associated morbidity and mortality. Despite these limitations, the trends identified by the authors underscore the powerful call to action needed to mitigate the harm of HCV infection: HCV morbidity and mortality are increasing, and these increases can be curbed by expanded access to HCV testing and a growing array of effective HCV therapies. This era of effective therapy for HCV creates opportunities for health leaders worldwide to identify and implement new strategies that increase the number of HCV-infected persons who are aware of their infection and who receive effective treatment. Further, with the collection of more robust primary data, countries can employ strategies reflective of their local epidemiology and feasible for their health systems. By implementing these changes, countries can achieve population-wide reductions in HCV-associated morbidity and mortality.

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City hitting hepatitis C

By CARL CAMPANILE

Last Updated: 1:41 AM, March 17, 2012

Posted: 1:41 AM, March 17, 2012

The Bloomberg administration is launching a campaign to prevent the spread of the deadly hepatitis C virus, The Post has learned.

The Check Hep C initiative targets high-risk populations in Harlem, the South Bronx, central Brooklyn and parts of Staten Island and Queens.

At-risk populations include drug users who have shared infected needles, people infected with HIV and immigrants from countries with high hepatitis prevalence, including Egypt, Pakistan and the former Soviet Union.

Hepatitis C, when undetected, can cause fatal liver disease.

The city Health Department will award up to $1.3 million in contracts to community-based medical clinics that would provide free counseling and hepatitis C testing.

Patients will also be given a “health coach” to help navigate the medical system. And there will be a community-awareness campaign to reach those at risk.

The Fund for Public Health, the fund-raising arm of the Health Department, is providing financing for the project.

ccampanile@nypost.com

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Bristol-Myers Squibb Foundation Announces Grants Focused on Prevention, Diagnosis and Care of Hepatitis B and Hepatitis C in Asia

PRESS RELEASE

Feb. 18, 2012, 9:00 a.m. EST

PRINCETON, N.J., Feb 18, 2012 (BUSINESS WIRE) -- The Bristol-Myers Squibb Foundation has awarded three new grants to improve prevention, diagnosis and care of hepatitis B (HBV) and hepatitis C (HCV) in China and India as part of its Delivering Hope(TM): Awareness, Prevention and Care umbrella program which is committed to reducing hepatitis-related health disparities in Asia. China and India together have an estimated 123 million people chronically infected with HBV and 59 million people chronically infected with HCV, accounting for almost 50 percent of all HBV and HCV infections worldwide.

The grant recipients, which range in scope from national and regional government health, charitable non-profit and advocacy organizations, were announced at the Asian Pacific Association for the Study of the Liver (APASL) 2012 Conference in Taipei, Taiwan, where leaders in the hepatology field gathered to promote scientific advancement and education in the Asia Pacific region. Organizations and projects receiving support include:

-- The Chinese Foundation for Hepatitis Prevention and Control (CFHPC), working in partnership with the Chinese Center for Disease Control and Prevention and Shanxi Center for Disease Control, will enhance HCV prevention, diagnosis, support and care through training of physicians and health providers at various levels, as well as patient and community outreach in the Shanxi Province.

-- The Shanghai Charity Foundation (China) will create a first of its kind program targeting high risk groups with disease management initiatives for HCV and HBV in Shanghai. This will include vaccinations, screenings and behavior change programs to strengthen prevention efforts.

-- The Liver Foundation, West Bengal (India) will establish and maintain an advocacy platform focused on empowerment of hepatitis patients, ensuring knowledge and awareness of their disease, rights and privileges, as well as access to care.

"The benefit of these organizations and programs lies in their ability to empower people in local communities with knowledge about prevention, diagnosis and care of hepatitis C and hepatitis B," said John Damonti, president, Bristol-Myers Squibb Foundation. "Through Delivering Hope, The Bristol-Myers Squibb Foundation continues to harness expertise and resources in community-based programs, and leverage those best practices to help others."

The mission of the Bristol-Myers Squibb Foundation is to help reduce health disparities in communities where the need is greatest. Marking a decade of support, Delivering Hope has invested and initiated 38 program grants across Asia totaling more than $9.7 million USD, specifically 16 grants in mainland China, three in Taiwan, 15 in India and four in Japan. In keeping with the Foundation's commitment to sharing lessons learned, funding recipients participated in a two-day conference to discuss tracking and reporting outcomes, impact and best practices. These reports will be shared with the HBV and HCV community to enhance the body of knowledge on hepatitis prevention, care and support.

About Chronic Hepatitis B

Chronic hepatitis B is a serious global health issue and is transmitted by person-to-person contact with infected blood or bodily fluids. Worldwide, more than 2 billion people have been in contact with the hepatitis B virus and approximately 350 million people are chronically infected, resulting in about one million deaths annually from liver cancer, cirrhosis or liver failure.

About Hepatitis C

Hepatitis C is a virus that infects the liver and is transmitted through direct contact with blood. An estimated 170 million people worldwide are infected with hepatitis C. One to five percent of people with chronic infection will develop liver cancer. Although there is no vaccine to prevent hepatitis C, it is a curable disease.

About Bristol-Myers Squibb Foundation and Delivering Hope

The Bristol-Myers Squibb Foundation is an independent charitable organization whose mission is to reduce health disparities and improve health outcomes around the world for patients disproportionately affected by serious disease. The Foundation accomplishes this by strengthening community-based health care worker capacity, integrating medical care and community-based supportive services, and mobilizing communities in the fight against disease.

The Foundation has supported efforts in Asia since 2002, initially focusing on preventing mother-to-child transmission of hepatitis B and promoting hepatitis B immunization in China. In 2006, the Foundation expanded those efforts to provide broader support for hepatitis B and C awareness, prevention and education, including the adoption of hepatitis B and C interventions and education in public health programs.

Today, the Foundation's priority hepatitis B and C programs encompass capacity building for health care professionals and lay health workers, disease education and awareness, and sharing of best practices in the prevention and management of hepatitis B and C to inform public health policy.

Beyond hepatitis, the Foundation also focuses on HIV/AIDS in Africa through its SECURE THE FUTURE(R) program; cancer in Central and Eastern Europe through its Bridging Cancer Care(TM) program; and diabetes and mental-health in the United States through its Together On Diabetes(R) and Mental Health and Well-Being in the U.S. programs. For more information, view the Bristol-Myers Squibb Foundation's Web site at: http://www.bms.com/foundation/pages/home.aspx .

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit www.bms.com , or follow us on Twitter at http://twitter.com/bmsnews .

SOURCE: Bristol-Myers Squibb

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