Showing posts with label HCV Baby Boomers. Show all posts
Showing posts with label HCV Baby Boomers. Show all posts

Friday, April 18, 2014

Previous Exposure to HCV Among Persons Born During 1945–1965

Previous Exposure to HCV Among Persons Born During 1945–1965

Prevalence and Predictors, United States, 1999-2008

Bryce D. Smith, PhD, Geoff A. Beckett, PA-C, MPH, Anthony Yartel, MPH, Deborah Holtzman, PhD, Nita Patel, DrPH, John W. Ward, MD
Am J Public Health. 2014;104(3):474-481.

Abstract and Introduction

Objectives. We examined HCV exposure prevalence and predictors among persons in the United States born during 1945–1965.

Methods. With data from the 1999–2008 National Health and Nutrition Examination Survey, we calculated the proportion of persons born during 1945–1965 who tested positive for HCV antibody (anti-HCV) and analyzed the prevalence by sociodemographic and behavioral risk factors.

Results. Anti-HCV prevalence in the 1945–1965 birth cohort was 3.2% (95% confidence interval [CI] = 2.8%, 3.8%), substantially higher than among other adults (0.9%). Within the cohort, anti-HCV prevalence was higher among non-Hispanic Blacks (6.4%; 95% CI = 5.3%, 7.7%), persons with injection drug use histories (56.8%; 95% CI = 48.4%, 64.8%), and persons with elevated alanine aminotransferase levels (12.7%; 95% CI = 10.7%, 15.1%). Injection drug use (adjusted odds ratio = 98.4; 95% CI = 58.8, 164.5) was the strongest anti-HCV prevalence predictor. Among anti-HCV–positive persons, 57.8% reported having 2 or more alcoholic drinks daily.

Conclusions. With the high prevalence of HCV among persons born during 1945–1965, the increasing morbidity and mortality associated with HCV, and reductions in liver cancer and HCV-related mortality when HCV is eradicated, it is critically important to identify persons with HCV and link them to appropriate care.

In the United States, the incidence of HCV infection rose dramatically through the 1970s and 1980s reaching more than 200 000 new infections per year through the mid- to late-1980s.[1] This high incidence resulted in a disproportionately high burden of HCV infection among Americans who were born between the mid-1940s and the mid-1960s, a birth cohort popularly referred to as the baby boom generation.[2] Alter et al. first documented the relatively high prevalence of HCV infection among this cohort in their analysis of1988–1994 National Health and Nutrition Examination Survey (NHANES) data, reporting that 65% of persons with HCV infection were aged 30 to 49 years during the survey period.[3] In an analysis of NHANES data from 1999 to 2002, a similarly high proportion of all persons with HCV antibody had been born from 1945 through 1964.[1] This cohort effect on the high prevalence of HCV infection in the baby boom generation has been attributed largely to exposures (principally injection drug use [IDU] and blood transfusion before 1992) that occurred many years before the survey periods.[1,3] However, a significant proportion of HCV-infected persons do not report any risk factors,[4–6] perhaps because of fear of being stigmatized,[7] or simply lack of recall or knowledge of exposures such as those that may occur in health care settings.[8,9]

A validated Markov model forecasting lifetime morbidity and mortality attributable to HCV infection projected that of 2.9 million persons with untreated HCV infection who did not have cirrhosis of the liver in 2005, 1 071 000 (36.8%) will die from complications of HCV.[10] In the United States, HCV-associated disease is the leading indication for liver transplantation and HCV infection is a leading cause of hepatocellular carcinoma.[11–14] Approximately 73.9% of HCV-associated mortality occurs among persons born from1945 to 1965.[15]

In 1998, the Centers for Disease Control and Prevention recommended[16] that persons with certain risk factors (e.g., any history of IDU) or medical conditions (e.g., persistently elevated alanine aminotransferase [ALT] levels) be tested for HCV infection. Despite these recommendations, testing practices over the past decade have had limited success in identification of HCV infection in the United States as estimates of the proportion of persons who are unaware of their infection range from 40% to 85%.[17–20] Contributing to the limited success of the recommendations is the difficulty in obtaining risk behavior history that occurred in the distant past, the primarily asymptomatic nature of the infection, and a less than optimal level of physician knowledge regarding the natural history and prevalence of infection, the current recommendations for testing, and interpretation of test results.[21–24]

In 2011, the prospects for successful medical treatment of HCV infection were significantly improved with the US Food and Drug Administration licensure of 2 direct-acting antiviral medications, both in the protease inhibitor class. In clinical trials, the rates of sustained viral response—equivalent to a "virological cure"—increased from 44% with use of the current standard regimen, to 75% when a direct-acting antiviral medication was added to that regimen in treatment of persons infected with HCV genotype 1, the genotype that is most common in the United States.[25] Since this article was accepted for publication, the US Food and Drug Administration has approved new HCV medications[26,27] that have further increased cure rates to as high as 90% in clinical trials.

Persons who achieve a sustained viral response after treatment experience significantly less liver-related morbidity (including hepatocellular carcinoma),[28] less liver-related mortality,[29] and reductions in all-cause mortality.[30] However, the potential population benefits from these improvements in treatment effectiveness will be limited unless there are concurrent increases in the rate of identification and treatment of HCV-infected persons.[31]

Because of the limited effectiveness of risk based testing strategies to date and the high prevalence of HCV infection and projected disease burden, the Centers for Disease Control and Prevention recently issued the Recommendations for the Identification and Initial Care of Chronic Hepatitis C Virus Infection Among Persons Born During 1945–1965[32] with the goal of identifying persons with HCV infection who are undiagnosed. The recommendation was subsequently made by the US Preventive Services Task Force.[33] The purpose of the current study was to determine the proportion of persons in the birth cohort who were positive for antibody to HCV (anti-HCV), and to examine the sociodemographic and behavioral risk factors associated with anti-HCV prevalence.

We analyzed NHANES data collected from 1999 to 2008. NHANES is an annual nationally representative multistage, stratified probability cluster survey of the US civilian, noninstitutionalized population. Information on the survey design and implementation, including institutional review board approval and consent, is detailed in the survey documentation.[34,35]
Anti-HCV testing is administered to NHANES participants aged 6 years or older. We restricted our analysis to adult participants born from 1945 to 1965 who were interviewed and provided serum samples for anti-HCV testing. Birth year was estimated by subtracting participant age at time of survey from estimated year in which participant was surveyed. Because NHANES does not release data on participant birth year or the actual year in which a participant was interviewed or examined, we estimated the earliest survey year for each participant according to the variable, "six month time period when the examination was performed: November 1 through April 30, May 1 through October 31." As an example, for the 1999–2000 survey cycle, participants examined from November 1 to April 30 were assigned an earliest survey year of 1999 and those examined from May 1 through October 30 were assigned to the 2000 survey year. We excluded participants without specimens for testing and those with indeterminate anti-HCV results from the final analytic sample.

Outcome Variable
The outcome measure was anti-HCV prevalence as determined by serologic testing. We chose anti-HCV status as an endpoint because HCV RNA testing was not performed for the 2003–2004 NHANES cycle, and we determined that combining data from all 10 years (1999–2008) was necessary to achieve sufficient subdomain sample sizes for improved precision and reliability of point estimates.

Specimens were tested for antibodies to HCV by repeated enzyme-linked immunosorbent assay (ELISA version 3.0, Ortho Diagnostic Systems Inc, Raritan, NJ). Reactive specimens were confirmed by recombinant immunoblot assay (RIBA version 3.0, Chiron Corporation, Emeryville, CA). Participants who tested positive by both ELISA and RIBA were categorized as anti-HCV–positive.

Independent Variables
We examined the following independent variables as potential predictors or confounders of anti-HCV prevalence within the birth cohort: race/ethnicity, gender, country of birth, veteran status, marital status, educational attainment, family income, health insurance status, daily alcohol consumption within the past 12 months, age at first sexual intercourse, number of lifetime sexual partners, lifetime IDU (cocaine, heroin, and methamphetamine), history of blood transfusion before 1992, and ALT level.[1,3] We categorized race/ethnicity as non-Hispanic White, non-Hispanic Black, Mexican American, and other. We categorized educational attainment as completed less than high school and completed high school or more; marital status as married or living with partner, divorced or separated or widowed, and never married; and family income as greater than 2 times federal poverty threshold, 1 to 2 times federal poverty threshold, and less than the federal poverty threshold. We defined elevated ALT as 40 or more international units per liter. For independent variables with 10% or more of observations with missing values, we created an "unknown" category to include those missing values as valid for analysis. Accordingly, we categorized alcohol consumption as 0 or 1, 2 or more, and unknown number of drinks per day within the past year; age at first sexual intercourse as 17 years or younger, 18 years or older, and unknown; number of lifetime sexual partners as 0 to 9, 10 to 19, 20 or more, and unknown; lifetime drug use as never, non–injection drug use, IDU, and unknown.
NHANES questions related to sexual behavior and history of IDU are restricted to adult participants younger than 60 years. Thus, all analyses involving these variables in the current study were similarly restricted.

Statistical Analysis
We generated proportions and 95% confidence intervals (CIs) to describe the characteristics of the 1945–1965 birth cohort. We also produced estimates of anti-HCV prevalence in the birth cohort and by subgroups. We specified linear contrasts of estimates to test for statistical differences in characteristics between anti-HCV–positive participants and all participants, and to test for differences in anti-HCV prevalence between subgroups. We assessed statistical reliability of estimated proportions by evaluating relative standard errors (< 30%) and by ensuring that subdomains met NHANES minimum sample size requirements. We generated unadjusted odds ratios from univariate logistic regression models. We defined statistical significance as P value less than .05.

We developed a multivariate logistic regression model to identify independent risk factors associated with anti-HCV positivity within the birth cohort after we controlled for covariates. We specified an estimated full model by including all independent variables with a P value of less than .1 from the univariate analyses. Using a backward elimination procedure, we removed variables with the lowest observed partial F-statistic at a predetermined P value of less than .1. We simultaneously tested for 2-way interaction effects between race and IDU or gender and IDU, by using multiple partial F-tests. We assessed multicollinearity among covariates by review of diagnostic statistics including variance inflation factors (> 2.5), condition indices (> 15), and variance proportions (> 0.5; SAS version 9.3, SAS Institute, Cary, NC). In deciding whether to exclude a covariate because of collinearity, we also considered the relative importance of the covariate, its relationship with key variables such as IDU, and its contribution to the overall model fit.

We used the Hosmer–Lemeshow goodness-of-fit test to evaluate the overall fit of the final model. Except as otherwise specified, we analyzed all data with SAS-callable SUDAAN to account for the complex survey design (version 10.0.1, Research Triangle Institute, Research Triangle Park, NC). We rescaled sample weights after combining data across multiple survey years. We estimated variance and standard errors by using the Taylor series (linearization) method

We identified a total of 8167 participants estimated to be born from 1945 to 1965 who were both interviewed and examined. After we excluded participants without specimens (n = 411) and those with indeterminate anti-HCV results (n = 33), the final analytic sample for the birth cohort was 7723 (95% of those examined). Table 1 shows the demographic, behavioral, and clinical characteristics of the birth cohort population and those in the cohort who were anti-HCV–positive. Relative to the total birth cohort population, a greater proportion of anti-HCV–positive participants were male, non-Hispanic Black, had a family income below the poverty threshold, and had no health insurance coverage. Among anti-HCV–positive participants, 41.9% reported a history of IDU, 16.2% received a blood transfusion before 1992, 57.8% consumed 2 or more alcoholic drinks per day, and 51.3% had elevated ALT levels. Combined, persons with a history of IDU or blood transfusion accounted for 51.7% of anti-HCV–positive participants; 48.3% reported no known exposure risks.

Prevalence of Anti-HCV in the Birth Cohort
Prevalence estimates for the birth cohort and subgroups are presented in Table 2. The overall prevalence of anti-HCV in the birth cohort was estimated at 3.2% (95% CI = 2.8%, 3.8%) or approximately 2.8 million (2.4 million to 3.2 million) persons with anti-HCV. Anti-HCV prevalence was higher among men (4.3%; 95% CI = 3.6%, 5.2%), non-Hispanic Blacks (6.4%; 95% CI = 5.3%, 7.7%), and persons with a family income below the poverty threshold (7.8%; 95% CI = 6.3%, 10.0%), respectively, compared with women, non-Hispanic Whites, and persons with a family income of more than 2 times the poverty threshold.

Table 2.  Characteristics and Risk Factors Associated With HCV Antibody Prevalence Among Adults Born From 1945 to 1965: National Health and Nutrition Examination Survey, 1999–2008
CharacteristicParticipants Tested, No.Prevalence of Anti-HCVUnadjusted Odds Ratios
% (95% CI)P a Unadjusted OR (95% CI)P
Overall77233.2 (2.8, 3.8)
   Female (Ref)39112.2 (1.7, 2.9)1.0
   Male38124.3 (3.6, 5.2)< .0012.0 (1.4, 2.8)< .001
   Non-Hispanic White (Ref)36482.9 (2.3, 3.6)1.0
   Non-Hispanic Black17006.4 (5.3, 7.7)< .0012.3 (1.7, 3.0)< .001
   Mexican American15643.3 (2.4, 4.4).511.1 (0.8, 1.6).5
Marital status
   Married or living with partner (Ref)51702.7 (2.2, 3.4)1.0
   Divorced, separated, or widowed16404.3 (3.3, 5.5).241.6 (1.1, 2.3).02
   Never married7475.7 (4.0 8.0).0042.2 (1.4, 3.3)< .001
Country of birth
   United States58363.6 (3.1, 4.2)< .0013.3 (1.9, 5.6)< .001
   Other (Ref)18841.1 (0.7, 1.8)1.0
Education level
   £ high school38384.8 (4.0, 5.9)< .0012.3 (1.7, 3.1)< .001
   > high school (Ref)38792.2 (1.8, 2.7)1.0
Family income to poverty threshold
   > 2 times (Ref)44642.1 (1.7, 2.7)1.0
   1–2 times15245.6 (4.2, 7.5)< .0012.8 (1.9, 4.1)< .001
   Below11837.8 (6.3, 9.6)< .0013.9 (2.9, 5.3)< .001
Health insurance coverage
   Yes (Ref)59192.7 (2.3, 3.1)1.0
   No17576.2 (4.8, 8.0)< .0012.4 (1.8, 3.3)< .001
Served in the US armed forces
   No (Ref)67653.0 (2.5, 3.5)1.0
   Yes9555.1 (3.7, 6.9).011.7 (1.2, 2.5).004
Average no. of alcoholic drinks/d, last y
   0–1 (Ref)24921.2 (0.8, 1.8)1.0
   ‡ 232724.3 (3.6, 5.3)< .0013.7 (2.3, 5.9)< .001
   Unknown19594.2 (3.3, 5.2)< .0013.6 (2.3, 5.6)< .001
Age at first sexual intercourse (up to 59b y; n = 7210), y
   £ 1732585.0 (4.3, 5.9)< .0013.7 (2.5, 5.5)< .001
   ‡ 18 (Ref)28711.4 (1.0, 2.1)1.0
   Unknown10813.5 (2.5, 5.0).0042.5 (1.5, 4.4)< .001
No. of lifetime sexual partners (up to 59b y; n = 7210)
   0–9 (Ref)45071.4 (1.0, 2.0)1.0
   10–199163.9 (2.6, 5.7).0012.9 (1.8, 4.6)< .001
   ‡ 2011339.9 (8.2, 11.9)< .0017.8 (5.2, 11.8)< .001
   Unknown6544.5 (3.1, 6.5).0013.3 (1.9, 5.7)< .001
Lifetime drug use (up to 59b y; n = 7210)
   Never (Ref)51011.2 (0.9, 1.6)1.0
   Non-IDU12803.7 (2.8, 4.8)< .0013.1 (2.1, 4.5)< .001
   IDU18756.8 (48.4, 64.8)< .001107.0 (69.3, 165.1)< .001
   Unknown6424.7 (3.3, 6.8)< .0014.0 (2.5, 6.6)< .001
Blood transfusion before 1992
   No (Ref)70302.9 (2.5, 3.5)1.0
   Yes5816.7 (4.8, 9.4).0022.4 (1.6, 3.5)< .001
Serum alanine aminotransferase level, U/L
   < 40 (Ref)65991.8 (1.5, 2.2)1.0
   ‡ 40105612.7 (10.7, 15.1)< .0018.0 (6.0, 10.5)< .001
Note. Anti-HCV = HCV antibody; CI = confidence interval; IDU = injection drug use; OR = odds ratio.

aObtained by specifying linear contrasts of proportions among the levels of the subgroups.

bNational Health and Nutrition Examination Survey data collection on certain risk factors was limited to participants aged 20–59 years at time of survey; accordingly the 2005–2006 and 2007–2008 National Health and Nutrition Examination Survey cycles do not contain data risk factor for participants born in 1945–1946 and 1945–1948, respectively.

Among participants reporting a history of IDU, 56.8% (95% CI = 48.4%, 64.8%) were anti-HCV–positive compared with 1.2% (95% CI = 0.9%, 1.6%) for those who had never used any illicit drugs. Persons who received a blood transfusion before 1992 had a higher prevalence of anti-HCV (6.7%; 95%CI = 4.8%, 9.4%) than did those without this history (2.9%; 95% CI = 2.5%, 3.5%). Among persons with elevated ALT levels, 12.7% (95% CI = 10.7%, 15.1%) were anti-HCV–positive relative to 1.8% (95% CI = 1.5%, 2.2%) for those with normal ALT levels.

Factors Associated With Anti-HCV Prevalence Within the Birth Cohort
Unadjusted odds ratios (ORs) and 95% CIs for characteristics associated with anti-HCV prevalence are displayed in Table 2. Men, non-Hispanic Blacks, and persons with a family income below the poverty threshold, respectively, were more likely to be anti-HCV–positive compared with women, non-Hispanic Whites, and persons with family income of more than 2 times the poverty level. Injection drug use was the strongest predictor of anti-HCV prevalence among the birth cohort. Other characteristics significantly associated with anti-HCV prevalence were elevated ALT level, consumption of 2 or more alcoholic drinks per day, sexual intercourse before age 18 years, 20 or more lifetime sexual partners, and blood transfusion before 1992.

After we controlled for covariates in a multivariate logistic regression model (Table 3), IDU (adjusted OR = 98.4; 95% CI = 58.8, 164.5) remained the strongest predictor of anti-HCV prevalence. We also identified the following variables as significant risk factors for anti-HCV prevalence in the multivariate model: elevated ALT level (9.0; 95% CI = 6.0, 13.7), a family income below the poverty threshold (4.7; 95% CI = 3.0, 7.4), US-born (3.2; 95% CI = 1.7, 6.1), non-Hispanic Black race (2.3; 95% CI = 1.7, 3.2), and blood transfusion before 1992 (2.3; 95% CI = 1.3, 4.0). We removed number of sexual partners and age at first sexual intercourse from the multivariate model because of collinear relationships with IDU. No interaction terms were significant.

These findings highlight the relatively high prevalence of anti-HCV (3.2%) among persons in the 1945–1965 birth cohort compared with the prevalence among adults aged 20 to 70 years during the 1999–2008 survey period, but born before 1945 or after 1965 (0.9%; unpublished Centers for Disease Control and Prevention data); persons in the birth cohort were 4 times more likely to be anti-HCV–positive than adults outside the cohort. Our finding that history of IDU, blood transfusion, elevated ALT, Black race, and poverty were associated with HCV infection within the birth cohort is consistent with previous findings based on the general US adult population.[1,3] However, IDU and blood transfusions before 1992, the most common exposure risks reported by persons infected with HCV, account for only 52% of infections and the remaining 48% report no known exposure risk and may not be identified through risk-based testing approaches. Testing for HCV infection on the basis of the birth cohort presents an opportunity to identify a significant proportion of cases that may otherwise go undetected in a subpopulation that accounts for approximately 75% of the burden of HCV infection in the adult US population.[5] The 1945–1965 birth cohort has the highest incidence of HCV-related liver disease and death, which is projected to increase sharply over the next 2 decades.[10,36,37]

Most persons in the birth cohort are likely to have been infected for 20 to 40 years or more, and multiple models have indicated that there will be dramatic increases in the numbers of HCV-infected persons with significant liver disease over the next 10 to 20 years[31,38] without effective public health interventions. Even with declining prevalence in the overall US population, HCV disease burden is expected to increase significantly because of the aging of the infected population.[10,36] Identification of HCV-infected persons and planning for care and therapy now, however, will improve efforts for long-term care and management of the infected population.[39] Although treatment response is better among persons younger than 40 years than those aged 40 years or older, persons older than 65 years have been shown to respond as well to therapy as those between the ages of 40 and 65 years, a fact that will become increasingly important as the birth cohort ages into retirement.[40]

For HCV-infected persons for whom antiviral treatment is indicated,[41] there have been recent medical advances that significantly improve the efficacy of therapy. Unfortunately, HCV treatment rates are low.[42] We found that almost one third of anti-HCV–positive persons in this cohort report being uninsured, a problem that certainly contributes to low treatment rates and difficulty accessing care. Expansion of coverage for medical care could increase access to care and treatment.
Even for those infected persons who do not receive antiviral medication, because of treatment contraindications or for other reasons, interventions are available that may limit disease progression and decrease HCV transmission to other persons. Reducing alcohol use can prevent exacerbation of liver disease. In our analysis, however, we found that nearly 58% of anti-HCV–positive persons in the birth cohort reported drinking 2 or more alcoholic drinks per day on average. Alcohol use is associated with development and progression of fibrosis and significant increase in liver-related and overallmortality.[41,43,44] Among HCV-infected persons, history of and current moderate alcohol use (approximately 2 drinks/day or less) have been found to be associated with a 2-fold increase in all-cause mortality and 7-fold increase for those who report drinking 2 or 3 drinks per day.[43] The prevalence of alcohol use among anti-HCV–positive birth cohort members suggests that use of Screening and Brief Interventions for Referral for Treatment of the Reduction of Alcohol Use as recommended by the US Preventive Services Task Force may be beneficial.[45] It has furthermore been suggested that, among heavy drinkers, knowledge of HCV-positive status and brief counseling received from health care providers upon diagnosis may be important factors in the reduction of alcohol use.[46,47]

There are limitations in this study. First, NHANES samples include only the US civilian, noninstitutionalized population. A large number of high-risk persons who are incarcerated, institutionalized, or homeless are excluded; thus, these analyses are likely to result in an underestimate of anti-HCV prevalence. Second, behavioral risk-factor data were limited to participants aged 60 years or younger. As a consequence, for the 2005–2006 NHANES cycle, no risk-factor information was available for participants born during 1945–1946 (who would have been aged 60–61 years during the 2005–2006 cycle). Likewise, there were no risk factor data for participants born during 1945– 1948 in the 2007–2008 cycle. Third, nearly all risk-factor data used in this analysis were self-reported. Participants may overreport or underreport behaviors in response to questions such as IDU or number of lifetime sexual partners, which might bias our results. Fourth, participant birth year was approximated from estimated year of interview and age at survey.
Finally, we did not examine differences by sociodemographic and risk characteristics between persons who knew and those who did not know their HCV-infection status (positive or negative) before testing because prior knowledge of HCV-infection status is not assessed for NHANES participants. However, among participants who test positive for anti-HCV or those with an indeterminate test result for anti-HCV plus a positive HCV-RNA, NHANES conducts a separate follow-up survey to ascertain knowledge of HCV infection status before receiving notification of results from NHANES. Although analyses[31,48] of the follow-up survey data have suggested differences— by age, access to health care, knowledge of risk factors—between HCV-positive persons who were aware of their status versus those who were unaware, those findings are by themselves limited by small sample sizes, low survey response rates, and their lack of generalizability to all persons, HCV-positive or -negative.

This study provides additional evidence of the high prevalence of anti-HCV among persons in the 1945–1965 birth cohort consistent with earlier studies of infection prevalence. Considerable racial and socioeconomic disparities by anti-HCV positivity status also are apparent within the cohort. High rates of alcohol use reported by anti-HCV–positive respondents suggest the importance of diagnosing infection and providing effective interventions to decrease alcohol consumption and slow the progression of liver disease. In light of the high prevalence of HCV infection among persons born during 1945–1965, the increasing morbidity and mortality associated with HCV infection, and reductions in liver cancer and HCV-related mortality when HCV infection is eliminated, it is critically important to identify those persons living with hepatitis C and link them to appropriate care and treatment.


Friday, January 17, 2014

Treatment of Chronic Hepatitis C Virus Infection: Some Remaining Obstacles in the United States

Treatment of Chronic Hepatitis C Virus Infection: Some Remaining Obstacles in the United States

Liver International
Accepted Articles, Accepted manuscript online: 13 JAN 2014

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

Review Article

Gloria Searson1, Ellen S. Engelson2,  Damaris Carriero1,3, Donald P. Kotler1,2,*
DOI: 10.1111/liv.12467

This article is protected by copyright. All rights reserved.

Publication History
Accepted manuscript online: 13 JAN 2014 01:05AM EST
Manuscript Accepted: 6 JAN 2014
Manuscript Revised: 25 DEC 2013
Manuscript Received: 27 JUN 2013

Keywords: effectiveness research;  health disparities;  substance abuse; alcoholism;  chronic liver disease

Hepatitis C infection is an important problem in inner city neighborhoods, which suffer from multiple health disparities. Important factors in this population include alcoholism and substance abuse, mental illness, and homelessness, which may be combined with mistrust, poor health literacy, limited access to health care, and outright discrimination. Systemic barriers to effective care include a lack of capacity to provide comprehensive care, insufficient insurance coverage, poor coordination among caregivers and between caregivers and hospitals, as well as third party payers. These barriers affect real world treatment effectiveness as opposed to treatment efficacy, the latter reflecting the world of clinical trials. The components of effectiveness include efficacious medications, appropriate diagnosis and evaluation, recommendation for therapy, access to therapy, acceptance of the diagnosis and its implications by the patient and adherence to the recommended therapy. Very little attention has been given to assisting the patient to accept the diagnosis and adhere to therapy, i.e., care coordination. For this reason, care coordination is an area in which greater availability could lead to greater acceptance/adherence and greater treatment effectiveness

These are exciting times in the field of Hepatitis C virus (HCV) infection. After many years of ominous predictions, the outlook fo r HCV-infected patients has im proved substantially with the introduction of direct acting agents (1, 2). However, it is too soon to declare victory. It has even been said that we are only ‘at the end of the beginning’ of the struggle (3). There are several remaining obstacles. The purpose of this paper is to enumerate and discuss some of the remaining barriers to effective HCV treatment in the United States, predominantly from an inner city perspective.

The medical and economic burdens of HCV have been increasing for the past 3 decades (4, 5), and will continue to rise for the next 15 years. The burden of managing HCV-infected patients will fall increasingly on public institutions, i.e., inner city hospitals, clinics and community health centers, and the costs will shift progressively to public payers, such as Medicaid and Medicare (5). Official estimates of disease prevalence in the United States range from around 4 million (6) to as high at 7 million (7 ). The largest subgroup, comprising almost 80%, was born between 1945 and 1965 (8). Other cohorts of HCV-infected individuals exist, including immigrants, patients with sexually transmitted HCV infection, plus other routes of transmission, including nosocomial. A majority are unaware of their HCV serostatus (9).

There are multiple obstacles to access of effective antiviral therapy in all countries, with variations within and between them for different subgroups of patients. The barriers can be classified as virologic, host, and systemic. Virologic factors will not be considered here. Host factors may be modifiable or non-modifiable. In addition to age, sex and HIV co-infection, genetic factors exist, such as the IL28B polym orphism, which partially explain the observed racial variation in treatment re sponse (15). While hepatitis C has its highest prevalence in a cohort defined by birth year, it is an especially important problem in African-American communities. The authors’ institutions treat residents of Harlem and surrounding neighborhoods in New York City, which have high prevalence rates for HCV infection and other co-morbidities (10). Similar conditions exist in many inner-city environments in the US.

It is not appropriate to discuss HCV infection in African-Americans without noting the presence of health disparities in general. In a recent publication, Williams and colleagues noted that overall death rates in African-Americans are 30% higher than in Caucasians (11), with higher death rates for 10 of the 15 leading causes of death, though not for liver cirrhosis. Health disparities also exist in HCV infection, in terms of higher prevalence (6) and poorer response to therapy (12). Despite these facts, African-Americans have long been under-represented in clinical trials (13). To identify and reduce such disparity, the FDA Safety and Innovation Act, recently passed by Congress, requires the FDA to report annually on the inclusion of subjects by age, sex, race, and ethnicity in clinical trials supporting applications of new drugs and medical devices (14).

Important host factors that are potentially modifiable include substance abuse, mental illness, and homelessness. A co-morbidity that ha s received very little attention is alcoholism. Alcohol accelerates hepatic fibrosis in mono- and co-infected patients with HCV infection (16, 17). A prospective, case-control study published in 1999, of chronic viral hepatitis, alcoholism, and the development of chronic liver disease at Harlem Hospital Center (18) showed that the combination of HCV infection and heavy alcohol intake, but not HCV infection or alcoholism alone, significantly promoted the development of chronic liver disease. The cohort was followed for four years and death rates were numerically higher in the HCV plus alcohol group. The authors called for greater attention to the management of alcoholism to mitigate the development of chronic liver disease, even in the absence of effective anti-HCV therapy at the time. In a review of HCV-infected patients followed over a 15-year period in clinics in Scotland, the fraction of cirrhosis attributable to heavy alcohol intake was estimated at 36%, and at 61% for heavy drinkers (19). Importantly, since active alcoholism is an absolute contraindication to anti- HCV therapy, the subgroup at most risk of disease progression often is excluded from treatment. Recent studies from Switzerland and France have demonstrated reasonable rates of sustained viral response in alcohol-dependent patients (20,21). Poorer responses to anti-HCV therapy in the US VA system were felt to be related more to poorer treatment adherence than a direct effect of alcohol intake (22). Maintaining adherence to treatment may be as important or even a more important goal than enforcing abstinence. A study to test this hypothesis would be one comparing the effects of abstinence and harm reduction. However, while determining the relative importance of HCV and of alcohol intake, including amount, drinking pattern, and chronicity, in liver disease progression is of interest, the ultimate goal of therapy should be to cure both conditions. Other host factors may affect treatment adherence, however. Simoni and colleagues analyzed 13 studies in HIV infection that used electronic drug monitoring. Demographic variables such as sex, age, economic status, education level, plus depression and substance abuse, did not fully explain a lower level of adherence observed in African-American subjects (23). The authors cited evidence that mistrust , poor health literacy, in equalities in access to health care, as well as outright discrimination might be responsible for the differences. Patient mistrust acts synergistically with nihilism and stigmatization to confound attempts at therapy. Patients whose clinical problems are related to socially unacceptably behaviors may be especially prone to feeling stigmatized, while caregivers may unconsciously express bias. Cultural competence, which involves developing attitudes, behaviors, and policies that enable effective work in cross-cultural situations, are routine medical education and core competency initiatives, but have not overcome the prevailing host barriers.

The host barriers to effective treatment may become institutionalized so that caregivers do not aggressively promote and patients do not aggressively seek proven therapies. These biases may be resistant to change.

A substantial proportion of patients currently presenting for HCV testing are aware of their HCV status or of the presence of liver disease (G. Searson, personal observations). In many cases, patients had been told by a health care provider one, two, or three decades ago that they were going to be OK or that their liver tests were relatively normal and not to worry, and now are being told that they have a serious disease. It is especially difficult for the medical establishment to engage patients who exist outside the formal health care system. The Affordable Care Act may be helpful in expanding coverage to some people, but it will not aid people who harbor a fundamental mistrust in the health care system. Community-based organizations may be helpful in this situation; fostering trust by helping people to feel at ease through non-judgmental treatment; creating an environment where people may be more truthful about personal matters: self-worth, future prospects, or even existential concerns.

Systemic barriers to effective care are multiple and diverse. Perhaps the most important is the lack of capacity of our system to provide comprehensive care to our patients. Mental health issues especially often are unrecognized, overlooked, or undertreated. In HIV infection, Ryan White funding allowed the development of a comprehensive care model, with resources devoted to social work needs, including food and shelter, as well as mental health needs. Such support is not available for HCV-infected patients.

Lack of insurance, or insufficient insurance coverage, is common among HCV-infected patients (24). Poor coordination between caregivers and hospitals and between caregivers and third party payers may lead to unanticipated treatment interruptions. Few institutions have a centralized system for toxicity management, relying on standard emergency services. However, a visit to an Emergency Department or a hospital admission is likely to lead to treatment interruption for a patient irrespective of the presenting complaint. Few hospitals have direct- acting anti-HCV agents on formulary and the patient is “supposed to” bring his/her outpatient medications to the hospital, which may not occur in the face of an emergency.

There are two ways to evaluate treatment success: efficacy and effectiveness. Most discussions are centered on the notion of treatment efficacy, which can be defined as the number cured/number treated, and which reflects the world of clinical trials. Inclusion and exclusion criteria minimize the host factors interfering with therapy while the study design and pharmaceutical support minimize the systemic obstacles to therapy. A more accurate measure of treatment success from a public health standpoint is treatment effectiveness, which can be defined as the number cured/number infected. Its importance is seen in the example of alcoholism.

As discussed above , alcoholism increases the risk for developing chronic liver disease, but is a contraindication for therapy, including inclusion in clinical trials. For this reason, alcoholism does not affect measured treatment efficacy though it markedly reduces treatment effectiveness, as might be measured by the prevention of chronic liver disease. Measured rates of effectiveness for pegylated interferon and ribavirin averaged 3.5% in clinical experience (25, 26), while the effectiveness in the registration trials ranged from 12-17%, and efficacy in the same trials aver aged around 45% (discussed in 25).

Recent and emerging advances in therapy will allow the role of new regimens on treatment effectiveness to be determined, especially the application of interferon-free regimens. Treatment efficacy for genotype 1, treatment-naïve patients in clinical trials averaged 40-50%, using pegylated interferon and ribavirin (27), compared to around 75% in trials also using a directing agent (1). However, real world results in an inner city population in New York City showed an efficacy of 14% in genotype 1 patient s. In addition, a recent presentation showed an SVR rate of 43% using a direct acting agent in a similar patient group (28). Treatment effectiveness, including cost effectiveness will require closing the gap between clinical trials and real world results. Depending on the specific community, net effectiveness also may require improvements in the prevention of risk behaviors, which may lead to reinfection after SVR (29). Furthermore, improvements in efficacy are irrelevant for a patient who remains unengaged with the formal health care system.

One can divide treatment effectiveness into several components (30). Effective therapy includes the availability of efficacious medications as well as a system to evaluate patients appropriately, recommend therapy, provide access to therapy, as well as patient compliance with the evaluation and recommendations as well as adherence to therapy. Developing efficacious medications is the task of the pharmaceutical industry, while making diagnoses and treatment recommendations plus providing access to therapy are tasks for the health care system. Accepting the diagnosis and adhering to therapy is the job of the patient and patient advocates. While great effort has gone into developing efficacious therapies and an increasing amount of attention is being given to screening, diagnosis, and evaluation, less attention has been placed on treatment access and very little attention has been given to assisting the patient to accept the diagnosis and adhere to therapy, i.e., care coordination. For this reason, care coordination is an area in which greater availability, supported by a currently nonexistent funding source, could lead to greater acceptance/adherence, and greater treatment effectiveness. The elements of care coordination, which include individual counseling, education, behavioral modification, and other support, are the same for the management of many diseases.

In summary, if we can overcome the obstacles to care delineated above, then treatment effectiveness will equal efficacy.


Thursday, January 9, 2014

Baby Boomers and the Hepatitis C Boom

Annals of Emergency Medicine

Volume 62, Issue 6
Pages A19-A21, December 2013

Baby Boomers and the Hepatitis C Boom
Ryan L. Nave

(Special Contributor to Annals News & Perspective)
Section editor: Truman J. Milling, Jr, MD

It didn't take long after rolling out a new screening program for emergency physicians at the University of Alabama at Birmingham (UAB) to realize the scope and complexity of what has been called a silent killer for baby boomers: hepatitis C.

“We had previously estimated that somewhere between 3% and 5% of persons born between 1945 and 1965, who were unaware of their hepatitis C status, would be hepatitis C antibody positive,” said James Galbraith, MD, an emergency physician at UAB.

As it turned out, the prevalence was much, much higher than anyone at UAB had expected. After screening 40 baby-boomer patients that first day, 6 results were antibody positive for hepatitis C, a blood-borne viral disease that attacks the liver but remains dormant in the body for decades before symptoms appear, typically in the form of cirrhosis, liver disease, or liver cancer.

The 76 million people born between 1945 and 1965—also known as baby boomers—are especially at risk, accounting for three quarters of all hepatitis C infections in the United States. The crisis so alarmed health officials that it prompted the US Preventive Services Task Force in 2012 to recommend that all baby boomers be screened once for the disease.

The initial higher-than-anticipated prevalence rates caused some of the emergency physicians at UAB to believe the results might be a fluke, but these continued into the next days and weeks. As of October 1, the screening program's prevalence rate of approximately 13.5% remained unchanged. In the first 2 weeks after commencing the tests, UAB tested 524 baby boomers, and 70 of those patients' results were antibody positive for hepatitis C, Dr. Galbraith said.

With numbers like that, the department is on course to screen 15,000 patients in the first year. So far, Dr. Galbraith said the department is doing fine managing the testing itself, but he's concerned about looming challenges.

“We're really trying to revise what we're doing because we were estimating somewhere between 300 and 500 [hepatitis C–positive patients] identified in the first year, and now we're talking about 1,500. The benefits to screening are lost if you're not assisting patients and getting them linked into care,” Dr. Galbraith said.

He added: “Hepatitis C is a treatable and increasingly curable disease that disproportionately affects this population. So the clock is ticking for this baby boomer generation to get them into care and possibly even curative treatment.”

The Root of the Problem

According to Centers for Disease Control and Prevention (CDC) estimates, about 3.2 million people in the United States have chronic hepatitis C infection. Present and past injection drug users are most at risk for the infection, as are people with HIV—10% to 15% of whom are coinfected with hepatitis C—and people who received blood transfusions before 1992 when hepatitis C screening became widely available.

Infection rates for hepatitis peaked in the mid-1970s, around the time injection drug use in the United States was also at its highest levels. Around 1960, hepatitis rates increased even though hepatitis C was then known only as hepatitis non-A non-B. By the early 1990s, injection drug use and transfusion-related transmissions experienced steep declines. Since then, hepatitis C infection rates have decreased 90%, data show.

In the 2 decades since, many of those individuals who were at the greatest risk during the height of the hepatitis C infection may have stopped using injection drugs or simply forgotten about a transfusion they received during a routine surgery such as a cesarean section and do not realize they should be screened for hepatitis C.

CDC data also show that for every 100 people infected with hepatitis C, somewhere between 5 and 20 will develop cirrhosis during a 2- to 3-decade period, and between 1 and 5 will die from cirrhosis or liver cancer. One-time screening of all baby boomers could result in identifying 800,000 people with hepatitis C, the CDC said.

In August 2012, the CDC published “Recommendations for the Identification of Chronic Hepatitis C Virus Infection Among Persons Born During 1945-1965” in the agency's Morbidity and Mortality Weekly Report, which helped sound the alarm.

“Hepatitis C virus (HCV) is an increasing cause of morbidity and mortality in the United States. Many of the 2.7 [to] 3.9 million persons living with hepatitis C virus infection are unaware they are infected and do not receive care (e.g., education, counseling, and medical monitoring) and treatment. CDC estimates that although persons born during 1945 [to] 1965 comprise an estimated 27% of the population, they account for approximately three fourths of all hepatitis C virus infections in the United States, 73% of hepatitis C virus–associated mortality, and are at greatest risk for hepatocellular carcinoma and other (hepatitis C)–related liver disease,” the report states.

Additionally, the CDC said that with the advent of new therapies that can halt disease progression and provide a virologic cure in most persons, targeted testing and linkage to care for infected persons in this birth cohort is expected to reduce hepatitis C virus–related morbidity and mortality.

John W. Ward, MD, director of the CDC's Division of Viral Hepatitis, said, “A major priority for hepatitis prevention is screening to identify persons living with chronic hepatitis B and hepatitis C and linking them to care to reduce the disease and death from chronic infection.”

In 2012, Congress directed $10 million to Dr. Ward's division from the Prevention and Public Health Fund, part of the Patient Protection and Affordable Care Act, to improve testing for hepatitis B and C. More than 150 providers applied 30 funding awards for specialized screening of foreign-born populations and injection drug users and at federally qualified health centers.

Separately, UAB received funding from the CDC Foundation's Viral Hepatitis Action Coalition to screen 8,000 baby boomers for hepatitis C for 1 year. The screen itself involves a polymerase chain reaction test (patients may opt out of the screen, but that is rare) performed on blood already drawn. And even though UAB may ultimately screen more patients than physicians planned for, the paying for the tests is only one part of the equation.

“A lot of these baby boomers who ultimately need treatment for hepatitis C infection…also have other comorbid conditions that need to be treated just to make them able to tolerate the regimens for hepatitis C treatment; you know: things like diabetes, high blood pressure,” Dr. Galbraith said. “Approximately 50% of patients that we're diagnosing have publicly funded insurances like Medicaid, indigent-care insurances, or are uninsured, and that becomes a real challenge in trying to get these individuals linked into care.”

Learning From Experience

Emergency departments are good for diagnosing problems but are not the best option for providing long-term treatment. At UAB, that's where the hospital's 1917 Clinic comes in. The clinic, which served almost 2,000 patients in 2012, is Alabama's largest HIV health care facility. A few years ago, the clinic expanded its services to include hepatitis C testing.

Ricardo Franco, MD, a member of the 1917 Clinic's staff said the hepatitis C screening program attempts to use a similar model for care as the clinic. “Many of them have the emergency room as the only source to have health care access, and not being insured, that probably favors a life trajectory of not really paying attention to health expenses,” Dr. Franco said.

Dr. Galbraith, Dr. Franco's colleague at UAB, said data suggest that hepatitis C affects men more than women and disproportionately minorities and the uninsured. Blacks have hepatitis C infection rates twice that of the general population. Information from CDC in 2012 shows that between 2000 and 2011, the rate of hepatitis C among blacks increased by 27.3%; among Hispanics, by 21.4%. Also, American Indian/Alaska natives were doubly likely to develop a case of hepatitis C compared with the white population in 2011.

Corinna Dan, RN, MPH, a viral hepatitis policy advisor with the US Department of Health and Human Services' Office of HIV/AIDS and Infectious Disease Policy, said culture could sometimes be a barrier to treatment in minority communities. “There are many challenges, including very low awareness among communities and the providers who serve them, stigma related to having hepatitis C and the behaviors that most often lead to exposure—ie, injection drug use—[and] low rates of health insurance coverage, as well as limited access to health care providers who are trained to identify individuals at risk, manage, and treat chronic hepatitis C infection. An additional challenge in the African American community is that the previously available treatment for hepatitis C was not as effective in eliminating the virus in African Americans as it was for other racial and ethnic groups. This led to people deferring screening or not following up on referral to care because there was a sense that there was no treatment for them,” Ms. Dan wrote in an e-mail.

In addition to the limited infrastructure that exists for hepatitis C screening in general, lack of public education of the disease presents an additional barrier. At the same time, though, she sees opportunities. “There is very low public awareness of this condition, but there are more materials available now than there have been in the past, including some developed specifically for minority communities. There has not historically been a large investment in hepatitis C testing by public health entities; however, with the [US Preventive Services Task Force] screening recommendation now a “B” grade, screening will be covered for individuals with health insurance as a preventive health service free of cost sharing or copay under the Affordable Care Act.” She added, “The challenge we are faced with is educating community members to request the test and health care providers to recommend the test.”

Safety Net

Ms. Dan, of the US Department of Health and Human Services, said that a variety of strategies should be developed to increase awareness of hepatitis C and encourage people to be tested for the infection, and that EDs “can be part of the solution.”

“We are working across government to increase awareness of and appropriate screening for hepatitis C, including working with colleagues at the Health Resources and Services Administration, which supports many safety net providers, including community health centers and hospitals,” she said.

Dr. Galbraith is in agreement. “We are the safety net for our communities and, to me, if you can do some of these screenings, which are burdensome and costly, if you can find ways to cover the costs, and make these things happen in the background without disturbing the other competing priorities we have in the emergency department, then we're doing a good service not just for our individual patients but for our community.”

Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see The author has stated that no such relationships exist.

The views expressed in News and Perspective are those of the authors, and do not reflect the views and opinions of the American College of Emergency Physicians or the editorial board of Annals of Emergency Medicine.

PII: S0196-0644(13)01487-X

© 2013 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

Article Outline
The Root of the Problem
Learning From Experience
Safety Net

Tuesday, November 12, 2013

News-Hepatitis C Found During ER Visits, Late relapse after SVR and SSRIs During Treatment

Hepatology: New At Healio

High prevalence of HCV found in baby Boomers via emergency room screening


SSRIs may reduce treatment-associated depression in HCV patients
Nov 12
Hou XJ. PLoS One. 2013;doi:10.1371/journal.pone.0076799.

Prophylactic use of selective serotonin reuptake inhibitors may significantly reduce the incidence of depression associated with pegylated interferon alfa-2a or 2b with ribavirin combination treatment for chronic hepatitis C, researchers from China reported.

Although pegylated interferon alfa-2a or alfa 2b (Peg-IFN a-2a or a-2b) with ribavirin is considered to be the most effective regimen for chronic hepatitis, the treatment is associated with “an approximately 70% incidence of mild to moderate depressive syndromes and 20% to 40% incidence of major depression” in patients with HCV infection, according to the researchers.
More »

Late relapse after SVR may not be new HCV infection
Nov 11
Hara K. J Infect Dis. 2013;doi:10.1093/infdis/jit541.

Patients with hepatitis C who relapse after achieving sustained virological response may be having a relapse of the initial infection rather than a reinfection with a different strain, recent data published in the Journal of Infectious Diseases suggest.

“In a few individuals, hepatitis C has found a sanctuary site and can remain dormant for a length of time,” Theo Heller, MD, chief of the translational hepatology unit at the Liver Diseases Branch of the National Institute of Diabetes & Digestive & Kidney Diseases, told Infectious Disease News. “This is important both biologically and clinically, even in the approaching era of direct-acting antivirals, where relapse may still be a problem. We already know it can and does occur.”
More »

Ongoing phase 2 trial finds RVR from all-oral regimen for HCV patients
November 11, 2013
WASHINGTON — An investigational, all-oral combination of protease inhibitor faldaprevir, non-nucleoside NS5B inhibitor deleobuvir and NS5A inhibitor PPI-668 with and without ribavirin has consistently demonstrated rapid virologic response among the hepatitis C genotype 1a population, a speaker said here.

“On a preliminary basis, it looks like we have another three-drug combo that’s active in the harder-to-treat [HCV] genotype 1a population,” Jacob P. Lalezari, MD, of the University of California, San Francisco, School of Medicine and director of Quest Clinical Research, said in discussing a late-breaking poster at The Liver Meeting.
More »

Additional headlines from The Liver Meeting 2013 @ Healio

Meeting News Coverage

Gamma-GT levels may predict HCC risk in noncirrhotic patients after SVR
November 8, 2013
Meeting News CoverageVideo

Breath analysis may offer noninvasive means to diagnose alcoholic hepatitis
November 8, 2013
Meeting News CoverageVideo

Triple therapy with sofosbuvir yields high SVR rates among cirrhotic patients with HCV
November 7, 2013
Meeting News CoverageVideo

ARF6 gene associated with biliary atresia
November 7, 2013
Meeting News Coverage

Public education on acetaminophen dangers vitally important
November 6, 2013
Meeting News Coverage

Interferon/ribavirin-free triple therapy highly effective for chronic HCV genotype 1
November 5, 2013
Meeting News Coverage

Immunosuppression, EVR predictive of SVR in liver transplant recipients with HCV
November 5, 2013
Meeting News Coverage

Severe fibrosis, not NAS, predicted disease-specific mortality in NAFLD
November 5, 2013
Meeting News Coverage

ED screening identifies previously undiagnosed patients with HCV
November 5, 2013
Meeting News Coverage

Medication trade-offs significantly associated with readmissions after liver transplant
November 5, 2013

Meeting News Coverage

No benefit from post-HPE corticosteroid therapy in infants with biliary atresia
November 4, 2013
Meeting News Coverage

Hepatotoxicity from herbal, dietary supplements rising
November 4, 2013
Meeting News CoverageVideo

3-D liver reproduction offers new planning, educational opportunities
November 4, 2013
Meeting News Coverage

Longer transplant waits for HCC patients may be beneficial
November 4, 2013
Meeting News CoverageVideo

Cell-based assay may predict liver transplant rejection in children
November 3, 2013
Meeting News Coverage

Accuracy, reproducibility of liver disease assessment poor in morbidly obese patients
November 3, 2013
Meeting News Coverage

Liver Meeting speaker: HCC exceptions contributing to MELD inflation, transplant inequity
November 3, 2013
Meeting News Coverage

Bleeding complications predict, but don’t cause poor outcomes in patients with acute liver failure
November 2, 2013
Meeting News Coverage

Fatty liver disease may overtake HCV as key cause of liver transplant, AASLD president says
November 2, 2013

Monday, October 7, 2013

Close to 146,500 New Yorkers infected with hepatitis C; roughly 50 percent do not know it

Health Department Announces Plan to Combat Hepatitis C

Approximately 146,500 New Yorkers are infected with hepatitis C; roughly 50 percent do not know that they are infected

October 7, 2013 – The Health Department today released the City’s first-ever plan for reducing illness and death from the hepatitis C virus (HCV), a disease that now accounts for more annual deaths nationwide than HIV/AIDS. In Hepatitis C in New York City: State of the Epidemic and Action Plan, the Health Department calls for new efforts to expand testing for HCV and to ensure that all people with HCV infection are evaluated for treatment.

“This is a very hopeful time for persons living with hepatitis C,” Health Commissioner Dr. Thomas Farley noted today. “After many years in which the infection was very difficult to treat, hepatitis C can now be cured. We also expect that medications that are easier to use and even more effective will be available in just a few months, and many other promising drugs should be approved for use in the next few years.”

The Health Department estimates that approximately 146,500 New Yorkers are infected with HCV, which is usually transmitted when contaminated blood from one person enters another’s bloodstream. Many live in neighborhoods with high levels of poverty, unemployment, and other indices of underlying health disparities, including the South Bronx and East and Central Harlem, and only 40 percent of New Yorkers with HCV have been evaluated by a doctor for possible treatment. Most people living with HCV have few symptoms of illness until 10 to 30 years after initial infection, when life-threatening complications can develop. People with HCV are at risk for developing cirrhosis, liver cancer, and other types of liver damage. Tens of thousands of New York City residents — infected in the 1970s and 1980s — may discover that they have advanced liver disease without ever knowing that they have HCV.

The anticipated wave of HCV-related illness, leading to billions of dollars in health care costs and lost productivity, can be blunted with a concerted public health campaign that takes advantage of new tests and medications.

“Unfortunately, roughly half of those living with HCV infection do not know that they are infected,” Farley added. “With new opportunities to treat and cure this disease, all health care providers in New York City must become familiar with current recommendations for testing and treatment.”

The Health Department’s action plan identifies seven public health objectives to address the HCV epidemic in New York City, including:
Enhancing public awareness of HCV;
Enhancing health provider awareness regarding screening, diagnosis, and referral for HCV infection and clinical providers’ capacity to manage and treat HCV;
Enhancing linkage to care for persons with current HCV infection, identifying and promoting successful models of care, and building clinical capacity to manage and treat HCV;
Promoting HCV testing;
Enhancing HCV surveillance activities to strengthen the Health Department’s capacity to manage and utilize data for evidence-based policies and practice;
Promoting primary prevention; and
Collaborating with other organizations to develop, promote and advance policies that will support the goals of this strategy.

Hepatitis C in New York City: State of the Epidemic and Action Plan (PDF)
About Hepatitis C

Hepatitis C (HCV) is a liver disease that results from infection with the HCV virus. It can range in severity from a mild illness lasting a few weeks to a serious, lifelong illness. HCV is usually spread when blood from a person infected with HCV enters the body of someone who is not infected. Today, most people become infected with HCV by sharing needles or other equipment to inject drugs. Before 1992, when widespread screening of the blood supply began in the United States, HCV was also commonly spread through blood transfusions and organ transplants.

HCV can be either “acute” or “chronic.” Acute HCV infection is a short-term illness that occurs within the first 6 months after someone is exposed to HCV. For most, but not all, people, acute infection leads to chronic infection. When people live with chronic infection for many years, the virus can damage the liver and interfere with its important functions. Eventually, this can lead to severe liver disease, including cirrhosis and liver cancer. If people with chronic HCV infection are treated effectively before this damage occurs, the virus can be eliminated, liver function can improve, and the risk from severe liver disease and liver cancer can be greatly reduced.

There is no vaccine for HCV. The best way to prevent HCV is by avoiding behaviors that can spread the disease, such as injection drug use.

Saturday, October 5, 2013

Lucinda K. Porter, RN: Hepatitis C Treatment One Step at a Time

Hepatitis C Treatment One Step at a Time

From the mid-1990s Lucinda K. Porter, RN, has devoted consistent and generous time as a hepatitis C advocate, educator, and author. Ms. Porter has written for numerous publications including a monthly health column for HCV Advocate.

The author's work has provided a global audience with facts, information, and skills needed to actively navigate conflicting and at times confusing research about the virus. This acquired knowledge has helped countless people eventually come to terms with their disease and explore all possible treatment options.

Ms. Lucinda K. Porter the author of "Free from Hepatitis C" has graced the HCV community with a second book "Hepatitis C Treatment One Step at a Time".

The timing of the book couldn't be more perfect. With screening strategies in place by the CDC and Task Force which recommend all people born from 1945 through 1965 get tested one time for hepatitis C, and new drugs moving through the final stages of FDA approval - the need for a guide during HCV therapy is paramount.

This comprehensive book provides tips for people starting hepatitis C treatment while slowly dissipating the fear of the unknown.

Some commonly asked questions are addressed such as; Will I be able to work during treatment? What about the side effects? How will these drugs make me feel? When will I know treatment is working?

Coping with the challenges of therapy may seem impossible at first, but getting to the finish line is made easier with each turn of the page. The author takes us on a physical and emotional journey of spiritual strength.

Porter offers what our families or physicians can not, advice on treatment from a patients perspective. She has undergone therapy twice before, and is currently awaiting the outcome from a third attempt.

The former Stanford nurse understands what is needed to succeed and thrive during the sometimes grueling days of treatment. The reader is gently cradled through therapy with daily advice, inspirational quotes, and encouragement. With each day of treatment a new bit of information awaits, starting with the first day which continues through 48 weeks.

The HCV community is fortunate to have such a compassionate expert offering us a personal guide through treatment. Ms. Porter's calm voice can be felt strongly throughout the book, a presence that will surely be reassuring to the reader.

Hepatitis C Treatment One Step at a Time is now available for your consideration, an excerpt is offered on the author's website.

Tina Banwart
HCV New Drugs

Monday, September 30, 2013

National screening strategy for hepatitis C urged for Canada

National screening strategy for hepatitis C urged for Canada

(TORONTO, Canada; Sept. 30, 2013) – Canada should begin screening 'Baby Boomers' for the hepatitis C virus infection, since this age group is likely the largest group to have the illness, and most don't know they have it, say a group of liver specialists in the Toronto Western Hospital Francis Family Liver Clinic.

Unlike many other chronic viral infections, early treatment makes hepatitis C curable.

Photo: Dr. Feld

(TORONTO, Canada; Sept. 30, 2013) – Canada should begin screening 'Baby Boomers' for the hepatitis C virus infection, since this age group is likely the largest group to have the illness, and most don't know they have it, say a group of liver specialists in the Toronto Western Hospital Francis Family Liver Clinic. Unlike many other chronic viral infections, early treatment makes hepatitis C curable.

In an article entitled, A Canadian Screening Program for hepatitis C – is Now the Time? published in the Canadian Medical Association Journal (CMAJ) Sept. 30, 2013, by Drs. Hemant Shah, Jenny Heathcote and Jordan Feld, the authors present arguments and data in favour of developing and implementing a national screening program for hepatitis C in Canada.

"Baby boomers are much more likely to be infected with hepatitis C than other age groups. Most people who have the infection have no or very few symptoms even if they've been infected for decades. Without symptoms, many infected people have no idea they have the disease until it's too late," says Dr. Jordan Feld, Toronto Western Hospital liver specialist and one of the authors of the article.

"Hepatitis C has the greatest impact of all infectious disease in Ontario, even more so than HIV, influenza virus or human papillomavirus," says Dr. Hemant Shah, Clinic and Education Director of the Francis Family Liver Clinic, Toronto Western Hospital. "It's a life-changing diagnosis, yet there is a huge gap in public and healthcare provider awareness about the disease, it's implications and the treatment options for patients."

Hepatitis C causes more years of life lost than any other infectious disease in Ontario, and likely in Canada, and is the leading indication for liver transplantation. The virus slowly destroys the liver over many years of infection eventually leading to cirrhosis and ultimately liver failure or liver cancer.

However, if hepatitis C is diagnosed early, it is curable. Once liver disease is very advanced, treatment is much less effective and may not be possible, so the goal is to find people with hepatitis C before the virus has caused liver damage. Screening for hepatitis C involves a simple blood test which is covered by all provincial health care plans.

Currently, the recommended Canadian approach is to test based on risk factors. These include: injection drug use (even once), receiving blood transfusions or blood products before 1992, piercings or tattoos done in an unclean environment with unsterile equipment, exposure to infected blood through sharing personal care items such as razors, toothbrushes, or even being immunized or receiving a medical procedure in countries where hepatitis C is common.

In contrast, the Centers for Disease Control and Prevention (CDC) in the U.S. has recently recommended screening all individuals born between 1945 and 1965 for hepatitis C virus (HCV). Even though most Baby Boomers do not have the infection, the CDC adopted the policy because they have shown that identifying infected people and treating them early will save lives and money by avoiding the costs associated with complications of liver disease.

The Canadian Liver Foundation has recently advocated that all those born between 1945 and 1975 get a test for HCV, basing their recommendations on the prevalence of the illness in Canada, and on the immigration into Canada from areas where hepatitis C is very common, such as Africa (particularly Egypt), southern Italy, Eastern Europe, and Central and Southeast Asia

The authors state that HCV meets all the criteria for a condition where wider screening, particularly among Baby Boomers, would be useful, namely:
  1. HCV is a major cause of morbidity and mortality
  2. Prevalence is increased in Baby Boomers
  3. Many individuals are unaware they are infected with HCV
  4. HCV is curable with early treatment.  
Photo: Dr. Shah

"There is a great deal of misinformation about the illness in the public domain, causing patients to feel fear, shame and stigmatized," says Dr. Shah, who is also an Assistant Professor in Medicine, University of Toronto. "An education campaign can help these patients feel more hopeful, and impress on everyone that early diagnosis and intervention can prevent much of the damage of the illness."

Two of the authors report receiving consulting or speaking fees from: Achillon, Abbott, Boehringer Ingeliheim, Gilead Sciences, Janssen, Merck. Hoffman, La-Roche, Vertex. 

About Toronto Western Hospital:
Toronto Western Hospital is a member of the University Health Network, along with Toronto General and Princess Margaret Hospitals and the Toronto Rehabilitation Institute. It is a teaching and research hospital affiliated with the University of Toronto. Toronto Western Hospital is a world leader in neuroscience, advanced liver disease, musculoskeletal health and arthritis, orthopaedics, the hand program, rheumatology and complex care.   

Key Facts about hepatitis C:

Burden of hepatitis C is high 

HCV is a major public health problem in Canada and world-wide; infection rates and diagnosis rates are often underestimated

HCV infection causes more years of life lost and illness than any other infectious disease in Ontario, and likely Canada

HCV is the leading indication for liver transplantation and the leading cause of liver cancer

The prevalence in Canada is estimated at about 250,000, but the authors state that this number is likely too low; they suggest that the number is closer to 400,000

Because it may take decades for any symptoms to appear, most people who have HCV are unaware that they have it

CDC in the U.S. estimates that Baby Boomers account for three fourths of all HCV infections and that anywhere from 45 % - 85 % of those living with HCV infection are unaware that they have it

Liver cancer rates are on the rise because the major causes of primary liver cancer – hepatitis B and C – are not being identified and treated early enough

An estimated 20% of infected persons will progress to cirrhosis 20 years after infection, which can then lead to liver failure and/or liver cancer

By 2022, the number of hepatitis C-related deaths will increase by one third How is it spread?

Hepatitis C virus is spread by blood-to-blood contact meaning that blood infected with the virus must get into a person's blood stream

Once infected with the virus, nearly 8 in 10 people remain infected for life

Chronic hepatitis C is often called a "silent" disease because no symptoms appear until the liver has been severely damaged; people can live from 20-30 years without feeling ill


There is no vaccine for Hepatitis C

Treatment with a combination of antiviral medications can cure the body of the virus with prevention of liver-related complications and death

Many direct–acting, anti-viral agents are being tested so that within the next five years, there will be improved and better-tolerated treatments with over 90% cure rates

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