Wa Doc Report to the Legislature on Hepatitis C 1999
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/ STATE OF WASHINGTON Department of COITections I REPORT ON THE MAl'iAGEMENT OF HEPATlTIS C IN THE CORRECTIONAL El'\VIRONMENT I Report to the Legislature December, 1999 ... TABLE OF CONTENTS PAGE NUMBER Executive Summary 1. Introduction and Background 1 Overview of Hepatitis C 1 Phannacological Treatment of Chronic Hepatitis C ChroniC Hepatitis C in Correctional Settings Prevalence of Hepatitis C in the Department of Corrections' Offender Population 2 4 Washington State Department of Corrections and the Cost Effective Management of Hepatitis C Current Approach to Treating this Disease The Offender Health Plan Sets the Standard Reviewing the Current Treatment Guideline 5 6 6 7 8 The Department's Proposed Plan to Implement a Disease State Management Protocol for Hepatitis C 10 Reassessment of Previously Identified Cases 13 Evaluation of Options 14 14 14 Option 1: Continue Current Approach Option 2: Mandatory Testing and Implementation of the Disease State Management Protocol Option 3: Voluntary Testing and Implementation of the Disease State l\tlanagement Protocol 15 Recommendations 16 Conclusions 16 EXECUTIVE SUMMARY Introduction Sec~i~n 22.2 , chapte~ 309 Law~ of 1999: ~equir~s the Departn:ent of Corrections to prepare a report outhnmg Its plan tor managmg hepatitis C m the correctional environment. In response, the Department broadened the efforts begun in March 1999 and developed not only a guideline for identifying offenders eligible for pharmacological therapy, but a disease state management protocol for hepatitis C, as described below. In addition to clinical management. this approach addresses public health concerns about preventing transmission of the virus. As required, the Department worked with recognized experts and used information available from the National Institute of Health and other states' correctional departments as resources to develop the guideline for pharmacological treatment that is part of this protocol. Background Hepatitis C is a blood-borne infectious disease annually infecting approximately 30,000 people in the United States. Over the 20 years following infection, the disease can become chronic and lead to a serious liver condition called cirrhosis. Increasingly smaller subsets of infected people develop lifethreatening complications, including liver cancer. Cancer and other life-threatening outcomes appear in about 3 percent of the original infected population. Hepatitis C is currently the leading reason for liver transplants in the country. Approximately 1.8 percent of Washingtonians may be infected with this virus. In a recent study, 25 percent of offenders entering the Department of Corrections tested positive for the hepatitis C virus. Fifty percent of these offenders had laboratory results indicating a potential for having chronic hepatitis C. In 1995. the Department began researching a uniform approach to managing hepatitis C. Interferon, the only therapy then recognized in the medical literature. had a success rate of about 12-15 percent. It also had serious side effects and was very expensive. A group of Department physicians developed clinical criteria to help identify offenders who might best respond to the therapy. In 1996, the Department adopted a policy including these clinical criteria and requiring authorization prior to rendering interferon therapy: This policy is still in effect. Since that time, the Federal Food and Drug Administration approved a new, more effective pharmacological treatment for hepatitis C with a 40 percent success rate. Also, the National Institute of Health and the Centers for Disease Control and Prevention published recommendations for diagnosing and treating hepatitis C. In March 1999, given these new developments, the Department began a literature review for the purpose of evaluating its current policy and guideline. Disease State Management Protocol for Hepatitis C The Department has developed a plan of action. referred to above as the disease state management protocol for hepatitis C, for managing offenders who are infected with this virus and are in a state correctional facility. This proposed plan is consistent with Legislative request. The disease state management protocol for hepatitis C includes: .:. A guideline for determining eligibility for pharmacological therapy; .:. Medical case management by the Department's primary care prov,!iders and infection control nurses; .:. Offender education to prevent the transmission of the virus; .:. Chemical dependency treatment to prevent the transmission and reinf~ction of the virus; .:. Mental health assessment and intervention as appropriate to addt!ess adverse mental health responses to the medication; i .:. Oversight and technical assistance by the Department's medical dir~ptor and the Central Utilization Review Committee to assure appropriate mana~ment and timely interventions; and ' .:. Clinical data collection to track offenders participating in the protoco;J. I Options C041 The Department evaluated three options for how to manage offenders in the ctional setting. The first option proposes the Department continue its current practice, w,' ich is to provide pharmacological intervention to only the few offenders who met very specific .linical criteria. This can be done within existing resources. However, this option is not consistent }'lith current national guidelines. it is not consistent with the mandate of the Legislature, it will hate limited impact on effectively managing the condition, and it does not address preventing trans~ission of the virus. However, this approach is less costly. . :j The second option proposes the Department institute mandatory testing of all current and incoming offenders and implement the disease state mar.agement protocol for hepatitis C described above. This approach assures all offenders infected with the virus are identified and a@,ropriately managed, but mandatory testing is not consistent with what is done in the community o~ in other correctional systems. The cost of this option is estimated to be $9,715,816 to manage the c'prrent population and I • an additional $3,568.626 for the incoming population each year. The third option includes the disease state management protocol for hepatitis cr., as described above, with a voluntary testing component. This option provides the Department t~e opportunity to test. manage, and treat, if eligible. all offenders who request testing and are positi~e for the virus. It is hoped offenders will self refer as a result of the Department's prevention educdtion program because they recognize they participated in high-risk behavior. It is assumed those wh~ want to be tested are truly concerned about their health and will be compliant with the protocoLj Voluntary testing is consistent with other correctional and community models. It will also prom~te appropriate use of state resources and a prudent return on the invested cost of the program. The ,.F'stimated s cost for this program is $4,180,465 for the current population and $1,606,512 for the inc~ing population each j year. Recommendation Assuming funding is provided. the Department of Corrections recommends implementation of option . 3. voluntary testing with management according to the disease state manageijnent protocol of those offenders who test positive for the virus. This comprehensive plan for mar . ·•.' ging hepatitis C best addresses the total health needs of infected offenders in a cost-effi' ctive manner, while acknowledging the Department's role in contributing to the public's health. .' ~ I~ '. ii Introduction and Background Section 222, chapter 309 Laws of 1999, directs the Secretary of the Department of Corrections to report on how the Department plans to manage hepatitis C in the offender population. As specified. the Department developed a treatment guideline for phannacological intervention in conjunction with experts in the field and in a manner that is similar to or consistent with those produced by the National Institute of Health and other state correctional systems. The other components of the recommended plan include offender prevention education about the disease, a process for how and when offenders will be tested, and a description of how the disease will be managed whether or not the offender is eligible for pharmacological treatment. The Department" evaluated three different options. The analysis of these options is' included in this report. This report also includes an estimate of the number of offenders that have hepatitis C in the Washington prison system. As required. an estimate of funding needed to implement the Department's recommendation is provided. Overview of Hepatitis C Hepatitis C, formerly referred to as non-A, non-B hepatitis, is the most common blood borne infection in the United States. Through the 1980s, blood product transfusions and intravenous drug use were the primary sources of infection. After 1992, when a n~w test for hepatitis became available to screen blood donor products, transmission through blood products became rare. For unknown reasons, infection transmitted through intravenous drug use also began to decline in the late 1980s. As a result, the rate for new infections has dropped 80 percent from the peak in the mid-1980s. Intravenous drug use accounts for about 60 percent of the new infections that have occurred since the mid1990s. Other risk factors for transmission of hepatitis C are tattooing' without sterilized needles, and using intranasal cocaine. l Whether sexual contact is a risk factor for the spread of hepatitis C is unclear. Most people in a long-term monogamous relationship appear to be at low risk of spreading or contracting the disease. The Centers for Disease Control statistics show that 1 in 65 people who have a'hepatitis C partner will contract the disease in this manner. However, having sex with multiple partners seems to increase the risk of transmitting hepatitis C. Women seem to become infected this way from male partners more frequently than the , reverse.- 1 Centers for Disease Control and Prevention. Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. MMWR 1998; 47 (No. RR-19)::1-37. Alter, MJ. Epidemiology of Hepatitis C. Hepatology 1997.625-655. 2 Colin. Molly. Being in Charge A Guide to Living with Chronic Hepatitis Band C. 5chering Corporation:1998.28. 1 Of the approximately 30,000 members of the non-incarcerated population who become infected annually, 80 percent, or 24,000, develop a chronic infection.) Studies show that of those who develop chronic infection, approximately 4,800 (20 percent) will develop 4 cirrhosis of the liver in an average of 20 years from the time they were infected. Regular consumption of alcohol expedites the development of this condition. S~bsequently, 960 (20 percent) of these people, or 3.2 percent of the originally infected population, will develop serious symptomatic and life threatening liver complication~ related to the cirrhosis. Of those who develop serious complications of cirrhosis, 1~92, less than 1 percent of the original population, will develop cancer of the liver in ap average of 30 years from the time they were infected5 (See Attachm~nt A). Hepatitis is the leading 6 indication for liver transplantation in the United States. F 1 Many people with hepatitis C do not realize they are ill because they ha~e no symptoms. Some experts estimate that 10 to 70 percent of patients with hepatitis C~have mild, nonspecific symptoms, described as flu-like, muscle and/or joint aches, h~adaches, nausea and loss of appetite, and sometimes stress and depression. An estimatedJ2,O to 30 percent develop jaundice. Fatigue seems to be the most prevalent symptom for tllJose infected. ' . I PhannacololZical Treatment of Chronic Hepatitis C Treatment for chronic hepatitis C has long been controversial. 8 Varieties of interferon have been the primary drug of choice for treatment since the 19805. However, the sustained response rate with the different types of interferons alone lingered around 15 percent for all patients treated and there are serious side effects tei the medication includiI1;g depression and suicidal behavior or ideation. 9 Since it cou](#not be predicted which patients with the virus would be among those 15 percent who wo~ld respond to the drug and who would progress to serious health problems, treatin$ everyone with interferon has not been popular in the medical community. Physicians/:onsider whether or not the risk for side effects outweighs the risk to the patient, who !i may or may not develop a serious complication and mayor may not respond. In light of the low efficacy rate and the lack of long term studies, some conununity physicians h~e chosen not to treat and to wait and see what new information becomes available or "hat new drug is :.1 it ,i 3 Alter, Mj, et. at. The prevalence of hepatitis C virus infections in the United States, 1$88 through 1994. New England Journal of Medicine 1993:341: 5 5 6 - 6 2 . ; 4 Alter, MJ. et. a!. The natural history of community-acquired hepatitis C if! the United'~tates. New England Journal of Medicine ed 1992; 3 2 7 : 1 8 9 9 - 9 0 5 . [ 5 Seeff, LS, et. al. Long term mortality after transfw,ion-associated non-A, non-B hep~itis. New England Journal of Medicine ed 1992; 327:1906-11. 6 Primary liver disease of liver transplant recipients 1991 and 1992 (from the UNOS S([#entific Registry). UNOS Update. 1993;9:27.· ' 7 Centers for Disease Control and Prevention. Recommendations for prevention and fntro' of hepatitis C virus (HCV) infection and HCV-related chronic disease. MMWR 1998: 47 (No. RR-19)'I: 1-37. 8 Koretz. RL. Interferon aAd chronic non-A, non-S hepatitis: whqm are we treating?'l Hepatology1990;1 2 : 6 1 3 - 5 . 1 9,McHutchison JG et.a!. Interferon Alpha-2b alone or in combination with ribarvirin as t~itia( treatment for chronic hepatitis C. New England Journal medicine 1998;339;1485-92. !I Bennett WG, et. al. Estimates of the cost effectiveness of single course of interferon-a!pha-2b in patients with histologically mild chronic hepatitis C. Ann Intern Med 1997; 127:855·65. 1 I 'I 2 approved. This is a safe approach given that chronic hepatitis C is a slow progressing condition and most complications do not develop for about 20 years after the onset of the disease. However, current research; including large studies published in the leading medical journals last year and this year, demonstrate that by combining interferon with the antiviral drug, ribavirin, better outcomes are achieved than using interferon alone. The combining of these two drugs, referred to as combination therapy, now increases the response rate to 40 percent. In other words, 40 percent of the patients who receive this therapy will not show the presence of the virus in their body 6 months after completing the therapy. Although this is a marked improvement, much controversy still exists. The long-tenn benefits of the treatment are still unknown. Most research equates successful treatment to eradicating the virus from the blood, nonnlilizing blood tests that measure liver function, and improving the microsGopic appearance of the liver. Since chronic hepatitis C progresses very slowly and this treatment has just become available, researchers have had difficulty in assessing the effects of the treatment on the development of cirrhosis and its complications. liver cancer, and death. Definitive data to answer the questions, "Does it prevent these conditions from developing or do infected persons continue to progress to this state?" will not be available for many years. Consequently, some physicians are still hesitant to treat, because of insufficient outcome data to justify the high cost and potential adverse side effects. However, in university centers and larger cities the therapy is being used. Many providers treating patients are collecting data regarding treatment interventions and outcomes to help them evaluate and adjust their own practice. Other researchers have evaluated the cost-effectiveness of the treatment of chronic hepatitis C with interferon therapy. Three of these studies published in prominent medical journals estimate that treating individuals between the ages of 18 and 60 years old with chronic hepatitis C is equal to or more cost-effective than treating hypertension or high cholesterol with medication, or treating severe coronary artery disease with Preliminary cost-effectiveness studies comparing monotherapy, using surgery. 10 interferon alone, to combination therapy, found the latter more cost-effective, although definitive studies remain to be done. 10 Wong JS et. al. Pretreatment evaluation of chronic hepatitis C: risks, benefits. and costs. JAMA 1998;280:2088-93. Bennett WG. et. al. Estimates of the cost effectiveness of single course interferon-a2b in patients with histologically mild hepatitis C. Ann Intem Med 1997;127:855-65 Kim WR et. al. Cost effectiveness of 6 months and 12 months of interferon -a-therapy for chronic hepatitis C. Ann Intem Med 1997;127:866-74. 3 Chronic Hepatitis C in Correctional Settings There is limited information available about the prevalence of chronic heM1atitis C or its impact in the prison population. It is not known whether the estiI;J1ates for the complication rates in the general population are applicable to the offend~r population. Recent statistics from the Federal Bureau of Prisons demonstrate the nwib.ber of deaths from liver disease surpassed those from Hwnan Immuno-Deficiency Virus ~d is now the third leading cause of death among their offender. I I Heart disease and canch remain their leading causes of death. A 1998 analysis of offender deaths found the sam~ pattern exists " in this state. The only fonnal study published about the prevalence of hepatitis C in tJ!1e correctional setting is from the California Department of Corrections. This study",found that 39 percent of male and 55 percent of female offenders entering me Califomjia correctional ' system in 1996, were hepatitis C positive. 12 I j At the time this report was prepared, the only other published study about hepatitis C in United States correctional settings was written by staff from the Rhode IsI$d Department of Corrections. That study surveyed state correctional departments abol1:t the screening and treatment of chronic hepatitis C. Thirty-six states and the Distriq/t of Columbia responded. The report was published in 1999, making the infonnation ov$' two years old ; at the time of publication. 13 In 1996, according to the Rhode Island study, only Colorado reported roU'~nely screening for hepatitis C. The rest of the states, including Washington, responded i"No", although some did clarify that high risk or symptomatic offenders were screened. ! I j :i Kendig N, Information presented at the Society of Correctional Physicians' Na~onal Meeting, November 1999 . I, 12 Ruiz, JOt etal. Prevalence and correlates of hepatitis c virus infection among j'rmates entering the California correctional system. West J Med 1999;170:156-160 'r 13 Spaulding, Anne. Hepatitis c in state correctional facilities. Prevention Medicinj!. 1999;28;92100. ~ 11 i ~ 4 The rest of the key indicators from the Rhode Island survey are summarized below: Survev of States' Corrections Departments Sununarized Responses Do you treat hepatitis C? Do you have an interferon protocol? Number of doses used in 1995? Type and Frequency of Response Sometimes-27 Never-8 Yes-4 No-2r Able to report-l 0 N/A or 0- 27 Other-2 Developing-6 This report indicates each state is addressing the condition differently (See Attachment B for this report and more detailed survey results). Over the last three years, the treatment of chronic hepatitis C in the correctional setting has been in a state of transition. While working on our guideline, Department of Corrections staff were in telephone contact and/or email correspondence with numerous states that were somewhere in the process of developing a treatment guideline. Guidelines available from other states were collected and used as references for the Department's latest guideline. Many states are struggling with how to manage hepatitis C, but some states are continuing to not address it. Prevalence of Hepatitis C in the Washinlrton State Department of Corrections' Offender Population For the purpose of this report, the Department collected preliminary data about the number of offenders entering the system who were positive for hepatitis C in the month of October 1999. Every offender who participated in intake that month at the Washington Corrections Center and the Washington Corrections Center for Women was tested for the hepatitis C virus. If the hepatitis C test was positive, a liver enzyme test (Ai T) was done to gi've a "rough measure" of the amount of liver damage present. The Department consulted with the Department of Health on the study design and they found the study results to be statistically valid. The data collected was used to project the percent of the population that is hepatitis C positive being admitted to the Department. Twenty-five percent of the offenders admitted to the system in the month of October were hepatitis C positive. In comparison, the information reviewed from a nation-wide study estimates 1.8 percent of the general population in this state is hepatitis C positive. Of those offenders who tested positive in October, 48 percent had elevated liver enzymes which may mean they are candidates for developing or have chronic hepatitis C. (Remember, in the general population 80 percent • This number erroneously includes Washington State. In July 1996. the Department implemented a policy about using interferon to treat hepatitis C. 5 of the acutely infected becomes chronically infected). A more detailed distribution of these results is provided below: WCC WCCW TOTAL Number of offenders tested 374 61 435 Percent of Hepatitis C positive 24% I 33% 25% Number Hepatitis C positive 89 20 109 Elevated ALTs ~ 48 4 52 Percent with elevated ALTs 54% 20% 48% Extrapolating this information to the Department's total incarcerated population of 14,000 offenders, 25 percent, or 3,500, could be hepatitis C positive. The~ if the risk for chronic infection is 80 percent, 2,800, of these infected offenders may d~e10p or have chronic infection. Continuing to apply the rate of progressive disease"statJs found in the general population and reported on page 2, 20 percent, or 560, of tho~e chronically infected may go on to develop cirrhosis in about 20 years from the time of their infection. Another 20 percent of those offenders, or 112, may develop a seriou$ complication related to their cirrhosis: and 22 more offenders, or 20 percent, of those may develop liver j cancer in about 30 years from the time they are infected. In the current offender population. using the data in the Otlender Based T$cking System for Health Services, 680 offenders are recorded as having hepatitis C. Oite hundred and two of these offenders have co-existing liver disease, including cirrhosi$, that is most . likely related to their hepatitis C. Washington State Department of Corrections and the Cost-Effective; i\tlanagement of Hepatitis C ~ .I Current Approach to Treating this Disease I~ I In July 1996, the Department of Corrections implemented a policy t~ treat chronic hepatitis C using interferon-alpha (See Attachment C). Various physician$ who practiced in our institutions use a consensus process to develop the policy and trea1ment guideline over a period of several months. The physicians included internists, geneIl~ practitioners, and ~. infect~ous d~s~a.se .specialist. This ~olicy requires authorization by ~ panel of three phySICIans pnor to InItiatIng pharmacologIcal therapy. . As referenced earlier, in 1996, there was limited published data available;;about the longterm outcomes and benefits of using interferon to treat chroclc hepatitis C. Some of the physicians wanted to aggressively treat the disease, but the majority wqted to wait and see what progress was made in available treatments and the possible imp~ct on sustained results. In ~ddition, comm~i~ gastroenterologists who were .treating nders were ~ot recommendmg treatment Wlth mterferon. Even though the lIterature c "uld not prOVIde sufficient evidence of a sustained response for everyone with the ·rus, there was 0l" 6 acknowledgment there may be some specific clinical indications as to when a person with hepatitis C may respond to .therapy. The guideline developed attempts to identify those patients who exhibit these specitic clinical indications. To address the issue of treatment for these specific offenders, Department physicians agreed to a peer review process whereby three medical directors from facilities where the offender was not housed would review a request by the attending provider to treat the offender with Interferon. Providers disagreeing with the panel's decision could request reconsideration of the decision through the Health Services Unit at headquarters. Offenders could use the Department's formal grievance process to request reconsideration of the panel's decision. Approximately, eight cases were referred by providers for prior authorization to treat chronic hepatitis C with interferon. In all cases, the physician peer review committee members agreed the referral did not meet the clinical 'indications established in the Department's guideline. All these offenders continued to receive ongoing monitoring of their condition and treatment for any .symptoms they developed. The Offender Health Plan Sets the Standard In December 1996. the Department implemented the statutorily required Offender Health Plan and supporting policy. This plan established a uniform set of standard health care services for offenders and was based on the State of Washington Basic Health Plan. A committee including representatives from the Departments of Health, Corrections, Social and Health Services, the Health Care Authority, and the qffice of the Attorney General wrote the plan. The Offender Health Plan stipulates that the Department of Corrections will only provide aI}.d reimburse for services that are medically necessary. Excluded services include those which are: • not supported by sufficient evidence to indicate that the service will directly improve the length or quality of the offender's life; • not supported by sufficient evidence to draw conclusions. Indications of sufficient evidence is demonstrated by: >- concurrence through peer review (as defined by the National Association of Insurance Commissioners); ~ well controlled studies; >- study outcomes which are directly or indirectly related to the length or quality of life; and >- reproducibility, both within and outside research settings. • not expected to have a ben~ficial effect on the length or quality of life, or not outweigh the expected harmful effects; and • not the most cost effective method available to address the disease, illness, or injury. (Cost-effective meaning there is no other equally effective intervention available or suitable for the patient which is more conservative or substantially less costly.) 7 UntiI recently, the decision to not uniformly provide interferon therapy to treat chronic hepatitis C was consistent with this provision of the Offender Health Plan. However, development of a new treatment regimen producing better long-term outcomes and sustainable results and the production of hepatitis C management guid~lines by The National Institute of Health and the Cente.!"s for Disease Control and Prev~ntion warrant the development of a new treatment guideline by the Department. . In addition, correctional departments in other states and the Federal Bureau of Priso6.s are actively addressing the issue of chronic hepatitis C in the incarcerated population.; Reviewing the Current Treatment Guideline 1 The advances cited above provides the Department with a credible ""dest practices" approach to treating the disease. Since March 1999, representati~es from the Department's Office of Correctional Operations Health Services Unit and Uwo physicians who practice in Department facilities have completed a literature review~' collected and other state's reviewed treatment guidelines from other health care providers, payers, arid I Department of Corrections; and drafted a new chronic hepatitis C treatII).ent guideline. The new medical director has assumed a leadership role in establishi~g the clinical direction in which the Department should move. 1 In September 1999, there was an educational meeting for Department provjders about the treatment and management of hepatitis C. The guest speaker at the meetiihg was Robert Carithers. M.D.• hepatologist from the University of \Vashington.br. Carithers' presentation provided our physicians and mid-level providers with· more current information about the management of hepatitis C and allowed them to 4iscuss current trends in treatment with a recognized national expert in the field. The dra~ guideline was presented at this meeting. Comments, concerns, and suggestions for mo~ification were requested and e n c o u r a g e d . ' In addition to the review and input by our own providers, the Depart~ent requested comments and input from: ~ Robert Carithers, M.D., and ~ many. of the gastroen.t~rologists and heptologis~s who pracfce in various WashlOgton conunumtIes and regularly prOVIde care to i the offender population, including Michael Lyons, M.D. and John Carroug!er M.D., from Tacoma Digestive Disease Center; James Harri, M.D., from WWla Walla; and George Cox, M.D., of Everett. :\1 I While developing the draft guideline, it became apparent that what woul<L.!be needed was not just a product to assure Department clinicians consistently identify optFal candidates for pharmacological treatment, but rather a comprehensive plan that V,yould establish appropriate and uniform management of any offender with hepatitis C. Cd~sequent1y, the draft guideline was expanded to establish expectations for periodi~, but regular, (. 8 monitoring of all offenders who are known to be hepatitis C positive. This approach would allow the Department to address hepatitis C from the perspective of disease state management, which includes strategies like prevention education and chemical dependency treatment to prevent transmission, rather than dealing with just the issue of rendering phannacological treatment (See Attachment D for this comprehensive protocol). In an effort to promote optimal outcomes from the therapy, the proposed protocol includes specific criteria that should be met in order to receive phannacological therapy. The decisions about inclusion and exclusion criteria were based on medical and nonmedical indications. The medical indications are consistent with the Federal Food and Drug Administration's recommendations and warnings and other available guidelines or protocols, both from correctional and non-correctional settings. The non-medical indications are consistent with the guidelines· or protoco.ls available from other correctional settings, including the Federal Bureau of Prisons (See Attachment E, a simplified version of the draft treatment guideline detailing this inclusion and exclusion criteria). An example of a medical indication for why an offender could ~e excluded from pharmacological treatment is the presence or history of an existing condition which could be made worse, possibly resulting in death, if given the medication. An example of a non-medical exclusion is when the offender's remaining period of incarceration is too short to allow the offender to complete the 24 to 48 week~ of treatment prior to release. Pharmacological treatment would not begin during the incarceration period because: • • it the Department cannot be assured it will be completed post release; If the full course of treatment is not completed, the condition will continue to be present. This would not be an efficient and prudent use of state resources; and it will result in a disruption of the continuity of care; and this would make the management of hepatitis C consistent with how other diseases are managed under the Offender Healtb Plan. Offenders not receiving phannacological treatinent would be regularly monitored until the period of incarceration is complete, ber:efiting from regular evaluations and education about their disease state. Prior to release, offenders would be provided assistance and consultation on how to enroll for medical benefits through other programs that they may be eligible for, including but not limited to Medical Assistance, the Veteran Administration, and/or the Basic Health Plan. The Department cannot assure the offender will receive treatment under any of these plans. The proposed protocol provides for t1:..: treatment of chronic hepatitis C using combination therapy. This regimen requires the administration of interferon three times a week and ribavirin daily. As previously stated, this therapy now has the best-documented outcomes. However, in those· cases where this may not be the best treatment for an 9 offender's specific situation, the Department's medical director would address exceptions. The Department's Proposed Plan to Implement a' Disease State.!, ManaKement Protocol for Hepatitis C Review of the proposed "Disease State Management for Hepatitis C" protocol indicates that management of this disease can be rather complex and detailed (See Attachment D). In order to assure optimal management, the Department's proposed protocol, or plan, includes: I) Medical Case Management by the Infection Control Nurses r All o.ffenders infected with the hepatitis C virus would be managed b this specially trained nurse responsible for: \ • educating the offenders about their disease and prevention of transmission and reinfection; • assuring that all diagnostics, random drug screens, e~aluations, and '-~ consults are scheduled and completed; • assisting offenders with managing adverse effects to the therapy; • assuring the data is entered into the data system describfd below; and • reporting infonnation to and consulting with the'l clinicians, as indicated. 2) Tools to Case Manage : To assist the infection control nurses the following tools have been ~ed: • a "Worksheet for Screening of Hepatitis C Positive Patients for Possible Phannacological Therapy" to support appropriate and consistent screening (See Attachment F); 1 • a "Hepatitis C Management Activity Sheet" to suppom the timeliness of consultations and diagnostic tests required in th~ screening and .treatment phases and, when possible, through the,! post-treatment periods to assess for a sustained response (See Attacbn1ent G); and • a "Hepatitis C Treatment Protocol-Patient Contract". '! This document would serve as a comprehensive informed consent fortn. It details for offenders what they: can expect throughout the cours~ of therapy and stipulates that their total and complete cooperation azid compliance is required. .Without the offender's thorough commitmept to the therapy period, the treatment would not be of any benefit aqd therefore, not cost-effective (See Attachment H). j 10 3) Comprehensive Data Collection Svstem The Department would collect all pertinent infonnation about hepatitis C positive offenders, and track them as they participate in the disease state management protocol. The Department would be able to identify offenders who: • do not progress to the chronic phase; • become chronic but not eligible for treatment and why • start treatment; • discontinue treatment and why; • complete treatment; and • achieve a sustained response. when available. 4) Management bv Onsite Providers Mid-level providers and physicians who practice at the facilities would reguiJIly monitor the health care status of these offenders. These providers would regularly assess the otTender's response to therapy, review lab work, adjust medication, reinforce education, confer with the infection control nurse, and consult the Department's medical director, as indicated. I~ 5) Vaccinations for feoatitis A and B ° Vaccinations against hepatitis A and B would be offered to all identified offenders with chronic hepatitis C to prevent the possibility of contracting a dual infection, which can result in death. 6) Consultation with the Department's Medical Director The Department's medical director would provide consultation and technical assistance for the infection control nurses and the medical providers to support appropriate application of this protocol and assist with the special needs of any offender's specific situation. 7) Pre-authorization through Central Utilization Review The Department's Central Utilization Review Conunittee would authorize all pharmacological therapy. This provides an opportunity to assure appropriate and consistent management of all cases. It also allows the Department to apply ° 14 At any point in the protocol, including the eOndpoints where the progress towards pharmacological treatment is stalled, the provider at the facility could consult with the Department's medical director to discuss the status of the case to date. This discussion should assure appropriate interventions have been taken and to determine measures needed to move the case in the best direction for the offender, as indicated. 11 "Continuous Quality Ir:nprovement" techniques as it reviews each case and assures quality-outcome orientated medical management. 8) Chemical Dependencv Treatment Since the primary mode of transmission of this virus is through intra~enous drug use and the sharing of needles, the proposed protocol includes the cpmpletion of a chemical dependency course, if indicated. Chemically dependent offtfuders who have not been treated for their dependency will probabl~ not benefit frotP treatment. In addition, any offender who responded to the treatment and then retunf).s to these risky behaviors can become re-infected, eliminating all benefits to the off~nder and to the public's health. Successful chemical dependency treatment should lhelp assure the offeQder is not re-infected after completing therapy or passes the ~rus to another " person. Offenders with chronic hepatitis C would have to agree to submit ~o random drug toxicology screens during the initial assessment and through the treatment phase of the protocol. An offender who fails to pass a screen will be referredlto the chemical dependency treatment program. If the offender had already started"i the hepatitis C treatment, this therapy will be discontinued until the offender comple~es the chemical dependency treatment. 9) Mental Health Assessment and Treatment Depression and suicidal ideation are serious side effects of the IlIhannacological treatment for hepatitis C. Consequently, the proposed protocipl includes an assessment of the offender's mental health history and current status djuring the initial screening phase and again immediately prior to the treatment phase. offender may be excluded from treatment if his or her mental health can be comptomised by this medication. When indicated, a psychiatric evaluation would be conducted to assure an accurate clinical assessment. This process may identify offender$ who were not previously known to be mentally ill, but would now need intenf~ntion prior to initiating the therapy for hepatitis C. I, ¥ ,1 It would also be necessary for the Department to provide mental heal~ intervention to any offender receiving the hepatitis C therapy who suddenly develops psychiatric symptoms as a side effect. The literature reports 33 percent of the res~arch subjects in the clinical trials of this treatment developed mental health sidq effects. The Department would add a two-hour training session to the annual nO.andatory block training sessions regarding the signs and symptoms of depressi~n and suicidal behavior. This training would be conducted to support timely ~ecognition and appropriate safe intervention by non-medical staff until a referral to .~ mental health professionals could be completed. The mental health professional ""'ould conduct a psychiatric evaluation and implement a treatment plan, as appropriat, to manage the . 12 I offender. These offenders may require a more aggressive treatment plan than just decreasing or discontinuing the therapy for the hepatitis C. 10) Offender Education and Screening The proposed disease state management protocol incorporates sound public health strategies. All offenders would be educated about hepatitis C at intake as part of an educational program including information on Human Immune-Deficiency Virus, tuberculosis, and other issues of special concern to correctional populations. Offenders would be informed about the disease, the risk factors for contracting and transmitting the virus. and the possible implications. In addition, educational materials would be available in the living units and the outpatient clinics. A team of the Department's infection control nurses would develop the prevention education materials with the consultation of the Department's medical director. A variety of resources would be used to produce this information, including those available from the public health system and the pharmaceutical companies. It is hoped education about the risk factors for hepatitis C will encourage offenders to avoid risky behavior and to seek testing. To support this effort, the statutorily required medical co-payment fee for offender initiated visits would not be assessed on any offender who seeks testing/screening for this condition. In addition to educating all offenders about the disease and the indications for screening, otfenders who are known to be positive for hepatitis C would receive additional education and counseling from their medical case managers. The team of infection control nurses and the Department's medical director would also develop this information. The focus of this education would be to reduce risky behaviors and improve self-care, thereby preventing transmission to others and preventing reinfection of those who are successfully treated. Reassessment of Previouslv Identified Cases As mentioned above, there are approximately eight cases which were previously referred to the physician peer review group for authorization to treat pharmacologically. Since these did not meet the Department's current guideline, authorization was not granted. In addition to these cases, there have been several offenders who have come forward requesting treatment. The clinicians felt that the clinical indications from the guideline currently in effect were not met, so a request for authorization was not submitted. Assuming funding is received, the Department will adopt the new protocol. These offenders and the other offenders known to have co-existing liver disease will be evaluated for appropriateness for receiving the combination therapy. An assessment of their current status will be conducted using the new disease state management protocol. A specific plan of care will be developed and implemented for each individual depending on what points of the protocol need to be addressed. Offenders excluded from 13 pharmacological treatment because they do not meet the eligibility crite~a will receive the other interventions called for in the proposed protocol, inclu¢iing chemical dependency treatment, if indicated, education, and monitoring. In addition, offenders excluded because their rel~ase date is pending, will receive assistanc~ in filing for medical coverage tluough a health care payer for which they may be apprppriate, just as provided for in the protocol. . Evaluation of Options The Department evaluated three options, or scenarios, as to how to be$t manage this condition in the correctional setting. The analysis of each one is provided below: Option 1: Continue the Current Approach: • j~ Option one continues managing offenders with cluonic hepatitis C ac~ording to the current policy and guideline. Only a minimal numbers of offenders wou$ ever receive pharmacological intervention because very few would ever meet this g*deline. This guideline is not consistent with the guidelines now being recommended by the National Institute of Health, the Centers for Disease Control and Prevention, or that ~f other state's correctional systems. It places the Department at risk for failing to fC!>llow what is becoming deemed a "best practice" in treating hepatitis C. If the Depa.rtnlent chose this option, it would not be compliant with th~ Legislative mandate in Section. 222, chapter 309 Laws of 1999. In addition, this approach fails to recognize the ;public health concerns about transmitting the disease to others either during or after th~ incarceration period. However, this approach would require limited funding to support. :1 Option 2: Mandatorv Testing and Implementation of the Proposed Disease State , Management Protocol: In this option, mandatory testing for hepatitis C will be conducted on fill offenders. Offenders in the current population who are not known to be positive will ~e tested. All incoming offenders wi~l be tested at intake. Any offender found to be inf~cted with the hepatitis C virus will be managed under the Department's "Disease Statei:Management Protocol for Hepatitis e" described in this report. Consistent with the~rotocol, any offender identified as positive for hepatitis C will be further evaluated tOI establish the presence of cluonic hepatitis C and to determine eligibility for treatment. rfjoffenders are not eligible for treatment, they will continue to be monitored, counseled, anU managed as called for in the protocol, including receiving prevention education ~d chemical dependency treatment, if it is indicated. . This option would assist the Department in assuring identification an~ appropriate management of all offenders who are infected with the virus. Treatment, those who are eligible, education, and chemical dependency treatment, as indicated, f~r all infected offenders should help prevent the transmission of the virus to others and the teinfection of the successfully treated offender. However, this approach is more aggressive than that lpr 14 used for identifying infec~ed patients in the general population or other correctional settings. Universal screening or testing is not being done elsewhere and it would me~ a higher standard of care is being offered to the offender population. Estimated costs to manage the current population of approximately 14,000 offenders are $9,715,816. In addition, an estimated $3,568,626 is needed to manage the incoming population estimated at 6,000 per year. (See Attachment I, "Option #2: Mandatory Testing" for a detailed accounting of the costs). Option 3: VoluntarY Testing and Implementation of the Proposed Disease State ManageI!lent Protocol: The third option differs slightly from option two, in that in this option, testing is voluntary. At reception, all offenders will receive educational information about this disease and its infectious nature. Educational material will also be available to offenders in their living units and in the health care clinic. Then any offender concerned about having the virus may request testing for the virus. In addition, any offender reporting high-risk behavior, or a blood transfusion prior to 1992, will be counseled and strongly encouraged to request testing. Consistent with Option 2, any offender identified as being positive for the virus will be managed under the "Disease State Management Protocol for Hepatitis C", as described in this report. Any offender identified as positive for hepatitis C will be further evaluated to establish the presence of chronic hepatitis C and to determine eligibility for treatment. Offenders not eligible for pharmacological treatment will continue to be monitored, counseled, and managed as called for in the protocol, including receiving chemical dependency treatment, if it is indicated. This option assures treatment for those who are probably most motivated to request testing and treatment and therefore, most likely to complete the difficult treatment regimen. Treating those most motivated to improve their health should prevent the transmission of the virus to others and may prevent the development of the more complicated liver diseases caused by hepatitis C. A voluntary approach to testing is consistent with the approach the Department uses to manage Human Immuno-Deficiency Virus and other conditions. All testing is consensual, except for mandatory tuberculin tests and any court ordered testing. This option is also consistent with the model being used in the general community and other correctional protocols reviewed. Testing for hepatitis C is being provided to those who request it or who consent after being encouraged by their provider because of high-risk behavior. In addition, this option will be less costly to implement than Option 2. Estimated costs for implementing Option 3, voluntary testing and disease state management protocol, for the current population of 14,000 offenders is $4,180,465. In addition, an estimated $1,606,512 is needed to manage the incoming population estimated at 6,000 per year. (See Attachment I, "Option #3 Voluntary Testing" for a detailed accounting of the costs). 15 Recommendation The Department of Corrections recommends implementing Option 3, as described above, because this option assures a public health-oriented and reasonable, yet cost-effective way to manage hepatitis C in the offender population. It allows offe~ders, who are concerned about their health, to request testing and evaluation for eligibility of phannacological treatment in a manner that is consistent v"ith that being used in other correctional settings and the general population. It also includes criteria for determining eligibility for treatment that is consistent with "best practices", while prPviding a very comprehensive management plan that includes offender prevention educ~tion, chemical dependency treatment and mental health therapy for those for which it ls indicated to assure maximum benefit. Conclusion The Department's vision is to provide a comprehensive program, as de$cribed in this report as a "Disease State Management Protocol for Hepatitis C". this approach, developed by Department health services staff, should assure an optimal ~utcome in the management of this disease through identification by testing, ongoing mo~itoring by the provider and a medical case manager, prevention education of the entijte incarcerated population, chemical dependency treatment, as indicated, mental health $sessment and inten"ention, when appropriate, and pharmacological treatment, when eligilllle. However, the funding needed to support implementation of Option 3 is not a~ailable in the Department's base budget since an extensive treatment program like thejone described has not been previously provided by the Department. 16 ATTACHMENTS ATTACHNIENT A ATTACHNlENT B ATTACIDvIENT C ATTACIDvIENT D ATTACIDvIENT E AITACHNlENTF AITACHNIENT G ATTACHMENT H AITACHMENT I ATTACHMENTJ ATTACHMENT K ATTACH1v1ENT L ATTACHNfENT 1'1 ATTACHNfENT N ATTACIDvfENT 0 Diagram: Impact of Virus on the General Population Publication: Hepatitis C in State Correctional Facilities DOC Policy 670.040: Interferon Therapy for Hepatiti~ C Diagram: Disease State rvlanagement Protocol for Hepatitis C Phannacological Therapy for Chronic Hepatitis C: Inclusion! Exclusion Criteria Worksheet for Screening of Hepatitis C Positive Patients for Possible Pharmacological Therapy Hepatitis C l\t1anagement Activity Worksheet Hepatitis C Treatment Protocol: Patient Contract Cost Model for Option #2: Mandatory Testing and the Disease State Management Protocol Option #2: Model for Determining Eligibility of Offenders in Current Population Option #2: Model for Determining Eligibility of Offenders in Incoming Population Cost Model for Option #3: Voluntary Testing and the Disease State l\t1anagement Protocol Option #3: Model for Determining Eligibility of Offenders in Current Population Option #3: Model for Determining Eligibility of Offenders in Incoming Population Model for Determining Response of Recipients to Pharmacological Combination Therapy Attachment A ~Page 1 of 1 Impact of Virus on the General Population Onset of illness Number who become infected with virus 30,000 Number who develop chronic hepatitis C infection 24,000 Number who develop cirrhosis 20 years post . exposure 4,800 Nu ber who develop seriou liver com ications secondary to irrhosis 960 ., '. ~ I ,.J 30 years post exposure ATIACBMENT B Preventivlt Medici::a 2:8. 92-100 Cl999) Artic!e ID pmed.1998..MlB., ~le online at ht;;r.//wwwldslilmuy.= oa IB£~l~ .... " Hepatitis C in State Correctional Facilities1 ~...o.ne SpauLding. M.D....p CarJ!yu Greene, B.A...,:l: Kerith. Davi~n. B.S.,; Michelle Sclme:ide:m.3:!:l.ll, B.S.,+ and Josiah Rich. M.D.• M.P.E.~ "Diui=ion 0; W~lU D"--. ill:cd4 laUmd Eoapit=Z, ~ RiIDt!z L!aM: i'1'..~ lsl.:nd Depc.-:mc-~ W~lTedm.3. C~ ~ !sJ4nd; ;!?n:ram rJ~ SdUJGl ar- ~ ~C!, ~ Is!.c.-.d; and iDwi:icn gl In{=ioIU iJi.ur:..u,. Tr.tt j(';rimn Eo:pit::1l. PraoilUr.a. ~ Uk:r.t:1. Backe'roW'ld: No previouutudies have era mined the extent to which correctio112l bcilities in the United States screen for and tre::1t hepatitis C CE:CVJ infection.. Merhods: MediCI! directors at state CUll ection.:1l f:1ciIi. tie:srespouded eo a~ asse:ssingth.e degree to which prisoas 5C::'eleA teJ:" and treat hepatit:i9 C. To estimate numhers ot inmates eliJ;tole for ii:Iter.feron b:'e:1t::rnene and l:o e..c amiM C:~ a~at.ed vrith RCV m.:m.:s.g'!lme:at, we constnJ.c:tQd 2 fQASil)ility mo<lei that incorporated 5C:reeni.t3g criteria used in CalitonJia and Rhode Island.. RauL~ Thirly-ro: states and W3Shin~ DC. roe-" 6pOaded,. ~ting in a survey response r:1te of 7370, represencmg' .'T':'D ot all inmates in state facilities natiouwide. Color.ld sl ~_~.&.:_ • o one repo~ roa"~e ~tung. Only CalifonUaret'ortad. conda.cfu1g a ~em:atic sereprev:l1ence study, which found that S9.4% of male inmates were hepatitis C antibody positive in l.9S4_ Sevellty-~bree percent of the respondents sometimes consider tnating with interferou. Four states follow a sc.a..cdard pnJtocoL The feuibilHy model ~ggest.:s th.:lt n-ea~g' suitabb" screened. inmateS is a reasoIl:lble ex· penditare fot" correctiona.l ~ t __ ~_ 'L._ •• fi COIl.cUW".,gn: ~ ...~ m.:ay uc: ~ :lpprapn::l.te setti.D.g or treatm 1: i h titis C If . _'L.stan D...:___ en 0 epa - accompmlYIng :n...... ce abuse issues :Jre 3ddre:ssed, instituting RCV ~tme:nt for cert:Un eliiihie inc:s.reer:ted individ~ m3y tM: :I worlhy t3rgQt COJ:" public health dollan_ et_ ~""-o 1'l\uIm ~ aaoi ~ Pfta " l!R7 Words: hepati:tis c; prisons; review; cost analysis. IN'1'RODUC'I'ION Hepatitis C viros c.HCV1 was recogIJized in the mid1970s ~ a distinct, "non-A, non-B,· viral cause oItz.-ansfusiou-83Sociated hepatitis; it was successfully cloned 1 or. S.il:h is Npported. by ~ gnnt 5:om tee Na.tl~l !zl.at:ib.t!:= QI1 NatUmal ~ a£Heal:!:l, Gtanc DAl102SS. 21il whom reprint Nqaesa should. be addre:rsed. F:rc (401) 462~o. E-m:W: .Aa4L.S,!l<I nId ing '4D@bl'Owu.ed.u. ~_-\bUllll with. the 1:::. the folIawUlg decs.de Uj. The development of an enzyme-linked. i!:I=:lunosoroeni; assay (EI.IS..4.. or EIA) made i.t pQssilile to sc::een donors for antibodies to Hev: I S ubsequer.tly, ';he risA". of a.cquiri:g ECV WQU:,a'h, tr:1nsfusion d....-oppee. to le::l3 I:h.an. 1 in 10,000 per unit t::ans-fused [2]." Apprc.::i:n3.tely 4. million Americ::an3 are cu:rrently infec+'..ed with. HCV [;3]. Due to the public health implic:ation.s. cc.e National Institutes of Eealtll CNIE) rece!li:ly held a c::r.:~e!lce to deve!otl a coasens-.:.s s-..atc- . I!lel1t OIl ::be ::.ca:eg""....ment ofheoades C (21. The roul:c of ECV tr.msm.issi~n can be id.~i::if.ed. i:!l more Clan 90% of Fiev infections [21. W.cile the vi..-us • . . '~L ~~ d' ""'" B snares t:t'ansmt3S1.cn rou~ Wll;.l;l, .o.l y an aep.e.tl!::S • H~~' .~ d _. .1, all Th ...... ~ ~!:ll_:a :::lost em~~!lW.7 pa..""e~te..- y. a major r".sk fac"..or for ac:-qw:nng ECV 10 ::he Umcad. States today fu mj~tion drug usa, wbich ac:::oU!l.ts fot' 50% of n.ew i:liP.ctioIlS aLld over one-hl£'ofc±racic Lr:.!:et:.on.:s [31. Rec=~:ly. in~al co~e use has also beec. li::Lked. wil:b. RCV transmission, perb.aos secondary to epista:cis and. sb.ari:ag of straws [41. m';'en the associa.. . b t.:/"I"t:" _ _ ~ •• dill _ l ..1 _ tion. etweec.=vy .... ~nus...l.onaIl ei><M ...... "'Suse. . . 1:1--1" • t 1 .. • t:h . 1 ed It IS J..I..ll.I:: Y tn..." a a.",:~ proporc.an at ose mvo v ...'to. ••• • " 'C"CV '. • F W1~ tile t:r'..:::u.::La.L ]cstice system are .Q. poSluve. or e:cmple, in 1994. California found all HCV seroprevalance of 39.4% in in.c:J.rcerated males (5] compared. with the HCV seroprevslen.ce of 0.5% by EtA npo~.edin the general blood do::.ar population (4.61. Given the relatively high rate off3l.se positives by ErA in. ?l9u1ations v.ith low RCV prevalence, this value probahly overotimates the actu.al se..'"QprevaI=.ce in donon- -<\pprcimately 83% of the !l3.tion's 2 i::nillion i..- d.."Ug users are ~ d at some time [7}. Thus, a signi:ficant POI't:i.an. of the 4- million .Ameri~ -with hepatitis C have mvolveInent with th.e correctional system. In R.i.OO2 Islac.d. 19.4% Ofprlsollers are serving sen· ten.ees for drug-rd.a.ted O£feIU~, mc:luding m.a.nufac tu..'"'e, delivery, ar.d ~ssession of d..""Ugs. Random. mine .::s' 4 92 aC91..'~ S30.110 ~t ¢ 1999 ':IT A.au:rica RaIth F~ti04.ulc1ActrWl:::c~ All ri;Il.t:I 0( ~u=.oa.:~lQ' ~ r- 93 drug tests an inmates rettI:r:l positive in about 2%, indi. c::ltlng some in-prison drtr.g usa. S~ estimate that np to 80% ofinma~ have a history oi~ abuse. AppraDmataly 85% ofin.dividu.aIs infected with HCV will develop cbrocic RCV iniecti01l (4,81. The na.turs.l history of the infection l:ypicaJ1y follows an indolent course (91. although. 3to.dies following patients over 2 dec:a.des e:timate that about 20% of those with chronic HCV- infection progress to cirrhosis within 20 years [10]. Oc.e to fIve pe..?t:e!l1: may develop hepatocenular c:arc::noma arCC) within this period. Once c:iJ:rh.osis is established, ECe develops at a. rata. of about 4.% per ye.!ir tl11. E:epat:i.tis C is now the le3.diog' indic:1ticm fot" liver t:"anspJantatiOIl, in t'l,'s country [21. Interi"emn (IFN) iu.s ~eri used to treat chrocic hepa.titis C since the mici-1980s Ll21. Use afIPN-a2b ~ in a ~t.ained l'eSpOnse in ap~tely20'% ofncipient3 U3-16}. S~..a.ined response is defined as no detectable virus by PeR and o.ormaIization of t:r:m.sacinases at 6 to 12 months ar..ar a comole!:ed. ~l::l::::t~t cou..-se. Patients who respond to IFN'.show re:n:is.sion oi ix:ilammation on liver histology [16-181. Theoretically. this should decrease the rUk of lethal sequelae of chronic RC\'- infecciOIl. The N'IE c:::lnseIlSUS state!n.ent er:.dorses a s~d.ard iciti3l therapy of ::hrice-weeIdy i:ni eetioIlS ofintexi"eron for a ceriod. of12 months (21. The statement alsa details guideim.es for initiating therapy: Some ci:l..-oDic medic:1l condicioIl.;, such as aw:oimmtme diseases. ar~ cont::-aindicaCoD.S to tr'e3.tJ:nent. Furi:b.ermore, substance abuse mould be treated. prior to iniliating therapy. Alcoilol use is associ.atad 'With exacerbation of HGY-re!a~ dise~e [9,lS-21J. Injection ~ use places peo91e at risk for reinfec;ion, and anim31 studies demonstrate that prior RCV infection does not confer protective im:x:.unity 1'22.231. Applying guidelines for managing RCV is particularly important within hi~-risklloPuhtiO:as. In. Rhode Island, prison physicians disc:1v~ !:he need. for clear I::1anagement c..'"iteria. when they found 3 high. HCV pre~ in ~ papuIariQll Until recently, all inmate kii:cl:um woO:Jmi wen prospectively screened for hepatitis B, hepatitis C, and mv: Officials £'ell: scre~.;. iIlg was necessary to appease prisoners who worried they could ac::rWre these disea:ses from infected food h.a.ndlers. Of those sc::eened.. approxi:na.te1y on.e-tbird of ~O tested positive for antibodies to :a::ev: The poliq was changed because sc:reeningfeod band1en far ~e vir31 iIlnesses had no pnc:t:i.c:J.1 impIicati<ms. However, a large number af HCV.posit:ve inmates were already idantt:fied. and were ask:ing for treatment.. CotTeCtional facilities in the United S~ part:ici"pated in. a nationwide survey to determine wbieh methods are being used to evaluate and b:'eal: this potentially curable fcn:c. a£ cbrtmic hepatitis. ME'mODS A one-page survey was m.aiIe4. to the Commissioner of the Depar=tent of Cor.r-ectio'PS far each of th~ 50 :state! pltlS the District of C:Jltimbia in. Dee-mher of 1996. A caver let:ar directed. the commissione.....-s to forward the sUrvey to their medi~ program. dired:ar for completion.: Sur;-ey C[lleSi:ians aslq,ed nspoudets for the nu.r:nber snd ge:l.der of inmates ~ thei:rF~ct:ian3Ild total n1J.ID..ber for the state, wheljher their system was privatized,. what wu the HIl'1l",!eropositivity ate, whether hepatitis e was tested. ror routi:::1ely. and the o.umber afhe-patitis C ~ pmapneci and t.."lQ ~t'l:Qt age thai: retum.ed :POSitive. Det3J1J.ed. in:br:n.ation about specific HCV SC'Qecing mathodsft;as not alicitad. Ii the jurisdiction treated hepatitis. i:li.e sur/eY we!lt on to ask whether liver biopsies were performed, haw many patient:! ~e..>Ved interi"e:'OIl. hoW' many das~ of inter· feron were ad:c:licistared, and. wh'~ther a writ-..an. treatment protocol e:risted. Responde!l.ts were invited to send sample protocols. P;..nally, the sutTey queried. wh.ether a syste::a.o1tic 3e...~~vale.o.ce studt had. be:.. c:mducted.. Responses were returned by m4iJ. or fax betw~-tt Decemhe:-1996 a!:.d. ~1a.rt:h 1997. MjediC21 progra..:n di.~· tors of ncm:espcc.db::!.g state corr~OJ:2lfacilities were teleph.ac.ed in March.:md. A~ 1997 ~ asked. to QQplete surveys at tl::Jis t:U:le. A secoxp.d copy of me orig"~ ~Url~ wa.5. Wed. to conbc'"..ed nqnre:spac.de-""':S. Sub:sequent replies, returned bj' mail ~:r fax. wer-e ~llected between April and July of 1997. ; A hepatitis C ~o:eening l:teal:::n.e.9}.t moc.e! was developed based on prs.ctice guidE$nes :md data ge:J.erated from the Rhode Island prisoJ:t, pollcla.tion to determine how m.a.:y in:::lates would. be eligible far ~. m.ent. Speci..:fc inclusion and ~u..siOI1 criteria were applied to the total numl:er off;una!:es to arrive at the number or pn::ouers who wo~ most benefit from treae:tlent. Total costoCECV ~lmtin these patients was -then e:stim.ated. to de.rmine if treatment would be eeoooc.icsD.y feasicle v4thin t:h.e prison 'SYS. tem.. Absolute <:ost of interferon per patient was obtained. from: the m2l1uf:1ci:urer, mel the cost ofFetreatment workup was ~..a.ined accounting records in t:he pr..:JOIl. !a.borabn'y.. ;, ;me: fro* " Survey Thirty-six ~tas and the Dist:ri.cijofColumbi.areplied.., re:mlting i:d ::L re:spCIUlc r:U:e of 73-$ ('!'able 1). N a mare than. one ~ was retw:ned W each state. Some sorvey:s we..~ answered by ~ dinctors responsible for cmly: part at a giveu st:ate'$~rrectionalsystem. The respondiAg coneeti:v~t.;t2resc.l: 77% of all inm.ate~ in zb.te con:ectian.al ~ '. .es nationwide, or :;taw . 94 SPAUlD~G TABLE 1 ~Q ai~ Stata Corract:iczud P:lc:ilities St.:lra A1uk:l A.ri::ol1.2. AdclDS'\S c.ili1im::ia CoLmda ~ ~. No No No No No No. of ~ces '!I-Mala BIV'!liPII': !RI.I"'"ty . 3,800 23,000 ao Uc!mawn 94 8,.503 93.4 L2 l.0 loU,9~ 93.l 2..S 92 95 rJll1 94 U 10.0 100 Dla 90 94 99.9 Dla. 93.3 96 95.5 0.3 la.OOO Di:=-:.= of Cola::bill No 9.000 ~ C~ rJlll Dii1 Ia.dI:m:l 'Y=s No Y=s 3,1332 11,'nS 1,31)0 No 1.2,179 ~ Xansa.s Ir..=mCtj Mai:l.e llW7Wld M,sscensees MiCig:m Mi=esob. Mi=o=i ~~ Nornda. Nww 3'o-;:::sl1ire NeW'Ya~ N~~~Oe.k= Oi:!2llaca. ~n P~va:\ia. 2..~ocill !sla:u:i. 64,02"35,200 P:lrtial 1.550 Y=s 2:l,3iiO y= lO,.S(lO ~ ~Q 3S~S Yes 20.185 9-4 No No No 3.180 8,300 90 5,090 2.055 6o.g34 ~o .....es rJla cJ~ ~ No j50 93 14.iOO ~o a,7CO 34.000 3,2S4 2l,094 20 93 9!3 Yes ~g 23.3 3., 3.0 1.0 fJ.S i.a 0.3 5.0 3.5 1.0 O.l 0.3 0.7 L5 0.7 14.0 0...3 0.1 1.1 ala 3.0 3.5 1.0 1.2 ~c.:m,li:u ?u:.1l SoQDwt:. Te=essee 'I'c:=s ¥~ Ut;:l::. No 4,584- v~ No No 25~1J0 12.579 2.500 91 1.0 <LO 14,l:li' 95 95 1..300 cJ:L W:u~..:In Wes;'it.~3 W'1.SCn15in W'yO:li..c: 2.15i 13.821 ala No ~2.346 ma No. No 9<4.3 93 97 ~5 ., -, 95 0.4. !l4.5 1.70 ~ 0.9 0.3 Not/:. da., noe ava.i!.ai:1e.. • IaIiC:cci :1umhl!n j, Wri:m. =~ent ~ ~ inciuded. "We tRsC an dem<lnd or wit:1 37=lptoms.- about 800,000 people t241. While 35 states (95%) reported seroprevalence data for mv; only 1 state ha.! completed. a foc::W RCV seropreV'lllence study. Table 2 lists infor:nationre:ardini'e:a::tnIlt se:reeni:c.g and. treal:ment prad:ices for hepatitis C in re..e:ponding' facilities. Only Colorado reported. "routine" hepat:il:i:s C testing'. ThIrtypen::ent ants ami-RCV tesi:ing'retUmed posith-e but only 1.224 tem were ran in 1 yett wh~ the total number otinmates in. the jurisdicti.anwas 10,000. It was lIIlclear haw ~ut:ine· testing wa:s defined. Neva.da.'s l10nr0uC::c..e testing for RCV antibodies f'otmri a positive nte of onl:110% by initial tes'tin& and RIBA c:omiI'med anti-RCV positivtty af l.2~_ I:.a. Matyland. 67$ of 120 test::s pe..--!ormed were pC:sitive for :e:<JV; and. in Mi.3souri, ET AI.. 59"1& Ot 840 l:es"'..s performed were positive. In Utah., 83% of 87 te~ wee posit:ve far HCV. Twene-.I-seven (73%) I'eS"Ooudenb s~t!d chs.t some RCV antibodJ'·pomive ~tes reciyed, t:reatme:::l.t. Eidlt (22%) re?Or"'..ed chat th.eir inmates neve:' receive ~ent and 1lO ~ac:l;ties repo~ always t:eatin~. The ~t to which a. ccuect:ional system pttrS'Ued tNatment ofECV was not cm::::elated with whei:h~ it was privatized. Fou: states (llS) fellow 3. 'i'r'ritten proto-col; an additional 6 (16%) are in the P~3 of developing one. The 'llw::lber ofdoses ofint:e:rfe.""On dispensed,. if 'are s1:.cwn in Table 2. One patie!lt r ~ interi'eron t:hne tt:l:!.es weekly would rec~ve 78 doses over 6 months a:.d 156 do:ses over 1 year.. Thera_fare, dividing the tl~ of do:!e5 by 150 gives the appro.-ci- mowc., mate'ucnber ai ~=ents !:reared. for an enti.-e year. Data ~ the number of inmates t:re:a.ted for hepatitis C, the n ~ not t:e:1ted, and th.e nu.mber of liver bicp.sies pe....form.ed for the yOW' was Ilot fortb.~ c:m:ring. Responses cf sta1:e:$ "';;'b.o p-t'Q-r..ded info:c:l3.tion are shoW'll in Tal:::.le 3. Ocly nine states (24%) repone-.:!. numbers of in=l.atas t=aated for b.e~tic.s C: E.-,e st3.ces reported !:hai: n.c i::.=lal:.e.s ~ ~!ltly t:e3.cad, whiie Rhode Island. reportad t:eaCng 23 i::::l:lCu. Six sQ.tes (16%) pr-,N [ded cab. :-egartii::lg- nw:tbe: ofliver bio~sies perfor:ned pe:- :e~ ::me!! r2por-..ad IlOIle, tl::.a District of Colt:::lbi.:l anC. A.:lns3S reoorted 2. and Rhode Island. repor-...ed per:c:-::l!::lg 30 liver biopsies :per year. Only C.ali:or-..i:J. C'Ollduc"'..ed 3. for:::13.l study of EQr se.~cre-.ale::ce.~-is studv was cor.duc:ed in the fall or: 1594 jomtiy by :he C.ali:iorui:J. Depa...-:::::Lent ot Eeal~ Serric~, the 0 Eee ofAIDS, e:1d the Califo.rr.ia Depa::· lne:lt of Cor=ac:ions (5J. T'c.a c::oss-seQoc.:U. blC.dee st'..lci] 3l:.0wed Qe "CV se..""opre....ale.aee t'3.te by EIA-2 was 41% o...·e.rall. The rata for mQn was 39.4.%, with. a. higher nte a.cor.g white5 compared with. mi..corities. Women had an overall rata ot 54.59&, with. !:he highest ra.te aI:l.ong La:-:-a s , fonowed by whites. A. lower tb..an average rata was found among' Af'ricm·AmU:c::u:. women. Of ide=.eed intravenous drug use.~. 76.1% were ECV pcsi.t:.·,e. In. Rhode Island, avar a 4:-month period from Septa!:lber to December 1996, 37% ofhepa.titis C Er.~ t,e!its re!:ur.c.ed positiVe. These data were generat.d. m.:1icly from prospective kitchen workers, a broad c::'OOS-5ec:!Or. of the in.ma.te population. with Rev Island pr.son syr..em, we created. a model !:a estimal:e numbers ofinmates eligible for sc:eeni:I.g and :ea.tment (Fig. 1). We juda~ that of approximately 3,000 total inmates, auly 40% will meee the length~f·sta.7 requirement of at least 15 months (Table 4). After howtll education sessiaa.s, abem 25% ofilia reT'"''''n;T' g 1,200 are e:cpected to ask for screeni:c.g. In an a~..eI:::t"l:t :0 assess costs associated ms.n.a.gem.ent ic. th.e Rhode 'I:ABLE2 Scree:Ungl'l"r=i:l:::1ent ~ot.oc:gls far ~ C in Sbte ~tW F~es State AIaUa ArU:ana. No nJa No Ark:m.3as No No TJla. Dis Cali!onli:&. Ccl.or:uio Tas: Dist:ic:!: at Calumbi4. No E'lor:..d:1 C-.!O~ Id:ilio No No ~4 taata riana ~ ~ No: 10 teac Wme No M:iul: No ~ Mass:l.C:1useC:S ~ i1~at:J, bW:sou."i NeQ~ia Nev:r.cb. New H:u:1;::shi.-e N~ Yaril: North Dwe O~io~ 30$ s.c~c::2S TJI" N'e'7e'l" 'Dia. 'Dill. nJa. No No B:=tw:kr DIs So=ae=a Sr.:eC::es Ne'V'l:!" Seoece:s No: UO !:s=::l acne No No No No: 2S8 ~u dc:z:.e :Ja. No: high rO..1k aery No:: a.t le:ut 1 ciac.e t-'o Sat::.~c=~ ~o Sac:::.ci=es 67% nia. Socc=e5 Sace=es s.cce,..l-..., cia Sac:.a':-es 59'ft. cia. lOS CF..I8A 1..2$) cia. Saca":-ps SacaC=cs Scce":-,., oJ:! Scc:.a":- es 51Jc:.a ::::'2:1 ~o ~o ~o 5oc.e::'e:s :fa Soc.eci.=.cs Z'io Cevelo,~ ala. ria. ala nh. .sOCIIC=e:I ~o: r-."o nla S4ucD~a~ T~~e:s::lee ~'o =ia NlIVur Ko ch..: Wa.s~.c11 Westv~ W"~csU:. Wym::Ucg ~;ct~t11~ :ia. ~io ~o ~0: 37S 5 tQsts cl.aD.ll So=c~es Soc.ec.:er Sv"S ala Soct~ci=~ N~ N~l" Di:s Dia fJis. 20<;'& Deve!c >. nia RhCllie Island Soat..'1 c.rn~ VJrt.c.a ala. 2011 Sa=!"';-e:o N~ Nev,u" Nlivur' > l....l3a cia nJa Scce=e:s Sccec=es Scc:ce::es 37 dQtl4. if'Sx Q a D~la~ No No No ::fa Sac:4tC=es NO) ~o: ~o ~o ~ Sctnce::es Ol"elJ'CtI Teus Uuh ala No ~o ~o 2~"'1ia 507 Test:::l Done o Yes S-IOS et cia 'fJia. cia. No: 840 e2St: dana No Yo Dev1li~ :fa No cia. ~o ~o cJ:! nh. 480 ala 236 Ye:s D~o~ No • D~~ a ~a ~C1 a Yo c!a lc=a l.3"-S~ 10 o , .'Y'e::s.' No 00 ::i:l 2,53'" a ~o cia a ::ora ::orQ 265 ::oro :13 :/3 N., ~o ':Ii:!. :13. No No No :/30 o Nore: 013.. tlot ;lva.il:able; =to esam:1te. • ~ut ;lOout til ~ . • "1.995 Na. IFN dllH: t9S tFN-a23; 1.032 ~-2b.· • -WQ CaV'l 1!:I:;lQriacced. & vfIay low pnrn1&m1:ll ofHIlP C SCI ~ "Omy i! symptoms.· ear..- I 'J !; Since 50-80% of IV dru: users acquire ECV within 6 l:lJ 12 months ofinject:i.t1g (4J, between 150 and 240 of the 300 are likely to have positive sc:eens. However. we estimate that at most, 100 will meet clinical exclusion and inclusion mteria tot' treatment, and only 50 will demonstrate no drug or alcohol use for a period of at: ~t 12 months. Of these, 10% will be exclUded secondary to liver biopsy and/or laboratory results. Fort'J-nve Infected pr..soners may begin IFN therapy. At. 3 months, 25~ will show ud responSe by PCR and. therapy 'NiIl. be discontinued. Of the remaining 34 treated. 10% will drop aut aftherapy due to intolerable side effe<:ts. T:1ir:y-<Jne HCV-posi~e prisoners may receive 12 ::nonc.s oi'IFN'. Th~ in the end. ;J.pproxi. mately 1% of the total prison pogulacion may receive the full COur.3e of IFN therapy. ••~ We c::aIculatad the com of scre~" . SJ1d tres.ti.ng the number of patients presented iJJ.,: . model (Table 5). The total'eost for our model is to Y $250,000. Drug treatment, avauable to varying d~ inmost CQl:':t"eCtiou.al sysI:e.:::.s, ha:s obviaws mmq beyond allowing patients to· qualify for hepatitis ~tment. The B40da Island Depart:-...ent of Corred::i.o~ offers both. supPort groups and residential treab:D.qt programs for in- 96 S?'\UUHNC Zl' AI- doses. Uncllr.l: ini'or.naticm and e:rt:imaf:e3 ma,v have introduced observer bias, m aI:in go it diflicult to interpret $OIl:1e of our results. For e:tSJ:1ple, many state-:! re. ~o:c.ded that they sometimes treat their HCV-positive in.m:J.tes without providing di.saet:e value::s £cr nu:cbcr3 =Dis:"'cr:-:cc:-'-o!-:-:Cal.~l!m-:b-i:J---O--~=-===--=:'::::=-tr--.:lt-ad. Th...is r!J.Ay again ave.."estimate the cient to ~ s:'a ~ which ~tate f:](::!;~ treat. Similarly, seven of eight ll:am:l.s 0 0 a st:a.te=s respo:c.di:Lg t:h.:1t tb.ey neyer treat HcY ocUtted MaiSaehlt5etb 8 TJlIl TJla. the nw:nl:er of S~~tests nerformed. It is not clear Nebr:uk:1 a 1JIQ 2 ~ew ~a:ilSbiro 1 w h efo!:he:.. the:3e states are notr treabg HCV-posit:i:ve o~ 2~:~: prisoners or simply not testing fer the disease. Rhode Island 23. :/s 30 The iiUt'Vey did. :lot ~~ mfo:rmation on sc=ee:aiIl~ ~ 0 1 0 protocols. Only cn:e st::I.~ t'OUtinely tests for Rev: We asswne that the other ~tates are oredominantly tesCnco Nou. w~ ~C &~!&. high.-r-=..sk or S"'jI:lptOmatie inmateS ot' thosewb.o t'eaUes~ • 0al79~(:H%Qf~e'1r=txmcient::t)~.Iied~~ tes~_ Based an California's seropreV':Cl1ence ~es =~~. '.. many poten.tia.il.y t=eatable im:J.ates with heoatitis • At the tima aI e!:a !tUdy. may ::lot be identified by these pr.tctice:rWhile most s"'..atas are Wniliar wit:!. mv se..""Coositi....mates. Methadone !Ilainte:c.ance is provided only to tty in tlleir pr.scu SJ"S'tC!IlS, olJi.y CaIifomis. reoorted Pl'e".an.ant fe~ Since these rehabilitative semc:es Jm.o~ HCV' seroprevalenc:e,. di:ing a rate o£ r~ugbly would e:dst in the ~ce helJatitis C, the cost of 39%. Tais vaiue is sigo.i:ficantly higher than the r:lca <hug tres.t::nenc programs was not included in the fas.si- for Err, for w r.~ch. many prisoI:S rou.eely se=eo..n. It is . TABr..E3 B:epatit!ls c: Na. af~ Trellted in. St:1te Co~ac.:U F~cilities in One Year' Na. or liVl!1" Nc. treated. No. untreaUd biap.si= ci or billey moaeL possible ~i: ~..:::ill.arrat::s would. be found in. other state DISCUSSION We are b Qe =idst ot an HCV epide:::::ic. Eeow:e 0: tb.e con"elatio~ ~~!:Weo-!l. p:1r"'...nte.."'2land intr3ll.3.Sal d.rug l.:::e and aCqOJ.Sltiotl. ofHCV, a signi:fiC3I1t pro'Po~oa of the population in.fef:"'..ed with HCV ~es in prUoe.. ~tmeo.c of an ap-p1'1)priate subgroup of this populacon may decrease their risk for ciI:rhosis and HCe and .potentia11yprcvenl: furtherl::ra:c.smissioo.. We have initiated. a. disC".1Ssioc. of tb.is issue by assessing the currenc stat'.1S of sC'e--..nmg fot' and treatin co chronic RCV wec. non in state prison systems. 0 Our surrey iVas purposefully short :md directed; we received. 3; of a potential 51 responses. Stata more ad:Ive in the surreillance and t:reatmen.~ oCh.epatitis C ma.y have been more likely to respond to the survey. This selection bw. ifanything, weald overestimate the e:::C:en1: of detection and mat!.3geme1lt of the disease in 3. correctional. se~. l'namtives such as the promise of teclmica1 help in developing a he~titi.s C protocol upon receipt of a completed ~e'l may have resulted in a higher response rate. Ma:.c.y of !:he SIlL 9 eys ~ retm:ned with partial re5pOIL6e6, estimates. and omissions of c:ritic::1l infOrm:l. tieo.. Man OJm-plet:e re5pOIlSe9 ms..y have been elicited h:ui the respondents bQQU talephoned. in. order to el3rify the OmissiODS. The qnestious that appeared tD pose the most difficulties included the numher of hepands C tests performed ana the percentage of tests ~ positive, the a~ O£~te9 tnated mel untreated, !:he n.umber of liver biopsies. and the: number of lFN prisons. Despita a t3.cl:. of routi:e sc:eeo.i.tlg one state COCI:le::.:ed, "We have expe::e.!::.ced. a very lClw prevale!:.cs of ae;! e so far."' This laclc or awar~ess of the potentially hi~ ?nyalence of ~CV c.a1re;l~!: the pau.citoi' ofi)cillis1l.ed. ~I:a on ECV sc=e!!cing a.ad. l:reatmeA: in the pr.sOIlS. Most pr..scr..s soc.e";.=e~ t..-es.t HCV~ s.lthot:gh onli £ou.: hay/! est3blished I2'l' protocols. ~I.a.n.y impor-..an.t questions ret:!.3in to be asked.. For ~ole what era the speC£c sc=ee.c..bg cdaria used in :aost-s~tes? What inclt.:Sioc. c:ii:eria a.""e used. SJ:c.OI:lg the 13% of state faciIi·ties tl::tat SOIr.etimes treac Be\;"? How, s;:eciiic=illy, is ReV t::"eatl:<1 in these fac:ilit:ies? Issues of cost aEectivea.ess potentially limit fea.sibility of f:reatm-mt. Determined to provide standard of care in afinar.ci.allyrestric:ive environment, Ca.I.i±"amia . and Rhode 'Uland i:c.c:orpataf:ed a ~et of inclusion and ezd.usiou c::i~ :nta their pratocols (Table 4). Itt. the yc:a:r prior to instituting these gnideIia.es, Rhode I.Wmd. ~ 23 inmates with IFN. This number was bi.gh CCr:1pared with. .c.u.mbexs reported in ather states . partly because. at that time. all pro&pective kitchen workers were sc=eaned for Rev: Some ofthe 23 mmateS would not meet e:::rrent i:c.clusion c:rlte:r::ia.. Intetferori prot:oeals shculd allow 1%5 to ident:ify the subset of poitient:s who will beo.efiJ: most from therapy. . We lXlu:ri: as~ the applicability of the cm:rent HCV tre3.tment. ~deJjn..'J t.o the prison population. A recently ~loped. fram~ prgpoees ~e:ting.:aine factan when deciding to implement health benefits tin' an in.t::.:lte: [25] (Table 6). In it. patient desi:re is m:L mr EEPAnTIS IN CORRECTIONAL S".\.CILl'l'lZS 91 Pool Excfuded from Sc:=in imna:es with le:ngrlc obtay > 15 montlu 2.S% prisanen motiwrreti to a:tlcfor HCY l~..ening 300 prisoners scnQu:d[or HCY .with EIA.-2 33% prisoner.: me!!! aLI diJrjcaI criceria for IFN prier fa blood work and liver biap.ry zoo prisoQe~ 100 HCV+ prisoners eligible for przrreatme1rt substance 1UJt abuse ~aluar:ion ~e:: diJUcal crireria Or :rurrztf: dt1r.u HC/ • EO'..;. !::Ul do 1I0f 50% prtsonen withau: s:UJs:anc.e cir.ue issues de:e:rmirted by r.lbr".m-.ce aCu.se CQoraUr.aron 90% pr..son.e7'S willi lab 45 HCY+ prisonen begin IFN rherapy wo,.k and oiopsy consistent with ~t c:ritI=:r.a 75% pris~~Jrow reporue to IFN ay PCR a.r 3 momr~ 34 :e:CV+ prisoners 11 HCV+ PrUQlle1'S cont:imuf IFN at 3 montJu lEN S'.tJpped aJ 3 mDnw 90% 31 HCV+ prisoners 3 HCV+ prisonC:n i1t:oleahla silk recdve 1.1 mt1'I'ltiu lFN r".tJPfJ«l at qru:= ta 1FN IFN J mon.dr:s or less FIG. 1. EivpaCti$ C ~ =d ~ t :lOdal mBhodIt IaW:td.s=.a c:aC'llC"'....l:RW StCIiCy. ~Iadal hued pri;:oners without - ~ within ttlc Rbode:b1md st:l.ta c:al.~onal mt:em. ~. ; lIStimatas ~ f:o=m 98 S?'\r.JI-OINC ET .-\I. TABI.E4r TaBLEs ~usi= C~.a fbr 'I'tes.t::l.ene aCRe'/' Fs.c:ran l. ~ =~ cri:uia. E'ailure to IU4"'OU in ~~\aI:.l:C abuse prag::J.m ;ar 12 prior Bisto17 ot dcc:=~ WIlt at iv drup or a1c::lhcl in aumw pncsclin!r 12 mGl1U:$ + + 2. 3. 4. + + ~. o. Pa<rr c:rm~l ai a =otjer :l1Illiical iIInasJ; or p5?ci1iarric Uh:a:a I..eui'"lt. oi stlLy ia. priscu. <13 m=:::s :ram iniCi.atiau of~=c + 7_ 8. O~ ~ ncipiac: d.!.Iieue 9. .,. P'.atzalac. cew::.I: <75.000 mv antibody po.s:i~ve RCV vir:llioad <3.S00 tn' >350,000 ana ~ <20 yea:s t..:v. lMpq: pns=o or c:i:rr'-~ :'t:y mm..-:lte Autllimmw:.e d.i3ord.er ~onabto SI!r"'..J:l. Cri:u".4 ECI antibeciy posi;7e ~>18oC'<65~ Ect >30S, ~ <3..5 m.gtd1. Cr tl:.yt'Qid l'u::.c:::Oll ':e:r~ w::hizl, <U ~dL ~-:a <l.2 :lorm.:U liJ::::ib Ccnsane si~ea fur :-:ndom drtz, 3I1d alcohol 3C"1le.S dur'.ng a"e:lcnen; Liver biopsy- ~t ".tIit::l. ciu=ic: vinl cepati:i:s tn ~ than r:rpper lbit:J of:=-.-II! ~ ru:ode {,la:.d infar.::w:i:la. ~m Or••~e SpauI.C.Qg. ~UClc::1l Pro&:=! Cire~~ ~..h. criCerb. =eci by ==::u:-~e s:eered by 01". N'acii.m K ShDa....,. =d Dt:. JaCn R.. c.,.,;~oQ, ~~at Deputy Di=at1, Ea1~ Ca., S ~ Di\-is:iol1. TABLE 5 tar Sc-a~ =d.1'nlttCllll.t oCZllgible I::l:1.3tes in Uw at ?r~ Sy~t:=:l aa.ed. on ){od.el in Fill'. I COBt3 pel" Yaar P:-ocedUI1! RCVElA Liva:- biaps1 ColTediolU1 oCi.cers! ti=1!" Case ~,.~ n.z;a No. oC p3tie:lt3 !oQ.l cost 300 SO $205 50 503.900 $10,250 $309 50 tt3,4S0 ~ntCC8tB ~~ Int:':ltre:ltl::1ent fDUo...-lJP'" $2,SSO 3-mcnth.~~ ~l 14- $3.51<' 12-mcmth Cl7lU'IOlI $74S 31 S23',095 DeC.silJ'll t:a Inl:arT1U:C'" Ur:rem:r CJf pr.x:eil;..~ E:r;lec:ed ~~ r:lmuicu of i:s:u:arc.~tion. Ne=l:nl:7 q£ ~t:rQ_ . P:cb:shility ui suc::asfUl outl:':l.lne or: tre:1t:::1~ i.nc:l.~ me rUk oJ: adverse side ~. Pacent's desire (CCT'IISud. CIT' tmpiiC!:} S3r ~'1.e ~Ccl1. E..-;c:"'..,ed ii::'tc:::ui impnm=m.t 1:1 :1 =It: of:he . ic.terYl::1tion. W"~ Q.e i:lee.~tion ia fbr a. p~ candiCQa... W"~..b.er the in~=an is ~1: fbr :1 ch~c D\tn1:iau of i.afecicll >5 JI!An CIinial sisns ar ~l:l:I3 qi liec:m:pcuated IiYtr ~ 1Jt,:~ I:mu~ ~ & c:m:..tinuacan at ~oWi amdia-. or is tb.e i1!i;i;lCOI1 af a l1aw catl~ oflouf""a::I. l:1!lLCI:l!.C1t. CJs:. ",se: R4!.2S. imoor"'--ant criterion foI' consideration oi treatment; oth· erS a..""e urgenq and necessity of the pT'Oceciure. likelihood of' success and improved. function with the motet'ventioc.. whether the conditiOl1 is pree."'tistb.g, whei:.her treabe:tt was beg'.J.:I. prior to in~ciC'C.. and waat the c~ a.nd. d::.e re?:l.sining length of t:ime witbin che syste:n are. 10 Rhode Island, iI:m3.tes receive health' educaticc ab:::c.t Rev: Only patiellts who $U.iJsequ~tly request: sc=e A ... ; " g 3!:d treatment are considered for I:F'l\ ther:lpy. As I:IC~ pr.soue.."'S a..-e treated and. have ma:lageable- sicie e£fec::s, the demand by fellow inmates for l:=eat::l.e.:1t inc:aa.ses. This pa9ulacia:1. has tolerated tr.-. ter:arcn at: ra1.es sU:::.i1ar to !:he ge!ler.J. papulation.. Further.::ore, compliar.ce rates a:e high. bec:luse of clOSe mediol tallow-up while i.e. pdsoc.. In=L:1tes must dec.or.stratc ~eir cici~ for creat::a.ent by absQi.~bm inj~t:iolJ. drug OI' alcohol use for the 12 month:! pr.or to b~ treacment. Since sharing inject::.on~g-us'l equipment puts Lnciividuals at risk for HCV inieccion, 'He cOJlSidered includ~iumal:es wao may bye i:a.jec::ed but [lot shared equipment in the past 12 I:lont.;.s_ However, the patients' reliabilitywith ~gard t.a t:b.i:i m:1t"'..er would be too difficult to assess. In addition, Cttrrellt drug USer3 lII.3.}" be at higher risk of $~-:ng equipce:a.t if clean paraphenWia is not aV3i!ahle. CarrectioWll health. care practiticner.s routinely con- sider duration. of incom:eration in their decision· mzk::c.g. For example, emel69ncy are is not denied for anin~.s:tawith even. the shartestsente:a.ce. On the other U4,246 3-mouth. am.'"3e 51.D1':.5O 1+ hand, elective surgery m:J.y be justffied only if an of31 S12&.J,70 12-manth e:ae::S4.070 $259,474, Tot:al ~ will not have ~ to outside care fer an extended par..od at ti::::te. In the C3Se of HCV: one of the • Cost oI 4. h of ~ fino 2 ai:ata =ec:ti0D3l ad'll:lln. inclusion criteria. for treatment in both Rhode Island &Includ~ CSC. LFra., -rsH, .l\NA. .U(A" ca-l ~ ccnIo:m.d Califomia is a length of prison stay of at Ie:1st 15 P1:w:liA. Rev qa:Uibtl.ve PeR. • Costs b:Ised lJ'll ~: Rev !!ow 3heerproax:aL mouth.s 1:0 allow for a 12-mol1th treatment course with. .. Ba:sed proMous studies. it i. ull'lmlAld. 25~ ol those b:e:1ted. follo";V'-o:o. While the cost or:screening and. treaQnent is .~ lUlt ruponcl by 3 macths -.d will l'ClCeive no fiIrthel' f:l:esi:lI:I.eut. Thcm'ore. cmly 75$ of Cu:se bqan ou tFN wU1 n!a!i.VG tha NIl U- potentiaiIy !:he limiting factOr for many pr'..son systems. ~t-benefi.t analFles in notlinc:areer:lted populations month. coarse. m; = 99 [26-291 suggest ~t IFN is a COS't-eiIe<:tive treab::a.eni: f01' an appropr..ate S"Clbse t ofpatieI:.t3. In 6e coz=ectianal. :set::ing', the savings m.:lynoi: be.reali:.i:ed dt:ring- a.si:c.g!e inm.:1te's prison term, but rather in the lcmg-ter.:n cost to society. The cost3 of sc=eening and. t:e.9.ting the patients pr~ ilented in our model totaled about a. craarter :niIlion dollars. This ~::len~ rou,g:l-ly 39& oi~ total health. care budget in the Rhode Wand cor=ectional system.. A cost-benefit analyais of RCV treatme~ in !:he prisous is Il-"'eeSS8.Ij' to e.'tP1ore potential costs sa'Ved and quality of life pined wicb. t::o..acnent. It is important to evaluate all sc=ee:ri:c.g and treat- ment protocols that are im~e!llentedin a prison ~ l:e:L. Of course. the most eff~ intervention program. would be to dec::-ease the acqc.is:ition of hepatitis C in the fiDt place. Correctional h.e.alth ~rvices could u:se strategies that have been suo::essf..I1 in lowerO...::l.g the risk ofacquir..n.g HIV-peer education. substance abuse treatment-and apply l:.h.em to hepatitis C p~e.:::.::icn (30]. CONCLUSION A ~H;C3.Ilt potion of the HCV-posiCi'le population resides m p~~:::lS. The association halc..s t4-Ji: c.oc ~t mthe L nited States but also in otherwesta:c cou.:nt:ies. In fact, a smd.:7 in the·Sydney, A~alia, prison s:;r..:.: discovered an ECY seI"O!lrevaleI:.~of 37%, verJ sU::illar ::.0 I:he value r-eported by CalUcruia and Rhode Isl~d [311. T:'e~c:' go aI:!. a-ppropr..ate subgroup ofb:u::.:1tes may t"epr-...:sent a public hesll:b. e.xpe~dil:ux': thaI: is cost effective. In this stl:d:; we found !:!:at only Ol:.e s-..ata routinely screens all im:1atas for Hey infection. While l:.h.e semp~o: in ClOst stata pr.soIl.3 is unk:!.ClWtl., the per· ceu~e of infec-'..ed inmate~ is signiliC3.lltly hidler than in the ~meral population. Multiple co.st-benefit aIUlyin nonincarce."P'3.ted populations have shown that the be::.clits of :re3.t:I:tg hepatitis C outweigh the costs (26-291. While a large proportion of sta.ta CQ~-cnal facilities reported tb.at.t:reatme:lt for HCV is sometimes coniliiered. it appean !:hat few inmaRs are actually treated. Fu:rther.:::tore, few sta.te~ have set criteri..s. to deterI:cinc who should be screened and treated. We advocate the development: of protocols that, while recogci%ing fin<md.:U constraints within state correctional systems, ~ that a-pproprlate inmates with hepatitis C sre treatad ao::ording to tile current sb.I1dard of care. Several new reltimena fiJr treat:mg hepatiti.$ C are under development, including. combination treatment with ribavirin. As trea.tment becomes mora e-aecdve and less costly, addressing HCV in prisotl.5 should b'!come an e~n higher priority. s= ~CES I. CJ.ao Q-4 Kuo G. Weiner AJ. o.4rlly l-'t.l3r.uilq OW; E:cu;haru M. wl.ulon at ~ e.D~ cltma derived ft'am II blood·bor::-..c non-A, llOC1·B viral h ~ gIZI1ome. Sdma 1989~:359-62. 2.. N ab=.Il !c.stfttIUS or E:e:s1ttl Coz2s _ee h:.eI. St:1l:~Qe:lt. ~ , L997;26 Sappl !:2S-1OS. 3• .All:c!r. W_ Epida=Ci.c:g)'ot1:cpuitis C. apc.mt c:.mtare::.a:: ~ of ai::aC'3.l::3. E~da. MD. 1991 ~ 2 .61-;0_ 4. CaDr,'-Cae-;eC;l C, Va:Ula.ri= MA. Gib Ie J, Melpalder J, Sh:1k:l AD, Viiadamill r., C': sL Roa:a:a ae' • 'em.";~ .md.li~ ciisoue Us. blcod do~ ibaz:d. :D have' tiCs C vU-.JS ~an. N ~ J M.ed. 159&:334:1691-6. S. B...:i::JD.~~,j.S~l21=c: ~hepa:iCsB,hep:1tit::J C, and. C:k ild-..rtian a=o~ inI::1:s. ' QI1r.eri:l.:r me Cali1imUa. cocec::oc.:L1 ~..a=.. S:u:r.1meutD: '.: ; Oepar=8!11: at HeaIQ S~ 199& M.Jr. 6. Altar YJ'_ '!:1:e de~ tnnsrri,liien. d OU:c:rmtl oi~t:.ti3 C virus i:.1ec:::c:. ~ ~t! D~ 1 ' 3~l.35--66. I 7. Browe. 3S. Bes6::.er GM: H3r'iboal,; . riaL: of AIDS: :::'ject'.cn drui ~ and. ur.wl ~er.:. Wi t1: (CD: ~wood ~, l293:338. 8. Alta:' }fJ• .MaquEs =:S, ~-:.~k::i K. u. The a.:lt=i ~istcry of Qm:ucity-=ui.."'=Ci ~atf:U C in. U4ited. Sb!Us- ~ F:lgJ J ~fed L.C92;32'i:iS99-s05. I 9. SeeifU!, EuslteU-3ales Z. Wri¢.: =:C. a ~ Lotl8'-tar:::t =r'"':wt'"J sP'~ c:--=tu:ioc-!nCCtad. ccn·A. llO B hepacitU. ~ ~(i J Mec: 199"'-;327:.!SOS-U. 10. Korct: RL. ~y ~ C~l~ =:. Cil;:!' G. NQI:l-A. ccl1-a ?QSttr:1r.:I~OI:l b.a~::'-: looking Cn-:e::\ ~.red L993:.!.l9:110-S. bac.:C ini .4 secol1d dec::L2. .~"t ' K:.:...-::ki 1'. N~ S. ·!oricot.O a T.1k.ed2 1', Nalaji::::l.:l. S. eo; :.!. ?..:u-..dac1i.:ed. ::::i;I.! ot ec"~ or ;=ci=:~ ou in.c::il:nC: at' hep:a.=iJilir ~ma.' C::-.ronie ~.1~ u;:ati::s C ~c C;:.r:'~i.'l. U.:::c-e~ L295:34:6:1051 • 12. Ec:a~a JE. ~ullll:1liD.Jones 08, I 1I. ~ ~ ~ S. no~-A, =-a I:a-;:;,:~ "litoi. •. N~J RL. Jr. Thersp1 at h.epa:itis I :er:Jn; ... il~"'Y :-e~rt. 13. Cari~ C~c.:e:::.S'.1' OC!'f1!lapc:~ Mllatic:is C. l'TC!J='3m and :Jbstnc:"~,a~ alpQ.a.~ 'cO:: ~~enc of - MD. 1997 ~ 2clr- b: Nm Ei;SS--i_ t986;3I.S:157S-3. c; Ul~:eral\ ! a 14. R.::ebrd 0, C:...3.=.a= Fryd=.J.,. Soll:1mo~ A., itt u. '!.'wo-year !:lioQemi logic:sl fallaw-up i:1 pa.cicna Wlth 6rani i: a.m:s=iJ:.cd !'::sltiau co int:ar.anJIL al' cgy 1995:2l:S18-22. ! 15. Sa= G. R.o:si::;l :. Abaca M:4 E, lit ai. Lc:r-te.--:: (ollaw...o;rp of paCa C Lnated. with ;it:cnmc dma ol in 1993:18:1300-.1. 16. Davis G:L. B.:l.la.r. SciIiiI'~ . • ~ra;;icU. iIl:1ci i1i:stohellatitill C respoad:.:\g' 2b tre:lt:l1Cnt. Hll:t&tol- us.i I.. G.1llo V, ~~ wit=l. .-.I1."llI1ic b.=p:l.titis e:oa.~~. Rep.atlllac- u.. Jr.P=:illoRP.~al. ~oC . bU:=.= ~ alp,ha: a. mw::HC:=;~1 t:i;al. ~ ~ J ~ 1989.,32~Ol~ 17. Sal"SC:l3 G. ia:i:.a ?, To~~N:is . L, GsIIa V. "t .u. A. r:mdom:iRCi. CD lid. trioU o( fn.tInf= al;aa·2!l as t:he~~,. cl=mc :mi.-A.. a.·B hepatitis. Jirl1patal 1990;11 SCp'plt=4:1-9; I· 18. ~ x.. Godi::.ac, H. ~ M:, ee:oa p. Zoulim F, Ou= D. ec 31. Coc;larl..san of 1 or 3 q{ mteri'eroll al~-~ SXI4 piaalOQ iz:I. ;::u:ients 1rith CmmU: -A. I1OI1-a he~ ~oa lS9l:101:497-S02. 1.9. c..-omi.oSL,I~lC=a~1.3owdaa.DS. c: e~ at al=bal au hepatic t:I:ll 1996;25:52:'-0. =- x::ivityl 100 20. Poyn.:lZ'li T. Bed.osa P, Opola.a. P. N~ h.isto.ry oltivar ~ P~11 in pati=u 1I'icf:. c!1to:aic hoplUit:. C. I.a.ncet 199'T;J4S:tl2S-32. 21. ~ AI. &= Q{. ~ JD. HeJ:autb C. Ann Intem M.lIIi 1996;:125:1558-68. • 22. IwU3OD. S. Nor~ G. Wesi«til:l. ~. C; uamnl b.i3taty of a uzUq,Ut: im"edoD. Clin In5n:: Dia 1995;2Q:1.361-':'0!l3. Fwl'•.A!bIr a;J'. GmI:llbr:l:ill.ll S. WQt14' DC. Eailo R. ~ki L~ en: al. ~ at ~tae:tm im=I:lit7 apinsl; ~ = ~t&. Cap;ltil:is C vf:u3. Sci4mCII 1992;29:1M-lD. 24. Cam;! CG. ~ GM: 'Ihe yurboak,'1S96. Scnnh Salem CNYI: cr.mi::W JU$cice rm=::ta. l..026. . 2$. Anno BJ. FUnEr E:3r:l=: JE. A preli::l1in3ry model for de'~...imng Ih:Ut:s !Dr =rncticu.:l h=lth are :ervic:=. J Corre:c: ===- n. Health Care 1996;3(1}:6i~. 26. DcsI:l..W:a GM. Robera JA. ~ al ~ tj:lQ B and. C hs1Jatitis with inw::"c:on ~ha: an lICll".QmiC~Ppraisal.E!rpuoL. olD' 1995;lllO3.7L 27. Shi2ll B'Cc:s A. FI1l::ell The ~ e ~ of alpha. a. ce. sam hepatitia C. Mod J Au.st 1994::68-272. . 28. &=.ett WG. P:l.uk.et' Sa., Davis GL. WaDS' J'B. Yodeli..: thIlr:tpeul:ic be:1d tn. Qe:1idst: oi~ ch2rapy !lr hc~t:tis C. Dtr Dts Sci ~:4(l: Suppl)~6S-82S. 23. BRit BS. ~TlI:.8SI malysis. In: NIH Ccm5en5U$ D~ ~ C~ ~ o( I:.e~l\til::fs C. ptopm =d interferon in the l::'211=e:1~ oi cilraaic = ~ Be~)[I), Ul97 ~ 24-fi;U;-9. = 30. SlI:lllcick A. !Aoit ~ fi7r kat amt:rU1 S'rDs. JXM..4,. 1998;27'9(:}):97-.9. • 31. Butler TG. DoLm KA. :mcl1 W. :!4cGa:i:mas1l U(. Braw: PRo. ~~ ?W F.e;::l.t!ti" B C in N'_ South Wa.l6 ~ prev:Ue11Cl:'mtl r.sic:~. ~ J'~ 1997;16&127-1.30. = C=:?,J,RTI,I:;:N, Dc C:::RPECT:G.'IS ~ ~ POLICY 570.0~O ,,, . 0 Pa;e101i ;;PC"EC71V; 0'>'7E. July Ii. ,>.UTHCi'lI1"Y: G~r1eral aWhc."lty cI ,o1e i~S~ S~c:a:a"l 01 COr1'~~C"S to :;.a~as~ a,-,c c:'ec: ',~e Depalt.T1en:. 72.0S.J50. PU;lPOSE: A PPLICA'; ILrn, C'\tis:cn 01 P"sons ar.d O,·,is:o" 01 Com.."nity Co..-..c-Jcns, C;;P i ~ ITI C.'! S, I G"i"elire5 Oe\telcpr-:em Cc.. mirtee . A tar..,,,I'y es;~e"ls~ec eomm,r.e~ of Oe::a'"':'''en: "ed':al eons"lti!.J"",lS al'c ;lhys:e:ens re;:'esen:lr,g all ~~e r1".aja' iac::'t:es. am:! ~he HeM,~ SeMees Utli;:a;;cn !'1C ReuT.::ursemer.~ .'.larage, e' desl~"ee. Tbs commlnee is resocnsde ~cr wn:,I';. develec·,,;. l.,·0 i..c'e"'en:;r,'1 '1"iceli;es 10' "e:erm,n".; acc,c?r1ateness 01 ;l1ecical ::eatment Review ?enel - A s,-tse~ ;'cup of '.re ;:h'ls;e;a.~s partictca:h~; cn the GuiJeliM <:),<,,='<;o,,",e"l COmmLf:ee ~o disouss indicanons fc' t,aatrr;er,l .,.r,en tre >::q:cse<: :reat;':lent C:oo<s r.ct meat 1.1e es:a:: ished \;uicelines ~O!.ICY: 1 Tne Oel:a~"ert 'NIIl ral aUIl'X)n:~, p,es~::te, or ,.ir::~u,-,;e ler 1.-.tarie'cn·Alona trer.;.~y to traa: :re e::"Cl(lon et !-,epal:IIS C, exc<,pt ."ner, app,o',ec :r.rcu;n ~"e prie, a~mori:a:le!l ~:Ce~"5 deso"teC: talow 2. ?~c· ac.c'orl::alic" :or aC:mi..istannG th,s :,eat,"T'.enl tS 'eq,,"ed. T:'e ;::,e'J;ew ~"ni,1 NiH eele"",lra the aoprocnaleneSS ct ~~e prcccsed :rea:;;:e::t a,~o ",c~e 1 :eo:::o"".menda:lon:o :re Healt~ Ca .. ~ ;',C.l.~Crit'l al :~e lac:li"l. ,,..e ;:,e'"ew r'ar.el ."ill C:iscuss :.~e propesed (rea:;ner.t aM aiin'cal inc:catlons p,s;;,acad ::y th,e cc"s~llin; ;as:rcer,1ar:la\;;S1 ""th ~:;e ,pi1ys:o:ap raO,a5~nl,ng t1"e faa':;ry ..... ~ere :ne o~ender IS hoc.sed. To assure cOlec~vlty. t'\e "-<,'new ?alle! mem:oi!rs ..... ,11 riot I':a"g a.~ a~ihalion ""m the lacili~! ·"nere :he or.ar,cer is nOllsa-e. Tne ~nysico1ns ~art<;:catr; cn mis :anel .,.111 =e ,clated. T,~e nevie." ?anel's c;S':;"S~LO'" 'N,il ~e a:e'dinale<:: t'rcu;h :he He:al~h Ser;joes U:,Ii:a~:cn and '='eimo~,seme"l Managar or deslg:-:ee, Th,s dsc~ssio'1 r:-:ay :~ Cct1du(::e~ ::>'1 a :elechcne ccn!erence ca.!. 2, T~e gr;e'/anoe orccess sho~ld be reccr:'mend"tior, at tr:e F.e\/le,., Panel. \.:H[(:e~ 4 A[I $:~~alions rec;c.I~t1g either clar.ticatl<;r1 01 the ;;cliC'l cr e "'\/lew c1 the pa... el's ~roce-=L;'es NlII::e ci rec.:ed to Ihe Heal\.' 'Oer,ices L:~ii:ltlcn er,c: ?Et::lOlirsemerl; 1-.lar,ao;er or cesi\;...ee. b't any o~ence' 'Nho w,shes ~o a;::;;eal t.",e 'H:''1I''W, The P-:lic'l Re',;ew Co""'''''.'tee ,rail oocreir.a:e the re',;ew 01 y~ars and ucdal€: as reecEd. R"PC:i=lENCE5. None. SUP "RS ,,5 51 ON, CE::ar.T.en~ ?olicES at jeast a',e'y ~NC (2) Clinical situations in which further hepatic eyalp.ation may be indicated and in which Interferon Alpha Therapy may be permitted in the Department of Corrections 1. 2. Evidence of persistent or progressive hepatic synthetic function impairment manifeSt by: a. Coagulopathy (prothrombin time more than 2 seconds prolonged without other e.:r:planation) b. Hypoalbuminemia (albumin less than 3.0 mg/dl without other explanation) c. Hyperbilirubinemia (bilirubin greater than 2.0 mg/dl without other explanation) Evidence of extrahepatic manifestations of Hepatitis C that may respond to interferon alpha a. Essential mixed cryoglobulinemia b. Membranaproliferative glomerulonephritis c. Mooren corneal ulcer