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Federal government websites often end in. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. NCBI Bookshelf. Viral hepatitis elimination is an international effort, but the scope of the problem varies by country. With this epidemiological perspective in mind, this chapter discusses some crucial actions that would help reduce the national burden of both infections. In identifying interventions with the greatest potential effect, the committee considered the care cascade across the continuum of services shown in Figure As much as possible, this chapter distinguishes between specific interventions against viral hepatitis and the manner in which such interventions are delivered, a topic covered in the next chapter. The continuum of viral hepatitis services and the retention cascade. Hepatitis B is preventable with immunization, so prevention is a matter of ensuring widespread vaccination and taking steps to prevent transmission from mother to child. There is no prophylactic vaccine for HCV, so services to prevent hepatitis C involve controlling the practices known to spread the virus and curing chronic infections. Since both viruses are transmitted primarily through blood contact, risk reduction measures most associated with hepatitis C and HIV are also useful to prevent HBV infection. Hepatitis B is preventable. The vaccines licensed in the s confer durable immunity to 95 percent of people who receive three doses CDC, d , f ; Mast et al. When the three-dose vaccine series is started at birth, children are protected against acquisition during the vulnerable preschool years; the birth dose also helps prevent vertical transmission of HBV. This number too could be reduced. Perfect vaccination of children would end HBV transmission in two generations, but the elimination goals set out in Chapter 2 require faster action than that Forcione et al. The prevalence of HBV in children decreased markedly after the introduction of hepatitis B vaccine Wasley et al. Vaccine-induced immunity is far less common in adults, however Wasley et al. Only about a quarter of adults older than 19 participating in the National Health Interview Survey reported having had three doses of hepatitis B vaccine Likelihood of full vaccination is only slightly better among people who travel internationally In , the Centers for Disease Control and Prevention's CDC's Advisory Committee on Immunization Practices ACIP recommended universal adult hepatitis B vaccination in places where a high proportion of people are likely at risk for HBV infection, such as clinics targeting people who inject drugs or men who have sex with men; it also recommended a standing order to identify adults for whom hepatitis B immunization is recommended in primary care and specialty clinics; it recommended that all diabetes patients be immunized against HBV in CDC, b ; Mast et al. Yet adult hepatitis B vaccination coverage remains low, even in high-risk groups CDC, b ; Mast et al. Only Studies have found low immunization coverage among people who inject drugs, men who have sex with men at HIV clinics, and clients at sexually transmitted disease clinics Bowman et al. Hepatitis B infection is also an occupational hazard for health care workers, who can be exposed to infected blood or tissue through needle stick and other sharp injuries, yet many health care workers remain unvaccinated. Only about two-thirds of providers in direct patient care have been immunized—well below the Healthy People target of 90 percent Byrd et al. Unvaccinated adults remain vulnerable to HBV infection through unprotected sex, unsafe injections and transfusions, and contact with infected blood. Thirty to 50 percent of adults who contract HBV will develop symptoms of acute hepatitis, a condition with a mortality rate of 0. About 5 percent will develop chronic hepatitis B Mast et al. From to , three Appalachian states reported a percent increase in the incidence of acute hepatitis B infection associated with increased injection drug use among white men in their thirties Harris et al. In , adults accounted for about 95 percent of the estimated 19, cases of acute hepatitis B in the United States CDC, i. Rates of acute infection were highest in those aged 30 to 39 years in 2. There are many reasons for low adult hepatitis B vaccine coverage. There is not good public awareness about hepatitis B; even health workers can be uninformed of its risk Ferrante et al. Clinics often fail to stock the hepatitis B vaccine, partly because there is no funding to deliver it to uninsured and underinsured people, and partly because they fear losing clients over the lengthy three-dose schedule Daley et al. Adult immunization does not have to be so complicated. Every year since about 40 percent of adults in the United States have received seasonal flu vaccine; coverage among those over 65 years is even better, around two-thirds CDC, b , c. If states supported hepatitis B vaccination to the same level as seasonal influenza vaccine, great improvements could be made in hepatitis B immunization. Recommendation States should expand access to adult hepatitis B vaccination, removing barriers to free immunization in pharmacies and other easily accessible settings. The relative success of seasonal influenza immunization is partly a matter of making vaccination convenient, especially for hard-to-reach patients, including homeless people and substance users Vlahov et al. Offering vaccination in pharmacies is one way to reach a broader cross-section of the population. Many pharmacies are open evenings and weekends, making them convenient to people whose jobs do not allow paid leave. Data from Walgreens pharmacies in 49 states showed that about 30 percent of vaccinations were given during off-clinic hours meaning weekends, evenings, and holidays Goad et al. The same data showed 40 percent of to year-olds seeking immunizations at Walgreens came during off-hours; 37 percent were uninsured Goad et al. All states now authorize pharmacists to vaccinate, but many restrict the types of vaccines and circumstances under which pharmacists can administer them American Pharmacists Association, ; Bach and Goad, ; Immunization Action Coalition, Pharmacists can administer hepatitis B vaccine in all states except New Hampshire and New York, although Georgia, Hawaii, Indiana, North Carolina, and Puerto Rico require a prescription for the vaccine, and 34 states have age restrictions on hepatitis B vaccination in pharmacies American Pharmacists Association, State laws on the reimbursement of vaccination delivered in pharmacies also vary widely Bach and Goad, Provisions to simplify reimbursement, such as the Medicare mass immunizer program, reduce the administrative barriers to vaccination, but hepatitis B vaccine is not included in the mass immunizer program ASTHO, ; CMS, a , b. The CDC can fund state and local health departments to buy vaccines through section of the Public Health Service Act, but the vast majority of these funds go to childhood immunizations Orenstein et al. The specific actions needed to make hepatitis B vaccine more widely available will vary by state. Prisons and jails are also an ideal venue for hepatitis B vaccination, a topic discussed in the next chapter. Reluctance to vaccinate against HBV in nontraditional settings may stem from some confusion over the importance of adherence to the standard dose schedule. Protective immunity to HBV is found in 30 to 55 percent of healthy adults after one dose of the vaccine Mast et al. A two-dose vaccine schedule has been shown to confer immunity in Patients may fear, erroneously, that receiving extra doses of the vaccine is harmful, a point that should be clarified for all vaccine providers. Similarly, when the interval between doses is lengthened there is no need to restart the series CDC, e. Some research has shown that delaying the last dose for years may even improve antibody response Jackson et al. Infants infected at birth are prone to chronic hepatitis B infection, which carries a 25 percent risk of premature death from liver cancer or cirrhosis later in life Beasley and Hwang, ; CDC, e ; Mast et al. Despite the initial good progress, further reduction in perinatal HBV transmission has lagged. Still, every year an estimated to 1, infants or about 3. Screening and referral algorithm for HBV infection among pregnant women. By some estimates as many as It is crucial that their newborns receive a dose of hepatitis B vaccine within 12 to 24 hours of birth to prevent transmission of the virus, but hepatitis B birth dose coverage 1 in the United States was only ACIP aimed to correct this in by recommending that all infants receive the initial dose of the hepatitis B vaccine within 24 hours of birth Chitnis, ; Jenco, Prophylactic antiviral therapy in the third trimester of pregnancy will further reduce perinatal HBV transmission among highly viremic women. At the same time, women may experience hepatitis flare after stopping treatment postpartum and require long-term antiviral therapy, which carries a risk of unclear potential for drug resistance in subsequent pregnancies ter Borg et al. Hepatitis B flare is common during pregnancy and after delivery and can lead to liver failure Elefsiniotis et al. A retrospective study of 29 pregnant women with chronic hepatitis B found three women developed severe hepatitis flare or liver failure and required antiviral therapy, and one woman required a liver transplant Nguyen et al. Affirmation of the importance of early viremia testing from CDC leadership would help enforce this point. Leadership from these societies would help draw attention to this essential service and end the vertical transmission of HBV. Until there is a vaccine for HCV, prevention will be mainly a matter of limiting exposure to the virus. One component of prevention discussed later in this chapter is curing all infected persons of their chronic infection. In some countries this means better screening of donor blood, ending use of reusable syringes, or reducing demand for unnecessary medical injections WHO, a. In the United States about 75 percent of the roughly 30, new HCV infections a year are caused by injection drug use Klevens et al. A key step to ending transmission of HCV in the United States is reducing the risk of infection among people who inject drugs. The United States has a drug injection problem of epidemic proportions Dart et al. The nonmedical use of prescription opioids has risen sharply since Keyes et al. National survey data suggest that , Americans use heroin, and another 4. These proportions could shift over time; heroin is often easier to buy and cheaper than prescription opioids, causing people addicted to painkillers to switch Cicero et al. The opioid problem is not simply a matter of more people using addictive drugs; a different cross-section of society is involved than was a generation ago. In the s, heroin use was mostly confined to cities; users were predominantly young, male, and disproportionately racial and ethnic minorities Cicero et al. In contrast, people who have become addicted to opioids in the last decade are male and female, overwhelmingly white, and living in rural areas, suburbs, and small towns Akyar et al. Nowadays about half of people who inject drugs live outside of cities, often in relative isolation, in areas not well equipped to access medical care or addiction treatment services Havens et al. In rural counties deaths from drug overdose have increased three times faster than in urban ones Keyes et al. HCV infection is a serious health consequence of injection drug use. Studies from the early s suggest an HCV antibody prevalence among people who inject drugs of 70 to 77 percent Nelson et al. About a third of people who inject drugs acquire HCV infection in their first year of injecting Hagan et al. Controlling HCV among drug injectors is challenging. The syringe exchange programs 3 that have reduced HIV incidence are less effective against hepatitis C Des Jarlais et al. HCV is also a relatively hardy virus, able to survive on fomites for hours or even days Krawczynski et al. For these reasons, needle or syringe sharing accounts for only about 63 percent of the risk of HCV infection among people who inject drugs, because the virus can survive on other equipment including cotton filters and rinse water Hagan et al. The most effective way to prevent hepatitis C among people who inject drugs is to combine strategies that improve the safety of injection with those that treat the underlying addiction Cox and Thomas, ; Hagan et al. Opioid agonist therapy 4 refers to the use of prescription medicines to bind opiate receptors in the brain, thereby relieving the symptoms of withdrawal IOM, Such therapy is part of the tertiary prevention of substance use disorders, meaning that it prevents the worst complications of the disorder, including overdose and transmission of blood-borne infections Kolodny et al. Nevertheless, most of the waivers have been issued to doctors on the coasts HHS, c ; Rosenblatt et al. A analysis found that 30 million Americans live in places where not a single provider can prescribe opioid agonists Rosenblatt et al. There is a need for wider access to treatment for opioid dependence, especially in rural areas Rosenblatt et al. Recent studies in rural Colorado, North Carolina, Oklahoma, and Pennsylvania are exploring strategies, such as tele-psychiatry, to bring opioid use treatment to rural areas AHRQ, Regarding medications, long-acting buprenorphine and naltrexone formulations may be more suitable in such areas Kjome and Moeller, ; Laffont et al. When naltrexone is administered via a sustained-release implant, for example, it can be active in blood, controlling drug cravings, for up to 6 months Hulse et al. Syringe exchange programs in the United States do not have sufficient coverage even in cities; availability is worse in rural areas Des Jarlais et al. Despite serving, in theory, half the people who inject drugs, rural and suburban areas have only 30 percent of the nation's syringe services and distribute almost 29 million fewer syringes only about 8 percent of the total Des Jarlais et al. Of every dollar spent on syringe services in the United States, about 17 cents goes to rural or suburban areas Des Jarlais et al. With fewer staff and smaller budgets, rural programs have to reach people injecting drugs in remote parts of the country, such as Appalachia, and vast ones, such as the Central Valley. When syringe services are far away, people are less likely to use them Allen et al. Transportation challenges can pale in comparison to the problem of protecting clients' privacy, something often taken for granted in the relative anonymity of big cities Benyo, Part of the value of both opioid agonist therapy and syringe exchange programs is that they provide clients with an entry point to the health system MacNeil and Pauly, Staff at exchanges, especially case managers, can also help interested clients enroll in drug counseling or cessation programs. A randomized, controlled trial in Baltimore syringe exchange programs found that clients working with case managers were 87 percent more likely to enter drug treatment within a week of their referral than clients without such support Strathdee et al. Staff can also counsel clients on the use of naloxone to treat overdose and offer testing for viral hepatitis and HIV. Three-quarters of syringe exchange programs responding to a survey reported offering HCV testing, though the proportion was lower in rural areas Des Jarlais et al. Ensuring linkage to care is more challenging; fewer than half of survey respondents a third in rural areas reported tracking the referral process for clients who tested positive Des Jarlais et al. Although legally prohibited in the United States, supervised injection facilities, clinics where people can inject under clinical supervision, may be another means of harm reduction Drug Policy Alliance, Supervised injection has been shown to reduce death from overdose; in Vancouver, the introduction of such a facility was associated with a 35 percent reduction in the rate of fatal overdose, compared to only a 9 percent reduction in other parts of the city Marshall et al. The possibility of curing HCV infection in a crucial population may warrant revisiting the strategy. A supervised injection facility in Vancouver reported an A systematic review of research mainly from Canada and Australia found supervised sites to be effective at reaching people with unstable housing and a recent history of incarceration Potier et al. Syringe exchange and opioid agonist treatment are cornerstones of viral hepatitis elimination. But these services are least available in the places that most need them, rural areas with an injection opioid problem see Box It is no coincidence that the same four states Kentucky, Tennessee, Virginia, and West Virginia that saw a percent increase in acute HCV infection between and have documented unmet needs for syringe services Des Jarlais et al. Expanding harm reduction services both exchanges and opioid agonist therapy to rural and suburban areas is complicated, as these parts of the country are characterized by fewer resources for health and principled opposition to anything seen to facilitate illicit drug use Havens et al. Such obstacles can be overcome, but only with commitment from states and federal agencies. Recommendation States and federal agencies should expand access to syringe exchange and opioid agonist therapy in accessible venues. The epidemic of nonmedical opioid use has captured the attention of policy makers and providers, with new emphasis on diagnosing substance use disorder and using opioid agonist therapy to treat it when possible Tetrault and Butner, Syringe services and treatment for substance use disorder, essential parts of the response to the opioid epidemic, can also prevent transmission of HCV HHS, ; Volkow et al. Action against the opioid epidemic complements work on viral hepatitis elimination, with attention to the two goals benefiting both. In some states, drug paraphernalia laws and rules regulating the prescription and sale of syringes can present an obstacle to full coverage Burris et al. In states without such restrictions, and with public funding available to syringe exchange programs, more equipment is distributed and the programs can offer complementary services, including HCV testing Bramson et al. Tracking the number of syringes distributed and the number of people who inject drugs in a program's coverage area could, in theory, afford a measure of progress against the UNAIDS target, though in practice it is difficult to estimate the latter with any precision Abdul-Quader et al. Evidence regarding unmet need for syringe services may help persuade legislators to remove restrictions on them, including the restrictions on the number of syringes exchanged per visit or per client. Such surveys will be valuable in charting progress on this recommendation and determining if the reach of the exchanges is expanding. Other valuable indicators will be the number of providers authorized to provide buprenorphine, and the number of people in opioid treatment programs. Expansion of syringe exchange to rural and suburban areas may require modifications to models developed in cities. Pharmacies are an accessible venue for people who inject drugs across a range of settings Hammett et al. Pharmacies in some jurisdictions can sell or distribute syringes, dispose of used ones, dispense naloxone for overdose, and test for HIV Hammett et al. When it is legal to buy syringes at pharmacies, more people who inject drugs do so Siddiqui et al. Pharmacies are often reasonably equipped to provide confidential space for patient counseling. Research in Rhode Island suggests that pharmacists and other pharmacy staff are willing to counsel clients who inject drugs on prevention and referrals for treatment when appropriate Zaller et al. Where pharmacists are not willing to participate, education may help persuade them Chiarello, ; Crawford et al. It is also essential to have clear laws and an unambiguous store or franchise policy supporting syringe exchange, so that no pharmacist fears retribution from management for dispensing syringes Chiarello, ; Crawford et al. Some reluctant pharmacists may be reassured by data showing that syringe sales at pharmacies are not associated with any increase in crime in the surrounding area Stopka et al. Mobile syringe exchange has the potential to reach a wide cross-section of people who inject drugs. Mobile exchanges typically operate from a van or bus, allowing them to bring services to their clients and to cover a wide area, conveying advantages in rural areas WHO, In cities, mobile programs are often meant to supplement fixed sites Ivsins et al. When the only fixed-site syringe exchange in Victoria, British Columbia, closed, syringe distribution in the city fell by a third Ivsins et al. Clients familiar with the fixed site complained that the switch to mobile clinics made it more difficult to safely dispose of syringes and to obtain clean ones Ivsins et al. On the other hand, mobile programs often face less community opposition than fixed sites Ivsins et al. Some observational studies suggest that mobile sites may be more acceptable to younger clients and to people engaging in higher risk behavior Jones et al. Mobile programs may also be more desirable in places where clients may fear harassment or public shaming WHO, Widening the reach of syringe exchange is ideologically complicated Rich and Adashi, Introducing such programs to new places requires sensitivity to local norms. Although the evidence indicates that exchange programs do not recruit new users or increase drug use among clients, people whose communities are being devastated by drug use may understandably object to actions seen to enable it Bramson et al. When such programs were starting in response to HIV, cultural opposition to them was particularly strong among police officers and African American and Hispanic community leaders Anderson, ; Barreras and Torruella, ; Bramson et al. Such attitudes can change, especially if community members are convinced of the exchange programs' effectiveness to reduce disease and keep used needles off the streets Barreras and Torruella, ; Keyl et al. Police officers in some areas have come to favor exchange programs, citing reduced risk of needle stick injury on the job and benefit to the community Davis et al. Project sponsors would do well to encourage local consultation in new exchange programs. Expansion of opioid agonist therapy will also be essential to preventing viral hepatitis infections. The Surgeon General's report Facing Addiction in America concluded that while medications are effective in treating serious substance use disorders, too few providers are able to prescribe them HHS, a. The increase in the allowable patient limit on providers managing buprenorphine therapy could help improve the reach of this essential health service. The Surgeon General's report also argued for better integration of opioid agonist therapy into mainstream medical practices as opposed to separate substance abuse clinics as a way to improve efficiency and lead to better health outcomes HHS, b. Consistent with this emerging consensus, the Comprehensive Addiction and Recovery Act aimed to make evidence-based treatments for opiate addiction more available around the country, including to incarcerated people Community Anti-Drug Coalitions of America, n. A better discussion of reaching people who inject drugs and people in prisons with a range of viral hepatitis services follows in the next chapter. The value of screening is already affirmed in the CDC and U. At the same time, chronic viral hepatitis is often clinically silent until its later stages. Early detection is the first step to preventing the complications of untreated infection. Wider screening for hepatitis C may be warranted in the United States, as it accounts for a considerably larger share of the national burden of viral hepatitis. By , however, it was evident that at least 20 percent of people with hepatitis C had no discernable risk factor for the infection, and that almost three-quarters were born between and CDC, i. The following year the USPSTF followed suit, revising its statement cautioning against widespread screening of asymptomatic adults, but that was a year before direct-acting antivirals came on the market Moyer, Recent estimates suggest that about 15 to 20 percent of the to birth cohort is screened in primary care Bourgi et al. Insufficient staff time and competing demands on providers' attention, a problem discussed in the next chapter, has been cited as a reason for the uneven implementation of the recommendation, as has providers' unwillingness to inquire about risk factors Jewett et al. It is not clear that provider education can improve this. One week intervention to improve adherence to national guidelines saw adherence to screening decrease from almost 60 percent at the start to about 13 percent in the last week Southern et al. Some settings have actively pursued wider HCV screening, including urban emergency departments, safety net providers for the uninsured. Screening in an Oakland emergency room found an HCV antibody prevalence of almost 14 percent among those in the to birth cohort, 38 percent among people who inject drugs, and about 3 percent among people with neither risk factor White et al. A similar program at an urban tertiary care hospital in Alabama found that one in every nine emergency department patients born between and had HCV antibody, nearly four times higher than the previously reported prevalence for that group Galbraith et al. Moreover, cases found in urban emergency rooms could be missed under current risk-based and birth cohort screening guidelines. Twenty-five percent of cases found in Baltimore and 28 percent in Cincinnati emergency departments were among people with no reported risk factor for the virus; an ambulatory care center in the Bronx, also a safety net provider, found 3 percent prevalence of HCV antibody in people with no obvious risk factors Hsieh et al. For these reasons, some researchers have suggested universal testing at clinics and hospitals that serve high-risk populations Southern et al. Mathematical models indicate that one-time universal adult screening for HCV would identify , patients who would be missed with birth cohort screening Kabiri et al. As the elimination effort continues, expanding testing, especially in settings likely to see high-risk patients, may be the key to continued progress Edlin, Recommendation The Centers for Disease Control and Prevention should work with states to identify settings appropriate for enhanced viral hepatitis testing based on expected prevalence. The decision to make a policy of widespread testing for any disease cannot be taken lightly. The procedure comes at an expense to the health system and puts a burden on providers. It also has the potential to cause distress in patients, especially when the disease screened for carries a social stigma, as viral hepatitis does. On the other hand, society stands to benefit from any measure that sheds light on the subclinical burden of HBV and HCV infections. The ability of direct-acting antivirals to cure infection can also change the risk to benefit calculation over time. The CDC, in cooperation with its state and local partners, has the ability to identify populations that would benefit from heightened screening, especially if state and local health offices make the surveillance improvements described in Chapter 3. There are core antigen tests for HCV with sensitivity of 90 percent and specificity of 98 percent Freiman et al. There are, at present, no Food and Drug Administration-approved point-of-care hepatitis B tests in the United States, partly because the relatively low prevalence of hepatitis B translates into less incentive to manufacturers to seek market authorization. The next chapter of this report discusses measures that could improve adherence to established screening guidelines. Taken together, adherence to existing guidelines and enhanced screening in certain settings might contribute to a greater demand for screening assays, and prompt manufacturers to seek U. The direct-acting antivirals that cure chronic HCV infection are what make elimination of hepatitis C as a public health problem a feasible goal in the United States; their importance cannot be understated Palese, At this time there are no comparable curative therapies for chronic hepatitis B, a problem discussed in Chapter 7. Identification of chronic HBV infections and their appropriate treatment will be crucial to ending transmission of the virus and to preventing death from chronic infection NASEM, Entecavir and tenofovir are highly effective at suppressing the virus and cost-effective even over decades Eckman et al. The management of chronic HBV infection requires wide access to integrated, comprehensive care, a topic discussed in Chapter 5. Hepatitis C treatments are costly, a topic discussed in detail in Chapter 6. The combination of cost and demand for these medicines has strained the budgets of many payers Brennan and Shrank, ; Saag, ; Steinbrook and Redberg, ; Trooskin et al. In response, insurers have established criteria for prescription approval, such as evidence of advanced liver fibrosis or consultation with a specialist Barua et al. Many insurers require a period of abstinence from drugs and alcohol; some confirm this with drug testing Grebely et al. Restrictions in state Medicaid programs have drawn particular scrutiny; criteria for approval vary widely among states Barua et al. As of , 74 percent of Medicaid programs required evidence of advanced fibrosis or cirrhosis; 69 percent required prescription by or consultation with a specialist, and half required a period of abstinence from drugs and alcohol Barua et al. Another six states required patients to undergo liver biopsy prior to treatment Barua et al. Because of the varying restrictions imposed by insurers, the process to obtain approval for direct-acting antiviral prescriptions has become laborious. These drugs are often listed as specialty products, a classification that requires a higher out-of-pocket payment from the patient, so when coverage is approved, the charge to the patient is often unaffordable Rodriguez and Reynolds, Among callers to a hepatitis C hotline, about 40 percent were commercial insurance clients asking for help paying for treatment, and a quarter were Medicare beneficiaries in the same position Rodriguez and Reynolds, Another strategy to control costs is to require these prescriptions undergo a pre-approval process sometimes called prior authorization to determine if the patient meets the insurer's criteria for treatment, a process that can require considerable effort on the part of providers Barua et al. The insurer reviews the prior authorization request and either approves the filling of the prescription or issues a denial. If the prescription is denied, the prescriber can appeal the decision, but the appeals process requires further documentation and review. Prescriptions that ultimately are not filled because of a lack of approval by the insurer are considered absolutely denied. Absolute denial of direct-acting antivirals is not uncommon. The Yale Liver Center reported that a quarter of its patients were denied ledipasvir-sofosbuvir upon first request Do et al. There is evidence of disparities in access to direct-acting antivirals. A cohort study of hepatitis C patients in the mid-Atlantic region analyzed the rate of absolute denial of treatment among Medicare, Medicaid, and commercial insurers Lo Re et al. Absolute denial was significantly more common among Medicaid patients, whose treatment was refused at a rate of Among cirrhotics, a quarter of Medicaid beneficiaries were denied treatment, compared to almost none of those with other types of insurance Lo Re et al. Another cohort study evaluated reasons why hepatitis C patients prescribed a sofosbuvir-based regimen never start it Younossi et al. Out of 3, patients, 8 percent did not start the prescribed therapy; financial reasons and the insurance companies' process accounted for 81 percent of such cases. As in the Lo Re study, non-start among patients who did not start therapy for financial or insurance reasons was highest among Medicaid beneficiaries 35 percent, 95 percent CI: 30 to 40 percent compared to patients covered with either Medicare 2 percent, 95 percent CI: 1 to 3 percent or commercial insurance 6 percent, 95 percent CI: 5 to 7 percent Younossi et al. In a class action lawsuit against the Washington state Medicaid agency ended in the ruling that restricting therapy to patients with advanced fibrosis was a violation of the Social Security Act Aleccia, The threat of similar legal action caused the Delaware Medicaid program to rescind its access restrictions in June Rini, The committee commends Medicaid programs that have removed fibrosis restrictions on treatment. Patients denied access to hepatitis C treatment can have continued progression of hepatic fibrosis and remain at risk for cirrhosis, end-stage liver disease, and hepatocellular carcinoma. Delaying treatment until hepatic fibrosis is more advanced has been shown to increase the risk of cirrhosis, liver cancer, and death, and the tests used to stage fibrosis cannot do so with great accuracy Degos et al. Research in the VA system suggests that deferring anti-HCV therapy until the development of advanced hepatic fibrosis or cirrhosis reduces the value of the treatment and increases the risk of liver-related complications and death McCombs et al. Denial of direct-acting antiviral treatment allows for ongoing liver inflammation, which can increase the risk of extra-hepatic complications. There are also consequences to society. As Appendix B makes clear, universal treatment of all hepatitis C patients would reduce infections 90 percent by relative to levels. By the same token, failure to treat chronic HCV infection enlarges the reservoir for transmission, while denying treatment can cause anxiety and may provoke distrust of the health system. Recommendation Public and private health plans should remove restrictions that are not medically indicated and offer direct-acting antivirals to all chronic hepatitis C patients. Curing chronic hepatitis C has immense clinical benefit Pearlman and Traub, Cured patients, even cirrhotics, may experience a reversal of hepatic fibrosis over time Everson et al. Reduction in fibrosis and return to normal liver function is associated with a decreased risk of hepatic decompensation, hepatocellular carcinoma, and all-cause mortality van der Meer et al. It is plausible that curing chronic hepatitis C will also improve the many complications of infection, including bone, kidney, cardiovascular, and neuropsychiatric problems Adinolfi et al. It also improves overall quality of life for the hepatitis C patient Smith-Palmer et al. Treating HCV infection is also cost-effective. In a review of both the clinical and financial value of direct-acting antiviral therapy, the California Technology Assessment Forum found that although treating all patients is costly, the benefits are sufficient to make it cost-effective Tice et al. Delaying treatment increases costs; it costs less to cure people who have never been through a course of treatment before and to cure people before they progress to cirrhosis, further evidence for the effectiveness of early action Chhatwal et al. Additionally, patients who are cured of chronic HCV infection have significantly lower medical expenses than those who are not Smith-Palmer et al. Treating everyone with chronic HCV infection, regardless of disease stage, would avert considerable suffering and anxiety. It is also a financially sensible course of action in the long run. The ability of these drugs to eradicate HCV infection in nearly all infected people has made the prospect of eliminating viral hepatitis in the United States plausible. Public and private health plans should not interfere with this goal. They should remove restrictions on direct-acting antiviral treatment for hepatitis C patients. The committee recognizes that the cost of the drugs presents an obstacle to implementing this recommendation. A strategy to better manage these costs is discussed in Chapter 6. Including full agonist therapy with methadone and partial agonist therapy with buprenorphine, sometimes complemented with the antagonist treatment naloxone SAMHSA, c , The waiver program only authorized the prescription of buprenorphine, alone or in combination with naloxone. Other opioid agonists are still restricted. Turn recording back on. Help Accessibility Careers. Search term. Opioid Agonist Therapy The most effective way to prevent hepatitis C among people who inject drugs is to combine strategies that improve the safety of injection with those that treat the underlying addiction Cox and Thomas, ; Hagan et al. Syringe Exchange Syringe exchange programs in the United States do not have sufficient coverage even in cities; availability is worse in rural areas Des Jarlais et al. 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