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“The only thing necessary for these diseases to the triumph is for good people and governments to do nothing.”

  


 

http://www.hivcorrections.org/archives/april02/

Hepatitis C Virus in Corrections: Frontline or Backwater?
Rebecca Nerenberg*, B.A., Managing Editor, HEPP News, Michael Wong**, M.D., Harvard Medical School and Anne De Groot***, M.D., Brown Medical School

Nationally, hepatitis C virus (Hepatitis C Virus) outstrips HIV by about 10 to 1 in sheer numbers of inmates infected. Even so, controversy and confusion surround the management of Hepatitis C Virus in correctional settings, while HIV testing and treatment is now relatively routine. This controversy stems from debate about the "best time" to treat Hepatitis C Virus, and whether Hepatitis C Virus treatment should begin to be included in the correctional health care budget or whether the cost should be borne by the public health sector.

While the debate about Hepatitis C Virus treatment in corrections continues, significant advances in the treatment of Hepatitis C Virus have occurred, and a number of correctional systems are taking advantage of this opportunity to intervene. Will improved care and accelerated implementation of the new therapies lead to diminished health care costs in years to come? Only time will tell. Meanwhile, education, testing, and prevention must be paramount. As has been observed for HIV, programs that test and educate inmates about Hepatitis C Virus may lead to a reduction in the transmission of Hepatitis C Virus after inmates are released into the community.

Hepatitis C Virus Epidemiology
It has been estimated that 1-2% of the general population (2.9 to 5.8 million people) in the United States has been exposed to HCV1, with 75% to 85% developing chronic Hepatitis C Virus infection. The behavior that puts people most at risk for exposure to Hepatitis C Virus is intravenous drug use (IDU). Other risks include use of shared injection equipment including cotton filters and "cookers,"2 unprotected sex with an Hepatitis C Virus-infected partner (3%-13% lifetime risk), and receipt of blood products prior to 1988. Prevalence rates in certain high-risk groups are as high as 90% (Figure 1). Since so many of the behaviors that put people at risk for developing Hepatitis C Virus infection also put them at risk for incarceration (ie IDU), it should not be surprising that Hepatitis C Virus is common in the correctional setting.

 


 Inmates at risk
The most comprehensive analysis of Hepatitis C Virus in the correctional system was compiled by Ted Hammet of Abt Associates in the context of a report for the NIJ and the NCCHC's report to Congress.5 In this report, the researchers estimated that approximately 30% of the total US population living with chronic Hepatitis C Virus was released from prisons and jails in the US in 1996 (1.0 to 1.25 million people). The overall prevalence of Hepatitis C Virus infection among inmates is estimated to be about 17% nationally, almost 10 times higher than the estimated 1.8% prevalence in the general US population.6 In certain sub-populations of inmates (ie those who are HIV-positive or who have abnormal liver function tests) the Hepatitis C Virus prevalence can be even higher. Furthermore, the Hepatitis C Virus/HIV co-infection rate is about a third higher in incarcerated women than incarcerated men, which reflects womens' participation in Hepatitis C Virus and HIV risk behaviors.4

HEPP News recently performed a survey to assess the current practices regarding Hepatitis C Virus management in state correctional facilities.7 Based on preliminary data from this study, the prevalence of Hepatitis C Virus in inmate populations ranges between 9% and 39% by state (Figure 2).

  


 

Targeted Screening
Approximately 50% of persons with chronic Hepatitis C Virus are unaware of their infection.5  Only about 2/3 of chronically infected individuals develop symptoms of infection, and these symptoms are often non-specific malaise and fatigue.8 The CDC states that "[t]esting persons  in settings with potentially high proportions of injecting-drug users (e.g., correctional institutions, HIV counseling and testing sites, or drug and STD treatment programs) might be particularly efficient for identifying Hepatitis C Virus-positive persons."9

Cost associated with Hepatitis C Virus screening can be reduced by focusing on certain sub-populations that have particularly high prevalence of Hepatitis C Virus infection (see HEPP News April 2001 p2).10 There are a variety of tests available for diagnosing Hepatitis C Virus. Enzyme immunoassay (EIA) is the most cost-effective screening test; recombinant immunoblot assay (RIA) helps confirm positive EIA results, while polymerase chain reaction (PCR) is the "gold standard" for confirming active Hepatitis C Virus infection with viral replication. In rare cases, the Hepatitis C Virus antibody tests can give false negatives. Repeat antibody or viral load testing may be necessary when there is a significant suspicion of Hepatitis C Virus infection in HIV infected patients, as low CD4 T cell counts have also been associated with false negative Hepatitis C Virus antibody and PCR tests.8, 11, 12

Testing for hepatitis infection informs the patient and physician about the potential for and possible existence of liver damage, and it should serve as an important prompt for a discussion about risky behaviors (particularly if the patient is not yet Hepatitis C Virus infected), of factors associated with more rapid progression of Hepatitis C Virus disease (such as alcohol abuse) and about the potential for transmission to others.13

Who should get treated?
A number of correctional facilities have developed protocols for deciding which patients should consider initiating treatment while incarcerated (HEPP News, April 2001).I HHS recommends antiviral treatment for "patients with chronic hepatitis C who are at greatest risk for progression to cirrhosis. These persons include anti-Hepatitis C Virus-positive patients with persistently elevated ALT levels, detectable Hepatitis C Virus RNA, and a liver biopsy that indicates either portal or bridging fibrosis or at least moderate degrees of inflammation and necrosis."30

I. See protocol developed by Lou Tripoli and colleagues for CMS in HEPP News, April 2001, p.6 for example

Shifting Standards for Treatment of Hepatitis C Virus
Pegylated interferon is the latest advance in Hepatitis C Virus treatment (FDA approved, 2001). The standard interferon alfa has been conjugated to a molecule of polyethylene glycol (PEG), which has increased the half-life of the interferon. Pegylated interferon can be given as a once-weekly injection in contrast with the three-times weekly injection of standard interferon alfa. 

For those Hepatitis C Virus-positive inmates who are going to be treated, initial treatment of chronic Hepatitis C Virus with ribavirin/pegylated-interferon alfa is rapidly becoming the standard of care due to improved outcomes (see Table 1), when compared to standard (non-pegylated) combination therapy.16 This will be a significant change from years past, when standard (non pegylated) interferon alfa, in combination with ribivarin, was the standard of care. 
The standard regimen now consists of daily oral ribavirin (usually five to six pills divided into two doses) and once-weekly pegylated alfa-interferon injections (dosed by weight; see Hepatitis C Virus 101 for dosing and side effects of treatment regimens). Standard interferon and/or monotherapy are currently only used if the patient cannot take pegylated interferon or ribavirin due to toxicities or side-effects (see Box 1 for anti-Hepatitis C Virus drugs).

Expect Delays
Currently, PEG-Intron (Schering Plough) is not available immediately to all patients who are prescribed treatment. Because demand has exceeded supply, the company has developed the "Access Assurance" program to ensure that all patients who begin PEG-Intron treatment can successfully complete it.18 A second pegylated interferon alfa (Pegasys, Roche), is expected to be approved by the FDA in the second half of 2002. This product will also require once-weekly injections. Roche is expected to release its own ribavirin along with Pegasys.

Length of treatment
Recommendations related to the duration of combination therapy depend on viral genotype. Genotypes 1a, 1b, 2, and 3 are the most common in the United States; 70% to 80% of patients are infected with genotype 1. 8  Recommendations are:
(1) Hepatitis C Virus genotype 1: A 48-week (12-month) course of therapy.
(2) Hepatitis C Virus genotype 2 or 3: A 24-week (6-month) course of therapy. 
Interferon monotherapy is no longer the standard of care for initial therapy.

Expected Outcome
The goal of Hepatitis C Virus therapy is to obtain a sustained virologic response (SVR), which implies that Hepatitis C Virus RNA remains undetectable for 6 months or more after therapy stops. This correlates with a viral response lasting >4 years and with a histologic response of regression or arrested progression of fibrosis or inflammation.8 In a randomized trial of patients with chronic Hepatitis C Virus infection, 42% of genotype 1 patients and 82% of genotype 2 or 3 patients on the pegylated regimen experienced SVR in a study of combination therapy (Table 1).16 Additionally, early Hepatitis C Virus viral clearance is a predictor of SVR. Patients on pegylated interferon therapy show an increased phase I Hepatitis C Virus viral clearance in comparison to patients on standard therapy. This may directly inhibit viral replication and release, resulting in a more rapid complete viral clearance as predicted by viral kinetics.19 
Adherence is also a key component to a favorable outcome: patients who receive >80% of their doses have significantly more favorable outcome than patients who do not.14,15 In addition, other factors, including combination therapy, careful dosing by weight (see HCV101), age <45, female gender, and mild (rather than advanced) chronic inflammation on liver biopsy also contribute to improved treatment outcomes.

Liver Biopsy
Liver biopsy is necessary to assess fibrotic damage because neither Hepatitis C Virus viral load nor ALT level correlates well with the degree of liver damage.17 There are three main indications for liver biopsy: 1) to rule out unsuspected diagnoses that may influence patient management, 2) to assess the severity of liver damage and 3) to assess response to therapy. However, the need for biopsy is a matter of debate in corrections since biopsies are both expensive and logistically complicated. Some state protocols do not require liver biopsies prior to starting treatment. Some facilities have liver biopsies provided on-site. An alternative for correctional settings is to carefully monitor response to therapy over the initial days and weeks of treatment since patients who respond immediately are believed to be likely to continue to benefit from treatment and those who do not are unlikely to benefit and might have treatment discontinued (see HEPP News, April 2001).20,21 

HIV/Hepatitis C Virus Coinfection
HIV/Hepatitis C Virus coinfection is extremely common in correctional settings. Since HIV and Hepatitis C Virus frequently occur in the same individual and Hepatitis C Virus exacerbates the progression of HIV, the United States Public Health Service and the Infectious Disease Society of America issued guidelines stating that HIV infected individuals should be screened for HCV23 and named Hepatitis C Virus an "opportunistic infection" in 1999.24 

Analyses of the effect of Hepatitis C Virus and HIV co-infection on progression of either disease are often confounded by coexisting risk factors (ie IDU, EtOH) for progression. However, available data seem to indicate that HIV infection accelerates Hepatitis C Virus liver disease causing coinfected patients to have a shortened natural history of Hepatitis C Virus infection.25-29  Furthermore, coinfected patients appear to have a 12 to 300 fold higher risk of developing hepatocellular carcinoma than non-carriers.30 Additionally, one study found that coinfected patients died earlier because of their more rapid progression to cirrhosis. In this study, patients died earlier due to liver failure and not due to the development of hepatocellular carcinoma.25 
Moreover, liver inflammation can be due to ART, and this may be more frequent in those who have underlying chronic hepatitis due to Hepatitis C Virus or HBV. It is estimated that the risk of hepatic inflammation by antiretroviral agents is approximately 4-6% in coinfected patients.31, 32 Those agents that have been associated with Grade 3 or 4 transaminase abnormalities include ritonavir44 and nevirapine. In contrast, other data have shown that those persons who were on PI containing regimens had lower fibrosis and necroinflammatory scores than those who were on non-PI containing regimens.32 Many Hepatitis C Virus treaters would avoid ritonavir as a PI in PI doses, but agree that the small amount        of ritonavir in boosted PI therapies (i.e., ritonavir/saquinavir 100/1000mg bid; ritonavir/indinavir 200/800 bid) probably poses a much smaller risk for liver inflammation in coinfected patients. Thus, for those coinfected persons in whom treatment has already been initiated, frequent evaluation including transaminases, total bilirubin, and CBC should be performed to monitor drug tolerance and safety. In those who are treatment naïve and HIV therapy is indicated, care should be used in choosing an initial regimen, avoiding the risk of added potential toxicity associated with certain agents.

Cellular immune response (T helper cells or CD4 T cells and Cytotoxic T lymphocytes or CD8 T cells) is involved in mounting an immune defense against Hepatitis C Virus. During the acute phase of Hepatitis C Virus infection, specific anti-Hepatitis C Virus CD4 and CD8 responses are important determinants of self-limited infection.33 Clearly, Hepatitis C Virus infected individuals who also have advanced HIV infection (and low CD4 T cell counts) may be less able to respond to Hepatitis C Virus infection due to their compromised cellular immune response. Therefore, in those with advanced HIV disease, it is important to treat the HIV infection first. Bringing the HIV infection under control may, in some cases, subsequently lower the Hepatitis C Virus RNA, slowing progression of Hepatitis C Virus-associated pathogenesis. With more CD4 cells, a patient will be more likely to mount a specific response against Hepatitis C Virus, which will then result in a more favorable outcome for the patient.  In the event that an individual is newly infected with HIV, has a good CD4 count, yet has advanced Hepatitis C Virus infection with enough liver damage to be unable to tolerate ART, then the Hepatitis C Virus must be treated first.

  


 

HIV/Hepatitis C Virus Response to therapy
Hepatitis C Virus-infected and HIV/Hepatitis C Virus coinfected patients respond to standard interferon plus ribavirin Hepatitis C Virus therapy34 provided that the HIV infection of the coinfected patient is under control, meaning that the patient's CD4 count is above 300 at the start of Hepatitis C Virus treatment.35 Studies of coinfected patients on the new treatment standard, pegylated interferon plus ribavirin, have shown that after 12 weeks, 35% of coinfected patients are Hepatitis C Virus RNA negative and 43% had achieved a minimum of a 2-log reduction in Hepatitis C Virus viral load.36 A study by Turriani and colleagues has found that HIV co-infection does contribute to a slower clearance rate of Hepatitis C Virus.37 However, the discontinuation rate of co-infected patients has matched discontinuation rates of Hepatitis C Virus monoinfected patients (about 14 %),38 indicating that HAART and Hepatitis C Virus therapy can be concomitantly administered. Patients who start HAART early in HIV have a better clinical prognosis and decreased liver fibrosis than patients who wait to begin HIV treatment.40 

Currently, when exclusionary criteria are not present, treatment of hepatitis C is recommended for patients when CD4 and viral load values reflect good response to antiretroviral treatment. Although some controversy remains in regard to the definition of a good response to HAART, a stable CD4 T cell count greater than 300 with a stable viral load less than 400 is generally accepted.35, 41 Coinfected patients should also be treated with pegylated interferon plus ribavirin, as this new standard of care results in better outcomes for coinfected as well as Hepatitis C Virus monoinfected patients. In a new study this treatment was well tolerated in coinfected patients, and there were no adverse affects on the HIV disease when using pegylated interferon in combination with ribavirin.35

Cost of treatment
With the cost of treatment ranging between $12,000 to $25,000 per year per patient, the cost of treating Hepatitis C Virus can be prohibitive to some correctional systems (see HCV101 for pricing guide). Although the treatment itself is expensive, its cost-effectiveness has been ranked in the same range as stool gualac testing, pneumococcal vaccination, and mammography (see Figure 3). Unfortunately for correctional budget managers, the cost burden falls on corrections, while the money saved by treating inmates benefits society as a whole. With rare exceptions, transplants (i.e., to replace the diseased liver with a disease-free liver) are not routinely performed on incarcerated individuals.

Management
Most experts recommend that Hepatitis C Virus treatment be monitored by an infectious disease or GI specialist. Many HIV specialists in correctional settings have become local experts on the management of Hepatitis C Virus, due to the high coinfection rate in their patients and because of their familiarity with the management of side effects (neutropenia, anemia) related to Hepatitis C Virus therapy. One expert believes that "HIV caregivers who are willing to learn about hepatitis C treatment and stay current should be the ones responsible for the day-to-day care" of coinfected patients.45 Patients must be monitored carefully for adherence, side effects, and response to treatment. See Table 2 for suggestions for monitoring Hepatitis C Virus treatment.

New Guidelines for Corrections?
The CDC and HHS have issued guidelines for the management of HIV and for Hepatitis C Virus. 42, 43 These guidelines do not specifically address the management of the two viral infections in correctional settings. Due to the disproportionate prevalence of viral hepatitis among incarcerated populations, the CDC is planning to issue corrections-specific Hepatitis C Virus management guidelines. The guidelines have been in progress since last year, and are expected to be released in late summer or early fall 2002. Although these guidelines will not suggest a specific treatment protocol, they may serve as an important reference for developing correctional standards of care and management protocols for the Hepatitis C Virus-infected inmate. The NIH will be revising its treatment guidelines in June (see Save the Dates page 9).

Conclusion
When thinking about managing the Hepatitis C Virus epidemic in corrections, it is important to keep the reality of correctional health care in perspective. If it is not possible to test all incoming inmates for Hepatitis C Virus, savvy providers will set up protocols that will help them identify inmates who may be at high risk for Hepatitis C Virus infection, and educate those who are not yet infected. And whereas treatment initiatives may have been poorly received in the past, armed with new data on the successful management of HIV and Hepatitis C Virus coinfected individuals and new data on improved outcomes due to pegylated interferon plus ribavirin, providers may be able to enroll more inmates in treatment protocols. As the CDC and the NIH compile guidelines and consensus papers this spring, correctional physicians eagerly await further direction in managing Hepatitis C Virus and HIV/Hepatitis C Virus co-infection among the inmate population

 

Prevalence of Communicable Diseases in Prison
According to the National Commission on Correctional Healthcare's "Health Status of Soon-to-be-Released Inmates" project, the     diseases that are particularly prevalent in prisons are HBV, Hepatitis C Virus, HIV, sexually transmitted diseases (STDs), including syphilis, chlamydia and gonorrhea, and airborne diseases such as TB (4,5,6). A summary of this report's findings is provided in the next four paragraphs.

HIV: 98,000 to 148,000 soon-to-be-released inmates were infected with HIV at the time the study was carried out (1998). This number     represents 12% to 18% of the total infected   population in the US. HIV infection is more prevalent among incarcerated women than incarcerated men, however the total number of infected women is small (due to lower overall numbers   of incarcerated women). (See Figure 1 and Table 1.)

STDs: Syphilis infection is highly prevalent in correctional settings: in 1999 it was estimated that 558,000 inmates were infected with syphilis (RPR+) compared to 186,000 inmates infected with chlamydia and 77,500 inmates infected with gonorrhea. In a 1999 study in New York City it was found that although the rate of syphilis infection among the general population had reached a record low, prevalence among incarcerated women was 25% (7). These high numbers for STD infection are not reserved for adult inmates: a study recently conducted at two juvenile detention facilities in Texas found that 22.2% of female and 8.7% of male participants were infected with chlamydia (8).

TB: Active tuberculosis disease (TB) was detected in 12,000 US inmates in 1999, which accounts for 35% of total cases of TB disease in the US. This TB case rate was more than 50 times that of non-incarcerated individuals (9). Active screening and appropriate medical intervention can have a dramatic effect on the incidence of TB in correctional settings, as demonstrated by the significant decline of TB cases, from 225/100,000 to 26/100,000, in the New York State Department of Corrections over the past decade (10). In other settings, factors such as failure to identify active TB and to adequately treat latent TB infection (LTBI) in inmate populations, difficulties obtaining previous TB treatment records and lack of continuity of care between institutions may contribute to ongoing outbreaks of TB such as the one recorded in Broad River, South Carolina, last year.

Hepatitis: In terms of sheer numbers, the two diseases that most disproportionately affect inmate populations are hepatitis B (HBV) and hepatitis C (Hepatitis C Virus). In 1999 it was estimated that 155,000 inmates being released were infected with HBV. Up to 1.25 million inmates being released were estimated to be infected with Hepatitis C Virus. (See Table 1.)

Risky Behavior in Correctional Settings
Very little information is available about the transmission of communicable diseases inside US prisons and jails. Studies performed outside of the United States have demonstrated that inmates participate in a number of high risk behaviors while incarcerated, including intravenous drug use (IDU), which is the risk behavior that contributes most to new HIV, HBV and Hepatitis C Virus infections. In a study conducted in England, for instance, 58% of IDU inmates admitted to injecting drugs while incarcerated, and 73% of those injecting in prison shared needles (11). A study in Canada also found that the overwhelming risk association for HIV and Hepatitis C Virus was IDU, either inside or outside prison (12). Two Australian studies have found proof of both Hepatitis C Virus and HIV transmission occurring within prison walls. It was determined that IDU was the probable cause for inmates contracting HIV and Hepatitis C Virus, while lacerations from barbers' shears and physical assault were the likely means of Hepatitis C Virus infection in other cases (13,14). It is unknown, however, whether conditions in British, Canadian and Australian institutions compare to conditions in US facilities.

Other factors that may contribute to the transmission of blood-borne, sexually transmitted and airborne diseases in prisons and jails include overcrowding, poor or delayed access to healthcare and treatment, recidivism and frequent transfers from one prison to another (15). Some correctional institutions have a policy of segregating HIV+ prisoners from seronegative inmates. While this practice may have some benefits, including being able to manage HIV+ prisoners' healthcare more efficiently, it also concentrates individuals who are at higher risk of opportunistic infections and disease. In 1999/2000, for instance, the CDC determined that segregation and concentration of HIV+ inmates in one dormitory had contributed to the outbreak of TB in a state correctional facility in South Carolina (2).

Communicable Disease Flags
Risky behaviors can be associated with infection by more than one communicable disease. For instance, acquiring an STD is linked to unprotected sexual contact, which should point to the associated risk of HIV infection. In the same way, it is highly probable that an inmate who is being treated for IDU has been exposed to unsafe sex (trading sex for drugs or money, for instance), meaning possible exposure not only to blood-borne viruses like HBV and Hepatitis C Virus, but also to HIV and other STDs.

Identifying communicable disease "flags" that signal the need to institute a screening protocol is one way to reduce disease transmission and improve patient education. Every medical encounter can be viewed as an opportunity to pick up on these signals, allowing providers to intervene with appropriate medical intervention and/or education (see HEPPigram page 6).

If limited resources for communicable disease screening are available, histories of high risk behavior and some laboratory tests can be used to identify higher-risk individuals, and testing can be confined to those determined to have the most at-risk profile (see HEPPigram). Childhood sexual abuse and sex work have both been associated with high risk of HIV infection, for instance (16). Screening for these two "flags", along with other indicators, can decrease the number of potential HIV test candidates.

Existing Protocols
Currently, different prisons have different protocols on testing and treating communicable diseases. One example of a protocol addressing Hepatitis C Virus comes from the Pennsylvania Department of Corrections (27). Inmates who are Hepatitis C Virus  positive or request an Hepatitis C Virus test are also tested for HIV, if at high risk. Those who are Hepatitis C Virus positive are educated about HAV and HBV vaccines, and those who have more than 12 months left on the minimum sentence and are not excluded from treatment for other medical reasons and are HIV negative are then offered Hepatitis C Virus treatment. If the inmate accepts, the treatment proceeds. (See April 2001 HEPP News, available on line at http://www.HIVcorrections.org, for a full discussion of Hepatitis C Virus treatment protocols). According to Dr. Fred Maue, MD, chief of clinical services in the Pennsylvania DOC, 10,135 inmates there have been tested as of May 31 2001, and 5,429 tested positive for Hepatitis C Virus infection. Of those, 292 have completed treatment and 378 are receiving treatment. Of those not receiving treatment, 40% are still under evaluation, some were excluded because of medical, psychiatric, drug and alcohol abuse and sentencing reasons, and 20% refused treatment after having met the criteria for receiving it (28). Every inmate has received one-on-one education about Hepatitis C Virus with a trained healthcare provider.

New protocols for treating latent TB infection were developed by the CDC and published in June, 2000. Updated protocols reflecting concerns about PZA/Rifampin toxicity (see Newsflash in this issue) and guidelines for appropriately identifying and treating latent TB infection in correctional settings can be obtained from the CDC Division of Tuberculosis Elimination, at www.cdc.gov/
nchstp/tb/pubs/mmwrhtml/mmwr_ updates.htm (29). HIV treatment protocols are revised by a committee of experts every year: updated protocols available online at the Health Resources and Services Administration website, www.hab.hrsa.gov, and at an AIDS Education website, www.aegis.com.