Hepatitis C: A Correctional-Public Health Opportunity

Hepatitis C: A Correctional-Public Health Opportunity
Anne S. De Groot, MD, Elizabeth Stubblefield, Joe Bick, MD
Authors and Disclosures

http://www.medscape.com/viewarticle/408298

Introduction

For a variety of reasons, many diseases are present at a higher prevalence in prisons and jails. Mental illness, HIV, hepatitis B and C, and drug and alcohol addiction are just a few of the conditions that are common in prisoners entering the correctional system. What is often seen as an overwhelming burden to correctional healthcare systems should more appropriately be seen as a tremendous public health opportunity. The stark truth is that most inmates will eventually be released from prisons and jails. Once released, many of them either do not have access to healthcare or fail to avail themselves of it. In focusing healthcare resources on the incarcerated, society has the opportunity to decrease crime rates (mental illness, addiction), prevent transmission (HIV, hepatitis, other sexually transmitted diseases [STDs]), and lower lifetime costs associated with untreated diseases. This article will focus on the challenges and opportunities associated with the treatment of hepatitis C virus (HCV) in the incarcerated.

Epidemiology of HCV in Correctional Settings

Hepatitis C infection outstrips HIV in correctional settings in terms of sheer numbers of inmates living with this infection (Table 1). According to a recent analysis performed by Dr. Ted Hammett (Abt Associates, Cambridge Massachusetts) and reported to Congress,^[1] between 1.0 and 1.25 million individuals harboring chronic HCV infection were released from prisons and jails in the United States in 1996, or approximately 30% (29% to 32%) of the estimated 4.5 million individuals living with chronic HCV infection in the United States. The prevalence of HCV infection among US prisoners is at least 10-fold higher than the estimated prevalence of 2% in the general population.^[2] Outside of correctional settings, 79% of current injection drug users (IDUs) have HCV infection.^[3] In fact, young IDUs acquire HCV infection at rates 4 times higher than the rate of acquisition of HIV; after 5 years of continuous injection drug use, 90% of IDUs are HCV infected.

HCV prevalence studies in correctional settings are rare; however, some statistics have been compiled from a number of sources by HIV and Hepatitis in Prison Project In the Colorado state prisons, for example, the prevalence of HCV among inmates has been reported to be 30%.^[4] A recent survey of Arizona reported a 31.3% prevalence rate among inmates (Gerard Chamberlin, personal communication). In Maryland, the prevalence of HCV among state inmates has been noted to be slightly higher, at 38%.^[5] One county jail in semi-rural Massachusetts recently reported that 20.7% of its jail inmates had HCV infection (Hampden County).^[6] In Virginia, 30% to 40% of inmates have been reported to have HCV infection.^[7] Approximately the same rate has been reported in Washington state (30% to 40%).^[8] The prevalence of HCV among state inmates in Pennsylvania is slightly lower, at 13%.^[9]

Reflecting their higher rate of participation in HIV and HCV risk behaviors, incarcerated women exhibit about a third higher HCV co-infection rate than incarcerated men.^[10] For example, in a sample of incoming inmates in California, 54% of women inmates, compared with only 40% of men inmates, have HCV infection.^[11] In Connecticut, 1 in 3 women (32%) incarcerated at the only state facility for women inmates has HCV infection.^[12] In Texas, 37% of incarcerated women and 28% of incarcerated men have HCV infection.^[3] Wisconsin reported HCV infection rates among women inmates that are almost 2-fold higher than the rates among men: 21% for women, 12.4% for men, 13.2% overall.^[13]

Hispanics and non-Hispanic blacks have higher rates of HCV and HBV infection and chronic disease than whites; most cases of HCV and HBV infections are found among persons who are male, members of minority populations, and 30 to 49 years of age.^[3] These race- and class-related risk factors for hepatitis infection probably contribute to the current concentration of HCV- and HBV-infected persons in prisons and jails.

Screening for and Treating HCV in Correctional Facilities

The CDC lists correctional institutions, HIV counseling and testing sites, and drug and STD treatment programs as sites where hepatitis screening and interventions should take place. (See Table 2 for screening recommendations.) Correctional facilities that screen for HCV and educate their inmates about HCV are performing a significant public service, since approximately 50% of persons with hepatitis are unaware of their hepatitis infection.^[1] 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 and transmission to others.^[1]

Treatment of HCV

The current standard of care in community settings is to treat chronic HCV patients who meet treatment selection criteria with a combination of ribavirin/interferon alpha (Table 3). Most correctional facilities have either developed protocols for screening and treating HCV-infected inmates, or are in the process of developing these protocols. However, the criteria for HCV treatment may vary slightly from one correctional system to another. The CDC is in the process of developing a set of guidelines for HCV screening and treatment that may assist correctional facilities with their decision-making process. (A draft of the hepatitis recommendations that are proposed for publication in MMWR [Morbidity and Mortality Weekly Report] in the fall of this year can be obtained by contacting Rob Lyerla or Cindy Wientraub or by calling 404-371-5460.)

In general, eligible patients meet the following criteria: (1) have evidence of persistent HCV infection and inflammation based on liver function test (LFT) abnormalities and detectable virus in the blood stream; (2) have enough time left in their sentence to allow for completion of treatment (6-12 months) (3) are committed to a life free from substance and alcohol abuse; (4) are educated about potential HCV treatment side effects and willing to adhere to an arduous course of treatment.

Standard therapy is to provide daily treatment with ribavirin (usually 5-6 pills divided into 2 doses) and thrice-weekly alpha-interferon injections. (See Table 3 for dosing and side effects of treatment regimens.) Pegylated interferon, a new form of interferon that permits once-weekly dosing, was approved by the FDA this year. Monotherapy is currently used only if the patient cannot take ribavirin due to toxicities or side effects.

Response Rates

Combination therapy consistently yields higher rates of sustained response compared with monotherapy. (A sustained response implies that HCV RNA remains undetectable for 6 months or longer after therapy stops.) With combination therapy, 40% of treatment-naive patients respond. Patients with genotype-1 have sustained response rates of 25% to 30% (slightly better response rates are seen with lower baseline HCV viral loads). Non-genotype-1 patients achieve response rates of 60% to 65%.^[14,15] Other factors that increase the likelihood of a response to therapy include age younger than 45, female gender, and mild (rather than advanced) chronic inflammation on liver biopsy. Histologic improvement occurs in 86% of patients who achieve a sustained response and 39% of patients who relapse after initial response to combination therapy.^[15]

Cost vs Benefits

As with many other chronic medical conditions, morbidity and mortality attributable to HCV may not manifest themselves until well after the end of incarceration. Treatment is often ineffective, poorly tolerated, and prohibitively expensive. Many correctional systems, still reeling from the impact of providing HIV treatment, have been slow to embrace wide-scale treatment of hepatitis C. Additionally, the therapy in most cases is being given to IDUs who are in forced institutional abstinence, have not had and will not have drug treatment, and will therefore probably be promptly reinfected upon release.

Despite these concerns, some state medical directors have led the way and adopted clear protocols for the screening and treatment of HCV in their facilities. These individuals are mindful that a year 2001 dollar spent on treatment may reduce the eventual cost (to society) of caring for patients who may require liver transplants in 20-30 years.^[4,16] Furthermore, combination therapy of HCV is leading to higher rates of cure (up to 88% in carefully selected patients); therefore, the overall cost-effectiveness of HCV interventions in corrections is improving.

Cost-benefit analyses have been performed. For example, medical decision analyst J. Wong calculated that 6 months of combination therapy resulted in net savings in the range of $400 to $3500 over the lifetime of each HCV-infected patient.^[17] Dr. Wong's analysis ranked combination therapy for HCV in the same range of cost-effectiveness as stool guaiac testing, pneumococcal vaccination, coronary bypass surgery, and mammography.^[17]

Liver Biopsy

The need for confirming the extent of damage to the liver by HCV and chronic HBV infection is another area of debate, since obtaining liver biopsies can be both costly and logistically complicated in correctional settings. LFTs can be normal in patients with rather advanced cirrhotic features. Likewise, LFTs may be consistently elevated in hepatitis C patients with normal histology. Some state correctional systems do not routinely perform liver biopsies prior to initiating treatment, because of cost and logistical difficulties. Other states (eg, Florida) believe biopsies are the only real way to measure disease progression over time and therefore have made arrangements to do them on site at very reduced costs ($200 per biopsy). Depending on the cost of obtaining a liver biopsy, electing to treat all incarcerated individuals who meet the criteria for treatment may be more cost-effective for society as a whole than management by biopsy.^[17]

The Lowest-Cost Intervention: Education

The lowest-cost intervention for the prevention of hepatitis infection is education. Given the risk of acquiring HCV (not to mention HIV), all bloodborne pathogen screening events should lead to careful discussion of the risks of acquiring HIV, HBV, and HCV infection (for those patients who have negative hepatitis serologies). The risk of transmitting hepatitis should also be made very clear (see Resources for information on educational materials).

The impact of continued drug use should also be made very clear to patients, especially those who are not yet HCV infected. For those inmates who are already HCV infected, education should be provided on the impact of alcohol abuse on HCV progression (4-fold increase in risk of progression, risk of liver damage directly correlated with alcohol intake) and the risk of transmission to uninfected sexual partners. Inmates who have HCV infection should, at the very least, be educated about options for treatment even if they are not eligible for treatment while incarcerated (see Resources for information on expanded access programs).

Additional Considerations

Another low-cost (but not no-cost) intervention is vaccination. For HCV-infected patients, vaccination against HBV and HAV is routinely recommended, as these relatively inexpensive vaccines may reduce the risk of fulminant liver failure and the need for liver transplantation for HCV-infected patients. A new schedule of HBV vaccination (3 shots at 0, 1, and 4 months) has received approval. The first shot provides up to 50% protection, and the series does have efficacy even if it is given over several years, so the new CDC guidelines are expected to encourage initiating HBV vaccination even in jail settings.

Management of HCV in Correctional Settings

Since the incidence of side effects to HCV combination therapy can be relatively high and it can be difficult for incarcerated patients to quickly gain access to their clinician to report side effects, it is important to:

Spend time preparing the patient for potential treatment-related side effects
Prescribe PRN medications for symptom management
Consider following the patients in a dedicated hepatitis clinic
Consider establishing a support group for patients under HCV treatment
Utilize peer education programs when possible
Use a nurse or other staff person to regularly check in with patients who are receiving HCV treatment so that side effects can be rapidly addressed

Without a good support system, a high percentage of patients will fail to complete therapy. Because of the high cost of treatment, time spent preparing patients and supporting them while on treatment is likely to be cost-effective. Table 4 provides guidelines for monitoring treatment.

HIV and HCV Coinfection

Analyses of the effect of HCV and HIV co-infection on progression of either disease are often confounded by concurrent risk factors for progression. However, available data seem to indicate that HIV infection accelerates HCV liver disease. Persons who are co-infected (HIV/HCV) appear to have a 12- to 300-fold higher risk of developing hepatocellular carcinoma compared with noncarriers.^[18] Furthermore, antiretroviral agents can contribute to liver inflammation, and this may be more frequent in those who have underlying chronic hepatitis due to HCV or HBV. Ritonavir and nevirapine appear to be the antiretroviral therapy medications that are most commonly associated with liver inflammation in HCV/HIV co-infected patients.^[19]

The impact of HCV infection on HIV infection is less clear. In some studies, HCV infection does not appear to have an effect on the progression of HIV.^[20] Other studies have reported an association between more rapid progression to AIDS or death in HIV-infected patients, particularly among those who were co-infected with HCV genotypes 1a and 1b.^[21,22] However, a report by Sulkowski^[23] at the 8th National Conference on Retroviruses and Opportunistic Infections (CROI), contraindicated these findings, suggesting that risk of progression was more closely linked to lack of access to medical care (for HIV) in his cohort of African American patients who had HIV and HCV co-infection.

Response to HCV therapy in individuals who also have HIV infection appears to be equivalent to that of non-HIV-infected individuals.^[24] A recent study in JAMA by Sulkowski and associates^[19] indicates that 88% of co-infected patients tolerate concurrent HCV treatment and highly active antiretroviral therapy (HAART). Following successful HCV treatment, co-infected patients are not more likely to relapse after HCV treatment than are patients who do not have concurrent HIV infection.

Currently, when exclusionary criteria are not present (see Table 2), treatment of hepatitis C is recommended for patients when CD4 and viral load values reflect good response to antiretroviral treatment. Although some controversy remains with regard to the definition of a good response to HAART, a stable CD4+ T-cell count greater than 200 with a stable viral load less than 400 is generally accepted.^[25]

Conclusion

The cost of HCV treatment is expected to be a major barrier to wide implementation of the guidelines in prisons and jails. There is a concern that treatment could overwhelm some systems' healthcare budgets. The high prevalence of hepatitis infections among incarcerated individuals and the availability of treatments with less than 100% efficacy force difficult decision making in correctional health facilities.

The clustering of individuals with hepatitis and other treatable illnesses in correctional facilities creates not only challenges but opportunities as well. With an effective public health-correctional collaboration, the opportunity exists to make a tremendous impact on the health of society as a whole. Without such initiatives, many prisoners will eventually return untreated to the communities from which they came. Prisons and jails are an ideal site for introducing public health interventions that will have a positive impact on hard-to-reach communities; this opportunity to improve public health should not be overlooked.

It must be noted, however, that the cost savings that may accrue from treatment of prisoners are primarily to society as a whole. While treatment of incarcerated individuals for hepatitis and HIV is the right thing to do and can tremendously benefit the public health, it is not realistic to expect correctional systems to shoulder this financial burden without assistance. Guidelines and standards for selecting patients who are to be treated, while providing access to care for HCV-infected individuals regardless of incarceration status, are forthcoming from the CDC. Correctional physicians eagerly anticipate further guidance from state and federal health officials on supplemental sources of funding for HCV treatment initiatives in correctional settings.