While it is still true that corrections agencies have differing approaches to the evaluation, testing and treatment of prisoners with hepatitis C (HCV), guidelines and standards are emerging as the profile of the disease is raised and those will likely translate to corrections policy.

Aside from the sheer number of infected offenders that corrections agencies are housing - estimates are that anywhere between 12 and 35 percent of inmates have HCV  - correctional health care practitioners are also being pushed to action by relatively new recommendations from the Centers for Disease Control.

And, beyond that, inmates have regularly begun to sue correction agencies for HCV treatment, all making for an increased need to address this disease among the inmate population.

"My sense is that most state [correctional] medical directors would like to test for hepatitis C in corrections because they understand the importance of identifying and treating, but they are waiting to hear from the financial authorities in their state," said Anne De Groot, Assistant Professor of Medicine and Community Health at Brown University and a correctional health care provider in the Connecticut Department of Corrections.

De Groot said that many state authorities are not fully aware of the importance of public health interventions in corrections and therefore haven't funneled money to those agencies. In addition, the medical directors of these facilities don't have the funds to implement hepatitis C-related programs on their own.

In many cases, what corrections agencies are faced with, during one of the most difficult fiscal times in a decade, is having to weigh which medical treatments take priority over others.

"It is true [that] medical directors are forced to pick and choose between programs. That means programs related to diabetes and pregnancy and hypertension are in the balance and we run the risk of asking corrections agencies to do these interventions and not do others," De Groot.

But with the release of new guidelines from the CDC in January, this may change as state agencies and public health departments pay more attention to the government's recommendations and provide more support to corrections agencies.

CDC Recommends HCV Prevention and Management for Corrections

In January of this year, the CDC issued recommendations for the prevention and control of hepatitis virus infection in corrections. The recommendations cover hepatitis A, B and C and discuss risk factors, statistics for prevalence in adult and juvenile correctional facilities and epidemiology as well as strategies for prevention and management. (See http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5201a1.htm)

In relation to hepatitis C, the document outlines the CDC's national strategy to prevent infection including risk-reduction counseling, appropriate medical management of infected persons, screening to eliminate transmission and improved infection reduction practices.

"The high prevalence of HCV infection and risk associated with HCV infection among inmates requires inclusion of HCV prevention activities in correctional settings. To be effective, risk reduction among this population often requires a multidisciplinary approach to address drug use as well as other medical, psychological, social, vocational, and legal problems," the recommendations say.

With specific regard to prevention, the recommendations state that those chronically infected with HCV can benefit from health education including substance abuse treatment, clean needle and syringe use, risks of sharing drug paraphernalia and condom use.

With testing, the CDC recommends that HCV testing be conducted routinely to identify infected persons.

These testing recommendations also include:
*that all inmates be asked questions regarding HCV risk factors during entry screening and all with risk factors be tested, and

*that identification of an inmate with acute HCV should prompt an epidemiologic investigation by correctional officials, in collaboration with health authorities, to determine the source of the infection. Depending on the results of the investigation, testing of contacts might be indicated.

One note in the document is that the testing does not distinguish between acute, chronic or resolved infection. So, for those testing positive, the CDC states that chronic HCV can be distinguished by persistence of RNA (ribonucleic acid) for greater than six months.

The recommendations also cover management of those with high levels of disease. Antiviral therapy is recommended as well as a liver biopsy to determine how advanced the disease is.

The recommendations specifically say that:
* all HCV-positive patients should be evaluated for chronic infection including the presence of chronic liver disease and candidacy for anti-retroviral therapy,

* treatment should be conducted in consultation with a specialist,

* inmates with chronic HCV should receive hepatitis B and A vaccination, and

* correctional facilities should establish criteria based on the latest treatment for the identification of prisoners who might benefit from antiviral treatment. For HCV-infected patients who are actively abusing substances, appropriate substance-abuse treatment should be initiated to limit disease transmission, re-infection, and liver disease progression.

The recommendations also list the three FDA-approved antiviral therapies for treatment of chronic hepatitis C in persons aged 18 years and older: alpha interferon, pegylated interferon, and alpha or pegylated interferon in combination with ribavirin. The period of time in which the medications are administered and the response rates for those medications is also listed.

The document also addresses coinfection of HCV and HIV and the decision to treat these persons. The CDC states that if CD4 counts are normal or minimally abnormal then, treatment responses to interferon monotherapy are similar to non-HIV-infected persons. Also, the efficacy of ribavirin/interferon combination therapy (for HCV) among HIV-infected persons has been tested in only a limited number of patients. As a result, the CDC states that each patient should be evaluated by a physician familiar with the treatment of patients with HCV infection and HIV infection when appropriate, and indications for therapy should be reassessed at regular intervals.

While the CDC has formulated these recommendations for corrections agencies to follow and consider, the document's authors also realize the challenges that corrections faces in providing testing and treatment for HCV.

"The challenges to integration of a comprehensive viral hepatitis prevention and control program in correctional health settings are substantial. They include budgetary and staffing constraints, priorities that compete with preventive health care, and lack of communication among correctional health, public health, and private health-care systems," the recommendations state.

It is those challenges that corrections agencies currently face.

Questions and Difficulties Remain

Many correctional health care providers who treat and evaluate inmates for HCV are torn about what is the best treatment for inmates with HCV.

Most agree that testing should be done for all because of the prevalence of HCV among the inmate population and the likelihood of intravenous drug use among the population, which is a major path of transmission. But the criteria and options for treatment are still a matter of debate.

Some say all with high levels of disease should be treated, while others are concerned that because more and more is being learned about the disease each year, the current treatments may not help in the end.

"I am very worried about this disease because what we are doing today may not be the best thing to do for our patients. We did the same with HIV [a decade ago] and the people who did the best with HIV [in the end] were those who ignored the best medical advice of the time. Then you gave them monotherapy, which we now know doesn't work," said David Thomas, Chairman of the Division of Correctional Medicine at Nova Southeastern University, a physician and former health director for the Florida Department of Corrections.

That said, Thomas and many others in the field are convinced that treatment should be provided to those who meet certain criteria, including a likelihood of progression to chronic liver disease and failure.

"I really think this ought to be a disease that is individually treated. You can be Hep C positive and have normal liver function tests and yet go onto a destroyed liver. [And,] you can be Hep C positive and have an abnormal liver test and never have a problem," said Thomas. "The only way to follow the disease is with serial liver biopsy and that's a difficult thing to do. It's uncomfortable, it has risk, and it does have morbidity and mortality associated with it."

De Groot agrees that liver biopsies are the most accurate way to determine how harmed a person's liver is by HCV, but acknowledges that may agencies do not use them routinely.

"It's very difficult because we don't have tools to determine which will progress to advanced liver disease. The liver function tests don't tell you enough. What they are recommending is biopsies every six months," she said. "I would say that probably we [in corrections] will come to a point where people will have to have biopsies to follow their HCV progression and that will have to be the test."

Once the determination is made that liver disease is eminent, then the decision has to be made by doctor and patient about treatment.

Keeping offenders off alcohol and drugs is the first essential step for anyone with HCV, which should be covered in educational programs for offenders on the disease, but those with a progressive form of HCV need drug therapy.

Thomas said that those most serious cases would likely benefit from the combination therapy that is now approved and available and he favors a relatively new pegylated interferon - Pegasys - because the dosing is simpler.

Yet, he adds, there is no real agreement on the drug therapy that should be offered either.

"There isn't any consensus on what we really should be doing. At the [corrections hepatitis C] conference in San Antonio this year, one excellent gastroenterologist felt it was too early in the disease to treat anybody and we may not be helping any of these people. I don't think anyone [there] felt we should treat based on a positive Hep C test [only]," he said.

Statistics show that of the more than 2 million people infected with the disease across the country, only 20,000 of them will progress to end-stage liver disease and it is difficult to predict who those 20,000 will be.

The lack of consensus about treatment is also apparent in the courts where some inmates with HCV have sued unsuccessfully for treatment to be provided for all positive-testing offenders.  "The science is not there yet," said Thomas, who has served as an expert witness in two HCV-related inmate cases.

Thomas likened the desire for treatment by some inmates who test positive for HCV, but show no signs of liver disease, to those with a stomachache who want an MRI.

"We're talking mostly about plain old hepatitis C and for that, we treat these people individually. I think they need a liver biopsy so they know where they are [in the progression of the disease], and so they can learn behavior modifications," he said.

For those with a co-infection of HCV and HIV, however, the treatment should be more aggressive. In these cases, patients tend to show more frequent liver failure and so the decision to treat with drug therapy should be an easier one for corrections physicians.

"You can't be quite as conservative with those patients and should consider treating them," Thomas said.

Some corrections agencies have already been testing offenders for the disease and are in the process of adopting new treatment protocols to match the CDC recommendations.

Pennsylvania DOC Moves Ahead with HCV Testing/Treatment

While the Pennsylvania Department of Corrections has been testing offenders for HCV and treating those who show advanced signs of the disease for more than a year, it has recently altered its protocols.

According to Susan McNaughton, spokesperson for the DOC, the agency's guidelines recently changed as of September 1, 2003 based on lessons the department has learned and the release of CDC guidelines.

One important change was the addition of pegylated interferon to the DOC's drug formulary for HCV treatment because if its efficacy and that the drug requires fewer injections for the offender.

Additionally, the DOC began conducting liver biopsies to determine which offenders who test positive are in fact at risk for liver failure.

"It allows us to pinpoint who has the fast progressing form or co-infection [with HIV]. We also monitor and educate the others and test them, and see if it is advancing faster," said McNaughton. "This is a disease that progresses over 30 years or more [so] you have to make sure you are spending the drugs and the treatment on those who need it most."

The DOC also changed its criteria for inmates who are eligible for treatment to include those who will be with the DOC for at least 18 months, in addition to the medical requirements.  McNaughton said that the DOC learned that it could not assume that services would be available for released offenders in the community after their sentence was over.

"The one thing we learned most was we could start the inmate on the treatment [but that did not mean] after release they would follow up and continue their treatment," she said.

If the inmates have less than 18 months to serve in their sentence, then they will receive medical release planning to prepare them for obtaining services in the community.

"We want to make sure they have enough time with us to go through their treatment with us. It's better for them and better for those they may have contact with," she said. "It really isn't good to start and stop treatment."

As of June 2003, the DOC was treating 447 HCV positive inmates or six percent of those testing positive. Those not receiving treatment included 859 who were excluded due to medical complications, drug and alcohol abuse or psychiatric complications; 2,095 who refused treatment and 690 who stopped or completed treatment.

Many believe that other DOCs will soon begin to follow similar protocols as they become more familiar with the national recommendations for prevention and treatment.

"I feel the crisis around Hep C treatment is reminiscent of the HIV crisis 10 years ago. At that point we were trying to understand what was the standard of care on the outside. Eventually it became clear that we had to treat and manage them appropriately. They had to find the funds and again that will have to happen with Hep C. People will be paying a lot more attention," said De Groot.

Resources:

To contact Anne De Groot, email her at anne_degroot@brown.edu and also visit the HEPP Report website at www.hivcorrections.org

To reach David Thomas, call him at Nova Southeastern University at 954-262-1554.

For information about the Pennsylvania DOC's program, call 717-975-4862.