With prevalence rates of Hepatitis C in prisons running between 12 and 35 percent, most  correctional agencies realize the importance of identifying which inmates have the disease. What has not yet become standard practice is the treatment provided to offenders who test positive.

The disease gives treatment providers mixed messages. Although prevalence levels are high, the number of those individuals who actually progress to end-stage liver disease and cirrhosis is relatively small. And, the disease has a slow progression, which means that getting to that serious stage may take decades. Nevertheless, early detection and proper treatment for those who are at high risk for liver disease and failure is important and life-saving.

According some correctional health care leaders, support from the top down is essential if an agency is to adhere to community standards of care for HCV.

“If the leaders are behind the treatment, it makes a big difference because you are given the resources you need to make it happen. Our director believes that by spending the money we need for treatment, we will save money in the long run,” said Fred Maue, Chief of Clinical Services for the Pennsylvania Department of Corrections. “He also likes to think we are treating so as not to create a public health hazard, so they [offenders] are not at risk to spread it to other people. It makes a big difference to us. We know we are going to be supported.”

Even though the National Institutes of Health and the Centers for Disease Control have issued guidelines and recommendations for the testing and treatment of those with hepatitis C, the process of adopting those standards has been slow for some correctional agencies.

Pennsylvania's corrections system has been ahead of the curve, beginning an aggressive program in 2000 that screened everyone who came in the door, initially with the idea of treating everyone and conducting no liver biopsies. That program was revised in 2003 to better target those offenders who would progress to liver disease and need treatment more quickly.

According to Maue, the DOC revised its testing and treatment protocols following the release of the CDC guidelines. It worked with its health care vendor PHS to develop the guidelines.

“PHS partnered with us and they felt they helped us develop [the protocol]. Part of our job is to monitor what the vendors are doing. We insisted they set up tracking systems and reports are generated so we can see how the numbers [of those getting treatment],” said Maue.

After the new guidelines came out in 2003, the DOC began looking to treat those who needed it the most, first and began using biopsies in combination with viral load levels and genotype to determine treatment need.

The criteria now involves a balance between genotype and viral load, with those having genotype 2 and 3 receiving treatment right away and those with genotype 1 and 4 referred for liver biopsy to determine the best avenue of treatment. If the viral loads rise above 600 copies, then the inmates are referred to treatment more quickly. In the meantime, those on the list for biopsy are monitored every few months to ensure the disease is not progressing more quickly.

Maue said currently there are 154 inmates in active treatment, but the DOC expects that number to rise to between 250-300 in a year when the biopsies have been completed for those on the referral list.

While the cost of providing treatment – including biopsies -- may be prohibitive for some agencies, in Pennsylvania, the DOC has implemented its HCV treatment program at a relatively low cost.

The DOC found providers local to many of the institutions to provide biopsies at a low cost. In addition, because the DOC initiated new pharmacy management techniques around the same time as the HCV treatment protocols, the DOC has actually decreased its health care budget.

“The biggest costs we have are in HIV medications and anti-psychotics, then the hepatitis C medications. To our surprise and delight, we have been under budget,” said Maue.

The DOC's aggressive approach to HCV has now carried over into an examination of how to treat those inmate patients considered “non-responders” to previous treatment.

Now the department is working out a protocol for treating those who received previous generations of HCV treatment – and as a result – have not progressed as well as those receiving treatment in recent years.

But while Pennsylvania is looking to upgrade its existing treatment protocols, other agencies have had difficulty meeting a consistent level of identification and treatment for those with HCV.

Rethinking Hep C Treatment in Oregon

In Oregon, for example, the corrections department is in the final stages of settling a class action lawsuit, Anstett et al. v. State of Oregon, brought by offenders who claimed that the department violated the constitution's prohibition of cruel and unusual punishment by having substandard treatment for their hepatitis c disease. In fact, the named plaintiff in the case, Rodger Anstett, died in custody – the plaintiffs claim – because of the lack of care he received. 

According to Phyllis Beck, Director of the Hepatitis C Awareness Project in Oregon – which is involved in the case – the state is now in the second phase of the settlement agreement after supporting other policy changes suggested by the plaintiffs.

“It was an overwhelming victory. The judge not only gave us what we wanted, she threw in things we didn't even think were possible,” said Beck.

Beck explained that her organization receives hundreds of letters from inmates in Oregon and elsewhere asking for help and claiming they are not receiving proper treatment for their HCV disease. In Oregon, it seems they have received some relief based on the Anstett case.

Based on the case settlement and recommendations from a three-physician panel that was commissioned by U.S. District Court Judge Anna Brown to review how the DOC diagnosed and treatment the disease, the DOC revised its evaluation and treatment guidelines last year. 

According to Oregon DOC spokes person Perrin Damon, the department won't officially comment on its hepatitis C treatment and evaluation protocols because the matter is still under litigation. However, documents from the attorneys representing the inmates in the Anstett case show that the DOC's policies did not meet community standards and the physicians did not necessarily follow the DOC's guidelines that existed anyway.

According to the plaintiffs' settlement documents, the ODOC had some guidelines for HCV inmate patients, but interviews with doctors and inmate patients showed that doctors did not follow what was written down in policy.

“Plaintiff notes a serious credibility gap between what the ODOC says it does and what it actually accomplishes; and, there is little relationship between the existing 2003 Guidelines and the reality of health care delivery inside the prison infrastructure at this time,” wrote attorney Michelle Burrows in the Plaintiff's Settlement Proffer in the case.

Beyond this, Burrows writes, that an ODOC physician in the case who was familiar with the department's policies and the treatment of inmate Anstett noted that his death was “avoidable and was due almost exclusively to the health care delivery inside the Oregon State Penitentiary and it was his opinion there was ‘no excuse' to Mr. Anstett's death or his treatment inside the prison system.”

According to the plaintiffs, problems with the system included failure to identify all HCV positive patients, failure to provide testing when requested, failure to advise inmates of HCV positive status, denial of testing because of claims of “no risk” behaviors without meaningful evaluation and an inadequate education component at intake.

The plaintiffs recommended that the department follow CDC guidelines regarding intake evaluation, ask all inmates about risk factors for HCV infection and test all those who reported any. In addition, the plaintiffs recommended that all inmates with these risk factors be referred for testing within 30 days of the evaluation and test results must be provided to the inmate within 15 days of receipt from the lab. Additionally, the patient must be seen by a physician to explain the results within 15 days of the receipt of the result.

Beyond improving its testing and evaluation procedures, the plaintiffs also demanded the DOC improve its education at intake to include information about hepatitis A, B and C, modes of transmission, developed the education program within the parameters of the NIH's Consensus Statements and recommendations from the CDC, and review the information on an annual basis.

“They need to be screening, they need to be vaccinating and they need to educate,” said Beck.

Finally, the plaintiffs demanded that the DOC begin to directly follow the medical workup recommendations from the CDC and the NIH Consensus statement. According to the plaintiff's settlement documents, the ODOC relies on a process of evaluation that “has no scientific or medical support” and is a “dangerous derivation from the accepted standard of care.”

As a result, the inmates demanded that all patients with a positive HCV test be referred to treatment within 30 days of the positive test and a full workup be completed within 30 days. Any patient with a single elevated viral load reading shall be referred for evaluation and treatment, and any patient with a normal reading should be monitored. It demanded that all HCV infected patients have a treatment plan and that it be provided to them. Also included in the plaintiffs' demands is a database to track HCV patient testing, status, education program participation, treatment, referrals and other aspects of their treatment.

While the DOC claims that the settlement demands are still under advisement, it seems clear that the DOC is poised to change its entire testing and treatment protocol to satisfy the court in this case. But according to those who follow HCV treatment closely, identification and treatment doesn't have to be torturous or costly for corrections agencies.

In Louisiana's correctional health care system, for example, doctors use “an index” to compare disease levels which is then translated by doctors who determine which patients need treatment first.

Using an Index

According to William Cassidy, Associate Professor of Medicine at Louisiana State University Heath Sciences Center and a treatment provider for the state's corrections system, the goal is to determine which patients have, or will develop, cirrhosis of the liver.

“The NIH consensus statement [for treatment of HCV] said that people with minimal or  null fibrosis [of the liver] may be clinically followed, but don't require treatment. They are effectively saying that if someone has been infected 20 years ago and has minimal scar tissue [they may not progress to a stage where they need treatment],” said Cassidy.

Because around 80 percent of those with HCV will not develop cirrhosis, or severe scarring of the liver, many of these patients will die with HCV disease, but not from it.

Cassidy believes that determining which patients are slow, intermediate and rapid “fibrosers” is important to determining which patients should be treated.

The fibrosis index that Cassidy uses indicates which stage of liver scarring the patient is in and then divides that number by the number of years that patient has presumably been infected. In the index, stage 0 is no scar tissue and stage 4 is severe scarring or cirrhosis.

According to Cassidy, if someone had a blood transfusion 35 years ago and was diagnosed with HCV in 2003, it is presumed they had the infection for 35 years. If a liver biopsy reveals that they are in stage 1 fibrosis, their index is calculated as 1/35 years and suggests it will take another 35 years for them to progress to stage 2.

In another example, Cassidy has written that the index can pinpoint which patients need treatment right away. If, for example, a patient shared needles with a known infected HCV drug user 10 years prior to a liver biopsy, and the patient has stage 2 fibrosis now, then it suggests he will reach stage 4 within another 10 years. It means he is at high risk to develop cirrhosis and treatment is a priority.

“It [the index] has been working for us in the sense that we feel we are focusing resources on those most likely to progress to end stage liver disease,” Cassidy said. “We are responsible to adhere to national guidelines that are objective. The objective guide from the NIH is to focus on young people with aggressive disease and young people with moderate active disease. The decision to treat someone has little or no basis in an emotional response.”

Cassidy said it is important not only to focus resources specifically, but also not to offer treatment with drugs that have serious side effects to those who don't need them.

“It's not just about costs, it's about side effects. People tend to get irritable [on these medications] and get into a fight. We have had patients who have lost their trustee status. You can't assume [the treatment] is benign,” he added.

Cassidy said those who frame the discussion about HCV treatment in prisons around money aren't seeing the whole picture. Since HCV-infected patients could be in dire need of treatment or they could easily wait another 30 years for treatment with no negative consequences, correctional agencies need to educate and then pinpoint treatment appropriately.

“They [corrections agencies] want to spend the money on those who need it. If you crowd your clinic with those who won't progress to cirrhosis, then you'll never get to treat those who really need it,” Cassidy said.

According to Maue, if the number of agencies calling his office is any indication, corrections officials are paying attention to national standards and want to improve screening and treatment for HCV infected patients behind the walls.

“It think more and more systems are addressing this. They call us and we send them our protocol and Hep C information. I can tell [they want to focus on this],” he said. “And, we are trying to stay on top of the literature [as well].”

Resources:

NIH Consensus Statement - http://consensus.nih.gov/2002/2002HepatitisC2002116html.htm

CDC Recommendations - http://www.cdc.gov/mmwr/PDF/rr/rr5201.pdf

BOP Clinical Practice Guidelines  2005 - http://www.bop.gov/news/PDFs/hepatitis.pdf

References:

Infectious Diseases in Corrections Report – www.idcronline.org

HCV Medical Writer's Circle – www.hcvadvocate.org/hcsp/articles/cassidy-1.html