Joseph Paris, MD, Medical Director for the Georgia Department of Corrections, wears many hats ,serving as a physician, administrator, accountant and even a politician in some instances. As a correctional medical director, Paris is never quite sure what role he will have to assume on a given day, especially when dealing with hepatitis C (HCV). Paris, though, always pays  close attention to what he calls “the numbers,” calculating costs at every turn.

“You are going to see a lot of numbers here,” Paris says before explaining the DOC’s HCV treatment protocol. “The numbers come from the fact that if you don’t do the numbers, your program stalls. Paris describes the Georgia DOC as a “lot of prisons with a lot of inmates and lots of new faces every year.” The DOC operates 79 sites throughout the state and holds 46,461 inmates, 3,000 of whom are females. About one third of that number—17,000 inmates—leave the system on a yearly basis and a similar number enter on an annual basis.

The first dilemma for any prison system confronting HCV care is whether to conduct universal or targeted HCV testing. The Georgia DOC, like many other prison systems, conducts targeted testing of incoming inmates, believing that the vast majority of inmates with HCV can be identified through targeted testing based on risk assessment questions. About 50 percent of the DOC’s new arrivals—about 8,500 inmates—are believed to be at risk for HCV, with about 2,550 testing positive for the disease every year.

“Anyone who tests positive is counseled,” explains Paris. “We will explain what the condition means, the risks of treatment and of non-treatment and the prognosis.” All HCV positive inmates are offered vaccinations for hepatitis A and B. It is interesting to note that the Georgia DOC spends $558,200 a year on vaccinations for hepatitis A and B before performing a single biopsy or treating a single patient for HCV.

Three Categories

Paris said HCV positive inmates generally fall into three categories— those who eschew treatment, those who are neutral about treatment and those who demand treatment.

“We have to tailor our approach to who we are seeing,” Paris said .From the outset, treatment candidates must have at least two years left on their sentences so that they  can start and finish treatment inside of prison.

“We may end up spending four or five months from the first test to the repeat test to the PCRs to the biopsy and then the counseling,” Paris exp lains. “Then in most cases, we need one year to treat and then we need six months to follow up.”

The Georgia DOC has a long list of exclusionary criteria, refusing to offer treatment to inmates with uncontrolled depression, co-infection with uncontrolled HIV disease, uncontrolled hyperthyroidism and evidence of autoimmune disease. Georgia also does not treat inmates with platelet counts less than 100,000 or evidence of prior organ transplants. In addition, officials require \inmates to undergo biopsies before treatment; those refusing are excluded from treatment consideration at least until they agree to a biopsy. Unlike many other prison systems, the Georgia DOC does not exclude inmates on the basis of drug or alcohol use and does not require enrollment in a drug abuse program.

In the Georgia DOC, there is little drug use among inmates, Paris says.   “In well run prison systems, if there are drugs, it is because the staff is selling them,” Paris explains. “They always get caught and they always get fired.” Without the temptation of drugs, inmates will attend drug treatment programs saying they are reformed and vowing never to use drugs again even though their statements mean little because illicit drugs are not readily available.

“Drug programs are welcome but are not a pre-condition for treatment in the Georgia DOC,” Paris says. The DOC’s exclusionary criteria eliminates about 65 percent of the 2,500 inmates who test positive for HCV in a given year, leaving about 892 inmates who are biopsy candidates.

In practice, the Georgia DOC has been performing 400 biopsies a year at a cost of $1,500 each, which amounts to $600,000 annually. To recap, the DOC will have spent $353,600 annually on HCV testing, another $234,600 on yearly vaccination costs and $600,000 on biopsies, generating a total cost of $1,188,200.000. And as Paris points out, “That is before treating anyone.”

Evaluating Treatment

The Georgia DOC treats inmates with stage 3 fibrosis and some inmates with stage 2, deferring treatment for inmates with stage 0 to 1 and those with decompensated cirrhosis, manifested by a fibrosis score of 4. Of the 400 biopsies performed ever year, 40 percent or 160 inmates will qualify for treatment based on their biopsy scores. DOC physicians will then conduct genotype tests on those 160 inmates to determine their genotype, which determines length of treatment and treatment response rates. Typically, 80 percent or 128 of those 160 inmates will have genotype 1a/b, which requires a year of treatment and responds least effectively to treatment. The other 32 inmates have other genotypes, requiring six months of treatment.

Medical staff check the response rates of inmates with genotypes 1a/b and non-1a/b at 12 weeks, dropping those who are non-responders. It is expected that 77 of the 128 inmates with genotype 1a/b respond to therapy by the end of the 12th week. These inmates are, in turn, approved to complete a year of therapy. In the non-1 a/b group, 26 inmates respond by the end of the 12-week period and are thus cleared to complete 24 weeks of therapy. A program of this scope may cost the Georgia DOC a grand total of nearly $3 million for the testing, evaluation and treatment of inmates with HCV. 

Paris describes HCV “as a very complicated  puzzle,” explaining that corrections is often left to treat inmates with advanced or end stage liver disease. The Georgia DOC averaged three deaths a year from HCV related end stage liver disease a few years ago, but is now averaging eight or nine deaths a year as a result of HCV. That figure will probably peak at about 30 a year within two or three years, predicts Paris.

“The morbidity and mortality we are seeing is likely from patients who have been infected for decades,” comments Paris.

Treatment Results

During a three-year period, from 1999 to 2002, the Georgia DOC started 105 inmates on treatment, treating 7 with interferon monotherapy and 78 with Rebetron. (The DOC did not start using pegylated interferon with ribavirin until March of 2003.) Paris reported that 8 left the DOC unexpectedly and were able to receive after care, and 12 had to stop due to side effects, leaving 85 in treatment. Thirty-five or about 40 percent of those patients failed to respond or clear the virus before the end of treatment. Fifty inmates or 59 percent cleared the virus by the end of treatment but 15 inmates relapsed by the end of the six-month follow-up, leaving 35 inmates who achieved a sustained viral response. 

Paris predicts, though, that with steady improvements in therapy, the  cost of treating HCV will be “reduced very soon.”“How much is a cure worth?” he asks. “How much is hope worth?”+