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Treating Hepatitis C in the Prison Population Is Cost Saving Hepatology 2008.pdf

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Treating Hepatitis C in the Prison Population
Is Cost-Saving
Jennifer A. Tan,1 Tom A. Joseph,2 and Sammy Saab1,2
The prevalence of chronic hepatitis C infection in U.S. prisons is 12% to 31%. Treatment of
this substantial portion of the population has been subject to much controversy, both
medically and legally. Studies have demonstrated that treatment of chronic hepatitis C with
pegylated interferon (PEG IFN) and ribavirin is a cost-effective measure in the general
population; however, no study has addressed whether the same is true of the prison population. The aim of this study was to determine the cost-effectiveness of hepatitis C treatment
with PEG IFN and ribavirin in the U.S. prison population. Cost-effectiveness was determined via a decision analysis model employing Markov simulation. The cohort of prisoners
had a distribution of genotypes and stages of fibrosis in accordance with prior studies
evaluating inmate populations. The probability of transitioning from one health state to
another, reinfection rates, in-prison and out-of-prison mortality rates, sustained viral response rates, costs, and quality of life weights were also obtained from the literature. Sensitivity analysis was performed. In a strategy without a pretreatment liver biopsy, treatment
was cost-effective for all ages and genotypes. This model was robust to rates of disease
progression, mortality rates, reinfection rates, sustained viral response rates, and costs. In a
strategy employing a pretreatment liver biopsy, treatment was also cost-saving for prisoners
of all ages and genotypes with portal fibrosis, bridging fibrosis, or compensated cirrhosis.
Treatment was not cost-effective in patients between the ages of 40 and 49 with no fibrosis
and genotype 1. Conclusion: Treatment of chronic hepatitis C with PEG IFN and ribavirin
in U.S. prisons results in both improved quality of life and savings in cost for almost all
segments of the inmate population. If the decision to treat hepatitis C is based on pharmacoeconomic measures, this significant proportion of infected individuals should not be denied
access to therapy. (HEPATOLOGY 2008;48:000-000.)

H

epatitis C infection is an important public
health problem in the United States, with 1.3%
of the population chronically infected with the
virus. An even larger proportion of the U.S. prison population is affected, where the prevalence of chronic infection ranges from 12% to 31%,1 likely a result of increased
rates of injection drug use within this group. Even more
striking, approximately 29% to 43% of the total number

Abbreviations: HCV, hepatitis C virus; ICER, incremental cost-effectiveness ratio; PEG IFN, pegylated interferon; QALY, quality-adjusted life year; SVR, sustained viral response.
From the Departments of 1Medicine and 2Surgery, University of California at
Los Angeles, Los Angeles, CA.
Received March 14, 2008; accepted June 23, 2008.
Address reprint requests to: Sammy Saab, M.D., M.P.H., Pfleger Liver Institute,
200 UCLA Medical Plaza, Suite 214, Box 957302, Los Angeles, CA 90095.
E-mail: SSaab@mednet.ucla.edu; fax: 310-206-4197.
Copyright © 2008 by the American Association for the Study of Liver Diseases.
Published online in Wiley InterScience (www.interscience.wiley.com).
DOI 10.1002/hep.22509
Potential conflict of interest: Nothing to report.

of persons infected with hepatitis C in the United States
pass through a correctional system each year.3
As of midyear 2006, the U.S. prison system was continuing to grow in size, housing 2,245,189 inmates per
year, or 497 per every 100,000 persons in the United
States.3 The average length of incarceration has been increasing as well, placing a greater burden on prison health
care systems to address chronic medical conditions such as
hepatitis C. With the predicted cost of medical expenditures related to hepatitis C rising to as high as $10.7
billion from 2010 to 2019,4 the U.S. prison health care
system could see an estimated 15% to 60% increase in its
budget in the coming years.5 Consequently, the cost-effectiveness of hepatitis C treatment in prisons has been a
matter of increasing public debate.
Proponents of treatment in prisons argue that we have
an ethical duty to provide prisoners with the contemporary best practices in medical care. They suggest that treatment of hepatitis C could be seamlessly integrated into
existing programs that successfully manage tuberculosis,
1

2

TAN ET AL.

HEPATOLOGY, Month 2008

Fig. 1. Schematic of Markov chain

human immunodeficiency virus, and other transmittable
diseases. Treatment could feasibly reduce the incidence of
new hepatitis C virus (HCV) infections and prevent future complications from liver disease. Substance abuse
and risk reduction counseling could be employed simultaneously, resulting in enduring benefits outside of prison.1,6-10
Those who oppose treatment note that therapy is often
interrupted by prison release or transfer, and that continued care for hepatitis C after release is often unavailable to
what is a largely uninsured population. This could promote resistance to therapy or inadequate management of
treatment-related adverse events. Furthermore, high rates
of relapse to injection drug use or other high-risk activity
result in considerable rates of reinfection after prison release, which could be expected to undermine the benefits
of treatment.1,6-10
Prior studies have demonstrated that treatment of
chronic hepatitis C with pegylated interferon (PEG IFN)
and ribavirin is a cost-effective measure in the general
population.10-23 However, no study has yet addressed
whether combination therapy would be cost-effective in
the prison population. This study aims to answer this
question in the male prison population, which makes up
87.3% of the inmate population.7

Patients and Methods
We conducted a MEDLINE search of the published
literature using various combinations of the search terms
“hepatitis C,” “treatment,” “cost-effectiveness,” “pris-

ons,” “pegylated-interferon and ribavirin,” “combination
therapy,” “jails,” and “inmates.”
Using data obtained from these articles, we used the
software Treeage Pro Health Module (Williamstown,
MA) to construct a decision analysis model employing
Markov simulation (Fig. 1). This allowed us to estimate
the incremental cost-effectiveness ratio (ICER) of combination therapy for hepatitis C in the U.S. prison population and thus compare the strategy of treatment to that of
no treatment. The perspective adopted was that of the
U.S. prison health care system. We used the generally
accepted cost-effectiveness threshold of $50,000 per quality-adjusted life years (QALYs) as the maximum value for
determining the preferred treatment option.
The target population at the beginning of our analysis
was a cohort of men, ages 40 to 49 years, who were incarcerated in the U.S. prison system and chronically infected
with hepatitis C as evidenced by positive serologic tests
and quantitative assays for HCV RNA. Their baseline
demographics were assumed to be similar to that of the
general U.S. prison population. In a bulletin published by
the Bureau of Justice in May 2006,24 Caucasians comprised the largest proportion of prisoners at 44.3%, followed by African Americans at 38.9% and Latinos at
15%. Men were 7 times more likely to be imprisoned than
females, and comprised 87.3% of the prison population.24 The average age of the prisoners was 41 Ϯ 7
years.25 These demographics were consistent with the inmate populations studied in the published literature we
used to make baseline assumptions for our model.

HEPATOLOGY, Vol. 48, No. 0, 2008

TAN ET AL.

Table 1. Clinical Assumptions
Variable

Baseline

Range

References

Prevalence of genotype 1
Prevalence of genotypes 2
and 3
SVR for genotype 1
SVR for genotypes 2 and 3
Mortality from other causes
in prison
Mortality from other causes
outside prison
Mortality from
decompensated cirrhosis
Mortality from hepatocellular
carcinoma
Mortality from treatment
Reinfection rate in prison
Reinfection rate outside
prison
Distribution of fibrosis
No fibrosis
Portal fibrosis
Bridging fibrosis
Compensated cirrhosis

0.78

0.68-0.80

25,26

0.22
0.42
0.79

0.20-0.32
0.20-0.70
0.70-1.00

25,26
10,25
10,25

0.00201

0-0.0025

3,35

0.00777

0-0.00777

35

0.218

0.129-0.315

10,23

0.574
0.0005
0.0071

0.319-0.99
0.00025-0.00075
0.004-0.011

10,23,41
10
42,43

0.0015

0.001-0.002

44

0.30
0.45
0.18
0.06

—
—
—
—

25
25
25
25

Data are expressed as rates per year.

We presumed that genotype determination was performed in all prisoners prior to commencement of therapy. The inmates were accorded a distribution of
genotypes as reported in the literature specific to the
prison population: 78% were assumed to have genotype
1, and 22% were assumed to have genotypes 2 and 3
(Table 1).25,26
Two strategies were then analyzed. In the first strategy,
prisoners did not undergo a liver biopsy prior to starting
treatment. They were assumed to have a distribution of
stages of fibrosis in accordance with the literature. Sterling
et al.25 conducted a retrospective study of 302 inmates in
Virginia with chronic hepatitis C who had undergone
liver biopsy and found that 30% of prisoners had no
fibrosis, 45% had portal fibrosis, 18% had bridging fibrosis, and 6% had cirrhosis (Table 1). An ICER was then
calculated for these prisoners as a pooled population in
various stages of fibrosis.
In the second strategy, all prisoners underwent a liver
biopsy prior to beginning therapy in order to determine
their stage of fibrosis. A modified METAVIR scoring system was used, and the patients were divided into four
groups: (1) no fibrosis, (2) portal fibrosis, (3) bridging
fibrosis, and (4) compensated cirrhosis.27,28 The most
cost-effective option was calculated for each group dependent on age and stage of fibrosis.
Treatment was assumed to follow current guidelines,
using a combination of weight-based PEG IFN-␣2a or
-␣2b and ribavirin.29,30 Patients with all disease states except for decompensated cirrhosis and hepatocellular car-

3

cinoma were eligible for treatment. Treatment was
administered for a total of 48 weeks in patients with genotype 1 and for a total of 24 weeks in patients with
genotypes 2 and 3. We assumed that treatment was discontinued after 12 weeks in patients with genotype 1 who
did not achieve an early virologic response, defined as a
2-log reduction in their levels of HCV RNA.29 Antidepressants and growth factors such as erythropoeitin were
not used. Sustained viral response (SVR) rates were obtained from the literature and were presumed to be identical to that of the general population— 42% for genotype
1 and 79% for genotypes 2 and 3.31-33 Although adherence would likely approach 100%, given that medication
would be administered under the direct supervision of
prison health care officials, we nevertheless varied compliance rates to account for patients who might discontinue
therapy because of side effects.
In all models, the prisoners transitioned in 6 month
intervals through a variety of health states until death. An
average life expectancy of 75 years was used, as per the
average life expectancy of males in the United States.34
The probability of progression from one health state to
another was estimated from published literature looking
at the natural history of HCV infection, and assumed to
be equivalent for patients both inside and outside prison
(Table 2). In addition, prisoners could be released from
prison or remain incarcerated at each stage of the model.
They could be reinfected with HCV at a rate determined
from prior studies, and they could die either from liver
disease or other causes. Both reinfection rates and mortalTable 2. Transition Probabilities
Variable

No fibrosis to portal fibrosis
Ages 40-49
Ages 50-59
Ages 60-69
Age Ͼ70
Portal fibrosis to bridging fibrosis
Ages 40-49
Ages 50-59
Ages 60-69
Age Ͼ70
Bridging fibrosis to cirrhosis
Ages 40-49
Ages 50-59
Ages 60-69
Age Ͼ70
Compensated cirrhosis to
hepatocellular carcinoma
Compensated cirrhosis to
decompensated cirrhosis
Decompensated cirrhosis to
hepatocellular carcinoma

Baseline

Range

0.054
0.125
0.221
0.301

0.027-0.095
0.073-0.161
0.125-0.349
0.152-0.478

0.027
0.0625
0.111
0.151

0.0135-0.0475
0.0365-0.0805
0.0625-0.1745
0.076-0.239

0.054
0.125
0.221
0.301

0.027-0.095
0.073-0.161
0.125-0.349
0.152-0.478

0.017

0.008-0.030

0.040

0.032-0.0052

0.006

0-0.014

Data are expresses as rates per year and were obtained from references 10, 11,
12, 14, 18, 21, 22, 38, and 44.

4

TAN ET AL.

HEPATOLOGY, Month 2008

Table 3. Costs Per Year

Results

Variable

Baseline

Reference

PEG IFN and ribavirin
Liver biopsy
No fibrosis*
Portal fibrosis*
Bridging fibrosis*
Compensated cirrhosis*
Decompensated cirrhosis†
Hepatocellular carcinoma
End-of-life care

$14,861
$1,368
$145
$145
$145
$1,053
$13,499
$42,255
$36,172

48,49
49,51
41,49
41,49
41,49
41,49
41,49
41,49
49,50

Costs have been adjusted to 2007 U.S. dollars.
*Costs consisted of clinic visits, laboratory tests, and adverse events.
†A composite cost was used for decompensated cirrhosis, taking into account
costs related to ascites, variceal bleeding, and hepatic encephalopathy.

ity rates were different in prison and out of prison (Table
1). It was assumed that mortality from liver disease could
only occur in patients with decompensated cirrhosis or
hepatocellular carcinoma, and that mortality rates from
both liver and nonliver causes were similar across age
groups. Furthermore, we presumed that disease progression could still occur in patients with compensated cirrhosis even after SVR.
Costs used in our analysis were obtained from the literature and were adjusted to 2007 U.S. dollars (Table 3).
We assumed that the absolute and incremental costs of
reinfection were identical to those incurred with primary
infection. Quality of life weights were similarly obtained
and were assumed to be similar to that of the general U.S.
population. A discount rate of 3% per year was used.
Sensitivity analysis was performed in order to address
our dynamic health care and economic system. Clinical
variables, costs, quality of life weights, and discount rate
were varied over wide ranges to assess their impact on the
calculated ICERs. The ranges used for the clinical variables were based on data from the literature or, in cases
where data was limited, were set from zero to the maximum value the model would allow. Costs were halved and
doubled to obtain lower and upper limits, and the annual
discount rate ranged from 0% to 10%.

Our model found that treatment was cost-effective in
prisoners of all age ranges and genotypes when liver biopsy was not a prerequisite to starting antiviral therapy
(first strategy). In other words, treatment resulted in both
decreased costs and improved quality of life. In prisoners
between 40 and 49 years of age, treatment saved $41,321
and increased QALYs by 0.75. For prisoners between 50
and 59 years of age, treatment decreased costs by $33,445
and increased QALYs by 0.69. In prisoners between 60
and 69 years of age, treatment produced $11,637 in savings and a gain of 0.5 in QALYs (Table 4). Sensitivity
analysis revealed that the model using this strategy was
robust to all variables, including in-prison and out-ofprison mortality rates, rates of disease progression, inprison and out-of-prison reinfection rates, SVR rates, and
costs of treatment.
Treatment was also cost-effective for most situations
employing pretreatment liver biopsy (second strategy). In
our base case population with portal fibrosis, treatment
resulted in $18,516 in saved costs and an increase in
QALYs of 0.58 (Table 5). It was also cost-effective in the
base case populations with bridging fibrosis and compensated cirrhosis. In prisoners with portal fibrosis and bridging fibrosis, the model was sensitive to life expectancy,
with treatment no longer cost-effective if lifespan after the
initiation of therapy was less than 10 years. For these
populations, the model was robust to all other clinical
variables and to costs.
In the subset of patients who had no fibrosis on pretreatment liver biopsy, treatment was not cost-effective in
those between ages 40-49 who had genotype 1, incurring
$3,367 in increased costs and a decrease in QALYs of 0.01
(Table 5). For patients in the same age group with genotypes 2 or 3, however, treatment resulted in $10,844 in
saved costs and a gain in QALYs of 0.11. For this cohort,
the model was sensitive to in-prison reinfection rates and
nonliver mortality rates, with treatment no longer pre-

Table 4. Summary of Costs, Efficacy, and ICERs for Strategy 1 (No Pretreatment Liver Biopsy)
Cost ($)

Ages 40–49 years
Genotype 1
Genotype 2/3
Ages 50–59 years
Genotype 1
Genotype 2/3
Ages 60–69 years
Genotype 1
Genotype 2/3

Efficacy (QALY)

Treatment

No Treatment

Treatment

No Treatment

179,484
189,598
141,820
113,485
122,294
82,252
52,667
57,697
34,833

220,715
220,834
219,750
146,930
146,847
147,223
64,304
65,395
64,697

18.25
18.09
18.82
15.00
14.86
15.52
10.48
10.37
10.87

17.50
17.4
17.50
14.31
14.31
14.30
9.98
9.98
9.99

ICER, U.S. $

No
No
No
No
No
No
No
No
No

treatment
treatment
treatment
treatment
treatment
treatment
treatment
treatment
treatment

dominated
dominated
dominated
dominated
dominated
dominated
dominated
dominated
dominated

HEPATOLOGY, Vol. 48, No. 0, 2008

TAN ET AL.

5

Table 5. Summary of Costs, Efficacy, and ICERs for Strategy 2 (Pretreatment Liver Biopsy)
Cost ($)

No fibrosis
Men, age 40–49
Genotype 1
Genotype 2/3
Men, age 50–59
Genotype 1
Genotype 2/3
Men, age 60–69
Genotype 1
Genotype 2/3
Portal fibrosis
Men, age 40–49
Genotype 1
Genotype 2/3
Men, age 50–59
Genotype 1
Genotype 2/3
Men, age 60–69
Genotype 1
Genotype 2/3
Bridging fibrosis
Men, age 40–49
Genotype 1
Genotype 2/3
Men, age 50–59
Genotype 1
Genotype 2/3
Men, age 60–69
Genotype 1
Genotype 2/3
Compensated cirrhosis
Men, age 40–49
Genotype 1
Genotype 2/3
Men, age 50–59
Genotype 1
Genotype 2/3
Men, age 60–69
Genotype 1
Genotype 2/3

Efficacy (QALY)

Treatment

No Treatment

Treatment

No Treatment

ICER, US $

126,200
129,459
114,640
78,735
82,755
64,483
34,663
37,140
25,880

125,900
126,092
125,524
84,672
84,762
84,855
33,641
33,696
33,444

19.18
19.15
19.28
15.60
15.53
15.82
10.91
10.86
11.07

19.16
19.16
19.17
15.38
15.38
15.39
10.76
10.76
10.76

$15,000/QALY
Treatment dominated
No treatment dominated
No treatment dominated
No treatment dominated
No treatment dominated
$6,813/QALY
$34,440/QALY
No treatment dominated

143,750
151,960
114,640
96,901
106,044
64,483
43,226
48,118
25,880

162,266
162,387
161,837
122,162
122,248
121,858
50,940
50,993
50,750

18.67
18.50
19.28
15.15
14.97
15.82
10.64
10.52
11.07

18.09
18.09
18.12
14.45
14.45
14.45
10.19
10.19
10.20

No
No
No
No
No
No
No
No
No

treatment
treatment
treatment
treatment
treatment
treatment
treatment
treatment
treatment

dominated
dominated
dominated
dominated
dominated
dominated
dominated
dominated
dominated

248,129
269,660
175,114
174,120
192,053
110,539
78,456
87,562
46,579

350,642
350,511
350,051
259,574
259,645
259,321
113,229
113,276
113,062

17.30
17.00
18.39
13.91
13.49
15.05
9.94
9.74
10.64

15.70
15.71
15.73
12.27
12.27
12.28
8.98
8.98
8.98

No
No
No
No
No
No
No
No
No

treatment
treatment
treatment
treatment
treatment
treatment
treatment
treatment
treatment

dominated
dominated
dominated
dominated
dominated
dominated
dominated
dominated
dominated

491,126
541,519
312,756
292,311
323,990
179,994
131,307
146,054
79,023

753,439
754,660
750,025
448,285
449,193
445,063
192,849
193,545
190,381

13.65
12.88
16.40
11.87
11.30
13.89
8.92
8.60
10.05

9.58
9.57
9.64
8.96
8.95
9.02
7.38
7.36
7.43

No
No
No
No
No
No
No
No
No

treatment
treatment
treatment
treatment
treatment
treatment
treatment
treatment
treatment

dominated
dominated
dominated
dominated
dominated
dominated
dominated
dominated
dominated

ferred if these rates increased to more than twice their
baseline values. Cost-effectiveness was also affected by
SVR rate, with a rate of less than 72.6% resulting in no
treatment being favored, and by costs, with sums greater
than $15,712 (baseline value $14,680) making treatment
cost-effective no longer.
Treatment was cost-effective in patients with no fibrosis between 50 and 59 years of age and cost-effective but
not dominant in patients between 60 and 69 years of age,
with an ICER of $6,813/QALY (Table 5). The model was
robust to all variables for patients in these age groups with
no fibrosis.

Discussion
Our results demonstrate that PEG IFN and ribavirin
combination therapy is cost-effective in the prison popu-

lation, both in strategies with and without biopsy. Incorporating a pretreatment liver biopsy may be the most
cost-effective approach, however, as one could potentially
exclude certain patients with no fibrosis from therapy.
Although we had not expected treatment to be cost-effective because of the high reinfection rates and nonliver
mortality rates both inside and outside prison, treatment
remained cost-effective despite varying these factors over
wide ranges.
The only segment of the prison population in which
treatment was not cost-effective was incarcerated individuals between the ages of 40 and 49 with genotype 1 and
no fibrosis. Given their age and lack of liver damage, they
have a lower probability than other groups of developing
cirrhosis and hepatic decompensation. Their disease process is largely silent, their quality of life is relatively unaf-

6

TAN ET AL.

fected, and they are more likely to die from non–liverrelated causes. SVR rates are low, and the benefits of
treatment are outweighed by the costs and morbidity of
treatment. On the other hand, although the risk of developing liver-related complications remains small in similarly aged patients with genotypes 2 and 3, higher SVR
rates make treatment more likely to result in benefits that
outweigh other factors. The ICER for this group with no
fibrosis between 40 and 49 years of age was particularly
sensitive to rates of SVR and costs of treatment, emphasizing that treatment in these patients is only worthwhile
if it is highly effective or relatively inexpensive.
Our study results apply only to prisoners in the United
States and are not meant to be applicable to the general
population. Nevertheless, prior cost-effective analyses
performed on nonprison cohorts show results similar to
ours, with most studies demonstrating that treatment
with PEG IFN and ribavirin is a cost-effective measure
regardless of stage of fibrosis.10-23 Although our analysis
differed from that of Salomon et al.,10 who reported that
treatment of men with no fibrosis was cost-effective in
patients with genotype 1 as well as patients with genotypes 2 and 3, the Salomon et al. study compared treatment with PEG IFN and ribavirin to treatment with
standard interferon and ribavirin, while our analysis compared treatment based on PEG IFN with no treatment.
Comparison to no treatment results in a substantially
greater incremental difference in cost, which likely accounts for these varying results.
This study is in large part limited by its reliance on data
obtained from prior literature rather than data gathered
prospectively. The natural history of hepatitis C and its
response to treatment has not been studied extensively in
the prison population, and we assumed for many aspects
of our model that the prison population would behave
similarly to the general U.S. population.
One such variable was rates of SVR, because only limited data exist on treatment response in prisoners. For
instance, one published study assessed the efficacy of standard rather than PEG IFN in prisoners in Rhode Island
but did not stratify outcomes according to genotype.26
One might expect SVR rates to be lower in the prison
population, because prior studies have shown SVR rates
to be significantly lower in African Americans than in
non–African Americans,52 and this group comprises a
larger proportion of the inmate population than the populations studied in registry trials. However, a retrospective
study comparing response rates to standard interferon between African Americans and Caucasians in the Virginia
correctional system found no significant difference in
SVR between the two groups, perhaps a result of increased
compliance with directly observed therapy.53 Further-

HEPATOLOGY, Month 2008

more, our model was robust to SVR rates varied over wide
ranges in all cohorts except prisoners between 40-49 years
of age with no fibrosis. Therefore, even if SVR was as low
as 28% in African American inmates,52 treatment would
still be at least cost-effective for almost all prison cohorts.
Similarly, rates of fibrosis and disease progression in
prisoners were assumed to be comparable to those of nonprisoners. Although there are no studies evaluating
whether the natural history of hepatitis C is identical in
this population, we accounted for possible differences by
varying rates of fibrosis and disease progression over wide
ranges. Because our model was robust to these variations,
this assumption is unlikely to be a source of bias.
Costs and quality of life weights were also obtained
from studies of nonprison populations.39,49-51 Despite the
increasing use of growth factors and antidepressants as
adjuncts to treatment, we elected not to include these as
potential costs. This is consistent with prior cost-effective
analyses of hepatitis C treatment in the general population.10-23 Most pivotal trials of hepatitis C treatment,
from which we estimated the SVRs for our model, did not
allow for growth factors, and their use may not be consistently available at all prison settings.31-33
Although the incidence of depression during hepatitis
C treatment is not trivial (20%–30%),54 this additional
cost would be unlikely to impact our analysis, because it
remains small relative to the total cost of therapy. The
average wholesale cost of 12 months of the antidepressant
oral medication citalopram, for instance,54 is approximately $972.48 Assuming that 30% of the inmates would
require citalopram during treatment, this would represent
less than 2% of the total cost of therapy.
Moreover, the high background rate of depression in
the prison population (an estimated 23.5% in state prisons and 16% in federal prisons)56 makes it difficult to
distinguish which patients would require antidepressants
as a complication of therapy and which patients would
already require antidepressants regardless of antiviral therapy. In contrast, the baseline rate of depression in registry
trials was 1% to 5%32 and in the general U.S. population
is reported to be approximately 10.6%.56 Potential treatment candidates in the prison setting would also need to
be carefully screened for other mental illnesses, because
they can be found in up to 50% of state and federal
inmates.56
Although quality of life in prisoners is lower than that
of the general population, hepatitis C infection has not
been shown to make a significant impact.57 This is likely
because non-HCV factors override HCV-specific quality
of life impairment. Furthermore, nonviral HCV-specific
quality of life impairments are likely to be equally distrib-

HEPATOLOGY, Vol. 48, No. 0, 2008

uted between prisoners who are and who are not treated
for hepatitis C infection.
Another assumption made in our model was that patients with cirrhosis who achieved SVR could still develop
decompensated cirrhosis and hepatocellular carcinoma at
rates similar to those who did not achieve SVR. This is a
bias against treatment. Recent studies have demonstrated
that cirrhotic patients who have achieved SVR actually
have lower rates of hepatic decompensation and hepatocellular carcinoma than those who do not achieve
SVR.36,37
Finally, the cohort we used for our model consisted of
only male prisoners. We felt this nevertheless resulted in
an adequate representation of the prison population, because men are 7 times more likely to be imprisoned than
females and make up 87.3% of the U.S. prison population.7 Furthermore, there have been no studies published
in the literature thus far showing significant sex differences in regard to both the natural history of hepatitis C
infection or response rates to treatment.
Currently, we are not aware of a standard policy on the
treatment of U.S. prisoners with chronic hepatitis C.
Even screening for hepatitis C infection remains controversial and is not universally performed.9 As of 2000,
1,209 of 1,584 state public and private adult correctional
facilities, housing 94% of all state prisoners, reported that
they tested inmates for hepatitis C; 1,104 (70%) state
correctional facilities reported that they had some type of
policy for treating hepatitis C in their inmates. Between
July 1, 1999, and June 30, 2000, 4,750 inmates were
treated for hepatitis C.58
Policies vary widely from state to state, however. In
some states, written protocols exist for the treatment of
prisoners, and in others, selection for treatment is performed on a case-by-case basis. In certain states, liver biopsy is mandatory prior to treatment, and in others, the
decision to biopsy is left to health care providers. A minimum prison sentence of 15 to 18 months is required by
many states in order to assure completion of treatment
and adequate follow-up prior to release. A minority of
states do not have any established programs for hepatitis
C treatment.38
In order to address this issue, the Federal Bureau of
Prisons put forth a set of clinical practice guidelines in
2005. They recommend that treatment be continued in
prisoners who are already on therapy and that therapy be
initiated in prisoners who meet criteria published by the
American Association for the Study of Liver Diseases,
provided that they do not have contraindications such as
severe psychiatric or medical illness. Prisoners must also
demonstrate a commitment to abstinence from alcohol
and other substances. Genotyping is suggested for all pa-

TAN ET AL.

7

tients, and liver biopsy is suggested for patients with elevated alanine aminotransferase levels, genotype 1, or
suspected compensated cirrhosis. The Bureau recommends that treatment not be initiated in short-term inmates, given the high likelihood that therapy will not be
completed.39 Enforcement of such a national guideline is
problematic, however, because there is currently no centrally funded or administered program to employ hepatitis C treatment. Each state manages its own budget and
therefore adopts its own set of treatment guidelines.
Ethical considerations also play a large role in this matter of public controversy, and the cost-effectiveness of
treatment must be weighed against these other concerns.
As with liver transplantation, proponents of treatment
argue that it is unconstitutional to deny inmates access to
treatment that is considered standard care. In 2003, Oregon inmates filed a class-action lawsuit against the state
prison system, alleging cruel and unusual punishment,
and sought $17.5 million in medical expenses, drug therapy, and potential liver transplantations (Anstett et al. v.
State of Oregon). A settlement was reached in 2004, resulting in liberalization of the state’s hepatitis C treatment
guidelines,59,60 and was considered by many to be a victory in favor of treatment.
Those who oppose therapy for prisoners, however,
maintain that incarcerated individuals, by virtue of their
offenses, have forfeited their right to receive these resources,40 particularly as treatment would be administered at
the expense of taxpayers, while a large proportion of uninsured patients continue to be denied access to therapy.
If the decision to treat is based on pharmaco-economic
measures, however, the results of our analysis suggest that
treatment is cost-saving and should not be withheld in
U.S. prisoners with hepatitis C. Because the efficacy of
treatment is diminished by relapse of injection drug use
and reinfection, this treatment strategy must be coupled
with educational and substance abuse programs. Furthermore, because mental illness is widespread in the prison
population and can often be exacerbated by treatment,
careful mental health screening and follow-up would be
required.
In conclusion, although the ethical debate regarding
the implementation of treatment for hepatitis C in prisons is not likely to be settled soon, we can assert that from
a pharmaco-economic standpoint, treatment of hepatitis
C in the prison population is cost-effective.

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