Memorandum by Schering Plough Ltd
Hepatitis C (hep C) is commonly acquired by
sharing needles through intravenous drug abuse50 per cent
of intravenous drug users are positive for hep C. It was also
spread through blood transfusion before the introduction of screening
in 1991 or by the administration of blood products before the
viral inactivation programme of the mid 1980s. Other methods of
transmission, eg sexual intercourse or mother to baby, are known
but are rarer. Up to 85 per cent of those exposed fail to clear
the virus and develop chronic hep C. The rate of progress of the
disease is variable and can take 20-50 years. Some 70 per cent
of patients who do not clear the virus will develop moderately
severe symptoms20-50 per cent of those infected will end
up with advanced liver disease or cirrhosis within 20 years and
eight-40 per cent develop liver cancer. Patients with cirrhosis
suffer severe symptoms and may need liver transplantation.
Estimates of those with hep C infection in England
and Wales vary between 200,000 and 800,000. There is no large
scale screening programme in existence or proposed to determine
the prevalence more accurately. Up to the end of 2001, 26,500
infections had been reported in England so even at the lower estimates
of the disease prevalence some 90 per cent remain so far undetected.
The British Liver Trust estimates that hep C could kill more than
60,000 people in the UK.
In October 2000, the National Institute for
Clinical Excellence (NICE) recommended the combination therapy
of interferon alpha by injection and ribavirin in tablet form
for the treatment of moderate to severe hepatitis C. NICE guidance
is mandatory upon health truststhey must find the funds
for the treatments recommended. The Government claims to have
"provided additional funds to the NHS to meet the costs of
these (drugs)." The treatment regime recommended lasts six
months, except for those patients suffering from hep C of genotype
one (up to two thirds of UK hep C sufferers fall into this category)
where 12 months treatment is recommended. NICE may review the
case for treatment of mild hep Cthe Department of Health
is currently running a multi-centre trial to investigate the heath
benefits from treating those with mild disease.
The aim of treatment is to clear the virus and
lower the enzyme (ALT) levels used as a marker of liver damage.
This results in improved quality of life, and reduced risk of
cirrhosis and cancer of the liver.
67 per cent of patients with hep C (other than
the more virulent genotype one) respond on a sustained basis after
six months; 28 per cent of patients with genotype one respond
on a sustained basis after 12 months. Relapse rates are low. There
is evidence from a new formulation of interferon alpha (a longer
acting "pegylated" version) of enhanced antiviral effectiveness.
In a trial in combination treatment, the pegylated formulation
achieved viral clearance for 48 per cent of genotype one patients
and 80 per cent for other genotypes. NICE has not yet produced
guidance on this formulation.
Side effects are possible on treatment, and
this, together with the unpleasant injections, can affect compliance
with the regime10-20 per cent may discontinue treatment.
The pegylated interferon may help compliance rates because it
requires injections once a week rather than three times weekly
for the non-pegylated version.
The Hepatitis C strategy within "Getting
Ahead of the Curve" calls for raising awareness of the disease
but does not set national targets, and does not propose an active
outreach programme to identify the 90 per cent of hep C sufferers
as yet undiagnosed. It should be remembered that the majority
of people infected do not develop symptoms in the short term.
Six months of combination therapy costs about
£4,800. However, without preventative treatment the costs
of treating chronic hepatitis C may be considerable. The CMO writes
in "Getting Ahead of the Curve": "Whilst the costs
of not treating are low initially, as the disease progresses many
more people move to decompensated cirrhosis where the treatment
costs, which may include liver transplantation, increase enormously".
The cost per life year saved in the UK is £10,990
for six months therapy. This compares favourably with other health
care interventions, eg cholesterol reduction in patients with
coronary heart disease costs £45,585 per life year saved.
HEPATITIS C IN
In 1999, new entrants in five Irish prisons
showed a prevalence of hep B as six per cent and hep C as 22 per
cent. Those who had not been in prison before had infection rates
of two per cent for hep B and three per cent of hep C. The conclusion
of the study was: "Increased risk associated with exposure
to prison is probably because of the high risk injecting practices
adopted in prison . . . It is clear that both use of injected
drugs and infection with hepatitis C virus are endemic in Irish
prisons . . . As imprisonment leads to high risk practices, this
survey points to the need for increased infection control and
harm reduction measures in Irish prisons."
A study of eight British prisons published in
"Communicable Disease and Public Health" (June 2000)
suggested that, "Hepatitis viruses are probably being transmitted
in prisons through sharing non-sterile injecting equipment".
43 per cent of injected drug users had not received treatment
or help in relation to drug use in prison. The study concluded
that policies intended to minimise harm within prison could "improve
prisoners' health greatly".
The Hepatitis C Strategy reports that in a study
of the prevalence of blood borne viruses in prisoners 29 per cent
of women, 24 per cent of men and four per cent of young offenders
claimed to have injected drugs at some time. Nearly a third of
men who had injected drugs had done so in prison and three quarters
of those who had injected in prison had shared needles. The prevalence
among men and women of hep C was 10 per cent (cf 0.6 per cent
in young offenders).
The Hepatitis C Strategy recommends that prisoners
should "have access" to clinical investigation and NHS
care for hep C and that information on hep C and harm minimisation
should be given especially to young people entering juvenile and
young offenders' establishments. It does not propose compulsory
screening of prisoners for hep C even though prisons are clearly
a reservoir of this disease. Prisoners are screened for hep B
if there are grounds for suspicion that they are infected.
UK PRISONS AND
C (HEP C)
The drug problem within prisons is particularly
severe. Nearly a third of all men who have ever injected drugs
have injected in prison, with all the risks of needle sharing
involved. The House of Commons Committee of Public Accounts reported
in September 2002: "Nearly six out of every 10 prisoners
are convicted of one or more offences within two years of being
released. Breaking this cycle of crime requires attention to address
drug misuse and offending behaviour . . . The Prison Service has
sought to improve the availability of drug treatment services
across the prison estate . . . However, the National Audit Office
found that drug treatment programmes were running in just 50 out
of 135 prisons, with marked variations in provision between different
types of prison." So, although there is a drug strategy in
place for prisons, current drug treatment programmes are unsatisfactory.
The rules governing clinical services for substance
misusers in prisons are laid out in Prison Service Order (PSO)
3550. Clinical management in prisons must follow the Department
of Health's guidelines, "Drug Misuse and Dependence"
published in 1999. These guidelines cover withdrawal, reduction,
detoxification and maintenance but they do not mandate any specific
choice between these. The PSO lays down that there must be guidelines
for maintenance and detoxification which must include certain
named specified drugs (such as methadone). Prisoners are meant
to be effectively screened on entry, and if they are identified
as misusers "access" to detoxification must be offered
to them. Clearly, there remains great scope for doctors in prison
to offer a variety of approaches: there is no mandatory regime,
and there is no reason to assume that the present patchwork of
treatment may resolve into a more uniform approach. Prisons are
mandated to keep their guidelines updated in the light of advances
in drug treatment within the NHS.
The Chief Medical Officer's Hepatitis C Strategy
for England (August 2002) accepts that, "Evidence for the
effectiveness of oral methadone (and more recently buprenorphine)
treatment and maintenance programmes in reducing the risk of hepatitis
C infection is well documented and is based on the success of
such treatments in reducing injecting and sharing behaviour."
However, the CMO also finds an unsatisfactory position in prisons:
"Clinical management of opiate misusers aims to provide effective
evidence-based management. The provision of oral methadone therapy
is proven to reduce the amount of injecting and risk behaviour.
However, there is currently a lack of uniformity in its provision
in prisons and this may lead to increased illicit drug use. Prison
guidelines for maintenance prescribing include those on remand
or with a short sentence and for pregnant women. The Prison Service
will examine the provision of methadone substitution treatment
programmes, including the commencement of prisoners into treatment."
In relation to Hep C, the UK has a strategy
based not on proactive surveillance but upon increasing awareness.
Some 90 per cent of carriers of this virus do not know they are
infected (or infectious). A significant proportion of these will
proceed to develop unpleasant diseases such as cirrhosis and liver
cancer which will in turn create a heavy burden upon NHS budgets
in the medium to long term. "We would suggest that the hepatitis
C strategy should be more aggressively based upon outreach to
at risk groups since timely treatment of the infection will clear
the virus from a large proportion of carriers."
Failure adequately to address the problems of
opiate abuse is particularly relevant to the UK prison population,
who are as a result apparently more likely to emerge from prison
with hep C than when they went in, and who represent a significant
and largely untreated reservoir of infection with the disease.
Under current policies, like the remainder of the population,
most will remain unscreened for the disease and a significant
proportion of those infected will go on to develop to a large
extent avoidable, but extremely unpleasant and often fatal disease.
As this group ages more and more will develop florid disease and
will come to pose a heavy cost burden on the NHSmuch of
which is potentially avoidable. "We recommend compulsory
screening of all prisoners for hepatitis B, hepatitis C and drug
abuse and for the application of treatment programmes to become
standard throughout the prison service."