Select Committee on Science and Technology Written Evidence

Memorandum by Schering Plough Ltd


  Hepatitis C (hep C) is commonly acquired by sharing needles through intravenous drug abuse—50 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 symptoms—20-50 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 trusts—they 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 C—the 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 regime—10-20 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.


  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.


  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 NHS—much 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."

October 2002

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