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Community care and hepatitis C

Case Report

A 48-year-old hepatitis C virus (HCV)-infected man was referred to the infectious diseases (ID) clinic at the Mater Hospital in Dublin from the Thompson Centre in North Dublin (a community GP methadone prescribing practice) for consideration of HCV treatment. He had a background medical history of HCV genotype 3 and was treatment-naive, with a history of alcohol excess (alcohol free for three years), a history of intravenous drug use (IVDU) (no injecting for 10 years) and a history of pulmonary TB, for which he completed treatment in 2011. He was on 40ml of methadone once a day and had no known drug allergies. He was single and lived at home with his sister, whose diagnosis of schizophrenia required him to be full-time carer for her, with close supervision and frequent accompanied visits with her to outpatient psychiatric services.

Initial evaluation took place as part of a community-performed FibroScan assessment, which revealed a significantly elevated score of 43.5KPa (consistent with F4 fibrosis/cirrhosis). Upon first evaluation following this FibroScan assessment performed in the community, his albumin was 26g/L, bilirubin 30umol/L and PT 13.6 seconds. His ALT was 3IU/L, AST 87IU/L; he had an estimated glomerular filtration of  >60ml/min/1.73; platelets were reduced at 61 x 10 ^ 9/L; he had a macrocytosis and WCC were slightly reduced at 3.08 x 10 ^ 9/L.  His AFP was increased at 21ug/L, HCV viral load was 348,814IU/ml; he was HBsAg negative, HIV-negative but Hep A-IgG positive. He had a Child-Turcotte-Pugh (CTP) score of 7, classification B. Liver ultrasound was normal. He had not been identified in the community site as having clinically-significant liver disease or cirrhosis.

Following initial detection and evaluation in the community, he was further evaluated in the ID clinic and commenced on daclatasvir 60mg po od, sofusbavir 400mg po od and ribavirin 400mg po mane, 600mg po nocte for a period of 24 weeks. He was reviewed in the ID clinic, alternating with the Thompson Centre weekly to monthly visits and successfully completed his treatment without complications.

Within one month of commencing the treatment, the virus became undetected. He will be followed up in the clinic for another three months to ensure the virus remains suppressed.  

Discussion

HCV infection is a major cause of chronic liver disease and death throughout the world. HCV infection is caused by an RNA virus that was first identified in 1989. Six distinct but related genotypes and multiple subtypes have been identified. In Western Europe, genotypes 1a and 1b are most common, followed by genotypes 2 and 3. HCV is transmitted by blood and now occurs primarily through injecting drug use, and less frequently through sex with an infected partner, occupational exposure, and mother-to-infant transmission.

Acute HCV infection, in general, is relatively mild, with only 20-30 per cent of infected people developing symptoms or clinically-evident acute infection. Chronic HCV infection is marked by persistence of HCV RNA for at least six months after onset of infection. Between 55 per cent and 85 per cent of those infected develop chronic infection. Spontaneous resolution after six or 12 months of infection is unusual.

Chronically-infected people are at risk of progressive liver disease characterised by hepatocellular inflammation, hepatic fibrosis, cirrhosis, and hepatocellular carcinoma (HCC).

Factors that have been shown to be associated with progression of liver fibrosis include older age at infection, male sex, genetic factors, metabolic factors (steatosis, diabetes and obesity), co-infection with HIV or hepatitis B, duration of infection, and alcohol intake.

Diagnosis

The availability of new rapid testing for HCV now makes possible accurate testing in the community for those who are not accessing care.

Once diagnosed with HCV, to assess the severity of liver disease liver biopsy was the gold standard to assess the need for treatment in those infected with HCV. Many patients have defaulted from HCV care because of the myths of the dangers of liver biopsy.

The liver stiffness test (FibroScan) is available as a non-invasive method of staging liver disease in persons with chronic HCV. The equipment can be transported to community sites to access patients, and in many HCV treatment guidelines (including Ireland), a FibroScan is used to determine eligibility for the State-supported HCV treatment utilising the oral-only direct acting antivirals (DAAs).

The FibroScan has proven in a number of studies to be equivalent to liver biopsy and has become an essential component of the evaluation.

Once diagnosed with HCV, to assess the severity of liver disease, liver biopsy was the gold standard to assess the need for treatment in those infected with HCV. Many patients have defaulted from HCV care because of the myths of the dangers of liver biopsy

Treatment

Treatment of chronic HCV infection has two goals. The first is to achieve sustained eradication of HCV (ie, sustained viral response (SVR)), which is defined as the persistent absence of HCV RNA in serum six months or more after completing antiviral treatment. 

Obtaining an SVR has the additional benefit of ‘secondary prevention’, where the individual is no longer infectious to others. Finally, eradication of HCV with HCV-specific treatment will halt and/or slow progression to cirrhosis, hepatocellular carcinoma (HCC), and decompensated liver disease requiring liver transplantation.

All patients with chronic HCV infection should be evaluated for treatment. Historically, treatment consisted of interferon administered subcutaneously weekly and ribavirin orally. The efficacy of these treatments was not great, with many treatment failures in those who completed 24-to-48 weeks of treatment and many, sometimes 10-20 per cent, did not complete treatment because of untoward side-effects.

New drug therapies such as protease and polymerase inhibitors (DAAs) have been developed in the last 10 years and have recently been licensed for use worldwide.

Many different options are now available, with interferon-free regimens of oral-only agents administered for eight-to-24 weeks for all genotypes, resulting in cure rates of 90-100 per cent being achieved. These DAAs have proven to be very well tolerated with minimal, and sometimes practically no, side-effects. 

Strategies to reach vulnerable populations in Ireland

Currently, treatment with DAAs is restricted to those with more advanced disease, specifically outlined by the Hepatitis C Clinical Advisory Group of the HSE, and is based on the degree of fibrosis as assessed by a FibroScan score, with current guidelines identifying those with scores of >8.5KPa as being eligible for treatment.

However, many patients, similar to this article’s case report, are in community centres with ‘occult cirrhosis’, not yet accessing care. In order to ensure these patients will access and engage with treatment, Ireland is part of an EU-funded community ‘integrated care’ project that partners the community with the treatment centres in Dublin, London, Bucharest and Seville: HepCare Europe. This €1.8 million, three-year project will be providing outreach and partnership, and ultimately community-based treatment for ‘vulnerable populations’ with the new DAAs.

Prof Walter Cullen, Professor of Urban General Practice, University College Dublin (UCD), has previously identified that GP practices that prescribe methadone to HCV-infected and at-risk populations are an ideal site to access, test and treat such patients, as they are not accessing hospital care.

HepCare Europe provides a unique opportunity to link vulnerable populations affected/infected with HCV to this ‘integrated care’ partnership. It will include a rapid-testing component (HepCheck) using an orally-administered point-of-care testing; HepCare integrated partnership, with community FibroScan testing, and community nursing liaison (HepScan and HepLink); a peer support partnership to assist patients in accessing and completing care in partnership with the Dublin NGO Community Response (HepFriend); community-based education focused both on caregivers and affected communities (HepED); and a cost-effectiveness evaluation of the interventions being performed by the University of Bristol in the UK (HepCost).

Summary   

HCV is now a curable disease. Many are now discussing elimination of HCV and making HCV a ‘rare disease’ in the European Union. Before we discuss ‘viral elimination’, we must discuss the targeting of HCV-related liver disease in affected communities. These communities include the homeless, current and past injecting drug users, and those attending drug treatment centres and GP practices in Ireland who are attending services for opiate substitution therapy.

The case report patient was regularly attending the Thompson Centre for his weekly testing and methadone treatment and had not been accessing care at the hospital centre, just three blocks away from the Thompson centre. He was not identified with clinically-significant liver disease, as he had not yet developed clinical manifestations of hepatic decompensation.

While the current Irish strategy for treatment of HCV has identified many of those with recognised HCV-associated liver complications, those identified are only those who are attending services. HepCare Europe aims to develop a model where the hospital comes to the patient, and not the patient comes to the hospital. Such a model will be necessary if we aim to engage the many vulnerable populations affected and infected with HCV.

A multidisciplinary partnership of many different services (hospital consultants, community drug treatment services, alcohol support services) and many different kinds of caregivers (consultants, community nurses, peer support counsellors and others) will need to be put together and work together for the goal of HCV treatment in all affected populations.

References on request

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