1 0N-SITE TREATMENT OF HEPATITIS C - A PILOT STUDY Shay Keating, MB, PhD Medical Officer

2 Background World Health Organisation – 170 million people infected with hepatitis C world-wide 80% of Intravenous Drug Users in the Dublin area (approximately 10,000) are thought to be have been exposed Without treatment, as many as 20% are expected to develop liver cirrhosis in 20years – 6% liver Ca. 6 genotypes world-wide, genotypes 1 and 3 commonest in Intravenous Drug Users in Dublin

3 Who to treat? It has been projected that hepatitis C will represent a substantial economic burden in the US over the next years – this may be reflected here Treatment is believed to be cost effective Ideally everyone who is infected with hepatitis C should be offered treatment. Genotype non-1 more responsive to current treatment

4 Goals of treatment Viral clearance Slow or reverse the disease progression Reduce the risk of hepatocellular carcinoma Improve health related quality of life

5 Current treatment of hepatitis C Very effective, especially with genotype non-1 Pegylated interferon – subcutaneous injection once a week Ribavirin – capsule – twice a day Treatment lasts 24 – 48 weeks according to genotype Success of treatment – sustained viral clearance

6 Side-effects of treatment Interferon Flu-like symptoms Haematological problems Depression – up to 30% of patients Ribavirin Anaemia Fetal abnormalities – contraception is essential

7 Treating Hepatitis C positive drug users Many unstable regarding drug and alcohol use Many drug users do not keep out-patient hospital appointments Adherence to treatment is often poor – chaotic lifestyles, homelessness, unemployment, poverty Retention in treatment can be poor – side effects not well tolerated Relapse into active addiction - a real possibility

8 On site treatment at the DTCB Rationale: To treat the patients with hepatitis C in the same location in which they receive their methadone with a view to retaining the patients in treatment Regular medical review with referral pathway to specialist care Regular psychiatric review – monitor for psychiatric complications/relapse into active addiction

9 On-site hepatitis C treatment pilot study Pilot study of nine patients all hepatitis C positive drug stable Directly observed therapy initiated at DTCB in liaison with Dr. Colm Bergin at St. Jamess hospital Regular psychiatric review by Dr. Jacinta OShea, registrar to Dr. Eamon Keenan

10 Pilot study Not to show that the treatment works But A proof of concept – that patient retention in treatment can be improved if therapy is initiated in a specialist drug treatment setting with directly observed therapy and with appropriate medical and psychiatric support on site.

11 The hepatitis C treatment team Medical Officer Direct liaison with Dr. Colm Bergin - Consultant in Infectious Diseases. St. James Hospital, Dublin. Psychiatric Registrar Under the guidance of Dr. Eamon Keenan – Consultant Psychiatrist in Substance Misuse, DTCB Dedicated Nurse Ms. Anne Bolger, Hepatitis C Liaison Nurse, DTCB Dedicated Counsellor Mr. Alan Furlong. Senior Counsellor, DTCB

12 Study phases Phase 1 Patient Recruitment – commenced March Phase 2 Treatment Phase 3 Follow up

13 To date………… 9 patients have been recruited 8 have continued on treatment Results of the study will be presented in February 2004, at end of the pilot study.

14 Efficacy and Tolerability Preliminary finding suggest that the treatment efficacy is comparable to that of a hospital based hepatitis C treatment setting 5 of the 9 patients experienced haematological difficulties, 4 of whom were supported haematologically on-site 5 out of 9 reported significant depressive symptoms – were treated on-site 3 out of 9 relapsed briefly into active addiction – addressed on the day

15 Cost Financial cost of treatment has many components – medical, nursing, administration, laboratory – comparable to a hospital based clinic The cost of on-site haematological support is offset by the savings on hospital admission

16 Conclusion This pilot study appears to validate the proof of concept that that patient retention in treatment can be improved, for drug users, if therapy is initiated in a specialist drug treatment setting with in- site directly observed therapy and appropriate nursing, medical, psychiatric and counselling support

17 Thank You