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NICE Guidelines on the Use of Ribavirin and Interferon Alpha for Hepatitis C

NICE Guidelines on the Use of Ribavirin and Interferon Alpha for Hepatitis C. Matt Johnson and Dr. Hunt / Asante / Jenkins. Hepatitis C - Transmission. There are 6 major types 40% are type 1, the rest are mainly type 2 + 3

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NICE Guidelines on the Use of Ribavirin and Interferon Alpha for Hepatitis C

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  1. NICE Guidelines on the Use of Ribavirin and Interferon Alpha for Hepatitis C Matt Johnson and Dr. Hunt / Asante / Jenkins

  2. Hepatitis C - Transmission • There are 6 major types • 40% are type 1, the rest are mainly type 2 + 3 • Parenteral transmission ( IV drugs, blood transfusion, tattooing, electrolysis, ear piercing, acupuncture) • 6% Vertical transmission • HIV increases transmission

  3. Hepatitis C - Risks • 20% develop acute hepatitis • Jaundice and RUQ pain • Flu like illness with muscle aches • Decreased appetite and nausea • generalized weakness • 85% of those exposed will develop chronic hepatitis C (15% clear virus) • can take between 20 - 50y to develop • 20% develop cirrhosis in <20y • 33%do not progress ( or do after 50y )

  4. Hepatitis - Prevalence • Prevalence in England and Wales • 200 - 400,000 • 0.04% blood donors • 0.4% antenatal attenders (in London) • 1% GU clinic attenders • 50% IV drug

  5. Treatments • Interferon • 47% respond to monotherapy within 3-4/12 but some had to continue for 12/12 • PEGulated IFN • Ribavirin • Licenced for use in combination therapy • Combination Therapy (>1744 )

  6. Treatments • Interferon • Mode of action ? • Dose = 3 million units s/c 3 times a week • Ribavirin • Nucleoside analogue with a broad spectrum of antiviral activity (esp RNA V) • 500mg (for<75kg) or 600mg (for>75kg) PO bd • Combination therapy • SE’s as for IFN include - Flu, Thyroid, Haematology, Psychiatric, GI, Dermatology

  7. Trial Evidence • 19 published RCTs involving 3765 patients and 2 meta analysis • First presentation with Hepatitis C • Sustained virology responses were seen in • Monotherapy = 6 % (24/52) and 16% (48/52) • Combination = 33% and 41% • For those who responded to IFN alone but relapsed within < 6/12 • Monotherapy = 5% (24/52) • Combination = 49% (24/52)

  8. Treatments • Combination Therapy (>1744 ) • Type 1 = 17% sustained response after 24/52 • = 28% (approx 1/3) after 48/52 • Others = 67% (approx 2/3) after 24/52 • = no further benefit with another 24/52

  9. Follow Up • PCR, LBx, Genotype testing, Viral load • Type 1 are treated for 12/12 • Types 2 - 6 treated for 6/12 • 6/12 Combination therapy costs £4800 • Tests cost a further £200 • Weekly for 1/12 • Then 1/12 OPA • FBC and TFT

  10. Additional Information • 10-20% of combination therapy in the trials was discontinued due to SE’s (usually haematological) • Eradication is more likely if the patient is <40y, female, viral load <3.5milli/ml, minimal portal fibrosis • Unknown • Benefits of Combo in non-responders to monotherapy • Treatment in <18y, or in mild hepatitis

  11. Costs • 18 million per year • However increasing numbers are being diagnosed • Advances • Pegylated Interferon = longer acting version of IFN alpha ( more effective ) • Prognostic and cost implications in monitoring at the 1 and 3 month stage. This enables stopping or reduced lengths of therapy in non-responders and early responders respectively.

  12. Summary • Indications • histologically proven, previously untreated Hep C, without liver decompensation • adult patients who have previously responded to monotherapy but relapsed within <6/12 • cirrhosis with increased risks of HCC • Contraindications • Continuing IV drug use (excluding methadone) • alcoholics • decompensated liver disease

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