7/30/2019 Interferon China

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Committees Verdict: NOT APPROPRIATE BNF: 8.2.4

Licensed I ndication:The committee considered the treatment of adult

patients with histologically proven chronic hepatitis Cwho have serum markers for virus C replication, e.g.

elevated transaminases without liverdecompensation, and who are positive for serumHCV-RNA or HCV antibodies.

The efficacy of recombinant interferon alfa 2a or

2b is enhanced when combined with ribavirin.

Pegylated interferon alfa 2a is not licensed for

combined use.

Monotherapy with interferon alfa (recombinant or

pegylated formulations) should be given in cases ofintolerance or contraindication to ribavirin.

The Summaries of Product Characteristicsrecommend that treatment should be initiated by or

administered under the supervision of a physician

experienced in the management of hepatitis C.

Clin ical Efficacy:There are numerous trials and several meta-analyses

of recombinant interferon alfa (IFN) monotherapy forchronic hepatitis C.

Overall a sustained response (normalisation ofalanine aminotransferase and absence of hepatitis C

virus RNA in the blood for at least 6 months aftertreatment is stopped) occurs in only 15-20% ofpatients treated for 6 months, increasing to 25-30%

with prolonged therapy for 12-18 months.

A single, randomised, controlled trial (n=1219)suggests that monotherapy with the pegylatedinterferon alfa 2b is associated with increased

efficacy compared to the recombinant formulation.

Ribavirin in combination with recombinant IFN ishowever the preferred treatment. Combined therapy

results in an approximately 2 to 3 fold enhancement inefficacy in the treatment nave population and 10 fold

enhancement in those who have relapsed followingan initial response to IFN monotherapy. Despite this

50-60% of patients still fail to achieve a sustained viralresponse.

There is as yet no firm evidence that treatmentreduces the risk of progression to cirrhosis and

hepatocellular carcinoma.

Safety:

Adverse effects seen with IFN include flu-likesymptoms, gastrointestinal irritation and

haematological disturbances. Less common eventsinclude cardiovascular reactions, neuro-psychiatric

side effects, induction of auto antibodies anddermatological reactions. The pegylated formulationis associated with a higher incidence of injection site

reactions.

Addit ional I nformation:The National Institute for Clinical Excellence

(NICE) has recommended the use of IFN and

ribavirin combination therapy for the treatment of

moderate to severe hepatitis C. (www.nice.org.uk)

At current prices 6 months treatment at standard

doses costs approximately: 1,260 with recombinant IFN 2a or 2b

2,600 with pegylated interferon alfa 2b

3,220 with ribavirin (ribavirin must however beused in conjunction with recombinant interferon

alfa).

Recombinant interferon alfa 2a and 2b areadministered by subcutaneous or intramuscular (2aonly) injection three times per week. Pegylated

interferon alfa 2b is administered subcutaneouslyonce a week.

Launch date: 1994/95, 2000 Manufacturer: Schering-Plough EU/1/99/127/001-2,004,006,028,031,034,037 EU/1/00/131/002,007,012,017,022; MA0201/0231-3;

EU/1/00/132/002,007,012; MA0201/0214Manufacturer: Roche PL0031/0485-8

This guidance is based on the published information available at the time the drug was considered. It remains open to review in the event of significant

new evidence emerging.

A summary sheet with more detailed information can be obtained from MTRAC at the Department of Medicines Management, Keele

University, Keele, Staffordshire ST5 5BG Tel: 01782 584131 FAX: 01782 713586 WEBSITE: http://www.mtrac.co.uk

Date: October 2000 MTRAC, Department of Medicines Management VS00/26

THIS VERDICT SHEET REPLACES VS97/18 WHICH SHOULD BE REMOVED AND DESTROYED

Midland Therapeutic Review

& Advisory Committee

(IntronA,Viraferon, Roferon A,PegIntron, Viraferon Peg)for the treatment of chronic he atitis C

Due to the need for careful patient selection and close monitoring, general practitioners are advised not to

prescribe interferon alfa (recombinant or pegylated formulations) for the treatment of hepatitis C. Thisguidance is in line with MTRACs recommendation on the prescribing of ribavirin for hepatitis C.

WARNI NG: This sheet should be read in conjunct ion wi th t he Summ ary of Product Characteri stics ( Datasheet )