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Interferon retreatment for chronic hepatitis C not advised

By News team

Interferon should not be used to retreat patients with relapsed or unresponsive chronic hepatitis C infection, a Cochrane review has concluded (Cochrane Database of Systematic Reviews 2013, Issue 1). It also argues that sustained viral response is not an appropriate outcome measure in this patient group.

Anja St Clair-Jones, lead pharmacist for surgery and digestive diseases at Brighton and Sussex University Hospitals NHS Trust, told The Journal: "This review may challenge the hepatitis C community to review current outcome measures and effectiveness of treatments, particularly as many new drugs are in the pipeline which are likely to be an expensive challenge in the current financial climate."

The review included seven trials (n=1,976) of interferon monotherapy versus placebo or no treatment in patients with chronic hepatitis C and severe fibrosis who had not responded to, or had relapsed after, previous interferon treatment.

Reusing interferon was linked with a reduced risk of variceal bleeding (risk ratio 0.24, 95 per cent confidence interval 0.09–0.67; n=1,710 [three trials]). However, adverse events tended to be more common in interferon recipients and the drug was not associated with improvements in all-cause mortality (RR 1.30, CI 0.95–1.79; n=1,710 [three trials]) or hepatic mortality (RR 1.07, CI 0.70–1.63; n=1,084 [two trials]).

When one of the trials was excluded because of its small cohort size, interferon therapy was associated with an increased risk of all-cause mortality (RR 1.41, CI 1.02–1.96).

Two of the commonly employed surrogate markers, sustained viral response and markers of inflammation, failed to be validated since they improved even though the clinical outcomes did not.

Surrogate outcomes are not adequate

The authors of the review say: "Retreatment with peg-interferon, while possibly reducing the subsequent incidence of variceal bleeding, may increase mortality and results in the occurrence of a number of other adverse events. As such, it cannot be recommended." However, they point out that no clinical data are available for patients with less severe fibrosis.

"Since retreatment with interferon does improve surrogate outcomes, especially rates of sustained viral response occurrence and reduction in markers of inflammation, these surrogates are not adequate outcomes to use for treatment," they add.

Mrs St Clair-Jones said: "[The use of] clinical outcome measures such as morbidity and mortality rather than the substitute biochemical and virological measures, which failed validation, [needs] to be considered for future trials. However, the question of practicality then remains, due to the slow progression of the disease."

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.11116065

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