Telaprevir improves hepatitis C treatment outcomes
Investigational hepatitis C drug telaprevir, in combination with the standard treatment of peginterferon alfa and ribavirin, is associated with improved rates of sustained virological response among previously untreated patients.
A phase III study reported in the (2011;364:2405) confirms earlier studies and suggests the drug combination has the potential to shorten treatment duration. Currently, at least 48 weeks of treatment with peginterferon alfa and ribavirin is required for most patients and toxic effects may limit treatment.
Over 1,000 patients with hepatitis C were assigned to treatment with peginterferon alfa-2a and ribavirin either placebo or the protease inhibitor telaprevir (see Panel). Significantly more patients who received either 12 or eight weeks of telaprevir treatment had a sustained virological response — defined as undetectable viral RNA 24 weeks after the last study dose — compared with those in the placebo group (75 per cent and 69 per cent versus 44 per cent; P<0.001).
Most patients who were treated with telaprevir had no detectable viral RNA at weeks four and 12 and required only 24 weeks of total therapy.
However, the incidence of gastrointestinal disorders such as nausea and diarrhoea, pruritus, rash and anaemia was at least 10 per cent higher with telaprevir than with placebo.
The study found higher response rates and a small increase in reversible adverse events with 12 weeks of telaprevir treatment compared with 8 weeks.
Study method and results
The researchers randomised 1,088 patients to one of three treatment groups assigned to peginterferon alfa-2a and ribavirin : placebo, for twelve weeks; telaprevir, for twelve weeks; or telaprevir for eight weeks and then placebo for four weeks.
This was followed by treatment with peginterferon alfa-2a and ribavirin for a further 12 weeks (36 weeks for those in the placebo group, or if viral RNA was detectable at weeks 4 or 12 in the plasma of those treated with telaprevir).
Citation: Electronicjuice URI: 11079600
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