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INCIVO® (Telaprevir) SVR Rates Unaffected by Ribavirin Dose Reduction in Treatment Naïve and Previously Treated Patients With Genotype-1 Chronic HCV
Date:4/18/2012

alfa and ribavirin alone (PR).[1] Results were categorized according to patients' previous response to treatment. For patients in the T12PR48 arms who had relapsed previously on treatment with PR alone, SVR was achieved by 93% (27/29) of patients who received a dose reduction to ≤ 600mg and 83% (20/24) who received a ribavirin dose reduction to 800-1000mg/day, compared to 82% (73/89) who had no reduction in their ribavirin dose. For patients who were prior partial responders, SVR was achieved by 62% (8/13), 50% (1/2) and 66% (21/32) respectively and 25% (2/8), 67% (2/3) and 31% (18/59) respectively for null responders. Analyses also examined the timing of the ribavirin dose reduction and the duration of the reduction during the studies and results were supportive of the study conclusions.[1]

These data suggest that timing, duration and extent of ribavirin dose reduction did not substantially impact SVR in the telaprevir treatment arms. Since ribavirin dose reduction was the mainstay of anemia management in the telaprevir development programme, these data suggest that reducing the ribavirin dose did not impact SVR rates.

"We have seen significant advances in the treatment of HCV with the approved direct-acting antivirals (DAAs), including  telaprevir which has reported high SVR rates for previously treated and treatment-naïve adults with genotype-1 chronic HCV, however we know management of side effects is still very important," said Professor Mark Sulkowski, Professor of Medicine, Johns Hopkins University School of Medicine, Baltimore. "These results demonstrate that the reduction of ribavirin to help manage treatment-related anaemia when treating with telaprevir did not compromise the chance of clearing the virus."

Ribavirin is a synthetic antiviral nucleoside analogue, co-administered with peginterferon alfa to increase the efficacy of treatment for chronic HCV.<
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SOURCE Janssen Pharmaceutica N.V
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