Telaprevir: Phase III data

In the open-label, international ILLUMINATE trial in 540 treatment-naïve patients with HCV genotype 1 infection, a 24-week telaprevir-based regimen (n=162) was non-inferior to a 48-week regimen (n=160) on the primary endpoint of the proportion of patients achieving an SVR 24 weeks after the end of treatment (92% vs. 88%). The primary analysis was conducted only in patients who achieved certain extended rapid viral response (eRVR) criteria. Relapse rates for the 24- and 48-week regimens were 5.7% and 1.9%, respectively. SVR and relapse rates for all patients were 72% and 7.7%, respectively, with an RVR rate of 72% and an eRVR rate of 65%.

All patients received 750 mg oral telaprevir every 8 hours plus Pegasys peginterferon alfa-2a and Copegus ribavirin for 12 weeks. Patients with an eRVR defined as an undetectable viral load (<25 IU/mL) at weeks 4 and 12 and who remained on treatment with Pegasys and Copegus through week 20 were randomized to stop treatment at week 24 or continue receiving Pegasys and Copegus through week 48. Patients who did not achieve an eRVR also continued receiving Pegasys and Copegus through week 48. Data will be presented at the American Association for the Study of Liver Diseases meeting in Boston in October. ...