Biotech Values

[DewDiligence]

Answer to VRTX Telaprevir quiz:

“Delayed start arm [the ‘lead-in’ idea premiered by SGP], comprised of 4 weeks of treatment with peg-IFN and RBV, followed by telaprevir dosed at 750 mg q8h for 12 weeks in combination with standard doses of peg-IFN and RBV, followed by another 32 weeks of peg-IFN and RBV alone.”

Correct—the above refers to the “4+12+32” arm in the phase-3 REALIZE study in the second-line setting (#msg-32901932). It is hoped that the 4-week “lead-in” period without Telaprevir will prevent or lessen the severity of Telaprevir-induced rash.

In summary, the two trial-design wrinkles in the phase-3 Telaprevir program that may help lessen the impact of rash are: i) the “8+16” arm in the ADVANCE study, which shortens the duration of Telaprevir treatment from 12 weeks to 8 weeks; and ii) the “4+12+32” arm in the REALIZE study, which defers the start of Telaprevir treatment by 4 weeks and thereby allows the patient to attain a steady-state concentration of interferon and ribavirin before adding Telaprevir to the cocktail.