Merck Frosst Canada Ltd. is pleased to announce that (Pr)ISENTRESS(R) (raltegravir) is now indicated for use in treatment-naïve HIV-1 infected adults in combination with other antiretroviral agents. The approval of ISENTRESS(R) (raltegravir) as part of a first line regimen is in addition to the previously approved use in treatment-experienced adults living with HIV-AIDS who have developed resistance to multiple antiretroviral agents. This new indication is testament to its efficacy and good tolerability profile.
"The availability of raltegravir as part of earlier HIV drug combinations is significant news for newly treated patients because we are able to decrease viral load without debilitating side effects," said Dr. Colin Kovacs, HIV specialist and Assistant Professor, University of Toronto. "Having this potent treatment as part of a first line course of therapy provides us with the option to use raltegravir in a broader spectrum of patients."
This indication is based on the evidence of efficacy of ISENTRESS(R) (raltegravir) from the analysis of 48-week data from three ongoing, randomized, double-blind, placebo-controlled trials, BENCHMRK 1 and BENCHMRK 2 (Protocols 018 and 019), in antiretroviral treatment-experienced HIV-1 infected adult patients and the analysis of 48-week data from an ongoing, randomized, double blind, active-control trial, STARTMRK (Protocol 021). These efficacy results were supported by the 48-week analysis of a randomized, double-blind, controlled, dose-ranging trial, Protocol 005, in antiretroviral treatment-experienced HIV-1 infected adult patients and 96-week analysis of a randomized, double-blind, controlled, dose-ranging trial, Protocol 004, in antiretroviral treatment-naïve HIV-1 infected adult patients.
In the STARTMRK study of treatment-naïve patients, raltegravir was found to be as effective as efavirenz (one of the standard antiretrovirals prescribed for treatment-naïve patients) at suppressing viral load and restoring immune system function through 48 weeks. Both medicines were administered in combination with tenofovir and emtricitabine.
Potent and durable efficacy in treatment-naive patients
The treatment-naïve indication for raltegravir in combination therapy was based on analyses of 563 treatment-naïve, HIV-1-infected patients through 48 weeks in an ongoing, multi-centre, double-blind, randomised, active-controlled, Phase III study called STARTMRK. Patients in the study received either 400 mg raltegravir>