RaltegravirIsentress and Isentress HD

7.1 The PBAC was of a mind to recommend raltegravir 600 mg tablets be listed on the PBS for the treatment of HIV infection on a cost-minimisation basis compared with raltegravir 400 mg tablets, noting that raltegravir 600 mg tablets should be available only under special arrangements under Section 100 – Highly Specialised Drugs Program (Community Access).PSD · Jul 2017

7.2 The PBAC considered that the restriction for raltegravir 600 mg tablets should be aligned with that for raltegravir 400 mg tablets, and for other single agent integrase inhibitors listed on the PBS.PSD · Jul 2017

6.16 Given the claim of non-inferior efficacy and safety, a cost-minimisation approach was appropriate.PSD · Jul 2017

6.17 The equi-effective doses were estimated as raltegravir 1200 mg QD and raltegravir 400 mg BID, each as continuous therapy. These estimates were derived from the results of the randomised head-to-head Trial PN292. The PBAC considered these estimates are reasonable for treatment naïve and treatment-experienced patients.PSD · Jul 2017

6.9 The submission’s clinical claim is that:  “once daily raltegravir 1200 mg, taken with Truvada® as backbone therapy, has non- inferior efficacy compared to raltegravir 400 mg BID, taken with Truvada® as backbone therapy, in the treatment of HIV-1 infection” (p.69 of the submission).  The submission further claimed that its analysis of safety demonstrated raltegravir QD is well tolerated and has a safety profile comparable to raltegravir 400 mg BID.PSD · Jul 2017

6.10 The therapeutic conclusion regarding efficacy was supported in HIV-1 infected patients who are treatment-naïve and treated in combination with Truvada® as a backbone therapy which was derived from the results of a single, randomised, head- to-head, double-blind, non-inferiority trial over 48 weeks. The primary outcome was based upon an objective laboratory test of HIV RNA <40 copies/mL.PSD · Jul 2017