raltegravir (Isentress)

Following a full submission.

Raltegravir (Isentress®) is accepted for restricted use within NHS Scotland.

Licensed indication under review: in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.

SMC restriction: to patients who are intolerant or resistant to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) or when these options are compromised due to drug-drug interactions.

Raltegravir has been shown to be non-inferior to efavirenz in combination with tenofovir and emtricitabine in treatment naïve patients.

In two small open-label studies, raltegravir demonstrated maintenance of viral suppression over 24 weeks when substituted for enfuvirtide in a combination regimen in highly pre-treated patients with a history of triple class failure or intolerance. 

The health economic case was demonstrated only for a sub-population of patients within the licensed indication.