Raltegravir (Isentress) is being made available to UK patients. The drug received formal EU marketing approval in late December.
The drug belongs to a new class of antiretrovirals called integrase inhibitors. It works against HIV’s integrase protein, inhibiting the virus’s integration into human cells. It has no known cross-resistance with any other currently available antiretroviral making it an attractive option for heavily treatment-experienced individuals.
Raltegravir’s approval was based upon the results from the BENCHMARK I and II studies. Data presented to a major conference in September 2007 showed that the drug had a durable anti-HIV effect in patients with limited treatment options.
Dr Mark Nelson, Director of HIV Services at London’s Chelsea and Westminster Hospital said raltegravir was an important new addition to the arsenal of drugs available for the treatment of HIV: “When used as part of individually tailored combination therapy, raltegravir will be an important step forward in our fight against HIV.”
The approved dose of raltergravir is 400mg twice daily. Side-effects include diarrhoea, nausea, and headache.
Although raltegravir will initially be used as a therapy for treatment-experienced patients, encouraging data regarding its safety and efficacy in treatment-naïve patients were presented to last year’s International AIDS Society Conference in Sydney.
The manufacturer of raltegravir, Merck Sharp & Dohme Ltd (MSD), has said that it intends to submit an application in 2009 for the use of the drug in treatment-naïve individuals.
Raltegravir’s NHS price has been set at £647.29 per patient, per month, with an EU-wide price of 810 euros per patient, per month, a price MSD says is in line with other recently approved antiretrovirals. Price negotiations are underway, however, between MSD and bulk NHS purchasers.