Raltegravir (ISENTRESS) 600mg has been launched in the UK for the treatment of HIV-1 infection in adults and paediatric patients (weighing at least 40kg), who are treatment-naïve or whose virus has been virologically suppressed on an initial regimen of raltegravir 400 mg twice daily, MSD UK has announced.
The treatment provides a new 1,200mg once-daily treatment, administered as two 600mg tablets with or without food, in combination with other antiretroviral medicinal products.
The news follows approval by the European Commission in July which allows marketing of once-daily raltegravir 600mg in the 28-member countries of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway.
Dr Andrew Ustianowski, Infectious diseases consultant at the Pennine Acute Hospitals NHS Trust, said: “We hope and believe that people living with HIV can lead a full and healthy life – but this requires long-term regular and effective anti-retroviral medication.
“Once-daily medications are an important contributor to aiding some individuals in taking their treatment well, and therefore the new once-daily raltegravir formulation is a welcome and important development for our patients.”
The approval of raltegravir 600 mg is supported by data from the pivotal Phase 3 ONCEMRK trial. At Week 48 of the study, 89% (472/531) of treatment-naïve HIV-1 infected patients receiving the 1,200mg once-daily dose of raltegravir 600mg (2 x 600 mg) achieved viral suppression of HIV-1 RNA <40 copies/mL compared to 88% (235/266) of patients receiving raltegravir 400mg twice a day, each in combination therapy with emtricitabine plus tenofovir disoproxil fumarate, with a treatment difference of 0.5%, (95% confidence interval of -4.2, 5.2). This was consistent across demographic groups at initiation of therapy and a variety of patient populations, including those with high viral load (HIV-1 RNA >100,000 copies/mL).
Louise Houson, Managing Director, MSD UK, said: “As a company, we have been involved with the global response to HIV for 30 years. Throughout that time, progress has only been possible through partnership with thousands of people living with HIV in scientific studies and trials and today we recognise their contribution with huge gratitude. The European Commission’s marketing authorisation of once-daily raltegravir 600mg exemplifies MSD’s commitment to innovate and invent to make a real-life difference. Our research and our partnerships with services, healthcare professionals and community organisations continue with a determination to keep improving the outlook for people living with HIV.”
Raltegravir 600mg can be co-administered with a wide range of antiretroviral agents and non-antiretroviral agents. The potential for drug-drug interactions must be considered prior to and during therapy. The co-administration of raltegravir 60 mg with calcium carbonate and aluminum/magnesium containing antacids, tipranavir/ritonavir, atazanavir, and other strong inducers of drug metabolizing enzymes (e.g., rifampicin) is not recommended.