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MSD’s Once-Daily Version Of Its Blockbuster HIV Treatment

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.

Two tablets of the integrase inhibitor can be taken with or without food in combination with other antiretrovirals to treat HIV-1 in adults and 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 percent (472/531) of treatment-naïve HIV-1 infected patients receiving the 1200 mg once-daily dose of raltegravir 600 mg (2 x 600 mg) achieved viral suppression of HIV-1 RNA <40 copies/mL compared to 88 percent (235/266) of patients receiving raltegravir 400 mg twice a day, each in combination therapy with emtricitabine plus tenofovir disoproxil fumarate, with a treatment difference of 0.5 percent, (95 percent 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).

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,

” said Dr Andrew Ustianowski, Infectious diseases consultant at the Pennine Acute Hospitals NHS Trust. “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.

As a company, we have been involved with the global response to HIV for 30 years,” said Louise Houson, Managing Director, MSD UK. “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 600 mg 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.

First launched in the UK in 2008 as a first-in-class integrase inhibitor, Isentress’ launch as a once-daily treatment will allow it to compete with ViiV’s newer, and once-daily, integrase inhibitor Tivicay (dolutegravir).

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