Merck Sharp & Dohme (MSD) has been granted an expanded licence from the European Commission (EC) for the use Isentress (raltegravir) in combination with other antiretrovirals for the treatment of HIV-1 in adults, including those starting therapy, as well as those already receiving it. The safety of Isentress has not been established in patients younger than 16. The EC's decision is applicable to all 27 EU members.
The decision, reflecting the positive opinion of the Committee for Medicinal Products for Human Use (CHMP), was based on data from three double-blind controlled Phase III studies. Two of these were conducted in clinically advanced, three-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults and one was conducted in treatment-naïve adults.
In patients using the therapy for the first time, raltegravir was found to be as effective as efavirenz (one of the standard antiretrovirals prescribed for treatment-naïve patients) at suppressing viral load and restoring immune system function after 48 weeks. Both medicines were administered in combination with tenofovir and emtricitabine.
"Having a therapeutic option like raltegravir, with an efficacy and safety profile established through clinical studies, provides adult patients treated for the first time with a new way of targeting the virus," said Dr Adriano Lazzarin, professor of infectious illnesses at the University Vita-Salute San Raffaele in Milan, Italy. "New treatment options in the EU may help physicians to better individualise treatment regimens, which is important due to the complexity of HIV and increasingly diverse patient needs."
Despite the availability of drugs to treat HIV and AIDS, the pandemic continues. In the EU, nearly 270,000 cases of HIV have been reported since 2002, according to the European Centre for the Epidemiological Monitoring of HIV and AIDS. An estimated 33 million people are infected with HIV and AIDS worldwide, and about 2.7 million new infections occurred worldwide in 2007.
"The expanded licence is important because it gives adult patients starting HIV therapy for the first time an additional treatment option," said Patrick Bergstedt, senior vice president and general manager of Infectious Diseases at Merck and Co.
