GSK receives positive opinion for once-daily HIV tablet

GlaxoSmithKline (GSK) has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the EMEA (European Agency for the Evaluation of Medicinal Products), recommending the granting of a marketing authorisation for a new HIV medication.

This medication, with the proposed trade name Kivexa in the EU, combines two antiretrovirals in one tablet dosed once a day with no food or fluid requirements. Kivexa is comprised of two widely used nucleoside reverse transcriptase inhibitors (NRTIs), Epivir (lamivudine, 3TC) and Ziagen (abacavir sulfate, ABC), for the treatment of HIV infection in adults in combination with other antiretroviral medications. The CHMP positive opinion will now be proposed for approval by the European Commission.

Kivexa, given once-daily as the backbone of a combination regimen, may help simplify treatment for some patients with HIV. Studies have shown that patients are more likely to adhere to their antiretroviral medication if they have to take the pills less frequently and if there are no food restrictions.^1,2 Adherence is vital for achieving maximal viral suppression³, thereby increasing the patient's chances of survival.

'The CHMP positive opinion is good news as Kivexa will provide clinicians and HIV-infected patients with a flexible, well-tolerated and potent combination of two NRTIs that have been widely used in antiretroviral therapy for years,' commented Dr Didier Lapierre, vice president of Infectious Diseases, GSK Europe. 'Prescribers are familiar with these medications, which have an established resistance and long-term safety profile.'

The components of the Kivexa tablet have proven efficacy and safety profiles, as well as a favourable resistance profile. Epivir and Ziagen have no known pharmacokinetic interactions with protease inhibitors (PIs) or non-nucleoside reverse transcriptase inhibitors (NNRTIs); therefore, Kivexa can be combined with PIs or NNRTIs. Epivir and Ziagen have each been well-studied in both once and twice-daily dosing regimens and in multiple combinations with other classes of antiretroviral drugs. Clinical trials have demonstrated the use of Epivir and Ziagen in more than 5,800 patients as a dual-NRTI backbone of multi-drug HIV regimens. Current experience with the two components includes more than 509,000 patient years' experience with regimens containing Ziagen and 2.6m patient years with regimens containing Epivir.