GlaxoSmithKline (GSK) has received marketing approval from the European Commission for Kivexa, a new HIV medication. Kivexa 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 combination with other antiretroviral medications in adults and adolescents from 12 years of age, a company release said.
Kivexa is administered as one pill, once-daily as the backbone of a combination treatment regimen.
Studies have shown that patients are more likely to adhere to their antiretroviral medication if they have to take fewer pills less frequently and if there are no food restrictions. Adherence is vital for achieving maximal viral suppression, thereby increasing the patient's chances of survival.
Kivexa provides potent and durable virological control and is compatible with multiple recommended third agents, including non-nucleoside reverse transcriptase inhibitors (NNRTIs) and boosted protease inhibitors (PI). In treatment-naïve patients, Kivexa is associated with a low risk of cross-resistance with other NRTIs, thus helping preserve future treatment options.
"Kivexa is an important advance in GSK's ongoing commitment to provide new options in antiretroviral therapy for HIV patients," commented Didier Lapierre, M.D., vice president of Infectious Diseases, GSK Europe. "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. Prescribers are familiar with these medications, which have an established resistance and long-term safety profile."
Clinical Data 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 PIs or 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.