GSK receives EU approval for Kivexa
GlaxoSmithKline (GSK) has received marketing approval from the EC for Kivexa, a new HIV medication.
GlaxoSmithKline (GSK) has received marketing approval from the EC 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.
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.1,2 Adherence is vital for achieving maximal viral suppression3, thereby increasing the patient's chances of survival3. 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 Dr Didier Lapierre, 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. In clinical trials, Kivexa has demonstrated its ability to reduce the concentrations of HIV in plasma in both antiretroviral treatment-naïve and experienced patients. 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 2.6 million patient years with regimens containing Epivir.
In study CNA300244, Ziagen 300mg twice-daily + Epivir 150mg twice-daily was as effective as Retrovir twice-daily + Epivir 150mg twice-daily in combination with efavirenz (EFV) at 48 weeks. Virological response within this study was equivalent to the current standard of care and was combined with significantly greater increases in CD4+ cell count from baseline with Ziagen + Epivir compared with Retrovir + Epivir.
Sustained virological response was demonstrated over 120 weeks with ABC + 3TC twice-daily in the SOLO/APV30005 study5 with 75 percent of patients who rolled over from the SOLO study achieving a plasma HIV-1 RNA of <400 copies/mL of blood at this time point.
In a multi-centre double-blind, controlled study (CAL30021, ZODIAC)5 in 770 adult patients, comparable efficacy and tolerability were demonstrated after 48 weeks between Ziagen dosed 300mg twice-daily and 600mg once-daily, when given in combination with Epivir 300mg once-daily and efavirenz 600mg once-daily. Virological failure in clinical trials with treatment-naïve subjects receiving ABC/3TC/EFV first-line therapy was infrequent.4,6 A low rate of lipoatrophy was observed over 120 weeks with the ABC + 3TC backbone.7
Abacavir hypersensitivity reactions (HSR) were reported in approximately 5% of patients across all abacavir clinical trials. In clinical trials using an abacavir once-daily regimen, the reported rate of HSR remained within the range recorded for abacavir given twice-daily. The hypersensitivity reaction is characterized by fever, rash, gastrointestinal symptoms, such as nausea, vomiting, diarrhea or abdominal pain, symptoms such as generalized malaise, fatigue or achiness and/or respiratory symptoms such as dyspnea, pharyngitis or cough. Symptoms of this reaction usually occur within the first six weeks of treatment although these reactions can occur at any time during therapy.