Epzicom, a new product combining two HIV medicines into one tablet dosed once a day (QD) with no food or fluid requirements, was cleared for prescription use by the US FDA. Epzicom combines two widely- used nucleoside reverse transcriptase inhibitors (NRTIs), Epivir (lamivudine, 3TC) and Ziagen (abacavir sulfate, ABC) for use in combination with other antiretroviral drugs.
"Epzicom marks an important advance in GSK's ongoing commitment to provide new options in antiretroviral therapy for HIV patients," Doug Manion, vice president for HIV Clinical Research for the Infectious Diseases Medicines Development Centre (MDC) for GSK said adding, the voucher programme will be particularly beneficial to people who are not covered by private health care plans or in specific states where the drug is not yet available on all formularies.
Dr. Manion added that Epzicom provides patients and treaters with a flexible and potent dosing option that combines 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 reflected in years of clinical experience," Dr. Manion said.
Epivir and Ziagen have no known pharmacokinetic interactions with protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs). Epzicom can be combined with PIs or NNRTIs.
There are more than 509,000 patients experience with regimens containing Ziagen and 2.64 million patients with regimens containing Epivir, according to Dr. Manion. Epzicom Tablets, in combination with other antiretroviral agents, are indicated for the treatment of HIV-1 infection. Epzicom is one of multiple products containing abacavir.
GSK developed the first two combination products to treat HIV infection. Combivir (lamivudine/zidovudine) was approved in 1997, and Trizivir (abacavir sulfate, lamivudine and zidovudine) was approved in 2000. The medications contained in Epzicom have been well studied in BID (twice a day) and QD dosing regimens and in multiple combinations with other classes of antiretroviral drugs. Multiple clinical trials have studied the use of Epivir and Ziagen in more than 5,800 patients as a dual-NRTI backbone of multi-drug regimens.