ABSTRACT

Lamivudine is the negative enantiomer of 2′-deoxy-3′-thiacytidine, the racemic mixture of the two enantiomers previously known as both BCH 189 and GR103365X. It is a member of the nucleoside analog reverse transcriptase inhibitor class of antiretroviral drugs. This dideoxynucleoside analog of cytidine is a potent inhibitor of HIV-1 and HIV-2, as well as of hepatitis B virus. Lamivudine—-manufactured by GlaxoSmithKline, approved by the US Food and Drug Administration (FDA) approved in 1995, and marketed by ViiV Healthcare—is registered for the treatment of HIV-1 infection and hepatitis B virus infection in a number of countries. Its trade name is Epivir, but it also comes in a number of fixed formulations, including with zidovudine (Combivir), with zidovudine and abacavir (Trizivir), and with abacavir as a single tablet (Kivexa, Epzicom). A tenofovir–lamivudine combination tablet, manufactured by Hetero Drugs in India, was approved by the FDA for use outside the USA (US Food and Drug Administration, 2009).