[Entry inhibitors: enfuvirtide, a reality for antiretroviral therapy].

Entry inhibitors make up a new class of antiretroviral agents that block HIV entry into body cells. The recent approval of the fusion inhibitor T-20 or enfuvirtide by both FDA and the European Agency for the Evaluation of Medicinal Products (EMEA) is a first step in the expansion of a therapeutic armamentarium that is expected to increase in at least half a dozen new drugs in oncoming years. T-20 is indicated for the treatment of HIV-1 infection--in combination with other antiretroviral drugs--in patients who are resistant to both protease and reverse transcriptase inhibitors. In phase III studies, T-20 has demonstrated adequate efficacy and safety at 24 weeks after treatment, but long-term effects remain to be established. Until it finally becomes available in Spain, the compassionate use-related Early Access to T-20 Program allows it to be employed in our country for patients who meet criteria specified in the manufacturers users guide.