(2003; 14 pages)
ANTIRETRO-VIRALS - Benefit/Risk balance remains strongly positive for combination antiretroviral therapy
Europe. The Committee for Proprietary Medicinal Products (CPMP) has issued a public statement that the benefit/risk balance of combination anti-retroviral treatment (CART) remains strongly positive in HIV infected patients. The statement follows an analysis of the results of studies undertaken by various groups to address questions concerning the prevalence and especially, the incidence of long-term cardiovascular and metabolic complications associated with CART. The CPMP holds that the long-term cardiovascular effect of CART has not been conclusively demonstrated and therefore concerns about the risk of cardiovascular disease should not lead to the withholding of CART when indicated for HIV-patients; ongoing studies of long-term cardiovascular complications should be continued for an extended follow-up time, at least till January 2005 to provide more conclusive results.
CPMP Public Statement, EMEA/CPMP/2383/03, 25 Apr 2003. Available from URL: http://www.emea.eu.int