Pharmacovigilance for antiretrovirals in resource-poor countries

Overview

There is considerable experience in the developed world with the use of antiretroviral medicines (ARVs). They are associated with significant safety concerns including serious adverse reactions to medicines (ADRs), with both short- and long-term effects. The outcome of these long-term adverse effects is unknown. The reactions include altered body fat distribution (lipodystrophy), hypersensitivity reactions, hepatic disorders, acute pancreatitis, muscle damage (myopathy) of the newborn and lactic acidosis. These and other reactions may damage confidence in any national ARV programme and affect patient adherence. With the erosion of confidence in the safety of medicines and of the programme, patients may stop taking these life-prolonging medicines leading to problems for themselves and for society as a whole. Poor adherence is known to lead to failure of therapy in the patient (he or she will not get well and may die) and development of resistance by the virus leading to reduced efficacy of these life-prolonging medicines.