Defining the toxicity profile of nevirapine and other antiretroviral drugs

Since there is currently no cure for HIV-1 infection, long-term remission of the disease is achieved by administering combinations of antiretroviral (ARV) agents for an indefinite period. During this time, the likelihood of developing toxicities is high, since all ARV drugs are associated with both short- and long-term toxicities. The major toxicity observed with nevirapine (NVP) is rash, which is usually mild and occurs early in treatment. However, in some cases, it may be severe or potentially life threatening. Using the recommended lead-in dosing schedule in conjunction with good health care management, this adverse event can be controlled in the vast majority of patients. The development of guidelines for management of NVP-associated rash, which are easy to use, have proven to be very effective; approximately half of the patients with mild or moderate rash can continue NVP therapy under close supervision. In order to facilitate better monitoring of toxic events associated with ARV therapy, a Toxicity Evaluation Group has been set up, with the objective of standardizing reporting of drug-related toxicities in all Adult AIDS Clinical Trials Group (AACTG) studies. These measures may help to identify potential toxicities better and any risk factors that predispose patients to the development of treatment-related side-effects.