Use of changes in plasma levels of human immunodeficiency virus type 1 RNA to assess the clinical benefit of antiretroviral therapy

Data from 1330 human immunodeficiency virus type 1 (HIV-l)-infected patients enrolled in seven antiretroviral treatment trials were analyzed to characterize the clinical benefit of treatment-mediated reductions in plasma HIV-I RNA levels. The risk of a new AIDS-defining event or death was reduced proportionally to the magnitude of the reduction of the HIV-1 RNA level during the first 6 months of therapy, Pretherapy HIV-1 RNA levels were prognostic independently of on-therapy levels, In addition, the reduction in risk associated with any given reduction of the level of HIV-1 RNA did not vary by pretherapy level, Having either a reduction in HIV-1 RNA level or an increase in CD4(+) lymphocyte count, or both, was associated with a delay in clinical disease progression, This indicates that patient prognosis should be assessed using both HIV-1 RNA and CD4(+) lymphocyte responses to therapy.