Clinical outcome after 4 years follow‐up of HIV‐seropositive subjects with incomplete virologic or immunologic response to HAART

Abstract

The duration of the clinical, virologic, and immunologic response to HAART, is not well defined. In this observational multi‐center study 2,143 patients were enrolled classified according to virologic suppression (100 CD4+ cells/μl from baseline) at month 12 of HAART as complete responders, virologic only responders, immunologic only responders and non‐responders. Kaplan Meyer curves, multivariate and politomous regression analysis were used. Complete responders patients were 781 (36.4%), immunologic only responders 441 (20.6%), virologic only responders 336 (15.7%), and non‐responders 585 (27.3%). Using multivariate analysis, being antiretroviral‐naïve increased the probability of having both a virologic only or a complete response and reduced the probability of an immunologic only response (P < 0.001 for all tests). Older age was associated directly with a virologic only response and inversely associated with an immunologic only response (P = 0.027 and P = 0.035, respectively). Using politomous analysis, patients baseline HIV‐RNA level more than 5 log cp/ml had a 1.9‐fold higher probability of an immunologic response than of a complete response (P = 0.001). After 4 years, the clinical progression rate was six times greater in non‐responders, 1.9 times greater in virologic only responders, and 2.3 times greater in immunologic only responders than for responders. However, patients with virologic only response or with immunologic only response had a significantly reduced risk for clinical progression than non‐responders (P < 0.001). After 4 years of HAART, the risk of clinical progression in patients with immunologic only or virologic only response is low but still higher than in complete responder patients. J. Med. Virol. 76:153–160, 2005.