Clinical outcome of patients with HIV-1 infection according to immunologicand virologic response after 6 months of highly active antiretroviral therapy

Background: The prognostic value of discordant immunologic (CD4 cell increa se) and virologic (plasma HIV RNA level decrease) responses to antiretrovir al treatment is not known. Objective: To study the relation between clinical outcome of HIV-infected p atients receiving highly active antiretroviral therapy (HAART) and early im munologic and virologic responses to such therapy, Design: Prospective cohort study. Setting: 68 hospitals in France. Patients: 2236 protease inhibitor-naive pa tients. Intervention: Initiation of HAART with one protease inhibitor and two nucle oside analogues between July 1996 and March 1997. Measurements: Immunologic and virologic response at 6 months. Multivariate Cox models were used to assess the relation between these responses and pro gression to a new AIDS-defining event or death. Results: On the basis of 6-month immunologic and virologic responses, patie nts were classified into four groups: complete response (47.5%), complete n onresponse (16.2%), immunologic response only (19.0%), and virologic respon se only (17.3%). After month 6 and within a median of 18 months, 69 patient s died and 123 experienced a new AIDS-defining event. After adjustment, com plete nonresponders and those with only a virologic response had significan tly higher risks for clinical progression at 6 months (relative risk, 3.38 [95% CI, 2.28 to 5.02] and 1.98 [CI, 1.26 to 3.10], respectively) than comp lete responders. The difference between complete responders and those with only an immunologic response at 6 months was weaker and nonsignificant (rel ative risk, 1.55 [CI, 0.96 to 2.50]). Conclusions: Immunologic response after 6 months of HAART indicates a favor able clinical outcome in HIV-infected patients regardless of virologic resp onse. This suggests that both immunologic and virologic markers should be u sed in clinical practice to evaluate treatment response.