Objective-To estimate the prognosis over 5 years of HIV-1-infected, treatment-naive patients starting HAART, taking into account the immunological and virological response to therapy.Design-A collaborative analysis of data from 12 cohorts in Europe and north America on 20 379 adults who started HAART between 1995 and 2003.Methods-Parametric survival models were used to predict the cumulative incidence at 5 years of a new AIDS-defining event or death, and death alone, first from the start of HAART and second from 6 months after the start of HAART. Data were analysed by intention-to-continuetreatment, ignoring treatment changes and interruptions.Results-During 61 798 person-years of follow-up, 1005 patients died and an additional 1303 developed AIDS. A total of 10 046 (49%) patients started HAART either with a CD4 cell count of less than 200 cells/μl or with a diagnosis of AIDS. The 5-year risk of AIDS or death (death alone) from the start of HAART ranged from 5.6 to 77% (1.8-65%), depending on age, CD4 cell count, HIV-1-RNA level, clinical stage, and history of injection drug use. From 6 months the corresponding figures were 4.1-99% for AIDS or death and 1.3-96% for death alone.Conclusion-On the basis of data collected routinely in HIV care, prognostic models with high discriminatory power over 5 years were developed for patients starting HAART in industrialized countries. A risk calculator that produces estimates for progression rates at years 1 to 5 after starting HAART is available from www.art-cohort-collaboration.org.
KeywordsAIDS; antiretroviral therapy; CD4 lymphocyte count; highly active; HIV infections; mortality; prognosis; risk factors; survival analysis; viral load
IntroductionEstimates of the probability of progression to AIDS or death are important for HIV-infected patients starting HAART and their treating physicians. Such estimates are also needed for a better understanding of the treated history of HIV infection, to monitor and predict the course of the epidemic, to develop treatment guidelines, and to plan health services.The Antiretroviral Therapy (ART) Cohort Collaboration, an international collaboration between the investigators of cohort studies from Europe and north America, was established in 2000 to monitor disease progression among treatment-naive patients starting HAART [1,2]. Pre-HAART era probabilities of progression by viral load and CD4 cell count were Mellors and colleagues [3] using the Multicenter AIDS Cohort Study (MACS) of homosexual men. In that study, the probability of progression to AIDS within 3 years for those with a high viral load and CD4 cell count between 201 and 350 cells/μl was estimated to be 64%, rising to 89% at 6 years. Since the introduction of HAART, the incidence of AIDS in treated patients has declined markedly. Previous analyses from the ART Cohort Collaboration showed that for those aged under 50 years and starting HAART in the same viral load and CD4 cell count stratum, the 3-year probability of AIDS or death had fallen to 6% [1].As treatment wi...