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Background: Since the introduction of highly active antiretroviral therapy (HAART), little is known about whether changes in HIV-1 mortality and morbidity rates have been sustained. We aimed to assess possible changes in these rates across Europe.Methods: We analysed data for 9803 patients in 70 European HIV centres including ones in Israel and Argentina. Incidence rates of AIDS or death were calculated for overall and most recent CD4 count in 6-monthly periods and in three treatment eras (pre-HAART, 1994-1995; early-HAART, 1996-1997; and late-HAART, 1998-2002).Findings: The incidence of AIDS or death fell after September, 1998, by 8% per 6-month period (rate ratio 0.92, 95% CI 0.88-0.95, p<0.0001). When AIDS and death were analysed separately, the incidence of all deaths during the late-HAART era was significantly lower than that during the early-HAART era in patients whose latest CD4 count was 20 cells/microL or less (0.43, 0.35-0.53, p<0.0001), but at higher CD4 counts, did not differ between early-HAART and late-HAART. Incidence of AIDS was about 50% lower in late-HAART than in early-HAART, irrespective of latest CD4 count (p<0.0001). In multivariate Cox's models, with early-HAART as the reference, there was an increased risk of AIDS (relative hazard 1.39; 95% CI 1.16-1.67, p=0.0004) and all deaths (1.29; 1.08-1.56, p=0.0065) in the pre-HAART era, and a reduced risk of AIDS (0.62; 0.50-0.77, p<0.0001) and all deaths (0.66; 0.53-0.82, p=0.0002) in the late-HAART era.Interpretation: The initial drop in mortality and morbidity after the introduction of HAART has been sustained. Potential long-term adverse effects associated with HAART have not altered its effectiveness in treating AIDS. [ABSTRACT FROM AUTHOR]

Background: The clinical presentation of HIV-1 related diseases could have changed after the introduction of highly active antiretroviral treatment (HAART). We aimed to assess changes over time in the incidence of ADIs overall and within CD4 lymphocyte count strata, the relationship with treatment and degree of immunodeficiency at diagnosis of ADIs.Methods: We did a prospective observational multicentre study of over 7300 patients in 52 European HIV-1 outpatient clinics. Incidence rates per 100 patient-years of observation were calculated.Findings: In total, we recorded 1667 new ADIs; the incidence of ADIs declined from 30.7 per 100 patient-years of observation during 1994 (95% CI 28.0-33.4) to 2.5 per 100 patient-years of observation during 1998 (95% CI 2.0-3.0, p<0.0001, test for trend). Median CD4 lymphocyte count at diagnosis of a new ADI increased from 28 cells/microL to 125 cells/microL between 1994 and 1998 (p<0.0001), yet a steep decline in the rate of ADIs was seen after stratification by latest CD4 lymphocyte count within each year (< or = 50, 51-200, and > 200 cells/microL). Patients on HAART had a lower rate of ADIs than patients not on this treatment within each CD4 lymphocyte count strata. The proportion of ADIs attributable to cytomegalovirus retinitis and Mycobacterium avium complex declined over time (p=0.0058 and 0.0022, respectively), whereas the proportion of diagnoses attributable to non-Hodgkin lymphoma has increased (p<0.0001). In 1994, less than 4% of ADIs were non-Hodgkin lymphoma, in 1998 the proportion was almost 16%. This condition has become one of the most common ADIs in patients on HAART.Interpretation: Our findings lend support to the idea that treatment regimens can lower the incidence of ADIs. The immediate risk of an ADI for a given CD4 lymphocyte count has declined over time and is lower among patients on HAART. Long-term follow-up of patients on combination treatment is essential to monitor the incidence of new and emerging diagnoses. [ABSTRACT FROM AUTHOR]