Progression to AIDS and death and response to HAART in men and women from a multicenter hospital-based cohort.

OBJECTIVE: To study if progression to AIDS and death, as well as clinical and virological response to highly active antiretroviral therapy (HAART), differs between men and women. METHODS: We studied a multicenter, hospital-based cohort of HIV-infected patients attending 10 hospitals in Spain from January 1997 to December 2003. Kaplan-Meier and Cox regression were used to assess the effect of sex on time to AIDS, survival from AIDS, onset of a new AIDS event or death, and viral suppression from HAART. RESULTS: Of 4643 patients, 27% were women. Women had statistically significant lower viral loads (VL) of 3.9 vs. 4.1 log10/mL (p = 0.02) and higher median CD4 counts of 339 vs. 288 cells/mm3 (p < 0.001) at entry and were more likely to be AIDS free at entry. In univariate analysis, women seemed to show a nonsignificant lower progression to AIDS (HR 0.88) (95 CI% 0.73-1.07), which disappeared in multivariate analyses (HR 1.03) (95% CI 0.82-1.29). Survival from AIDS seemed to be higher in women (HR 0.65) (95% CI 0.40-1.05), but differences became clearly nonsignificant after adjustments (HR 0.71) (95% CI 0.42-1.23). No differences were seen in time to new AIDS condition or death after HAART (HR 1.08) (95% CI 0.80-1.46) in multivariate analyses. No differences were seen for time to VL suppression after initiation of HAART (HR 1.07) (95% CI 0.92-1.24). CONCLUSIONS: We have found no differences in HIV progression and response to HAART attributable to gender among patients accessing the Spanish hospital network.

Clinical outcome of HIV-infected patients with sustained virologic response to antiretroviral therapy: long-term follow-up of a multicenter cohort.

BACKGROUND: Limited information exists on long-term prognosis of patients with sustained virologic response to antiretroviral therapy. We aimed to assess predictors of unfavorable clinical outcome in patients who maintain viral suppression with HAART. METHODS: Using data collected from ten clinic-based cohorts in Spain, we selected all antiretroviral-naive adults who initiated HAART and maintained plasma HIV-1 RNA levels <500 copies/mL throughout follow-up. Factors associated with disease progression were determined by Cox proportional-hazards models. RESULTS: Of 2,613 patients who started HAART, 757 fulfilled the inclusion criteria. 61% of them initiated a protease inhibitor-based HAART regimen, 29.7% a nonnucleoside reverse-transcriptase inhibitor-based regimen, and 7.8% a triple-nucleoside regimen. During 2,556 person-years of follow-up, 22 (2.9%) patients died (mortality rate 0.86 per 100 person-years), and 40 (5.3%) died or developed a new AIDS-defining event. The most common causes of death were neoplasias and liver failure. Mortality was independently associated with a CD4-T cell response <50 cells/L after 12 months of HAART (adjusted hazard ratio [AHR], 4.26 [95% confidence interval {CI}, 1.68-10.83]; P = .002), and age at initiation of HAART (AHR, 1.06 per year; 95% CI, 1.02-1.09; P = .001). Initial antiretroviral regimen chosen was not associated with different risk of clinical progression. CONCLUSIONS: Patients with sustained virologic response on HAART have a low mortality rate over time. Long-term outcome of these patients is driven by immunologic response at the end of the first year of therapy and age at the time of HAART initiation, but not by the initial antiretroviral regimen selected.