| BackgroundNatural history refers to the course of a disease from onset to death without any intervention. The natural history of HIV infection refers to disease progression from the onset of HIV infection to AIDS (AIDS incubation), from infection to death (Survival time of HIV infection), and from diagnosis of AIDS to death (AIDS survival time). Since the first AIDS case was reported in 1981, enormous amounts of studies have focused on survival time from HIV infection to death. UNAIDS/WHO recommended that, an overall median survival time of 9 years should be used as an estimate for adults who are not receiving antiretroviral therapy, with arrange of 8 to 11 years, the age at HIV seroconversion and HLA gene have effects on disease progression. Many potential factors, such as immune factors, genetic factors, the age at HIV seroconversion, gender, mode of transmission, smoking, nutrition and co-infection with other diseases were studied, while only a few factors (such as the age at HIV seroconversion and HLA gene) were confirmed to be associated with the progress of the disease, others should be investigated further.Studies from China on the natural history of HIV-positive former blood doners are limited. A survey in Shanxi Province showed that the median survival time of HIV-positive former blood donors was 7.4 years, but the 78 participants in Shanxi Province were HIV-positive former blood donors who were identified before 2002, they were received HIV testing and discovered to be HIV-infected due to the AIDS symptom. Although the Chinese government eradicated the illegal plasma/blood collection practices in 1996, antiretroviral therapy (ART) was not available to those HIV-infected rural residents until the end of 2003. Since then, HIV-infected FBDs have received free ART for three years, only limited data are available on the effect of antiretroviral therapy (ART). This is the first investigation on the natural history and the effect of antiretroviral therapy (ART) among the HIV-1 infected former blood donors which largely occurred in the mid of 1990s in China.Objectives1. To estimate the progress of the disease and its impact factors among HIV-1- positive former blood donors in Fuyang of Anhui province, China.2. To estimate the median survival and the effect of antiretroviral therapy (ART) among HIV-1-positive former blood donors in Fuyang of Anhui province, China.Methods1. From June through August 2005, 294 HIV-positive former blood donors were recruited from Fuyang, Anhui, and interviewed. Factors hypothesized to be associated with with the progress of the disease were analyzed with chi-square test in univariate analysis and Logistic regression model in multivariate analysis.2. In September 2005, a baseline survey was conducted to recruit 206 HIV-sero- negative FBDs for a prospective cohort study in Fuyang County of Anhui Province, China. Follow-up visits were conducted every 6 months to investigate clinical symptoms and signs, and blood specimens were also collected to test for HIV antibody, HBsAg, hematology, CD4, CD8, CD8+ T cell, HIV-1 RNA, HIV subtype, HIV-1 phenotype. Factors hypothesized to be associated with the progress of the disease were analyzed with univariate and ultivariate Cox regression analysis.3. From May to August, 2006, a retrospective survey was conducted to collect data about demographics, high risk HIV behaviors, death and ART among HIV-positive former blood donors who were identified from the HIV/AIDS reporting system between 1995 or 1996. Weibull function was used to calculate median survival of HIV-positive former blood donors. The effect of ART was estimated through comparing the actual number of deaths and the expected number of deaths.Results1. Of the 294 HIV-positive former blood donors, 82 (27.9%) had progression (CD4+ counts<200 cells/mm3 or Clinical StageⅢ/Ⅳas per WHO Staging System) of HIV-1 disease. Considering viral load, multiple logistic regression analyses demonstrated that Hematocrit≥35% (OR, 0.28; 95% CI, 0.14-0.54, P=0.0002), CD8+ T cell counts≥1200 cells/mm3 (OR, 0.18; 95% CI, 0.09-0.37; P<0.0001),ELISPOT Env≥300 SFC/106 (OR, 5.58; 95% CI, 2.13-14.61; P=0.0005) and HLA B15 (OR,2.17, 95% CI, 1.06-4.44; P=0.0341) were associated with the progress of the disease; if viral load not included, then Hematocrit≥35% (OR, 0.27; 95% CI, 0.14-0.51, P<0.0001), total lymphocyte counts≥1200 cells/mm3 (OR, 0.04; 95% CI, 0.01-0.29; P<0.0001),ELISPOT Env≥300 (OR, 3.39; 95% CI, 1.43-8.06; P=0.0056) and HLA B15 (OR, 2.06; 95% CI, 1.08-3.94; P=0.0284) were associated with the progress of the disease.2. A total of 59 progressors (CD4+ counts<200 cells/mm3 or Clinical StageⅢ/Ⅳas per WHO Staging System or initiation of ART for any reason or death) were found during the 1.5-year follow-up study. The progress rate of the cohort was 26.85 per 100 person-years (95% CI: 20.00-33.70), decreasing from 28.26/100 person-years at the first followup (95%CI: 15.46-31.06), to 34.23/100 person-years at the second followup (95%CI: 21.77-46.69), to 13.04/100 person-years at the last followup (95% CI: 3.38-22.70). Neutrophil≥2.0×109/l, (Hazard Ratio [HR], 0.43; 95% CI: 0.26, 0.73; P=0.0015), GHOST(IC50)≥100, (HR, 2.64; 95% CI: 1.11, 6.30; P=0.0282) and ICS IL-2+ IFN-γ- Tat+Rev>0%, (HR, 3.04; 95% CI: 1.60, 5.77; P=0.0007) were found to be associated with the progress of the disease in the final Cox regression model.3. The median period of HIV infection was at the end of 1994, the median survival of HIV-positive former blood donors in Fuyang was 9.7 years. 65.3% of death among HIV-positive former blood donors was reduced by ART initiated by the end of 2003.Conclusion1. Hematocrit, Neutrophil, CD8+ T cell counts, total lymphocyte counts, ELISPOT Env, HLA B15, GHOST(IC50) and ICS IL-2+ IFN-γ- Tat+Rev were associated with the progress of the disease.2. The median survival was 9.7 years and ART has a great effect of reducing death among HIV-positive former blood donors.
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