| Background:Since the first case of HIV in 1985, HIV/AIDS epidemic has experienced three periods, introduction period (1985～1988), transmission period (1989～1994) and increase period (1995 to this day) in China. It is estimated that, by the end of 2009, there were 740,000 individuals living with HIV in China, including 105,000 AIDS patients. HIV has deeply influenced individuals, families and society. While the National Free ART Program full began in 2003, free antiretroviral therapy for AIDS patients became routine responsibility and work of all level governments, and distributed through the country. By the end of 2010, there were 100,000 accumulated patients accepted free ART. The average mortality of AIDS patients (including naive-and accepted-ART patients) had declined from 28.9/100 person-years in 2003 to 13.5/100 person-years in mid of 2009, and the mortality of patients accepted ART 4-5/100 person-years.ART effectively declined the mortality of AIDS patients, extended the survival time, reduced the opportunistic infection, improved the quality of life, and reduce the spread of HIV/AIDS.Emerging drug resistance posed a growing threat to the ongoing success and durability of highly active antiretroviral therapy (HAART). The developed countries had developed many researches on the epidemic and influence of HIV drug resistance. Because the National Free ART Program full began late and was based on community, we has few similar researches. Most HIV/AIDS patients in Henan province were infected by commercial denoting plasma or blood. The National Free ART Program was firstly piloted in Henan province, which was one of provinces with the most patients. The studies on outcomes of HAART, especially on drug resistance among AIDS patients in Henan province were rare.In our study, we investigated the factors which might affect the prevalence and incidence of HIV drug resistance, to guide the antiretroviral therapy in our country. Objective:1. To estimate the prevalence of drug resistance and its factors among AIDS patients who were treated by HAART2. To understand the incidence of drug resistance among AIDS patients who were treated by HAARTMethods and contents:1. The prevalence of HIV drug resistance and its factors among AIDS patients who accepted ART in Henan provinceA cross-sectional study was conducted among AIDS patients who accepted ART from 12,2008 to 8,2009. The data include demographics, ethology, situation of treatment. Blood samples were collected for Laboratory test which included immunology indicators (CD4 cell counts), virology indicators (viral load) and drug resistance indicators (genotype). The factors on HIV drug resistance were analysed to value the effect of ART.2. I year Cohort study of incidence of drug resistance among patients who were treated with HAARTFrom 12 of 2008 to Aug of 2009, a cohort study was conducted in Xihua and Zhecheng counties. All patients who started ART from 2005 to 2009 were included, and 20% patients who started ART in 2003 and 2004 were sampled. Inclusion criteria were adult patients (≥18 years of age), duration of treatment greater than or equal to 6 months, and initially receiving standard first-line HAART regimens as prescribed by the National Therapy Guidelines of China, without drug resistance. The number of patients analysed was 480. After informed consent was obtained, baseline information was collected. Participants were administered standardized questionnaires to collect their socio-demographic and treatment status information. Blood samples were collected for Laboratory test which included immunology indicators (CD4 cell counts), virology indicators (viral load) and drug resistance indicators (genotype drug resistance). All participants were followed up after 12 months.We analysed the rates of drug resistance and factors on incidence of drug resistance in 12 months, to value the effection of ART. Results:1. The prevalence of HIV drug resistance and its factors among AIDS patients who accepted ART in Henan provinceOf the 717 patients who met the inclusion criteria, the median duration of accepted ART was 4.2 years, and 33.1%(237/717) demonstrated drug resistance. The prevalence of drug resistance among patients who accepted ART 6-11 months, 12-23 months and≥24 months were 18.8%(9/48),33.3%(19/57) and 34.2% (209/612), respectively. The rate of non-nucleoside reverse transcriptase inhibitor (NNRTI) drug resistance was higher than that of nucleoside reverse transcriptase inhibitor (NRTI) drug resistance (32.8% vs 26.4%). The rate of multidrug resistance to both NNRTI and NRTI was 26.1%(187/717).103 and 108 sites mutations occurred in 19.4%(139/717) samples, which cause drug resistance to NNRTIs and NRTIs respectively. In the multivariate Logistic regression model, survey location (AOR [adjusted OR],2.9; P<0.0001), initial HAART regimen (AOR,1.8; P=0.0031), missed doses in the past month (AOR,1.7; P=0.0131) and changed regimens (AOR,1.5; P=0.0301) were significantly associated with drug resistance.2.1 year Cohort study of incidence of drug resistance among patients who were treated with HAARTThere were 480 objects in our cohort, the rate of follow-up was 88.8% (426/480) at 12 months. There were 9 patients dead and 45 lost to follow-up. The total observed person-year was 476.9, and 29 demonstrated drug resistance. The incidence of drug resistance of this study is 6.1 per 100 person-years. In the multivariate Cox regression model, the patients who had lower viral load (HR=0.3, 95%CI:0.1-0.7, P=0.0039) were more likely to defense drug resistance.Conclusions:1.33.1%(237/717) patients who accepted ART demonstrated drug resistance. The prevalence rate of multidrug resistance to both NNRTI and NRTI was 26.1% (187/717). Initial HAART regimen, missed doses in the past month and changed regimens were significantly associated with drug resistance. It suggested the need of strengthening ART management and study to reduce the prevalence of drug resistance.2. The incidence rate of drug resistance was 6.1 per 100 person-years for 1 year follow-up. The result is higher than the similar research in developed countries of the similar periods, but lower than the results of African countries. Baseline viral load≥1000copies/ml was significantly risk factors associated with incidence of drug resistance. So viral load testing is of great help to avoid incidence of drug resistance during ART. |
PDF Full Text Request