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Purpose In the recent antiretroviral therapy (ART) era, a large proportion of Korean patients with human immunodeficiency virus (HIV) infection were shown to have low CD4 cell counts at diagnosis and during ART initiation. We investigated the survival trends in patients living with HIV/acquired immunodeficiency syndrome (AIDS) in Korea who started ART in the 2000s, and evaluated the risk factors for mortality to elucidate the association between survival and low CD4 cell counts at ART initiation. Materials and Methods Patients with HIV infection who were aged >18 years and had started ART between 2001 and 2015 in the Korean HIV/AIDS cohort study were enrolled. We compared the clinical characteristics, mortality, and causes of death among the enrolled subjects based on the time of ART initiation. Cox regression analysis was used to estimate the adjusted hazard ratios of mortality based on the time of ART initiation. Results Among the 2474 patients enrolled, 105 (4.24%) died during the follow-up period of 9568 patient-years. Although CD4 cell counts at the time of ART initiation significantly increased from 161 [interquartile range (IQR), 73.5–303] in 2001–2003 to 273 (IQR, 108–399) in 2013–2015 (p40 years [adjusted hazard ratio, 3.71; 95% confidence interval (CI), 2.35–5.84] and low CD4 counts (

Background Owing to the continuous increase in the number of new human immunodeficiency virus (HIV) infection in Korea, public health centers (PHCs) have performed anonymous tests since 1989. No study has examined the patterns of anonymous HIV testing performed at PHCs and the characteristics of HIV infection detected in those tests. We aimed to assess the influence of anonymous HIV testing on Korea’s national HIV surveillance. Methods HIV screening test data from 253 PHCs over a 16-year period were classified into 13 groups based on reason for testing. For anonymous HIV test takers (Anonymous), the HIV positivity per 10,000 tests was calculated, as repetitions could not be distinguished. Those with suspected HIV infection voluntarily underwent HIV testing and revealed their identity (Suspected). HIV prevalence was calculated as the number of HIV-positive persons per 10,000 test takers. Analyses were performed using chi-square and Cochran-Armitage trend test with SAS 9.4. Results Approximately 400,000 HIV screening tests were performed at PHCs annually, which remained unchanged in the past 10 years. The proportion of anonymous testing increased from Conclusions Anonymous and Suspected, which were driven by similar motives, impacted each other. Increase in HIV prevalence among the suspected led to a higher HIV prevalence among all test takers in PHCs and higher proportions of HIV infection nationwide, which could be attributed to the increase in the number of anonymous tests performed in PHCs. HIV positivity among the anonymous and HIV prevalence among the suspected are key indexes of the national HIV surveillance in Korea.

In Korea, subtype B is the predominant variant of HIV-1, but full genome sequencing and analysis of its viral variants are lacking. We performed near full-length genome (NFLG) sequencing and phylogenetic and recombination analyses of fifty plasma samples from HIV-positive men who have sex with men (MSM) from a Korea HIV/AIDS cohort study. Viral genomes were amplified and the near-full-length sequences were determined using next-generation sequencing (NGS) and Sanger sequencing. We focused on the HIV-1 subtype classification and identification of HIV recombinants. Twelve HIV-1 NFLGs were determined: ten were subtyped as pure HIV-1 subtype B and two recombinant strains as a common subtype CRF07_BC, and a novel subtype CRF43_02G recombined with CRF02_AG again, or a new CRF02_AG and subtype G recombinant. For the ten NFLGs determined by NGS, “the novel recombinant emerged at approximately 2003 and the other nine subtype B about 2004 or 2005”. This is the first report analyzing HIV-1 NFLG, including recombinants and clinical characteristics, by subtype among MSM in Korea. Our results provide novel insights for understanding the recombinants in the HIV-1 epidemic in Korea.

Objectives The aim of effective data quality control and management is to minimize the impact of errors on study results by identifying and correcting them. This study presents the results of a data quality control system for the Korea HIV/AIDS Cohort Study that took into account the characteristics of the data. Methods The HIV/AIDS Cohort Study in Korea conducts repeated measurements every 6 months using an electronic survey administered to voluntarily consenting participants and collects data from 21 hospitals. In total, 5,795 sets of data from 1,442 participants were collected from the first investigation in 2006 to 2016. The data refining results of 2015 and 2019 were converted into the data refining rate and compared. Results The quality control system involved 3 steps at different points in the process, and each step contributed to data quality management and results. By improving data quality control in the pre-phase and the data collection phase, the estimated error value in 2019 was 1,803, reflecting a 53.9% reduction from 2015. Due to improvements in the stage after data collection, the data refining rate was 92.7% in 2019, a 24.21%p increase from 2015. Conclusions Despite this quality management strategy, errors may still exist at each stage. Logically possible errors for the post-review refining of downloaded data should be actively identified with appropriate consideration of the purpose and epidemiological characteristics of the study data. To improve data quality and reliability, data management strategies should be systematically implemented.

Although the number of newly diagnosed cases of HIV is decreasing worldwide, those in Korea have been steadily on the rise, especially among adolescents (ages 10-19 years) and young adults (ages 20-29 years). To identify the characteristics in the new diagnosis among these age groups, we analyzed HIV testing sizes and HIV prevalence under the national HIV surveillance system in Korea in the last six years. We collected data of HIV tests conducted at Blood Banks (BB), Public Health Centers (PHCs), and Military Manpower Administration (MMA) nationwide every year from 2010 to 2015, except for anonymous tests. HIV prevalence, calculated as the number of new HIV-diagnosed cases per 10,000 test-takers per year, was analyzed according to sex, age, institution, and reason for HIV testing. Data were analyzed using logistic regression. In the three testing institutes, there were new cases of HIV with 50% and 95% of cases diagnosed in young adults and adolescents, respectively. The total size of HIV tests at the three sites was approximately 3.5 million tests per year; 80% of these were conducted in BBs, 10% in PHCs, and 10% in MMA. HIV prevalence, according to age, increased across all age groups for the six years, especially prevalent in young adults doubled during that period (1.01 per 10,000 test-takers in 2010, 2.45 in 2015). HIV prevalence among the "suspected" young male adults who visited PHCs for tests, was highest during the six years, increasing 6.5 times in the last two years (315.79 per 10,000 test-takers in 2014, 335.55 in 2015) compared to before 2014. We identified the characteristics of growing HIV infection in Korea as the increase of HIV prevalence among the suspected of young male adults at PHCs. Further, we propose that HIV prevalence in MMA can be used as an essential index for national HIV surveillance of adolescent boys in Korea.

Although the number of newly diagnosed cases of HIV is decreasing worldwide, those in Korea have been steadily on the rise, especially among adolescents (ages 10–19 years) and young adults (ages 20–29 years). To identify the characteristics in the new diagnosis among these age groups, we analyzed HIV testing sizes and HIV prevalence under the national HIV surveillance system in Korea in the last six years. We collected data of HIV tests conducted at Blood Banks (BB), Public Health Centers (PHCs), and Military Manpower Administration (MMA) nationwide every year from 2010 to 2015, except for anonymous tests. HIV prevalence, calculated as the number of new HIV-diagnosed cases per 10,000 test-takers per year, was analyzed according to sex, age, institution, and reason for HIV testing. Data were analyzed using logistic regression. In the three testing institutes, there were new cases of HIV with 50% and 75% of cases diagnosed in young adults and adolescents, respectively. The total size of HIV tests at the three sites was approximately 3.5 million tests per year; 80% of these were conducted in BBs, 10% in PHCs, and 10% in MMA. HIV prevalence, according to age, increased across all age groups for the six years, especially prevalent in young adults doubled during that period (1.01 per 10,000 test-takers in 2010, 2.45 in 2015). HIV prevalence among the “suspected” young male adults who visited PHCs for tests, was highest during the six years, increasing 6.5 times in the last two years (315.79 per 10,000 test-takers in 2014, 335.55 in 2015) compared to before 2014. We identified the characteristics of growing HIV infection in Korea as the increase of HIV prevalence among the suspected of young male adults at PHCs. Further, we propose that HIV prevalence in MMA can be used as an essential index for national HIV surveillance of adolescent boys in Korea.

Objectives Since 2007, human papillomavirus (HPV) vaccines have been administered for the prevention of cervical cancer in Korea. We investigated the status of HPV vaccination among HPV-infected adult women with abnormal cervical cytology before the introduction of National Immunization Program. Methods From 2010 to 2016, HPV-positive women (age, 20-60 years) with atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion (LSIL) were enrolled from five hospitals across Korea. Their HPV genotype, epidemiologic, and clinical data, including HPV vaccination history, were obtained. We compared the epidemiological characteristics and prevalence of HPV-16/18 genotypes between vaccinated and unvaccinated women. Results Among the 1,300 women, approximately 26% had a history of vaccination. Vaccinated patients were significantly younger, unmarried, and had a higher education level than unvaccinated women. For HPV-vaccinated individuals by vaccine dose, there was a significant younger age at vaccination initiation (p=0.025), longer duration from HPV vaccination to Pap test date (p=0.001), and lower proportion of HPV-16/18 (p=0.028) in the women with three doses. There was a significantly lower prevalence of HPV-16/18 genotypes in women who were vaccinated at least 12 months prior than in unvaccinated women (adjusted prevalence ratio [aPR]=0.51; 95% confidence interval [CI]=0.29-0.88). For women with LSIL, the prevalence of the HPV-16/18 genotypes was significantly lower in women who were vaccinated more than 12 months prior than in unvaccinated women (aPR=0.35; 95% CI=0.13-0.96). Conclusion This study highlighted the status of HPV vaccination and the prevalence of HPV-16/18 genotypes among HPV-infected women with abnormal cervical cytology according to HPV vaccination. It provides preliminary information regarding the status of HPV vaccination among Korean adult women.

From December 2006 to December 2016, 1093 human immunodeficiency virus (HIV) individuals < 70 years enrolled in Korea human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) cohort were analyzed to investigate the prevalence of HIV/HBV co-infection rate and hepatitis B virus surface antibody (HBsAb) positive rate based on birth year. The HBV co-infection prevalence rate was the highest (8.8%) in patients born between 1960 and 1964 and the lowest (0%) among those born between 1995 and 1999. A decreasing linear trend of HBV co-infection rate was observed according to the 5-year interval changes. HBsAb-positive rate was only 58.1% in our study. The national HBV vaccination programs have effectively lowered the HBV co-infection rate in HIV population. However, it is identified that the HIV population has low HBsAb positive rate. Further evidences supporting efficacy of booster immunization for HBsAb negative HIV patients are required and efforts should be made to increase HBsAb positive rates among HIV patients to prevent horizontal transmission., Graphical Abstract

목적: 전 세계적으로 매년 신규 HIV 감염의 발생은 서서히 감소하는 추세를 보이고 있다. 그러나 국내 신규 HIV 감염의 발생은 도리어 급격히 증가하는 양상을 보이고 있으며, 젊은 층에서의 급격한 증가가 원인으로 알려졌다. 이에 국내에서 HIV 감염의 감염 경로를 분석하고 규명함은 국내에서의 급격한 증가 원인을 밝히고, 그에 대한 예방 및 관리 대책을 수립함에 있어서 중요한 근거가 되겠다. 방법: 2006년 12월부터 2018년 1월 까지 ‘한국 HIV/AIDS 코호트’에 등록된 HIV 감염인을 조사하여 분석하였다. 전국21개 참여 병원에서 진료를 받고 있는 18세 이상의 HIV 감염인으로서 등록 시에 주치의의 역학 관련 문진에 이어 훈련된 전문 상담 간호사가 제시하는 표준화된 설문지를 통해서 역학 조사를 실시하였다. 수집된 자료를 분석하여 전체 대상 및 연령군에 따른 감염 경로를 규명하였고, 특히 젊은 층에서는 좀 더 세부적으로 연령을 구분하여 감염 경로를 조사하고 비교하였다. 결과: 조사 대상은 1,474명이었으며, 남자는 1,377명, 여자는 97명이었다. 조사 대상의 평균 연령값은 41.4 ± 12.6세였으며, 남녀 성비는 14.2:1이었다. 전체 대상 HIV 감염인의 감염 경로를 분석해 보면 동성 및 양성 간 성접촉이 886명 (60.1%), 이성 간 성접촉이 508명(34.6%), 수혈 및 혈액제제에 의한 감염이 5명(0.3%), 마약주사 공동사용에 의한 감염이 1명(0.0%)이었다. 연령군에 따른 감염 경로를 비교해 보면 젊은 연령군으로 갈수록 동성 및 양성 간 성접촉에 의한 비율이 증가하였다. 다시 말해서, 18-29세의 젊은 연령군에 있어서는 동성 및 양성 간 성접촉이 71.5%로 크게 증가하였다. 또한, 18-29세의 젊은 연령군을 좀 더 세분화해서 조사해보면 젊을수록 동성 및 양성 간 성접촉에 의한 감염이 크게 증가하여 18-19세의 10대에서는 92.9%가 동성 및 양성 간 성접촉에 의해서 감염되었다. 결론: 국내 HIV 감염의 가장 주된 감염 경로는 동성 및 양성 간 성접촉이며, 이러한 경향은 연령이 젊어질수록 더욱 뚜렷이 나타났다. 특히, 10대의 경우에는 대부분이 동성 및 양성 간 성접촉에 의하여 감염되었다. 따라서 그에 따른 합리적인 예방 및 관리 정책을 수립하는 것이 절실히 요구된다 하겠다.

Background CD4+ cell counts reflect immunologic status of human immunodeficiency virus (HIV) patients. Recommended CD4+ cell counts for the initiation of highly active antiretroviral therapy (HAART) has increased over the past several years in various HIV treatment guidelines. We investigated the trend of CD4+ cell counts at diagnosis and treatment start using data from the Korea HIV/acquired immune deficiency syndrome (AIDS) Cohort Study. Materials and methods The Korea HIV/AIDS Cohort Study started in 2006 and enrolled HIV patients from 21 tertiary and secondary hospitals in South Korea. The data for CD4+ cell counts at diagnosis and HAART initiation from these HIV patients were analyzed by three-year time intervals and presented by number of CD4+ cells (≤100, 101-200, 201-350, 351-500 and >500 cells/mm³). The HIV-RNA titer at diagnosis and HAART initiation were presented by 3-year intervals by groups ≤50,000, 50,001-100,000, 100,001-200,000, 200,001-1,000,000, and >1,000,000 copies/mL. Results Median values of CD4+ cell count and HIV-RNA titer at initial HIV diagnosis were 247 cells/mm³ and 394,955 copies/mL, respectively. At time of initiating HAART, median values of CD4+ cell count and HIV-RNA were 181 cells/mm³ and 83,500 copies/mL, respectively. Patients with low CD4+ cell count (CD4+ cell count ≤200 cells/mm³) at diagnosis (31-51%) and initiation of HAART accounted for the largest proportion (30-65%) over the three-year time intervals. This proportion increased until 2010-2012. Conclusion CD4+ cell count at initiation of HAART was found to be very low, and the increase in late initiation of HAART in recent years is of concern. We think that this increase is primarily due to an increasing proportion of late presenters. We recommend early detection of HIV patients and earlier start of HAART in order to treat and prevent spread of HIV infection.

By comparing the data of prospectively and retrospectively enrolled cohorts, we evaluated whether the prospective cohort represented all patients in the retrospective cohort. The prospectively enrolled subjects were older and had lower CD4+ T cell counts, higher viral load. In addition, the initial antiretroviral treatment regimen of the prospective cohort consisted of less integrase strand transfer inhibitor-containing regimens. The 20-year survival rate was 51.8% in the prospective cohort and 84.6% in the retrospective cohort, respectively (P = 0.844). This study suggests the prospective cohort study may not represent all patients.

OBJECTIVES: To manage evidence-based diseases, it is important to identify the characteristics of patients in each country.METHODS: The Korea HIV/AIDS Cohort Study seeks to identify the epidemiological characteristics of 1,442 Korean individuals with human immunodeficiency virus (HIV) infection (12% of Korean individuals with HIV infection in 2017) who visited 21 university hospitals nationwide. The descriptive statistics were presented using the Korea HIV/AIDS cohort data (2006-2016).RESULTS: Men accounted for 93.3% of the total number of respondents, and approximately 55.8% of respondents reported having an acute infection symptom. According to the transmission route, infection caused by sexual contact accounted for 94.4%, of which 60.4% were caused by sexual contact with the same sex or both males and females. Participants repeatedly answered the survey to decrease depression and anxiety scores. Of the total participants, 89.1% received antiretroviral therapy (ART). In the initial ART, 95.3% of patients were treated based on the recommendation. The median CD4 T-cell count at the time of diagnosis was 229.5 and improved to 331 after the initial ART. Of the patients, 16.6% and 9.4% had tuberculosis and syphilis, respectively, and 26.7% had pneumocystis pneumonia. In the medical history, sexually transmitted infectious diseases showed the highest prevalence, followed by endocrine diseases. The main reasons for termination were loss to follow-up (29.9%) and withdrawal of consent (18.7%).CONCLUSIONS: Early diagnosis and ART should be performed at an appropriate time to prevent the development of new infection.

From December 2006 to December 2016, 1,429 patients enrolled in the Korea human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) Cohort Study were investigated. Based on the year of diagnosis, the time interval between HIV diagnosis and initiation of antiretroviral therapy (ART) was analyzed by dividing it into 2 years. The more recent the diagnosis, the more likely rapid treatment was initiated (P < 0.001) and the proportion of patients starting ART on the same day of HIV diagnosis was increased in 2016 (6.5%) compared to that in 2006 (1.7%). No significant difference in the median values of CD4+ cell counts according to the diagnosis year was observed. In the past 20 years, the time from the HIV diagnosis to the initiation of ART was significantly reduced. Rapid treatment was being implemented at the HIV diagnosis, regardless of CD4+ cell count. Considering the perspective “treatment is prevention,” access to more rapid treatment is necessary at the time of HIV diagnosis., Graphical Abstract

Objective Human papillomavirus (HPV) infection is the most important risk factor for cervical cancer, which progresses from precursor lesions with no symptom if left untreated. We compared the risk of cervical dysplasia among HPV-positive Korean women based on HPV types and infection patterns. Methods We observed participants of a 5-year multicenter prospective cohort study, comprising HPV-positive women with either atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion of the cervix at their enrollment. Follow-ups, comprising cytology and HPV DNA testing results, were included in the final analysis. Incidence was calculated for each infection pattern (persistent infection, incidental infection, and clearance). To investigate cervical dysplasia risk, we used Cox proportional hazard models adjusted for variables that were significantly different among infection patterns. From April 2010 to September 2017, 71 of 1,027 subjects developed cervical dysplasia more severe than high-grade squamous intraepithelial lesion of the cervix. Results Of these 71 subjects, persistent infection, incidental infection, and clearance were noted in 30, 39, and 2 individuals, respectively. Based on changes in DNA results during follow-up, cumulative incidence was 27.2%, 10.4%, and 0.5% for persistent infection, incidental infection, and clearance, respectively. Compared to clearance, the adjusted hazard ratios for cervical dysplasia were 51.6 and 24.1 for persistent and incidental infections, respectively (p

Background/Aims: The frequencies of opportunistic diseases (ODs) vary across countries based on genetic, environmental, and social differences. The Korean HIV/AIDS cohort study was initiated in 2006 to promote research on human immunodeficiency virus (HIV) infection in Korea, and to provide a logistical network to support multicenter projects on epidemiological, clinical, and laboratory aspects of HIV infection. This study evaluated the prevalence of ODs among HIV-infected patients in the era of highly active antiretroviral therapy, and the risk factors associated with ODs. Methods: The study enrolled 1,086 HIV-infected patients from 19 hospitals. This study examined the baseline data of the HIV/AIDS Korean cohort study at the time of enrollment from December 2006 to July 2013. Results: Candidiasis was the most prevalent opportunistic infection (n = 176, 16.2%), followed by Mycobacterium tuberculosis infection (n = 120, 10.9%), Pneumocystis jirovecii pneumonia (n = 121, 11.0%), cytomegalovirus infection (n = 52, 4.7%), and herpes zoster (n = 44, 4.0%). The prevalence rates of Kaposi’s sarcoma (n = 8, 0.7%) and toxoplasmosis (n = 4, 0.4%) were very low compared with other countries. The risk factors for ODs were a low CD4 T cell count at the time of HIV diagnosis (odds ratio [OR], 1.01; p < 0.01), current smoking (OR, 2.27; p = 0.01), current alcohol use (OR, 2.57; p = 0.04), and a history of tuberculosis (OR, 5.23; p < 0.01). Conclusions: Using recent Korean nationwide data, this study demonstrated that an important predictor of ODs was a low CD4 T cell count at the time of HIV diagnosis. Tuberculosis remains one of the most important ODs in HIV-infected patients in Korea.

ObjectiveThis study was conducted to evaluate the role of methylation of adenylate cyclase activating peptide 1 (ADCYAP1), paired box gene 1 (PAX1), cell adhesion molecule 1 (CADM1), and T-lymphocyte maturation–associated protein (MAL) during carcinogenesis.MethodsWe evaluated the methylation of 4 genes by using the cervical carcinoma cell lines (CaSki, SiHa, HeLa, and C33A) and cervical neoplastic cells from 56 subjects with human papillomavirus 16 (HPV16)–infected low-grade squamous intraepithelial lesions (LSILs), 50 subjects with HPV16-infected high-grade squamous intraepithelial lesions (HSILs), and 24 subjects with HPV16-infected invasive cervical cancer who attended Seoul St. Mary’s Hospital. Methylation of the 4 genes was evaluated using quantitative bisulfate pyrosequencing.ResultsThe ADCYAP1 promoter was hypermethylated in the 4 cell lines (CaSki, 97.40 ± 1.39; SiHa, 82.04 ± 17.02; HeLa, 96.14 ± 2.08; and C33A, 78 ± 10.18). PAX1 and CADM1 were hypermethylated in the HPV16/18-infected cell lines CaSki (PAX1, 91.18 ± 9.91; CADM1, 93.5 ± 7.33), SiHa (PAX1, 96.14 ± 2.08; CADM1, 93.15 ± 8.81), and HeLa (PAX1, 82.04 ± 17.02; CADM1, 92.43 ± 9.95). MAL was hypermethylated in the CaSki cell line (96.04 ± 4.74). Among human cervical neoplastic cells, the methylation indices of ADCYAP1 were 7.8 (95% confidence interval [95% CI], 7.0–8.6) in subjects with LSILs and 39.8 (95% CI, 29.0–54.7) in those with cervical cancer (P < 0.001); for PAX1, 7.2 (95% CI, 6.1–8.5) and 37.8 (95% CI, 27.1–52.7), respectively; for CADM1, 3.5 (95% CI, 3.0–4.0) and 17.7 (95% CI, 10.8–29.1), respectively; for MAL, 2.7 (95% CI, 2.5–3.0) and 13.0 (95% CI, 7.6–22.0), respectively (P < 0.001 for each). Immunohistochemical staining results were positive in the cytoplasm of subjects with low methylation of the 4 gene promoters; however, they were negative in the cytoplasm of those with hypermethylation of the 4 gene promoters.ConclusionsThe results of this study suggest that the methylation of ADCYAP1, PAX1, CADM1, and MAL may be highly associated with the development of cervical cancer, and that gene expression can be suppressed by gene promoter hypermethylation.

Background and Aims The outcomes of hepatitis C virus (HCV)-related liver cirrhosis was limitedly studied in a hepatitis B virus-endemic area. This multicenter, prospective cohort study was conducted to elucidate the incidence of hepatocellular carcinoma (HCC) and mortality in the Korean patients with HCV-related cirrhosis. Methods From January 2007 through June 2012, 196 patients with HCV-related cirrhosis were prospectively enrolled and regularly followed at six university hospitals to determine HCC occurrence and mortality. A multivariable analysis using Cox proportional hazards regression was performed to clarify the related factors to the outcomes. Results During a mean follow-up period of 39.2 months, 31 (15.8%) patients developed HCC, and 33 (16.8%) patients died or underwent liver transplantation. The estimated HCC incidence was 5.8 per 100 person-years, and the independent factors for HCC were absence of anti-HBV surface antibody (HBs hazard ratio [HR], 5.018; 95% confidence interval [CI], 1.710–14.726; P = 0.003) and serum albumin

ObjectivesTo estimate human immunodeficiency virus (HIV) incidence using HIV avidity assays in Korea, we established a serological testing method to differentiate recent HIV infections from long-standing ones.MethodsWe adopted two incidence assays, the BED HIV-1 incidence test (Calypte Biomedical) and an HIV avidity assay (using Abbott AxSYM HIV Antigen/Antibody Combo), and performed them on Korean HIV samples obtained from 81 HIV seroconverters (n = 193), 135 HIV-positive samples, and three HIV commercial incidence panels (PRB965, PRB933, and PRB601 from SeaCare). To determine the most optimal concentration of the chaotropic agent (Guanidine) and the cutoff value for the avidity assay, we evaluated the sensitivity and specificity of the assay at different concentration levels.ResultsWe determined that the concentration of Guanidine to be used in the avidity assay was 1.5M. The cutoff value of the avidity index (AI) was 0.8, and the sensitivity and specificity were 90.2% and 83.8%, respectively, under this condition. The gray zone for the avidity assay was 0.75–0.85 AI. The mean of coefficient of variation was low, at 5.43%.ConclusionAn optimized avidity assay for the diagnosis of recent HIV infections using Korean samples was established. This assay will be applied to investigate the level of recent infection and will provide basic data to the HIV prevention policy in Korea.

Background Highly active antiretroviral therapy (HAART) including protease inhibitors (PIs) has been used in South Korea since 1997. Currently, more than 20 types of antiretroviral drugs are used in the treatment of human immunodeficiency virus-infected/acquired immune deficiency syndrome patients in South Korea. Despite the rapid development of various antiretroviral drugs, many drug-resistant variants have been reported after initiating HAART, and the efficiency of HAART is limited by these variants. Objectives To investigate and estimate the annual antiretroviral drug resistance and prevalence of antiretroviral multi-class drug resistance in Korean patients with experience of treatment. Study design The amplified HIV-1 pol gene in 535 patients requested for genotypic drug resistance testing from 2004 to 2009 by the Korea Centers for Disease Control and Prevention was sequenced and analyzed annually and totally. The prevalence of antiretroviral drug resistance was estimated based on “SIR” interpretation of the Stanford sequence database. Results Of viruses derived from 787 specimens, 380 samples (48.3%) showed at least one drug class-related resistance. Predicted NRTI drug resistance was highest at 41.9%. NNRTI showed 27.2% resistance with 23.3% for PI. The percent of annual drug resistance showed similar pattern and slightly declined except 2004 and 2005. The prevalence of multi-class drug resistance against each drug class was: NRTI/NNRTI/PI, 9.8%; NRTI/PI, 21.9%; NNRTI/PI, 10.4%; and NRTI/NNRTI, 21.5%. Conclusions About 50% and less than 10% of patients infected with HIV-1 have multidrug and multiclass resistance linked to 16 antiretroviral drugs, respectively. The significance of this study lies in its larger-scale examination of the prevalence of drug-resistant variants and multidrug resistance in HAART-experienced patients in South Korea.

Accurate human papillomavirus (HPV) typing is essential for evaluating and monitoring HPV vaccines in cervical cancer screening and in epidemiological surveys. In our country, different HPV DNA detection and genotyping methodologies have been established for diagnosing and monitoring HPV-related disease in clinical practice and for research. However, there is a lack of reference materials to standardize the methods for HPV detection and genotyping. In this study, we constructed candidate reference materials comprising 15 targets (13 types of high-risk HPV, two types of low-risk HPV). We evaluated whether the candidate reference materials could be used as the reference for HPV detection and genotyping using quantitative real-time polymerase chain reaction. Standard curves for the wide linear range (101–106 copies/μL) produced high correlation regression coefficient R2 of 0.99. The reaction efficiencies were 96.3% to 101.2% for the standard curves, indicating highly efficient reactions. Specific genotypes were detected in single or multiple mixed samples. Our results suggest that these reference materials may provide useful standards for standardizing quality assurance for different HPV-typing assays and for proficiency testing in diagnostic laboratories.

ObjectivesFrom the introduction of HIV into the Republic of Korea in 1985 through 2012, 9,410 HIV-infected Koreans have been identified. Since 2000, there has been a sharp increase in newly diagnosed HIV-infected Koreans. It is necessary to estimate the changes in HIV infection to plan budgets and to modify HIV/AIDS prevention policy. We constructed autoregressive integrated moving average (ARIMA) models to forecast the number of HIV infections from 2013 to 2017.MethodsHIV infection data from 1985 to 2012 were used to fit ARIMA models. Akaike Information Criterion and Schwartz Bayesian Criterion statistics were used to evaluate the constructed models. Estimation was via the maximum likelihood method. To assess the validity of the proposed models, the mean absolute percentage error (MAPE) between the number of observed and fitted HIV infections from 1985 to 2012 was calculated. Finally, the fitted ARIMA models were used to forecast the number of HIV infections from 2013 to 2017.ResultsThe fitted number of HIV infections was calculated by optimum ARIMA (2,2,1) model from 1985–2012. The fitted number was similar to the observed number of HIV infections, with a MAPE of 13.7%. The forecasted number of new HIV infections in 2013 was 962 (95% confidence interval (CI): 889–1,036) and in 2017 was 1,111 (95% CI: 805–1,418). The forecasted cumulative number of HIV infections in 2013 was 10,372 (95% CI: 10,308–10,437) and in 2017 was14,724 (95% CI: 13,893–15,555) by ARIMA (1,2,3).ConclusionBased on the forecast of the number of newly diagnosed HIV infections and the current cumulative number of HIV infections, the cumulative number of HIV-infected Koreans in 2017 would reach about 15,000.

Background The use of antiretroviral drugs has reduced the mortality and morbidity of patients with HIV/AIDS. More than 20 antiretroviral drugs have been used in patients with HIV/AIDS since zidovudine was first introduced in 1991 in South Korea. Objectives To investigate and estimate the annual prevalence of transmitted drug resistance and drug-resistant variants of HIV-1 in newly diagnosed antiretroviral-naive patients in South Korea during 1999–2012. Study design Plasma specimens were collected from 928 antiretroviral-naive patients during 1999–2012. Mutations in the protease and reverse transcriptase sections of the HIV-1 pol gene were identified using the Stanford HIV Drug Resistance Database (Stanford DB). Results Among 928 HIV-1 isolates from antiretroviral-naive patients, 45 (4.8%) showed ‘intermediate’ or ‘resistant’ drug resistance. The predicted prevalence of drug resistance among isolates was 2.2%, 2.7%, and 0.3% for resistance to nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors, respectively. Conclusions There was no significant increase in the prevalence of drug resistance among antiretroviral-naive patients infected with HIV-1 during 1999–2012 in South Korea, although there was a slight increase during 2009–2012. The emergence of drug-resistant variants will continue to be monitored by national surveys.

PURPOSE The purpose of this study is to evaluate the impact of high-risk human papillomaviruses (HPVs) other than HPV 16/18 on the natural course of atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL). MATERIALS AND METHODS The study population was derived from the Korean HPV cohort (2010-2014). Women aged 20 to 60 who satisfied the criteria of having both HPV infection and abnormal cervical cytology of either ASC-US or LSIL were recruited from five institutions nationwide. Enrolled patients underwent cervical cytology and HPV DNA testing every 6 months. RESULTS A total of 1,158 patients were enrolled. The 10 most common HPV types were HPV 16 (12.3%), 58 (10.0%), 56 (8.8%), 53 (8.4%), 52 (7.7%), 39 (6.2%), 18 (6.0%), 51 (5.7%), 68 (5.1%), and 66 (4.6%). Among these patients, 636 women were positive for high-risk HPVs other than HPV 16 or 18, and 429 women were followed for more than 6 months. Cytology evaluations showed progression in 15.3% of women, no change in 22.6%, and regression in 62.1% of women at 12 months. In cases of HPV 58 single infection, a more highly significant progression rate, compared to other high-risk types, was observed at 6 months (relative risk [RR], 3.3; 95% confidence interval [CI], 2.04 to 5.30; p < 0.001) and 12 months (RR, 5.03; 95% CI, 2.56 to 9.91; p < 0.001). CONCLUSION HPV genotypes numbered in the 50s were frequent in Korean women with ASC-US and LSIL. HPV 58 was the second most common type, with a high progression rate of cervical cytology.

Objective DNA methylation has been shown to be a potential biomarker for early cancer detection. The aim of this study was to evaluate DNA methylation profiles according to liquid-based Pap (LBP) test results and to assess their diagnostic value in a Korean population. Methods A total of 205 patients with various Papanicolaou test results were enrolled to this study (negative, 26; atypical squamous cells of undetermined significance, 39; low grade squamous intraepithelial lesion, 44; high grade squamous intraepithelial lesion (HSIL), 48; and cancer, 48). DNA methylation analysis of four genes, ADCYAP1, PAX1, MAL, and CADM1, was performed on residual cervical cells from LBP samples using a quantitative bisulfite pyrosequencing method. To evaluate the diagnostic performance of the four methylated genes for cancer detection, receiver operating characteristic (ROC) curves were drawn. Sensitivities and specificities were also tested at cutoffs determined from the ROC curves. Results Cervical cancer cells showed dramatically increased methylation levels for the four genes analyzed. ADCYAP1 and PAX1 also trended toward elevated methylation levels in HSIL samples, although the levels were much lower than those in cancer cells. The sensitivities of methylated ADCYAP1, PAX1, MAL, and CADM1 for the detection of cancer were 79.2%, 75.0%, 70.8%, and 52.1%, and the specificities were 92.0%, 94.0%, 94.7%, and 94.0%, respectively. Methylated ADCYAP1 and PAX1 demonstrated relatively better discriminatory ability than did methylated MAL and CADM1 (area under the curves 0.911 and 0.916 vs. 0.854 and 0.756, respectively). Conclusion DNA methylation status, especially in the ADCYAP1 and PAX1 genes, showed relatively good specificity, ranging from 90% to 94%. The possible additive and complementary roles of DNA methylation testing with respect to conventional cervical cancer screening programs will need to be validated in prospective population-based studies.

Objectives The Korea HIV/AIDS cohort was constructed with 18 hospitals that care for HIV-infected individuals in 2006. We compared the epidemiological and immunological characteristics of the cohort registrants with those of the HIV-infected population at the time of HIV diagnosis. Methods This study was conducted on 5717 people living with HIV/AIDS from 1985 to 2009, of which 789 individuals registered with the Korea HIV/AIDS cohort study. Individuals who had data from initial CD4+ T-cell counts measured within 6 months following HIV diagnosis were selected as study participants to predict the status of disease progression at the time of HIV diagnosis. A total of 2886 patients (50%) were selected from people living with HIV/AIDS, of whom 424 individuals (54%) were cohort registrants. The χ2 test and Wilcoxon rank sum test were used for analysis. Results The distributions of age, marital status, diagnosed regions, reason for HIV testing, and screening site were similar between the HIV-infected population and the cohort registrants. In 1985–2004, the male ratio for the cohort registrants (94.3%) was significantly higher than that measured for the HIV-infected population (89.5%) (p = 0.0339). With regard to transmission route, homosexual contact of cohort registrants (46.6%) was higher than that of the HIV-infected population (40.1%) (p = 0.022) in 2005–2009. No statistical difference in CD4+ T-cell counts at the time of HIV diagnosis was found between the HIV-infected population and cohort registrants (p = 0.2195). Conclusion The Korea HIV/AIDS cohort registrants represent the HIV-infected population, and the data collected from this cohort could be used as a foundation for national statistics.

ObjectivesThe detection of HIV seroconverters increased annually since HIV antigen/antibody testing kits have been available widely in South Korea. This study aimed to identify the epidemiological characteristics of HIV seroconverters and their immune level at HIV diagnosis.MethodWe analyzed the epidemiological and immunological characteristics of 341 HIV seroconverters among 6,008 HIV-diagnosed individuals from 1999 and 2009. The analysis of immune level and epidemiological factors of HIV seroconverters was conducted by using chi-square test on SAS version 9.1.ResultsThe seroconverters among newly-identified HIV cases each year increased from 0.5% in 1999 to over 5% or in 2009. The sex ratio of seroconverters was 18:1 (male:female), and 33% were in their 30s, and 28% were in their 20s. Reasons for HIV testing were involvement in voluntary test due to risky behaviors (43%), and health check-up (36%). Discovery of HIV infection occurred primarily in hospitals (84%). Among seroconverters, 55 percent had a CD4 T-cell count of more than 350/μl.ConclusionKorean HIV seroconverters tended to be younger at diagnosis, diagnosed during a voluntary test, and their CD4+ T-cell counts at HIV diagnosis were higher than those of non-seroconverters all HIV-infected individuals. This study of HIV seroconverters will be important foundational in future studies on HIV incidence, disease progress, and survival rate.

ObjectivesThe incidence of anal disease is higher among persons with human immunodeficiency virus (HIV) infection than among the general population. We surveyed the status of seroprevalence in colorectal hospitals in Korea.MethodsThe survey was conducted in colorectal hospitals in Korea from November to December 2008. The questionnaire was comprised of six topics about the status of HIV testing in colorectal hospitals. We gathered the data by website (http://hivqa.nih.go.kr/risk) or fax.ResultsAmong 774 colorectal hospitals contacted, 109 (14%) hospitals participated in the survey. Among these, 48 hospitals (44%) performed HIV tests in their own hospitals and 11 (23%) took HIV testing by rapid method. The main reason for recommending an HIV test was surgical operation (54%) followed by endoscope (11%) and health checkup (9%). The annual number of HIV tests increased from 58,647 (at 21 hospitals) in 2002 to 246,709 (at 58 hospitals) in 2007. HIV seroprevalence was >3.0 per 10,000 individuals during 2002–2005, decreased to 2.2 per 10,000 individuals in 2006 and rose to 2.8 per 10,000 individuals in 2007.ConclusionsHIV seroprevalence of colorectal hospitals was more than twice that of general hospitals in Korea. HIV surveillance systems based on colorectal hospitals for HIV/AIDS transmission prevention by early HIV diagnosis are needed.

The number of persons infected by HIV/AIDS has consistently increased in Korea since the first case of HIV/AIDS infection in 1985 and reached 15,208 by 2016. About 1,100 new patients with HIV/ AIDS infections have emerged every year since 2013. In Korea, the Korea HIV/AIDS Cohort Study was established for the evidenced-based prevention, treatment, and effective management of patients infected with human immunodeficiency virus (HIV) in December 2006. This study monitored 1,438 patients, who accounted for about 10% of all patients with HIV/AIDS in Korea, for 10 years with the following aims: (1) to develop an administrative system for the establishment of a HIV/AIDS cohort-based study; (2) to standardize methodologies and the case report forms; and (3) to standardize multi-cohort data and develop a data cleaning method. This study aims to monitor at least 1,000 patients (excluding those for whom investigation had been completed) per year (estimated number of patients who can be monitored by January 2018: 939). By December 2016, the sex distribution was 93.3% for men, and 6.7% for women (gender ratio, 13.9:1.0), and 98.9% of all participants were Korean. More than 50.0% of the participants were confirmed as HIV positive after 2006. This study reports competitive, long-term research that aimed to develop policies for the prevention of chronic infectious diseases for patients with HIV. The data collected over the last decade will be used to develop indices for HIV treatment and health promotion.

Objective This study was to identify the risk factors for cytological progression in women with atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesions (LSIL). Methods We analyzed data from women infected with the human papillomavirus (HPV) who participated in the Korean HPV cohort study. The cohort recruited women aged 20-60 years with abnormal cervical cytology (ASC-US or LSIL) from April 2010. All women were followed-up at every 6-month intervals with cervical cytology and HPV DNA testing. Results Of the 1,158 women included, 654 (56.5%) and 504 (43.5%) women showed ASC-US and LSIL, respectively. At the time of enrollment, 143 women tested positive for HPV 16 (85 single and 58 multiple infections). Cervical cytology performed in the HPV 16-positive women showed progression in 27%, no change in 23%, and regression in 50% of the women at the six-month follow-up. The progression rate associated with HPV 16 infection was higher than that with infection caused by other HPV types (relative risk [RR], 1.75; 95% confidence interval [CI], 1.08-2.84; P =0.028). The cytological progression rate in women with persistent HPV 16 infection was higher than that in women with incidental or cleared infections (P

Genotyping Tool for Viral SEQuences (GTVseq) provides scientists with the genotype information on the viral ge-nome sequences including HIV-1, HIV-2, HBV, HCV, HTLV-1, HTLV-2, poliovirus, enterovirus, flavivirus, Han-tavirus, and rotavirus. GTVseq produces alternative and additive genotype information for the query viral se-quences based on two different, but related, scoring methods. The genotype information produced is re-ported in a graphical manner for the reference genotype matches and each graphical output is linked to the de-tailed sequence alignments between the query and the matched reference sequences. GTVseq also reports the potential 'repeats' and/or 'recombination' sequence re-gion in a separated window. GTVseq does not replace completely other well-known genotyping tools such as NCBI's virus sequence genotyping tool (http://www.ncbi. nlm.nih.gov/projects/genotyping/formpage.cgi), but pro-vides additional information useful in the confirmation or for further investigation of the genotype(s) for the newly isolated viral sequences.Keywords: Genotyping, Recombination, Subtyping, Viral Genome, Viral Sequence, Virus database, Visualization, Web-Server

Genetic polymorphisms of chemokine genes and chemokine-receptor genes in HIV-infected patients have been associated with delayed progression of this disease. The allelic frequencies of these genetic variants also differ between ethnic groups. To investigate the effects of the SDF1 and CCR2b genotypes on disease progression, survival of 200 HIV-infected persons for whom at least four subsequent immunologic data items had been collected was analyzed. A genotyping assay of SDF1 and CCR2b genes was carried out using polymerase chain reaction-restriction fragment length polymorphism analyses. HIV-infected persons heterozygous for the SDF1-3'A or CCR2b-64I alleles were included in the survival analysis, but homozygotes were excluded because of a very small sample number. Neither the CCR2b-+/64I allele nor the SDF1-+/3'A allele, separately or in combination, had a significant impact on survival during the asymptomatic period of HIV infection. However, CCR2b-+/64I alleles were associated with accelerated disease progression during the advanced period of HIV infection. The survival time of HIV-infected people with CCR2b-+/64I and SDF1-+/+ genotypes was significantly shorter than those of the other groups (p < 0.01), but this effect was not apparent in persons with CCR2b-+/64I alleles and SDF1-+/3'A genotypes. These results suggest that the effect of CCR2b-64I polymorphisms on disease progression may differ according to the stage of HIV infection and interactions with other gene variants.

Patients infected with human immunodeficiency virus (HIV) may develop mental health problems such as anxiety and depression, which negatively impact of disease progression. We investigated factors associated with the prevalence of anxiety and depression symptoms among HIV-infected patients in Korea. A total of 840 HIV-infected patients who participated in the Korea HIV/AIDS Cohort Study from 2006 to 2012 were evaluated. Socio-demographic, epidemiologic, and clinical variables were obtained through standardized questionnaires. The State-Trait Anxiety Inventory and Beck Depression Inventory were used to assess the symptoms of anxiety and depression. Multiple logistic regression analyses were performed to identify factors associated with symptoms of anxiety and depression. The prevalence of anxiety and depressive symptoms among HIV-infected patients was 32% and 36%, respectively. Ex-smoker and persistent symptoms for more than one week within the past six months and diagnosis of HIV infection within one year were associated with increased anxiety symptoms (odds ratio [OR] 1.71, 95% confidence interval [CI] 1.09-2.69; OR 1.52, 95% CI 1.09-2.11; OR 1.49, 95% CI 1.02-2.20) and current smoking and persistent symptoms were also associated with increased depressive symptoms (OR 2.10, 95% CI 1.31-3.30; OR 1.87, 95% CI 1.25-2.79). Marital status, current smoking, current drinking, and persistent symptoms were associated with both increased anxiety and depressive symptoms (OR 1.75, 95% CI 1.07-2.88; OR 1.66, 95% CI 1.06-2.61; OR 1.88, 95% CI 1.18-2.99). The prevalence of anxiety and depressive symptoms among HIV-infected patients is higher than those estimated for the general population. This study shows the necessity to evaluate symptoms of anxiety and depression and suggest psychological support for HIV-infected patients who smoke or have persistent symptoms or have sexual partner or drink.

The transmission of antiretroviral-resistant HIV-1 strains is associated with suboptimal virological responses to initial antiretroviral therapy. However, certain types of resistance mutations are known to be associated with decreased viral fitness, which confers a lower replication capacity than that of the wild-type virus in the absence of antiretroviral drugs. Therefore, we evaluated the relationship between antiretroviral resistance mutations and viral replication in the primary HIV-1 infection (PHI) period. From January 2002 to March 2005, 52 PHI patients were identified in the Republic of Korea. HIV-1 RNA genotyping was performed, and the resistance mutation score was obtained from the HIV Drug Resistance Database of Stanford University. We defined the sum of the average resistance mutation scores (SARMS) for each antiretroviral drug class as a measure of the degree of resistance of any specific strain. The overall mean SARMS was 2.00 +/- 2.74, and the annual mean did not change significantly during the study period. No critical resistance mutation gene was identified in the study group. The SARMS showed a weak negative correlation with the viral load log10 during PHI, but without statistical significance (r = -0.274, p = 0.051). But the mean SARMS of patients with a viral load exceeding 100,000 copies/ml was significantly lower than that of patients with a viral load of less than 100,000 copies/ml (p = 0.03). Evaluation of the potency of antiretroviral resistance revealed a weak negative correlation with viral replication in the PHI period. This could be one reason why the transmission of resistant strains in PHI patients is not increasing significantly despite the widespread use of highly active antiretroviral therapy (HAART).

We aimed to determine the initial adherence of HIV cohort patients to ART (antiretroviral therapy), and reasons for non-adherence. Patients who received ART at the time of enrollment in the Korea HIV/AIDS Cohort were included in this study. Treatment adherence was determined at the baseline interview by self-reported questionnaire. Eight-hundred thirty two HIV-infected patients received ART. Of these, 253 (30.4%) patients skipped ART more than once a month. The most common reason of skipping medication was "simply forgot" (60.4%).

ObjectivesThe Republic of Korea reports approximately 35,000 new tuberculosis (TB) patients each year, and the number of HIV-infected individuals is steadily increasing. Public health centers (PHCs) conduct TB diagnosis and treatment for risk groups in communities. This study aimed to identify possible trends and characteristics of HIV infection among suspected TB cases in PHCs.MethodsStudy subjects were suspected TB cases in PHCs who agreed to be tested for HIV from 2001 to 2013. Trends in HIV seroprevalence were assessed through a series of annual cross-sectional analyses. We analyzed suspected TB cases, and HIV-infected individuals among suspected TB cases, by gender, age, nationality, and region.ResultsThe number of suspected tuberculosis cases who took an HIV test in PHCs was approximately 6,000 each year from 2001 to 2013. Among the suspected TB cases who took an HIV test, the number of those aged 20–39 is gradually decreasing, while the number of those aged 50–69 is increasing. During this period, 32 HIV-infected individuals were identified; the majority were men (94%), aged 30–49 (68%), Korean (94%), and residents in a metropolitan area (53%). HIV seroprevalence decreased from 8.2 per 10,000 persons in 2001 to 1.9 per 10,000 persons in 2013.ConclusionThis study has identified trends and characteristics of HIV infection among suspected tuberculosis cases in PHCs. This national data provides a basis for public health policy for HIV and tuberculosis infections.

To investigate the sexual behavioral characteristics and HIV/AIDS knowledge among men who have sex with men (MSM), one of the HIV high risk groups.A three month survey among individuals who were able to be contacted was carried out over the entire Republic of Korea, between May and August, 2001. 348 individuals completed a self-administered questionnaire. The data collected included demographic information, sexual behavior and AIDS knowledge.Eighty-seven and ninety-two per cent of the 348 MSM were aged 20-39 years and had never been married, respectively. Fifty-five per cent of participants reported at least one sexual contact with women, and a quarter of the MSM surveyed had engaged in high-risk sexual behavior (more than 6 partners) during the previous year. About twenty per cent of the MSM had anal sex as their favorite way of having sex, and seventy-four per cent did not use condoms regularly due to loss of enjoyment, and were more likely to be engaged in risky behaviors. Only ten per cent had a regular HIV test history, and most had obtained knowledge or information on HIV/AIDS through the mass media.A large proportion of the MSM in Korea still remain at an elevated risk for contracting HIV infection. Change in high-risk sexual behaviors will prevent the spread of HIV infection among the MSM population, which requires public health education for preventive interventions, and should be culturally and socially specific in order to be effective.

BACKGROUND The external quality assessment schemes (EQAS) organizer provides a suitable program to monitor and improve the quality of human immunodeficiency virus (HIV) testing laboratories with EQAS panels prepared under various conditions. The aim of the current study was to investigate the effects of human plasma samples on the EQAS results of HIV obtained from hospital-based clinical laboratories. METHODS From 2007 to 2009, HIV EQAS panels consisted of four to six samples that consisted of undiluted positive and negative samples and were provided to laboratories twice per year. Up until the first half EQAS in 2008, EQAS panel materials were obtained by converting acid citrate dextrose treated plasma to serum via chemical treatment with CaCl2. Beginning with the second EQAS in 2008, all materials were prepared without the defibrination process. RESULTS Approximately 300 HIV clinical laboratories participated in this program. The overall performance of clinical laboratories was shown to be improved when using unrecalcified plasma panels compared with recalcified panels. Significant differences were observed in EIA analyses of plasma for both positive (p

We have designed a five-year multicentre prospective cohort study in women who are both human papillomavirus (HPV)-positive with either atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesion (LSIL) of cervix. This study aimed to analyze the risk of developing a high-grade squamous intraepithelial lesion (HSIL) from either ASCUS or LSIL in HPV-positive women, so called 'progression' rate, to investigate differences in the progression rates according to HPV type-specific infection, and to evaluate the various factors associated with the persistence or clearance of HPV infection in the Korean population. At present, the study protocol composed of cervical cytology, HPV DNA testing, and questionnaire have been conducted actively since the first participant was enrolled in 2010. This study is the first nationwide Korea HPV cohort study. Our data will provide valuable information about not only the ambiguous cytology results of ASCUS and LSIL but also the effect of the specific HPV type and other various factors on the progression to HSIL. Finally, the results of our study will be helpful and applicable to determine the primary cervical cancer prevention strategies.

Background Korea saw a sharp increase in HIV diagnosis from 2000. This serious public health concern must be monitored diligently. We identified the characteristics and trends in HIV prevalence among visitors to public health centers (PHCs) from 2000 to 2009. Methods We retrieved ten-year data of HIV tests from 253 PHCs. The HIV prevalence was analyzed by gender, age, nationality, region, and reason for HIV testing. Data were analyzed using logistic regression and score test for trend. Results HIV prevalence among PHCs’ visitors has rapidly increased for six years since 2000, decreased from 2006, and then remained stable. Approximately 50% of total HIV tests were performed for sexually transmitted infection risk group (STI RG), who were tested 1.4 times within a year. Women and the 20s comprised approximately 70% and 40% of PHCs’ visitors, respectively. The prevalence of voluntary test takers was the highest and showed most rapid increase (P = 0.007), but that of prisoners declined (P = 0.003). The prevalence of STI RG was lower than those of the other groups and remained stable throughout the ten-year period (P = 0.606). Percentage of anonymous tests was 2–3% of a total HIV tests, but overall HIV-positive rate showed a rapid increase (P Conclusions As voluntary or anonymous testing groups are actively engaged in learning their status of HIV, these groups showed the highest in HIV infection. Groups in the population with these characteristics should be located and encouraged to be tested, and offered anonymity. This study suggests that it is important to ascertain the characteristics of people choosing to take voluntary testing.

Background Human immunodeficiency virus type-1 (HIV-1) RNA viral load is a surrogate marker that is routinely used to determine indications for, and monitor the effectiveness of HIV-1 treatment. We developed three reagents for potential use in routine quality control of HIV-1 RNA quantitative assays. In this report, we compare the stability of these re-agents in storage and compare their performance in three different HIV-1 RNA quantitative assays. Methods The candidate reagents were derived from readily available pre-existing reagents and examined for stability at different storage temperatures. They were compared in three commercially available HIV-1 RNA quantitative assays: the Cobas TaqMan HIV-1 Test (Cobas TaqMan), the RealTime HIV-1 Assay (Abbott RealTime), and the NucliSens EasyQ HIV-1 Assay v1.1 (NucliSens EasyQ). Results The candidate reagent derived from an HIV culture supernatant (candidate CS) was the most stable of the three candidates and showed good reproducibility. Candidate CS yielded the highest HIV-1 titer of the three candidates in the Cobas TaqMan assay and the lowest HIV-1 titer and stability of the three candidates in the NucliSens EasyQ system. Conclusions The candidate CS is the most appropriate of the three candidate reagents for quantitative testing of HIV-1 RNA. This working reagent should be useful for use in routine calibration for quality control in centers with limited financial resources. The Cobas TaqMan assay tended to yield higher viral load results than the other assays when used with our three candidate reagents.

Background In Korea, approximately 70% of HIV-positive individuals are currently diagnosed in hospitals, while most HIV-positive patients were diagnosed at public health centers in 1980 s and 1990 s. However, there are no reporting systems to identify how many HIV tests are performed in the Korean hospitals different from public health centers and Blood centers. We estimated how many HIV tests were performed in hospitals and analyzed the nationwide hospital-based HIV seroprevalence in the present study. Methods Between 2002 and 2008, data included HIV tests on insurance claims in hospitals and the proportion of computerized insurance claims from the Health Insurance Review and Assessment Services. The number of HIV tests from the survey in the External Quality Assurance Scheme for hospital laboratories was collected to calculate the insurance claim proportion. HIV seroprevalence was estimated using data of tested individuals, including infected individuals. Statistical analysis was confirmed with the 95% confidence interval. Statistical significance was defined at p-values < 0.05. Results The number of HIV tests in hospitals increased from 2.7 million in 2002 to 5.0 million in 2008. The trend of HIV seroprevalence was decrease (1.5-1.3 per 10,000 individuals, P < 0.0028), except in 2002. The number of women tested was greater than men, and the proportion increased in older individuals and in small towns. Men had a higher annual HIV seroprevalence than women (P < 0.0001). The annual seroprevalence decreased in men (P = 0.0037), but was stable in women. The seroprevalence in the 30-39 year age group demonstrated higher than other age groups except 2008. Conclusions The nationwide hospital-based number of HIV tests and seroprevalence were estimated using a new method and seroprevalence trends were identified. This information will facilitate improvement in national HIV prevention strategies.

Background This report presents HIV External Quality Assessment (EQAS) results by the KCDC from the 17 HIV testing laboratories that also performed HIV-1 western blot testing of the 585 laboratories. Method The HIV EQAS panel consisted of 10 undiluted plasma samples from donors who were 3 positive, four indeterminate and 3 negative for HIV antibody. The results were analyzed by traditional methods (mean ± 2 SD), robust statistics (median), and Youden plots (99% coverage). Results The sensitivities for the HIV antigen and antibody ELISAs were 94.1% and 98.3%, respectively, with the inconsistent 1.7% caused by indeterminate, weakly positive samples. The specificities of HIV antigen and antibody ELISAs were 93.3% and 100%, respectively. The traditional method detected 2 laboratories as outliers for HIV antigen testing and 3 laboratories as outliers for HIV antibody testing. The robust statistics method showed better discrimination of outliers, detecting seven laboratories as outliers for HIV antigen testing and six for HIV antibody testing. The outliers detected by the Youden plot were differentiated as six systematic and 2 random errors. Conclusion Therefore, the design of reliable EQAS based on HIV panels with varied and specified titers is prerequisites for quality improvement of HIV testing laboratories.

Background The number of Koreans diagnosed with human immunodeficiency virus (HIV) infections is increasing annually; however, CD4+ T-cell counts at diagnosis have decreased. The purpose of the present study was to identify clinical and epidemiologic associations with low CD4+ T-cell counts at the time of HIV diagnosis in a Korean population. Methods Data from 2,299 HIV-infected individuals with initial CD4+ T-cell counts measured within 6 months of HIV diagnosis and reason for HIV testing were recorded and measured from 2000 to 2007. Data were selected from the database of the Korea Centers for Disease Control and Prevention. Late diagnosis was defined by CD4+ T-cell counts 3. Reasons for HIV testing were analyzed using logistic regression including epidemiologic variables. Results A total of 858 individuals (37.3%) were included in the late diagnosis group. Individuals with a late diagnosis were older, exposed through heterosexual contact, and demonstrated clinical manifestations of acquired immunodeficiency syndrome (AIDS). The primary reason for HIV testing was a routine health check-up (41%) followed by clinical manifestations (31%) of AIDS. The proportion of individuals with a late diagnosis was higher in individuals tested due to clinical symptoms in public health centers (adjusted odds ratio [AOR], 17.3; 95% CI, 1.7-175) and hospitals (AOR, 4.9; 95% CI, 3.4-7.2) compared to general health check-up. Late diagnosis annually increased in individuals diagnosed by voluntary testing both in public health centers (PHCs, P = 0.017) and in hospitals (P = 0.063). Routine testing due to risky behaviors resulted in earlier detection than testing secondary to health check-ups, although this difference was not statistically significant (AOR, 0.7; P = 0.187). Individuals identified as part of hospital health check-ups more frequently had a late diagnosis (P = 0.001) Conclusions HIV infection was primarily detected by voluntary testing with identification in PHCs and by testing due to clinical symptoms in hospitals. However, early detection was not influenced by either voluntary testing or general health check-up. It is important to encourage voluntary testing for early detection to decrease the prevalence of HIV infection and AIDS progression.

Greater than 90 per cent of HIV-infected Koreans are men, and therefore the majority of Korean HIV/AIDS studies reflect the male population. We wished to evaluate the characteristics of HIV infection in women, and to compare our results with those in other countries. To better elucidate HIV infection in Korean women, we examined the characteristics of heterosexual transmission and studied the dynamics of HIV infection in heterosexual couples. We evaluated 479 HIV-infected women who were registered with the government during 1985-2007. The median age at registration and median CD4 cell count were 37 years (N = 479), 362 cells/mm(3) (N = 276), respectively. About 68 per cent had a regular sexual partner and 26 per cent were diagnosed because they had HIV-positive male partners. Eighty-five per cent of women of concordant couples were detected because of previously diagnosed male partners (N = 115). We verified that the majority of HIV-infected women were infected by male sexual partners. These results suggest that early and active detection of HIV-positive men will facilitate earlier detection and prevention in women.