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8.  Greater Suppression of Nevirapine Resistance With 21- vs 7-Day Antiretroviral Regimens After Intrapartum Single-Dose Nevirapine for Prevention of Mother-to-Child Transmission of HIV 
Seven- or 21-day regimens of tenofovir/emtricitabine, zidovudine/lamivudine, or lopinavir/ritonavir after single-dose nevirapine (NVP) were effective in suppressing NVP resistance detected by population genotype. Allele-specific polymerase chain reaction revealed that the 21-day regimens were significantly better at preventing the emergence of minor NVP resistance.
Background. Nevirapine (NVP) resistance emerges in up to 70% of women exposed to single-dose (sd) NVP for prevention of mother-to-child transmission of human immunodeficiency virus (HIV).
Methods. HIV-infected pregnant women were randomized to receive sdNVP and either zidovudine/lamivudine (3TC), tenofovir/emtricitabine (FTC), or lopinavir/ritonavir for either 7 or 21 days. The primary endpoint was the emergence of new NVP resistance mutations as detected by standard population genotype at 2 and 6 weeks after treatment. Low-frequency NVP- or 3TC/FTC-resistant mutants at codons 103, 181, and 184 were sought using allele-specific polymerase chain reaction (ASP).
Results. Among 484 women randomized, 422 (87%) received study treatment. Four hundred twelve (98%) women had primary endpoint results available; of these, 5 (1.2%) had new NVP resistance detected by population genotype: 4 of 215 in the 7-day arms (1.9%; K103N in 4 women with Y181C, Y188C, or G190A in 3 of 4) and 1 of 197 (0.5%; V108I) in the 21-day arms (P = .37). Among women with ASP results, new NVP resistance mutations emerged significantly more often in the 7-day arms (13/74 [18%]) than in the 21-day arms (3/66 [5%], P = .019). 3TC/FTC-resistant mutants (M184V/I) emerged infrequently (7/134 [5%]), and their occurrence did not differ by arm.
Conclusions. Three short-term antiretroviral strategies, begun simultaneously with the administration of sdNVP, resulted in a low rate (1.2%) of new NVP-resistance mutations when assessed at 2 and 6 weeks following completion of study treatment by standard genotype. ASP revealed that 21-day regimens were significantly better than 7-day regimens at preventing the emergence of minor NVP resistance variants.
Clinical Trials Registration. NCT00099632.
doi:10.1093/cid/cis1219
PMCID: PMC3588119  PMID: 23300238
nevirapine; mother-to-child transmission; pregnancy; resistance; HIV
9.  Efficacy and Safety of Tribendimidine Against Clonorchis sinensis 
In this randomized open-label trial, tribendimidine was shown to have an efficacy comparable to praziquantel for the treatment of Clonorchis sinensis infection. Patients treated with praziquantel experienced significantly more adverse events than tribendimidine recipients.
Background. Clonorchiasis is of considerable public health importance, particularly in the People's Republic of China (PR China), where most of the 15 million individuals infected with Clonorchis sinensis are currently concentrated. Praziquantel is the drug of choice, but tribendimidine might be an alternative.
Methods. We performed a randomized open-label trial in Guangxi, PR China, to assess the efficacy and safety of 400 mg tribendimidine once, 400 mg tribendimidine daily for 3 days, and 75 mg/kg praziquantel in 1 day divided in 3 doses against parasitological-confirmed C. sinensis infections. Cure and egg reduction rates were determined 3 weeks posttreatment using available case analysis. Clinical symptoms were documented at baseline, and adverse events were recorded and graded 3 and 24 hours after each dose.
Results. A total of 74 patients were included in the final analysis. Single-dose tribendimidine achieved a cure rate of 44%, whereas cure rates of 58% and 56% were obtained for tribendimidine administered for 3 days and praziquantel, respectively. High egg reduction rates (97.6%–98.8%) were observed for all treatment regimens. Single-dose tribendimidine was the best-tolerated treatment scheme. Patients treated with praziquantel experienced significantly more adverse events than did tribendimidine recipients (P < .05).
Conclusions. Tribendimidine has an efficacy comparable to praziquantel in the treatment of C. sinensis infection and resulted in fewer adverse events compared to praziquantel. Larger clinical trials are warranted among C. sinensis–infected patients to determine the potential of tribendimidine against clonorchiasis and other helminthiases.
Clinical Trials Registration. Controlled-Trials.com, ISRCTN80829842.
doi:10.1093/cid/cis1011
PMCID: PMC3588115  PMID: 23223597
tribendimidine; praziquantel; Clonorchis sinensis; clonorchiasis; People's Republic of China
10.  Standard Treatment Regimens for Nongonococcal Urethritis Have Similar but Declining Cure Rates: A Randomized Controlled Trial 
Cure rates for nongonococcal urethritis (NGU), were approximately 80% and there was no significant difference between azithromycin and doxycycline for clinical or microbiologic cure. Chlamydia trachomatis, Ureaplasma urealyticum biovar 2, and idiopathic NGU remained relatively sensitive to standard therapies, but Mycoplasma genitalium was not.
Background. Azithromycin or doxycycline is recommended for nongonococcal urethritis (NGU); recent evidence suggests their efficacy has declined. We compared azithromycin and doxycycline in men with NGU, hypothesizing that azithromycin was more effective than doxycycline.
Methods. From January 2007 to July 2011, English-speaking males ≥16 years, attending a sexually transmitted diseases clinic in Seattle, Washington, with NGU (visible urethral discharge or ≥5 polymorphonuclear leukocytes per high-power field [PMNs/HPF]) were eligible for this double-blind, parallel-group superiority trial. Participants received active azithromycin (1 g) + placebo doxycycline or active doxycycline (100 mg twice daily for 7 days) + placebo azithromycin. Urine was tested for Chlamydia trachomatis (CT), Mycoplasma genitalium (MG), Ureaplasma urealyticum biovar 2 (UU-2), and Trichomonas vaginalis (TV) using nucleic acid amplification tests. Clinical cure (<5 PMNs/HPF with or without urethral symptoms and absence of discharge) and microbiologic cure (negative tests for CT, MG, and/or UU-2) were determined after 3 weeks.
Results. Of 606 men, 304 were randomized to azithromycin and 302 to doxycycline; CT, MG, TV, and UU-2 were detected in 24%, 13%, 2%, and 23%, respectively. In modified intent-to-treat analyses, 172 of 216 (80%; 95% confidence interval [CI], 74%–85%) receiving azithromycin and 157 of 206 (76%; 95% CI, 70%–82%) receiving doxycycline experienced clinical cure (P = .40). In pathogen-specific analyses, clinical cure did not differ by arm, nor did microbiologic cure differ for CT (86% vs 90%, P = .56), MG (40% vs 30%, P = .41), or UU-2 (75% vs 70%, P = .50). No unexpected adverse events occurred.
Conclusions. Clinical and microbiologic cure rates for NGU were somewhat low and there was no significant difference between azithromycin and doxycycline. Mycoplasma genitalium treatment failure was extremely common.
Clinical Trials Registration. NCT00358462.
doi:10.1093/cid/cis1022
PMCID: PMC3588116  PMID: 23223595
urethritis; treatment; Mycoplasma genitalium; Chlamydia trachomatis; randomized trial
11.  Breast Milk Parasite-Specific Antibodies and Protection From Amebiasis and Cryptosporidiosis in Bangladeshi Infants: A Prospective Cohort Study 
In this prospective cohort study, the presence of parasite-specific immunoglobulin A in breast milk was associated with protection of Bangladeshi infants from cryptosporidiosis and amebiasis. Our findings suggest that passive immunity could be harnessed for the prevention of Entamoeba histolytica and Cryptosporidium species infection in children living in endemic regions.
doi:10.1093/cid/cis1044
PMCID: PMC3588117  PMID: 23243179
diarrhea; Cryptosporidium species; Entamoeba histolytica; Giardia lamblia; breast milk
12.  Rapid Progression to Decompensated Cirrhosis, Liver Transplant, and Death in HIV-Infected Men After Primary Hepatitis C Virus Infection 
Four men from a cohort of HIV-infected men who did not achieve cure after primary hepatitis C virus infection developed decompensated cirrhosis within 17 months to 6 years after infection, with subsequent rapid progression to liver transplant and death.
Background. We and others have shown that primary hepatitis C (HCV) infection in men infected with human immunodeficiency virus (HIV) causes early-onset liver fibrosis; however, little is known about the long-term natural history of the liver disease in these HIV-infected men.
Methods. We followed a cohort of HIV-infected men with primary HCV infection in New York City.
Results. Four men who were not cured after their primary HCV infection developed decompensated cirrhosis within 17 months to 6 years after primary HCV infection. Three died within 8 years of primary HCV infection, and 1 survived after liver transplant done 2 years after primary HCV infection. Three of the 4 men had AIDS at the time of primary HCV infection, and the most rapid progression occurred in the 2 men with the lowest CD4 counts at the time of HCV infection. Liver histopathology was most consistent with HCV-induced damage even though some had exposures to other potential hepatotoxins.
Conclusions. Primary HCV infection resulted in decompensated cirrhosis and death within 2–8 years in 4 HIV-infected men. The rapid onset of fibrosis due to primary HCV infection in HIV-infected men cannot therefore be considered benign. The rate of continued progression to liver failure may be proportional to the degree of underlying immunocompromise caused by HIV infection. More research is needed to better define the mechanisms behind accelerated liver damage.
doi:10.1093/cid/cis1206
PMCID: PMC3588118  PMID: 23264364
liver failure; primary acute hepatitis C infection; HIV infection/AIDS; immunocompromise; men who have sex with men
13.  Assessment, Diagnosis, and Treatment of HIV-Associated Neurocognitive Disorder: A Consensus Report of the Mind Exchange Program 
Based on evidence from a literature search and consensus expert opinion, the Mind Exchange program provides practical guidance in the diagnosis, ongoing monitoring, and treatment of HIV-associated neurocognitive disorder that is of direct relevance to daily practice.
Many practical clinical questions regarding the management of human immunodeficiency virus (HIV)–associated neurocognitive disorder (HAND) remain unanswered. We sought to identify and develop practical answers to key clinical questions in HAND management. Sixty-six specialists from 30 countries provided input into the program, which was overseen by a steering committee. Fourteen questions were rated as being of greatest clinical importance. Answers were drafted by an expert group based on a comprehensive literature review. Sixty-three experts convened to determine consensus and level of evidence for the answers. Consensus was reached on all answers. For instance, good practice suggests that all HIV patients should be screened for HAND early in disease using standardized tools. Follow-up frequency depends on whether HAND is already present or whether clinical data suggest risk for developing HAND. Worsening neurocognitive impairment may trigger consideration of antiretroviral modification when other causes have been excluded. The Mind Exchange program provides practical guidance in the diagnosis, monitoring, and treatment of HAND.
doi:10.1093/cid/cis975
PMCID: PMC3657494  PMID: 23175555
AIDS dementia complex; HIV-associated dementia (HAD); HIV-associated neurocognitive disorder (HAND); HIV encephalopathy; neurocognitive impairment
14.  Low Rates of Treatment Failure in Children Aged 2–59 Months Treated for Severe Pneumonia: A Multisite Pooled Analysis 
Low rates of treatment failure and death in >6000 cases of children treated for severe pneumonia with oral antibiotics support supports the shift to management of severe pneumonia to outpatients and in the community.
Background. Despite advances in childhood pneumonia management, it remains a major killer of children worldwide. We sought to estimate global treatment failure rates in children aged 2–59 months with World Health Organization–defined severe pneumonia.
Methods. We pooled data from 4 severe pneumonia studies conducted during 1999–2009 using similar methodologies. We defined treatment failure by day 6 as death, danger signs (inability to drink, convulsions, abnormally sleepy), fever (≥38°C) and lower chest indrawing (LCI; days 2–3), LCI (day 6), or antibiotic change.
Results. Among 6398 cases of severe pneumonia from 10 countries, 564 (cluster adjusted: 8.5%; 95% confidence interval [CI], 5.9%–11.5%) failed treatment by day 6. The most common reasons for clinical failure were persistence of fever and LCI or LCI or fever alone (75% of failures). Seventeen (0.3%) children died. Danger signs were uncommon (<1%). Infants 6–11 months and 2–5 months were 2- and 3.5-fold more likely, respectively, to fail treatment (adjusted OR [AOR], 1.8 [95% CI, 1.4–2.3] and AOR, 3.5 [95% CI, 2.8–4.3]) as children aged 12–59 months. Failure was increased 7-fold (AOR, 7.2 [95% CI, 5.0–10.5]) when comparing infants 2–5 months with very fast breathing to children 12–59 months with normal breathing.
Conclusions. Our findings demonstrate that severe pneumonia case management with antibiotics at health facilities or in the community is associated with few serious morbidities or deaths across diverse geographic settings and support moves to shift management of severe pneumonia with oral antibiotics to outpatients in the community.
doi:10.1093/cid/cis1201
PMCID: PMC3657495  PMID: 23264361
severe pneumonia; amoxicillin; meta-analysis; treatment failure; mortality
15.  Promising New Assays and Technologies for the Diagnosis and Management of Infectious Diseases 
Recent advancements in technology have led to the development of new techniques that hold promise for improved diagnosis and management of infectious diseases. Here, we review new assays that help better identify pathogens and tailor antibiotic therapy to patients' needs.
In the first decade of the 21st century, we have seen the completion of the human genome project and marked progress in the human microbiome project. The vast amount of data generated from these efforts combined with advances in molecular and biomedical technologies have led to the development of a multitude of assays and technologies that may be useful in the diagnosis and management of infectious diseases. Here, we identify several new assays and technologies that have recently come into clinical use or have potential for clinical use in the near future. The scope of this review is broad and includes topics such as the serum marker procalcitonin, gene expression profiling, matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS), and nucleic acid aptamers. Principles that underlie each assay or technology, their clinical applications, and potential strengths and limitations are addressed.
doi:10.1093/cid/cis1014
PMCID: PMC3657496  PMID: 23223587
procalcitonin; gene expression profiling; mass spectrometry; MALDI-TOF MS; sepsis
18.  Determinants of Hepatitis C Virus Treatment Completion and Efficacy in Drug Users Assessed by Meta-analysis 
Based on meta-analysis, the higher the proportion of addiction-treated patients, the higher the treatment completion rate. The rate of sustained virologic response rate in drug users is very similar to that in the general population.
Background. Hepatitis C virus (HCV)–infected drug users (DUs) have largely been excluded from HCV care. We conducted a systematic review and meta-analysis of the literature on treatment completion and sustained virologic response (SVR) rates in DUs. We assessed the effects of different treatment approaches and services to promote HCV care among DUs as well as demographic and viral characteristics.
Methods. Studies of at least 10 DUs treated with pegylated interferon/ribavirin that reported SVR were analyzed. Heterogeneity was assessed (Cochran test) and investigated (meta-regression), and pooled rates were estimated (random effects).
Results. Thirty-six studies comprising 2866 patients were retrieved. The treatment completion rate among DUs was 83.4% (95% confidence interval [CI], 77.1%–88.9%). Among studies that included addiction-treated and untreated patients during HCV therapy, the higher the proportion of addiction-treated patients, the higher the HCV treatment completion rate (P < .0001). After adjusting for human immunodeficiency virus (HIV)/HCV coinfection, sex, and treatment of addiction, support services during antiviral therapy increased treatment completion (P < .0001). The pooled SVR rate was 55.5% (95% CI, 50.6%–60.3%). Genotype 1/4 (P = .0012) and the proportion of HIV-coinfected DUs (P = .0173) influenced the SVR rate. After adjusting for HCV genotype 1/4 and HIV/HCV coinfection, the SVR rate was positively correlated with involvement of a multidisciplinary team (P < .0001).
Conclusions. Treatment of addiction during HCV therapy results in higher treatment completion. Our pooled SVR rate is similar to that obtained in registration trials in the general population. Treatment of addiction during HCV therapy will likely be important for HCV-infected DUs undergoing treatment with more complex regimens including direct-acting antivirals.
doi:10.1093/cid/cis1007
PMCID: PMC3582354  PMID: 23223596
drug users; hepatitis C virus; treatment completion; SVR; meta-analysis
19.  Aggressive Regimens for Multidrug-Resistant Tuberculosis Reduce Recurrence 
In an extensively previously treated patient population, receipt of an aggressive regimen (ie, one containing ≥5 likely effective drugs, including a fluoroquinolone and injectable) for ≥18 months following sputum conversion, was associated with a reduced risk of recurrence.
Background. Recurrent tuberculosis disease occurs within 2 years in as few as 1% and as many as 29% of individuals successfully treated for multidrug-resistant (MDR) tuberculosis. A better understanding of treatment-related factors associated with an elevated risk of recurrent tuberculosis after cure is urgently needed to optimize MDR tuberculosis therapy.
Methods. We conducted a retrospective cohort study among adults successfully treated for MDR tuberculosis in Peru. We used multivariable Cox proportional hazards regression analysis to examine whether receipt of an aggressive MDR tuberculosis regimen for ≥18 months following sputum conversion from positive to negative was associated with a reduced rate of recurrent tuberculosis.
Results. Among 402 patients, the median duration of follow-up was 40.5 months (interquartile range, 21.2–53.4). Receipt of an aggressive MDR tuberculosis regimen for ≥18 months following sputum conversion was associated with a lower risk of recurrent tuberculosis (hazard ratio, 0.40 [95% confidence interval, 0.17–0.96]; P = .04). A baseline diagnosis of diabetes mellitus also predicted recurrent tuberculosis (hazard ratio, 10.47 [95% confidence interval, 2.17–50.60]; P = .004).
Conclusions. Individuals who received an aggressive MDR tuberculosis regimen for ≥18 months following sputum conversion experienced a lower rate of recurrence after cure. Efforts to ensure that an aggressive regimen is accessible to all patients with MDR tuberculosis, such as minimization of sequential ineffective regimens, expanded drug access, and development of new MDR tuberculosis compounds, are critical to reducing tuberculosis recurrence in this population. Patients with diabetes mellitus should be carefully managed during initial treatment and followed closely for recurrent disease.
doi:10.1093/cid/cis1008
PMCID: PMC3582355  PMID: 23223591
resistance; recurrence; relapse; Peru; regimen
20.  Antiretroviral Drug-Related Liver Mortality Among HIV-Positive Persons in the Absence of Hepatitis B or C Virus Coinfection: The Data Collection on Adverse Events of Anti-HIV Drugs Study 
In a large prospective multicohort study 22 910 human immunodeficiency virus–positive participants without hepatitis B or C virus coinfection were followed for 114 478 patient-years. The incidence of liver-related death was low at 0.10 per 1000 patient-years. Liverrelated mortality due to antiretroviral drug-related toxicity was rare.
Background. Liver diseases are the leading causes of death in human immunodeficiency virus (HIV)–positive persons since the widespread use of combination antiretroviral treatment (cART). Most of these deaths are due to hepatitis C (HCV) or B (HBV) virus coinfections. Little is known about other causes. Prolonged exposure to some antiretroviral drugs might increase hepatic mortality.
Methods. All patients in the Data Collection on Adverse Events of Anti-HIV Drugs study without HCV or HBV coinfection were prospectively followed from date of entry until death or last follow-up. In patients with liver-related death, clinical charts were reviewed using a structured questionnaire.
Results. We followed 22 910 participants without hepatitis virus coinfection for 114 478 person-years. There were 12 liver-related deaths (incidence, 0.10/1000 person-years); 7 due to severe alcohol use and 5 due to established ART-related toxicity. The rate of ART-related deaths in treatment-experienced persons was 0.04/1000 person-years (95% confidence interval, .01, .10).
Conclusions. We found a low incidence of liver-related deaths in HIV-infected persons without HCV or HBV coinfection. Liver-related mortality because of ART-related toxicity was rare.
doi:10.1093/cid/cis919
PMCID: PMC3582358  PMID: 23090925
liver-related mortality; drug toxicity; antiretroviral therapy; HIV infection; cohort study
22.  Antituberculosis Drug Resistance Acquired During Treatment: An Analysis of Cases Reported in California, 1994–2006 
Our analysis of population-based tuberculosis surveillance data shows that in California, baseline isoniazid or rifampicin drug resistance, human immunodeficiency virus infection, and cavitary lung lesions in the absence of directly observed therapy were independent predictors of acquired tuberculosis multidrug resistance.
Background. To inform efforts to prevent antituberculosis drug resistance acquired during treatment, particularly multidrug-resistant (MDR) tuberculosis, we analyzed surveillance records from the US state with the highest morbidity.
Methods. Surveillance data from the California tuberculosis registry of cases reported between 1994 and 2006 were examined retrospectively. Crude risks of acquired resistance were estimated. Multivariate logistic regression was used to estimate odds ratios of demographic, clinical, and case management characteristics associated with acquired drug resistance (ADR), and secular trends in the incidence of ADR were assessed.
Results. One in 688 patients acquired MDR tuberculosis, with crude risks varying greatly by initial drug susceptibility test results: 1 in 1909 if initially susceptible to isoniazid and rifampin, 1 in 113 if initially isoniazid resistant, and 1 in 23 if initially rifampicin resistant. Acquired isoniazid and rifampicin monoresistance occurred in 1 in 1018 and 1 in 1455 patients, respectively. Independent predictors of acquired MDR tuberculosis were initial isoniazid resistance (odds ratio [OR], 19.2; 95% confidence interval [CI], 8.25–44.7; P < .001), initial rifampicin resistance (OR, 35.9; 95% CI, 8.61–150; P < .001), human immunodeficiency virus (HIV) infection (OR, 5.07; 95% CI, 1.73–14.9; P = .003), and cavitary disease in the absence of directly observed therapy throughout therapy (OR, 2.65; 95% CI, 1.05–6.69; P = .04). The annual incidence of ADR declined over the study period.
Conclusions. Although ADR is rare and declining in California, its costly consequences warrant improvements in treatment practices. Our findings suggest that we ensure DOT throughout the course of therapy for patients with baseline drug resistance, cavitary disease, or HIV infection.
doi:10.1093/cid/cis989
PMCID: PMC3657489  PMID: 23223590
tuberculosis; isoniazid; rifampicin; multidrug resistance; acquired drug resistance
23.  Community-Associated Extended-Spectrum β-Lactamase–Producing Escherichia coli Infection in the United States 
During 2009 and 2010, an observational study in US hospitals found that a substantial portion community-onset, ESBL-producing E. coli infections now occur among patients without discernible healthcare-associated risk factors. This epidemiologic shift has implications for the empiric management of community-associated infection when involvement of E. coli is suspected.
Background. The occurrence of community-associated infections due to extended-spectrum β-lactamase (ESBL)–producing Escherichia coli has been recognized as a major clinical problem in Europe and other regions.
Methods. We conducted a prospective observational study to examine the occurrence of community-associated infections due to ESBL-producing E. coli at centers in the United States. Five academic and community hospitals and their affiliated clinics participated in this study in 2009 and 2010. Sites of acquisition of the organisms (community-associated or healthcare-associated), risk factors, and clinical outcome were investigated. Screening for the global epidemic sequence type (ST) 131 and determination of the ESBL types was conducted by polymerase chain reaction and sequencing.
Results. Of the 291 patients infected or colonized with ESBL-producing E. coli as outpatients or within 48 hours of hospitalization, 107 (36.8%) had community-associated infection (81.5% of which represented urinary tract infection), while the remainder had healthcare-associated infection. Independent risk factors for healthcare-associated infection over community-associated infection were the presence of cardiovascular disease, chronic renal failure, dementia, solid organ malignancy, and hospitalization within the previous 12 months. Of the community-associated infections, 54.2% were caused by the globally epidemic ST131 strain, and 91.3% of the isolates produced CTX-M–type ESBL.
Conclusions. A substantial portion of community-onset, ESBL-producing E. coli infections now occur among patients without discernible healthcare-associated risk factors in the United States. This epidemiologic shift has implications for the empiric management of community-associated infection when involvement of E. coli is suspected.
doi:10.1093/cid/cis942
PMCID: PMC3563390  PMID: 23150211
extended-spectrum beta-lactamase (ESBL); Escherichia coli; community-associated infection
24.  Mortality and Treatment Outcomes of China's National Pediatric Antiretroviral Therapy Program 
Human immunodeficiency virus–positive children enrolled in China's national pediatric antiretroviral therapy program experience a mortality rate of 2.3 per 100 child-years, survival rate of 94%, and improved treatment outcomes including elevated CD4 percentage, hemoglobin, and weight-for-age and height-for-age z scores after 3 years of follow-up.
Background. The aim of this study was to describe 3-year mortality rates, associated risk factors, and long-term clinical outcomes of children enrolled in China's national free pediatric antiretroviral therapy (ART) program.
Methods. Records were abstracted from the national human immunodeficiency virus (HIV)/AIDS case reporting and national pediatric ART databases for all HIV-positive children ≤15 years old who initiated ART prior to December 2010. Mortality risk factors over 3 years of follow-up were examined using Cox proportional hazards regression models. Life tables were used to determine survival rate over time. Longitudinal plots of CD4+ T-cell percentage (CD4%), hemoglobin level, weight-for-age z (WAZ) score, and height-for-age z (HAZ) score were created using generalized estimating equation models.
Results. Among the 1818 children included in our cohort, 93 deaths were recorded in 4022 child-years (CY) of observed time for an overall mortality rate of 2.31 per 100 CY (95% confidence interval [CI], 1.75–2.78). The strongest factor associated with mortality was baseline WAZ score <−2 (adjusted hazard ratio [HR] = 9.1; 95% CI, 2.5–33.2), followed by World Health Organization stage III or IV disease (adjusted HR = 2.4; 95% CI, 1.1–5.2), and hemoglobin <90 g/L (adjusted HR = 2.2; 95% CI, 1.2–3.9). CD4%, hemoglobin level, WAZ score, and HAZ score increased over time.
Conclusions. Our finding that 94% of children engaged in this program are still alive and of improved health after 3 years of treatment demonstrates that China's national pediatric ART program is effective. This program needs to be expanded to better meet treatment demands, and efforts to identify HIV-positive children earlier must be prioritized.
doi:10.1093/cid/cis941
PMCID: PMC3657487  PMID: 23175558
HIV; mortality; pediatric; antiretroviral therapy; China
25.  A Dual Point-of-Care Test Shows Good Performance in Simultaneously Detecting Nontreponemal and Treponemal Antibodies in Patients With Syphilis: A Multisite Evaluation Study in China 
A multisite evaluation of a dual point-of-care syphilis test with 3 types of specimens (N = 3134) in China indicates good overall sensitivity and specificity: 95%–97% and 99%–100% in detecting treponemal antibodies, and 86%–88% and 94%–96% in detecting nontreponemal antibodies.
Background. Rapid point-of-care (POC) syphilis tests based on simultaneous detection of treponemal and nontreponemal antibodies (dual POC tests) offer the opportunity to increase coverage of syphilis screening and treatment. This study aimed to conduct a multisite performance evaluation of a dual POC syphilis test in China.
Methods. Participants were recruited from patients at sexually transmitted infection clinics and high-risk groups in outreach settings in 6 sites in China. Three kinds of specimens (whole blood [WB], fingerprick blood [FB], and blood plasma [BP]) were used for evaluating sensitivity and specificity of the Dual Path Platform (DPP) Syphilis Screen and Confirm test using its treponemal and nontreponemal lines to compare Treponema pallidum particle agglutination (TPPA) assay and toluidine red unheated serum test (TRUST) as reference standards.
Results. A total of 3134 specimens (WB 1323, FB 488, and BP 1323) from 1323 individuals were collected. The sensitivities as compared with TPPA were 96.7% for WB, 96.4% for FB, and 94.6% for BP, and the specificities were 99.3%, 99.1%, and 99.6%, respectively. The sensitivities as compared with TRUST were 87.2% for WB, 85.8% for FB, and 88.4% for BP, and the specificities were 94.4%, 96.1%, and 95.0%, respectively. For specimens with a TRUST titer of 1:4 or higher, the sensitivities were 100.0% for WB, 97.8% for FB, and 99.6% for BP.
Conclusions. DPP test shows good sensitivity and specificity in detecting treponemal and nontreponemal antibodies in 3 kinds of specimens. It is hoped that this assay can be considered as an alternative in the diagnosis of syphilis, particularly in resource-limited areas.
doi:10.1093/cid/cis928
PMCID: PMC3657488  PMID: 23132172
point-of-care test; syphilis; sensitivity; specificity

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