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1.  Etiologic Agents of Central Nervous System Infections among Febrile Hospitalized Patients in the Country of Georgia 
PLoS ONE  2014;9(11):e111393.
Objectives
There is a large spectrum of viral, bacterial, fungal, and prion pathogens that cause central nervous system (CNS) infections. As such, identification of the etiological agent requires multiple laboratory tests and accurate diagnosis requires clinical and epidemiological information. This hospital-based study aimed to determine the main causes of acute meningitis and encephalitis and enhance laboratory capacity for CNS infection diagnosis.
Methods
Children and adults patients clinically diagnosed with meningitis or encephalitis were enrolled at four reference health centers. Cerebrospinal fluid (CSF) was collected for bacterial culture, and in-house and multiplex RT-PCR testing was conducted for herpes simplex virus (HSV) types 1 and 2, mumps virus, enterovirus, varicella zoster virus (VZV), Streptococcus pneumoniae, HiB and Neisseria meningitidis.
Results
Out of 140 enrolled patients, the mean age was 23.9 years, and 58% were children. Bacterial or viral etiologies were determined in 51% of patients. Five Streptococcus pneumoniae cultures were isolated from CSF. Based on in-house PCR analysis, 25 patients were positive for S. pneumoniae, 6 for N. meningitidis, and 1 for H. influenzae. Viral multiplex PCR identified infections with enterovirus (n = 26), VZV (n = 4), and HSV-1 (n = 2). No patient was positive for mumps or HSV-2.
Conclusions
Study findings indicate that S. pneumoniae and enteroviruses are the main etiologies in this patient cohort. The utility of molecular diagnostics for pathogen identification combined with the knowledge provided by the investigation may improve health outcomes of CNS infection cases in Georgia.
doi:10.1371/journal.pone.0111393
PMCID: PMC4219716  PMID: 25369023
2.  Virologic outcomes of second-line antiretroviral therapy in Eastern European country of Georgia 
Background
Data on the effectiveness of second-line antiretroviral therapy (ART) in resource-limited countries of Eastern Europe is limited. Objective of this study was to evaluate virological outcomes of second-line ART in Georgia.
Methods
We conducted retrospective analysis using routinely available program data. Study included adult HIV-infected patients with confirmed HIV drug resistance, who were switched to second-line ART from August 2005 to December 2010. Patients were followed until July 1, 2011. Primary outcome was achievement of viral suppression. Demographic, clinical, laboratory and adherence data were abstracted from medical and program records. Adherence was expressed as percentage based on medication refill data, and was calculated as days supply of medications dispensed divided by days between prescription fills. Predictors of primary outcome were assessed in modified Poisson regression analysis.
Results
A total of 84 patients were included in the study. Among them 71.4% were men and 62% had history of IDU. All patients were receiving non-nucleoside reverse transcriptase based regimen as initial ART. The mean 6-month adherence prior to virologic failure was 75%, with 31% of patients showing 100% adherence. All patients were switched to protease inhibitor based regimens. Patients were followed for median 27 months. Over this period 9 (10.7%) patients died. Among 80 patients remaining alive at least 6 month after ART regimen switch, 72 (90%) patients ever reached undetectable viral load. The mean first 6-month adherence on second-line treatment was 81%, with 47.5% of patients showing 100% adherence. The proportion of patients achieving viral suppression after 6, 12, 24 and 36 months of second-line ART did not vary significantly ranging from 79 to 83%. Percentage of IDUs achieving viral suppression ranged from 75% and 83%. Factors associated with failure to achieve viral suppression at 6-months of second-line ART were: adherence <80% (Risk ratio [RR] 5.09, 95% CI: 1.89-13.70) and viral load >100,000 at the time of treatment failure (RR 3.39, 95% CI: 1.46-7.89).
Conclusions
The study demonstrated favourable virological outcomes of the second-line ART in Georgia. Majority of patients, including IDUs, achieved sustained virological response over 36 month period. The findings highlight the need of improving adherence.
doi:10.1186/1742-6405-11-18
PMCID: PMC4102034  PMID: 25035708
HIV; Antiretroviral therapy; Second-line ART; Eastern Europe
3.  Evaluation of multiple measures of antiretroviral adherence in the Eastern European country of Georgia 
Introduction
There is little information on adherence to antiretroviral therapy (ART) in the Eastern European region. This prospective study evaluated multiple measures of adherence and their association with viral suppression among HIV patients in Georgia.
Methods
A prospective cohort study enrolled 100 consecutive antiretroviral-naïve adult (age ≥18 years) patients, who were followed for three months. Adherence was assessed by medication refill and three self-report measures (an AIDS Clinical Trial Group [ACTG] tool for four-day adherence, a visual analogue scale [VAS] and a rating task for 30-day adherence). The VAS represented a line anchored by 0 and 100% corresponding to the percentage of prescribed doses taken. The rating task asked patients to rate their ability to take all medications as prescribed, with responses categorized into six levels of adherence: very poor (0%), poor (20%), fair (40%), good (60%), very good (80%) and excellent (100%). Patients with adherence of ≥95% by medication refill, ACTG and VAS, and ≥80% by rating task, were defined as adherent.
Results
Of 100 patients enrolled, eight had missing data and were excluded from analysis. Among the remaining 92 patients, the median age was 39 years, and 70% were men. Major modes of HIV acquisition were injection drug use (IDU; 47.3%) and heterosexual contact (44.1%). The proportions of adherent patients were as follows: 68% by medication refill, 90% by ACTG questionnaire, 38% by VAS and 42% by rating task. On average, four months after commencing ART, 52 (56.5%) patients had a viral load <400 copies/ml and 26 (28.3%) patients had a viral load <50 copies/ml. Of 43 persons with a history of IDU, 22 (51.2%) reached a viral load of <400 copies/ml. In multivariate analysis, only refill adherence was a statistically significant predictor of viral suppression of <400 copies/ml: the risk ratio was 1.7 (95% CI: 1.1–2.8). Refill adherence, VAS and rating task were associated with viral suppression of <50 copies/ml. Non-IDUs were twice as likely to achieve viral load <50 copies/ml compared to IDUs. Refill adherence had the largest area under the receiver-operating characteristic curve for predicting viral suppression.
Conclusions
Medication refill adherence was the strongest predictor of viral suppression. IDUs can achieve optimal virologic outcomes, but may require additional adherence support.
doi:10.7448/IAS.17.1.18885
PMCID: PMC3983475  PMID: 24721464
antiretroviral therapy; adherence; Eastern Europe; injection drug use; viral suppression
4.  Poor agreement between interferon-gamma release assays and the tuberculin skin test among HIV-infected individuals in the country of Georgia 
BMC Infectious Diseases  2013;13:513.
Background
Improved tests to diagnose latent TB infection (LTBI) are needed. We sought to evaluate the performance of two commercially available interferon-gamma release assays (IGRAs) compared to the tuberculin skin test (TST) for the diagnosis of LTBI and to identify risk factors for LTBI among HIV-infected individuals in Georgia, a country with high rates of TB.
Methods
HIV-patients were enrolled from the National AIDS Center in Tbilisi, Georgia. After providing informed consent, each participant completed a questionnaire, had blood drawn for QuantiFERON-TB Gold in-Tube (QFT-GIT) and T-SPOT.TB testing and had a TST placed. The TST was read at 48–72 hrs with ≥ 5 mm induration considered positive.
Results
Between 2009–2011, 240 HIV-infected persons (66% male) with a median age of 38 years and a median CD4 count of 255 cells/μl (IQR: 124–412) had diagnostic testing for LTBI performed. 94% had visible evidence of a BCG scar. The TST was positive in 41 (17%) patients; QFT-GIT in 70 (29%); and T-SPOT.TB in 56 (24%). At least one diagnostic test was positive in 109 (45%) patients and only among 13 (5%) patients were all three tests positive. Three (1%) QFT-GIT and 19 (8%) T-SPOT.TB test results were indeterminate. The agreement among all pairs of tests was poor: QFT-GIT vs. T-SPOT.TB (κ = 0.18, 95% CI .07-.30), QFT-GIT vs. TST (κ = 0.29, 95% CI .16-.42), and TST vs. T-SPOT.TB (κ = 0.22, 95% CI .07-.29). Risk factors for LTBI varied by diagnostic test and none showed associations between positive test results and well-known risk factors for TB, such as imprisonment, drug abuse and immunological status.
Conclusions
A high proportion of HIV patients had at least one positive diagnostic test for LTBI; however, there was very poor agreement among all tests. This lack of agreement makes it difficult to know which test is superior and most appropriate for LTBI testing among HIV-infected patients. While further follow-up studies will help determine the predictive ability of different LTBI tests, improved modalities are needed for accurate detection of LTBI and assessment of risk of developing active TB among HIV-infected patients.
doi:10.1186/1471-2334-13-513
PMCID: PMC3817813  PMID: 24176032
Latent tuberculosis infection; Screening; TST; Interferon-gamma; Eastern Europe
5.  IL28B favorable genotype and ultra rapid viral response as earliest treatment predictors of sustained viral response among Georgian cohort infected with hepatitis C genotype one 
Objectives
Early identification of factors contributing to successful treatment of hepatitis C infection is important for researchers and clinicians. Studies conducted on the role of ultra rapid viral response (URVR) for prediction of sustained viral response (SVR) have shown its high positive predictive value (PPV). However, data on the combined effect of URVR with IL28B genotypes for prediction of SVR are lacking. Our aim was to study the role of URVR and IL28B genotypes for prediction of SVR among patients in Georgia infected with genotype 1.
Methods
Of a total of 156 patients enrolled in the study, 143 were included in the final analyses. Viral load testing for monitoring viral response was done at 3, 24, and 48, 72 hours and at 1, 2, and 4 weeks after treatment initiation. IL28B single nucleotide polymorphisms in rs12979860 were genotyped by real time PCR methods.
Results
Our study revealed URVR as the earliest treatment predictor among genotype 1 patients harboring IL28B C/C genotype (PPV-100%). Moreover, C/C genotype was found have a high PPV among genotype 1 patients without URVR or RVR unlike patients infected with genotype 2 or 3. URVR and IL28B C/C genotype were not as predictive of an SVR among genotype 2 and 3 patients; however RVR were highly predictive of an SVR in these patients.
Conclusions
Our results suggest that testing for IL28B genotypes and viral load at week one and two may improve the ability to predict an SVR among HCV genotype 1 patients; this information can be useful to encourage patients to remain on treatment.
doi:10.1097/MEG.0b013e328353fd11
PMCID: PMC3368996  PMID: 22569080
HCV viral load; SNPs; interferon treatment
6.  Characteristics of HIV-infected women and factors associated with HCV seropositivity in the Republic of Georgia 
Background
The aim of this study was to describe the extent of the HIV epidemic among women in the Republic of Georgia and to identify factors associated with HCV co-infection in this population.
Findings
All women aged ≥18 years who were diagnosed with HIV between 1989 and 2006 were identified through the National HIV/AIDS surveillance database. Medical records were reviewed for demographic characteristics, risk factors and HCV serostatus. A total of 249 women were identified. Only 4% declared injection drug use (IDU); sex work was reported by 9%. Substantial risk factors were identified among the women's sexual partners, nearly 69% of whom were IDUs, 84% were HIV positive and 66% HCV positive. Seventeen percent of women were seropositive for HCV. Factors significantly associated with HCV seropositivity in bivariate analyses among non-IDU women were partner IDU+ [Prevalence ratio (PR): 4.5 (95% CI: 1.4, 14.2)], and partner HCV+ [PR: 7.2 (95% CI: 1.8, 29.5)].
Conclusions
The HIV epidemic in the Republic of Georgia is closely tied to the IDU community. Evidence-based interventions targeting IDU and partners of IDU are urgently required to halt the spread of the HIV epidemic in the country.
doi:10.1186/1742-6405-8-25
PMCID: PMC3154141  PMID: 21787384
7.  Outcomes of Universal Access to Antiretroviral Therapy (ART) in Georgia 
AIDS Research and Treatment  2011;2011:621078.
Since 2004, Georgia achieved universal access to free antiretroviral therapy (ART). A retrospective cohort study was conducted to evaluate the outcomes of Georgia's ART program. The study included adult patients enrolled in the ART program from 2004 through 2009. Of 752 patients, 76% were men, 60% were injection drug users (IDU), 59% had a history of an AIDS-defining illness, and 53% were coinfected with hepatitis C. The median baseline CD4 cell count was 141 cells/mm3. During followup, 152 (20%) patients died, with the majority of deaths occurring within 12 months of ART initiation. Mortality was associated with advanced immunodeficiency or the presence of incurable disease at baseline. Among patients remaining on treatment, the median CD4 gain was 216 cell/mm3 and 86% of patients had viral load <400 copies/ml at the last clinical visit. The Georgia ART program has been successful in treating injection drug users infected with HIV.
doi:10.1155/2011/621078
PMCID: PMC3065882  PMID: 21490781
8.  Etiology of Neonatal Blood Stream Infections in Tbilisi, Republic of Georgia 
Introduction
Neonatal blood stream infections (BSI) are major cause of morbidity and mortality in developing countries. It is crucial to continuously monitor the local epidemiology of neonatal BSI to detect any changes in patterns of infection and susceptibility to various antibiotics.
Objective
To examine the etiology of BSI in two neonatal intensive care units (NICU) in the Republic of Georgia, a resource-poor country, and to determine antibiotic susceptibility of the isolated organisms.
Methods
Cross-sectional study among all septic infants was conducted in NICU of two pediatric hospitals in Tbilisi between 09/2003-09/2004.
Results
A total of 200 infants with clinical signs of sepsis were admitted in two NICUs. Of these, 126 (63%) had confirmed bacteremia. Mortality rate was 34%. A total of 98 (78%) of 126 recovered isolates were Gram-negative organisms, and 28 (22%) were Gram-positive. Klebsiella pneumoniae was the most common pathogen, accounting for 36 (29%) of 126 isolates, followed by Enterobacter cloacae – 19 (15%), and S. aureus – 15 (12%). The gram-negative organisms showed high degree of resistance to commonly used antibiotics such as ampicillin, amoxicillin/clavulanate, and comparatively low resistance to amikacin, ciprofloxacin, carbapenems, and gentamicin; 40% of S. aureus isolates were methicillin resistant (MRSA). In multivariate analysis only umbilical discharge was a significant risk factor for having positive blood culture at admission to NICU (PR=2.25, 95% CI 1.82-2.77).
Conclusions
Neonatal BSI was mainly caused by gram-negative organisms, which are developing resistance to commonly used antibiotics. Understanding the local epidemiology of neonatal BSI can lead to the development of better medical practices, especially more appropriate choices for empiric antibiotic therapy, and may contribute to improvement of infection control practices.
doi:10.1016/j.ijid.2008.08.020
PMCID: PMC2695829  PMID: 19058989
blood stream infections; Republic of Georgia; neonatal
9.  Not All Injection Drug Users are Created Equal: Heterogeneity of HIV, Hepatitis C Virus, and Hepatitis B Virus Infection in Georgia 
Substance use & misuse  2008;43(10):1424-1437.
Injection drug users (IDU) are widely believed to have accelerated the looming HIV/AIDS epidemic now faced by the Russian Federation and countries of the former Soviet Union. However, IDUs may be heterogeneous with regard to risk behaviors and a sub-population may be responsible for the majority of blood-borne pathogen transmission. We studied 926 adult injection drug users (IDU) from the cities of Tbilisi, Batumi, and Poti in Georgia, a small country in the Caucuses region between the Black and Caspian Seas, between 1997 and 1998. Study participants were administered a confidential questionnaire and were tested for antibody to HIV, hepatitis C virus (HCV), hepatitis B virus surface antigen (HBsAg), and hepatitis B core antibody (anti-HBc). Five (0.5%) individuals were positive for HIV, 539 (58.2%) for HCV, 67 (7.2%) for HBsAg, and 475 for (51.3%) for anti-HBc. 88.7% of the surveyed individuals reported sharing needles with others, and needle sharing with more than ten other individuals versus no sharing was a highly significant predictor (OR: 278.12, 95% CI: 77.57, 997.20) of HCV seropositivity. In adjusted analysis, individuals who usually injected stolen medical/synthetic drugs had significantly lower odds of HCV (OR: 0.38, 95% CI: 0.22, 0.68) and HBV (OR: 0.58, 95% CI: 0.37, 0.90) than individuals most commonly injecting opium. Despite some limitations, these results suggest the presence of substantial heterogeneity between different injection drug-using groups in Georgia. Identification of high risk IDU sub-populations is vital to efficiently target risk reduction programs, and to prevent confounding by risk status in large HIV/AIDS behavioral intervention and vaccine trials.
doi:10.1080/10826080802108293
PMCID: PMC2825388  PMID: 18696377
epidemiology; HIV; hepatitis C virus; hepatitis B virus; injection drug users; heroin; synthetic drugs; Georgia; Caucasus region; former Soviet Union
10.  Prevalence and Risk Factors for Latent Tuberculosis Infection among Health-care Workers in the Country of Georgia 
SUMMARY
BACKGROUND
Tuberculosis (TB) is a major public health problem in Georgia, but few TB infection control measures have been implemented in health-care facilities.
OBJECTIVE
To assess the prevalence and risk factors for latent TB infection (LTBI) among Georgian health-care workers (HCWs) using two diagnostic tests, the tuberculin skin test (TST) and the QuantiFERON-TB in-tube-test (QFT-3G), an interferon-γ release assay.
METHODS
A cross-sectional study was conducted between June-August 2006 among HCWs at the Georgian National TB Program.
RESULTS
265 HCWs were enrolled; 177 (67%) had a positive TST and 159 (60%) had a positive QFT-3G. 203 (77%) had a positive result for at least one of the tests and 50% tested positive for both tests. There was moderately good agreement between the tests (74%, κ=0.43 95% CI 0.33-0.55). In multivariate analysis, employment for >5 years was associated with increased risk of a positive TST (OR=5.09; 95% CI, 2.77-9.33) and QFT-3G (OR=2.26; 95% CI, 1.27-4.01); age >30 years, was associated with an increased risk of a positive QFT-3G (OR=2.91; 95% CI, 1.32-6.43).
DISCUSSION
A high prevalence of LTBI was found among Georgian HCWs and longer duration of employment was associated with increased risk. These data highlight the need for effective TB infection control measures and provide important baseline information as TB infection control measures are implemented.
PMCID: PMC2742226  PMID: 18419886
tuberculosis infection; interferon-γ assay; nosocomial transmission; skin test
11.  Hantavirus Infection in the Republic of Georgia 
Emerging Infectious Diseases  2009;15(9):1489-1491.
We describe a laboratory-confirmed case of hantavirus infection in the Republic of Georgia. Limited information is available about hantavirus infections in the Caucasus, although the infection has been reported throughout Europe and Russia. Increasing awareness and active disease surveillance contribute to our improved understanding of the geographic range of this pathogen.
doi:10.3201/eid1509.090617
PMCID: PMC2819886  PMID: 19788822
Hantavirus; hantavirus infections; viruses; Georgia; acute febrile illness; dispatch
12.  Risk factors and algorithms to identify hepatitis C, hepatitis B, and HIV among Georgian tuberculosis patients 
Summary
Objectives
To determine prevalence, risk factors, and simple identification algorithms for HIV, hepatitis B, and hepatitis C co-infection; factors that may predispose for anti-tuberculosis therapy-induced hepatoxicity.
Methods
We recruited 300 individuals at in-patient tuberculosis hospitals in three cities in Georgia, administered a behavioral questionnaire, and tested for antibody to HIV, hepatitis C (HCV), hepatitis B core antigen (anti-HBc), and the hepatitis B surface antigen (HBsAg).
Results
0.7% of the individuals were HIV positive, 4.3% were HBsAg positive, 8.7% were anti-HBc positive, and 12.0% were HCV positive. In multivariable analysis, a history of blood transfusion, injection drug use, and prison were significant independent risk factors for HCV, while a history of blood transfusion, injection drug use, younger age at sexual debut, and a high number of sex partners were significant risk factors for HBV. Three-questionnaire item algorithms predicted HCV serostatus 74.1% of the time and HBV serostatus 85.2% of the time.
Conclusions
Treatment of tuberculosis patients in resource-limited countries with concurrent epidemics of HCV, HBV, and HIV may be associated with significant hepatoxicity. Serologic screening of tuberculosis patients for HBV, HCV and HIV or using behavioral algorithms to identify patients in need of intensive monitoring during anti-tuberculosis therapy may reduce this risk.
doi:10.1016/j.ijid.2007.04.015
PMCID: PMC2649965  PMID: 17644020
hepatitis C; HIV; hepatitis B; tuberculosis; hepatoxicity; Georgia; epidemiology
13.  Prevalence of Hepatitis C, HIV, and Risk Behaviors for Blood-Borne Infections: A Population-Based Survey of the Adult Population of T'bilisi, Republic of Georgia 
Journal of Urban Health   2006;83(2):289-298.
Injection drug use and associated hepatitis C virus (HCV) and HIV infections are on the rise in Russia and the republics of the former Soviet Union. While small targeted studies have found widespread drug use and disease among at-risk populations, there have been few attempts to comprehensively evaluate the extent of these epidemics in general post-Soviet societies. We conducted a two-stage cluster randomized survey of the entire adult population of T'bilisi, Republic of Georgia and assessed the burden of HCV, HIV, and risk behaviors for blood-borne infections in 2,000 study participants. Of the 2,000 surveyed individuals, 162 (8.1%) had injected illicit drugs during their lifetimes. Of the individuals who had injected illicit drugs, 138 (85.2%) reported sharing needles with injection partners. HCV was found in 134 (6.7%) of the total surveyed population, but in 114 (70.4%) of those who had injected illicit drugs. We found HIV in only three (0.2%) individuals, all of whom had injected illicit drugs. Injection drug use and high-risk injection practices are very common in Georgia and may be harbingers of a large burden of HCV-associated liver diseases and a potentially serious HIV epidemic in the years to come.
doi:10.1007/s11524-006-9032-y
PMCID: PMC2527157  PMID: 16736377
Hepatitis C virus; HIV; Injection drug use; Needle sharing; Republic of Georgia

Results 1-13 (13)