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1.  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
2.  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
3.  Hepatitis C Virus Co-Infection Increases the Risk of Anti-Tuberculosis Drug-Induced Hepatotoxicity among Patients with Pulmonary Tuberculosis 
PLoS ONE  2013;8(12):e83892.
Background
The country of Georgia has a high prevalence of tuberculosis (TB) and hepatitis C virus (HCV) infection.
Purpose
To determine whether HCV co-infection increases the risk of incident drug-induced hepatitis among patients on first-line anti-TB drug therapy.
Methods
Prospective cohort study; HCV serology was obtained on all study subjects at the time of TB diagnosis; hepatic enzyme tests (serum alanine aminotransferase [ALT] activity) were obtained at baseline and monthly during treatment.
Results
Among 326 study patients with culture-confirmed TB, 68 (21%) were HCV co-infected, 14 (4.3%) had chronic hepatitis B virus (HBV) infection (hepatitis B virus surface antigen positive [HBsAg+]), and 6 (1.8%) were HIV co-infected. Overall, 19% of TB patients developed mild to moderate incident hepatotoxicity. In multi-variable analysis, HCV co-infection (adjusted Hazards Ratio [aHR]=3.2, 95% CI=1.6-6.5) was found to be an independent risk factor for incident anti-TB drug-induced hepatotoxicity. Survival analysis showed that HCV co-infected patients developed hepatitis more quickly compared to HCV seronegative patients with TB.
Conclusion
A high prevalence of HCV co-infection was found among patients with TB in Georgia. Drug-induced hepatotoxicity was significantly associated with HCV co-infection but severe drug-induced hepatotoxicity (WHO grade III or IV) was rare.
doi:10.1371/journal.pone.0083892
PMCID: PMC3868578  PMID: 24367617
4.  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.  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
7.  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 1-7 (7)