title: Virologic outcomes of second-line antiretroviral therapy in Eastern European country of Georgia.
abstract: 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.
authors.affiliation: Infectious Diseases, AIDS and Clinical Immunology Research Center, 16 Al. Kazbegi Avenue, Tbilisi 0160, Georgia.
authors.forename: Nikoloz
authors.initials: N
authors.lastname: Chkhartishvili
authors.affiliation: Infectious Diseases, AIDS and Clinical Immunology Research Center, 16 Al. Kazbegi Avenue, Tbilisi 0160, Georgia ; I. Javakhishvili Tbilisi State University Faculty of Medicine, 16 Al. Kazbegi Avenue, Tbilisi 0160, Georgia.
authors.forename: Lali
authors.initials: L
authors.lastname: Sharvadze
authors.affiliation: Infectious Diseases, AIDS and Clinical Immunology Research Center, 16 Al. Kazbegi Avenue, Tbilisi 0160, Georgia.
authors.forename: Natia
authors.initials: N
authors.lastname: Dvali
authors.affiliation: Infectious Diseases, AIDS and Clinical Immunology Research Center, 16 Al. Kazbegi Avenue, Tbilisi 0160, Georgia.
authors.forename: Marine
authors.initials: M
authors.lastname: Karchava
authors.affiliation: Infectious Diseases, AIDS and Clinical Immunology Research Center, 16 Al. Kazbegi Avenue, Tbilisi 0160, Georgia.
authors.forename: Nino
authors.initials: N
authors.lastname: Rukhadze
authors.affiliation: Infectious Diseases, AIDS and Clinical Immunology Research Center, 16 Al. Kazbegi Avenue, Tbilisi 0160, Georgia.
authors.forename: Maia
authors.initials: M
authors.lastname: Lomtadze
authors.affiliation: Infectious Diseases, AIDS and Clinical Immunology Research Center, 16 Al. Kazbegi Avenue, Tbilisi 0160, Georgia.
authors.forename: Otar
authors.initials: O
authors.lastname: Chokoshvili
authors.affiliation: Infectious Diseases, AIDS and Clinical Immunology Research Center, 16 Al. Kazbegi Avenue, Tbilisi 0160, Georgia ; I. Javakhishvili Tbilisi State University Faculty of Medicine, 16 Al. Kazbegi Avenue, Tbilisi 0160, Georgia.
authors.forename: Tengiz
authors.initials: T
authors.lastname: Tsertsvadze
keywords: Antiretroviral therapy; Eastern Europe; HIV; Second-line ART