Dr. Anca StreinuDr. Anca Streinu--CercelCercelNational Institute of Infectious DiseasesNational Institute of Infectious Diseases
Prof. Dr. Matei BalsProf. Dr. Matei BalsBucharest, Romania Bucharest, Romania
STUDY DESIGNSTUDY DESIGNThis study was a cross-sectional observational study to evaluate the prevalence of HLA-B*5701 in the CEE countries.
Any HIV-1 infected patient was eligible for this study including treatment naïve and experienced patients, as well as patients previously tested for HLA-B*5701.
OBJECTIVESOBJECTIVES & & ENDPOINTSENDPOINTSPrimary
To determine the prevalence of HLA-B*5701 in the CEE HIV-1 infected population as a whole.
SecondaryTo assess the prevalence of HLA-B*5701 in the Caucasian CEE study population. The primary interest was the prevalence of Caucasians (representing the majority of patients) and other ethnic groups.To describe the HLA-B*5701 results provided by local laboratory methods.To asses the prevalence of HLA-B*57 throughout monoclonal antibody method in Caucasian CE study population.
STUDY DESIGNSTUDY DESIGN
Any HIV-1 infected patient was eligible for this study including treatment naïve and experienced patients, as well as patients previously tested for HLA-B*5701.
1440 HIV positive patients
Naïve pts and Experienced pts.
HLA B*5701 genetic testing
Reproducible methodology – Assign SBT v3.5 Abbott
Results for CEE countries
Positive pts Negative pts UD* pts
STUDY STUDY POPULATIONPOPULATIONEnroled 1440 subjects naive and experienced from February 2008 to February 2009 in CEE area – for an IC 95%
Participating Countries:Bulgaria – 41 ptsEstonia – 352 ptsHungary – 136 ptsLatvia – 160 ptsLithuania –71 ptsRomania – 640 ptsSlovenia – 40 pts
Hungary136 Romania
640
Bulgaria41
Slovenia40
Estonia352
Latvia160
Lithuania71
CEE included countries
STUDY ASSESSMENTS AND STUDY ASSESSMENTS AND PROCEDURESPROCEDURESDuring a single visit for each patient were:
Assessed patient’s demography (age, sex, mode of HIV transmission, ethnicity, country of origin and parental country of origin) was conducted, Collected blood sample to determine HLA-B*5701 genotype by the local laboratories (Sequence Specific Primer-based methodologies).
Data on patient treatment was not collected
5% of the total patients tested for HLA-B*5701 genotype supposed to be tested also for HLA-B*57 –monoclonal antibody method
Demographic dataDemographic dataCharacteristsCharacterists Total no of ptsTotal no of pts
14401440CICI Standard Standard
errorerror
SexSex No of patients / %No of patients / %
Male Male FemaleFemale
839 / 58.26839 / 58.26601 / 41.73601 / 41.73
Age Age –– yryr Mean valueMean value
Mean for HLA B5701 Mean for HLA B5701 ++
Mean for HLA B5701 Mean for HLA B5701 ––
24.89 (deviation 7.96)24.89 (deviation 7.96)28.22 (deviation 11.17)28.22 (deviation 11.17)
95%95%95%95%
1.931.930.500.50
Race & Ethnic groupRace & Ethnic group No of patients / %No of patients / %
AfrAmAfrAmAsCtrSudAsCtrSudAsSudEstAsSudEstWithCauCEEWithCauCEE
1 / 0.11 / 0.12 / 0.12 / 0.11 / 0.11 / 0.11436 / 99.71436 / 99.7
Risk factors Risk factors ––global global resultsresults
Risk factors associatedRisk factorsRisk factors nono %% Pearson correlationPearson correlation Sperman correlationSperman correlation
IVDUIVDU 261261 18.118.1 0.000.00 0.000.00
HemophHemophiliacsiliacs 44 0.30.3 0.000.00 0.000.00
HeterosexualsHeterosexuals 410410 28.528.5 0.000.00 0.000.00
Hetero & IVDUHetero & IVDU 2020 1.41.4 0.000.00 0.000.00
Hetero & IVDU & TransfHetero & IVDU & Transf 11 0.10.1 0.560.56 0.700.70
Hetero & TransfHetero & Transf 11 0.10.1 0.740.74 0.700.70
MSMMSM 193193 13.413.4 0.000.00 0.000.00
MSM & HeteroMSM & Hetero 11 0.10.1 0.000.00 0.000.00
MSM & otherMSM & other 11 0.10.1 0.000.00 0.000.00
TransfusionsTransfusions 66 0.40.4 0.000.00 0.000.00
Transfusions & otherTransfusions & other 11 0.10.1 0.0430.043 0.0430.043
Vertical transmitionsVertical transmitions 1111 0.80.8 0.000.00 0.000.00
OthersOthers 515515 35.835.8 0.000.00 0.000.00
UnknownUnknown 1515 1.01.0 0.000.00 0.000.00
Cronbachs Alpha = -12.152907, Standardized Cronbachs Alpha = -1.771626
56; 4%
1290; 89%
94;7%
Pozitiv Negativ Undeterminate
Global CEE ResultsGlobal CEE Results
Positive HLA-B*5701 HIV-1 Pts
Country absolute no. Country absolute no. resultsresults
4.87%4.87%
6.61%6.61% 5.0%5.0% 4.22%4.22%
2.65%2.65%
2.5%2.5%
4.0%4.0%
Country pts sex distribution
Female/male positive results Female/male positive results distributiondistribution
P< 0.05
Subgroup Subgroup analyzesanalyzesCorelation with the risk factors and HLA results was not statistical significant-subgroups analyzes ( p>0.05)
Corelation by ethnicity was statistical significant for male patients who represent the majority of patients positive for HLA B 5701 (p <0.05), if both parents are the same race (p=0.05)
Statistical analysesStatistical analyses
All dates were analyzed using SPSS 16.0 for Windows.
ConclusionsConclusions
HLA B*5701 prevalence for participating CEE countries was similar to other available study results, but on a significantly larger population (1440 pts)
The positive results on male patients was significant higher for the total number of patients.(p<0.05)
Ethnic correlation for male patients with both parents from same race was statisticalysignificant (p=0.05)
AcknowledgeAcknowledge::Study team:
Prof. Adrian Streinu/Cercel Romania: [email protected]. Tania Cherveniakova Bulgaria: [email protected]. Matti Maimets Estonia: [email protected]. Denes Benhegy Hungary: [email protected]. Inga Januskevica Latvia: [email protected]. Vilma Updaviviene Lithuania: [email protected]. Janez Tomazic Slovenia: [email protected]
GSKGSK –supporting the study
