Dr. Anca Streinu Dr. Anca Streinu - - Cercel Cercel National Institute of Infectious Diseases National Institute of Infectious Diseases Prof. Dr. Matei Bals Prof. Dr. Matei Bals Bucharest, Romania Bucharest, Romania
Oct 31, 2020
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