Epidemiologic Analysis of Hepatitis Pilot Data Sets
This content presents an epidemiologic analysis of pilot data sets related to Hepatitis, focusing on chronic/recovered infection rates, viral genotyping/sequencing, and host genotyping. It includes information from pilot studies in Nigeria and Ghana, discussing seroprevalence of HIV, HCV, HBV, and ALT levels among study populations. The data analysis plan, comparison of positive to negative populations, and results from the pilot studies are also highlighted.
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Presentation Transcript
Jennifer Layden, MD, PhD Assistant Professor of Medicine and Public Health Sciences Loyola University Health System
Review of Pilot data Discuss 2 pilot data sets Review basic epidemiologic data Discuss ongoing / planned analyses
Hepatitis Pilot Data from two source populations METS Nigeria Pilot Study Pilot Study Samples from Ghana (H3N Study) ff Subjects enrolled in H3N study (B Tayo) N: 200 (METS study; A Luke, PI) N=493 Aims: Aims: -chronic/recovered infection rates -immediate cases/controls for: -viral genotyping/sequencing -chronic/recovered infection rates --immediate cases/controls for: -viral genotyping/sequencing -host genotyping -host genotyping
Data Analysis Plan Stored samples run in LUMC reference lab HCV: 4th generation Ab HBV: Surface Ag HIV: HIV-1/2 Ab Aminotransferase level (ALT)
METS Cohort Pilot Study (N=493) Seroprevalence 3.9% N=19 5.9% N=29 14.2% N=70 HIV (% HIV Ab positive) HCV (% HCV Ab positive) HBV (% HBV Surface Antigen positive) ALT Median (Range) 17 (5-95)
METS Pilot Study Comparison of HCV Antibody Positive to Negative Population HCV Ab Positive (N=29) 19 13.8% (4) 13.8% (4) HCV Ab Negative (N=461) 17 3.8% (16) 14.1% (65) P-value NS 0.01 NS ALT (median) HIV Ab positive HBsAg positive Comparison of HBV S Antigen Positive to Negative Population HBsAg Positive (N=70) HBsAg Negative (N=423) P-value ALT (median) 21 16 0.001 HIV Ab positive 4.3% (3) 5.9% (25) NS HCV positive 5.8% (4) 5.9% (25) NS
Nigeria (H3N) Pilot Study (N=200) Seroprevalence HIV 5.0% N=10 (% HIV Ab positive) HCV 3.0% N=6 (% HCV Ab positive) HBV 7.5% N=15 (% HBV Surface Antigen positive) ALT Median (Range) 13.8 (5-171)
Nigeria Pilot Results Comparison of HCV Antibody Positive to Negative Population HCV Ab Positive (N=6) 12.8 5.6 33.3% (2) 16.6% (1) HCV Ab Negative (N=194) 13.8 16.1 4.1% (8) 7.2% (14) P-value 0.88 0.001 0.4 ALT HIV Ab positive HBsAg positive Comparison of HBV S Antigen Positive to Negative Population HBsAg Positive (N=15) HBsAg Negative (N=185) P-value 24.5 41.1 12.9 11.53 ALT 0.006 HIV Ab positive 53.3% (8) 1.1% (2) 0.1 HCV positive 6.7% (1) 2.7% (5) 0.4
Logistic Regression: Association with HCV Seropositivity Univariable Analyses Variable OR 95% CI P-value HIV + 6.7 2.7-16.9 <0.001 HBV S Ag+ 1.4 0.6-3.5 0.5
Logistic Regression: Association with HBV S Ag Seropositivity Univariable Analyses Variable OR 95% CI P-value HIV + 1.5 0.6-4.1 0.4 HCV Ab+ 1.4 0.6-3.5 0.5 ALT 1.03 1.01-1.04 0.001
Summary of Basic Analysis Overall higher than expected HCV Sero- positivity in Ghana and Nigeria Low mean ALT levels Overall low values No variation seen by HCV status Higher values in those with +S Ag HCV Seropositivity associated with: HIV + status (>6 OR s) HBV S Ag + associated with: -higher ALT values
Ongoing Analyses Samples to CDC: HCV / HBV viral sequencing / genotyping Viral load measurements Samples to Duke: Genotyping of IL28B SNP s Association of cleared vs chronic infection Overall allelic variation
HBV S Antigen / S Gene Sequencing Concordancy Results S Ag positive: 85 individuals S Gene positive: 136 individuals S gene+ S gene - N HBV S Ag + 53 (7.6%) 32 (4.6%) 85 HBV S Ag- 83 (12.0%) 525 (75.8%) 508 N 136 557 593
Factors Associated HbSAg and S gene Status S Ag+ Sag- Variable S Gene+ N=53 S Gene- N=32 S Gene+ N=83 S Gene N=525 HIV Ab + 5.7% 6.2% 3.6% 4.0% HCV Ab+ 9.4% 3.1% 4.8% 5.1% ALT 22.7 22.9 16.8 16.3
Questions Arising from these results What contributes to the discordant results? Is there a high level of occult HBV? Significance? Can there be mutations within the SAg causing the low rate?
Current Progress of Pilot Data CDC based testing: HBV: Check HBV EAg and EAb, CoreAb, SAb and HBV DNA quant HCV: Finishing sequencing results Assess for chronic infection rates Duke IL28B genotyping Allelic variation across SNPs
Kumasi Blood Bank Protocol Active Enrollment Re-testing and survey administration to assess risk factors of acquistion
Investigators LUMC: N Mora, I Berzin, L Dugas, B Tayo, A Luke METS: A Luke, PhD; J Plange-Rhule, MD, PhD Nigeria: B Tayo, PhD, B Salako, MD, A Akere, MD CDC: J Forbi, PhD, Y Khadanov, PhD Duke: T Urban, PhD, PharmD
