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Hepatitis A Vaccine in HIV+: Low Response Rates Seen in Study
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Reported by Jules Levin
11th Annual Retrovirus Conference
Feb 8-11, 2004, San Francisco
S Weissman*1, C Feucht2, and H Yarmohammadi3; 1Hosp. of Saint Raphael New Haven, CT USA; 2Louis Stokes Cleveland VAMC, Cleveland, OH USA; and 3Mount Sinai Hosp. NYC, NY USA
Author's Conclusions:
--50% of HIV positive patients responded to a series of two hepatitis A vaccination. This is much lower than reported response rates of 96% and 100% response in HIV negative populations.
--Responders to vaccine had higher CD4 counts at the time of vaccination (486 vs 358 cd4s) and were more likely to be female than nonresponders
--CD4 nadir and HIV viral load did not predict response to hepatitis A vaccine.
--Age, race, ART use, Hepatitis B and C status did not predict responseto vaccine.
You can see the data in tables below.
Hepatitis A is a highly contagious virus seen commonly in an HIV+Population 30-50% of HIV+ patients in the U.S. are co-infected with hepatitis C Superinfection with hepatitis A in hepatitis C carrier can lead tofulminant hepatic failure. USPHS/IDSA guidelines recommend that all HIV/HCV co-infected patients who are not immune to hepatitis A receive hepatitis A vaccination. Immune response to hepatitis A vaccine has not been well studied inHIV positive patients.
Study objectives were to assess the immune response to hepatitis A vaccination in HIV positive patients; to assess the effect of viral load, CD4 nadir, CD4 count at vaccination, on immune response rates to hepatitis A vaccination in HIV positive patients; to assess the effect of current ART use, hepatitis B and hepatitis Cco-infection on immune response rates.
HIV positive patients were tested for HAV IgG antibodies (HAV ab). Patients with negative HAV ab received two HAV vaccines (HAVRIX) 6 to 12 months apart.Post HAV ab response was measured after the 2nd vaccine. Medical charts were reviewed. Data on race, age, gender, CD4 count, viral load, ART use, and hepatitis B and C status was collected. Bivariate and multivariate analysis was done using SPSS software.
All HIV positive patients were included who were seen at Hospital of Saint Raphael(HSR) HIV Clinic and Louis Stokes Cleveland VAMC HIV clinic who had hepatitis Aserologies checked prior to vaccination. Patients were excluded if they had Hepatitis A IgG positivity prior to hepatitis A vaccination and if they had contraindications for Hepatitis A vaccination. A total number of 490 patients were included (349, HSR; 141 Cleveland). 59% were included and 41% were excluded: total studied 285 pts, and complete data was available on 123 pts.
The mean age was 41 for pts included; 84% were <50; 36% white; 66% male; HIV risk group: 29% MSM; 9% IVDU; 62% heterosexual; CD4 nadir 216; 32% were HCV+; and 10% had HBV exposure. Older age, HIV risk group, and non-white race were associated with prior HAV ab positivity.
PREDICTORS of RESPONSE TO VACCINE
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Responders n=61
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Nonresponders n=62
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p
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Age
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43.9
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44.7
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0.6
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Age >50
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22.0
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30.6
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0.3
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Gender (male)
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62.3
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82.3
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Race (white)
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35.0
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42.6
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0.4
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HIV Risk group
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-MSM
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34%
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33%
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-IVDU
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7%
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9%
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-Hetero
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59%
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58%
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PREDICTORS OF RESPONSE TO VACCINE
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Responders n=61
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nonresponders n=62
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p
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Cd4 at vaccine
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486
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358
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0.02
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Cd4 at vaccine <200
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12%
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32%
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0.08
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ART therapy
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85%
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84%
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0.84
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VL at vaccine (copies/ml)
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6099
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25,848
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0.04
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Log VL at vaccine
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2.58
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2.51
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0.11
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VL at vaccine <400
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67%
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56%
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h 0.32f
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There were some nonresponders with over 500 cd4s; and there were some responders with <200 cd4s but not many. There were some nonresponders with low HIVviral load and some responders with over 10,000 copies/ml viral load but no responders had HIV VL >100,000 c/ml. The study did not state if some patients did in fact have >100,000 c/ml.
MULTIVARIATE LOGISTIC REGRESSION
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OR
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95% CI
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p-value
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Sex
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3.33
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1.20-9.25
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0.02
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Cd4 nadir
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1.00
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0.99-1.00
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0.90
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Cd4 <200 at vaccine
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0.28
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0.09-.84
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0.02
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HCV+
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1.89
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0.84-4.20
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0.12
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Study site
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1.60
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0.66-3.87
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0.30
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RESULTS
--123 patients had completed their hepatitis A vaccine series and hadpost vaccine hepatitis A IgG results available for analysis
--Of the 123 patients included in the analysis, 72% were male witha mean age of 43 years
--61 of 123 patients (50%) had a positive post vaccine hepatitis A IgGtiter (Responders)
--62% of Responders were male vs. 82% of Nonresponders (p=0.01)
--68% of women were Responders vs. 43% of men (data not shown)
--Mean CD4 count nadir of Responders vs. Nonresponders is241 cells/mm3 vs. 195 cells/mm3, (p=0.19)
--52% of Responders vs. 61% of Nonresponders had CD4 count nadirs<200 cells/mm3 (p=0.29)
--The mean CD4 count at vaccine was 486 cells/mm3 for Respondersvs. 358 cells/mm3 for Nonresponders (p=0.02)
--12% of Responders had CD4 counts of <200 cells/mm3 at vaccine vs.32% of Nonresponders (p=0.008)
--The mean log HIV viral load at vaccine was 2.58 for Responders vs.2.51 for Nonresponders (p=0.11)
--67% of Responders had HIV viral load <400 copies/ml at vaccine vs.56% of Nonresponders (p=0.32)
--85% and 84% of Responders and Nonresponders, respectively, wereon antiretroviral therapy at the time of HAV vaccine
--The scatter plots show that there is a wide range of CD4 count andviral load levels for Responders and Nonresponders. There is nota CD4 count or HIV viral load level that predicts nonresponse toHAV vaccine.
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