NEW CHALLENGES FOR ACCURATE HIV-1 DIAGNOSIS ALL BELGIAN AIDS REFERENCE LABORATORIES KAROLIEN STOFFELS (ARL VUB STP) & FIEN VANROYE (ARL ITM)
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1 NEW CHALLENGES FOR ACCURATE HIV-1 DIAGNOSIS ALL BELGIAN AIDS REFERENCE LABORATORIES KAROLIEN STOFFELS (ARL VUB STP) & FIEN VANROYE (ARL ITM) 30 NOVEMBER 2018, BRUGGE 0
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3 NEW CHALLENGES FOR ACCURATE HIV-1 DIAGNOSIS ALL BELGIAN AIDS REFERENCE LABORATORIES KAROLIEN STOFFELS (ARL VUB STP) & FIEN VANROYE (ARL ITM) 30 NOVEMBER 2018, BRUGGE 2
4 DIAGNOSIS HIV IN BELGIUM Very sensitive but less specific 1st serology screen test for HIV reactif (Ag+Ab) Very specific but less sensitive 2nd serology screen test for HIV (Ag+Ab) confirmation test (Ab) - Immunoblot (INNO-LIA HIV I/II - FujiRebio) - Immunochromatography (Geenius HIV 1/2 - BioRad) - Western Blot (HIV Blot MP Biomedicals) additional tests (Ag p24, VL) if confirmation is negative or indeterminate 3
5 gp120 gp41 p31 p24 p17 gp105 gp36 gp160 gp120 p66 p55 p51 gp41 p39 p31 p24 p17 Serum control HIV-2 NEG INNO-LIA HIV I/II Score Geenius HIV 1/2 HIV Blot 2.2 controls C IND HIV-1 HIV HIV-2 HIV-1 HIV-1 HIV-2 HIV-1 HIV-2 4
6 DIAGNOSIS IN RESOURCE- CONSTRAINT SETTINGS: RAPID TESTS 5
7 TEST WINDOW PERIOD RAPIDS 4th BM Branson, Acquir Immune Defic Syndr 2010,vol 5 6
8 DIAGNOSIS HIV IN CASE OF ART? 7
9 DIAGNOSIS HIV IN CASE OF ART? 8
10 DIAGNOSIS HIV IN CASE OF ART? 9
11 CASE: BRAZILIAN PATIENT 2006 : HIV diagnosis in Brasil 2007: start treatment 2009: follow-up in ARC STP Date SCREENING INNO-LIA VL (cp/ml) 28/09/2009 POS IND <40 06/12/2011 POS IND <20 06/06/2012 POS IND <20 04/2012 : STOP TREATMENT 28/09/2012 POS HIV /2012 : RESTART TREATMENT Atripla 14/03/ /07/2013 <20 10
12 7.2% (386/5331) of requested confirmations are not performed because the patients are already known as HIV infected in the corresponding ARL (2017) Taking any treatment? No... 11
13 INFLUENCE OF ART ON HIV DIAGNOSIS IN BELGIUM? 12
14 ARL STUDY ON HIV DIAGNOSTIC TESTS IN BELGIUM EFFICIENT TREATMENT GROUP 1: CHRONIC Treatment for >10 years GROUP 2: ACUTE Start treatment during acute infection Standard confirmation tests used in Belgium Rapid tests used in resource-constrained settings 13
15 RAPID TESTS Assay Manufacturer CE WHO Abon HIV1/2/O Tri-Line Rapid Test Device Abon, China No Yes Determine HIV 1/2 Alere Health, Japan Yes Yes First Response HIV 1.2.O Card Test Premier Medical Coorporation, India Yes Yes INSTI HIV Test Biolytical Laboratories, Canada Yes Yes SD Bioline HIV 1/2 Alere Health, Japan Yes Yes HIV 1/2 STAT PAK Chembio, USA Yes Yes First Response Rapid test for Ab to HIV (colloidal gold) Wantai, Shanghai No Yes First Response SD Bioline Abon STAT PAK Wantai Determine 14
16 GROUP 1: chronic, treatment >10 years Inclusion criteria: - Patients with HIV-1 VL <50 cp/ml for at least 10 years with a maximum interval between 2 consecutive VL determinations of 18 months no blips allowed - With documented results at least uptill end patients, undetectable VL for 14 years in average [10y ; 21y] 15
17 GROUP 1: chronic, treatment >10 years CONFIRMATION REFERENCE TESTING ON MOST RECENT SAMPLE: GEENIUS OR INNO-LIA OR WB 1.5% (6/388) was not confirmed to be HIV-1 positive 98.5% HIV-1 (382) 1.3% IND (5) 0.2% NEG (1) 16
18 GROUP 1: chronic, treatment >10 years (388 patients) Rapid tests 3.7% (14) Reference tests Rapid tests 17% (1) 96.3% (368) 98.5% HIV-1 (382) 1.3% IND (5) 0.2% NEG (1) 83% (5) All (7) Rapid Tests Reactive 1/7 Rapid Test Non Reactive 17
19 GROUP 1: chronic, treatment >10 years 18
20 DIAGNOSIS HIV IN CASE OF ART? 19
21 GROUP 2: ART during acute infection Inclusion criteria: - All patients diagnosed HIV-1 in 2010 or later and not lost to follow-up after diagnosis With documented acute HIV-1 infection HIV confirmation test negative or indeterminate AND Ag p24 positive or RNA VL positive acute only - AND started efficient treatment within 3 months no blips once undetectable viral load has been obtained treatment started between 0 and 88 days after diagnosis 83 patients included in study 20
22 GROUP 2: ART during acute infection (83 patients) 1st sample HIV-1 acute infection Follow-up samples Most recent sample time routine confirmation test: (INNO-LIA OR Geenius OR MP Blot 2.2) 90.4% HIV-1 (79) 9.6% IND (8) 9.6% (8/83) were not confirmed as HIV-1 positive 21
23 GROUP 2: ART during acute infection (83 patients) 1st sample HIV-1 acute infection routine confirmation test: (INNO-LIA OR Geenius OR MP Blot 2.2) 90.4% HIV-1 (79) Follow-up samples Most recent sample 9.6% IND (8) time 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Start treatment after diagnosis Q1 0 6 days Q days Q days Q days Start treatment after diagnosis Q1 Q2 Q3 Q4 HIV-1 IND 22
24 Evolution of the 9.6% IND results 1st sample HIV-1 acute infection NEG Follow-up samples IND Most recent sample IND time 3 patients Subtype A1 CRF36 CRF01_AE Time between first and recent sample 2.4 years 1.8 years 0.4 years Start treatment after diagnosis 8 days 7 days 0 days NEG / IND HIV-1 IND 4 patients B B B CRF02_AG 1.7 years 3.7 years 3.1 years 2.0 years 12 days 12 days 7 days 47 days NEG? IND 1 patient B 0.4 years 54 days 9.6% IND 90.4% HIV-1 23
25 GROUP 2: ART during acute infection Rapid tests Rapid tests 25,3% (19) 74,7% (56) 90.4% HIV-1 (75) Reference tests 9.6% IND (8) 37,5% (3) 62,5% (5) All (7) Rapid Tests Reactive 1/7 Rapid Test Non Reactive 24
26 GROUP 2: ART during acute infection 25
27 Acute Chronic Reference testing Conclusion study Rapid tests 1.3% IND (5) 0.2% NEG (1) 98.5% HIV-1 (382) 26
28 DIAGNOSIS HIV IN CASE OF PREP? 27
29 CASE: ITM PREP PATIENT Date Screening Antigen Confirmation (Geenius) Inno- Lia HIV-1 Viral load (cp/ml) HIV-1 DNA CD4 Therapy 06/2017 NEG/NEG NEG / / / / / / 07/2017 START PREP TRUVADA 07/2017 NEG/POS NEG NEG / <60 / / TDF/FTC 09/2017 POS/POS NEG NEG / / / / TDF/FTC 12/2017 START TRITHERAPY STRIBILD 12/2017 POS/POS NEG IND (gp41) IND (gp41) <20 NEG 844 EVG/c/TAF/FTC 03/2018 POS/POS NEG IND (gp41) / <20 / 1029 EVG/c/TAF/FTC Additional tests performed in Ghent: all tests are negative 28
30 Conclusion: Do we need other markers for diagnosis? Ag/Ab based NAT Screening tests DNA detection Confirmation tests (blots) RNA viral load Rapid tests 29
31 30
32 Thank you! Any questions? 31
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