Initiation of antiretrovirals in HIV/HCV co-infected MSM: Are we too late?

Transcription

1 Initiation of antiretrovirals in HIV/HCV co-infected MSM: Are we too late? Thomas Martin, Sophie Jose, Alicia Thornton, Natasha Martin, Caroline Sabin, Mark Nelson

2 Background Antiretroviral therapy (ART) in HIV/HCV co-infected individuals reduces risk of liver disease progression and may reduce risk of HIV transmission in MSM UK treatment guidelines have changed to reflect this, recommending ART initiation at higher CD4 counts in co-infected individuals Year CD4 < * * * HIV/HCV specific guidelines CD CD CD4 >500 Start ART Consider Defer However, the level of ART coverage and timing of ART initiation in this group is unknown

3 Key outcomes by calendar year 1. Proportion of people on ART (>1 drug at any time in year) 2. Mean HIV viral load (VL) and proportion with VL suppression 3. Median (IQR) most recent and nadir CD4 count* at ART initiation 4. Proportion of all CD4 counts* triggering ART initiation (within 6 months and before next CD4 count), according to CD4 strata 5. Probability of initiating ART by a given CD4 count* cumulative incidence estimated with death as a competing risk stratified by calendar year of positive HCV Ab test * Where confirmatory CD4 counts (within 45 days) were recorded, an average of these CD4 counts was used

4 Inclusion criteria Outcome Inclusion N 1. Proportion on ART 2. Mean HIV VL and proportion with VL suppression Exposed to HIV through sex between men (MSM) HCV Ab +ve* prior to 2012 >1 day follow up 1587 * Once positive, assumed to remain positive for the analysis

5 Inclusion criteria Outcome Inclusion N 1. Proportion on ART 2. Mean HIV VL and proportion with VL suppression Exposed to HIV through sex between men (MSM) HCV Ab +ve* prior to 2012 >1 day follow up Median (IQR) most recent & nadir CD4 at ART initiation 4. Proportion of CD4 counts triggering ART First HCV Ab +ve result in follow up whilst ART naïve >1 CD4 count between follow up start and ART initiation /follow up end 535 * Once positive, assumed to remain positive for the analysis Sensitivity analysis further excluding late presenters

6 Inclusion criteria Outcome Inclusion N 1. Proportion on ART 2. Mean HIV VL and proportion with VL suppression Exposed to HIV through sex between men (MSM) HCV Ab +ve* prior to 2012 >1 day follow up Median (IQR) most recent & nadir CD4 at ART initiation 4. Proportion of CD4 counts triggering ART First HCV Ab +ve result in follow up whilst ART naïve >1 CD4 count between follow up start and ART initiation /follow up end Probability of initiating ART by given CD4 count CD4 count >500 cells/mm 3 at first HCV Ab +ve result 208 * Once positive, assumed to remain positive for the analysis Sensitivity analysis further excluding late presenters

7 Characteristics at first positive HCV Ab N=1587 Age, mean (SD) 39 (8.2) Ethnicity, n (%) White Other/unknown Year of HCV diagnosis, n (%) < (85.7) 227 (14.3) 192 (12.1) 378 (23.8) 410 (25.8) 607 (38.2) Years diagnosed with HIV, median (IQR) 6.2 (2.2, 11.7) CD4 count [cells/mm 3 ], median (IQR) 461 (325, 630) HIV VL [log 10 copies/ml], median (IQR) 2.1 (1.7, 4.5) ART naïve, n (%) 673 (42.4)

8 Percent (%) Patients on ART, with VL suppression and mean VL in full study group On ART VL <200 copies/ml* Year * Based on last viral load available in each year

9 Percent (%) Patients on ART, with VL suppression and mean VL in full study group Viral Load (log 10 copies/ml) On ART VL <200 copies/ml* Mean VL 0 0 Year Mean of all viral loads over the year calculated for each person then averaged. Half the lower limit of detection for assay used if viral load undetectable.

10 CD4 count (cells/mm 3 ) Median (IQR) recent/nadir CD4 at ART initiation Most recent CD4 Nadir CD4 Year

11 CD4 count (cells/mm 3 ) Median (IQR) recent/nadir CD4 at ART initiation Most recent CD4 Nadir CD4 Year

12 Percent (%) % of CD4 counts that result in ART initiation, by CD4 strata <200 (n=177) (n=867) (n=1146) >500 (n=1245) Year ART initiations CD4 counts

13 Percent (%) % of CD4 counts that result in ART initiation, by CD4 strata <200 (n=177) (n=867) (n=1146) >500 (n=1245) Year ART initiations CD4 counts

14 Probability of initiating ART by a given CD4 count Median CD4 count at ART initiation (cells/mm 3 ) : : : 245

15 Probability of initiating ART by a given CD4 count Median CD4 count at ART initiation (cells/mm 3 ) : : : 320

16 Probability of initiating ART by a given CD4 count HIV mono-infected MSM ( ) Median CD4 at initiation 357 cells/mm 3 54% initiated ART by a CD4 of 350 cells/mm 3 97% initiated ART by a CD4 of 200 cells/mm 3

17 Conclusions ART coverage has increased and mean HIV VL decreased in the HIV/HCV co-infected MSM population over time Despite guidelines recommending ART at CD4 counts <350 cells/mm 3, the majority of patients had not initiated ART by this threshold between , when diagnosed at a higher CD4 count Reasons for delayed ART initiation are unknown; future studies should identify factors associated with this outcome More recent follow up needed to see if patterns remain and to assess more recent changes to guidelines The benefits of ART for HIV/HCV co-infected MSM should be emphasised to clinicians and patients

18 UK CHIC: Acknowledgements Research Department of Infection and Population Health, UCL Medical School: C Sabin, T Hill, A Phillips, S Jose, S Huntington, A Thornton Medical Research Council Clinical Trials Unit (MRC CTU): D Dunn, A Glabay Brighton and Sussex University Hospitals NHS Trust : M Fisher, D Churchill, N Perry, S Tilbury Chelsea and Westminster NHS Trust: B Gazzard, M Nelson, M Waxman, D Asboe, S Mandalia Kings College London School of Medicine, GKT Hospitals: F Post, H Korat, C Taylor, Z Gleisner, F Ibrahim, L Campbell Mortimer Market Centre, UCL Medical School: R Gilson, N Brima, I Williams Royal Free NHS Trust/UCL Medical School: M Johnson, M Youle, F Lampe, C Smith, A Phillips, R Tsintas, C Chaloner, S Hutchinson Imperial College Healthcare NHS Trust: J Walsh, N Mackie, A Winston, J Weber, F Ramzan Barts and the London NHS Trust: C Orkin, J Lynch, J Hand, C de Souza Homerton University Hospital NHS Trust: J Anderson, S Munshi, D Awosika The Lothian University Hospital NHS Trust: C Leen, A Wilson North Middlesex University Hospital NHS Trust: A Schwenk, J Ainsworth, C Wood, S Miller Health Protection Agency Centre for Infections: V Delpech North Bristol NHS Trust: M Gompels, S Allan University of Leicester NHS Trust: A Palfreeman, A Moore, L Fox South Tees Hospitals NHS Foundation Trust: D Chadwick, K Baillie Woolwich NHS Trust: S Kegg, P Main Coventry NHS Trust: S Allan St. George s NHS Trust: P Hay, M Dhillon York: F Martin, S Douglas UK CHIC is funded by the UK Medical Research Council