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Twenty-four month outcome of the PASER cohort: what happens to patients failing ART?

Twenty-four month outcome of the PASER cohort: what happens to patients failing ART? . Pascale Ondoa Sonia Boender. PASER studies in figures . 6 countries 13 clinical sites . 2 nd line. 1 st line. 2755 patients initiating 1 st line followed up for at least 24 month.

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Twenty-four month outcome of the PASER cohort: what happens to patients failing ART?

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  1. Twenty-four month outcome of the PASER cohort: what happens to patients failing ART? Pascale Ondoa Sonia Boender

  2. PASER studies in figures 6 countries 13 clinical sites 2nd line 1st line 2755 patients initiating 1st line followed up for at least 24 month 253 patients enrolled at second line switch followed up for 24 months Baseline Switch Month 12 Switch Month 24 Switch >month 48

  3. Month 12 and month 24 outcomes of 1st and 2nd line ART

  4. Month 12 and month 24 outcomes: 1st versus 2nd line 2755start 1st line 253 start 2nd line • 200 deaths • 253 LTFU • 80 Transfer out • 10 Stop PASER/ART • 26 early switch to 2nd line 12 • 11 deaths • 20 LTFU • 5 transfer out 12 • 217 (85.7%) alive active in the cohort still on 2nd line after 12M • 2186(79.3%) alive active in the cohort still on first line after 12M • 7 miss VL results • 23 (10.9%) with VF • 85 miss VL results • 175 (8.3%) with VF • 5 deaths • 10 LTFU • 4 Transferred out • 3 switch to 3nd line • 20 deaths • 84 LTFU • 38 Transferred out • 7 Stop PASER/ART • 53 switch to 2nd line 24 24 • 1984(72.0%) alive active in the cohort still on first line after 24 M • 195(77.0%) alive active in the cohort still on 2nd • line after 24 M • 110 miss VL • 171 (10.7%) with VF • 14 miss VL results • 27(14.9%) with VF

  5. HIVDR mutations in patients failing 1st line at month 12 and 24 (overall). Number of mutation/sequences increases from 2.16 (month 12) to 2.64 (month 24). Prevalence comparable between the 13 sites

  6. Effect of baseline resistance at initiation of 1st line ART on 12 and 24 months outcomes – excluding participants not on standard 1st line 12 months 24 months Baseline 2084 (75.9%) participants remained in care, on 1st-line ART 1859 (67.7%) participants remained in care, on 1st-line ART 2745 participants initiating 1st -line ART 2562 received fully active regimen (GSS ≥ 3) 149 (7.5%) VF 157 (8.8%) VF 22 (21.2%) VF 14 (19.4%) VF 158 received partially active regimens (GSS < 3) P<0.001 P=0.002

  7. HIVDR mutations in patients failing 2nd- line ART at month 12 and month 24 Overall prevalence of mutations at month 12 (55%) is relatively low. number mutations/sequence= 2.66 (month 12) and 2.87 (month 24). Prevalence of TAM and PI is higher than at baseline and than 1st line profile.

  8. Effect of resistance at switch to 2nd line ART on 12 and 24 months outcomes – excluding participants with PI exposure 12 months 24 months Baseline 213 (88%) participants remained in care, on 2nd-line ART 192 (79%) participants remained in care, on 2nd-line ART 243 participants switched to 2nd-line ART 109 received fully active regimen (GSS ≥ 3 or VL< 1000) 14 (16%) VF 11 (15%) VF 15 (13%) VF 16 (15%) VF 132 received partially active regimens (GSS < 3) p=0.586 p=0.897

  9. Key messages of month 12 and 24 outcome High rates of viral suppression (>70%) and resistance profiles indicate that current 1st and 2nd line regimen do not need to be changed. Relatively similar HIVDR mutation profiles at month 12 and 24. Prevalence of mutations slightly increase over time in both 1st and 2nd line. Prevalence of TAMS and PI especially increase from month 12 to month 24 in patient failing 2nd-line. Initiating a partially active 1st but not 2nd line regimen is associated with a higher odds for VF at month 12 and 24

  10. What happens to patients failing ART in the course of PASER?

  11. Switch to 2nd line before or @ next visit Re-suppression/or not(?) Not switched but suppressed at next visit Identified ? Adherence counseling Viral blip? Patient failing VL>1000 cp/mL Accumulation of DR mutations and worsening of clinical status Not switched, still failing at next visit ? ? Attrition

  12. PASER sites represent very different settings that can influence the management of virological failure Adapted from Hamers et al, 2010

  13. What becomes of patients failing between month 12 and month 24? 198virological failures at month 12 M12 M24 52% of persisting VF in sites where VL testing is available

  14. What is the VL of patients that are switched to next line in the course of PASER? 23.6% of switches are unnecessary

  15. Conclusions VL testing availability does not seem to translate into optimal use of laboratory information for the management of ART. Barriers to the utilization of laboratory tools need to be identified and mitigated as technology is being scaled up.

  16. Thank you

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