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Supported by: NIAID/NHLBI R24 AI067039, NIAID R21 AI087360 Viremia copy-years: A measure of cumulative HIV burden among patients initiating antiretroviral.

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Presentation on theme: "Supported by: NIAID/NHLBI R24 AI067039, NIAID R21 AI087360 Viremia copy-years: A measure of cumulative HIV burden among patients initiating antiretroviral."— Presentation transcript:

1 Supported by: NIAID/NHLBI R24 AI067039, NIAID R21 AI087360 Viremia copy-years: A measure of cumulative HIV burden among patients initiating antiretroviral therapy predicts long-term clinical outcomes Michael Mugavero 1, Sonia Napravnik 2, Stephen Cole 2, Joseph Eron 2, Bryan Lau 3, Heidi Crane 4, James Willig 1, Mari Kitahata 4, Michael Saag 1, and CFAR Network of Integrated Clinical Systems (CNICS) 1 University of Alabama at Birmingham, 2 University of North Carolina at Chapel Hill, 3 Johns Hopkins University, and 4 University of Washington

2 Supported by: NIAID/NHLBI R24 AI067039, NIAID R21 AI087360 Background Single plasma HIV viral load (VL) on combination antiretroviral therapy (cART) predicts clinical outcomes (Egger M et al. Lancet 2002;360:119-29, Chene G et al. Lancet 2003;362:679-86, Lanoy E et al. AIDS 2009;23:2199-2208) But a single VL value cannot capture effects of intermittent viral replication over time Therefore, we developed viremia copy-years (VCY) to capture longitudinal cumulative VL burden

3 Supported by: NIAID/NHLBI R24 AI067039, NIAID R21 AI087360

4 Viremia Copy-Years Estimate of cumulative HIV burden over time Example: 10,000 copy-years  1,000 c/mL per day for 10 years  10,000 c/mL per day for 1 year VCY approximated as time-weighted sum using trapezoidal rule: Cole SR et al. Am J Epidemiology 2010;171:198-205

5 Supported by: NIAID/NHLBI R24 AI067039, NIAID R21 AI087360 Aims Evaluate patient factors associated with VCY following modern cART initiation Estimate the prognostic value of VCY following modern cART initiation

6 Supported by: NIAID/NHLBI R24 AI067039, NIAID R21 AI087360 Methods Cohort: CNICS  8-site US clinical cohort  Kitahata et al., Int J Epi 2008. 37:948-955 Eligibility Criteria  ART-naïve initiating therapy 2000-08  Initiated with modern cART  PI/r or NNRTI-based regimen  At least 12 months f/u from cART start Principal exposure: Viremia Copy-Years (VCY)

7 Supported by: NIAID/NHLBI R24 AI067039, NIAID R21 AI087360 Methods Relationships between patient factors and VCY  Multivariable linear regression of log 10 VCY with robust variances Relationship between log 10 VCY and all- cause mortality  Cox proportional hazards models

8 Supported by: NIAID/NHLBI R24 AI067039, NIAID R21 AI087360 Results: Study Population Characteristic (N=1906)N (%) or Median (IQR) Female381 (20%) Black724 (38%) Ritonavir-boosted PI591 (31%) Pre-cART CD4 cell count, cells/mm 3 181 (55, 282) Pre-cART log 10 VL, copies/mL4.9 (4.4, 5.4) Follow-up, years3.5 (2.0, 5.4) VL measures contributed (n=24,105)11 (6, 17) VCY, log 10 copy-years/mL2.76 (2.21, 3.89) VCY, copy-years/mL575 (162, 7762)

9 Supported by: NIAID/NHLBI R24 AI067039, NIAID R21 AI087360 Results: Relationship between patient factors and VCY from modern cART initiation Patient Factorslog 10 VCY a 95% CIP value CD4 at cART-initiation (per 100 cell increase) -0.08-0.13, -0.03<0.01 Women0.410.19, 0.63<0.01 Ritonavir-boosted PI b 0.340.17, 0.50<0.01 a Multivariable linear regression model controlling for CD4 at cART initiation, sex, initial cART, duration of treatment and site. b Measured at cART-initiation, comparison group are patients initiating an NNRTI- based regimen, intention to treat approach * Higher pre-cART VL was associated with greater VCY in bivariable but not multivariable models

10 Supported by: NIAID/NHLBI R24 AI067039, NIAID R21 AI087360 Results: Relationship between VCY and all- cause mortality from modern cART initiation a Multivariable Cox proportional hazards model controlling for pre-cART VL, peak VL, time-updated VL, time-updated CD4, age, sex, initial cART (cART switches / discontinuations were not included), HIV acquisition mode, and site Hazard Ratio a 95% CIP value VCY, log 10 copy-years/mL2.161.15, 4.060.02 Pre-cART VL, log 10 copies/mL0.960.68, 1.360.82 Peak VL on cART, log 10 copies/mL0.790.46, 1.380.41 Time-updated VL, log 10 copies/mL1.180.91, 1.520.22 Time-updated CD4 (per 100 cell increase) 0.710.59, 0.85<0.01

11 Supported by: NIAID/NHLBI R24 AI067039, NIAID R21 AI087360 Conclusions VCY, an estimate of cumulative HIV burden, was associated with several patient characteristics following cART-initiation  Independent of cross-sectional VL and CD4 cell count  Among patients initiating modern cART regimens VCY had demonstrable prognostic value for all-cause mortality  Independent of cross-sectional and time-updated VL and CD4 measures, and other patient factors

12 Supported by: NIAID/NHLBI R24 AI067039, NIAID R21 AI087360 Conclusions Future studies of VCY will include:  Evaluating the effect of VCY on clinical outcomes among specific groups of patients, including those with low- level or intermittent viremia  Estimating the relationship between VCY and AIDS- and non-AIDS events  Assessing relationships between VCY and markers of inflammation and immune activation

13 Supported by: NIAID/NHLBI R24 AI067039, NIAID R21 AI087360 Acknowledgements Co-authors CNICS patients CNICS site PIs & co-investigators Stephen Van Rompaey Donna Porter CNICS site staff

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