1. Mortality during the first year of HAART in HIV-1-infected patients in 7 countries from Latin America and the Caribbean Suely H. Tuboi, MD, PhD On behalf of CCASAnet – Caribbean, Central and South America network

2. Background Latin America and the Caribbean largely underrepresented in cohorts assessing HAART effectiveness CCASA-net: – Region 2 of IeDEA (International Databases to Evaluate AIDS) – 8 sites from 7 countries: Argentina, Brazil, Chile, Haiti, Honduras, Mexico, and Peru

3. Background Objectives of the study: – To describe first year mortality of HIV-infected adult individuals initiating HAART – To assess prognostic factors – To discuss country-specific issues associated with risk of death

4. Methods Primary outcome – All-cause mortality in the first year of HAART Analysis time – From start of HAART to the earliest of death, last follow-up visit, or 365 days after starting HAART Loss to follow-up – Status not known 1 year after HAART initiation and last visit occurred more than 1 year before the closing date of the database

5. Methods Statistical analysis – Kaplan-Meier estimates to describe time to outcome – Cox proportional hazards models for each site – Missing values Multiple imputations – Losses to follow-up Inverse probability weighted methods – Comparisons between alive, lost to follow-up, and dead Chi Square Rank sum

6. Results Number of participants by site and country FH – Argentina (N=794) HUCFF –Brazil (N=522) FA – Chile (N=547) GHESKIO – Haiti (N=1672) IHSS/HE – Honduras (N=329) INNSZ – Mexico (N=416) ImTavH – Peru (N=873)

7. Results Baseline characteristics of the 5152 patients VariableFH Argentina (794) HUCFF Brazil (522) FA Chile (547) GHESKIO Haiti (1672) IHSS/HE Honduras (328) INNSZ Mexico (416) IMTAvH Peru (873) Female (%)29331353391230 Age (years)35373639 3534 Clinical AIDS (%)31744543404463 CD4 count (cells/  L) 1631531161021058879 Regimen type (%) NNRTI based 65559395967092 PI based43241342 Boosted PI268.7.4.6254 Other6523.311

8. Results Loss to follow-up (LFUP) and mortality rates in the first year of HAART

9. Results Probability of death in the first year of HAART

10. Results Probability of death in the first year of HAART adjusted for baseline CD4 A B C M Ha P Ho

11. Results Factors associated with mortality in the first year of HAART VariableHR (95% Confidence Interval) Male1.09 (0.78 – 1.50) Age ( per 10 years)1.13 (1.02 – 1.25) Clinical AIDS2.93 (2.08 – 4.15) CD4 count (cells/  L) 100 vs. 500.79 (0.68 – 0.93) 200 vs. 500.59 (0.40 – 0.86) 350 vs. 500.44 (0.22 – 0.86) Year of HAART initiation 2003 (ref)1 20041.08 (0.86 – 1.35) 20051.14 (0.74 – 1.77) 2006NA Regimen type NNRTI based1.08 (0.86 – 1.35) Other1

12. Conclusions Overall mortality rate in the first year of HAART similar to that of lower income countries with active follow-up (ART-LINC) Substantial differences between countries Higher mortality rates in Haiti and Honduras independent of baseline CD4 cell count

13. Conclusions Country-specific factors: – Different stages of disease at HAART initiation Late presentation for care Programme ability to detect candidates for treatment – Age of programme – Different guidelines – Different impact of loss to follow-up

14. Summary In CCASA-net, the overall reported mortality in the first year of HAART is similar to that of other lower income countries Substantial differences between countries – Differences in programme characteristics Need for operational research

15. Acknowledgements Bryan Shepherd, Catherine McGowan, Stephany Duda (Vanderbilt University) CCASAnet Steering Group: Pedro Cahn (Argentina), Mauro Schechter (Brazil), Marcelo Wolff (Chile), Jean William Pape (Haiti), Denis Padgett (Honduras), Eduardo Gotuzzo (Peru), Juan Sierra Madero (Mexico), Daniel Masys (USA). CCASAnet Sites: – Fundacion Huesped and Hospital Fernandez (Argentina), – Universidade Federal do Rio de Janeiro (Brazil) – Universidad de Chile (Chile) – GHESKIO (Haiti) – Instituto Hondureño de Seguridad Social and Universidad Autonoma de Honduras (Honduras) – Universidad Peruana Cayetano Heredia (Peru) – Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (Mexico) – Vanderbilt University School of Medicine (USA) National Institutes of Health Program Officer: Melanie Bacon.

16. Thank you!

17. Methods Baseline CD4 – Closest to HAART initiation (− 6mo/+7d) Baseline HIV-1 plasma viral load (PVL) – Pre-HAART measurement closest to (− 6mo) Baseline weight – Closest to HAART initiation (+/ − 30d) HAART regimen – PI-based (one PI + two NRTI) – PI-boosted regimens – NNRTI-based (one NNRTI plus two NRTIs) – Nonstandard (any other regimen w/ a minimum of 3 ARVs) Clinical stage of disease – AIDS (WHO stage 4, CDC stage C, or 1986 CDC stage 4) – Non-AIDS – Unknown

18. Results Adjusted Hazard Ratios and 95%CI for mortality in the first year of HAART

19. ART-LINC/ART-CC definition of loss to follow-up Initiation Jan/01/2006 Database A close Nov/01/2007 Last visit Oct/01/2006 Jan/01/2007 Lost Not Lost Status 1 year after HAART initiation not known and last visit occurred more than 1 year before the closing date of the database. Database B close Nov/01/2006