Progression to AIDS or death in HIV‐infected patients initiating cART with CD4<200 cells/µ L: the role of CD4 and viral load changes during follow‐up

Abstract

Purpose of the study: Our aim was to evaluate factors associated with progression to AIDS/death in HIV-infected naive pts initiating cART with low CD4 counts. Methods: Adult HIV-infected ARV-naive pts with CD4 B200 who initiated NNRTI or PI-containing regimens between 1998 and 2009, were included. Primary end point was progression to AIDS (a first episode or a new AIDS-defining condition in pts with prior AIDS) or death. Kaplan-Meier curves were used to determine progression-free survival and multivariate Cox regression models were used to identify independent predictive factors of progression to AIDS/death. Summary of results: We included 1427 patients (80% men, median age 38 years, 25% IDU, 37% AIDS, 20% HCV) between 1998 and 2009. At baseline (BL), median (range) CD4 and viral load (VL) was 77 (1- 199) cells/muL and 170,000 (19-8,750,000) copies/muL, respectively. After a median follow-up 4.6 years, 70% of pts reached CD4>200/ mL, 65.2% reached undetectable VL and 268 (19%) pts progressed to AIDS/death during follow-up. The probability of AIDS/death at 5 years was 76%, 34%, 3% and 3%, in pts with BL CD4<100/VL>5 log and CD4<200/VL detectable during FU, BL CD4<100/ VL>5 log and CD4<200/VL undetectable during FU, BL CD4<100 and/or VL>5 log and CD4>200/VL undetectable during FU and BL CD4>100/ VL <5 log and CD4>200/VL undetectable during FU, respectively. In the multivariate analysis, several variables were associated with AIDS/death: CD4< 200 during FU (HR 10.89, p<0.001), detectable VL during FU (HR 3.49, p<0.001), age>50 years (HR 1.75, p=0.001), prior AIDS (HR 1.71, p<0.001) and BL VL>5 log (HR 1.45, p=0.011). If only pts without prior AIDS (n=895) were analyzed, the variables independently associated with AIDS/death were: CD4<200 during FU (HR 9.90, p<0.001), detectable VL during FU (HR 2.78, p<0.001) and BL VL>5 log (HR 1.62, p=0.016). Conclusions: In immunosuppressed patients initiating cARV therapy, not reaching CD4>200/muL during FU was the strongest variable associated with progression to AIDS/death. VL at BL and mainly at follow up also played a role in patient outcome.