Background:  Renal dysfunction is associated with worse clinical outcomes in ART-naïve, HIV-infected U.S. women. The objective of this analysis is to determine if renal dysfunction in patients (both men and women) not meeting criteria for ART initiation at enrollment to an HIV-care program in western Kenya is associated with HIV disease progression and early mortality.

Methods:  The electronic medical records of all adult, non-pregnant patients with WHO (World Health Organization) stage 1 or 2 disease and with CD4 cell count >200/mm³ who enrolled in the USAID-AMPATH Partnership between July 2002 and October 2007 were retrospectively reviewed. The associations between renal function (creatinine clearance [CrCl] estimated by Cockcroft-Gault; glomerular filtration rate [GFR] estimated by simplified MDRD) at enrollment and times to CD4 cell count decline to <200/mm³, development of WHO (World Health Organization) stage 3 or 4 disease, mortality, and loss to follow-up were determined. Hazard ratios [HR], 95%CI per 1 unit were estimated using Cox regression models.

Results:  Study eligibility was met by 8737 HIV-infected Kenyans (27% men; 68% WHO stage 1). Median (IQR) enrollment CD4 cell count, age, and hemoglobin were 386 (282 to 546)/mm³, 35 (29 to 43) years, and 12.6 (10.9 to 14.0) g/dL, respectively. Median (IQR) follow-up was 53 (25 to 91) weeks. At enrollment, 36%, 45%, and 19% had CrCl >89, 60 to 89, and <60 mL/min, respectively; 58%, 33%, and 9% had GFR >89, 60 to 89, and <60 mL/min/1.72 m³, respectively. At enrollment, higher CrCl was significantly associated with WHO stage 1 disease (vs stage 2), higher CD4 cell count, and higher hemoglobin (all p <0.0001). After adjustment for enrollment age, sex, CD4 cell count, and hemoglobin, higher enrollment CrCl was associated (all p <0.0001) with slower decline in CD4 cell count to <200/mm³ (0.997 [0.994 to 1.000]), slower development of WHO stage 3 or 4 (0.992 [0.989 to 0.995]), and with longer time to loss to follow-up (0.997 [0.995 to 0.999]); there was no association with mortality. Similar associations were seen between higher GFR and slower development to WHO stage 3 or 4 and longer time to loss to follow-up, but GFR was not associated with time to CD4 <200/mm³ or mortality.

Conclusions:  Renal function is an independent predictor of HIV disease progression in Kenyans not requiring ART at presentation and, as such, may provide additive utility in identifying those who may benefit more from earlier initiation of ART. The cost of measuring serum creatinine at program enrollment may be justified in this context.