Table 3.

Characteristics of persons with creatinine abnormality-related permanent drug discontinuation

Group	Sex	Age-years	Baseline eGFR mL/min/1.732 (serum Creatinine mg/dL)	Last on-treatment eGFR mL/min 1.732 (serum Creatinine mg/dL); months in the study	Last observed post-study drug eGFR mL/min 1.732 (serum Creatinine mg/dL)	Relevant history†
FTC-TDF	F	55	119 (0.60)	95 (0.9, a 1.5 fold increase in creatinine from baseline) at month 24	101 (0.75)	-No history of use of known nephrotoxic drugs within 1 month. Drug discontinuation based on creatinine clearance which was <50 mL/min) -Baseline serum phosphate: 2.7 mg/dL
FTC-TDF	F	38	127 (0.70)	72 (1.03) at month 15	122 (0.71)	-Treated for upper respiratory tract infection with cephalosporin and fluconazole in proceeding 2 weeks - Creatinine fold change from baseline had resolved by 4 weeks after drug discontinuation (serum creatinine 0.78 mg/dL, eGFR 110 mL/min/1.732)
TDF	F	50	117 (0.70)	55 (1.30) at month 6	98 (0.80)	-Pre-existing Cervical lesions with history of laparotomy and chronic use of analgesics including NSAID - eGFR was >90mL/min by 8 weeks after drug discontinuation, remained stable and non-progressive until exit
TDF	M	56	99 (0.98)	57 (1.53) at month 30	78 (1.18)	-History of recent relocation to a hot and dry region -No urine dipstick protein /glucose -eGFR was 74 mL/min by 2 weeks after drug discontinuation
TDF	F	30	134 (0.7)	98 (0.9) at month 18	110 (0.81)	Had ≥25% eGFR decline from baseline at month 18. Creatinine elevation grade was based on calculated creatinine clearance. Baseline weight=45 kg (BMI=24)
Placebo	F	40	93 (0.9)	41 (1.78) at month 1	109 (0.78)	-Baseline weight=46 kg (BMI=19) -No urine dipstick protein/ glucose - eGFR was >60 mL/min within 8 weeks after drug discontinuation

For the present analysis, eGFR was calculated from serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration Equation, although the Cockcroft-Gault equation was used for safety monitoring during the study.

eGFR denotes estimated glomerular filtration rate, FTC denotes emtricitabine TDF denotes tenofovir disoproxil fumarate

^†All persons had normal serum phosphate at the last on-treatment visit.