Evaluation of hypophosphataemia in tenofovir disoproxil fumarate (TDF)‐exposed and TDF‐unexposed HIV‐infected out‐patients receiving highly active antiretroviral therapy

Objectives Cases of hypophosphataemia (often coincident with renal dysfunction) have been reported in HIV‐infected patients taking tenofovir disoproxil fumarate (TDF), but randomized placebo‐controlled trials of HIV‐infected persons with normal baseline renal function have found a comparable incidence of hypophosphataemia in the TDF and placebo groups. We assessed the incidence of grade 2 and higher hypophosphataemia in the HIV Outpatient Study (HOPS). Methods We analysed a prospective cohort of patients who initiated either a TDF‐containing highly active antiretroviral therapy (HAART) regimen [TDF‐exposed (TDF+) group; n=165] or a TDF‐sparing HAART regimen [TDF‐unexposed (TDF–) group; n=90], and who had normal baseline phosphate and creatinine values. Results The TDF+and TDF−groups had comparable median follow‐up times (10.9 vs 8.8 months, respectively; P=0.18) and number of phosphate measurements (median=3 for both) and were similar on most clinical and demographic factors. During follow up, 12.7% of TDF+vs 6.7% of TDF−patients developed grade 2 hypophosphataemia (2.0–2.4 mg/dL), and 2.4% of TDF+patients vs 0% of TDF−patients developed grade 3 hypophosphataemia (1.0–1.9 mg/dL); none developed grade 4 hypophosphataemia (