* The HOPS Investigators are listed in the Appendix.
Evaluation of hypophosphataemia in tenofovir disoproxil fumarate (TDF)-exposed and TDF-unexposed HIV-infected out-patients receiving highly active antiretroviral therapy
Version of Record online: 22 AUG 2006
Volume 7, Issue 7, pages 451–456, October 2006
How to Cite
Buchacz, K., Brooks, J., Tong, T., Moorman, A., Baker, R., Holmberg, S., Greenberg, A. and the HIV Outpatient Study (HOPS) Investigators (2006), Evaluation of hypophosphataemia in tenofovir disoproxil fumarate (TDF)-exposed and TDF-unexposed HIV-infected out-patients receiving highly active antiretroviral therapy. HIV Medicine, 7: 451–456. doi: 10.1111/j.1468-1293.2006.00407.x
- Issue online: 22 AUG 2006
- Version of Record online: 22 AUG 2006
- Received: 4 October 2005, accepted 5 January 2006
- renal disease;
- serum phosphate;
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).
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.
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 (<1.0 mg/dL). The incidence of grade 2 or higher hypophosphataemia was 16.7 per 100 person-years among TDF+patients vs 8.0 per 100 person-years among TDF−patients (P=0.11).
The incidence of hypophosphataemia was somewhat elevated in HOPS patients who took TDF-containing HAART compared with those who took TDF-sparing HAART during the first 1 to 2 years of observation, but the difference was not statistically significant. Longer follow-up of a larger population is needed to determine if this trend towards an association achieves statistical significance and to evaluate the clinical consequences of hypophosphataemia.