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 aTDF-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 (<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). CONCLUSIONS: 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.
RCT Entities:
OBJECTIVES: Cases of hypophosphataemia (often coincident with renal dysfunction) have been reported in HIV-infectedpatients taking tenofovir disoproxil fumarate (TDF), but randomized placebo-controlled trials of HIV-infectedpersons 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 (<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). CONCLUSIONS: The incidence of hypophosphataemia was somewhat elevated in HOPSpatients 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.
Authors: Peter L Havens; Charles B Stephensen; Rohan Hazra; Patricia M Flynn; Craig M Wilson; Brandy Rutledge; James Bethel; Cynthia G Pan; Leslie R Woodhouse; Marta D Van Loan; Nancy Liu; Jorge Lujan-Zilbermann; Alyne Baker; Bill G Kapogiannis; Kathleen Mulligan Journal: Clin Infect Dis Date: 2012-01-19 Impact factor: 9.079
Authors: Peter L Havens; Jennifer J Kiser; Charles B Stephensen; Rohan Hazra; Patricia M Flynn; Craig M Wilson; Brandy Rutledge; James Bethel; Cynthia G Pan; Leslie R Woodhouse; Marta D Van Loan; Nancy Liu; Jorge Lujan-Zilbermann; Alyne Baker; Bill G Kapogiannis; Catherine M Gordon; Kathleen Mulligan Journal: Antimicrob Agents Chemother Date: 2013-09-03 Impact factor: 5.191
Authors: Gregory M Lucas; Michael J Ross; Peter G Stock; Michael G Shlipak; Christina M Wyatt; Samir K Gupta; Mohamed G Atta; Kara K Wools-Kaloustian; Paul A Pham; Leslie A Bruggeman; Jeffrey L Lennox; Patricio E Ray; Robert C Kalayjian Journal: Clin Infect Dis Date: 2014-09-17 Impact factor: 9.079
Authors: Christopher Nyirenda; Isaac Zulu; Edmond K Kabagambe; Shashwatee Bagchi; Dara Potter; Claire Bosire; Zipporah Krishnasami; Douglas C Heimburger Journal: BMJ Case Rep Date: 2009-04-03