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Background: Cases of renal dysfunction have been reported in HIV-infected patients taking tenofovir (TDF), but few large studies have examined population-level changes in renal function associated with TDF use in patients in routine care. Methods: The authors analyzed data from participants in the HIV Outpatient Study (HOPS) who had normal baseline renal function and received &gt;1 month of TDF-containing (n = 593) or TDF-sparing (n = 521) HAART after November 1, 2001. Results: Median baseline CrCl estimated by Cockcroft-Gault equation was 106 mL/min for TDF-exposed and 110 mL/min for TDF-unexposed patients (P = 0.06). In multivariable analyses, 1-year changes in CrCl (mL/min) from baseline were —5.7 among TDF-exposed and 2.6 among TDF-unexposed (P &lt; 0.001). Incident renal disease was diagnosed in 7 TDF-exposed and 3 TDF-unexposed patients. Conclusions: In this large cohort of HIV-infected outpatients, use of TDF-containing HAART was associated with modest decreases in CrCl during the first year, but not with frequent, clinically significant renal toxicity.

Renal Function in Tenofovir-Exposed and Tenofovir-Unexposed Patients Receiving Highly Active Antiretroviral Therapy in the HIV Outpatient Study