Madeddu, Giordano and Bonfanti, Paolo and De Socio, Giuseppe Vittorio Luigi and Carradori, Silvia and Grosso, Carmela and Marconi, Patrizia and Penco, Giovanni and Rosella, Elena and Miccolis, Sebastiano and Melzi, Sara and Mura, Maria Stella Anna and Landonio, Simona Maria Chiara and Ricci, Elena and Quirino, Tiziana (2008) Tenofovir renal safety in HIV-infected patients: results from the SCOLTA project. Biomedicine & Pharmacotherapy, Vol. 62 (1), p. 6-11. ISSN 0753-3322. Article.
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Objective: To evaluate the prevalence and incidence of nephrotoxicity in HIV-infected patients enrolled in the SCOLTA Project tenofovir cohort and to identify possible risk factors. Design: The SCOLTA Project is a prospective, observational, multicenter study involving 25 infectious disease departments in Italy created to assess the incidence of severe adverse events in patients receiving new antiretroviral drugs. Patients: The SCOLTA Project tenofovir cohort includes a total of 754 HIV infected patients. Results: Data including grade IIeIV creatinine elevations according to ACTG scale were available in 354 patients, 237 (67%) males with a mean age of 40.1 ± 7.6 years enrolled in the SCOLTA Project tenofovir cohort. During a mean follow up of 19.5 ± 11.5 months creatinine elevations were reported in 9/354 (2.5%) patients, all males. Mean duration of tenofovir therapy at the event was 9.5 ± 5 months. The overall incidence was 1.6 (95% CI 1.5e1.7) per 100 person-years (p-y) and 0.5 (95% CI 0.4e0.6) p-y for grade III. No grade IV creatinine elevations were reported. Patients with nephrotoxicity were older and more frequently male, HCV infected, in CDC stage C and their CD4 cell count was significantly lower than those without nephrotoxicity. No significant difference was found between tenofovir co-administered antiretroviral drugs. Conclusions: Both prevalence and incidence of nephrotoxicity were low in patients receiving tenofovir in a non-selected clinical setting. Renal injury in patients receiving tenofovir seems associated with the presence of co-morbidities and with advanced HIV infection.
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