Tenofovir renal safety in HIV-infected patients: results from the SCOLTA project

Abstract 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 II–IV 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 1.5–1.7) per 100 person-years (p-y) and 0.5 (95% CI 0.4–0.6) 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.