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


METHODS
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.


METHODS
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.
Madeddu
Giordano
G
Department of Infectious Diseases, University of Sassari, Via De Nicola 1, Sassari, Italy. giordano.madeddu@uniss.it
Bonfanti
Paolo
P
De Socio
Giuseppe V
GV
Carradori
Silvia
S
Grosso
Carmela
C
Marconi
Patrizia
P
Penco
Giovanni
G
Rosella
Elena
E
Miccolis
Sebastiano
S
Melzi
Sara
S
Mura
Maria Stella
MS
Landonio
Simona
S
Ricci
Elena
E
Quirino
Tiziana
T
D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000367:Age Factors; D019380:Anti-HIV Agents / Q000009:adverse effects* / Q000627:therapeutic use; D015331:Cohort Studies; D015897:Comorbidity; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D015994:Incidence; D007558:Italy; D007674:Kidney Diseases / Q000139:chemically induced* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000009:adverse effects* / Q000627:therapeutic use; D015995:Prevalence; D011446:Prospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D012737:Sex Factors; D000068698:Tenofovir
D019380:Anti-HIV Agents; D063065:Organophosphonates; D000068698:Tenofovir; D000225:Adenine