05E. VIRAL HEPATITIS – E) HEPATITIS B – CLINICAL (THERAPY, NEW COMPOUNDS, RESISTANCE) S259 694 MDRD CREATININE CLEARANCE IS NOT ALTERED IN HIV-HBV CO-INFECTED PATIENTS WITH A NORMAL RENAL FUNCTION AND TREATED WITH TENOFOVIR

Background: It is not known whether HIV-HBV co-infected patients are at risk for an increased rate of renal impairment when treated with TDF, compared to other NRTIs. Methods: A prospective analysis was held in patients with the following criteria: treatment with either TDF or other NRTIs-containing regimen and MDRD creatinine clearance (CLCR) at treatment initiation >60ml/mn. A clinical and biological follow up was performed every 3 months. The endpoint was defined as the first episode of CLCR< 60ml/mn. Censoring was applied at TDF introduction or cessation if patients belonged to the NRTI or the TDF groups, whichever came first. Results: 240 patients (156 in the TDF group) were followed for a mean duration of 31.2 months. Patients differed by age (41.7 v. 39.5 years, p = 0.03), duration of HIV infection (10.7 v. 8.6 years, p = 0.005) and HBV-DNA at inclusion (1.98 v. 2.50 log copies/mL, p = 0.05) in the TDF and NRTI groups, respectively. Twenty-five cases of CLCR< 60ml/mn (15 with TDF and 10 with NRTI) was recorded, for an incidence of 4.6 v. 4.4/person-year of exposure in the TDF and NRTI groups. The median time to renal event was 17.4 months in the TDF group and 14.6 months in the NRTI group. No significant difference was found in median MDRD CLCR between both groups at inclusion (94.8 v. 94.4ml/mn) and at the time of last follow-up (97.8 v. 99.2ml/mn in the TDF and NRTI groups, respectively). Survival analysis showed no difference in the time to CLCR< 60ml/mn according to treatment group (p = 0.8) or concomitant treatment with didanosine (p = 0.9). Only age (HR= 1.08, 95%CI 1.03−1.14) and CLCR at inclusion (HR= 0.05, 95CI 0.01−0.41) were factors associated with renal impairment in the multivariate Cox proportional hazards analysis. Conclusion: The incidence of moderate renal impairment under TDF was low in HIV-HBV co-infected patients with no prior renal impairment, and not significantly different from that in the NRTI group. Older age and creatinine clearance close to 60ml/mn should be an indication for a more extensive evaluation of renal function in this population.