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      A magnifying glass onto renal function and serum lipid evolutions after tenofovir (TDF) and emtricitabine (FTC) in combination with atazanavir/ritonavir (ATV/r) versus efavirenz (EFV) as first-line HAART (the INCA trial)

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          Background Measures of glomerular filtration rate (GFR) showed discordant results. CKD-EPI creatinine formula resulted more accurate than other equations in subjects with normal or mildly decreased renal function in the general population and cystatin C could be even a more sensitive measure. As for lipids, lipoprotein subfractions were suggested to be more informative on the cardiovascular risk than the commonly used cholesterol subfractions, with protection conferred especially by HDLp-small (Baker et al. JID 2010). Prospective evaluation of all these markers upon initiation of standard HAART regimens is lacking. We conducted a small, intensive, randomized study in naïve HIV-infected patients comparing TDF/FTC+ATV/r versus TDF/FTC+EFV as first-line therapy for these novel markers. Methods Antiretroviral-naïve HIV-infected patients, recruited from 4 centers in Italy (Brescia, Rome, Ferrara, Bari), were randomized to ATV/r or EFV standard doses, in combination with fixed-dose TDF/FTC. Patients had to have creatinine clearance>50 ml/min. Outcome measures included serum creatinine and cystatin C levels and derived eGFRs corrected for body surface area. Lipoprotein particle size and concentration were estimated using an NMR spectroscopy method at Jochen-Hunter Lab., Germany. Results 91 patients were randomized (48 ATV/r, 43 EFV; 80% males; mean age 43 years; 4 patients class C; mean CD4+ 283/mm3, SD: 119/mm3). No significant differences were found between the two arms at baseline, but for some lipids (total cholesterol: mean 173 mg/dL ATV/r vs. 156 mg/dL EFV; p=0.04; HDL-cholesterol: 44 mg/dL vs. 38 mg/dL; p=0.007; HDLp: 36 mg/dL vs. 32 mg/dL; p=0.02). At baseline, a correlation between CKD-EPI creatinine and CKD-EPI cystatine C was found (R2=0.51; p<0.0001). Through CKD-EPI creatinine formula, we detected a significant decrease in eGFR from baseline to week 48 in patients, receiving ATV/r (-4.8233 mL/min/m2; p=0.002) but not in those receiving EFV. Greater GFR reductions were found with CKD-EPI cystatin C than with CKD-EPI creatinine not only in the ATV/r arm up to week 48 (-15.1388 mL/min/m2; p<0.0001), but also in the EFV arm from baseline to week 24 (-7.2233 mL/min/m2; p=0.04). As for lipids, cholesterol subfractions increased more after EFV than after ATV/r: mean increase from baseline to week 48 was 44.15 mg/dL vs. 15.51; p=0.002 for total cholesterol, 32.4 mg/dL vs. 12.47 mg/dL; p=0.007 for LDL cholesterol, 9.31 mg/dL vs. 2.13 mg/dL; p=0.002 for HDL cholesterol. Total/HDL cholesterol ratio remained stable in both arms. As for lipoprotein subfractions, total HDLp increased more after EFV than after ATV/r (11.97 mg/dL vs. 7.97 mg/dL; p=0.03), but HDLp-small increased significantly in both arms, without statistical differences between the two (1.71 mg/dL vs. 1.86 mg/dL). Conclusions Patients receiving TDF in combination with ATV/r had greater decline in renal function than those receiving TDF plus EFV, although eGFR decrease was small in both arms. Interestingly, CKD-EPI cystatin C appeared to be a stricter measure. As for lipids, EFV induced greater LDL cholesterol increases but the risk appeared to be counteracted by greater increase of both HDL-cholesterol and HDLp, even though HDLp-small increased similarly in the two arms. We suggest that these novel measures provide additional information so as to better characterize the toxicity profiles of the antiretroviral regimens.

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          Author and article information

          J Int AIDS Soc
          Journal of the International AIDS Society
          BioMed Central
          8 November 2010
          : 13
          : Suppl 4
          : P85
          [1 ]Institute of Infectious and Tropical Diseases, University of Brescia, Brescia, Italy
          [2 ]National Institute of Infectious Diseases, Rome, Italy
          [3 ]“S. Anna” Hospital, Ferrara, Italy
          [4 ]Department of Nephrology, Spedali Civili, Brescia, Italy;
          [5 ]Chair of Hygiene, University of Brescia, Brescia, Italy
          Copyright ©2010 Izzo et al; licensee BioMed Central Ltd.

          This is an open access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

          Tenth International Congress on Drug Therapy in HIV Infection
          Glasgow, UK
          7-11 November 2010
          Poster Presentation

          Infectious disease & Microbiology


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