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• W2023182351 abstract "Crane et al.[1] recently reported the evolution of kidney function in a group of patients who were receiving a tenofovir-based treatment, concluding that the concomitant use of amprenavir or didanosine was associated with an increased risk of kidney function decline. We would like to share our experience with the PROTECTION cohort. This cohort is an observational, retrospective cohort collecting data from 75 HIV units in Spain of patients who were taking a tenofovir plus protease inhibitor-containing regimen [2–5]. The study period ranged from July 2002 (the first date in which tenofovir became commercially available in Spain) until July 2006. A total of 1428 patients were included in the cohort. Among several other parameters, we have assessed the evolution of kidney function both in the global cohort and in different protease inhibitor-based subsets. From the total cohort, 105 patients (7%) received a tenofovir plus fosamprenavir-containing regimen. The demographic characteristics of these patients were quite similar to those described by Crane et al. [1] except for race and HIV risk factor (mean age 43 year; male 74%; white race 90%; former intravenous drug user 53%). Regarding baseline clinical characteristics 73% were Centers for Disease Control and Prevention category C. Seven patients (7%) were treatment naive and the rest had a median duration of previous antiretroviral treatment of 68 months (interquartile range 21–111). Thirty-one per cent had an undetectable viral load at baseline (the regimen was prescribed within a simplification approach or to manage drug toxicities) and the mean CD4 cell count was 335 cells/μl (SD 221). Of interest is the fact that 16% of the patients had history of the use of nephrotoxic agents. The follow-up of these patients has been collected for a mean of 10.5 months (SD 9.5). In those patients with 6 months data available (n = 60) a slight, clinically meaningless decrease of glomerular filtration rate (−4.7 ml/min) was observed (P < 0.05); however, this was not maintained after 12 months of treatment (n = 33), with an increase of 1.6 ml/min (P = 0.42). The change in serum creatinine levels did not reach statistical significance either at 6 or 12 months, with mean values of 0.9, 1.1 and 0.9 mg/ml, respectively. Only two cases (1.9%) of renal adverse events were reported (grade 1 and 2 creatinine increases) although none led to the discontinuation of tenofovir. The rate of renal adverse events in the global PROTECTION cohort (n = 1428) after a mean follow-up of 11 months was also low (1.3%). The use of ritonavir boosting did not increase the risk (1.2% for boosted protease inhibitors versus 1.4% for unboosted combinations). Finally, the rate of withdrawal because of renal adverse events was (0.6%) [4,5]. All these data do not seem to support the findings of Crane et al.[1]. Since its commercial release, however, tenofovir has been associated with rare, and in some cases severe, renal events leading to treatment discontinuation, whose paradigm would be Fanconi syndrome. On the other hand, the long-term administration of tenofovir seems to be associated with a mild decrease in renal function, frequently within the normal limits and not requiring treatment interruption. It is not uncommon to see that different cohorts with retrospective approaches show contradictory outcomes. We believe that the importance and clinical implications of these abnormalities, or variations within the normal limits in our cohort, are still to be established, and completly agree with Crane et al.[1] that new studies are needed to reach final conclusions and recommendations, with the aim of avoiding or minimizing this adverse effect." @default.
• W2023182351 created "2016-06-24" @default.
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• W2023182351 date "2007-11-30" @default.
• W2023182351 modified "2023-10-18" @default.
• W2023182351 title "Reply to Crane et al., ‘Amprenavir and didanosine are associated with declining kidney function among patients receiving tenofovir’" @default.
• W2023182351 cites W2008858806 @default.
• W2023182351 doi "https://doi.org/10.1097/qad.0b013e3282f13a62" @default.
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