دورية أكاديمية
Discontinuation of tenofovir disoproxil fumarate from initial ART regimens because of renal adverse events: An analysis of data from four multi-country clinical trials.
| العنوان: | Discontinuation of tenofovir disoproxil fumarate from initial ART regimens because of renal adverse events: An analysis of data from four multi-country clinical trials. |
|---|---|
| المؤلفون: | Ngongondo M; UNC Project Malawi, Lilongwe, Malawi., Ritz J; Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Harvard University, Boston, Massachusetts, United States of America., Hughes MD; Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Harvard University, Boston, Massachusetts, United States of America., Matoga M; UNC Project Malawi, Lilongwe, Malawi., Hosseinipour MC; UNC Project Malawi, Lilongwe, Malawi.; The University of North Carolina School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America. |
| مؤلفون مشاركون: | AIDS Clinical Trials Group A5208, A5221, A5175 and A5274 Study Teams |
| المصدر: | PLOS global public health [PLOS Glob Public Health] 2024 Jan 04; Vol. 4 (1), pp. e0002648. Date of Electronic Publication: 2024 Jan 04 (Print Publication: 2024). |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Public Library of Science Country of Publication: United States NLM ID: 9918283779606676 Publication Model: eCollection Cited Medium: Internet ISSN: 2767-3375 (Electronic) Linking ISSN: 27673375 NLM ISO Abbreviation: PLOS Glob Public Health Subsets: PubMed not MEDLINE |
| أسماء مطبوعة: | Original Publication: San Francisco, California : Public Library of Science, [2021]- |
| مستخلص: | Tenofovir disoproxil fumarate (TDF), a potent and commonly used antiretroviral drug, is associated with renal tubular dysfunction and renal adverse events. We evaluated the frequency of, time to, and baseline risk factors for discontinuing TDF from initial antiretroviral therapy (ART) regimens because of renal adverse events from presumed tenofovir renal toxicity. We conducted an observational cohort study as a secondary analysis of data from four clinical trials conducted mainly in low- and middle-income countries. We included ART naïve participants living with HIV who started TDF-containing ART regimens in the trials. Participants had to have estimated creatinine clearance (eCrCl) equal to or greater than 60ml/min before starting ART. The primary outcome was the first instance of discontinuing TDF because of renal adverse events attributed to tenofovir renal toxicity during the first 48 weeks after starting ART. We evaluated the cumulative incidence of discontinuing TDF and associated risk factors using Fine and Gray competing risk regression models with a backward elimination variable selection strategy. There were 2802 ART-naïve participants who started TDF-containing ART from the four clinical trials were included in the analysis. Fifty-eight percent were female, the median age was 34 years, and 87% had CD4 cell counts less than 200 cells/μl. Sixty-four participants (2.4%, 95% CI 1.7%-2.8%) discontinued TDF due to renal adverse events. Among the 64 participants, the median time to discontinue TDF was 9.4 weeks (IQR: 3.4-20.7 weeks). From multivariable Fine and Gray regression models, risk factors for discontinuing TDF were older age, CD4 cell count <200 cells/μl, presence and severity of anemia, and eCrCl <90 ml/min. The risk of discontinuing TDF because of renal adverse events was low in participants initiating TDF-containing ART with advanced HIV and normal renal function, attesting to the tolerability of TDF in ART in low- and middle-income countries. Competing Interests: The authors have declared that no competing interests exist. (Copyright: © 2024 Ngongondo et al. 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 author and source are credited.) |
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| معلومات مُعتمدة: | D43 TW010060 United States TW FIC NIH HHS; UM1 AI068634 United States AI NIAID NIH HHS; UM1 AI068636 United States AI NIAID NIH HHS; UM1 AI106701 United States AI NIAID NIH HHS |
| تواريخ الأحداث: | Date Created: 20240104 Latest Revision: 20240210 |
| رمز التحديث: | 20240210 |
| مُعرف محوري في PubMed: | PMC10766173 |
| DOI: | 10.1371/journal.pgph.0002648 |
| PMID: | 38175824 |
| قاعدة البيانات: | MEDLINE |
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