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Trend of estimated glomerular filtration rate during ombistasvir/paritaprevir/ritonavir plus dasabuvir ± ribavirin in HIV/HCV co-infected patients
The renal function is a key-issue in HIV/HCV co-infected patients, nevertheless, it has not established so far whether HCV treatment with new direct acting agents could impact on estimated glomerular filtration rate (eGFR) variations. In the present work, we examined the real-life data on renal func...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5819795/ https://www.ncbi.nlm.nih.gov/pubmed/29462201 http://dx.doi.org/10.1371/journal.pone.0192627 |
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author | Taramasso, Lucia Di Biagio, Antonio Bovis, Francesca Nicolini, Laura Ambra Antinori, Andrea Milazzo, Laura Sollima, Salvatore Gubertini, Guido Niero, Fosca Saracino, Annalisa Bruno, Raffaele Borghi, Vanni Montagnani, Francesca Cattelan, Annamaria Hasson, Hamid Taliani, Gloria D’Arminio Monforte, Antonella Mastroianni, Claudio Di Perri, Giovanni Bigoni, Sara Puoti, Massimo Spinetti, Angiola Gori, Andrea Boffa, Nicola Cacopardo, Bruno Giacometti, Andrea Parruti, Giustino Vullo, Vincenzo Chirianni, Antonio Teti, Elisabetta Pasquazzi, Caterina Segala, Daniela Andreoni, Massimo |
author_facet | Taramasso, Lucia Di Biagio, Antonio Bovis, Francesca Nicolini, Laura Ambra Antinori, Andrea Milazzo, Laura Sollima, Salvatore Gubertini, Guido Niero, Fosca Saracino, Annalisa Bruno, Raffaele Borghi, Vanni Montagnani, Francesca Cattelan, Annamaria Hasson, Hamid Taliani, Gloria D’Arminio Monforte, Antonella Mastroianni, Claudio Di Perri, Giovanni Bigoni, Sara Puoti, Massimo Spinetti, Angiola Gori, Andrea Boffa, Nicola Cacopardo, Bruno Giacometti, Andrea Parruti, Giustino Vullo, Vincenzo Chirianni, Antonio Teti, Elisabetta Pasquazzi, Caterina Segala, Daniela Andreoni, Massimo |
author_sort | Taramasso, Lucia |
collection | PubMed |
description | The renal function is a key-issue in HIV/HCV co-infected patients, nevertheless, it has not established so far whether HCV treatment with new direct acting agents could impact on estimated glomerular filtration rate (eGFR) variations. In the present work, we examined the real-life data on renal function that have been prospectively collected in the SIMIT compassionate-use program of ombitasvir/paritaprevir/ritonavir plus dasabuvir (OBV/PTV/r + DSV) in 144 HIV/HCV genotype 1 co-infected patients. The population was 74% male, 30.5% in CDC stage C, with median age of 52 years (48.0–56.5) and median liver stiffness of 7.8 kPa (6.7–9.2). Median baseline eGFR was 102.0 (90.8–108.1), changing to 99.8 (83.5–104.8) at the end of treatment (EoT), and 100.0 (87.3–105.6) 12 weeks after the EoT (FU12), p<0.0001. No patient had grade 3–4 increase of creatinine. At EoT 60/144 (41.7%) patients had ≥ 5% reduction in their eGFR, confirmed at FU12 in 39/60 (65.0%) cases. Longer duration of HCV infection (cut-off 12.9 years), lower HCV-RNA viral load (cut-off 1,970,160 IU/ml) and lower platelet count (cut-off 167,000 x10(6)/L) were significantly associated with eGFR decline at logistic analysis ((adj)OR 2.9, 95%CI 1.0–8.8, p = 0.05; (adj)OR 3.5, 95%CI 1.2–10.4, p = 0.02; (adj)OR 2.8, 95%CI 1.1–6.8, p = 0.03, respectively). After repeating the analysis throughout a mixed model, a higher eGFR decline was highlighted in patients concomitantly treated with tenofovir (p = 0.0001), ribavirin (p = 0.0001), or integrase inhibitors (p <0.0001), with longer duration of HIV (p = 0.0002) and HCV infection (p = 0.035), lower baseline HCV RNA (p <0.0001), previous HCV treatment (p<0.0001), and older age (p<0.0001). In conclusion, our study confirms a good renal safety profile of OBV/PTV/r + DSV treatment in HIV/HCV patients, and the median decline of 2 ml/min in eGFR, albeit statistically significant, is of doubtful clinical significance. The role of aging, concomitant therapies and duration of HIV/HCV infection needs to be further investigated. |
format | Online Article Text |
id | pubmed-5819795 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-58197952018-03-15 Trend of estimated glomerular filtration rate during ombistasvir/paritaprevir/ritonavir plus dasabuvir ± ribavirin in HIV/HCV co-infected patients Taramasso, Lucia Di Biagio, Antonio Bovis, Francesca Nicolini, Laura Ambra Antinori, Andrea Milazzo, Laura Sollima, Salvatore Gubertini, Guido Niero, Fosca Saracino, Annalisa Bruno, Raffaele Borghi, Vanni Montagnani, Francesca Cattelan, Annamaria Hasson, Hamid Taliani, Gloria D’Arminio Monforte, Antonella Mastroianni, Claudio Di Perri, Giovanni Bigoni, Sara Puoti, Massimo Spinetti, Angiola Gori, Andrea Boffa, Nicola Cacopardo, Bruno Giacometti, Andrea Parruti, Giustino Vullo, Vincenzo Chirianni, Antonio Teti, Elisabetta Pasquazzi, Caterina Segala, Daniela Andreoni, Massimo PLoS One Research Article The renal function is a key-issue in HIV/HCV co-infected patients, nevertheless, it has not established so far whether HCV treatment with new direct acting agents could impact on estimated glomerular filtration rate (eGFR) variations. In the present work, we examined the real-life data on renal function that have been prospectively collected in the SIMIT compassionate-use program of ombitasvir/paritaprevir/ritonavir plus dasabuvir (OBV/PTV/r + DSV) in 144 HIV/HCV genotype 1 co-infected patients. The population was 74% male, 30.5% in CDC stage C, with median age of 52 years (48.0–56.5) and median liver stiffness of 7.8 kPa (6.7–9.2). Median baseline eGFR was 102.0 (90.8–108.1), changing to 99.8 (83.5–104.8) at the end of treatment (EoT), and 100.0 (87.3–105.6) 12 weeks after the EoT (FU12), p<0.0001. No patient had grade 3–4 increase of creatinine. At EoT 60/144 (41.7%) patients had ≥ 5% reduction in their eGFR, confirmed at FU12 in 39/60 (65.0%) cases. Longer duration of HCV infection (cut-off 12.9 years), lower HCV-RNA viral load (cut-off 1,970,160 IU/ml) and lower platelet count (cut-off 167,000 x10(6)/L) were significantly associated with eGFR decline at logistic analysis ((adj)OR 2.9, 95%CI 1.0–8.8, p = 0.05; (adj)OR 3.5, 95%CI 1.2–10.4, p = 0.02; (adj)OR 2.8, 95%CI 1.1–6.8, p = 0.03, respectively). After repeating the analysis throughout a mixed model, a higher eGFR decline was highlighted in patients concomitantly treated with tenofovir (p = 0.0001), ribavirin (p = 0.0001), or integrase inhibitors (p <0.0001), with longer duration of HIV (p = 0.0002) and HCV infection (p = 0.035), lower baseline HCV RNA (p <0.0001), previous HCV treatment (p<0.0001), and older age (p<0.0001). In conclusion, our study confirms a good renal safety profile of OBV/PTV/r + DSV treatment in HIV/HCV patients, and the median decline of 2 ml/min in eGFR, albeit statistically significant, is of doubtful clinical significance. The role of aging, concomitant therapies and duration of HIV/HCV infection needs to be further investigated. Public Library of Science 2018-02-20 /pmc/articles/PMC5819795/ /pubmed/29462201 http://dx.doi.org/10.1371/journal.pone.0192627 Text en © 2018 Taramasso et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Research Article Taramasso, Lucia Di Biagio, Antonio Bovis, Francesca Nicolini, Laura Ambra Antinori, Andrea Milazzo, Laura Sollima, Salvatore Gubertini, Guido Niero, Fosca Saracino, Annalisa Bruno, Raffaele Borghi, Vanni Montagnani, Francesca Cattelan, Annamaria Hasson, Hamid Taliani, Gloria D’Arminio Monforte, Antonella Mastroianni, Claudio Di Perri, Giovanni Bigoni, Sara Puoti, Massimo Spinetti, Angiola Gori, Andrea Boffa, Nicola Cacopardo, Bruno Giacometti, Andrea Parruti, Giustino Vullo, Vincenzo Chirianni, Antonio Teti, Elisabetta Pasquazzi, Caterina Segala, Daniela Andreoni, Massimo Trend of estimated glomerular filtration rate during ombistasvir/paritaprevir/ritonavir plus dasabuvir ± ribavirin in HIV/HCV co-infected patients |
title | Trend of estimated glomerular filtration rate during ombistasvir/paritaprevir/ritonavir plus dasabuvir ± ribavirin in HIV/HCV co-infected patients |
title_full | Trend of estimated glomerular filtration rate during ombistasvir/paritaprevir/ritonavir plus dasabuvir ± ribavirin in HIV/HCV co-infected patients |
title_fullStr | Trend of estimated glomerular filtration rate during ombistasvir/paritaprevir/ritonavir plus dasabuvir ± ribavirin in HIV/HCV co-infected patients |
title_full_unstemmed | Trend of estimated glomerular filtration rate during ombistasvir/paritaprevir/ritonavir plus dasabuvir ± ribavirin in HIV/HCV co-infected patients |
title_short | Trend of estimated glomerular filtration rate during ombistasvir/paritaprevir/ritonavir plus dasabuvir ± ribavirin in HIV/HCV co-infected patients |
title_sort | trend of estimated glomerular filtration rate during ombistasvir/paritaprevir/ritonavir plus dasabuvir ± ribavirin in hiv/hcv co-infected patients |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5819795/ https://www.ncbi.nlm.nih.gov/pubmed/29462201 http://dx.doi.org/10.1371/journal.pone.0192627 |
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