Trend of estimated glomerular filtration rate during ombistasvir/paritaprevir/ritonavir plus dasabuvir± ribavirin in HIV/HCV co-infected patients

L Taramasso, A Di Biagio, F Bovis, LA Nicolini, A Antinori, L Milazzo, S Sollima, G Gubertini, F Niero, A Saracino, R Bruno, V Borghi, F Montagnani, A Cattelan, H Hasson, G Taliani, ADA Monforte, C Mastroianni, GD Perri, S BigoniM Puoti, A Spinetti, A Gori, N Boffa, B Cacopardo, A Giacometti, G Parruti, V Vullo, A Chirianni, E Teti, C Pasquazzi, D Segala, M Andreoni

Research output: Contribution to journalArticle

Abstract

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 × 10 6 /L) were significantly associated with eGFR decline at logistic analysis ( adj OR 2.9, 95%CI1.0-8.8, p = 0.05; adj OR 3.5, 95%CI1.2-10.4, p = 0.02; adj OR 2.8, 95%CI1.1-6.8, 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. © 2018 Taramasso 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.
Original languageEnglish
Article numbere0192627
JournalPLoS One
Volume13
Issue number2
DOIs
Publication statusPublished - 2018

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Ritonavir
glomerular filtration rate
Ribavirin
Glomerular Filtration Rate
HIV
Tenofovir
renal function
duration
Kidney
Therapeutics
Integrase Inhibitors
RNA
Compassionate Use Trials
blood platelet count
Viral RNA
HIV infections
logit analysis
Platelets
viral load
infection

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Trend of estimated glomerular filtration rate during ombistasvir/paritaprevir/ritonavir plus dasabuvir± ribavirin in HIV/HCV co-infected patients. / Taramasso, L; Di Biagio, A; Bovis, F; Nicolini, LA; Antinori, A; Milazzo, L; Sollima, S; Gubertini, G; Niero, F; Saracino, A; Bruno, R; Borghi, V; Montagnani, F; Cattelan, A; Hasson, H; Taliani, G; Monforte, ADA; Mastroianni, C; Perri, GD; Bigoni, S; Puoti, M; Spinetti, A; Gori, A; Boffa, N; Cacopardo, B; Giacometti, A; Parruti, G; Vullo, V; Chirianni, A; Teti, E; Pasquazzi, C; Segala, D; Andreoni, M.

In: PLoS One, Vol. 13, No. 2, e0192627, 2018.

Research output: Contribution to journalArticle

Taramasso, L, Di Biagio, A, Bovis, F, Nicolini, LA, Antinori, A, Milazzo, L, Sollima, S, Gubertini, G, Niero, F, Saracino, A, Bruno, R, Borghi, V, Montagnani, F, Cattelan, A, Hasson, H, Taliani, G, Monforte, ADA, Mastroianni, C, Perri, GD, Bigoni, S, Puoti, M, Spinetti, A, Gori, A, Boffa, N, Cacopardo, B, Giacometti, A, Parruti, G, Vullo, V, Chirianni, A, Teti, E, Pasquazzi, C, Segala, D & Andreoni, M 2018, 'Trend of estimated glomerular filtration rate during ombistasvir/paritaprevir/ritonavir plus dasabuvir± ribavirin in HIV/HCV co-infected patients', PLoS One, vol. 13, no. 2, e0192627. https://doi.org/10.1371/journal.pone.0192627
Taramasso, L ; Di Biagio, A ; Bovis, F ; Nicolini, LA ; Antinori, A ; Milazzo, L ; Sollima, S ; Gubertini, G ; Niero, F ; Saracino, A ; Bruno, R ; Borghi, V ; Montagnani, F ; Cattelan, A ; Hasson, H ; Taliani, G ; Monforte, ADA ; Mastroianni, C ; Perri, GD ; Bigoni, S ; Puoti, M ; Spinetti, A ; Gori, A ; Boffa, N ; Cacopardo, B ; Giacometti, A ; Parruti, G ; Vullo, V ; Chirianni, A ; Teti, E ; Pasquazzi, C ; Segala, D ; Andreoni, M. / Trend of estimated glomerular filtration rate during ombistasvir/paritaprevir/ritonavir plus dasabuvir± ribavirin in HIV/HCV co-infected patients. In: PLoS One. 2018 ; Vol. 13, No. 2.
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abstract = "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 × 10 6 /L) were significantly associated with eGFR decline at logistic analysis ( adj OR 2.9, 95{\%}CI1.0-8.8, p = 0.05; adj OR 3.5, 95{\%}CI1.2-10.4, p = 0.02; adj OR 2.8, 95{\%}CI1.1-6.8, 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. {\circledC} 2018 Taramasso 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.",
author = "L Taramasso and {Di Biagio}, A and F Bovis and LA Nicolini and A Antinori and L Milazzo and S Sollima and G Gubertini and F Niero and A Saracino and R Bruno and V Borghi and F Montagnani and A Cattelan and H Hasson and G Taliani and ADA Monforte and C Mastroianni and GD Perri and S Bigoni and M Puoti and A Spinetti and A Gori and N Boffa and B Cacopardo and A Giacometti and G Parruti and V Vullo and A Chirianni and E Teti and C Pasquazzi and D Segala and M Andreoni",
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TY - JOUR

T1 - Trend of estimated glomerular filtration rate during ombistasvir/paritaprevir/ritonavir plus dasabuvir± ribavirin in HIV/HCV co-infected patients

AU - Taramasso, L

AU - Di Biagio, A

AU - Bovis, F

AU - Nicolini, LA

AU - Antinori, A

AU - Milazzo, L

AU - Sollima, S

AU - Gubertini, G

AU - Niero, F

AU - Saracino, A

AU - Bruno, R

AU - Borghi, V

AU - Montagnani, F

AU - Cattelan, A

AU - Hasson, H

AU - Taliani, G

AU - Monforte, ADA

AU - Mastroianni, C

AU - Perri, GD

AU - Bigoni, S

AU - Puoti, M

AU - Spinetti, A

AU - Gori, A

AU - Boffa, N

AU - Cacopardo, B

AU - Giacometti, A

AU - Parruti, G

AU - Vullo, V

AU - Chirianni, A

AU - Teti, E

AU - Pasquazzi, C

AU - Segala, D

AU - Andreoni, M

PY - 2018

Y1 - 2018

N2 - 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 × 10 6 /L) were significantly associated with eGFR decline at logistic analysis ( adj OR 2.9, 95%CI1.0-8.8, p = 0.05; adj OR 3.5, 95%CI1.2-10.4, p = 0.02; adj OR 2.8, 95%CI1.1-6.8, 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. © 2018 Taramasso 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.

AB - 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 × 10 6 /L) were significantly associated with eGFR decline at logistic analysis ( adj OR 2.9, 95%CI1.0-8.8, p = 0.05; adj OR 3.5, 95%CI1.2-10.4, p = 0.02; adj OR 2.8, 95%CI1.1-6.8, 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. © 2018 Taramasso 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.

U2 - 10.1371/journal.pone.0192627

DO - 10.1371/journal.pone.0192627

M3 - Article

VL - 13

JO - PLoS One

JF - PLoS One

SN - 1932-6203

IS - 2

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