TY - JOUR
T1 - Trend of estimated glomerular filtration rate during ombistasvir/paritaprevir/ritonavir plus dasabuvir ± ribavirin in HIV/HCV co-infected patients
AU - Taramasso, Lucia
AU - Di Biagio, Antonio
AU - Bovis, Francesca
AU - Nicolini, Laura Ambra
AU - Antinori, Andrea
AU - Milazzo, Laura
AU - Sollima, Salvatore
AU - Gubertini, Guido
AU - Niero, Fosca
AU - Saracino, Annalisa
AU - Bruno, Raffaele
AU - Borghi, Vanni
AU - Montagnani, Francesca
AU - Cattelan, Annamaria
AU - Hasson, Hamid
AU - Taliani, Gloria
AU - D'Arminio Monforte, Antonella
AU - Mastroianni, Claudio
AU - Di Perri, Giovanni
AU - Bigoni, Sara
AU - Puoti, Massimo
AU - Spinetti, Angiola
AU - Gori, Andrea
AU - Boffa, Nicola
AU - Cacopardo, Bruno
AU - Giacometti, Andrea
AU - Parruti, Giustino
AU - Vullo, Vincenzo
AU - Chirianni, Antonio
AU - Teti, Elisabetta
AU - Pasquazzi, Caterina
AU - Segala, Daniela
AU - Andreoni, Massimo
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 x106/L) were significantly associated with eGFR decline at logistic analysis (adjOR 2.9, 95%CI 1.0-8.8, p = 0.05; adjOR 3.5, 95%CI 1.2-10.4, p = 0.02; adjOR 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.
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 x106/L) were significantly associated with eGFR decline at logistic analysis (adjOR 2.9, 95%CI 1.0-8.8, p = 0.05; adjOR 3.5, 95%CI 1.2-10.4, p = 0.02; adjOR 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.
KW - Antiviral Agents/administration & dosage
KW - Drug Therapy, Combination
KW - Female
KW - Glomerular Filtration Rate
KW - HIV Infections/complications
KW - Hepatitis C/complications
KW - Humans
KW - Macrocyclic Compounds/administration & dosage
KW - Male
KW - Middle Aged
KW - Ribavirin/administration & dosage
KW - Ritonavir/administration & dosage
KW - Sulfonamides/administration & dosage
KW - Uracil/administration & dosage
U2 - 10.1371/journal.pone.0192627
DO - 10.1371/journal.pone.0192627
M3 - Article
C2 - 29462201
VL - 13
SP - e0192627
JO - PLoS One
JF - PLoS One
SN - 1932-6203
IS - 2
ER -