Efficacy and safety of direct antiviral agents in a cohort of cirrhotic HCV/HIV-coinfected patients. Navarro, J., Laguno, M., Vilchez, H. H., Guardiola, J. M., Carrion, J. A., Force, L., Cairó, M., Cifuentes, C., Vilaró, J., Cucurull, J., Marco, A., Roget, M., Erice, E., Crespo, M., & Catalano-Balear Study Group Journal of Antimicrobial Chemotherapy, 72(10):2850–2856, 2017. doi abstract bibtex Background: New direct-acting antiviral agents (DAAs) have shown great efficacy and tolerability in clinical trials and real-life cohorts. However, data are scarce regarding efficacy and safety in cirrhotic HCV/HIV-coinfected patients. Methods: A multicentre prospective analysis was performed in 13 Spanish hospitals, including all cirrhotic HCV/HIV-coinfected patients starting DAA combinations from January to December 2015. Sustained virological response 12 weeks after treatment (SVR12) was analysed. Withdrawal due to toxicity and/or hepatic decompensation and change in liver stiffness measurement (LSM) after HCV treatment were evaluated. Results: Patients (n = 170) were mostly male (n = 125; 74.3%) with the following HCV genotype (Gt) distribution: Gt-1a, 68 (40%); Gt-1b, 21 (12.4%); Gt-4, 47 (27.6%); and Gt-3, 26 (15.3%). Baseline median LSM was 20.6 kPa (IQR 16.1-33.7) and log10 HCV-RNA 6.1 IU/mL (IQR 5.7-6.5). Most patients had a Child-Pugh class A score (n = 127; 74.7%) and 28 (16.5%) had prior hepatic decompensation. There were 89 (52.4%) pretreated patients with 40.4% (n = 36) of null responders. Preferred regimens were as follows: sofosbuvir/ledipasvir + ribavirin, 43 (25.3%) patients; sofosbuvir + simeprevir + ribavirin, 34 (20%); sofosbuvir/ledipasvir, 26 (15.3%) and sofosbuvir + daclatasvir + ribavirin, 25 (14.7%). Overall SVR12 was 92.9% (158/170), without differences between genotypes. Pretreated patients had lower SVR12 rates compared with naive (88.8% versus 97.5%; P = 0.026). Treatment failures were as follows: 7 (4.1%) relapses; 2 (1.2%) lost to follow-up; 1 (0.6%) toxicity-related discontinuation; 1 (0.6%) hepatic decompensation; and 1 (0.6%) viral breakthrough. On-treatment hepatic decompensation was recorded in four (2.4%) patients (encephalopathy and ascites, two each). Paired LSM in 33 patients showed a decrease of 5.6 kPa (95% CI 1.8-9.2; P = 0.004). Conclusions: In our cohort of cirrhotic HCV/HIV-coinfected patients, DAAs were highly safe and efficacious. Viral eradication was associated with a significant decrease in liver stiffness.
@article{navarro_efficacy_2017,
title = {Efficacy and safety of direct antiviral agents in a cohort of cirrhotic {HCV}/{HIV}-coinfected patients},
volume = {72},
issn = {1460-2091},
doi = {10.1093/jac/dkx223},
abstract = {Background: New direct-acting antiviral agents (DAAs) have shown great efficacy and tolerability in clinical trials and real-life cohorts. However, data are scarce regarding efficacy and safety in cirrhotic HCV/HIV-coinfected patients.
Methods: A multicentre prospective analysis was performed in 13 Spanish hospitals, including all cirrhotic HCV/HIV-coinfected patients starting DAA combinations from January to December 2015. Sustained virological response 12 weeks after treatment (SVR12) was analysed. Withdrawal due to toxicity and/or hepatic decompensation and change in liver stiffness measurement (LSM) after HCV treatment were evaluated.
Results: Patients (n = 170) were mostly male (n = 125; 74.3\%) with the following HCV genotype (Gt) distribution: Gt-1a, 68 (40\%); Gt-1b, 21 (12.4\%); Gt-4, 47 (27.6\%); and Gt-3, 26 (15.3\%). Baseline median LSM was 20.6 kPa (IQR 16.1-33.7) and log10 HCV-RNA 6.1 IU/mL (IQR 5.7-6.5). Most patients had a Child-Pugh class A score (n = 127; 74.7\%) and 28 (16.5\%) had prior hepatic decompensation. There were 89 (52.4\%) pretreated patients with 40.4\% (n = 36) of null responders. Preferred regimens were as follows: sofosbuvir/ledipasvir + ribavirin, 43 (25.3\%) patients; sofosbuvir + simeprevir + ribavirin, 34 (20\%); sofosbuvir/ledipasvir, 26 (15.3\%) and sofosbuvir + daclatasvir + ribavirin, 25 (14.7\%). Overall SVR12 was 92.9\% (158/170), without differences between genotypes. Pretreated patients had lower SVR12 rates compared with naive (88.8\% versus 97.5\%; P = 0.026). Treatment failures were as follows: 7 (4.1\%) relapses; 2 (1.2\%) lost to follow-up; 1 (0.6\%) toxicity-related discontinuation; 1 (0.6\%) hepatic decompensation; and 1 (0.6\%) viral breakthrough. On-treatment hepatic decompensation was recorded in four (2.4\%) patients (encephalopathy and ascites, two each). Paired LSM in 33 patients showed a decrease of 5.6 kPa (95\% CI 1.8-9.2; P = 0.004).
Conclusions: In our cohort of cirrhotic HCV/HIV-coinfected patients, DAAs were highly safe and efficacious. Viral eradication was associated with a significant decrease in liver stiffness.},
language = {eng},
number = {10},
journal = {Journal of Antimicrobial Chemotherapy},
author = {Navarro, Jordi and Laguno, Montserrat and Vilchez, Helem Haydee and Guardiola, Jose M. and Carrion, Jose A. and Force, Luis and Cairó, Mireia and Cifuentes, Carmen and Vilaró, Josep and Cucurull, Josep and Marco, Andrés and Roget, Mercè and Erice, Eva and Crespo, Manuel and {Catalano-Balear Study Group}},
year = {2017},
pmid = {29091196},
keywords = {Article, Digestiu},
pages = {2850--2856},
}
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{"_id":"QT4kjvJmify2MbRTb","bibbaseid":"navarro-laguno-vilchez-guardiola-carrion-force-cair-cifuentes-etal-efficacyandsafetyofdirectantiviralagentsinacohortofcirrhotichcvhivcoinfectedpatients-2017","downloads":0,"creationDate":"2018-10-11T03:50:31.309Z","title":"Efficacy and safety of direct antiviral agents in a cohort of cirrhotic HCV/HIV-coinfected patients","author_short":["Navarro, J.","Laguno, M.","Vilchez, H. H.","Guardiola, J. M.","Carrion, J. A.","Force, L.","Cairó, M.","Cifuentes, C.","Vilaró, J.","Cucurull, J.","Marco, A.","Roget, M.","Erice, E.","Crespo, M.","Catalano-Balear Study Group"],"year":2017,"bibtype":"article","biburl":"https://bibbase.org/zotero/Bibliotecacst","bibdata":{"bibtype":"article","type":"article","title":"Efficacy and safety of direct antiviral agents in a cohort of cirrhotic HCV/HIV-coinfected patients","volume":"72","issn":"1460-2091","doi":"10.1093/jac/dkx223","abstract":"Background: New direct-acting antiviral agents (DAAs) have shown great efficacy and tolerability in clinical trials and real-life cohorts. However, data are scarce regarding efficacy and safety in cirrhotic HCV/HIV-coinfected patients. Methods: A multicentre prospective analysis was performed in 13 Spanish hospitals, including all cirrhotic HCV/HIV-coinfected patients starting DAA combinations from January to December 2015. Sustained virological response 12 weeks after treatment (SVR12) was analysed. Withdrawal due to toxicity and/or hepatic decompensation and change in liver stiffness measurement (LSM) after HCV treatment were evaluated. Results: Patients (n = 170) were mostly male (n = 125; 74.3%) with the following HCV genotype (Gt) distribution: Gt-1a, 68 (40%); Gt-1b, 21 (12.4%); Gt-4, 47 (27.6%); and Gt-3, 26 (15.3%). Baseline median LSM was 20.6 kPa (IQR 16.1-33.7) and log10 HCV-RNA 6.1 IU/mL (IQR 5.7-6.5). Most patients had a Child-Pugh class A score (n = 127; 74.7%) and 28 (16.5%) had prior hepatic decompensation. There were 89 (52.4%) pretreated patients with 40.4% (n = 36) of null responders. Preferred regimens were as follows: sofosbuvir/ledipasvir + ribavirin, 43 (25.3%) patients; sofosbuvir + simeprevir + ribavirin, 34 (20%); sofosbuvir/ledipasvir, 26 (15.3%) and sofosbuvir + daclatasvir + ribavirin, 25 (14.7%). Overall SVR12 was 92.9% (158/170), without differences between genotypes. Pretreated patients had lower SVR12 rates compared with naive (88.8% versus 97.5%; P = 0.026). Treatment failures were as follows: 7 (4.1%) relapses; 2 (1.2%) lost to follow-up; 1 (0.6%) toxicity-related discontinuation; 1 (0.6%) hepatic decompensation; and 1 (0.6%) viral breakthrough. On-treatment hepatic decompensation was recorded in four (2.4%) patients (encephalopathy and ascites, two each). Paired LSM in 33 patients showed a decrease of 5.6 kPa (95% CI 1.8-9.2; P = 0.004). Conclusions: In our cohort of cirrhotic HCV/HIV-coinfected patients, DAAs were highly safe and efficacious. Viral eradication was associated with a significant decrease in liver stiffness.","language":"eng","number":"10","journal":"Journal of Antimicrobial Chemotherapy","author":[{"propositions":[],"lastnames":["Navarro"],"firstnames":["Jordi"],"suffixes":[]},{"propositions":[],"lastnames":["Laguno"],"firstnames":["Montserrat"],"suffixes":[]},{"propositions":[],"lastnames":["Vilchez"],"firstnames":["Helem","Haydee"],"suffixes":[]},{"propositions":[],"lastnames":["Guardiola"],"firstnames":["Jose","M."],"suffixes":[]},{"propositions":[],"lastnames":["Carrion"],"firstnames":["Jose","A."],"suffixes":[]},{"propositions":[],"lastnames":["Force"],"firstnames":["Luis"],"suffixes":[]},{"propositions":[],"lastnames":["Cairó"],"firstnames":["Mireia"],"suffixes":[]},{"propositions":[],"lastnames":["Cifuentes"],"firstnames":["Carmen"],"suffixes":[]},{"propositions":[],"lastnames":["Vilaró"],"firstnames":["Josep"],"suffixes":[]},{"propositions":[],"lastnames":["Cucurull"],"firstnames":["Josep"],"suffixes":[]},{"propositions":[],"lastnames":["Marco"],"firstnames":["Andrés"],"suffixes":[]},{"propositions":[],"lastnames":["Roget"],"firstnames":["Mercè"],"suffixes":[]},{"propositions":[],"lastnames":["Erice"],"firstnames":["Eva"],"suffixes":[]},{"propositions":[],"lastnames":["Crespo"],"firstnames":["Manuel"],"suffixes":[]},{"firstnames":[],"propositions":[],"lastnames":["Catalano-Balear Study Group"],"suffixes":[]}],"year":"2017","pmid":"29091196","keywords":"Article, Digestiu","pages":"2850–2856","bibtex":"@article{navarro_efficacy_2017,\n\ttitle = {Efficacy and safety of direct antiviral agents in a cohort of cirrhotic {HCV}/{HIV}-coinfected patients},\n\tvolume = {72},\n\tissn = {1460-2091},\n\tdoi = {10.1093/jac/dkx223},\n\tabstract = {Background: New direct-acting antiviral agents (DAAs) have shown great efficacy and tolerability in clinical trials and real-life cohorts. However, data are scarce regarding efficacy and safety in cirrhotic HCV/HIV-coinfected patients.\nMethods: A multicentre prospective analysis was performed in 13 Spanish hospitals, including all cirrhotic HCV/HIV-coinfected patients starting DAA combinations from January to December 2015. Sustained virological response 12 weeks after treatment (SVR12) was analysed. Withdrawal due to toxicity and/or hepatic decompensation and change in liver stiffness measurement (LSM) after HCV treatment were evaluated.\nResults: Patients (n = 170) were mostly male (n = 125; 74.3\\%) with the following HCV genotype (Gt) distribution: Gt-1a, 68 (40\\%); Gt-1b, 21 (12.4\\%); Gt-4, 47 (27.6\\%); and Gt-3, 26 (15.3\\%). Baseline median LSM was 20.6 kPa (IQR 16.1-33.7) and log10 HCV-RNA 6.1 IU/mL (IQR 5.7-6.5). Most patients had a Child-Pugh class A score (n = 127; 74.7\\%) and 28 (16.5\\%) had prior hepatic decompensation. There were 89 (52.4\\%) pretreated patients with 40.4\\% (n = 36) of null responders. Preferred regimens were as follows: sofosbuvir/ledipasvir + ribavirin, 43 (25.3\\%) patients; sofosbuvir + simeprevir + ribavirin, 34 (20\\%); sofosbuvir/ledipasvir, 26 (15.3\\%) and sofosbuvir + daclatasvir + ribavirin, 25 (14.7\\%). Overall SVR12 was 92.9\\% (158/170), without differences between genotypes. Pretreated patients had lower SVR12 rates compared with naive (88.8\\% versus 97.5\\%; P = 0.026). Treatment failures were as follows: 7 (4.1\\%) relapses; 2 (1.2\\%) lost to follow-up; 1 (0.6\\%) toxicity-related discontinuation; 1 (0.6\\%) hepatic decompensation; and 1 (0.6\\%) viral breakthrough. On-treatment hepatic decompensation was recorded in four (2.4\\%) patients (encephalopathy and ascites, two each). Paired LSM in 33 patients showed a decrease of 5.6 kPa (95\\% CI 1.8-9.2; P = 0.004).\nConclusions: In our cohort of cirrhotic HCV/HIV-coinfected patients, DAAs were highly safe and efficacious. Viral eradication was associated with a significant decrease in liver stiffness.},\n\tlanguage = {eng},\n\tnumber = {10},\n\tjournal = {Journal of Antimicrobial Chemotherapy},\n\tauthor = {Navarro, Jordi and Laguno, Montserrat and Vilchez, Helem Haydee and Guardiola, Jose M. and Carrion, Jose A. and Force, Luis and Cairó, Mireia and Cifuentes, Carmen and Vilaró, Josep and Cucurull, Josep and Marco, Andrés and Roget, Mercè and Erice, Eva and Crespo, Manuel and {Catalano-Balear Study Group}},\n\tyear = {2017},\n\tpmid = {29091196},\n\tkeywords = {Article, Digestiu},\n\tpages = {2850--2856},\n}\n\n","author_short":["Navarro, J.","Laguno, M.","Vilchez, H. H.","Guardiola, J. M.","Carrion, J. 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