Risk of multiple drug interactions potentially linked to safety in patients receiving pangenotypic direct-acting antivirals for the treatment of Hepatitis C
Introduction and Objectives: Previous studies have evaluated the risk of drug-drug interactions (DDI) in HCV patients receiving pangenotypic direct-acting antivirals (pDAA), but all are based on pairwise interaction. The aim of the study was to describe the prevalence of the risk of potential multip...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2022-12-01
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| Series: | Annals of Hepatology |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1665268122001661 |
| _version_ | 1811320004690313216 |
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| author | J Mendez-Navarro J Turnes A García-Herola R Morillo M Méndez M Rueda C Hernández A Sicras-Mainar |
| author_facet | J Mendez-Navarro J Turnes A García-Herola R Morillo M Méndez M Rueda C Hernández A Sicras-Mainar |
| author_sort | J Mendez-Navarro |
| collection | DOAJ |
| description | Introduction and Objectives: Previous studies have evaluated the risk of drug-drug interactions (DDI) in HCV patients receiving pangenotypic direct-acting antivirals (pDAA), but all are based on pairwise interaction. The aim of the study was to describe the prevalence of the risk of potential multiple DDI (multi-DDI) and its clinical impact in patients treated with pDAAs. Materials and Methods: Retrospective observational study from a Spanish database of 1.8 million inhabitants, including patients treated with Sofosbuvir/Velpatasvir [SOF/VEL] or Glecaprevir/Pibrentasvir [GLE/PIB] (2017- 2020). Demographics, comorbidities, comedications, and DDIs were evaluated for the pDAA therapy period. The severity and impact of the DDIs were evaluated using the University of Liverpool tool. Additionally, the ICD-9 coding system was used to identify the presence of suspected adverse drug reactions (SADR) during the treatment with pDAAs. An indirect indicator of effectiveness was evaluated (requirement of a new DAA in the six months after the end of the pDAA). Results: 1620 patients were included; 730 with SOF/VEL (median age: 55 y; 62% men; 37.8% F3/4) and 890 with GLE/PIB (53 y; 60% men; 28% F3/4). The most prescribed drugs were nervous drugs (35.8%), digestive (24.1%) and cardiovascular (14.2%). 77.5% of patients received ≥2 comedications. The number of patients receiving ≥ 2 comedications at risk of multi-DDI with pDAAs was 123 (9.8%, 123/1256), 52 with SOF/VEL and 71 with GLE/PIB. Patients showing increased risk in comedication as a DDI outcomes were 31% (22) with GLE/PIB and 11% (6) with SOF/VEL (p <0.001). The risk of decrease in pDAA with GLE/PIB was 32% (23) and with SOF/VEL 46% (24) (p=NS). Regarding SADR, there was a higher number in the GLE/PIB group (14) vs. SOF/VEL group (4) (p<0.05). 84% (16/18) of patients with SADR had a multi-DDI profile. 13% of total multi-DDIs patients showed SADR; GLE/PIB group showed SADR in 18% (13/71) vs. 6% (3/52) in SOF/VEL group (p <0.05). Most SADR were reported with statin group, being the percentage higher in the GLE/PIB group vs. SOF/VEL group (p <0.05).Both pDAAs showed a similar percentage of patients restarting a new pDAA within the six months after the end of treatment (1.0% and 1.1%, respectively, p=NS). Conclusions: In Spain, about 10% of HCV patients taking ≥ 2 comedications are at risk of multiple DDI with pDAAs. The potential risk of increased comedication as DDI outcome and the presence of suspected adverse reactions were higher in GLE/PIB in comparison with SOF/VEL. Funding: The resources used in this study were from the hospital without any additional financing Declaration of interest: The authors declare no potential conflicts of interest. |
| first_indexed | 2024-04-13T12:51:58Z |
| format | Article |
| id | doaj.art-4895a70a40474182931c21856dbcc3fe |
| institution | Directory Open Access Journal |
| issn | 1665-2681 |
| language | English |
| last_indexed | 2024-04-13T12:51:58Z |
| publishDate | 2022-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Annals of Hepatology |
| spelling | doaj.art-4895a70a40474182931c21856dbcc3fe2022-12-22T02:46:10ZengElsevierAnnals of Hepatology1665-26812022-12-0127100824Risk of multiple drug interactions potentially linked to safety in patients receiving pangenotypic direct-acting antivirals for the treatment of Hepatitis CJ Mendez-Navarro0J Turnes1A García-Herola2R Morillo3M Méndez4M Rueda5C Hernández6A Sicras-Mainar7Medical Affairs. Gilead Sciences MexicoGastroenterology and Hepatology Department. CHU. Pontevedra, SpainDigestive Medicine Department. Hospital Marina Baixa de Villajoyosa (Alicante), SpainHospital Pharmacy. Hospital de Valme. AGS Sur de Sevilla. SpainMedical Affairs. Gilead Sciences S.L. Madrid, SpainMedical Affairs. Gilead Sciences S.L. Madrid, SpainGlobal Medical Affairs. Gilead Sciences Europe Ltd. U.K.Health Economics and Outcomes Research. Atrys Health. Barcelona, SpainIntroduction and Objectives: Previous studies have evaluated the risk of drug-drug interactions (DDI) in HCV patients receiving pangenotypic direct-acting antivirals (pDAA), but all are based on pairwise interaction. The aim of the study was to describe the prevalence of the risk of potential multiple DDI (multi-DDI) and its clinical impact in patients treated with pDAAs. Materials and Methods: Retrospective observational study from a Spanish database of 1.8 million inhabitants, including patients treated with Sofosbuvir/Velpatasvir [SOF/VEL] or Glecaprevir/Pibrentasvir [GLE/PIB] (2017- 2020). Demographics, comorbidities, comedications, and DDIs were evaluated for the pDAA therapy period. The severity and impact of the DDIs were evaluated using the University of Liverpool tool. Additionally, the ICD-9 coding system was used to identify the presence of suspected adverse drug reactions (SADR) during the treatment with pDAAs. An indirect indicator of effectiveness was evaluated (requirement of a new DAA in the six months after the end of the pDAA). Results: 1620 patients were included; 730 with SOF/VEL (median age: 55 y; 62% men; 37.8% F3/4) and 890 with GLE/PIB (53 y; 60% men; 28% F3/4). The most prescribed drugs were nervous drugs (35.8%), digestive (24.1%) and cardiovascular (14.2%). 77.5% of patients received ≥2 comedications. The number of patients receiving ≥ 2 comedications at risk of multi-DDI with pDAAs was 123 (9.8%, 123/1256), 52 with SOF/VEL and 71 with GLE/PIB. Patients showing increased risk in comedication as a DDI outcomes were 31% (22) with GLE/PIB and 11% (6) with SOF/VEL (p <0.001). The risk of decrease in pDAA with GLE/PIB was 32% (23) and with SOF/VEL 46% (24) (p=NS). Regarding SADR, there was a higher number in the GLE/PIB group (14) vs. SOF/VEL group (4) (p<0.05). 84% (16/18) of patients with SADR had a multi-DDI profile. 13% of total multi-DDIs patients showed SADR; GLE/PIB group showed SADR in 18% (13/71) vs. 6% (3/52) in SOF/VEL group (p <0.05). Most SADR were reported with statin group, being the percentage higher in the GLE/PIB group vs. SOF/VEL group (p <0.05).Both pDAAs showed a similar percentage of patients restarting a new pDAA within the six months after the end of treatment (1.0% and 1.1%, respectively, p=NS). Conclusions: In Spain, about 10% of HCV patients taking ≥ 2 comedications are at risk of multiple DDI with pDAAs. The potential risk of increased comedication as DDI outcome and the presence of suspected adverse reactions were higher in GLE/PIB in comparison with SOF/VEL. Funding: The resources used in this study were from the hospital without any additional financing Declaration of interest: The authors declare no potential conflicts of interest.http://www.sciencedirect.com/science/article/pii/S1665268122001661 |
| spellingShingle | J Mendez-Navarro J Turnes A García-Herola R Morillo M Méndez M Rueda C Hernández A Sicras-Mainar Risk of multiple drug interactions potentially linked to safety in patients receiving pangenotypic direct-acting antivirals for the treatment of Hepatitis C Annals of Hepatology |
| title | Risk of multiple drug interactions potentially linked to safety in patients receiving pangenotypic direct-acting antivirals for the treatment of Hepatitis C |
| title_full | Risk of multiple drug interactions potentially linked to safety in patients receiving pangenotypic direct-acting antivirals for the treatment of Hepatitis C |
| title_fullStr | Risk of multiple drug interactions potentially linked to safety in patients receiving pangenotypic direct-acting antivirals for the treatment of Hepatitis C |
| title_full_unstemmed | Risk of multiple drug interactions potentially linked to safety in patients receiving pangenotypic direct-acting antivirals for the treatment of Hepatitis C |
| title_short | Risk of multiple drug interactions potentially linked to safety in patients receiving pangenotypic direct-acting antivirals for the treatment of Hepatitis C |
| title_sort | risk of multiple drug interactions potentially linked to safety in patients receiving pangenotypic direct acting antivirals for the treatment of hepatitis c |
| url | http://www.sciencedirect.com/science/article/pii/S1665268122001661 |
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