Uso concomitante de antivirales de acción directa (AAD) y fármacos con acción sobre el sistema nervioso central: Consideraciones en el perfil actual del paciente con hepatitis C

Sicras‐Mainar, Antoni; Morillo-Verdugo, Ramón

doi:10.20882/adicciones.1551

Cited by 3 publications

(8 citation statements)

References 16 publications

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“…The concomitant treatments prescribed were in line with the results reported in a Spanish real-world study, in which the most consumed therapeutic groups belonged to the class of alimentary tract and metabolism (37.5%), cardiovascular system (37.5%), and nervous system (34.1%) [15][16][17]. In the Spanish cohort, GLE/PIB showed a higher prevalence of DDIs (17.8%), which was followed distantly by SOF/VEL (2.8%) [15].…”

Section: Discussionsupporting

confidence: 85%

“…However, the most common medications with significant CNS DDIs were found in the GLE/PIB cohort (2%): antipsychotics (1.3%) represented by quetiapine (1.1%) and analgesics (0.7%) led by oxycodone (0.6%). Both CNS drugs were also frequently found in the HCV patients Spanish cohort [ 16 ].…”

Section: Discussionmentioning

confidence: 99%

“…For DAAs with protease inhibitors, potential DDIs should be checked before recommending their use; NS5A protein inhibitors are potent and effective but have a low resistance barrier and variable toxicity profiles, while NS5B polymerase inhibitors have a high genetic barrier, and their metabolism generally does not depend on cytochrome P450 [ 16 ]. In general, regimens with the NS5B inhibitor sofosbuvir plus an HCV NS5A inhibitor, which do not affect CYP450, were relatively free of significant pharmacokinetic interactions, even in patients with moderate to severe liver impairment [ 7 ].…”

Section: Discussionmentioning

confidence: 99%

“…In general, regimens with the NS5B inhibitor sofosbuvir plus an HCV NS5A inhibitor, which do not affect CYP450, were relatively free of significant pharmacokinetic interactions, even in patients with moderate to severe liver impairment [ 7 ]. Actually, recent reviews reported that the administration of drugs concomitantly with SOF generally resulted in fewer DDIs than with protease inhibitor-based regimens [ 15 , 16 , 23 ]. Currently, the most widely used DAAs demonstrate a moderate DDI risk profile, which is significantly lower compared with first-generation protease inhibitors [ 24 , 25 ].…”

Section: Discussionmentioning

confidence: 99%

“…Clinical trials that investigated the DDI between DAAs and some key drugs generally included patients with limited concomitant medications [ 11 , 12 ]; however, in real life clinical practice, the presence of polypharmacology regimens can make the HCV treatment more challenging than expected [ 13 , 14 , 15 ]. Indeed, studies performed in real-world settings observed among HCV patients high rates of comorbidities and the use of concomitant medication, especially in older ones, which means a greater exposure to potential DDI; moreover, the most commonly concomitant drugs were reported to belong to cardiovascular and central nervous system classes [ 6 , 15 , 16 , 17 ].…”

Section: Introductionmentioning

confidence: 99%

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Drug–Drug Interactions in Italian Patients with Chronic Hepatitis C Treated with Pangenotypic Direct Acting Agents: Insights from a Real-World Study

Mangia

Scaglione

Toniutto

et al. 2021

IJERPH

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This Italian observational real-world study aims to assess in chronic hepatitis C virus (HCV) patients treated with pangenotypic direct acting agents (pDAAs) glecaprevir/pibrentasvir (GLE/PIB) or sofosbuvir/velpatasvir (SOF/VEL) the potential drug–drug interactions (DDIs) with concomitant medications prescribed, with a focus on cardiovascular and system nervous (CNS) co-medications. Data were collected from administrative databases covering 6.9 million health-assisted individuals. All patients prescribed SOF/VEL or GLE/PIB between 11/2017 and 12/2018 were included. Patients were analyzed while on DAA. DDIs were identified according to the Liverpool University tool. Overall, 3,181 HCV patients were included: 1619 in the GLE/PIB cohort and 1,562 in the SOF/VEL cohort. SOF/VEL patients were generally older than GLE/PIB ones (mean age 58.4 vs. 53.1, p < 0.001) and had more cardiovascular and CNS comorbidities (58% vs. 42%, p < 0.001 and 33% vs. 28%, p = 0.002, respectively). Contraindications due to DDIs in the GLE/PIB cohort affected 9.3% and 3.2% of patients before and on DAA, respectively, while the percentages in the SOF/VEL cohort were 3.2% before and 0.4% after pDAAs initiation. Among GLE/PIB patients, 2.7% had cardiovascular drugs (all statins) contraindicated while on DAA. The potential DDIs between cardiovascular drugs and SOF/VEL were mainly with statins (5%). SOF/VEL was prescribed in patients with older age and with more cardiovascular and CNS comorbidities. Despite this, a proportion of contraindicated drugs lower than that of GLE/PIB was registered.

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Section: Discussionsupporting

confidence: 85%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Drug–Drug Interactions in Italian Patients with Chronic Hepatitis C Treated with Pangenotypic Direct Acting Agents: Insights from a Real-World Study

Mangia

Scaglione

Toniutto

et al. 2021

IJERPH

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Italian Real-World Analysis of the Impact of Polypharmacy and Aging on the Risk of Multiple Drug–Drug Interactions (DDIs) in HCV Patients Treated with Pangenotypic Direct-Acting Antivirals (pDAA)

Fagiuoli

Toniutto

Coppola

et al. 2023

TCRM

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Purpose The study aims at investigating the impact of polymedication and aging in the prevalence of multiple drug-drug interactions (DDIs) on HCV patients treated with sofosbuvir/velpatasvir (SOF/VEL) or glecaprevir/pibrentasvir (GLE/PIB). Patients and Methods This is a retrospective analysis based on administrative data covering around 6.9 million individuals. Patients treated with SOF/VEL or GLE/PIB over November 2017–March 2020 were included. Index date corresponded to SOF/VEL or GLE/PIB first prescription during such period; patients were followed up for treatment duration. Analyses were then focused on patients with ≥2 comedications at risk of multiple DDIs. The severity and the effect of multiple DDI were identified using the Liverpool University tool. Results A total of 2057 patients with SOF/VEL and 2128 with GLE/PIB were selected. Mean age of SOF/VEL patients was 58.5 years, higher than GLE/PIB ones (52.5 years) (p < 0.001), and patients >50 years were more present in SOF/VEL vs GLE/PIB cohorts: 72% vs 58%, (p < 0.001). Most prescribed co-medications were cardiovascular, alimentary and nervous system drugs. Proportion of patients with ≥2 comedications was higher in SOF/VEL compared to GLE/PIB cohort (56.5% vs 32.3%, p < 0.001). Those at high-risk of multiple DDIs accounted for 11.6% (N = 135) of SOF/VEL and 19.6% (N = 135) of GLE/PIB (p < 0.001) patients with ≥2 comedications. Among them, the potential effect of DDI was a decrease of DAA serum levels (11% of SOF/VEL and GLE/PIB patients) and an increased concentration of comedication serum levels (14% of SOF/VEL and 42% of GLE/PIB patients). Conclusion This real-world analysis provided a thorough characterization on the burden of polymedication regimens in HCV patients treated with SOF/VEL or GLE/PIB that expose such patients to an increased risk of DDIs. In our sample population, SOF/VEL regimen was more frequently detected on elderly patients and on those with ≥2 comedications at risk of multi-DDI, ie, among patients characterized by higher rates of comorbidities and polypharmacy.

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Global Real-World Evidence of Sofosbuvir/Velpatasvir as a Highly Effective Treatment and Elimination Tool in People with Hepatitis C Infection Experiencing Mental Health Disorders

Wedemeyer

Marco

García–Retortillo

et al. 2022

Viruses

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Hepatitis C virus (HCV) is prevalent in people with mental health disorders, a priority population to diagnose and cure in order to achieve HCV elimination. This integrated analysis pooled data from 20 cohorts in seven countries to evaluate the real-world effectiveness of the pangenotypic direct-acting antiviral (DAA) sofosbuvir/velpatasvir (SOF/VEL) in people with mental health disorders. HCV-infected patients diagnosed with mental health disorders who were treated with SOF/VEL for 12 weeks without ribavirin as part of routine clinical practice were included. The primary outcome was sustained virological response (SVR) in the effectiveness population (EP), defined as patients with an available SVR assessment. Secondary outcomes were reasons for not achieving SVR, characteristics of patients with non-virological failures, adherence, and time from HCV RNA diagnosis to SOF/VEL treatment initiation. A total of 1209 patients were included; 142 did not achieve an SVR for non-virological reasons (n = 112; 83 lost to follow-up, 20 early treatment discontinuations) or unknown reasons (n = 30). Of the 1067 patients in the EP, 97.4% achieved SVR. SVR rates in the EP were ≥95% when stratified by type of mental health disorder and other complicating baseline characteristics, including active injection drug use and antipsychotic drug use. Of 461 patients with data available in the EP, only 2% had an adherence level < 90% and 1% had an adherence level < 80%; all achieved SVR. Patients with mental health disorders can be cured of HCV using a well-tolerated, pangenotypic, protease inhibitor-free SOF/VEL regimen. This DAA allows the implementation of a simple treatment algorithm, with minimal monitoring requirements and fewer interactions with central nervous system drugs compared with protease-inhibitor DAA regimens.

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Uso concomitante de antivirales de acción directa (AAD) y fármacos con acción sobre el sistema nervioso central: Consideraciones en el perfil actual del paciente con hepatitis C

Cited by 3 publications

References 16 publications

Drug–Drug Interactions in Italian Patients with Chronic Hepatitis C Treated with Pangenotypic Direct Acting Agents: Insights from a Real-World Study

Drug–Drug Interactions in Italian Patients with Chronic Hepatitis C Treated with Pangenotypic Direct Acting Agents: Insights from a Real-World Study

Italian Real-World Analysis of the Impact of Polypharmacy and Aging on the Risk of Multiple Drug–Drug Interactions (DDIs) in HCV Patients Treated with Pangenotypic Direct-Acting Antivirals (pDAA)

Global Real-World Evidence of Sofosbuvir/Velpatasvir as a Highly Effective Treatment and Elimination Tool in People with Hepatitis C Infection Experiencing Mental Health Disorders

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