Myo-pericarditis secondary to ledipasvir-sofosbuvir therapy

Padegimas, Allison; Forde, Kimberly A.; Goldberg, Lee R.; Birati, Edo Y.

doi:10.1016/j.jhep.2016.01.015

Cited by 11 publications

(8 citation statements)

References 4 publications

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“…Certainly, it is our opinion that without this network and that kind of approach, in a real life setting, it would be really hard to identify minor adverse events related to these antivirals that could have important impact on patients. According to previous evidences and our results on possible cardiovascular system adverse events [ 14 – 16 ], a well defined approach and management to this new treatment focusing on ADR according to our network may really be useful for future strategies in treatment schedule in particular setting of patients as our findings on over 65 years old seem to suggest.…”

Section: Discussionsupporting

confidence: 51%

“…Despite these patients should be treated in an urgent manner, on the other hand they should be managed with caution as at now only few safety data are available for DAAs in real life on the above mentioned clinical condition. Same consideration should also be done for possible cardiovascular system adverse events in those patients having cardiac diseases, since the new antivirals seem to be related to the onset of cardiotoxicity, particularly in elder population [ 13 , 14 ]. In fact, according to our results on adverse events and some literature evidences [ 13 , 14 ], all patients, particularly those over 65 years, should be referred to a reference centre in case of rapid clinical deterioration.…”

Section: Discussionmentioning

confidence: 99%

“…Same consideration should also be done for possible cardiovascular system adverse events in those patients having cardiac diseases, since the new antivirals seem to be related to the onset of cardiotoxicity, particularly in elder population [ 13 , 14 ]. In fact, according to our results on adverse events and some literature evidences [ 13 , 14 ], all patients, particularly those over 65 years, should be referred to a reference centre in case of rapid clinical deterioration. The same caution applies in the pre- and post-transplant setting where drug-to-drug interactions, kidney function and many other factors should be taken into consideration [ 13 ].…”

Section: Discussionmentioning

confidence: 99%

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Safety of new DAAs for chronic HCV infection in a real life experience: role of a surveillance network based on clinician and hospital pharmacist

Nappi

Perrella

Bellopede

et al. 2017

Infect Agents Cancer

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BackgroundDirect Antiviral Agents (DAAs) for HCV therapy represents a step ahead in the cure of chronic hepatitis C. Notwithstanding the promising results in several clinical trials, few data are available on adverse effects in real life settings.MethodsWe have evaluated 170 patients with persistent infection and on those eligible to treatment we have followed up them through a network managed by clinician and hospital pharmacist.ResultsAccording to our data we have found that 41% (32 out of 78) of enrolled patients experienced adverse reactions, of these 40% were in those under 65 years while 60% was in patients older than 65 years, SVR was achieved in 88% of the patients (including drop-out). We had 4 drop-out treatment due to major adverse reaction (heart and lung related).ConclusionEven if new antiviral drugs seem to be promising, according to SVR, they require careful follow-up, possibly managed by clinician and hospital pharmacist, to avoid unrecognized side effects which may affect adherence and the real impact of these drugs on chronically infected subjects.

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Section: Discussionsupporting

confidence: 51%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Safety of new DAAs for chronic HCV infection in a real life experience: role of a surveillance network based on clinician and hospital pharmacist

Nappi

Perrella

Bellopede

et al. 2017

Infect Agents Cancer

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“…Systematic cardiological follow-up will reveal to what extent and in which fraction of these patients HCV eradication does improve cardiac function. These patients need to be closely monitored for possible side effects (e.g., electrolyte disturbances) 24 , 27 since the DAAs are in general well tolerated by nonHF patients, 18 – 22 but experience with HF cohorts, especially with patients in advanced stages of HF, is lacking. There have been reports of serious bradycardia among patients treated with sofosbuvir and amiodarone, but systematic review and meta-analysis of pooled data from randomized controlled trials did not show an increased risk of cardiac outcomes.…”

Section: Cardiovascular Implications Of Chronic Hcv Infectionsmentioning

confidence: 99%

Cardiovascular Involvement in Chronic Hepatitis C Virus Infections – Insight from Novel Antiviral Therapies

Poller¹,

Haghikia²,

Kasner³

et al. 2018

Journal of Clinical and Translational Hepatology

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Whereas statistical association of hepatitis C virus (HCV) infection with cardiomyopathy is long known, establishment of a causal relationship has not been achieved so far. Patients with advanced heart failure (HF) are mostly unable to tolerate interferon (IFN)-based treatment, resulting in limited experience regarding the possible pathogenic role of HCV in this patient group. HCV infection often triggers disease in a broad spectrum of extrahepatic organs, with innate immune and autoimmune pathogenic processes involved. The fact that worldwide more than 70 million patients are chronically infected with HCV illustrates the possible clinical impact arising if cardiomyopathies were induced or aggravated by HCV, resulting in progressive HF or severe arrhythmias. A novel path has been opened to finally resolve the long-standing question of cause-effect relationship between HCV infection and cardiac dysfunction, by the recent development of IFN-free, highly efficient, and well tolerable anti-HCV regimens. The new direct-acting antiviral (DAA) agents are highly virus-specific and lack unspecific side-effects upon cardiac function which have always confounded the interpretation of IFN treatment data. The actual frequency of unexplained HF in chronic HCV infection will be determined from a planned large-scale study. Whereas such patients probably constitute a rather small fraction of all those harboring HCV, they have major clinical relevance. It is not yet known which fraction of these patients will significantly benefit from HCV eradication, but this issue will be addressed now in a prospective study.

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“…Komorbiditäten folgende Therapieoptionen eingesetzt werden: ▪ Velpatasvir plus Sofosbuvir ± Ribavirin für 12 oder 24 Wo-Inhibitoren wie Ledipasvir oder Velpatasvir in Kombination mit Sofosbuvir und ggf. Ribavirin bei Patienten mit dekompensierter Zirrhose, die einen primären renalen Metabolisierungsweg aufweisen, wurde über ein gehäuftes Auftreten von Infektionen, Laktatazidosen und anderen Komplikationen berichtet (III)[66][67][68]. Ein eindeutiger kausaler Zusammenhang mit der antiviralen Therapie konnte jedoch nicht nachgewiesen werden, sodass bei Patienten mit dekompensierter Zirrhose aufgrund der insgesamt erhöhten Suszeptibilität infolge der Initiierung einer antiviralen Therapie vermutlich das Risiko für Komplikationen leicht erhöht wird (I)[69].Grundsätzlich sind bei Patienten mit einer dekompensierten Leberzirrhose die Indikation und die Möglichkeit zur Lebertransplantation zu prüfen.…”

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