Successful treatment of chronic hepatitis C infection with crushed elbasvir/grazoprevir administered via a percutaneous endoscopic gastrostomy tube

Yap, John Erikson L.; Jaiswal, Palashkumar; Ton, Loc; Szynkarek, R.; Attar, Bashar M.; Gandhi, Seema

doi:10.1111/jcpt.12713

Cited by 9 publications

(7 citation statements)

References 12 publications

(23 reference statements)

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“…A previous case successfully reported SVR12 after administering crushed EBR/GZR via PEG for 16 weeks 10 . Clinical characteristics were similar to our patient with the exception of chronic kidney disease secondary to HCV‐related membranoproliferative glomerulonephritis.…”

Section: Discussionsupporting

confidence: 81%

“…A previous case successfully reported SVR12 after administering crushed EBR/GZR via PEG for 16 weeks. 10 were similar to our patient with the exception of chronic kidney disease secondary to HCV-related membranoproliferative glomerulonephritis. Other details were extremely limited, such as the method of dose preparation, preventing replicability for clinicians.…”

Section: Elbasvir/grazoprevirsupporting

confidence: 88%

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Elbasvir/grazoprevir administered for 12 weeks via percutaneous endoscopic gastrostomy tube achieves sustained virologic response: A case report and a review of the literature

et al. 2021

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Enteral tubes are necessary for certain patients; however, medication absorption can be affected by this route of administration potentially resulting in decreased efficacy. All first-line treatments for Hepatitis C Virus (HCV) infection are only available as tablets and may have decreased absorption if administered via an enteral tube.This report describes the first case of a pegylated interferon and ribavirin treatmentexperienced patient who successfully achieved HCV cure after 12 weeks of elbasvir/ grazoprevir administered via percutaneous gastrostomy tube. We further review the available pharmacokinetic and clinical literature regarding administration via enteral feeding tubes for all first-line direct-acting antivirals (DAAs). The literature suggests that crushed administration can be considered for DAAs in patients with gastric access. However, caution should be exercised in patients with extragastric enteral tubes and in those with altered gastrointestinal tract anatomy.

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Section: Discussionsupporting

confidence: 81%

Section: Elbasvir/grazoprevirsupporting

confidence: 88%

Elbasvir/grazoprevir administered for 12 weeks via percutaneous endoscopic gastrostomy tube achieves sustained virologic response: A case report and a review of the literature

et al. 2021

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“…However, stability and pharmacokinetic data of crushed or split tablets are not readily available. Reports of DAA tablet manipulation are limited to 2 small phase 1 pharmacokinetic studies [ 12 , 13 ] and case reports ( Table 2 ) [ 14–23 ]. Pijnenburg et al [ 12 ] conducted a phase 1, single-dose trial evaluating pharmacokinetic data of elbasvir/grazoprevir in 11 healthy adult volunteers.…”

Section: Discussionmentioning

confidence: 99%

“…To date, 11 individual case reports of DAA tablet manipulation have been published ( Table 2 ) [ 14–24 ]. Five cases describe treatment with sofosbuvir/velpatasvir in patients with HCV genotypes 1a, 1b, 2b, and 4 [ 19–23 ].…”

Section: Discussionmentioning

confidence: 99%

Crushing and Splitting Direct-Acting Antivirals for Hepatitis C Virus Treatment: A Case Series and Literature Review

Whelchel

Zuckerman

Koren

et al. 2021

Open Forum Infectious Diseases

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“…In 2018, Yap et al . 11 described successful treatment of a patient treated with elbasvir/grazoprevir for a 16 week course through a percutaneous endoscopic gastrostomy (PEG) tube. There are no further data available supporting the efficacy, safety and pharmacokinetics of crushed elbasvir/grazoprevir.…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetic similarity demonstrated after crushing of the elbasvir/grazoprevir fixed-dose combination tablet for HCV infection

Pijnenburg¹,

Seyen²,

Abbink

et al. 2020

Journal of Antimicrobial Chemotherapy

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Background Finding a suitable treatment for HCV patients with swallowing disorders is still a major challenge. In practice, direct-acting antivirals are crushed without knowledge of adequate absorption. Crushing can alter drug exposure, possibly leading to treatment failure, development of resistance or toxicity. Currently, there is no information about crushing of the fixed-dose combination tablet of elbasvir/grazoprevir; therefore, crushing of this tablet is not recommended. Objectives To investigate the influence of crushing on the pharmacokinetics of the elbasvir/grazoprevir fixed-dose combination tablet. Methods We conducted an open-label, two-period, randomized, cross-over, Phase I, single-dose trial in 11 healthy adult volunteers. Subjects randomly received whole-tablet elbasvir/grazoprevir or crushed and suspended elbasvir/grazoprevir in a fasted state. Pharmacokinetic similarity criteria (90% CIs lie within 70%–143% acceptance range) were used for AUC0–∞ and AUC0–72. Results Mean plasma concentration–time curves of elbasvir and grazoprevir showed similar pharmacokinetic profiles. The primary pharmacokinetic parameters AUC0–∞ and AUC0–72 of elbasvir and grazoprevir after intake of a crushed tablet were on average 12%–16% higher compared with the whole tablet, but 90% CIs were all within the predefined boundaries of pharmacokinetic similarity. Crushing leads to a higher Cmax of grazoprevir (42%); no significant difference was found between treatments with regard to the Cmax of elbasvir. No serious adverse events were reported during the trial. Conclusions Pharmacokinetic similarity could be demonstrated for a crushed and suspended tablet compared with a whole tablet, without impacting drug safety or efficacy. Crushed and suspended administration of elbasvir/grazoprevir can be used in patients with swallowing disorders.

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Successful treatment of chronic hepatitis C infection with crushed elbasvir/grazoprevir administered via a percutaneous endoscopic gastrostomy tube

Cited by 9 publications

References 12 publications

Elbasvir/grazoprevir administered for 12 weeks via percutaneous endoscopic gastrostomy tube achieves sustained virologic response: A case report and a review of the literature

Elbasvir/grazoprevir administered for 12 weeks via percutaneous endoscopic gastrostomy tube achieves sustained virologic response: A case report and a review of the literature

Crushing and Splitting Direct-Acting Antivirals for Hepatitis C Virus Treatment: A Case Series and Literature Review

Pharmacokinetic similarity demonstrated after crushing of the elbasvir/grazoprevir fixed-dose combination tablet for HCV infection

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