Compliance and tolerability of subcutaneous hepatitis B immunoglobulin self-administration in liver transplant patients: A prospective, observational, multicenter study

Klein, Christian; Cicinnati, Vito R.; Schmidt, Hartmut; Ganten, Tom M.; Scherer, Marcus N.; Braun, Felix; Zeuzem, Stefan; Wartenberg-Demand, Andrea; Niemann, Gabriele; Schmeidl, R.; Beckebaum, Susanne

doi:10.12659/aot.889269

Cited by 11 publications

(4 citation statements)

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“… 99 A prospective, observational, 18-week, open-label, single-arm, multicenter study confirmed that self-administering SC HBIG at home achieved high compliance and tolerability in maintenance liver transplant patients. 100 Thürmann et al investigated pharmacokinetics and safety of a novel HBIG (Biotest AG) in healthy volunteers after a single SC or IM dose of 30 IU/kg and observed that the two routes have comparable pharmacokinetic parameters. 101 Biotest AG launched Zutectra ® as a new SC prophylaxis against HBV reinfection in 2010.…”

Section: Resultsmentioning

confidence: 99%

The optimal choice of medication administration route regarding intravenous, intramuscular, and subcutaneous injection

Jin¹,

Zhu²,

Chen³

et al. 2015

PPA

128

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BackgroundIntravenous (IV), intramuscular (IM), and subcutaneous (SC) are the three most frequently used injection routes in medication administration. Comparative studies of SC versus IV, IM versus IV, or IM versus SC have been sporadically conducted, and some new findings are completely different from the dosage recommendation as described in prescribing information. However, clinicians may still be ignorant of such new evidence-based findings when choosing treatment methods.MethodsA literature search was performed using PubMed, MEDLINE, and Web of Sciences™ Core Collection to analyze the advantages and disadvantages of SC, IV, and IM administration in head-to-head comparative studies.Results“SC better than IV” involves trastuzumab, rituximab, antitumor necrosis factor medications, bortezomib, amifostine, recombinant human granulocyte-macrophage colony-stimulating factor, granulocyte colony-stimulating factor, recombinant interleukin-2, immunoglobulin, epoetin alfa, heparin, and opioids. “IV better than SC” involves ketamine, vitamin K1, and abatacept. With respect to insulin and ketamine, whether IV has advantages over SC is determined by specific clinical circumstances. “IM better than IV” involves epinephrine, hepatitis B immu-noglobulin, pegaspargase, and some antibiotics. “IV better than IM” involves ketamine, morphine, and antivenom. “IM better than SC” involves epinephrine. “SC better than IM” involves interferon-beta-1a, methotrexate, human chorionic gonadotropin, hepatitis B immunoglobulin, hydrocortisone, and morphine. Safety, efficacy, patient preference, and pharmacoeconomics are four principles governing the choice of injection route. Safety and efficacy must be the preferred principles to be considered (eg, epinephrine should be given intramuscularly during an episode of systemic anaphylaxis). If the safety and efficacy of two injection routes are equivalent, clinicians should consider more about patient preference and pharmacoeconomics because patient preference will ensure optimal treatment adherence and ultimately improve patient experience or satisfaction, while pharmacoeconomic concern will help alleviate nurse shortages and reduce overall health care costs. Besides the principles, the following detailed factors might affect the decision: patient characteristics-related factors (body mass index, age, sex, medical status [eg, renal impairment, comorbidities], personal attitudes toward safety and convenience, past experience, perception of current disease status, health literacy, and socioeconomic status), medication administration-related factors (anatomical site of injection, dose, frequency, formulation characteristics, administration time, indication, flexibility in the route of administration), and health care staff/institution-related factors (knowledge, human resources).ConclusionThis updated review of findings of comparative studies of different injection routes will enrich the knowledge of safe, efficacious, economic, and patient preference-oriented medication administration as well as...

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Section: Resultsmentioning

confidence: 99%

The optimal choice of medication administration route regarding intravenous, intramuscular, and subcutaneous injection

Jin¹,

Zhu²,

Chen³

et al. 2015

PPA

128

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“…Higher HBIg dosage is associated with a lower frequency of HBV recurrence even in patients receiving combination prophylaxis [ 7 ]. When dosed correctly, HBIg is highly effective in maintaining adequate titers [ 14 , 15 ]. In the present cohort, 14.6% of patients had a serum anti-HBs level <100 IU/l, suggesting failure to maintain protective titers in this subpopulation.…”

Section: Discussionmentioning

confidence: 99%

Recurrence of Hepatitis B Infection in Liver Transplant Patients Receiving Long-Term Hepatitis B Immunoglobulin Prophylaxis

et al. 2018

Self Cite

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BackgroundLong-term real-world data are relatively sparse regarding recurrence of chronic hepatitis B virus (HBV) infection after liver transplantation using hepatitis B immunoglobulin (HBIg) and nucleos(t)ide analogue (NUC) prophylaxis.Material/MethodsData from 371 adults transplanted for HBV-related disease at 20 European centers and given HBIg for ≥12 months ± NUC therapy were analyzed retrospectively.ResultsHBIg comprised Hepatect® (iv HBIgB; n=299), subcutaneous Zutectra® (sc HBIg, n=236), and other HBIg preparations (n=130); 93.5% received NUC therapy. Mean follow-up was 6.8±3.5 years. The primary efficacy variable, freedom from HBV recurrence, occurred in 95.7% of patients (95% CI [93.1%, 97.5%]). The observed incidence of recurrence was 16/371 (4.3%) (annual rate 0.65%); 5/16 patients with recurrence had discontinued HBIg and 7/16 had anti-HBs <100 IU/l. Excluding these 7 patients, the HBV recurrence rate was 2.4%. The recurrence rate while on HBIg therapy was 1 per 2069 months. In patients who discontinued HBIg, risk of HBV recurrence versus sc HBIg users was increased by 5.2-fold (1 per 1 603 versus 1 per 8379 treatment months). The annual rate of HBV-related hepatocellular carcinoma (HCC) recurrence was 1.7%.ConclusionsThese results support the long-term use of HBIg with NUC therapy as an effective management strategy to minimize risk of HBV recurrence and virus-related complications after liver transplantation.

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“…During the COVID-19 pandemic, there has been a significant shift in clinical trial management to allow for self-isolation, with remote trials becoming more commonplace [ 34 ]. Decentralised trials have been associated with increased patient empowerment and patient-centred care [ 35 ], and it has been suggested that the convenience of home administration may improve patient retention and compliance [ 36 , 37 ].…”

Section: Discussionmentioning

confidence: 99%

Methodology of the SORENTO clinical trial: a prospective, randomised, active-controlled phase 3 trial assessing the efficacy and safety of high exposure octreotide subcutaneous depot (CAM2029) in patients with GEP-NET

Singh,

Ferone,

Capdevila

et al. 2024

Trials

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Background The current standard of care (SoC) for the initial treatment of unresectable or metastatic well-differentiated gastroenteropancreatic neuroendocrine tumours (GEP-NET) requires initiation of first-generation somatostatin receptor ligand (SRL) therapy, octreotide and lanreotide, which provide safe and efficacious tumour/symptom control in most patients. However, disease progression can occur with SoC SRL treatment and the optimal dose response of SRL remains unknown. Octreotide subcutaneous depot (CAM2029) is a novel, long-acting, high-exposure formulation that has shown greater bioavailability and improved administration than octreotide long-acting release (LAR) with a well-tolerated safety profile. Retrospective data have highlighted a potential benefit of high-exposure SRL for improved disease control in patients who did not adequately respond to the current SoC SRL treatment. This trial will investigate the efficacy and tolerability of CAM2029 compared to the current SoC, including octreotide LAR and lanreotide autogel (ATG). Methods SORENTO is a prospective, multicentre, randomised, active-controlled, open-label phase 3 trial aiming to demonstrate superiority of treatment with 20 mg octreotide subcutaneous depot (CAM2029) every 2 weeks (Q2W) compared to treatment with the Investigator’s choice of SRL therapy at standard doses for tumour control (octreotide LAR 30 mg or lanreotide ATG 120 mg every 4 weeks [Q4W]) as assessed by progression-free survival (PFS) in approximately 300 patients with unresectable/metastatic and well-differentiated GEP-NET. Upon confirmation of disease progression (determined by a Blinded Independent Review Committee [BIRC] and defined as per RECIST 1.1), patients may enter an open-label extension treatment period with once weekly dosing, to investigate the effects of higher frequency dosing. Overall survival follow-up will end a maximum of 2 years after primary analysis. The primary endpoint will be analysed after 194 confirmed PFS events. Discussion This is the first trial investigating the efficacy of CAM2029 versus SoC SRL therapy using a head-to-head, superiority trial design. It is expected to be the first trial to investigate the efficacy of increased dosing frequency of a high-exposure SRL. A BIRC will limit bias and measurement variability and ensure high-quality efficacy data. Additionally, inclusion of patients with well-differentiated Grade 3 NET may elucidate treatment strategies for this rarely investigated patient population. Trial registration ClinicalTrials.gov NCT05050942. Registered on 21st September 2021.

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Compliance and tolerability of subcutaneous hepatitis B immunoglobulin self-administration in liver transplant patients: A prospective, observational, multicenter study

Abstract: Subcutaneous HBIg home-based self-administration under routine, real-life conditions is well-tolerated and associated with high compliance and maintaining protective anti-HBs serum concentration.

Cited by 11 publications

References 0 publications

The optimal choice of medication administration route regarding intravenous, intramuscular, and subcutaneous injection

The optimal choice of medication administration route regarding intravenous, intramuscular, and subcutaneous injection

Recurrence of Hepatitis B Infection in Liver Transplant Patients Receiving Long-Term Hepatitis B Immunoglobulin Prophylaxis

Methodology of the SORENTO clinical trial: a prospective, randomised, active-controlled phase 3 trial assessing the efficacy and safety of high exposure octreotide subcutaneous depot (CAM2029) in patients with GEP-NET

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