Long-Term Effectiveness, Safety, and Patient-Reported Outcomes of Self-Administered Subcutaneous Hepatitis B Immunoglobulin in Liver Post-Transplant Hepatitis B Prophylaxis: A Prospective Non-Interventional Study

Bruno Roche; Artur Bauhofer; Miguel Ãngel Gomez Bravo; Georges Philippe Pageaux; Fabien Zoulim; Alejandra Otero; Martin Prieto; Carmen Baliellas; Didier Samuel

doi:10.12659/AOT.936162

10 May 2022 : Original article

Long-Term Effectiveness, Safety, and Patient-Reported Outcomes of Self-Administered Subcutaneous Hepatitis B Immunoglobulin in Liver Post-Transplant Hepatitis B Prophylaxis: A Prospective Non-Interventional Study

Bruno Roche^1BCDE, Artur Bauhofer^2ACDEF*, Miguel Ãngel Gomez Bravo^3BCDE, Georges Philippe Pageaux^4ABCDE, Fabien Zoulim^5BDE, Alejandra Otero^6BC, Martin Prieto^78BC, Carmen Baliellas^9BC, Didier Samuel^1ACDE

DOI: 10.12659/AOT.936162

Ann Transplant 2022; 27:e936162

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Table 5 Summary of adverse drug reactions.

	Full analysis set (N=195)

Total (serious+nonserious)	29
Serious	12

Total (serious+nonserious)	16 (8.2)
Serious	5 (2.6)

Asthenia	3 (1.5)
Back pain	2 (1.0)
Headache	2 (1.0)
Nausea	2 (1.0)
Pyrexia	2 (1.0)
Rash pruritic	2 (1.0)

Arthralgia, blood pressure increased, decreased appetite, discomfort, dizziness, drug ineffective, erythema, fatigue, hepatitis B antibody abnormal, hepatitis B surface antigen, hernia, muscle injury, myalgia, product dose omission issue, pruritus, vomiting

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Long-Term Effectiveness, Safety, and Patient-Reported Outcomes of Self-Administered Subcutaneous Hepatitis B Immunoglobulin in Liver Post-Transplant Hepatitis B Prophylaxis: A Prospective Non-Interventional Study

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