Q7-26: History of Antiviral Therapy for Hepatitis – Recipient

Question 7: Did the recipient receive therapy for hepatitis prior to HCT?

Hepatitis antiviral therapy is intended to prevent progression of the disease and minimize sequelae of infection. The National Institutes of Health (NIH) in the United States recommends antiviral therapy for Hepatitis B patients with acute liver failure, cirrhosis or advanced cirrhosis with positive viral load, and for reactivation of chronic HBV during or after chemotherapy and/or immunosuppression.² Lamivudine, pegylated interferon alfa, entecavir, and tenofovir are medications currently used to treat Hepatitis B. Hepatitis C therapy has similar goals of sustaining a viral response and minimizing sequelae of infection. Therapy is generally recommended for patients with elevated liver enzymes and/or significant histologic damage on liver biopsy.

Indicate if the recipient received antiviral therapy for hepatitis at any time prior to the preparative regimen. If “yes,” continue with question 8. If “no,” continue with question 27 for allogeneic recipients and the signature section for autologous recipients.

² Sorrell MF, Belongia EA, Costa J, Gareen IF, Grem JL, Inadomi JM, et al. (2009). National Institutes of Health Consensus Devlopement Conference Statement: management of Hepatitis B. Annals of Internal Medicine, 150(2):104-110.

For each therapeutic agent below, create an instance for each course. A course is defined as the period from therapy start to discontinuation of therapy, during which the patient is regularly scheduled to receive the medication; if the dose is changed, please continue the course and only report therapy stopped if the medication is discontinued for at least 14 consecutive days.

Question 8: Lamivudine therapy – course given

Indicate if the recipient received a course at any time prior to the start of the preparative regimen; create an instance for each course given. If “yes,” continue with question 9; if “no,” continue with question 14.

Question 9: Date started

Report the date therapy was initiated and continue with question 10.

Question 10: Daily dose

Report the daily prescribed dose at the start of the therapy

Question 11: Reason started

This is a free text data field. Concisely document the rationale for starting this course of therapy; suggested examples include “prophylaxis” and “treatment.” If the patient received multiple courses of therapy, use this field to provide rationale for the dose change at onset of new course. If the rationale for therapy is not available in the records, document “unknown.”

Question 12: Therapy stopped?

Indicate if therapy was stopped prior to the start of the preparative regimen. If “yes,” continue with question 13. If “no,” continue with question 14.

Question 13: Date stopped

Report the date therapy was stopped and continue with question 14.

Question 14: Interferon therapy – course given

Indicate if the recipient received a course at any time prior to the start of the preparative regimen; create an instance for each course given. If “yes,” continue with question 15; if “no,” continue with question 20.

Question 15: Date started

Report the date therapy was initiated and continue with question 16.

Question 16: Daily dose

Report the daily prescribed dose at the start of the therapy

Question 17: Reason started

This is a free text data field. Concisely document the rationale for starting this course of therapy; suggested examples include “prophylaxis” and “treatment.” If the patient received multiple courses of therapy, use this field to provide rationale for the dose change at onset of new course. If the rationale for therapy is not available in the records, document “unknown.”

Question 18: Therapy stopped?

Indicate if therapy was stopped prior to the start of the preparative regimen. If “yes,” continue with question 19. If “no,” continue with question 20.

Question 19: Date stopped

Report the date therapy was stopped and continue with question 20.

Questions 20-21: Other antiviral therapy – course given

Indicate if the recipient received a course of any other (not Lamivudine or interferon) antiviral therapy for hepatitis infection at any time prior to the start of the preparative regimen; create an instance for each course given. If “yes,” continue with question 21 and specify the other antiviral therapy given; if “no,” continue with question 27.

Question 22: Date started

Report the date therapy was initiated and continue with question 23.

Question 23: Daily dose

Report the daily prescribed dose at the start of therapy.

Question 24: Reason started

This is a free text data field. Concisely document the rationale for starting this course of therapy; suggested examples include “prophylaxis” and “treatment.” If the patient received multiple courses of therapy, use this field to provide rationale for the dose change at onset of new course. If the rationale for therapy is not available in the records, document “unknown.”

Question 25: Therapy stopped?

Indicate if therapy was stopped prior to the start of the preparative regimen. If “yes,” continue with question 26. If “no,” continue with question 27.

Question 26: Date stopped

Report the date therapy was stopped and continue with question 27.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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