Ipilimumab administration for advanced melanoma in patients with pre-existing Hepatitis B or C infection: a multicenter, retrospective case series

Ravi, Sowmya; Spencer, Kristen; Ruisi, Mary; Ibrahim, Nageatte; Luke, Jason J; Thompson, John A; Shirai, Keisuke; Lawson, David; Bartell, Heddy; Kudchadkar, Ragini; Gunter, Ngoc Thi; Mehnert, Janice M; Lipson, Evan J

doi:10.1186/s40425-014-0033-1

Table 1 Clinical summary of patients with pre-existing Hepatitis B and C treated with ipilimumab

From: Ipilimumab administration for advanced melanoma in patients with pre-existing Hepatitis B or C infection: a multicenter, retrospective case series

Case No.	Age (yrs)	Sex	Liver metastases?	Type of Hepatitis	Evidence of liver fibrosis?	Therapy for metastatic melanoma prior to ipilimumab	LFTs prior to administration of ipilimumab	Change in LFTs during Ipilimumab	Best Response to Ipi	Comments
1	65	M	N	HCV (active)	Y	High dose Interleukin-2	Gr 1 AST, Gr 1 ALT	None	PD	HCV viral load increased four-fold after IL-2, ipilimumab and temozolomide
2	56	M	N	HCV (active)	Unknown	Stereotactic Radiotherapy, then WBRT	AST & ALT WNL	None	PD	Possible drug-related hepatitis detected 2 months after receiving 4 doses of ipilimumab
3	43	M	N	HCV (active)	N	Temozolomide	Gr 2 AST, Gr 2 ALT	Normalized by cycle 4	Mixed response	HCV viral load decreased to undetectable levels after 4 doses of ipilimumab
4	71	M	N	HCV (active)	Y	None	Gr 1 AST, Gr 1 ALT	Gr 2 AST, Gr 3 ALT after cycle 3	SD	HCV viral load decreased 5-fold to 408,000 IU/mL after 3 doses of ipilimumab; ocular melanoma
5	56	M	(multiple tumors involving 25-75% of liver, largest = 6.4 cm)	HBV (inactive)	Unknown	None	Gr 1 AST, ALT WNL	None	PD	Concurrent administration of entecovir for prophylaxis against HBV reactivation
6	60	M	N	HBV (active)	Unknown	high-dose interleukin-2, talimogene laherparepvec and dacarbazine	AST & ALT WNL	None	PD	Tenofovir administration prior to ipi brought HBV viral load from 2950 to 41 IU/mL; became undetectable and remained so throughout ipilimumab
7	42	F	(multiple tumors involving 30-40% of liver, largest = 2.7 cm)	HBV (inactive)	Unknown	None	AST & ALT WNL	None	PD	HBV viral load undetectable prior to starting ipilimumab
8	56	M	N	HBV (active)	Unknown	None	AST & ALT WNL	None	PD	Entecavir administration prior to ipi brought HBV viral load from 9560 to 454 IU/mL; became undetectable and remained so throughout ipilimumab
9	71	M	N	HBV (active)	Cirrhosis noted on CT; no confirming path findings	None	Gr 1 AST, ALT WNL	None	SD	HBV viral load 700 IU/mL prior to starting ipilimumab

Table 1 (Gr, Grade of toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0; AST, aspartate aminotransferase; ALT, Alanine aminotransferase; LFT, Liver function tests; PD, Progressive disease; Ipi, ipilimumab; SD, Stable disease)).

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