. Author manuscript; available in PMC: 2019 Dec 11.

Published in final edited form as: Clin Gastroenterol Hepatol. 2019 Feb 8;17(12):2541–2551.e2. doi: 10.1016/j.cgh.2019.02.005

Table 3.

Association Between ALT Flares >10× ULN and Clinical Outcomes for HBeAg-Positive Participants

Clinical outcome	Participants free of ALT flares			Participants with ALT flares			P value
Treatment initiation		N = 353			N = 51		<.0001
	N	PYR	Rate	N	PYR	Rate
	104	297.2	35	26	30.7	85
Specific treatments
TDF or ETV		83			19
Other NA		10			4
PEG-IFN		4			1
Combination		7			2
HBV DNA decline (>1 log)		N = 351			N = 47
	N	PYR	Rate	N	PYR	Rate
Untreated^a	54	235.1	23	12	20.4	59	.003
Treated^a	73	42.6	171	20	12.0	167	.91
HBeAg loss		N = 340			N = 51
	N	PYR	Rate	N	PYR	Rate	.002
Untreated^a	33	218.9	15	10	21.2	47
Treated^a	13	39.3	33	3	10.1	30	.87
HBsAg loss		N = 292			N = 47
	N	PYR	Rate	N	PYR	Rate
Untreated^a	2	199.8	1	1	19.2	5	.18
Treated^a	2	37.6	5	0	8.5	0.0	1.0
Disease progression^b		2			0		1.0

ALT, alanine aminotransferase; Combination, being in >1 of the previous therapy groups in the course of the 48-week window; ETV, entecavir; HBeAg, hepatitis B e antigen; HBsAg, hepatitis B surface antigen; HBV, hepatitis B virus; IFN, interferon (including pegylated [PEG] form); Other NA, telbivudine, adefovir, emtricitabine, truvada, lamivudine; PYR, person-years; TDF, tenofovir; ULN, upper limit of normal.

Event rates per 100 PYR. Event was considered to be related to ALT flare if occurring within 48 weeks (± 12-week window) of ALT flare. Participants may contribute PYR as both treated and untreated.

Disease progression is defined as composite outcome of hepatic decompensation (variceal bleeding, ascites, hepatic encephalopathy), death, or transplant.