. 2020 Nov 13;5(2):189–202. doi: 10.1002/hep4.1633

TABLE 2.

Virologic Response in the REP 301 and REP 301‐LTF Studies

Participant	Parameter	Baseline*	EOT*	FW24*	F 1Y*	F1.5Y	F2Y	F2.5Y	F3Y	F3.5Y
001‐01	HBsAg (IU/mL)	13,988	<0.005	<0.005	<0.005	<0.005	0.05	0.15	NA	0.83
	anti‐HBs (mIU/mL)	1.03	6,633	7,585	5,073	820	318	151	NA	86
	HBV DNA (IU/mL)	<LLOQ	<LLOQ	TND	<LLOQ	TND	TND	<LLOQ	NA	TND
	HDV RNA (IU/mL)	394,000	TND	TND	TND	TND	TND	TND	NA	TND
	HBV RNA (log₁₀ copies/mL)	TND	TND	TND	ND	ND	ND	ND	NA	ND
	HBV pgRNA (log₁₀ U/mL)	ND	ND	ND	TND	TND	<LLOQ	TND	NA	1.86
	HBcrAg (log₁₀ U/mL)	<LLOQ	<LLOQ	<LLOQ	<LLOQ	<LLOQ	<LLOQ	<LLOQ	NA	<LLOQ
001‐02	HBsAg (IU/mL)	27,264	<0.005	<0.005	<0.005	<0.005	<0.005	<0.005	NA	<0.005
	anti‐HBs (mIU/mL)	1.29	51,970	13,540	1,873	639	345	320	NA	172
	HBV DNA (IU/mL)	<LLOQ	TND	ND ^†	TND	TND	TND	TND	NA	TND
	HDV RNA (IU/mL)	47,100,000	TND	TND	TND	TND	TND	TND	NA	TND
	HBV RNA (log₁₀ copies/mL)	TND	TND	TND	ND	ND	ND	ND	NA	ND
	HBV pgRNA (log₁₀ U/mL)	ND	ND	ND	TND	TND	TND	TND	NA	TND
	HBcrAg (log₁₀ U/mL)	<LLOQ	<LLOQ	<LLOQ	<LLOQ	<LLOQ	<LLOQ	<LLOQ	NA	<LLOQ
001‐03	HBsAg (IU/mL)	28,261	<0.005	<0.005	<0.005	<0.005	<0.005	<0.005	NA	<0.005
	anti‐HBs (mIU/mL)	<0.1	86,532	13,566	5,079	2,603	1,261	590	NA	612
	HBV DNA (IU/mL)	<LLOQ	TND	TND	TND	179	TND	TND	NA	TND
	HDV RNA (IU/mL)	697,000	TND	TND	TND	TND	TND	TND	NA	TND
	HBV RNA (log₁₀ copies/mL)	TND	TND	TND	ND	ND	ND	ND	NA	ND
	HBV pgRNA (log₁₀ U/mL)	ND	ND	ND	TND	TND	TND	TND	NA	TND
	HBcrAg (log₁₀ U/mL)	4.1	<LLOQ	<LLOQ	<LLOQ	<LLOQ	<LLOQ	<LLOQ	NA	<LLOQ
001‐06	HBsAg (IU/mL)	17,511	29.7	239	146	103	19.6	0.29	NA	<0.005
	anti‐HBs (mIU/mL)	2.1	1.13	1.07	0.1	0.56	0.7	1.21	NA	7.6
	HBV DNA (IU/mL)	726	<LLOQ	13	21	122	183	TND	NA	TND
	HDV RNA (IU/mL)	5,490,000	TND	TND	TND	TND	TND	TND	NA	TND
	HBV RNA (log₁₀ copies/mL)	1.73	TND	TND	ND	ND	ND	ND	NA	ND
	HBV pgRNA (log₁₀ U/mL)	ND	ND	ND	TND	<LLOQ	<LLOQ	TND	NA	<LLOQ
	HBcrAg (log₁₀ U/mL)	4.1	2.8	<LLOQ	<LLOQ	<LLOQ	<LLOQ	<LLOQ	NA	<LLOQ
001‐09	HBsAg (IU/mL)	16,426	399	2,646	6,621	10,627	10,772	9,080	NA	8,686
	anti‐HBs (mIU/mL)	<0.1	7.76	1.42	0.78	<0.1	<0.1	<0.1	NA	<0.1
	HBV DNA (IU/mL)	104	31	10	1,696	6,386	297	148	NA	546
	HDV RNA (IU/mL)	211,000	TND	1,390	4,438	7,890	4,253	TND	NA	1,580
	HBV RNA (log₁₀ copies/mL)	TND	TND	TND	ND	ND	ND	ND	NA	ND
	HBV pgRNA (log₁₀ U/mL)	ND	ND	ND	2.66	2.65	<LLOQ	1.72	NA	2.53
	HBcrAg (log₁₀ U/mL)	3.2	4.5	4.4	4.40	4.60	4.50	4.30	NA	4.10
001‐11	HBsAg (IU/mL)	12,382	<0.005	<0.05	<0.05	15.7	71.4	461	NA	1,596
	anti‐HBs (mIU/mL)	0.55	34,749	1,772	231	4.32	1.39	0.76	NA	0.38
	HBV DNA (IU/mL)	<LLOQ	<LLOQ	TND	TND	<LLOQ	TND	TND	NA	13
	HDV RNA (IU/mL)	12,100,000	TND	TND	TND	TND	TND	TND	NA	TND
	HBV RNA (log₁₀ copies/mL)	TND	TND	TND	ND	ND	ND	ND	NA	ND
	HBV pgRNA (log₁₀ U/mL)	ND	ND	ND	TND	TND	TND	TND	NA	TND
	HBcrAg (log₁₀ U/mL)	<LLOQ	<LLOQ	<LLOQ	<LLOQ	<LLOQ	<LLOQ	<LLOQ	NA	<LLOQ
001‐17	HBsAg (IU/mL)	8,314	0.26	214	4,754	6,250	5,479	NA	5,693	5,221
	anti‐HBs (mIU/mL)	<0.1	28	<0.1	<0.1	0.11	<0.1	NA	0.29	0.22
	HBV DNA (IU/mL)	350	<LLOQ	10	1,992	1,386	1,894	NA	105	569
	HDV RNA (IU/mL)	1,690,000	TND	TND	TND	TND	TND	NA	TND	TND
	HBV RNA (log₁₀ copies/mL)	TND	TND	TND	ND	ND	ND	NA	ND	ND
	HBV pgRNA (log₁₀ U/mL)	ND	ND	ND	2.56	2.12	2.19	NA	2.19	2.17
	HBcrAg (log₁₀ U/mL)	<LLOQ	2.9	2.3	<LLOQ	<LLOQ	<LLOQ	NA	<LLOQ	<LLOQ
001‐20	HBsAg (IU/mL)	13,430	9,964	14,943	14,917	18,955	18,162	NA	21,993	22,503
	anti‐HBs (mIU/mL)	<0.1	<0.1	0.19	<0.1	<0.1	<0.1	NA	<0.1	<0.1
	HBV DNA (IU/mL)	<LLOQ	25	28	10	37	76	NA	TND	TND
	HDV RNA (IU/mL)	27,400	4,920 ^‡	2,250	485	2,440	9,300	NA	7,880	11,800
	HBV RNA (log₁₀ copies/mL)	TND	TND	TND	ND	ND	ND	NA	ND	ND
	HBV pgRNA (log₁₀ U/mL)	ND	ND	ND	<LLOQ	<LLOQ	<LLOQ	NA	TND	<LLOQ
	HBcrAg (log₁₀ U/mL)	4.5	4.6	4.3	4.60	4.60	4.60	NA	4.60	4.70
001‐22	HBsAg (IU/mL)	7,836	917	1,225	1,281	1,508	1,386	NA	1,362	1,341
	anti‐HBs (mIU/mL)	<0.1	<0.1	0.3	0.11	<0.1	<0.1	NA	<0.1	<0.1
	HBV DNA (IU/mL)	16	<LLOQ	23	10	18	<LLOQ	NA	160	<LLOQ
	HDV RNA (IU/mL)	1,090,000	TND	17	93.8	101	1,340	NA	1,090	2,310
	HBV RNA (log₁₀ copies/mL)	2.22	TND	TND	ND	ND	ND	NA	ND	ND
	HBV pgRNA (log₁₀ U/mL)	ND	ND	ND	TND	TND	TND	NA	<LLOQ	<LLOQ
	HBcrAg (log₁₀ U/mL)	5	4.6	4.3	4.00	3.90	3.70	NA	3.40	3.60
001‐24	HBsAg (IU/mL)	20,473	34,201	29,724	32,519	26,814	28,317	NA	29,012	25,184
	anti‐HBs (mIU/mL)	<0.1	<0.1	<0.1	<0.1	<0.82	0.1	NA	0.31	<0.1
	HBV DNA (IU/mL)	<LLOQ	<LLOQ	10	35	13	1	NA	65	37
	HDV RNA (IU/mL)	1,890,000	1,090,000 ^§	3,280,000	2,074,000	955,000	1,490,000	NA	1,190,000	906,000
	HBV RNA (log₁₀ copies/mL)	TND	TND	TND	ND	ND	ND	NA	ND	ND
	HBV pgRNA (log₁₀ U/mL)	ND	ND	ND	<LLOQ	1.93	2.12	NA	TND	<LLOQ
	HBcrAg (log₁₀ U/mL)	2.8	<LLOQ	<LLOQ	3.10	3.10	3.00	NA	3.20	3.10
001‐26	HBsAg (IU/mL)	5,854	<0.005	<0.005	<0.005	<0.005	<0.005	NA	<0.005	<0.005
	anti‐HBs (mIU/mL)	0.25	11,291	32,543	30,018	15,920	7,773	NA	3,034	677
	HBV DNA (IU/mL)	256	<LLOQ	TND	TND	TND	TND	NA	TND	TND
	HDV RNA (IU/mL)	3,760,000	TND	TND	TND	TND	TND	NA	TND	TND
	HBV RNA (log₁₀ copies/mL)	TND	TND	TND	ND	ND	ND	NA	ND	ND
	HBV pgRNA (log₁₀ U/mL)	ND	ND	ND	TND	TND	TND	NA	TND	TND
	HBcrAg (log₁₀ U/mL)	4.5	3.1	<LLOQ	<LLOQ	<LLOQ	<LLOQ	NA	<LLOQ	<LLOQ

Previously published (in graphic format)¹⁹ except HBV pgRNA.

^{^†}

PCR inhibition prevented HBV DNA determination.

^{^‡}

HDV RNA rebound occurred after removal of REP 2139‐Ca.

Abbreviations: NA, no serum taken for assessment during this visit (see Materials and Methods); ND, not determined.