. 2021 Jun 29;8:713–739. doi: 10.2147/JHC.S292139

Table 2.

Characteristics of Studies Reporting Data on HCC Occurrence (de-novo HCC) in Patients with Cirrhosis or Advanced Fibrosis

Author	Enrollment Period	Study Design	Patients	Males	Age	Fibrosis	CPT Score	SVR	HCC	Follow-Up
Cirrhosis (n=18)
Conti, 2016⁸	Italy 2015	Multicenter, retrospective	285	167 (59%)	61 (37–86)	LSM	CPT-A 256	261 (91.6%)	9 (3.1%)	24 w^°°
						24.4 ± 0.88	CPT-B 29		SVR 7
						24.4 ± 0.88	CPT-B 29		CPT-A 5
Cardoso, 2016¹⁰	Portugal 2015	Single-center, retrospective	54	38 (70%)	41–81	APRI	CPT-A 34	54 (100%)	4 (7.4%)	12.0 (IQR 9.4–12.5) m^°°°°°
Cardoso, 2016¹⁰	Portugal 2015	Single-center, retrospective	54	38 (70%)	41–81	1.02–4.04	CPT-A 34	54 (100%)	CPT-A 67%	12.0 (IQR 9.4–12.5) m^°°°°°
Kanwal, 2017³⁴	US 2015	Multicenter, retrospective	7495^#	NA	NA	NA	NA**	7495 (100%)	139 (1.8%)	NA
Ravaioli, 2018²⁵	Italy 2015–2016	Single-center, retrospective	119	91 (65.5%)^§	63 (52–73)^§	LSM^§	CPT-A 108	131 (94.2%)^ç	13 (10.8%)	15 (12–19) m^°°ç
						18.6 (15.0–26.0)
						FIB-4^§
						4.7 (3.0–6.8)
						4.7 (3.0–6.8)	CPT-B 11
						APRI^§
						1.67 (0.86–2.63)
Calvaruso, 2018²⁰	Italy 2015–2016	Multicenter, prospective	2249	1280 (57%)	65 ± 11	LSM	CPT-A 2035	2140 (95.2%)	78 (3.4%)	14 (6–24) m
Calvaruso, 2018²⁰	Italy 2015–2016	Multicenter, prospective	2249	1280 (57%)	65 ± 11	22.4 ± 11.9	CPT-B 214	2140 (95.2%)	SVR 64	14 (6–24) m
Nahon, 2018²¹	France 2014–2016	Multicenter, prospective	336	212 (63%)	59 (54–67)	NA	CPT-A 173	336 (100%)	15 (4.5%)	21.2 (IQR 13.5–26.9) m^°
							CPT-B 19
							CPT-C 1***
Finkelmeier, 2018³⁵	Germany 2014–2016	Single-center, retrospective	269	183 (68%)	58 (29–86)	LSM	CPT-A 211	242 (90%)	25 (3.6%)	364 (0–950) d^°
						LSM	CPT-B 50		CPT-A 24
						20.6 (6.1–63.9)	CPT-B 50		CPT-A 24
						20.6 (6.1–63.9)	CPT-C 8		CPT-B 1
Degasperi, 2019²²	Italy 2014–2016	Single-center, longitudinal	505	302 (60%)	63 (28–87)	LSM	CPT-A 442	546 (97%)^ç	28 (4.9%)	25 (3–39) m^°
Degasperi, 2019²²	Italy 2014–2016	Single-center, longitudinal	505	302 (60%)	63 (28–87)	19.1 (12.0–75.0)	CPT-B 63	546 (97%)^ç	28 (4.9%)	25 (3–39) m^°
Degasperi, 2019²⁶	Italy 2014–2016	Single-center, retrospective	452	58%	63 (28–87)	LSM	CPT-A 393	96%	31 (6.9%)	33 (3–47) m^°
						19.1 (12.0–75.0)	CPT-A 393
						FIB-4	CPT-B 59
						4.9 (0.3–46.0)	CPT-B 59
Rinaldi, 2019²⁷	Italy 2015–2017	Multicenter, prospective	258	143 (55%)	68 (61–74)	LSM	CPT-A 242	NA	35 (13.6%)	NA
Rinaldi, 2019²⁷	Italy 2015–2017	Multicenter, prospective	258	143 (55%)	68 (61–74)	25.5 (18.0–35.6)	CPT-B 16	NA	CPT-A 30	NA
Rinaldi, 2019³⁶	Italy 2015–2017	Multicenter, prospective	731	NA	NA	NA	CPT-A 649 CPT-B 82	714 (97.7%)	35 (4.8%)	48 w^°°
									SVR 33
									25 CPT-A
Lleo, 2019²⁸	Italy 2015	Multicenter, longitudinal	1766	1094 (62%)	1529 (87%) ≥50	500 (28%) LSM ≥25	CPT-A 1561	1679 (95.1%)	50 (2.8%)	NA
							CPT-B 201		SVR 9
							CPT-B 201		CPT-A 37
Casadei-Gardini, 2019²⁹	Italy 2015–2016	Multicenter, retrospective	416	242 (58%)	63 (31–90)	NA	CPT-A 351	NA	29 (7%)	18 (0.4–26.4) m^°ç
Casadei-Gardini, 2019²⁹	Italy 2015–2016	Multicenter, retrospective	416	242 (58%)	63 (31–90)	NA	CPT-B 65	NA	29 (7%)	18 (0.4–26.4) m^°ç
Abe, 2020³⁷	Japan	Multicenter, retrospective	188	90 (48%)	70 (61–77)	FIB-4	CPT-A 188*	188 (100%)	19 (10%)	46 (37–52) m^°°
Abe, 2020³⁷	Japan	Multicenter, retrospective	188	90 (48%)	70 (61–77)	6.2 (4.3–8.7)	CPT-A 188*	188 (100%)	19 (10%)	46 (37–52) m^°°
Degasperi, 2020³¹	Italy 2014–2016	Single-center, retrospective	452	261 (58%)	63 (28–87)	LSM	CPT-A 393	96%^ç	36 (7.9%)	43 (3–57) m^°
						17.4 (12.0–75.0)	CPT-A 393		36 (7.9%)
						FIB-4	CPT-B 59		CPT-A 31
						4.9 (0.3–46.3)	CPT-B 59		CPT-A 31
Sangiovanni, 2020³²	Italy 2015–2017	Multicenter, prospective	1161	686 (59%)	65 (22–85)	NA	CPT A 1066	1119 (96%)	48 (4.1%)	17 (3–43) m^°
Sangiovanni, 2020³²	Italy 2015–2017	Multicenter, prospective	1161	686 (59%)	65 (22–85)	NA	CPT A 1066	1119 (96%)	SVR 47	17 (3–43) m^°
Fan, 2020³³	East Asia, Europe, US 2014–2016	Prospective, observational cohorts or RCT	2489	71%	55 (46–63%)	NA	2.489 (100%)**	2489 (100%)	NA	NA
Bergna, 2021³⁰	Italy	Single-center, retrospective	577	58%	64	LSM 17.3	CPT-A 513	577 (100%)	46 (8%)	52 (8–62) m^°
Bergna, 2021³⁰	Italy	Single-center, retrospective	577	58%	64	LSM 17.3	CPT-B 64	577 (100%)	46 (8%)	52 (8–62) m^°
Advanced Fibrosis (n=5)
Romano, 2018¹¹	Italy 2015–2017	Multicenter, prospective	3917 F3/F4	2437 (62%)	58 (21–90)	LSM	2958****	2637 (94%)	55 (1.4%)	536 ± 198 d^°
						18.8 (1.1–75.0)	2958****		SVR 33
						FIB-4	(CPT-A 2388)		SVR 33
						4.7 (3.0–6.8)	(CPT-A 2388)		F4 55
						APRI	(CPT-B 352)		F4 55
						1.8 (0.1–43.1)	(CPT-B 352)		CPT-A 38
Rinaldi, 2019³⁶	Italy 2015–2017	Multicenter, prospective	985 F3/F4	543 (55%)	67 (59–73)	LSM	731	966 (98.1%)	35 (3.6%)	48 w^°°
						LSM	(CPT-A 649)		SVR 33
						17.3 (11.9–35.3)	(CPT-A 649)		SVR 33
							(CPT-B 82)		F4 35
							(CPT-B 82)		CPT-A 25
Shiha, 2020⁴⁴	Egypt 2015–2018	Multicenter, observational	2372 F3/F4	1242 (52%)	56 (50–62)	NA	1734	2372 (100%)	109 (4.6%)	23.6 ± 8.3 m^°°
							(CPT-A 1294)		F4 101
							(CPT-B 440)		CPT-A 66
Alonso Lopez, 2020⁴⁵	Spain 2015–2017	Multicenter, observational	993 F3/F4	551 (55.5%)	62 (26–88)	LSM	NA*	993 (100%)	35 (3.9%)	17 (3–43) m^°
						19.0 ± 10.7
						FIB-4
						4.1 ± 3.8
Pons, 2020⁴⁶	Spain 2015–2016	Multicenter, prospective	572 cACLD	282 (49.3%)	64 ± 11	LSM	NA*	572 (100%)	25 (4.4%)	2.9 (0.3–3.8) y
						20.2 ± 10.4
						FIB-4
						5.6 ± 4.4

Notes: Values are expressed as median (range), mean ± standard deviation and/or percentages (%). Age is calculated in years-old; LSM is calculated in kPa. ^°From DAA start; ^°°From EOT; ^°°°From SVR12; ^°°°°From SVR24; ^°°°°°From HCV-RNA undetectability. ^#Patients with and without an SVR were included in the study. ^çAvailable for patients with and without HCC history. *Only CPT-A patients included; **CPT criteria at enrollment not available; ***CPT score available in 193; ***CPT score available in 2640. LSM by FibroScan^®.

Abbreviations: HCC, hepatocellular carcinoma; CPT, Child-Pugh-Turcotte score; SVR, sustained virological response; F, fibrosis; LSM, liver stiffness measurement; IQR, interquartile range; w, weeks; NA, not available; FIB-4, fibrosis-4 index; APRI, AST to platelet ratio index; m, months; y, years; F4, cirrhosis; US, United States; cACLD, chronic advanced liver disease; DAA, direct-acting antivirals; EOT, end of treatment; RCT, randomized controlled trials.