De novo hepatocellular carcinoma occurrence in hepatitis C cirrhotics treated with direct-acting antiviral agents

Figures & data

Figure 1. Study enrollment. This flowchart depicts the study inclusion and exclusion criteria utilized to select the patient population.

Table 1. Patient demographics.

Primary characteristics	Sub-characteristics	n	Total percentage
Overall	–	150	100
Viral response	SVR	140	93
	Relapse	10	7
Gender	Male	89	59
	Female	61	41
Race/ethnicity	Asian	3	2
	Black/African-American	6	4
	Hispanic	6	4
	White	46	31
	Unknown	89	59
BMI	<25	43	29
	25–29.9	50	33
	30–35	33	22
	>35	23	15
	No data	1	1
HCV genotype	1	115	77
	2	11	7
	3	19	13
	4	1	1
	6	4	3
Compensation	Compensated	107	71
	Decompensated	43	29
Treatment regimen	SOF+LDV +/-RBV	74	49
	SIM+SOF+/-RBV	33	22
	SOF+RBV	20	13
	GRZ+ELB	6	4
	SOF+DCV +/-RBV	8	5
	SOF+VEL+/-RBV	5	3
	SOF+PEG-IFN+RBV	4	3
Treatment history	Naive	87	58
	Experienced (IFN or IFN/DAA)	63	42

BMI: Body mass index; DAA: Direct-acting antiviral ; DCV: Daclatasvir; ELB: Elbasvir; GRZ: Grazoprevir; HCV: Hepatitus c virus; IFN: Interferon; LDV: Ledipasvir; PEG: Pegylated; RBV: Ribavirin; SIM: Simeprevir; SOF: Sofosbuvir; SVR: Sustained virologic response.

Table 2. Characteristics of patients with de novo hepatocellular carcinoma occurrence.

Primary characteristics	Sub-characteristics	n	% total
Overall new HCC		7	4.7%
Age	>40–70	7	100%
Gender	Male	4	57.1%
	Female	3	42.9%
Cirrhosis	Compensated	3	43.0%
	Decompensated	4	57.0%
Laboratory values at baseline
ALT	≤40	4	57%
	>40	3	43%
Platelet	≤150	6	86%
	>150	1	14%
Time to diagnosis of new HCC	0–6 months post-treatment	5	71.4%
	7–12 months post-treatment	2	28.6%
LIRADs classification	LIRADS 4	6	86%
	LIRADS 5	1	14%
HCV genotype	1	4	2.6%
	3	2	1.3%
	6	1	0.7%
Treatment status	Treatment-naive	5	71.4%
	Treatment-experienced (IFN or IFN/DAA)	2	28.6%
Treatment response	SVR	7	100%

ALT: Alanine aminotransferase; DAA: Direct-acting anitiviral; HCC: Hepatocellular carcinoma; HCV: Hepatitus C virus; IFN: Interferon; LIRADS: Liver reporting and data system; SVR: Sustained virologic response.

Table 3. Rates of de novo hepatocellular carcinoma per patient populations.

Group	Number of new HCC	Total number of patients	Rate (95% CI)	p-value ^†
Treatment-naive	5	87	5.75% (2.16%, 13.07%)	0.192
Treatment-experienced	2	63	3.17% (0.23%, 11.50%)	0.714
Compensated	3	107	2.80% (0.61%, 8.27%)	> 0.999
Decompensated	4	43	9.30% (3.12%, 22.16%)	0.040
Male	4	89	4.49% (1.41%, 11.35%)	0.345
Female	3	61	4.92% (1.14%, 14.03%)	0.433
GT 1a	4	77	5.19% (1.64%, 13.00%)	0.296
GT 3	2	19	10.53% (1.70%, 32.63%)	0.110
GT 6	1	4	25.00% (3.41%, 71.09%)	0.115

^†p-value of < 0.05 is considered statistically significant from historical HCC rate of 3%(Bold font indicates that rates of de novo HCC were significantly higher in patients with decompensated cirrhosis)

GT: Genotype; HCC: Hepatocellular carcinoma.