Patient-reported outcomes in individuals with hepatitis C virus infection treated with elbasvir/grazoprevir

Figures & data

Table 1 Baseline clinical and demographic characteristics of study sample

Characteristics	Total		EBR/GZR (N=129)		SOF/PR (N=126)
	N	%	N	%	N	%
Age (mean, SD)	47.9 (12.4)		47.6 (12.4)		48.2 (12.4)
Gender
Male	117	45.9	55	42.6	62	49.2
Female	138	54.1	74	57.4	64	50.8
Race
White	253	99.2	128	99.2	125	99.2
Asian	^Citation2	0.8	^Citation1	0.8	^Citation1	0.8
IL28B genotype
CC	52	20.4	26	20.2	26	20.6
Non-CC	198	77.6	100	77.5	98	77.8
Missing	5	2.0	^Citation3	2.3	^Citation2	1.6
Baseline HCV RNA
>800,000 IU/mL	171	67.1	90	69.8	81	64.3
>2,000,000 IU/mL	106	41.6	57	44.2	49	38.9
>10,000,000 IU/mL	10	3.9	4	3.1	6	4.8
Baseline BMI (mean, SD)	25.8 (4.0)		25.9 (3.9)		25.6 (4.0)
HCV genotype
1a	35	13.7	^Citation18	14.0	^Citation17	13.5
1b	209	82.0	105	81.4	104	82.5
4	11	4.3	6	4.7	5	4.0
Cirrhosis
Non-cirrhotic	212	83.1	107	82.9	105	83.3
Cirrhotic	43	16.9	^Citation22	17.1	^Citation21	16.7
Prior treatment response
Naïve	191	74.9	100	77.5	91	72.2
PR null responder	25	9.8	11	8.5	14	11.1
PR partial responder	14	5.5	6	4.7	8	6.3
PR relapser	25	9.8	12	9.3	13	10.3

Abbreviations: BMI, body mass index; EBR/GZR, elbasvir/grazoprevir; HCV, hepatitis C virus; PR, pegylated interferon and ribavirin; RNA, ribonucleic acid; SOF/ PR, sofosbuvir with pegylated interferon and ribavirin.

Table 2 Baseline PRO scores of the treatment groups

PRO instrument	EBR/GZR			SOF/PR
	N	Mean	SD	N	Mean	SD
SF-36v2
Physical functioning	125	89.76	15.54	123	88.33	17.81
Role limitations-physical	125	82.10	19.01	123	82.16	21.71
Bodily pain	125	87.56	18.58	123	85.21	21.07
General health	125	68.98	18.57	123	65.98	18.29
Vitality	125	69.20	18.70	123	68.45	19.04
Social functioning	125	88.60	17.32	123	87.09	18.24
Role limitations-emotional	125	88.00	17.47	123	86.86	20.66
Mental health	125	76.04	15.82	123	76.10	17.50
PCS	125	54.10	6.21	123	53.34	7.39
MCS	125	50.85	8.15	123	50.64	8.47
FACIT-fatigue scale score	123	44.58	7.51	122	43.01	8.61

Abbreviations: EBR/GZR, elbasvir/grazoprevir; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; MCS, mental component summary; PCS, physical component summary; PRO, patient-reported outcome; SF-36v2, Short Form-36 version 2; SOF/PR, sofosbuvir with pegylated interferon and ribavirin.

Figure 1 Mean change in SF-36v2 scores from baseline.

Note: Error bars indicate 95% CIs.
Abbreviations: BP, bodily pain; EBR/GZR, elbasvir/grazoprevir; GH, general health; MCS, mental component summary; MH, mental health; PCS, physical component summary; PF, physical functioning; RE, role limitations-emotional; RP, role limitations-physical; SF, social functioning; SOF/PR, sofosbuvir with pegylated interferon and ribavirin; VT, vitality.

Figure 2 Summary of between-group differences and effect sizes for change in SF-36v2 scores from baseline.

Notes: Error bars indicate 95% CIs.
Abbreviations: BP, bodily pain; EBR/GZR, elbasvir/grazoprevir; GH, general health; MCS, mental component summary; MH, mental health; PCS, physical component summary; PF, physical functioning; RE, role limitations-emotional; RP, role limitations-physical; SF, social functioning; VT, vitality.

Figure 3 Mean change in FACIT-Fatigue Scale scores from baseline.

Note: Error bars indicate 95% CI.
Abbreviations: EBR/GZR, elbasvir/grazoprevir; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; SOF/PR, sofosbuvir with pegylated interferon and ribavirin.

Figure 4 Summary of between-group differences and effect sizes for change in FACIT-Fatigue scale scores from baseline.

Notes: Error bars indicate 95% CIs.
Abbreviations: BP, bodily pain; EBR/GZR, elbasvir/grazoprevir; FACIT-Fatigue Scale, Functional Assessment of Chronic Illness Therapy-Fatigue Scale.

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