Personalized treatment of hepatitis C genotype 1a in Norway and Sweden 2014–2016: a study of treatment outcome in patients with or without resistance-based DAA-therapy

Figures & data

Figure 1. Flowchart of patients included in the study. Baseline resistance testing in the control group was performed retrospectively.

Table 1. Patient demographics and baseline characteristics.

	Intervention group (N = 92 )	Control group (N = 101)	p
Median age, year (range)	56 (27–74)	56 (28–74)	.9
Sex, male, n (%)	61 (66)	70 (69)	.8
Cirrhosis, n (%)	40 (43)	42 (42)	.9
Child A, n (%)	35 (87.5)	40 (95.2)	–
Child B, n (%)	5 (12.5)	2 (4.8)	–
Child C, n (%)	0	0	–
Median HCV RNA, log10 IU/ml (range)	6.1 (3.3–7.5)	6.1 (4.4–7.2)	.7
Baseline Q80K and R155K RAS, n (%)	11 (12.0%)	13 (12.9)	.6
HCV antiviral treatment history, n (%)			.07
Treatment-naïve	45 (48.9)	67 (66.3)	–
Non-responder	21 (22.8)	14 (13.9)	–
Relapse/ breakthrough	19 (20.7)	12 (11.9)	–
Other^a	7 (7.6)	8 (7.9)	–
Previous therapy with PI^b, n (%)	11 (12.0)	6 (5.9)	.2

^a Reinfection, discontinuation.

^b PI: protease inhibitor (boceprevir or telaprevir).

Table 2. Treatment characteristics.

	Intervention group (N = 92 )	Control group (N = 101)	p
Treatment regime, n (%)			.023
Simeprevir + Sofosbuvir	46 (50.0)	30 (29.7)	–
Ledipasvir + Sofosbuvir	34 (37.0)	58 (57.4)	–
Daclatasvir + Sofosbuvir	11 (12.0)	11 (10.9)	–
OBV/PTV/r + DSV^a	1 (1.0)	2 (2.0)	–
Addition of ribavirin, n (%)	14 (15.0)	9 (8.9)	.2
Treatment duration, week (%)			.4
8	5 (5.4)	3 (3.0)	–
12	73 (79.3)^b	88 (87.1)	–
16	3 (3.3)	1 (1.0)	–
24	11 (12.0)	9 (8.9)	–

^a Ombitasvir/paritaprevir/ritonavir + dasabuvir.

^b One patient scheduled for 12 weeks of treatment discontinued after 4 weeks because of an accident, but achieved SVR.

Figure 2. Sustained virologic response rates (SVR) in the intervention and control groups. SVR rates in the intervention group (dark grey bars) and the control group (light grey bars). The two bars to the right show SVR rates by simeprevir treatment in patients with baseline Q80K and R155K RAS in the control group.

Table 3. Clinical characteristics, baseline and emerging RASs (NS3 and NS5A) in the non-responders.

Age (year)	Study group	Metavir score (child pugh)	Fibro Scan (kPa)	Treatment	Previous treatment response	Baseline viral load, log10 (IU/ml)	Baseline RAS(s)	RAS(s) at relapse	Ribavirin	Treatment time (week)
60	I	4 (B)	42.8	S + S	N	5.2	0	R155K	Yes	12
54	I	3	10.4	S + S	NR	5.7	0	0	No	12
56	C	4 (A)	–	S + S	N	6.1	0	0	Yes	12
46	C	4 (A)	–	S + S	N	6.2	R155K	R155K	No	12
66	C	4 (A)	–	L + S	N	6.9	0	Q30R + L31M	No	12
59	C	4 (A)	–	L + S	NR	6.0	0	L31I	No	12
52	C	4 (A)	75	S + S	NR	5.8	0	D168A	No	12
52	C	4 (B)	75	S + S	N	4.8	Q80K	Q80K	No	12
65	C	4 (A)	47.2	L + S	N	6.4	M28A, Q30R	M28A, Q30R	Yes	12

I: intervention group; C: control group; L + S: ledipasvir plus sofosbuvir; N: naïve; NR: null responder to pegylated interferon plus ribavirin; S + S: simeprevir plus sofosbuvir