Short interferon and ribavirin treatment for HCV genotype 2 or 3 infection: NORDynamIC trial and real-life experience

Figures & data

Table I. Sensitivity, specificity, positive and negative predictive values of various markers on the likelihood of achieving SVR in patients with HCV genotype 2 (n = 50) and genotype 3 (n = 111) included in the per-protocol analysis treated for 12 weeks.

	Genotype 2	Genotype 3
	Sensitivity	Specificity	PPV	NPV	Sensitivity	Specificity	PPV	NPV
Age <40 years	31%	95%	90%	50%	64%	76%	84%	53%
41% of patients (66/161)	(9/29)	(20/21)	(9/10)	(20/40)	(47/73)	(29/38)	(47/56)	(29/55)
ITPase activity <100%	57%	90%	89%	60%	38%	73%	72%	39%
35% of patients (54/154)	(16/28)	(18/20)	(16/18)	(18/30)	(26/69)	(27/37)	(26/36)	(27/70)
IL28B genotype (CC vs. CT/TT)	54%	43%	55%	41%	44%	58%	66%	36%
47% of patients (74/157)	(15/28)	(9/21)	(15/27)	(9/22)	(31/70)	(22/38)	(31/47)	(22/61)
Non-significant fibrosis	46%	58%	62%	42%	65%	70%	79%	53%
(Ishak stage 0–2)	(13/28)	(11/19)	(13/21)	(11/26)	(42/65)	(26/37)	(42/53)	(26/49)
50% of patients (74/149)
Non-cirrhosis	93%	21%	63%	67%	97%	19%	68%	78%
(Ishak stage 0–4)	(26/28)	(4/19)	(26/41)	(4/6)	(63/65)	(7/37)	(63/93)	(7/9)
90% of patients (134/149)
No steatosis	64%	58%	69%	52%	35%	78%	74%	41%
(Steatosis grade 0)	(18/28)	(11/19)	(18/26)	(11/21)	(23/65)	(29/37)	(23/31)	(29/71)
38% of patients (57/149)
IP-10 baseline <150 pg/mL	36%	47%	50%	33%	51%	69%	76%	41%
44% of patients (66/151)	(10/28)	(9/19)	(10/20)	(9/27)	(35/69)	(24/35)	(35/46)	(24/58)
IP-10 baseline <600 pg/mL	93%	11%	60%	50%	94%	14%	68%	56%
91% of patients (138/151)	(26/28)	(2/19)	(26/43)	(2/4)	(65/69)	(5/35)	(65/95)	(5/9)
HCV RNA day 7 < 1000 IU/mL	36%	100%	100%	54%	42%	97%	97%	46%
26% of patients (39/150)	(10/28)	(21/21)	(10/10)	(21/39)	(28/67)	(33/34)	(28/29)	(33/72)
HCV RNA undetectable week 4 (RVR)	76%	43%	65%	56%	72%	67%	81%	55%
62% of patients (98/158)	(22/29)	(9/21)	(22/34)	(9/16)	(52/72)	(24/36)	(52/64)	(24/44)
Age <40 years or	57%	95%	94%	62%	78%	75%	86%	61%
HCV RNA day 7 < 1000 IU/mL	(16/28)	(20/21)	(16/17)	(20/32)	(56/73)	(27/36)	(56/65)	(27/44)
52% of patients (82/158)
Age <40 years and RVR	24%	95%	88%	48%	45%	95%	94%	47%
27% of patients (43/161)	(7/29)	(20/21)	(7/8)	(20/42)	(33/73)	(36/38)	(33/35)	(36/76)
Age ≥40 years and HCV RNA day 7 < 1000 IU/mL	25%	100%	100%	50%	12%	100%	100%	36%
10% of patients (16/158)	(7/28)	(21/21)	(7/7)	(21/42)	(9/73)	(36/36)	(9/9)	(36/100)
Age <40 years or	79%	85%	88%	74%	83%	53%	78%	61%
ITPase Activity <100% or HCV RNA day 7 < 1000 IU/mL	(22/28)	(17/20)	(22/25)	(17/23)	(60/72)	(19/36)	(60/77)	(19/31)
65% of patients (102/156)

Figure 1. Proportion of HCV genotype 2 (A) or 3 (B) infected patients achieving SVR following 12 or 24 weeks included in the intention-to-treat (ITT) and per-protocol (PP) analyses among patients achieving <1000 vs. ≥1000 IU/mL day 7 in the NORDynamIC trial. The number of patients under each column reflects the ITT population.

Figure 2. Proportion of HCV genotype 2 (A) or 3 (B) infected patients achieving SVR following 12 or 24 weeks included in the intention-to-treat (ITT) and per-protocol (PP) analyses among patients with age <40 vs. ≥40 years in the NORDynamIC trial. The number of patients under each column reflects the ITT population.

Table II. Real-Life SVR data among Finish HCV genotype 2/3 infected patients where duration is determined by age; Ribavirin 800 mg per day.

	Genotype 2		Genotype 3
Year	<40 years (12 weeks of treatment)	≥40 years (24 weeks of treatment)	<40 years (12 weeks of treatment)	≥40 years (24 weeks of treatment)
2007	9 of 9 (100%)	8 of 9 (89%)	21 of 28 (75%)	12 of 19 (63%)
2008	9 of 11 (82%)	2 of 4 (50%)	30 of 37 (81%)	16 of 21 (76%)
2009	8 of 10 (80%)	11 of 13 (85%)	24 of 32 (75%)	16 of 25 (64%)
2010	2 of 2 (100%)	9 of 14 (64%)	27 of 31 (87%)	12 of 15 (80%)
2011	1 of 1 (100%)	7 of 7 (100%)	32 of 35 (91%)	10 of 12 (83%)
2012	5 of 6 (83%)	9 of 9 (100%)	14 of 19 (74%)	13 of 16 (81%)
2013	7 of 8 (88%)	8 of 12 (67%)	17 of 26 (65%)	7 of 17 (41%)
Total	41 of 47 (87%)	54 of 68 (79%)	165 of 208 (79%)	86 of 125 (69%)

Table III. Real-life SVR data among Swedish genotype 2/3 infected patients achieving <1000 IU/mL day 7 or age <40 years treated for 12–16 weeks.

Center	HCV genotype 2	HCV genotype 3	Ribavirin dosing	Treatment duration	Criteria for patient selection
Gothenburg	6 of 6	16 of 17	11 mg/kg per day	12 weeks	<1000 IU/mL day 7 or <40 years
Karlstad	5 of 5	5 of 6	11 mg/kg per day	12 weeks	<1000 IU/mL day 7
Gävle	6 of 6	19 of 19	11 mg/kg per day	12–16 weeks	<1000 IU/mL day 7
Borås	7 of 8	9 of 10	11 mg/kg per day	12–16 weeks	<1000 IU/mL day 7
Skövde	2 of 2	18 of 20	11 mg/kg per day	12–16 weeks	<1000 IU/mL day 7 or <40 years
Trollhättan	3 of 3	10 of 10	11 mg/kg per day	12–16 weeks	<1000 IU/mL day 7 or <40 years
Halmstad	2 of 2	3 of 3	800 mg daily	12–16 weeks	<1000 IU/mL day 7 or <40 years
Total	31 of 32 (97%)	80 of 85 (94%)