High real-world effectiveness of 12-week elbasvir/grazoprevir without resistance testing in the treatment of patients with HCV genotype 1a infection in Norway

Figures & data

Figure 1. Outcome among 433 patients with HCV infection treated with EBR/GZR for 12 weeks.

Table 1. Baseline characteristics (according to availability of data).

	All patients (n = 433)	Baseline HCV RNA, n (%)
		≤800 000 IU/mL (n = 192)	>800 000 IU/mL (n = 235)
Sex, n (%)
Male	291 (67.2)	110 (57.3)	178 (75.7)
Female	142 (32.8)	82 (42.7)	57 (24.3)
Age, mean, years (range)	45.7 (22–73)	43.4 (22–72)	47.6 (22–73)
Weight (kg), Median (IQR)
Male (n = 100)	77.5 (70–93)
Female (n = 42)	71.5 (57–80)
BMI (kg/m^2), Median (IQR)
Male (n = 50)	23.5 (20.7–27.2)
Female (n = 16)	21.6 (18.6–26.2)
Region of origin, n (%)
Scandinavia	346 (90.1)
Europe, except Scandinavia	19 (4.9)
World, except Europe	19 (4.9)
Diabetes mellitus (n = 181)^a	3.9 %
Recent injecting drug use, n (%)
Yes	93 (27.4)	50 (31.1)	43 (24.2)
No	247 (72.6)	111 (68.9)	135 (75.8)
Elastography/liver elasticity (kPa)
Median, (range)	5.7 (1.8–47)	5.4 (2.5–47)	5.9 (1.8–27)
Cirrhosis, n (%)
Yes	17 (4.0)	10 (5.2)	7 (3.0)
No	407 (96.0)	181 (94.8)	224 (97.0)
Previous treatment, n (%)
Any previous treatment	36 (8.4)
• PegIFN/riba	36
• Boceprevir (+ pegIFN/riba)	1

kPa, kilopascal.

PegIFN/riba, pegylated interferon alfa 2a or 2b, and ribavirin.

Boceprevir, 1. generation protease inhibitor, marketed by MSD.

Body Mass Index (BMI).

^aDiabetes mellitus defined as either HbA1c > 48 mmol/mol, or patient on antidiabetics.

Figure 2. Outcome among 388 patients included in the mITT population and treated for 12 weeks of EBR/GZR without ribavirin and with no baseline RAS testing.

Table 2. Sustained viral response (SVR). HCV RNA results at week 12, or at week 4 to 11 if not available at week 12. Outcomes for all 433 patients together, and for 427 patients apportioned to baseline viral load above, and at or below 800 000 IU/mL, respectively. The results are presented as modified Intention-To-Treat (mITT) and Intention-To-Treat (ITT) analysis with 95% confidence intervals (95% CI).

	HCV RNA at week 12 (or 4–11)		All results mITT	Lost to follow up	All results ITT	SVR 12 (or 4)
						mITT, % (95% CI)	ITT, % (95% CI)
	Negative	Positive
All patients	377	11	388	45	433	97.2 (95.4–99.0)	87.1 (83.8–90.3)
≤800 000	169	3	172	20	192	98.3 (95.8–100)	88.0 (83.3–92.8)
>800 000	202	8	210	25	235	96.2 (93.3–99.1)	86.0 (81.4–90.5)

Table 3. Virologic failures. Eleven patients did not achieve SVR. Of these 5 were successfully retreated with alternative DAA-regimes, and 1 were lost to follow up. There was no information retrieved on 5 patients (N.D, not determined).

Sex, Age	HCV-RNA Week 4 Post-treatment	HCV-RNA Week 12 Post-treatment	Baseline viral load	Recent intravenous drug use (3–6 months)	Cirrhosis	SVR12 after retreatment
Female, 56	Positive	Positive	4 500 000	No	No	N.D
Female, 64	Positive	Positive	2 700 000	No	No	N.D
Male, 30	Negative	Positive	9 400 000	No	No	N.D
Male, 61	Negative	Positive	1 500 000	No	No	N.D
Male, 48		Positive	3 981 000	Yes	No	N.D
Male, 38		Positive	2 062 171	Yes	No	Yes
Female, 38		Positive	365 121	Yes	No	Yes
Male, 51		Positive	2 581 719	No	Yes	Lost to follow up
Male, 57		Positive	2 913 627	No	No	Yes
Female, 58	Positive	Positive	340 795	No	Yes	Yes
Female, 35	Positive	Positive	424 952	Yes	No	Yes

There is no information on pre- or post-treatment RAS testing in these 11 treatment failures.