Second-generation direct-acting-antiviral hepatitis C virus treatment: Efficacy, safety, and predictors of SVR12

Table 2 Predictive model of sustained virological response analyzed for all patients treated with second generation direct acting antiviracombination therapy (n = 256)

	SVR 12 (n/N; %)2	Univariate analysis		Multivariate analysis
		Odds ratio (95%CI)	Wald P value	Odds ratio (95%CI)	Wald P value
Viral kinetics
RVR	143/152; 94%
vs Non-RVR	83/89; 93%	1.149 (0.395, 3.341)	0.799		0.728
Baseline demographic parameters
Fibrosis
Liver Cirrhosis	76/87; 87%
vs no Liver Cirrhosis	164/169; 97%	0.211 (0.071, 0.627)	0.005		0.290
Transplant Status
LTx	15/17; 88%
vs no LTx	225/239; 94%	0.467 (0.097, 2.246)	0.467		0.972
Sex
Male	140/153; 92%
vs female	100/103; 97%	0.329 (0.091, 1.184)	0.089		0.282
Age
Patients ≥ 60 yr	68/71; 96%
vs < 60 yr	172/185; 93%	0.999 (0.959, 1.04)	0.948		0.078
Baseline viral load
High viral load (> 6 Mio IU/mL)	28/28; 100%
vs low viral load ( ≤ 6 Mio IU/mL)	212/228; 93%	NA	0.998		0.251
Genotype
1	180/192; 93%
vs 3	38/42; 90%	1.606 (0.510, 5.060)	0.418		0.424
Genotype1
1 IFN-free, per protocol	160/164/; 98%
vs 3 IFN-free, per protocol	16/20/; 80%	5.000 (1.355, 18.45)	0.016		NA
Baseline platelet count
Platelets ≤ 100/nL	45/55; 82%
vs > 100/nL	195/201; 97%	0.138 (0.048, 0.401)	< 0.0001	0.24 (0.072, 0.88)	0.031
Baseline MELD ≥ 10
MELD ≥ 10	18/25; 72%
vs MELD < 10	222/231; 96%	0.104 (0.035, 0.313)	< 0.0001	0.117 (0.037, 0.373)	< 0.0001
Previous treatment response
Pre-treated	133/142; 94%
vs treatment-naive	107/114; 94%	0.967 (0.349, 2.681)	0.948		0.457

¹This analysis excluded patients co-treated with IFN, and patients with premature discontinuation (“per protocol analysis”);

²Number of patients who achieved SVR12 in category/total number in category. Univariate and multivariate models for prediction of SVR [n = 256, modified intention-to-treat (mITT) analysis] were used. This mITT analysis excluded patients, who were lost to follow-up (n = 4). Significant calculations (P < 0.05). RVR: Rapid viral response (hepatitis C virus RNA negative at treatment week 4); LTx: Liver transplantation; SVR: Sustained virological response; NA: Not available.