First-generation protease inhibitor-triple therapy: SVR 24, safety, and predictors of response in a large single center cohort

Table 3 Univariate and multivariate models for prediction of SVR (for all patients treated with PI-triple therapy; n = 131)

	Univariate analysis		Multivariate analyses**
	Odds ratio (95% CI)	Wald p value	Odds ratio (95% CI)	Wald p value
Viral kinetics
eRVR vs. no eRVR	8.875 (3.66, 21.51)	<0.0001	8.875 (3.66, 21.51)	<0.0001
PI-TW 4 < LLOD vs. > LLOD	7.115 (3.04, 16.65)	<0.0001		n/a***
PI-TW 4 viral load > LLOQ vs. < LLOQ	0.049 (0.01, 0.24)	<0.0001		n/a***
Baseline demographic parameters
Fibrosis
Liver Cirrhosis (Ishak 5 + 6) vs. no Liver Cirrhosis (Ishak 1–4)	0.528 (0.24, 1.18)	0.118		0.858
Sex
Male vs. female	0.533 (0.239, 1.187)	0.123		0.194
Age
Patients < 60 years vs. ≥ 60 years	0.894 (0.358, 2.23)	0.811		0.751
Baseline viral load
High viral load (>800.000 IU/ml) vs. Low viral load (<800.000 IU/ml)	0.679 (0.29, 1.58)	0.367		0.165
Genotype
1a vs. 1b	1.565 (0.678, 3.62)	0.294		0.308
Baseline platelet count
Platelets < 100/nl vs. > 100/nl	0.1 (0.029, 0.341)	<0.0001	0.112 (0.032, 0.394)	0.001
Previous treatment response
Non-response vs. other*	0.313 (0.137, 0.715)	0.006	0.357 (0.147, 0.867)	0.023

Significant calculations (p < 0.05) are printed bold. For absolute numbers see Table 2. *Other (includes treatment naïve, relapsers, unknown response, pretreatment with other interferon than pegylated interferon). **Multivariate analysis was performed twice: first, all shown parameters were included, showing significant results for “eRVR vs. no eRVR”, and “Platelets < 100/nl vs. > 100/nl”, secondly multivariate analysis was conducted only with “baseline demographic parameters” (excluding parameters of viral kinetics), showing significant results for “Platelets < 100/nl vs. > 100/nl”, and additionally “Non-response vs. other”. ***“PI-TW4 < LLOD vs. > LLOD” and “PI-TW 4 viral load > LLOQ vs. < LLOQ” both had to be excluded from the multivariate analysis due to strong collinearity with “eRVR vs. no eRVR”. The width of the confidence intervals might be due to the limited number of cases in our sample. Abbreviations: eRVR Extended rapid virological response, LLOD Lower limit of detection, LLOQ Lower limit of quantification, PI Protease inhibitor, SVR Sustained virological response, TW Treatment week, n/a Not applicable.

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