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

Werner, Christoph R; Franz, Carolin; Egetemeyr, Daniel P; Beck, Robert; Malek, Nisar P; Lauer, Ulrich M; Berg, Christoph P

doi:10.1186/s12985-015-0261-0

Table 2 Predictive model of SVR analyzed for all patients treated with PI-triple therapy (TVR + BOC; n = 131), and analyzed for subgroups of patients treated with TVR (n = 102) or BOC (n = 29)

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

	SVR 24	p value	SVR 24	p value	SVR 24	p value
	(TVR + BOC)	(TVR + BOC)	(TVR)		(BOC)	(BOC)
	(n/N;% ^# )		(n/N;% ^# )	(TVR)	(n/N;% ^# )	(BOC)
Viral kinetics ^##
eRVR	71/80; 89%	<0.0001	58/64; 91%	<0.0001	13/16; 81%	0.0969
Non-eRVR	23/45; 51%	<0.0001	18/34; 53%	<0.0001	5/11; 45%	0.0969
PI-TW 4 < LLOD	72/83; 87%	<0.0001	59/67; 88%	0.0005	13/16; 81%	0.0969
PI-TW 4 > LLOD	22/42; 52%	<0.0001	17/31; 55%	0.0005	5/11; 45%	0.0969
PI-TW 4 < LLOD	72/83; 87%	0.0193	59/67; 88%	0.0619	13/16; 81%	0.5528
PI-TW 4 minimal viral load (> LLOD, < LLOQ)	20/29; 69%	0.0193	17/24; 71%	0.0619	3/5; 60%	0.5528
PI-TW 4 viral load < LLOQ	92/112; 82%	<0.0001	76/91; 84%	<0.0001	16/21; 76%	0.1358
PI-TW 4 viral load > LLOQ	2/13; 15%	<0.0001	0/7; 0%	<0.0001	2/6; 33%	0.1358
Baseline demographic parameters
Fibrosis
Liver Cirrhosis (Ishak 5 + 6)	26/41; 63%	0.0931	24/34; 71%	0.3331	2/7; 29%	0.0712
No Liver Cirrhosis (Ishak 1–4)	70/90; 78%	0.0931	54/68; 79%	0.3331	16/22; 73%	0.0712
Sex
Male	49/73; 67%	0.1675	39/53; 74%	0.6541	10/20; 50%	0.0959
Female	46/58; 79%	0.1675	38/49; 78%	0.6541	8/9; 89%	0.0959
Age
Patients ≥ 60 years	23/31; 74%	1.0000	19/26; 73%	0.6053	4/5; 80%	0.6221
Patients < 60 years	73/100; 73%	1.0000	59/76; 78%	0.6053	14/24; 58%	0.6221
Baseline viral load ^###
High viral load (>800.000 IU/ml)	60/84; 71%	0.6804	49/66; 74%	0.8126	11/18; 56%	0.6942
Low viral load (<800.000 IU/ml)	35/46; 76%	0.6804	27/35; 77%	0.8126	8/11; 73%	0.6942
Genotype
1a	23/35; 66%	0.3763	19/28; 68%	0.3068	4/7; 57%	1
1b	72/96; 75%	0.3763	58/74; 78%	0.3068	14/22; 64%	1
Baseline platelet count
Platelets > 100/nl	91/116; 78%	0.0001	73/90; 81%	0.0012	18/26; 69%	0.0452
Platelets < 100/nl	4/11; 36%	0.0001	4/12; 33%	0.0012	0/3; 0%	0.0452
Previous non-response vs. other*
Non-response	20/36; 55%	0.0075	19/28; 68%	0.2948	1/8; 13%	0.0014
Other	76/95; 80%	0.0075	59/74; 80%	0.2948	17/21; 81%	0.0014

Fisher’s exact test was used. Significant calculations (p < 0.05) are printed bold. ^#number of patients who achieved SVR 24 in category/total number in category. ^##6 patients (4 TVR-, 2 BOC-patients) had no measurement of viral load at TW 4 due to premature treatment discontinuation or because they did not show up for scheduled visit; therefore they were excluded from analysis. ^###1 baseline viral load missing. *Other (includes treatment naïve, relapsers, unknown response, pretreatment with other interferon than pegylated interferon). Abbreviations: BOC Boceprevir, eRVR Extended rapid virological response, LLOD Lower limit of detection, LLOQ Lower limit of quantification, PI Protease inhibitor, SVR Sustained virological response, TVR Telaprevir, TW Treatment week.

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