Boceprevir triple therapy of HCV genotype 1 (G1) infection in German real-life: comparable high SVR rates up to 87% in treatment-naïve and previously treated patients who achieve an early virologic response

Background: Since 2011, triple therapy with the HCV protease inhibitor boceprevir (BOC) is widely used as standard of care for patients (pts) with chronic HCV G1 infection. The present interim analysis of the German NOVUS observational study was aimed to compare the efficacy of BOC triple therapy in previously untreated and previously treated patients in German real-world and, in particular, to compare the virologic outcome of pts who achieve an early virologic response (EVR) at treatment week (TW) 8.

Methods: From April 2012 until January 2014, 536 pts with genotype 1 infection were recruited in the ongoing NOVUS study by 97 practices and hospitals in Germany. Pts were treated with pegylated interferons (PegIFN) and ribavirin (RBV) together with BOC up to 44 weeks after a 4 weeks lead-in period with PegIFN/RBV. The present interim analysis was restricted to 275 treatment-naïve pts and 140 previously treated pts who started triple therapy at least 12 month ago.

Results: Overall 275 previously untreated pts were compared with 140 previously treated pts (37% relapsers, 14% partial responders, 19% null-responders, 6% breakthrough and 21% with unknown previous response to dual therapy) who showed the following characteristics (untreated vs. treated): Mean age: 45 vs. 51 years (P 400,000 IU/mL: 68% vs. 72%; G1a: 37% vs. 33%; G1b: 50% vs. 49%; liver cirrhosis: 5% vs. 11%; co-infection with HIV: 4% vs. 4%; opioid substitution: 12% vs. 10%. Previously untreated pts achieved more frequently undetectable HCV-RNA levels at TW8 (EVR), TW12 and at end of treatment (EOT) than pretreated pts (table). Until now, follow-up data available from 199 untreated and 108 pretreated pts indicated significantly higher SVR rates in treatment-naïve pts (table). Notably, comparable high/low SVR rates were observed in untreated and pretreated pts with/without EVR (table).

Conclusions: Untreated and previously treated pts undergoing BOC triple therapy for HCV G1 infection in German real-world attain SVR rates of 76% and 57%. When pts achieve an EVR, SVR rates are comparably high in untreated (87%) and pretreated pts (86%).

	Previously untreated patients	Previously treated patients	P
Virologic response	- % (n/N)	- % (n/N)
HCV-RNA undetectable at TW8 (EVR)	71.8 (173/241)	58.8 (70/119)	0,0135
HCV-RNA undetectable at TW12	86.8 (197/227)	76.8 (86/112)	0,0197
HCV-RNA undetectable at EOT	87.8 (201/229)	76.9 (90/117)	0,009
Sustained virologic response (SVR)	75.9 (151/199)	57.4 (62/108)	0,0008
SVR after achieving EVR	87.2 (116/133)	86.0 (43/50)	0,8278
SVR after not achieving EVR	45.5 (25/55)	34.1 (14/41)	0,2645