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DOI: 10.1055/s-0034-1397256
Treatment of previously untreated patients with chronic HCV genotype 1 infection with boceprevir in German real-life: high end of treatment response of 95% in patients with early virologic response
Background: The achievement of early virologic response (EVR) during triple therapy of chronic HCV genotype 1 infection with the HCV protease inhibitor boceprevir has been identified as predictor to shorten treatment to 24 weeks. The present interim analysis of the NOVUS observational study was aimed to determine the frequency of EVR during boceprevir triple therapy in German real-life and to determine the virologic outcome of patients with and without EVR.
Methods: From April 2012 until January 2014, 536 patients (pts) with genotype 1 infection were recruited in the ongoing NOVUS study by 97 practices and hospitals in Germany. Patients were treated with pegylated interferons (PegIFN) and ribavirin (RBV) together with BOC for 24 to 44 weeks after a 4 weeks lead-in period with PegIFN/RBV. The present interim analysis was restricted to 222 previously untreated patients with documented HCV-RNA at treatment week (TW) 8.
Results: Overall, 158 of 222 pts (71.2%) undergoing boceprevir triple therapy achieved an EVR (59.5% male, 32.9% > 50 years, 61.8% with baseline viral load > 400.000 IU/mL) while 64 pts (28.8%) did not (48.4% male, 48.4% > 50 years, 82.8% with baseline viral load > 400.000 IU/mL). Pts who achieved EVR showed more frequent a HCV-RNA decline > 1log10 to PegIFN/RBV lead-in at the end of TW4 (89.3% vs. 54.1%, p < 0.0001). In addition there was a significant higher virologic response at TW12 in pts with EVR (90.9% vs. 67.8%, p<.0001). Only 1 patient (0.8%) with EVR had HCV-RNA levels > 100 IU/mL thereby fulfilling TW12 stopping rules in contrast to 9 pts (9.2%) without EVR. Furthermore, a better virologic response was found at TW24 (87.2% vs. 64.9%, p = 0.0006) and at the end of treatment (EOT) with EOT response rates of 94.9% and 65.9% (p < 0.0001) in pts with and without EVR. Follow-up data were available from 123 pts with EOT documentation: Until now, 78 of 89 pts with EVR (87.6%) achieved SVR in contrast to only 14 of 34 (41.2%) in the subgroup of pts without EVR.
Conclusions: Approximately 70% of treatment-naïve pts with HCV G1 infection undergoing triple therapy with boceprevir in German real-life experience an EVR which allows shortage of triple therapy to 24 weeks. In addition, achieving EVR is associated with high EOT response rates as well as high SVR rates of 95% and 88%. The more rapid HCV-RNA decline at the end of lead-in suggests a higher sensitivity to PegIFN/RBV backbone in pts who achieve EVR.
Corresponding author: Bilzer, Manfred
E-Mail: manfred.bilzer@bilzer-consulting.de