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Treatment of chronic hepatitis C Genotype 1 (G1) infection with boceprevir (Victrelis®) in the German real-life setting: First results for treatment-naïve patients from the Novus observational study
Aims: Triple therapy with the HCV protease inhibitor boceprevir (Victrelis®) combined with pegylated interferons (PegIFN) and ribavirin (RBV) has recently been approved as new standard of care for patients (pts) with chronic HCV genotype 1 (G1) infection. As a consequent next step we conducted a non-interventional observational study (NOVUS) to investigate the efficacy and safety of this novel and more complex therapeutic approach in the German real-life setting.
Methods: From April 2012 until March 2013, 307 pts with G1 infection were recruited in the ongoing NOVUS study by 85 practices and hospital ambulances in Germany. According to European label, triple therapy with PegIFN/RBV/boceprevir for 24 to 44 weeks after a 4 week lead-in period with PegIFN/RBV was recommended, but due to the character of this study, the responsible physicians treated pts at their discretion. In the present interim analysis with focus on the 4 weeks lead-in period documented data of 126 treatment-naive pts were regarded.
Results: Median age of pts was 47yrs and 44% were older than 50yrs. 59% of pts were male, 93% Caucasian, 34% with migration background, median BMI was 25.9 kg/m2, 4.0% and 1.6% were coinfected with HIV and HBV, and 18% were opioid user under stable substitution. HCV G1 subtypes were distributed as follows: G1a 33%, G1b 44%, unknown 21%. High baseline viral load > 800.000 IU/ml was found in 54% of patients. Liver cirrhosis was apparent in 4%, while 16% had baseline platelet count ≤150/nL which indirectly reflects advanced fibrosis or cirrhosis. Mean duration of lead-in was 30 ± 5 days. During the lead-in period 59% and 41% of pts were treated with Peg2a/RBV and Peg2b/RBV. At the end of treatment week 4 a HCV-RNA decline > 1 log10 was achieved by 87% of pts.
Conclusions: First data from the NOVUS observational trail show promising early virologic response rates at the end of the lead-in period with PegIFN/RBV. In NOVUS 87% of previously untreated patients gained a HCV-RNA decline > 1log10 which was associated with high SVR rates > 80% following addition of boceprevir in the SPRINT-2 registration trail (Poordad, NEJM 2011). However, the favorable outcome of this dominating patient subgroup needs confirmation in real-life as addressed by the ongoing NOVUS trail.