Gender-dependent differences in the efficacy and safety of Boceprevir triple therapy in German real-life

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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. Until now, there is limited information about the efficacy and safety of BOC triple therapy in clinical practice and whether differences occur between female and male pts. Methods: From April 2012 until January 2014, 536 pts with HCV G1 infection were recruited in the ongoing NOVUS observational study by 97 practices and hospitals in Germany. Pts 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 275 treatment-naïve pts. Results: Overall, 114 female pts were compared with 161 male pts who showed the following baseline characteristics (female vs. male): Mean age: 46 vs. 44 years; BMI: 26.4 vs. 26.6 kg/m 2 ; baseline viral load > 400,000 IU/mL: 68% vs. 69%; liver cirrhosis: 6% vs. 4%; opioid substitution: 10% vs. 14%. Female pts had a significantly higher frequency of HCV-G1b infections (60% vs. 42%, P = 0.012) while co-infections with HBV or HIV were absent (males: 4% and 7%). After starting triple therapy, there was a trend towards a better virologic response at treatment week (TW) 8 and at TW12 in male pts leading to significantly higher end of treatment (EOT) response rates, lower treatment discontinuation rates, and higher SVR rates in the male population (table). Regarding adverse events, female pts more frequently developed anemia (Hb < 10 g/dL) (57% vs. 23%, P < 0.0001), thyroid dysfunctions (28% vs. 9%, P = 0.0006) and eGFR declines to < 60 mL/min per 1.73 m 2 (7.0% vs. 1.2%, P = 0.0184). Conclusions: The findings of the present interim analysis strongly suggest gender-dependent differences in the efficacy and safety of BOC triple therapy in German real-life. Compared to female pts, male pts achieve higher SVR rates together with a lower frequency of adverse events such as anemia, renal dysfunction grade III and thyroid dysfunctions. Female patients Male patients P Virologic response - % (n/N) - % (n/N) HCV-RNA undetectable at TW8 (EVR) 68.6 (70/102) 74.1 (103/139) 0,3509 HCV-RNA undetectable at TW12 82.6 (76/92) 89.6 (121/135) 0,1252 HCV-RNA undetectable at EOT 82.3 (79/96) 91.7 (122/133) 0,0315 Sustained virologic response (SVR) 67.9 (57/84) 81.7 (94/115) 0,0238 Treatment discontinuations 31.6 (36/114) 21.1 (34/161) 0,0498

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