High virologic response rate at End of Treatment (EOT) following triple therapy of previously untreated HCV Genotype 1 (G1) infection with boceprevir in German real-life

• Published in: Zeitschrift für Gastroenterologie
• Main Authors: Buggisch, P, Löhr, H, Teuber, G, Steffens, H, Kraus, M, John, C, Geyer, P, Weber, B, Witthoeft, T, Herrmann, A, Hoesl, M, Naumann, U, Dahhan, T, Hartmann, D, Dreher, B, Bilzer, M
• Format: Conference Proceeding
• Language: English; German
• Published: 11.08.2014
• ISSN: 0044-2771; 1439-7803
• DOI: 10.1055/s-0034-1386302

Background: Triple therapy with the HCV protease inhibitor boceprevir has been approved as new standard of care for patients with chronic HCV G1 infection. The NOVUS observational study was conducted to investigate the efficacy of this novel antiviral therapy in German real-life. Methods: From April 2012 until January 2014, 536 patients with G1 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 boceprevir for 24 to 44 weeks after a 4 weeks lead-in period with PegIFN/RBV according to the discretion of the responsible physician. The present interim analysis was restricted to 180 untreated patients who have started treatment at least 44 weeks ago. Results: Patient characteristics and virologic response rates are shown in the table. Mean duration of lead-in with PegIFN/RBV was 32 ± 9 days. Among patients with evaluable data 71% were early responders with undetectable HCV-RNA at treatment week (TW) 8. At TW12 HCV-RNA was undetectable in 79% while only 3% (5/163) fulfilled TW12 stopping rules with HCV-RNA levels > 100 IU/mL. At TW24 HCV-RNA was undetectable in 80%. Of these 3% achieved undetectable HCV-RNA for the first time between TW12 and TW24. At end of treatment (EOT) HCV-RNA was undetectable in 79% of patients. Treatment discontinuations were reported for 25 patients (16%). Treatment-naïve patients with HCV G1 infection N = 180 Median age , years Age > 50 years , % (N) Female/male , % (N) Median BMI , kg/m 2 4641 (73)44 (79)/56 (101)26.2 HCV G1 subtypes , % (N)G1a/G1b/subtype unknown Baseline viral load > 800,000 IU/ml , % (N) Liver cirrhosis , % (N) 32 (57)/49 (89)/19 (34)54 (97)5 (8) Co-infection with HIV/HBV , % (N) Opioid user under stable substitution , % (N) 4 (7)/0.6 (1)12 (21) Virologic response , % (n/N)HCV-RNA decline > 1log 10 at TW4HCV-RNA undetectable at TW8HCV-RNA undetectable at TW12HCV-RNA undetectable at TW24HCV-RNA undetectable for the first time between TW12 and TW24HCV-RNA undetectable at EOT 80 (133/167)74 (114/154)81 (111/163)80 (117/147)3 (6/147)79 (127/161) Conclusions: Interim results from the NOVUS study show a possible shortening of triple therapy with boceprevir to 24 weeks in 74% of untreated patients with early virologic response at TW8. Virologic response rates of 79% at EOT together with moderate treatment discontinuation rates demonstrate a high efficacy of this novel antiviral therapy in real-life. Sustained virologic response rates are still under investigation and will be presented at the conference.