Z Gastroenterol 2012; 50 - P4_29
DOI: 10.1055/s-0031-1295915

Confirmation of high SVR rates after shortening duration of treatment with Peginterferon alfa–2a (PEG) and Ribavirin (RBV) in Chronic Hepatitis C (CHC) Patients with RVR in Real Life

D Hüppe 1, S Mauss 2, T Lutz 3, M Schuchmann 4, G Moog 5, A Schober 6, R Heyne 7, C John 8, W Schiffelholz 9, C Eisenbach 10, G Teuber 11, A Baumgarten 12, E Schott 13, U Alshuth 14, P Buggisch 15
  • 1Gastroenterologische Gemeinschaftspraxis, Herne
  • 2Center for HIV and Hepatogastroenterology, Düsseldorf
  • 3Infektiologikum, Frankfurt/M
  • 4Johannes-Gutenberg University, Mainz, Mainz
  • 5Gastroenterologische Praxis, Kassel
  • 6Gastroenterologische Praxis, Göttingen
  • 7Hepatologische Schwerpunktpraxis in den Checkpoint- Arkaden, Berlin
  • 8Praxis, Berlin
  • 9Gastroenterologische Praxis, Augsburg
  • 10University Hospital Heidelberg, Heidelberg
  • 11Interdisziplinäres Facharztzentrum Sachsenhausen, Frankfurt/M
  • 12mib Dienstleistungs GmbH, Berlin
  • 13Charite Berlin Campus Virchow-Klinikum Berlin, Berlin
  • 14Roche Pharma AG, Grenzach
  • 15ifi – Institut für Interdisziplinäre Medizin Asklepios Klinik St. Georg, Hamburg

Studies showed that SVR in patients with low viral load (LVL) is high and treatment duration can be reduced while maintaining high SVR rates. But is this true under real life conditions? Methods: Between 2008 and 2011 data of 3810 patients completing a treatment period of 6 months for GT 2/3 or 12 months for GT 1 plus 6 months follow-up were recorded in a noninterventional study. This analysis included 745 naïve patients of G–1/2/3 with RVR and achievement of planned end of therapy, 165 patients of them got shortened treatment: GT 1 20–28 wks (n=110) and GT 2/3 (n=55) 14–18 wks in comparison to standard duration of 40–52 wks in GT 1 and 22–26 wks in GT 2/3. Results: 64.8% male, 38.7 yrs old, BMI 24.8kg/m², mean duration of infection 10.5 yrs. There were no major differences between genotypes or patient demographics with shorter vs. standard therapy. Standard treatment duration were 47.8 and 24.0 wks in GT 1 and GT 2/3 patients whereas shortened therapies were 24.4 and 15.9 wks, respectively.110/278 patients (39.6%) with GT1 and 55/467 patients with GT 2/3 (11.8%) got a shorter treatment. 91.7% of GT 1 and 96.4% of GT 2/3 patients with shortened treatment had LVL ( 800,000 IU/ml). Patients with standard treatment duration and RVR had low viral load in 59.5% of GT 1 and 61.1% of GT 2/3 patients. Rates of AEs and SAEs were 68.2%, 1.8% in GT 1 and 58.2%, 1.8% in GT 2/3 with shorter therapy and 70.2%, 3.6% in GT 1 and 62.1%, 0.7% in GT 2/3 with standard therapy. Conclusion: In real life patients with RVR were considered eligible for shorter therapy only with LVL in the majority of cases. These patients achieved high rates of SVR, similar to standard therapy in patients with RVR. Shorter treatment duration led to better tolerability especially in GT 1 patients. This analysis with very high SVR rates particular in GT 1 patients argues for a 4 week lead-in PEG/RBV period to identify RVR patients before starting triple therapy with protease inhibitors.

Table: Virological Responses

G-1

G-2/3

Shorter duration

Standard duration

Shorter duration

Standard duration

EVR (%)

74.5

81.0

74.5

73.8

EoTR (%)

96.4

96.4

100.0

96.6

SVR (%)

84.5

85.1

78.2

77.7