Z Gastroenterol 2012; 50 - P4_65
DOI: 10.1055/s-0031-1295951

The Role of Weight Loss (WL) as On-Tretament Predictive Factor for SVR in the Treatment of Chronic Hepatitis C (CHC) Patients with Peginterferon alfa–2A (PEG) and Ribavirin (RBV)

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

Aim: It is helpful to know different baseline and on-treatment factors that help in decision making for intensifying or facilitating therapy. Here we analysed the value of WL during PEG/RBV. Methods: From 2008–2011, 3810 pts were fully documented in a noninterventional study of bng and Roche. Of them 1100 were treated according to consensus guidelines (GT–1/4/5/6 for 48±4 wks, GT–2/3 for 24±2 wks). Pts with HIV or HBV coinfection were excluded. Descriptive, univariate and multivariate analyses were performed to determine factors associated with SVR. Results: Demographics: 59.7% male, 44.2 yrs of age, BMI 25.5kg/m², initial weight 76,1kg, 67,0% of pts with GT–1/4/5/6 and 33.0% with GT–2/3. Mean maximum WL –5.0kg in GT–1/4/5/6 and –3.6kg in GT–2/3, at which 39.3 and 51.5% of pts lost this weight in the first 12 weeks. The allocation of WL was <1kg 18.6%, 1< 2kg 9.5%, ≥ 2–<5kg 31.2%, ≥ 5–<10kg 26.5% and ≥10kg 14.1%. For discrimination of WL related to SVR or Nonresponse a best cut of 2kg duringtherapy was found by ROC analysis. RVR was achieved in 20.6% of GT–1/4/5/6 and 82.1% of GT–2/3 pts, EVR in 64.7% and 75.8%, rsp. In univariate analysis variables associated significantly with SVR were: age (<45 vs. ≥45 yrs), GT (1/4/5/6 vs. 2/3), RVR, EVR and WL (<2 vs. ≥2kg). Multivariate analysis included all significant parameters of univariate analysis. EVR [p< .001, OR=4.816 (CI95 3.503–6.621)], RVR [p< .001, OR=3.343 (CI95 2.523–4.430)] age [p< .001, OR=0.472 (CII95 0.358–0.623] and WL [p=0.003, OR=1.601 (CI95 1.173–2.184)] remained significant predictors, but no more GT. Conclusion: Since treatment discontinuations like non-compliance or lost of follow-up have been excluded, these data indicate that WL may be a consequence of PEG/RBV effects. So WL seems to be a further reliable predictive factor for estimating the chance for SVR and can be useful to recognize early need for treatment intensification in pts without WL.

Table 1: RVR, EVR and SVR rates differentiated to WL

GT-1/4/5/6

GT-2/3

Virological Response (%)

WL <2kg

WL ≥2kg

WL <2kg

WL ≥2kg

RVR

12.4

23.6

79.3

83.4

EVR

51.5

69.4

65.5

80.6

SVR

25.3

44.4

55.2

68.8