Steatosis, Obesity, Peg-IFN Dose Reduction & Menopause are Associated with Relapse in Chronic Hepatitis C Patients Treated with Pegylated Interferon Plus Ribavirin

Reported by Jules Levin, AASLD Nov 2 2010

C. Stern1; M. Martinot-Peignoux1; M. Ripault1; N. Boyer1; A. Cardoso1; A. El Ray1; T. Asselah1; D. Valla1; P. Marcellin1 1. Service d'Hepatologie, Hôpital Beaujon, Clichy, France.

BACKGROUND/AIMS: Relapse after treatment of chronic hepatitis C (CHC) patients with the combination of pegylated interferon (PEG-IFN)-α and ribavirin (RBV) is observed in 30% of patients with end of therapy (EOT) response. Factors associated with relapse are not well known. The aim of this study was to evaluate the factors related to relapse in CHC patients, particularly in female patients, treated with PEG-IFN in combination with RBV.

METHODS: A total of 249 consecutive naive CHC patients treated with PEG-IFN-α-2a or -2b plus RBV (800 to 1200 mg/day) and with EOT response were included. Among these, 84 (34%) patients were female. Duration of therapy was defined according to the current guidelines. Clinical, biological, virological and histological data were collected. Type of PEG-IFN, initial doses and modifications of therapy were analyzed. The efficacy of treatment was evaluated with a sensitive qualitative HCV RNA assay (<15 IU/mL). Factors associated with relapse were analyzed.

RESULTS: Relapse was observed in 34% of patients; 50% received PEG-IFN-α2a. Overall population presented the following characteristics: mean age 47±11, obesity (BMI ≥30) in 10%, genotype 1 in 33%, advanced fibrosis (≥F3) in 24% and marked steatosis (≥30%) in 27%.

In the logistic regression, factors related to relapse in overall population were: obesity (p=0.011), genotype 1 (p=0.001), marked steatosis (p=0.006) and PEG-IFN dose reduction (p<0.001). In female patients, menopause was observed in 59% (mean age 48±6). Therefore, to confirm a possible impact of menopause on relapse in CHC female patients, we compared patients under and older than 50 years according to gender. In males (n=165), relapse was present in 22% and 28% of patients under 50 years and older than 50 years (p=0.38), respectively. When relapse rates were analyzed in females (n=84), a statistically difference related to age was observed (14% vs 37%, p=0.023). Among female patients, factors associated with relapse were: menopause (p=0.006), obesity (p=0.031), high viral load (≥400,000 IU/mL) (p=0.014), genotype 1 (p=0.034) and necro-inflammatory activity ≥A2 (p=0.043). In the logistic regression, only menopause was independently associated with relapse in CHC female patients (p=0.007, 95% CI 1.66 - 24.47).

CONCLUSION: CHC patients infected with genotype 1 and presenting obesity and marked steatosis have higher rates of relapse. PEG-IFN reduction, but not ribavirin reduction, is associated with relapse. In female patients, menopause has a negative impact on SVR rates.

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