Is the rapid virologic response a positive predictive factor of sustained virologic response in all pretreatment status genotype 1 hepatitis c patients treated with peginterferon-alpha2b and ribavirin?

INTRODUCTION: Currently it is not yet defined if the rapid virologic response (RVR) can predict a sustained virologic response (SVR) in relapsers and nonresponders. OBJECTIVE: To evaluate treatment-RVR as a predictive factor of SVR in genotype 1 hepatitis C treatment naive, relapsers, and nonresponder patients treated with pegylated interferon-alpha (PEG-IFN-alpha2b) and ribavirin. METHODS: One hundred sixty-seven genotype 1 hepatitis C patients who were treated with PEG-IFN-alpha2b and ribavirin and had SVR assessed were included. Hepatitis C virus RNA analysis at the fourth week of treatment was performed in all patients. The exclusion criteria were hepatitis B virus and/or HIV co-infection. A comparative analysis was performed between the groups with and without RVR and a logistic regression model was applied. RESULTS: One hundred sixty-seven patients were analyzed, 103 (62%) were naives, 22 (13%) relapsers, and 42 (25%) nonresponders. The SVR rates were 44% in naives, 68% in relapsers, and 12% in nonresponders. RVR was attained in 51/167 (31%) patients and in this group the SVR was higher than in those without RVR (75% vs. 23%; P<0.001). This difference was also observed in all subgroups: naives (71% vs. 29%; P=0.001), relapsers (92% vs. 40%; P=0.02), and nonresponders (50% vs. 8%; P=0.06). A stepwise logistic regression model identified RVR and absence of cirrhosis as the factors independently associated to SVR. CONCLUSIONS: RVR and absence of cirrhosis are the strongest predictive factors of SVR in HCV genotype 1 patients. Assessment of RVR is very useful in all pretreatment status patients in predicting SVR and provides information for individualizing therapy.

HBV-DNA levels in HBsAg-positive blood donors and its relationship with liver histology.

INTRODUCTION AND OBJECTIVES: The clinical meaning of viremia, especially at low levels, in chronic hepatitis B virus (HBV)-infected patients remains unknown. The objective of the present study was to determine serum HBV-DNA levels and its relationship with liver histology in HBsAg-positive blood donors. METHODS: A cross-sectional study was conducted on 78 blood donors, with alanine aminotransferase (ALT) and HBeAg evaluation and quantitative determination of HBV-DNA by polymerase chain reaction (Amplicor, HBV Monitor, Roche; lower limit of sensitivity 1,000 copies/mL). Liver biopsy was obtained from all patients with detectable viremia irrespective of ALT and HBV-DNA levels. RESULTS: Among 78 blood donors, serum HBV-DNA was detected in 47 (60%) patients; 39 (83%) were males; mean age 37.6+/-10.4 years; 31 (66%) were HBeAg-negative, and ALT was elevated in 26 (55%). The median of HBV-DNA levels was 24,000 copies/mL and 31 (40%) subjects had no detectable serum HBV-DNA. Although the histologic lesions were mild in the majority of patients, HBV-DNA levels were significantly higher in patients with chronic hepatitis or cirrhosis when compared with patients without histologic liver disease (25,260,000 vs. 9480 copies/mL; P<0.001). There was a significant correlation between HBV-DNA levels and necroinflammatory score (r=0.59) and fibrosis (r=0.50); however, in the subset of HBeAg-negative patients with HBV-DNA levels below 30,000 copies/mL, 25% presented histologic disease related to HBV. CONCLUSIONS: Most HBsAg-positive blood donors show low viral load. There is a significant association between viral replication and liver damage; however, low HBV-DNA levels do not exclude the presence of histologic disease.

Gamma-glutamyl transferase (GGT) as an independent predictive factor of sustained virologic response in patients with hepatitis C treated with interferon-alpha and ribavirin.

BACKGROUND: Recently, gamma-glutamyl transferase (GGT) has been investigated as a predictive factor for therapy response in hepatitis C patients, but so far its value in pretreatment screening has not been established. Therefore, this study aimed at evaluating GGT as an independent predictive factor for the response to treatment with interferon-alpha and ribavirin in hepatitis C virus (HCV)-infected patients. METHODS: Naive chronic hepatitis C patients undergoing a 6-month follow-up after interferon-alpha and ribavirin therapy had their sustained virologic response (SVR) analyzed according to age, sex, body mass index, GGT levels, genotype, and liver histology by use of a multivariate logistic regression model. RESULTS: Of the 211 patients studied with a mean age of 48+/-10 years, 125 (59%) were males. Overweight was detected in 47% of patients. Genotype 1 was detected in 141 (75%) of the 187 patients tested. Cirrhosis was present in 67 (32%). A high pretreatment GGT level was observed in 134 (63%). SVR was obtained in 84 (40%) patients. In the final logistic regression model, the variables independently associated with SVR were GGT (P<0.001), genotype (P<0.001), and liver histology (P<0.001). CONCLUSION: A normal GGT level is an independent predictive factor for SVR in HCV-infected patients and should be considered for pretreatment screening.