biopsy (ALT: 0/2, HBV-DNA: 8/20, TE: 7/23, ALT+TE: 3/3, HBV-DNA+TE: 5/10).Grading and staging did not differ significantly in patients with or without HBV-DNA > 2000 IU/mL and with or without stiffness > 6.5 kPa, but were higher in the 8 patients with ALT+TE/HBV-DNA+TE biopsy indications than in the remaining 15 patients (grading:3.9±1.0 vs 2.9±1.0,p = 0.056; staging:1.9±0.8 vs 0.9±0.8,p = 0.016).Moderate fibrosis (staging score = 2-3) was found in 7/23 (30%) patients (grading minimal/mild: 3/4) being more frequent in cases with than without ALT+TE/HBV-DNA+TE [5/8 (63%) vs 2/15 (13%), p = 0.026] or with than without ALT+TE/HBV-DNA+TE or stiffness > 9.5 kPa [6/9 (67%) vs 1/14 (7%), p = 0.005].Conclusions: Up to 30% of HBeAg-negative chronic HBV carriers without elevated both ALT and HBV-DNA levels may have relatively high stiffness values (>6.5 kPa) by TE.However, only the rare cases with very high stiffness (>9.5 kPa) or those with the combination of stiffness values >6.5 kPa with elevated ALT (>ULN) and/or HBV-DNA (>2000 IU/mL) may benefit from a liver biopsy usually showing moderate fibrosis with minimal-mild necroinflammatory activity.

Summary. Low pretreatment viral load has consistently been shown to be an independent predictor of sustained response (SR) in patients with chronic hepatitis C infection. We assessed the efficacy of interferon (IFN) plus ribavirin vs IFN alone in low viraemic patients (<2 millions copies/mL) who had relapsed to a previous course of IFN and the efficacy of 24 vs 48 week combination therapy in high viraemic patients. Two hundred and ninety‐seven patients were randomly assigned to one of the four regimens after stratification on pretreatment viral load. All patients received IFN‐α2b (6 million units thrice weekly for 24 weeks and 3 million units thrice weekly for 24 weeks). Patients with low viraemia received either IFN‐α2b alone for 48 weeks (R1: 42 patients) or IFN‐α2b plus ribavirin (600 mg/day) for 24 weeks and IFN‐α2b alone for the next 24 weeks (R2: 48 patients). Patients with high viral load received either IFN‐α2b plus ribavirin for 24 weeks and then IFN‐α2b alone for the next 24 weeks (R3: 104 patients) or IFN‐α2b plus ribavirin for 48 weeks (R4: 103 patients). In low viraemic patients the rate of SR was 37.7% in group R1 and 59.6% in group R2 (P < 0.05). In high viraemic patients, the rate of SR was 44.7% in group R3 and 51.4% in group R4 (P: NS). Thirty‐one patients discontinued treatment (10.4%) without difference regarding treatment regimen. In the regimen using ribavirin we found no difference in terms of SR between patients receiving a dose of ribavirin below 10.6 mg/kg/day (55%) or over 10.6 mg/kg/day (58%). Histological improvement occurred in 70.2% of patients regardless of the regimen. Logistic regression showed that genotype 2 and 3, Knodell score <6 and alanine aminotransferase pretreatment level >3 × upper limit of normal were significantly and independently correlated with SR. In low viraemic patients who relapsed to a previous IFN treatment, combination therapy using high‐dose IFN and low‐dose ribavirin is better than high‐dose IFN alone. In high viraemic patients there was no benefit in increasing the duration of combination therapy from 24 to 48 weeks. In this study, it was found that low dose of ribavirin can be used safely and there is no effect of ribavirin dose on SR.