Source aDepartment of Surgical and Gastroenterological Sciences bDepartment of Hygiene and Public Health, University of Padova, Padova cNational Centre for Health and Gender Medicine dDepartment of Infectious Disease, Bergamo Hospital, Bergamo, Italy.
BACKGROUND: Patients with chronic hepatitis C and persistently normal alanine transaminase levels have recently been included in the guidelines for antiviral treatment.
AIM: To evaluate the efficacy of PEG-interferon α-2a and weight-based ribavirin doses in patients with these characteristics in a single Italian centre.
MATERIALS AND METHODS: Patients with chronic hepatitis C and at least three normal alanine transaminase values over a 12-month period were offered a treatment with PEG-interferon α-2a 180 mg/week and ribavirin (800 mg/day for weight <60 kg; 1000 mg/day for weight >60 and <75 kg; 1200 mg/day for weight >75 kg) for 24 weeks (according to genotype 2 or 3) or for 48 weeks (according to genotype 1 or 4). Each patient at baseline underwent liver stiffness (LS) examination using Fibroscan. Data were analysed according to the intention-to-treat criteria.
RESULTS: A total of 227 patients (55 men, 172 women) were enrolled into the study: 65 (28.6%) had genotype 1, 144 (63.4%) genotype 2, nine (4.0%) genotype 3 and nine (4.0%) genotype 4. Patients with genotype 2 or 3 (N=153 with easy genotypes) were allocated in group 1 and those with genotype 1 or 4 (N=74 with difficult genotypes) in group 2. According to the LS measurement, patients were classified as follows: 159 (70.0%) presented absent or mild fibrosis (LS=2.5-7.0 kPa), 61 (26.9%) patients had significant fibrosis (LS=7.1-9.5) and seven (3.1%) patients had severe fibrosis (LS >9.6). Twelve patients (5.3%) dropped out within 4 months because of side-effects, whereas 215 patients completed the study. Overall, 13 patients were considered nonresponders (5.7%) and six patients (2.6%) were relapsers to the therapy. The sustained virological response (SVR) rate was 85.4% and it was higher in 'easy' genotypes (2 or 3) compared with 'difficult' genotypes (1 or 4) (92.2 vs. 74.3%, P<0.001). No statistical difference was found in the SVR rate between patients presenting absent or mild fibrosis as against those with significant fibrosis. Multivariate analysis, including factors correlated with SVR, showed that easy genotype and female sex are significantly associated with a SVR.
CONCLUSION: Patients with chronic hepatitis C and persistently normal transaminases have an 85.4% chance to clear the virus with conventional antiviral treatment. Female patients in fertile age with easy genotypes have a 100% chance to reach a SVR.