Female patients in fertile age with chronic hepatitis C, easy genotype, and persistently normal transaminases have a 100% chance to reach a sustained virological response.

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.

Retreatment of patients with chronic hepatitis C relapsers to a previous antiviral treatment.

BACKGROUND: The efficacy of retreatment with pegylated interferon (PEG-IFN) plus ribavirin for patients relapsing after a previous treatment remains to be fully elucidated, although extended treatment seems to be the best option in such cases. AIM: To evaluate the efficacy of two extended protocols in patients with genotypes 1 or 4, or those with genotypes 2 or 3. METHODS: A total of 181 patients who had relapsed after a previous antiviral treatment with PEG-IFNα2a plus weight-based ribavirin were offered retreatment with the same dose of both PEG-IFN plus ribavirin, to be continued for 48 weeks in those with genotypes 2 or 3 (group 1), and for 72 weeks in those with genotypes 1 or 4 (group 2). RESULTS: A total of 59 patients (32.5%) refused the retreatment, while 122 (78 men, 44 women) patients were enrolled in the study: 41 were allocated in group 1 and 81 in group 2. Cirrhosis at baseline (staging 5/6 according to Ishak's score was recorded in 11 patients, six in group 1 and five in group 2). Nine patients (7.3%) in group 2 discontinued the treatment (due to lack of response). The remaining patients completed the treatment and were followed-up for at least 12 months after the treatment. Sustained virological response (SVR) rate was 82.9% in group 1 and 50.6% in group 2. CONCLUSION: Patients with chronic hepatitis C with 'easy genotypes' relapsers to a previous antiviral treatment have more than 80% probability of achieving a SVR with a 48-week retreatment. Patients with 'difficult genotypes' have more than 50% chance of a SVR after a 72-week extended treatment.