However, the classification F4 is not included in Japanese clinical trials, and there have been no reports of therapeutic results stratified for the degree of hepatic fibrosis. Taken together, the results of Japanese and overseas clinical trials showed no clear age-related differences in therapeutic effect of SMV + Peg-IFN + RBV find protocol triple therapy. Although IL28B SNPs and the degree of fibrosis may influence therapeutic efficacy, SVR rates of 60–80% were still achieved in patients with IL28B minor alleles and advanced fibrosis ≥ F3. Accordingly, at present we cannot say that age, IL28B SNPs or the degree of fibrosis exerts any great influence on the therapeutic

efficacy of this treatment regimen. Recommendations SMV + Peg-IFN + RBV triple therapy is at present the treatment of first choice in IFN-naïve patients. IL28B polymorphism has little influence on the SVR rate in IFN-naïve patients undergoing SMV + Peg-IFN + RBV triple therapy, with relatively high SVR rates achieved even in patients with Etoposide solubility dmso the TG/GG minor alleles. In Japanese clinical trials conducted with subjects aged ≤ 70, no clear correlation could be identified between age and SVR rates. Although Japanese data is lacking, the results of overseas clinical trials indicate that advanced hepatic fibrosis may influence SVR rates. From the above, in general, if treatment is likely to be tolerated, SMV-based triple

therapy is indicated in all patients who meet the criteria for antiviral therapy (ALT > 30 U/L or platelet count <150 000/μL), irrespective of IL28B SNP status. In some patients, however, in whom adverse reactions are a concern, and the MCE risk of carcinogenesis is considered low, it may be possible to await the introduction of the new agents with more favorable safety profiles. In this patient group at high risk of hepatocellular carcinogenesis, the best possible antiviral therapy should be promptly commenced. However, the possibility of adverse reactions, and

the possibility that viral eradication may not be achieved, should be thoroughly explained to the patient in advance. Although the introduction of TVR + Peg-IFN + RBV triple therapy improved SVR rates in comparison to Peg-IFN + RBV dual therapy,[1] postmarketing surveys revealed serious adverse reactions in approximately 40% of elderly patients. Accordingly, it is recommended that TVR therapy should be commenced at a reduced dosage of 1500 mg/day,[18] although great caution is still required in its use in this age group. On the other hand, clinical trials of SMV + Peg-IFN + RBV triple therapy for treatment-naïve patients have reported an SVR rate of 86% (19/22) in elderly patients aged ≥ 65 (and ≤70), indicating a therapeutic efficacy similar to that seen in non-elderly patients (Fig. 4). Furthermore, very little difference is seen between SMV-based triple therapy and Peg-IFN + RBV dual therapy in terms of safety.