Eiichi Ogawa1, Norihiro Furusyo1, Naoki Yamashita2, Akira Kawano3, Kazuhiro Takahashi4, Kazufumi Dohmen5, Makoto Nakamuta6, Takeaki Satoh7, Hideyuki Nomura8, Koichi Azuma9, Toshimasa Koyanagi10, Kazuhiro Kotoh11, Shinji Shimoda12, Eiji Kajiwara13, Jun Hayashi14. 1. Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan. 2. Department of Hepatology, Steel Memorial Yawata Hospital, Kitakyushu, Japan. 3. Department of Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan. 4. Department of Medicine, Hamanomachi Hospital, Fukuoka, Japan. 5. Department of Internal Medicine, Chihaya Hospital, Fukuoka, Japan. 6. Department of Gastroenterology, Kyushu Medical Center, National Hospital Organization, Fukuoka, Japan. 7. Center for Liver Disease, Kokura Medical Center, National Hospital Organization, Kitakyushu, Japan. 8. The Center for Liver Disease, Shin-Kokura Hospital, Kitakyushu, Japan. 9. Department of Medicine, Kyushu Central Hospital, Fukuoka, Japan. 10. Department of Medicine, Fukuoka City Hospital, Fukuoka, Japan. 11. Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 12. Department of Medicine and Biosystemic Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 13. Kajiwara Clinic, Kitakyushu, Japan. 14. Kyushu General Internal Medicine Center, Haradoi Hospital, Fukuoka, Japan.
Abstract
AIM: The aim of this study was to evaluate the efficacy and safety of 24-week daclatasvir (NS5A inhibitor) plus asunaprevir (NS3/4 A protease inhibitor) treatment for elderly patients with hepatitis C virus (HCV) genotype 1b infection. METHODS: This prospective, multicenter study consisted of 321 Japanese HCV genotype 1b patients who were interferon-ineligible/intolerant or non-responders to interferon-based regimens, including 103 (32.1%) aged ≥75 years and 127 (39.6%) with cirrhosis. Sustained virological response (SVR) at 24 weeks after the end of treatment and adverse effects were analyzed according to age. RESULTS: The overall SVR rate was 90.3%. In terms of by age, 94.5% (69/73), 88.3% (128/145), and 90.3% (93/103) of the patients aged <65, 65-74, and ≥75 years, respectively, achieved SVR. For the entire cohort, pre-existent NS5A resistance-associated variants and prior simeprevir failure were independently associated with treatment failure. According to the analysis of patients without these unfavorable pretreatment factors, 90.8% (89/98) aged ≥75 years achieved SVR, although this was significantly lower than for those aged <65 years (98.5%, 66/67) (P < 0.05). The frequency of adverse effects was comparable for the <75 and ≥75 age groups, the most common being an elevated alanine aminotransferase level (>150 U/L, 8.7%), however, no decompensating events were seen. CONCLUSIONS: Daclatasvir plus asunaprevir for HCV genotype 1b was well tolerated and effective for patients without pre-existent NS5A resistance-associated variants or simeprevir failure, irrespective of fibrosis status. However, it was less effective for very old patients aged ≥75 years compared to those aged <65.
AIM: The aim of this study was to evaluate the efficacy and safety of 24-week daclatasvir (NS5A inhibitor) plus asunaprevir (NS3/4 A protease inhibitor) treatment for elderly patients with hepatitis C virus (HCV) genotype 1b infection. METHODS: This prospective, multicenter study consisted of 321 Japanese HCV genotype 1b patients who were interferon-ineligible/intolerant or non-responders to interferon-based regimens, including 103 (32.1%) aged ≥75 years and 127 (39.6%) with cirrhosis. Sustained virological response (SVR) at 24 weeks after the end of treatment and adverse effects were analyzed according to age. RESULTS: The overall SVR rate was 90.3%. In terms of by age, 94.5% (69/73), 88.3% (128/145), and 90.3% (93/103) of the patients aged <65, 65-74, and ≥75 years, respectively, achieved SVR. For the entire cohort, pre-existent NS5A resistance-associated variants and prior simeprevir failure were independently associated with treatment failure. According to the analysis of patients without these unfavorable pretreatment factors, 90.8% (89/98) aged ≥75 years achieved SVR, although this was significantly lower than for those aged <65 years (98.5%, 66/67) (P < 0.05). The frequency of adverse effects was comparable for the <75 and ≥75 age groups, the most common being an elevated alanine aminotransferase level (>150 U/L, 8.7%), however, no decompensating events were seen. CONCLUSIONS:Daclatasvir plus asunaprevir for HCV genotype 1b was well tolerated and effective for patients without pre-existent NS5A resistance-associated variants or simeprevir failure, irrespective of fibrosis status. However, it was less effective for very old patients aged ≥75 years compared to those aged <65.