Masanori Atsukawa1,2, Akihito Tsubota3, Yohei Koushima4, Tadashi Ikegami5, Kouji Watanabe6, Noritomo Shimada7, Shinichi Sato8, Keizo Kato9, Hiroshi Abe9, Tomomi Okubo2, Taeang Arai2, Norio Itokawa2, Chisa Kondo1, Shigeru Mikami10, Toru Asano11, Yoshimichi Chuganji11, Yasushi Matsuzaki5, Katsuhiko Iwakiri1. 1. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan. 2. Department of Internal Medicine, Division of Gastroenterology, Nippon Medical School Chiba Hokusoh Hospital, Chiba, Japan. 3. Core Research Facilities for Basic Science, Jikei University School of Medicine, Tokyo, Japan. 4. Division of Gastroenterology and Hepatology, Japanese Red Cross Saitama Hospital, Saitama, Japan. 5. Department of Internal Medicine, Division of Hepatology and Gastroenterology, Tokyo Medical University, Ibaraki Medical Center, Ibaraki, Japan. 6. Department of Internal Medicine, Division of Gastroenterology, Mito Saiseikai General Hospital, Ibaraki, Japan. 7. Department of Internal Medicine, Division of Gastroenterology and Hepatology, Otakanomori Hospital, Chiba, Japan. 8. Department of Internal Medicine, Division of Gastroenterology and Hepatology, Seirei Sakura Citizen Hospital, Chiba, Japan. 9. Department of Internal Medicine, Division of Gastroenterology and Hepatology, Shinmatsudo Central General Hospital, Chiba, Japan. 10. Department of Internal Medicine, Division of Gastroenterology, Kikkoman General Hospital, Chiba, Japan. 11. Department of Internal Medicine, Division of Gastroenterology and Hepatology, Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan.
Abstract
AIM: From a pharmacokinetic viewpoint, the use of ombitasvir/paritaprevir/ritonavir, one of the standards of care for genotype 1b chronic hepatitis C in Japan, could be possible in patients with impaired renal function. The aim of this study was to assess the efficacy and safety of this combination that have not yet been addressed in patients undergoing dialysis. METHODS: A retrospective, multicenter study evaluated the outcome of 12-week ombitasvir (non-structural protein [NS]5A inhibitor)/paritaprevir (NS3/4A protease inhibitor)/ritonavir combination therapy for dialysis patients. The primary end-point was sustained virologic response 12 weeks after therapy (SVR12). RESULTS: The subjects were 31 patients with a median age of 64 years (range, 49-85 years), including 10 cirrhotic patients. All of the 31 patients had an estimated glomerular filtration rate level <15 mL/min/1.73 m2 , defined as end-stage renal disease (ESRD). Pre-existing resistance-associated substitutions at position L31 and Y93 of the NS5A region were detected in 0% and 3.6% (1/28), respectively. The rates of rapid virologic response, end-of-treatment response, and SVR12 were 93.5% (29/31), 100% (31/31), and 96.8% (30/31), respectively. The incidence of adverse events was 35.5% (11/31). Of the 11 patients, one discontinued the treatment due to erythema multiforme and thereafter relapsed. The most frequent adverse event was pruritus (6.5%; 2/31). CONCLUSIONS: The present study suggests that ombitasvir/paritaprevir/ritonavir combination therapy is effective and safe for genotype 1b chronic hepatitis C patients undergoing dialysis due to ESRD.
AIM: From a pharmacokinetic viewpoint, the use of ombitasvir/paritaprevir/ritonavir, one of the standards of care for genotype 1b chronic hepatitis C in Japan, could be possible in patients with impaired renal function. The aim of this study was to assess the efficacy and safety of this combination that have not yet been addressed in patients undergoing dialysis. METHODS: A retrospective, multicenter study evaluated the outcome of 12-week ombitasvir (non-structural protein [NS]5A inhibitor)/paritaprevir (NS3/4A protease inhibitor)/ritonavir combination therapy for dialysis patients. The primary end-point was sustained virologic response 12 weeks after therapy (SVR12). RESULTS: The subjects were 31 patients with a median age of 64 years (range, 49-85 years), including 10 cirrhotic patients. All of the 31 patients had an estimated glomerular filtration rate level <15 mL/min/1.73 m2 , defined as end-stage renal disease (ESRD). Pre-existing resistance-associated substitutions at position L31 and Y93 of the NS5A region were detected in 0% and 3.6% (1/28), respectively. The rates of rapid virologic response, end-of-treatment response, and SVR12 were 93.5% (29/31), 100% (31/31), and 96.8% (30/31), respectively. The incidence of adverse events was 35.5% (11/31). Of the 11 patients, one discontinued the treatment due to erythema multiforme and thereafter relapsed. The most frequent adverse event was pruritus (6.5%; 2/31). CONCLUSIONS: The present study suggests that ombitasvir/paritaprevir/ritonavir combination therapy is effective and safe for genotype 1b chronic hepatitis C patients undergoing dialysis due to ESRD.