Treatment with sofosbuvir and ledipasvir without ribavirin for 12 weeks is highly effective for recurrent hepatitis C virus genotype 1b infection after living donor liver transplantation: a Japanese multicenter experience

• Published in: Journal of gastroenterology 2017-08, Vol.52 (8), p.986-991
• Main Authors: Ueda, Yoshihide, Ikegami, Toru, Akamatsu, Nobuhisa, Soyama, Akihiko, Shinoda, Masahiro, Goto, Ryoichi, Okajima, Hideaki, Yoshizumi, Tomoharu, Taketomi, Akinobu, Kitagawa, Yuko, Eguchi, Susumu, Kokudo, Norihiro, Uemoto, Shinji, Maehara, Yoshihiko
• Format: Article
• Language: English
• Subjects: Abdominal Surgery; Aged; Alveoli; Antiviral agents; Antiviral Agents - adverse effects; Antiviral Agents - therapeutic use; Antiviral drugs; Benzimidazoles - adverse effects; Benzimidazoles - therapeutic use; Biliary Tract; Biological response modifiers; Care and treatment; Colorectal Surgery; Development and progression; Diseases; Donation of organs, tissues, etc; Drug Resistance, Viral - genetics; Drug Therapy, Combination - adverse effects; Female; Fluorenes - adverse effects; Fluorenes - therapeutic use; Gastroenterology; Genetic aspects; Genomes; Genomics; Genotype; Genotype & phenotype; Hemorrhage; Hepacivirus - genetics; Hepatitis; Hepatitis C; Hepatitis C virus; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - virology; Hepatology; Humans; Infection; Infections; Interferon; Japan; Liver; Liver Transplantation; Liver transplants; Living Donors; Male; Medical research; Medicine; Medicine & Public Health; Medicine, Experimental; Middle Aged; Organ transplant recipients; Original Article—Liver; Pancreas; Pleural effusion; Pneumonia; Postoperative Period; Recurrence; Recurrent infection; Relapse; Ribavirin; Sofosbuvir - adverse effects; Sofosbuvir - therapeutic use; Surgical Oncology; Sustained Virologic Response; Transplantation; Transplants & implants; Ulcers; Viral Nonstructural Proteins - genetics
• ISSN: 0944-1174; 1435-5922
• DOI: 10.1007/s00535-017-1310-9

Background The optimal therapy for recurrent hepatitis C virus (HCV) infection after liver transplantation has not yet been established. This study aimed to clarify the efficacy and safety of interferon-free therapy with sofosbuvir and ledipasvir without ribavirin for 12 weeks in Japanese patients with HCV genotype 1b infection after living donor liver transplantation. Methods A cohort study of living donor liver transplant recipients with recurrent HCV genotype 1b infection treated with sofosbuvir (400 mg/day) and ledipasvir (90 mg/day) was performed at six liver transplant centers in Japan. Results Fifty-four patients were treated with sofosbuvir and ledipasvir. Thirty-eight patients (70%) were treatment experienced, including 17 patients who had undergone prior direct-acting-antiviral-based triple therapy. Ten patients had resistance-associated substitutions at L31 or Y93 in the NS5A region of the HCV genome. Fifty-three patients completed the 12-week treatment protocol; treatment was discontinued in one patient who developed pneumonia at 4 weeks and died thereafter. All 53 patients who completed the treatment regimen achieved a sustained virological response 12 weeks after completion of treatment. Treatment was well tolerated in most patients, but seven patients developed serious adverse events, including hemorrhagic duodenal ulcers ( n  = 3), infection ( n  = 2), pleural effusion ( n  = 1), and alveolar hemorrhage ( n  = 1). Conclusions Sofosbuvir and ledipasvir treatment without ribavirin for 12 weeks was highly effective in achieving a sustained virological response in Japanese patients who developed recurrent HCV genotype 1b infection after living donor liver transplantation.