An 8- or 12-week regimen of glecaprevir and pibrentasvir is efficacious and safe in patients with hepatitis C virus (HCV) infection after liver transplantation, according to a study published in the Journal of Gastroenterology.1
Liver cirrhosis and hepatocellular carcinoma caused by HCV infection are leading indications for liver transplantation,2 and interferon-free therapy for recurrent HCV after liver transplantation has been shown to be highly efficacious and safe.3,4 While the efficacy and safety of a 12-week regimen with once-daily glecapravir and pibrentasvir in patients with HCV genotypes 1 through 6 after liver transplantation have been reported,5 several questions remain with regard to efficacy of an 8-week regimen, efficacy in patients with prior failure of therapy with a direct-acting antiviral (DAA) medication, and efficacy and safety in patients with severe renal impairment or cirrhosis and/or jaundice.
Therefore, researchers in Japan evaluated the efficacy and safety of an 8- and 12-week regimen of glecaprevir and pibrentasvir in 25 patients with recurrent HCV infection after liver transplantation.1 They found that all 24 patients who completed the study achieved a sustained virologic response 12 weeks after completion of treatment. Sustained virologic response rates at 12 weeks in patients with HCV genotype 1 and 2 were 100% (21 of 21 patients) and 75% (3 of 4 patients), respectively. In addition, all patients with prior DAA therapy failure, jaundice, and liver cirrhosis achieved sustained virologic response at 12 weeks, as well as 88% of patients with severe renal impairment. Adverse events occurred in 24% of patients, including serious adverse events in 2 patients (8%). Treatment-related adverse events included nausea, pruritus, and mild renal dysfunction.
“In conclusion, 8- or 12-week regimens of glecaprevir and pibrentasvir are effective and safe in patients with recurrent HCV infection after liver transplantation, even in difficult-to-treat populations including patients with severe renal impairment, with prior DAA experience, with liver cirrhosis, or with jaundice after liver transplantation” stated the study authors.1
References
- Ueda Y, Kobayashi T, Ikegami T, et al. Efficacy and safety of glecaprevir and pibrentasvir treatment for 8 or 12 weeks in patients with recurrent hepatitis C after liver transplantation: a Japanese multicenter experience [published online February 26, 2019]. J Gastroenterol. doi:10.1007/s00535-019-01561-1
- Umeshita K, Inomata Y, Furukawa H, et al. Liver transplantation in Japan: registry by the Japanese Liver Transplantation Society. Hepatol Res. 2016;46:1171-1186.
- American Association for the Study of Liver Diseases/Infectious Diseases Society of America. HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. Patients Who Develop Recurrent HCV Infection Post Liver Transplantation. September 21, 2017. Accessed April 24, 2019.
- Belli LS, Duvoux C, Berenguer M, et al. ELITA consensus statements on the use of DAAs in liver transplant candidates and recipients. J Hepatol. 2017;67:585-602.
- Reau N, Kwo PY, Rhee S, et al. Glecaprevir/pibrentasvir treatment in liver or kidney transplant patients with hepatitis c virus infection. Hepatology. 2018;68:1298-1307.