Glecaprevir + Pibrentasvir: Efficacious, Safe for HCV After Liver Transplantation

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

1. 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
2. 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.
3. 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.
4. 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.
5. 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.