Study shows the safety and efficacy of treatment with sofosbuvir and velpatasvir in adults with recurrent chronic genotypes 1-4 HCV infection after liver transplant.
Patients with hepatitis C virus (HCV) infection who receive a liver transplant typically experience disease recurrence that can damage the transplanted liver. In a new study, researchers evaluated the safety and efficacy of treatment with sofosbuvir and velpatasvir (SOF/VEL) in adults with recurrent chronic genotype 1-4 HCV infection after liver transplant.
SOF/VEL is a combination therapy approved for patients with chronic HCV. To determine whether the treatment effectively cured HCV after liver transplantation, patients were treated with SOF/VEL 400/100 mg daily and evaluated for sustained virologic response rates 12 weeks after treatment (SVR12).
For the study, a total of 79 patients with genotype 1-4 HCV infection were enrolled and treated. Eighty-one percent of patients were men, 82% were white, 18% had compensated cirrhosis, and 59% were treatment experienced, according to the study.
The researchers found that treatment with SOF/VEL produced high SVR12 and demonstrated no clinically relevant drug interactions with immunosuppressants. Commonly used immunosuppressants included tacromilus (71%), mycophenolic acid (24%), and cyclosporine (14%), and azathioprine (11%). Ninety-six percent of patients were cured of HCV infection following 3 months of treatment with SOF/VEL.
By genotype, SVR12 rates were 95% for genotype 1, 100% for genotype 2, 97% for genotype 3, and 100% for genotype 4.
Of the patients treated, 2 experienced virologic relapse: 1 with genotype 1a infection was non-cirrhotic and treatment naïve and 1 with genotype 3 infection was non-cirrhotic and treatment experienced. One patient discontinued treatment with SOF/VEL due to hyperglycemia, but no serious or severe adverse events were found to be related to treatment. Additionally, no liver transplant rejection episodes or deaths occurred during the study period.
Overall, treatment with SOF/VEL for 12 weeks was found to be highly effective and well tolerated in transplant recipients with HCV infection with and without cirrhosis. Patients experiencing recurring HCV infection following a liver transplant can benefit from the combination treatment without any drug interactions with immunosuppressive therapy, according to the study authors.
Agarwal K, Castells L, Müllhaupt B, et al. Sofosbuvir/velpatasvir for 12 weeks in genotype 1-4 HCV-infected liver transplant recipients. Journal of Hepatology. 2018. Doi: https://doi.org/10.1016/j.jhep.2018.05.039