Grazoprevir/Elbasvir for Genotype 1b Chronic Hepatitis C After Liver or Kidney Transplantation
Grazoprevir/Elbasvir for Genotype 1b Chronic Hepatitis C After Liver or Kidney Transplantation
Grazoprevir/elbasvir combination therapy is highly effective in the treatment of genotype 1b
 chronic hepatitis C, and the drug-drug interaction with central immunosuppressant, such as
 tacrolimus, should be manageable. The aim of this study is to assess the efficacy and
 tolerability of grazoprevir/elbasvir combination therapy in treating genotype 1b chronic
 hepatitis C after liver or kidney transplantation.
Grazoprevir/elbasvir combination therapy (grazoprevir 100 mg/ elbasvir 50 mg, Zepatier®, MSD)
 has been recommended as the 1st-line treatment for genotype 1b chronic hepatitis C by the
 updated international guidelines, and the rates of sustained virologic response (SVR) can be
 higher than 95% in either treatment-naïve or peginterferon-experienced patients with genotype
 1b chronic hepatitis C. Moreover, even among patients with liver cirrhosis, the efficacy of
 grazoprevir/elbasvir combination therapy remains very high. In addition, drug-related adverse
 effects (AEs) were quite low in previous studies, and less than 1% of cirrhotic patients
 discontinued this therapy during treatment period (4). Grazoprevir/elbasvir combination
 therapy is an effective and safe treatment for chronic hepatitis C.

 Chronic hepatitis C is one of the most common indications for liver transplantation. Patients
 underwent liver or kidney transplantation always suffer from recurrent chronic hepatitis C.
 Recurrent chronic hepatitis C can result in liver cirrhosis, liver decompensation, and death.
 Chronic hepatitis C is also associated with a higher incidence of chronic rejection, graft
 failure and mortality after kidney transplantation. Treating hepatitis C virus (HCV)
 infection after liver or kidney transplantation was a big challenge before the development of
 new direct-acting antiviral (DAA). Not only a low SVR rate but also a high rate of severe
 adverse effects results in the hesitation of peginterferon-ribavirin combination therapy.
 Although some new DAAs can be used in organ transplantation, the cost remains quite high.
 More new DAA choices for patients underwent organ transplantation are needed.

 The clinical data of grazoprevir/elbasvir combination therapy on the treatment for patients
 with chronic hepatitis C after liver or kidney transplantation remain lacking. With high
 virologic response rates and low adverse effects in the management for chronic hepatitis C,
 grazoprevir/elbasvir combination therapy could be a good option for patients underwent liver
 or kidney transplantation. No drug-drug interaction (DDI) was noted between
 grazoprevir/elbasvir combination therapy and steroid, and the DDI with the most commonly-used
 immunosuppressant, tacrolimus, was also not significant, The drug levels of
 immunosuppressants can be carefully monitored and adjusted during treatment period. The aim
 of this study is to assess the efficacy and tolerability of grazoprevir/elbasvir combination
 therapy in treating genotype 1b chronic hepatitis C after liver or kidney transplantation.
Inclusion Criteria:

 1. At least 20 years of age

 2. Chronically infected with genotypes 1b HCV

 3. Underwent liver and/ or kidney transplantation

 4. Without clinical or pathologic evidence of moderate or severe rejection

 Exclusion Criteria:

 1. HCV genotype other than 1b

 2. Liver decompensation (Child-Pugh score > 6)

 3. Co-infected with human immunodeficiency virus: Positive HIV1/2 or hepatitis B virus :
 Positive HBsAg and detected HBV DNA

 4. Prior exposure to an NS5A inhibitor

 5. Any active malignancies

 6. Hemoglobin level less than 10 g/dl

 7. Platelet level of 75,000/mm3 or less

 8. Alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase level 10
 times or more the upper limit of normal

 9. Total bilirubin level greater than 3 times or more the upper limit of normal

 10. Albumin less than 3 g/dL

 11. Using medication that is not considered safe to co-administer with , such as
 cyclosporine

 12. Pregnant or breast-feeding women

 13. Known allergy to grazoprevir or elbasvir

 (Unregistered liver or kidney transplant in other countries is illegal in Taiwan)