Aims of the work

[1] To assess the pattern of response in chronic HCV infected patients treated with non-interferon antiviral therapy.

[2] To study the predictors of non-response to interferon free antiviral therapy in the non-responder and relapsed groups.

                               Patients and Methods

Patients:

          Prospective study will be conducted on the patients attending our Tropical Medicine and Gastroenterology outpatient clinic of Sohag University Hospital. Two hundred  HCV patients will be recruited in the study and will be advised to receive anti HCV treatment in a specialized center.

          Before starting treatment, patients will be categorized into:

  • Chronic HCV infected patients with non-cirrhotic liver.
  • Chronic HCV infected patients with liver cirrhosis (compensated or decompensated).

          The cirrhotic patients will be classified according to Child-Pugh score (only A and B classes will be included).

          After completing the course of treatment, all patients will be followed up for 6 months and then categorized into:

  • Sustained virological responders.
  • Non Sustained virological responders.

Inclusion Criteria:                                                                                                          

            Patients infected with  chronic HCV and prepared for receiving interferon free antiviral therapy.

 Exclusion Criteria:                                                                                                        

             Chronic HCV infected patients with the following co-morbidities or complications will be excluded from the study.

-Patients with chronic renal failure.

-patients with HCV and HBV co infection.

-patients previously received a liver transplant.

Methods:

           All participants will give a written consent before participating in the study which will be approved by the Faculty Ethical Committee.

          Complete medical history and clinical examination will be performed to all patients.

          The following drug regimens will be given to the patients according to the National Program of treatment of chronic HCV in Egypt:

  • Non cirrhotic patients will receive sofosbuvir 400 mg plus daclatasvir 60 mg for 12 weeks.
  • The cirrhotic patients will receive sofosbuvir 400 mg plus daclatasvir 60 mg plus ribavirin 400 mg for 12 weeks.
  • The cirrhotic patients with anemia will receive sofosbuvir 400 mg plus daclatasvir 60 mg for 24 weeks.

           Pretreatment abdominal ultrasonography, fibroscan, alpha fetoprotein (AFP), and random blood sugar will be performed to all patients.

           Pretreatment Glycated hemoglobin (HbA1C) will be performed to diabetic patients.

           Body mass index (BMI) will be measured for all patients.

           Hepatitis C virus RNA polymerase chain reaction (PCR)  will be assayed using the Roche COBAS AmpliPrep/COBAS TaqMan HCV Test. This test will be performed pretreatment, at the end of the treatment, post treatment week 12, and post treatment week 24.

           Liver function tests and complete blood picture (CBC) will be performed pretreatment, treatment week 4, 8, 12.

         Serum sample will be taken pretreatment and frozen at -80Co, to measure C-X-C motif chemokine-10 (CXCL-10) using IP-10 Quantikine
ELISA test.

Statistical analysis:

         

          We will compare  between the pattern of response to non-interferon antiviral therapy in HCV infected patients included in the study. We will compare between the sustained virologic responders and non sustained virologic responders regarding the level of C-X-C motif chemokine-10 (CXCL-10), liver function tests, CBC, BMI, AFP, and random blood sugar. Both univariate and multivariate logistic regression analysis will be performed. P value <0.5 will be considered statistically significant.