Metabolic Changes in Chronic HCV Patients Receiving DAAS (HCV DAAS)

Metabolic Changes in Chronic Hepatitis C Virus Patients Receiving Direct Acting Antivirals

Observational Study to check metabolic changes between two different hepatitis C antiviral medication groups. This study will evaluate the impact of different treatments on Serum lipid changes, fasting blood glucose and glycated hemoglobin . It will determine if changes are due to different Antiviral regimens or due to different Sustained virological response rates.

Study Overview

• Status: Unknown
• Conditions: Chronic Hepatitis C
• Intervention / Treatment: Drug: sofosbuvir plus daclatasvir; Drug: Sofosbuvir plus Ledipasvir

Detailed Description

The aim of this study is;

• To investigate and compare the changes in the total lipid profile and glycated hemoglobin (HbA1c) for chronic hepatitis C patients after receiving either one of two different direct antiviral regimens: sofosbuvir/daclatasvir and sofosbuvir/ledipasvir (Harvoni).
• To evaluate the impact of treatment response on the serial changes of serum lipid levels and glycated hemoglobin after receiving either of the two different direct antiviral regimens.
• To determine whether the change in the lipid profile and HbA1C is due to different antiviral regimens or due to different SVR rates.

Recruitment will be based on reviewing newly admitted patients and choosing those who are treatment naive and easy to treat according to study inclusion criteria. Thorough check of patient file will be done before starting the study. Eligible patients will sign a consent before starting both the treatment and the study. Patients will be divided into two groups taking treatment for 12 weeks. After treatment, patients will be followed-up for up to 12 weeks.

Patients will be asked to fast for a total of 12 hours. First 8 hours of fasting, a blood sample will be withdrawn for fasting blood sugar and glycated hemoglobin. At 12 hours of fasting, another sample will be withdrawn for lipid profile.

At baseline, patients dermographics (sex, age, weight, height, BMI), full medication history and full medical history will be collected from both patient file and patient consultation. After end of treatment at week 24, weight will be measured and BMI will be also be calculated. Adverse effects reporting:Patients will be asked about any undesirable effects detected throughout the trial which would be reported.

For the whole study period, patients will be subjected to assessment of the following:

• CBC, ALT, AST, total serum bilirubin, and creatinine will be done every 4 weeks (week 0, 4, 8, 12, 16, and 24)
• Complete lipid profile, fasting blood glucose, and HbA1c levels at baseline, during therapy (week 4), and at week 24 after discontinuation of therapy.
• Quantitative PCR for HCV RNA at week 0 and 24.

Results will be collected and tabulated in excel sheet to undergo statistical analysis. Statistical analyses will be done using the SPSS software (Statistical Package for the Social Sciences). Proportions will be compared using Fisher's exact test and means will be compared with Student's t-test or Wilcoxon rank sum test, where appropriate.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Egypt
  • Abbasseya
    • Cairo, Abbasseya, Egypt, 11588
      • Recruiting
      • El demerdash hospital
      • Contact: Nehal Abdel Fattah, pharmB; Phone Number: +201065600196; Email: nehal_gb@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The cases involved in the study will be recruited from El-Demerdash Ain Shams University Hospital in Cairo, Egypt. Patients will be followed up at the "HCV treatment unit Ain Shams University Hospital" for the whole study period.

Description

Inclusion Criteria:

• Male or female patients age 18 to 75 years old. Patients ≥ 65 years old should undergo cardiological assessment prior to therapy by ECG, echocardiography and cardiological consultaion.
• Easy to treat group: treatment naïve patients with serum HCV RNA positivity by PCR.
• Clinically stable condition.
• Platelet count ≥ 150,000/mm³.
• INR ≤ 1.2
• Serum albumin ≥ 3.5 g/dl.
• Total serum bilirubin ≤ 1.2 mg/dl.
• eGFR > 30 ml/min

Exclusion Criteria:

• Pregnancy or inability to use effective contraceptives.
• Inadequately controlled diabetes mellitus (HbA1c > 9%)
• HCV-HIV co infection.
• HBV-HCV co infection.
• Any cause for chronic liver disease other than hepatitis C
• Hyper or hypothyroidism.
• Hepatocellular carcinoma, except 6 months after intervention aiming at cure with no evidence of activity by dynamic imaging (CT or MRI)
• Extra-hepatic malignancy except after two years of disease-free interval.
• Fibrosis: FIB-4 index ≥ 3
• Patients prescribed with lipid-lowering agents (statins).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
sofosbuvir plus daclatasvir; 50 patients receiving 400 mg sofosbuvir plus daclatasvir 60 mg once daily for 12 weeks. Blood samples are taken at baseline (week 0), week 4 (during treatment) and week 24 (post treatment after discontinuation of treatment at sustained virological response). Samples will be evaluated for lipid profiles, fasting blood sugar and glycated hemoglobin.	Drug: sofosbuvir plus daclatasvir; 50 patients in the first group will receive 400 mg sofosbuvir plus daclatasvir 60 mg once daily for 12 weeks.; Other Names: Sovaldi Daklinza
sofosbuvir plus ledipasvir; 50 patients receiving 400 mg sofosbuvir plus ledipasvir 90 mg (Harvoni) once daily for 12 weeks. Blood samples are taken at baseline (week 0), week 4 (during treatment) and week 24 (post treatment after discontinuation of treatment at sustained virological response). Samples will be evaluated for lipid profiles, fasting blood sugar and glycated hemoglobin.	Drug: Sofosbuvir plus Ledipasvir; 50 patients in the second group will receive 400 mg sofosbuvir plus ledipasvir 90 mg (Harvoni) once daily for 12 weeks.; Other Names: Harvoni

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Total Lipid Profile within 6 months	serum cholesterol, High density lipoproteins, Low density lipoproteins, Triglycerides, very low density lipoprotein , all measured in mg/dL after 12 hours of fasting	baseline, week 4 (during treatment), week 24 (after end of treatment)
Change from baseline Glycosylated Hemoglobin within 6 months	average level of blood sugar over the past 2 to 3 months, measured in percentage %	baseline, week 4 (during treatment), week 24 (after end of treatment)
Change from baseline Fasting Blood Glucose within 6 months	measured as mg/DL after 8 hours of fasting	baseline, week 4 (during treatment), week 24 (after end of treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Response	Sustained Virological Response at week 12 after end of treatment ( SVR 12)	12 WEEKS after end of therapy

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Nehal Abdel Fattah, PharmB, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C; Hepatitis, Chronic; Hepatitis C, Chronic; Anti-Infective Agents; Antiviral Agents; Sofosbuvir; Ledipasvir
• Other Study ID Numbers: 164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No