Clinical trial NCT04211844: Metabolic Changes in Chronic HCV Patients Receiving DAAS
Official title: Metabolic Changes in Chronic Hepatitis C Virus Patients Receiving Direct Acting Antivirals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis C
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 First 8 hours of fasting, a blood sample will be withdrawn for fasting blood sugar and glycated hemoglobin.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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline Total Lipid Profile within 6 months
timeFrame: baseline, week 4 (during treatment), week 24 (after end of treatment)
measure: Change from baseline Glycosylated Hemoglobin within 6 months
timeFrame: baseline, week 4 (during treatment), week 24 (after end of treatment)
measure: Change from baseline Fasting Blood Glucose within 6 months
timeFrame: baseline, week 4 (during treatment), week 24 (after end of treatment)
Secondary outcomes:
measure: Treatment Response
timeFrame: 12 WEEKS after end of therapy
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: El Demerdash Hospital
state: Abbasseya
Study officials:
affiliation: Ain Shams University
name: Nehal Abdel Fattah, PharmB
role: PRINCIPAL_INVESTIGATOR
References: