Impact of Metabolic Changes and Vitamin D Status on Virological Response in Patients With HCV Infection Treated by DAAs

Impact of Metabolic Changes and Vitamin D Status on Virological Response in Patients With Hepatitis C Viral Infection Treated by Direct Acting Antiviral Drugs

1. Study Changes in lipid profile and the impact of Insulin resistance on virological response in patients with Hepatitis C viral infection treated by Direct Acting Antiviral agents
2. The assessment of serum vitamin D levels in HCV infected patients and predictive value of pre-treatment serum vitamin D level for achieving sustained virological response at 12 weeks post-treatment

Study Overview

• Status: Unknown
• Conditions: HCV

Detailed Description

Patients and methods:

This cross-sectional study will include 100patients of chronic HCV infection who attend El Raghy Assiut university Hospital, either inpatients or outpatients. Chronic HCV infection will be diagnosed based on detectable HCV RNA with anti-HCV Ab in patient with clinical and/or ultrasonographic criteria of chronic liver disease.

Patients will receive treatment to HCV by DAAs and follow up for 12 weeks to confirm sustained virological response

Method:

Patients presenting in this study will be subjected to the following:

1. Full history and clinical evaluation.
2. Body weight (kg) and height (m).
3. BMI will calculate as weight divided by squared height (kg/m2).
4. Waist circumference will measured at a level midway between the lowest rib and the iliac crest, and the hip circumference at the level of the great trochanters, with the legs close together.
5. Blood pressure (mmHg) was measured twice in the upper arm after a 10-min period of rest and taken an average.

Laboratory investigations will include:

• Complete blood count (CBC)
• Liver function test
• HCV Ab and HCV RNA by PCR
• HBs Ag
• Alpha fetoprotein
• Lipid profile
• Serum urea and creatinine
• Fasting blood sugar (FBG)and Serum fasting insulin level
• Insulin resistance determined via Homeostasis Model Assessment (HOMA-IR) IR = fasting insulin (µu/ml) × fasting glucose (mmol/L) ----------------------------------------------------------------- 22.5 An index value of ˃ 2. 5 was defined as IR (Huang et al., 2011)
• Vitamin D level:

Vitamin D deficiency wasdefined as a 25 (OH)-vitamin D serum level < 20 ng/mL, vitaminD insufficiency as 25 (OH)-vitamin D levels of 20 - 29.9ng/mL, and normal vitamin D levels ≥ 30 ng/mL (Holick MF et al.,2011)

• Abdominal Ultrasound
• Electrocardiogram (ECG)

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

Contacts and Locations

• Study Contact: Name: Mohamed H Abdelgawad, specialist; Phone Number: 01008778754; Email: d_m_h_80@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1. Full history and clinical evaluation.
2. Body weight and height
3. BMI will calculate as weight divided by squared height (kg/m2)
4. Waist circumference
5. Blood pressure (mmHg)

Laboratory investigations will include:

• Complete blood count (CBC)
• Liver function test
• HCV Ab and HCV RNA by PCR
• HBs Ag
• Alpha fetoprotein
• Lipid profile
• Serum urea and creatinine
• Fasting blood sugar and Serum fasting insulin level
• Insulin resistance determined via Homeostasis Model Assessment (HOMA-IR) IR = fasting insulin (µu/ml) × fasting glucose (mmol/L)

22.5 An index value of ˃ 2. 5 was defined as IR (Huang et al., 2011)

• Vitamin D level:
• Abdominal Ultrasound
• Electrocardiogram

Description

Inclusion Criteria:

• Chronic HCV will receive DAAs for treatment

Exclusion Criteria:

1. Decompensated liver cirrhosis, hepatocellular carcinoma, history of liver transplant
2. Co-existing liver disease (hepatitis B virus, autoimmune hepatitis, human immunodeficiency virus)
3. Extra-hepatic malignancy except after two years of disease free interval.
4. Patients with diabetes mellitus.
5. Patients with Chronic kidney disease.
6. Pregnancy or in ability to use effective contraception.
7. Patients with history of using lipid lowering therapy
8. relapser or failure of previous HCV treatment

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Vit D deficiency; Chronic HCV patients with vitamin D deficiency Sustained virological response after treatment
Normal Vit D; Chronic HCV patients with normal vitamin D level Sustained virological response after treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SVR12	sustained virological response 12 week after treatment	12 week after treatment

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Chair: Laila Abd Elbaky, profesor, Assiut University

Publications and helpful links

General Publications

• Janovy J Jr. Problems in the comparative physiology of some trypanosomatid flagellates. Acta Trop. 1977 Jun;34(2):177-84.
• Selhub J, Rosenberg IH. Demonstration of high-affinity folate binding activity associated with the brush border membranes of rat kidney. Proc Natl Acad Sci U S A. 1978 Jul;75(7):3090-3. doi: 10.1073/pnas.75.7.3090.
• Ramachandran N, Colman RF. Evidence for a critical glutamyl and an aspartyl residue in the function of pig heart diphosphopyridine nucleotide dependent isocitrate dehydrogenase. Biochemistry. 1977 Apr 19;16(8):1564-73. doi: 10.1021/bi00627a006.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 3, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: IR,VitD in HCV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No