Chronic Hepatitis C Clinical Trial
Official title:
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.
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sample will be withdrawn for fasting blood sugar and glycated hemoglobin.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fasting, another sample will be withdrawn for lipid profile.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.
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