Antiviral Drug Clinical Trial
Official title:
Effect of Direct AntiViral Drugs of Chronic HCV on eGFR in Assuit Universiry Hospital
1. evaluation of glomerular filtration rate(eGFR)changes during HCV treatment with direct
antiviral drugs according to 2018 guideline.
2. TO estimate the frequency of renal impairment by direct antiviral drugs By detection of
any changes in e GFR.
3. Assessment The Renal safety during HCV treatment with direct antiviral drugs according
to 2018 guideline.
4. To clarify the importance of laboratory and other modalities in detection and estimation
of frequency of renal impairment by direct antiviral drugs according to 2018 guideline.
Hepatitis C virus (HCV) has an estimated global prevalence of 2%-3% with 130-170 million
people infected with HCV.(1) HCVcauses chronic inflammation of the liver leading to chronic
hepatitis, which can advance to liver cirrhosis and hepatocellular carcinoma and significant
extrahepatic complications.(2) Additionally, HCV has been shown to have a significant
negative effect on apatient's overall quality of life, including decreased work hours and
productivity and increased healthcare costs.(3) Cirrhosis and hepatocellular carcinoma
related to HCV infection represent the most common indications for liver transplantation duo
to poor treatment options.(4) Until recently, interferon-based treatments were thebackbone of
HCV treatment options.(5) Unfortunately,therapy was only modestly effective and
associatedwith significant side effects.(6) Therefore, research has focused on HCV
eradication using oral antiviral therapy.
Recent clinical studies have demonstrated efficacy using the nucleotide analogue inhibitor
sofosbuvir(Sovaldi; Gilead Sciences, Inc., Foster City, CA) as the backbone in treatment of
non transplant and post transplant recurrent HCV.(7) Both the ION-1 and ION-2 trials
demonstrated nearly 99% efficacy in the treatment ofnontransplant, noncirrhotic HCV
patientsusing sofosbuvir in a fixed-dose combination with theNS5A inhibitor ledipasvir
(Harvoni, Gilead Sciences,Inc.), both with and without ribavirin.(8,9) The side effect
profile of ledipasvir/sofosbuvir (LDV/SOF) hasbeen relatively mild and the drug has been well
tolerated in trials, especially compared with previous interferon-based regimens.
The ION trials report that LDV/SOF therapy was primarily complicated by headaches or fatigue
inapproximately 10% of patients. Less frequently, patients experienced rashes, nausea,
diarrhea, and insomnia.Serious side effects, such as nephrotoxicity, were not demonstrated by
the ION-1 and ION-2 trials; however, these trials were conducted in a controlled clinical
setting with rigorous exclusion criteria. Such trials are not always entirely reflective of
the general patient population. Early data suggest possible risk of renal impairment during
treatment with the use of direct antiviral drugs(10) this study is about renal safety and
changes in eGFR in patients with chronic HCV undergoing direct acting antiviral therapy
according to 2018 guideline.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT04942886 -
Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation
|
N/A |