the Pulmonary Safety of Antihepatitis C Treatment

• Conditions: Hepatitis C
• Interventions: Drug: sofosbuvir \daclatsvir

• Registration Number: NCT04122066
• Lead Sponsor: Assiut University

Brief Summary

pulmonary side effects of the new regimen of antihepatitis C

Detailed Description

Hepatitis C is a liver disease caused by the hepatitis C virus.The hepatitis C virus is a blood borne virus The most common modes of infection are through exposure to small quantities of blood, through injection drug use, unsafe injection practices, unsafe health care, and the transfusion of unscreened blood and blood products.

An estimated 71 million people have chronic hepatitis C infection. A significant number of those who are chronically infected will develop cirrhosis and or liver cancer. the treatment of hepatitis C virus (HCV) infection has been difficult, particularly in patients with HCV genotype 1. Reasons for the difficulty include the inherent toxicity and limited efficacy of interferon-based therapy, which has been the cornerstone of anti-HCV efforts during the past 2 decades.

Newly available direct-acting antiviral agents (DAAs) have the potential to dramatically improve HCV eradication rates. Despite these new drugs has been characterized by a very low adverse events rate in the published clinical trials Few data are available on pulmonary adverse events based real life studies

Study Timeline

• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-10
• Status Verified: 2019-11
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-30
• Study Start: 2020-06
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. HCV RNA positivity .

Exclusion Criteria

• Child C cirrhosis.
• Clinically manifest liver decompensation :ascites ,encephalopathy, wasting, hepatorenal syndrome.
• Serum albumin less than 2.8 g/dl,total serum bilirubin more than 3 mg/dl ,INR1.7 or more .
• absolute neutrophil counts < 1500\mm3 and\or platelet less than 50,000/mm3.
• HCC except 6 months after concluding intervention aiming at cure with no evidence of activity by dynamic CT or MRI.
• Extrahepatic malignancy except after two years of disease\disease free interval
• In lymphomas and chronic lymphatic leukemia can be initiated immediately after remission based on the treating oncologist's report
• Pregnancy or inability to use effective contraception
• Inadequately controlled diabetes mellitus (HbA1c>9%)
• sever renal impairment in which creatinine clearance < 30 ml\min
• chronic lung diseases .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
respiratory symptoms reported in studied patients	sofosbuvir \daclatsvir	If Sofosbuvir\\Daclatasvir regimen has respiratory side effects or not and the factors increase incidence of respiratory complications

Primary Outcome Measures

Name	Time	Method
the pulmonary side effect of the new anti HCV medication in our population.	3 months	find out the pulmonary side effects of the new anti hepatitis C treatment (sovosbuvir based regimen )

Secondary Outcome Measures

Name	Time	Method
the factors that increase the incidence of pulmonary complications	3 months	Identification the factors that increase the incidence of pulmonary complications with the new anti HCV medications