Hepatitis C Virus Infection in Patients With Hemoglobinopathies
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|ClinicalTrials.gov Identifier: NCT03149289|
Recruitment Status : Completed
First Posted : May 11, 2017
Last Update Posted : May 11, 2017
|Condition or disease||Intervention/treatment|
|Hepatitis C, Chronic Hemoglobinopathies||Drug: Antiviral drugs|
Many patients with hemoglobinopathies have been infected with hepatitis C virus (HCV) through blood transfusion, mostly before screening of blood donors was introduced in 1992. The reported prevalence of anti-HCV-positive thalassemia patients varies between 4.4% in Turkey and 85.4% in Italy. HCV infection is associated with decompensated cirrhosis, hepatocellular carcinoma and other liver complications, especially if left untreated. Prevalence of cirrhosis in thalassemia patients up to 32% have been reported.
Thalassemia patients with cirrhosis have an increased risk of death. Progression of liver fibrosis is strongly related to the presence of chronic HCV infection and extent of iron overload. Thalassemia patients with elevated serum aminotransferase levels for >6 months should be tested for HCV infection and, in the event of HCV infection, HCV genotyping is recommended in order to plan antiviral therapy and the likelihood of response. Noninvasive transient elastography (FibroScan®) can be used to determine the presence of fibrosis in thalassemia patients with HCV infection.
Effective chelation therapy and treatment of HCV infection are needed in order to prevent liver complications and decrease morbidity and mortality. For many years, pegylated interferon (peg-IFN) plus ribavirin was the standard of care for the treatment of chronic HCV infection and decompensated cirrhosis. Studies of peg-IFN plus ribavirin have demonstrated sustained virological response (SVR) rates of 25−64% in patients with thalassemia and HCV infection. However, peg-IFN and ribavirin are both associated with anemia. Ribavirin-associated hemolysis leads to an increased requirement for blood transfusions, which in turn can lead to worsening of iron overload. Therefore, European Association for the Study of the Liver (EASL) 2015 guidelines recommend interferon-free regimens for the treatment of HCV infection in patients with hemoglobinopathies. The aim of this study was to evaluate the safety and efficacy of DAA standard regimens in patients with hemoglobinopathies and chronic HCV liver disease treated in Italy.
Antiviral treatments were administered according to Italian Medicines Agency (AIFA) guidelines.
|Study Type :||Observational|
|Actual Enrollment :||168 participants|
|Official Title:||Treatment of Hepatitis C Virus Infection With Direct-acting Antiviral Drugs in Patients With Hemoglobinopathies|
|Study Start Date :||March 1, 2015|
|Actual Primary Completion Date :||March 1, 2016|
|Actual Study Completion Date :||February 1, 2017|
HCV RNA positive
hemoglobinopathies with hepatites C treated with antiviral drugs
Drug: Antiviral drugs
sofosbuvir, ribavirin, daclatasvir, ledipasvir, simeprevir, paritaprevir, dasabuvir, ombitasvir
Other Name: Direct-acting antiviral drugs'
- Change in the number of participants with undetectable serum HCV RNA is being assessed at the end of treatment [ Time Frame: baseline and 12 weeks ]The quantification of hepatitis virus particles in serum is assessed and expressed in IU/mL (IU, international units ) through quantitation of virus ribonucleic acid by real time polymerase chain reaction (PCR).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149289
|Study Director:||Vito Di Marco, MD||University of Palermo, Palermo, Italy|