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IRCT20170213032547N1 IRCT 2018-06-25 Kerman University of Medical Sciences Hepatitis C Treatment in a Community-based Setting Effectiveness of Sofosbuvir/Daclatasvir for Treatment of People Who Inject Drug with HCV Infection in a Community-based Setting 2018-06-10 anticipated 110 Complete https://irct.ir/trial/31356 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 3 Hepatitis C. Treatment with daily single-dose of Daclasfovir Shari® (400 mg Sofosbuvir/60 mg Daclatasvir) made in Shari/Bakhtar Bioshimi Co (BBpharmaco) for 12 weeks.. Yes - There is a plan to make this available What will be shared: All available deidentified individual participant data will be shared. When: After publication of study. To whom: Researchers in the field. Conditions: No additional publication can be conducted based on the shared data. Where to obtain: Corresponding author of publication. How to obtain: A written request through email. Comments:
public Dr. Armita Shahesmaeili
HIV Hub, Kerman University of Medical Sciences, Haft Bagh Alavi Road, Kerman
Kerman Iran (Islamic Republic of) 76169-13555 +98 34 3211 3012 armita.shahesmaeili@gmail.com Kerman University of Medical Sciences scientific Dr. Ali Mirzazadeh
550 16th. Street San Francisco CA
San Francisco United States of America 94158 +1 415-476-5821 Ali.Mirzazadeh@ucsf.edu University of California, San Francisco Iran (Islamic Republic of) Being male or female (including transgender) Being 18 years or older at the time of baseline interview Self-reported drug injection with verification for non-medical purposes in the past twelve months Having chronic infection of HCV as confirmed by HCV-RNA Having lived for at least six months in Kerman and have no plan to move out for another three months Having written informed consent to participate in the study Understanding the Farsi language 18 years 80 years Both Cirrhosis HBV/HCV Coinfection Pregnant woman TB/HCV Coinfection eGFR<30 mL/min or chronic renal failure Drug-drug interactions B18.2 Chronic viral hepatitis C Treatment - Drugs Treatment with daily single-dose of Daclasfovir Shari® (400 mg Sofosbuvir/60 mg Daclatasvir) made in Shari/Bakhtar Bioshimi Co (BBpharmaco) for 12 weeks. Sustained Virologic Response. Timepoint: 12 weeks after termination of treatment. Method of measurement: HCV RNA using sensitive RT-PCR. Treatment uptake. Timepoint: At the study entry. Method of measurement: Acceptance to be treated. Treatment Adherence. Timepoint: 12 weeks of treatment. Method of measurement: Pill count. National Institute for Medical Research Development Kerman University of Medical Sciences National Institute for Medical Research Development Approved 2018-04-16 Ethics committee of Kerman University of Medical Sciences Ibn sina St., Jahad Boulevard, Somayeh Cross road. Kerman Kerman Iran (Islamic Republic of)