The fixed-dose combination of sofosbuvir and daclatasvir in a single pill is being used for the treatment of hepatitis C in Iran. In this study the efficacy of this combination is evaluated in 1000 patient with hepatitis C.
All cases of hepatitis C whether cirrhotic, post organ transplant, co-infected with HIV or hepatitis B, active drug abuse, on immune suppression and from all genotypes will be included. Patients will be treated by a single daily dose of a fixed-dose combination pill of 400mg sofosbuvir and 60 mg daclatasvir for 12 weeks. If a patient is cirrhotic, defined by liver stiffness \> 12 kilopascal, either weight based ribavirin will be added or the treatment duration will be prolonged to 24 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,448
A fixed dose combination pill containing 400mg sofosbuvir and 60 mg daclatasvir given daily for 12 weeks. If a patient is cirrhotic, treatment duration would be 24 weeks.
Shariati Hospital
Tehran, Iran
The sustained viral response rate
Qualitative hepatitis C virus RNA polymerase chain reaction
Time frame: 12 weeks after end of treatment
Adverse drug events
Questionnaire
Time frame: weeks 2, 4, 8, 12 and 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.