Hepatitis C
Conditions
Keywords
Hepatitis C, sofosbuvir, daclatasvir
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart
Exclusion criteria
* Heart rate \< 50/min, * Taking amiodarone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The sustained viral response rate | 12 weeks after end of treatment | Qualitative hepatitis C virus RNA polymerase chain reaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse drug events | weeks 2, 4, 8, 12 and 24 | Questionnaire |
Countries
Iran
Outcome results
None listed