Health Condition 1: K732- Chronic active hepatitis, not elsewhere classified
Conditions
Interventions
Intervention1: Sofosbuvir plus Daclatasvir: Sofosbuvir 400 mg once daily along with Daclatasvir 60 mg once daily for 8 weeks
Control Intervention1: Sofosbuvir plus Daclatasvir: Sofosbuvir 400 mg once
Sponsors
Sanjay Gandhi Postgraduate Institute of Medical Sciences Uttar Pradesh India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 years or more 2. HCV mono-infection 3. Detectable HCV RNA (more than 10,000 IU/mL) 4. No evidence of cirrhosis based upon a combination of history, examination, ultrasound, Transient elastography, APRI, FIB-4, Upper GI endoscopy
Exclusion criteria
Exclusion criteria: 1. Presence of cirrhosis 2. HBsAg or HIV coinfection 3. Estimated GFR below 30 ml/ minute 4. Prior exposure to oral anti-HCV drugs, i.e, DAAs 5. Hepatocellular carcinoma or any other malignancy 6. High-risk population such as people living with HIV, people on maintenance hemodialysis, thalassaemic or haemophiliacs, people who inject drugs, men have sex with men, high risk sexual behaviour
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants who achieved the sustained virological response after the completion of 8 weeks or 12 weeks of sofosbuvir/daclatasvir treatmentTimepoint: Proportion of participants who achieved the sustained virological response after the completion of 8 weeks or 12 weeks of sofosbuvir/daclatasvir treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: Not applicable | — |
Countries
India
Contacts
Public ContactDr Amit Goel
SGPGIMS lucknow
Outcome results
None listed