Health Condition 1: K738- Other chronic hepatitis, not elsewhere classified
Conditions
Interventions
Intervention1: Sof-Vel eight weeks: Sofosbuvir plus velpatasvir combination for a duration of eight weeks
Control Intervention1: Sof-Vel twelve weeks: Sofosbuvir plus velpatasvir combination for a dur
Sponsors
Department of Health Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >18 years 2. HCV mono-infection or HCV-HIV coinfection 3. Detectable HCV RNA ( >10,000 IU/mL) in serum 4. Chronic HCV infection 5. 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. HCV-HBsAg coinfection 3. Prior exposure to oral anti-HCV drugs, i.e, DAAs 4. Hepatocellular carcinoma or any other malignancy 5. Portal vein thrombosis 6. High-risk population such as people on maintenance hemodialysis, talassaemic 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 have achieved SVR12, i.e, sustained virological response at week 12 after stopping the sofosbuvir/velpatasvirTimepoint: Proportion of participants who have achieved SVR12, i.e, sustained virological response at week 12 after stopping the sofosbuvir/velpatasvir | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of participants who have completed their planned anti-HCV treatmentTimepoint: Eight (intervention arm) or twelve weeks (standrad arm) after start of anti-HCV drugs | — |
Countries
India
Contacts
Public ContactAmit Goel
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGI)
Outcome results
None listed