Reduced duration of eight versus twelve weeks of Sofosbuvir-daclatasvir in treatment naive non-cirrhotic patients with chronic hepatitis C virus infection: An open-label, randomized pilot trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Proportion of participants who achieved the sustained virological response after the completion of 8 weeks or 12 weeks of sofosbuvir/daclatasvir treatment
Study Overview
Brief Summary
Background: HCV is a hepatotropic virus and all those with HCV viremia need treatment. In absence of cirrhosis, HCV is treated with pan-genotypic drug, sofosbuvir/daclatasvir, for 12 weeks and the treatment is successful if HCV RNA is remained undetectable at 12 weeks (SVR12) after stopping the drugs. Recent data and our own experience have shown that the treatment duration can be reduced from 12 to 8 weeks for without compromising the response. Large, good quality data are required on effectiveness of 8 weeks of sofosbuvir/daclatasvir combination.
Research question: Can anti-HCV treatment duration be reduced from 12 weeks to 8 weeks without compromising the virological response?
Primary objective: Compare the sustained virological response (SVR12) in non-cirrhotic HCV infected patients treated with 8 weeks versus 12 weeks of sofosbuvir/daclatasvir combination
Methodology: This open label, randomized pilot study will include 180 treatments naïve, viraemic, non-cirrhotic HCV patients. Participants will be randomized to receive either 8- or 12-week treatment followed by HCV RNA testing at 12 weeks after treatment completion for SVR12 to define treatment success or failure. A blood specimen will also be collected at baseline (for HCV genotype determination), at 4 weeks of treatment (for early virological response).
Proposed outcome: The study will provide data on efficacy of 8 weeks of treatment as compared to standard of care (12 weeks) in non-cirrhotic patients with active HCV infection.
Future plan: If the results of our study will support, we will plan a double-blind, multicentric, RCT to provide a reliable evidence and reach the final conclusion.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age 18 years or more
- •HCV mono-infection
- •Detectable HCV RNA (more than 10,000 IU/mL)
- •No evidence of cirrhosis based upon a combination of history, examination, ultrasound, Transient elastography, APRI, FIB-4, Upper GI endoscopy.
Exclusion Criteria
- •Presence of cirrhosis
- •HBsAg or HIV coinfection
- •Estimated GFR below 30 ml/ minute
- •Prior exposure to oral anti-HCV drugs, i.e, DAAs
- •Hepatocellular carcinoma or any other malignancy
- •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.
Outcomes
Primary Outcomes
Proportion of participants who achieved the sustained virological response after the completion of 8 weeks or 12 weeks of sofosbuvir/daclatasvir treatment
Time Frame: Proportion of participants who achieved the sustained virological response after the completion of 8 weeks or 12 weeks of sofosbuvir/daclatasvir treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Amit Goel
SGPGIMS lucknow