Table of Contents
- Trial overview
- Yellow Fever prevention study in healthy volunteers
- Chronic hepatitis C study
- Main endpoints and what they mean
- Study status, phase, and size
Trial overview
The source data includes two interventional clinical trials studying SOFOSBUVIR.[1][2] Both are Phase 3 studies, which means they are later-stage trials in larger groups of people.[1][2]
One trial is completed and focused on healthy volunteers in Yellow Fever vaccine research.[1] The other is authorised and focused on people with chronic Hepatitis C Virus (HCV) infection.[2]
Yellow Fever prevention study in healthy volunteers
The first trial is called YF_PROTECT and studied prophylactic treatment with SOFOSBUVIR for Yellow Fever.[1] The brief summary says the goal was to assess the effect of SOFOSBUVIR on YF17D replication, which means the study looked at whether the virus used in the vaccine multiplied in the body.[1]
This study enrolled healthy volunteers, not people with chronic liver disease or hepatitis C.[1] The enrollment was 30 participants, and the study status is completed.[1]
The primary outcome measured whether there was viremia (virus in the blood), viruria (virus in the urine), or neutralizing antibodies on day 28 after vaccination.[1] These outcomes help researchers see if the study treatment changed viral replication or the immune response after vaccination.[1]
Chronic hepatitis C study
The second trial is a Phase 3 study in patients with Chronic Hepatitis C Virus (HCV) Infection.[2] Its title says it compares whether BEM/RZR is similar to SOF/VEL in patients with hepatitis C virus infection.[2]
The brief summary says the study evaluates the efficacy of BEM/RZR fixed dose combination given for 8 or 12 weeks once daily versus SOF/VEL given for 12 weeks once daily.[2] The source data also lists SOFOSBUVIR / Velpatasvir as one of the interventions.[2]
This trial is authorised and has an enrollment of 880 participants.[2] The main patient group is people living with chronic HCV infection.[2]
Main endpoints and what they mean
The Yellow Fever study used a primary endpoint based on whether YF17D virus was found in plasma or urine, and whether neutralizing antibodies were present on day 28.[1] In simple terms, this checks both virus activity and the body’s immune response after vaccination.[1]
The hepatitis C study used a primary endpoint of the proportion of subjects with HCV RNA below the lower limit of quantitation at study week 24.[2] This means the trial looked at how many people reached a very low or unmeasurable amount of virus in the blood by that time point.[2]
Study status, phase, and size
Both studies are Phase 3, so they are designed to gather important data in larger groups after earlier testing.[1][2] The Yellow Fever study is completed with 30 participants, while the hepatitis C study is authorised with 880 participants planned or enrolled.[1][2]
