In short
Clinical trials are studying Ruzasvir in people with chronic hepatitis C virus (HCV) infection. These trials are looking at safety, tolerability, and how well Ruzasvir-based treatment works, including in combination with other antiviral drugs and compared with standard treatment.
Key points
- Clinical trials of Ruzasvir are focused on chronic hepatitis C virus infection. One Phase 2 study tested Ruzasvir with bemnifosbuvir and looked at safety, tolerability, and SVR12 in 249 people. A Phase 3 study is authorised and is comparing a bemnifosbuvir/Ruzasvir fixed-dose combination with sofosbuvir/velpatasvir in 880 people. The main Phase 3 outcome is whether HCV RNA is below the lower limit of quantitation at week 24. Together, these trials are checking how well Ruzasvir-based treatment works and how it compares with an established option.
Clinical trials overview
These studies are testing Ruzasvir in people with chronic hepatitis C virus (HCV) infection. The trials are looking at whether Ruzasvir-based treatment is safe, tolerable, and effective for this condition.
Both trials are interventional studies, which means researchers give a study treatment and then measure the results. The studies include a Phase 2 trial and a Phase 3 trial.
Phase 2 study of Ruzasvir and bemnifosbuvir
The Phase 2 study, NCT05904470, was completed and included 249 participants with chronic HCV infection. It studied Ruzasvir together with bemnifosbuvir, both taken by mouth.
The study aimed to evaluate safety and tolerability, as well as how well the treatment worked. This makes it an early study that helps show whether the treatment may be useful for people with hepatitis C.
Phase 3 comparison study
The Phase 3 trial, 2025-521096-31-00, is authorised and plans to enroll 880 people with chronic HCV infection. It compares a fixed-dose combination of bemnifosbuvir/Ruzasvir with sofosbuvir/velpatasvir.
The study is designed to see whether the bemnifosbuvir/Ruzasvir treatment is similar to the comparison treatment. The trial uses once-daily treatment for 8 or 12 weeks in the study arm and 12 weeks in the comparison arm.
Outcomes and endpoints
The main result in the Phase 2 study is SVR12, which means sustained virologic response 12 weeks after treatment ends. In simple terms, this checks how many people still have no detectable virus after treatment.
The main result in the Phase 3 study is the proportion of people with HCV RNA below the lower limit of quantitation at study week 24. This means the test looks for whether the virus level is so low that the lab test cannot measure it accurately.
The Phase 2 study also summarized reasons why some people did not reach SVR12. That kind of information helps researchers understand where treatment may fail and how future studies can improve.
Who the trials are for
Both studies are for people with chronic hepatitis C virus infection. The trial data do not list more detailed patient rules, such as age limits or other health requirements.
- The Phase 2 trial included people already living with chronic HCV infection and measured how they responded to the study treatment.
- The Phase 3 trial is larger and is comparing the study treatment with a standard treatment option in the same disease group.
Key terms explained
Chronic hepatitis C virus infection means a long-lasting infection that can affect the liver over time. Interventional study means the researchers give a treatment and watch what happens.
Enrollment is the number of people planned or included in a study. Authorised means the Phase 3 trial has been approved to move forward.