Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Comparing bemnifosbuvir-ruzasvir and sofosbuvir-velpatasvir for treatment of chronic hepatitis C virus infection in adult patients

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating people with Chronic Hepatitis C Virus Infection, a long-term liver condition caused by the hepatitis C virus. The study compares two different combination treatments: Bemnifosbuvir-Ruzasvir (also known as BEM/RZR) and Sofosbuvir-Velpatasvir (also known as SOF/VEL). Both treatments are taken as tablets by mouth.

The purpose is to determine if BEM/RZR treatment, given once daily for either 8 or 12 weeks, works as well as SOF/VEL treatment, which is given once daily for 12 weeks. These medications work by directly targeting the virus that causes the infection.

During the study, participants will receive one of these treatments and will have their virus levels monitored through blood tests. The study will track how well the medications clear the virus from the body and whether the infection returns after treatment ends. The total duration of monitoring for each participant extends to 24 weeks to ensure long-term effectiveness of the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment assignment

    You will be randomly assigned to one of two treatment groups:

    Group 1: BEM/RZR (bemnifosbuvir/ruzasvir) tablets taken once daily for either 8 or 12 weeks

    Group 2: SOF/VEL (sofosbuvir/velpatasvir) tablets taken once daily for 12 weeks

  2. Step 2

    Treatment period

    Take the assigned medication orally once daily according to your group assignment

    The treatment period will last either 8 or 12 weeks depending on your assigned group

    Regular blood tests will be performed to measure HCV RNA (hepatitis C virus levels) in your blood

  3. Step 3

    Post-treatment follow-up - Week 12

    Blood tests will be conducted 12 weeks after your last dose of study medication

    These tests will check if the virus levels remain below detectable limits

  4. Step 4

    Final evaluation - Week 24

    Final blood tests will be performed at week 24 of the study

    This test will determine if the HCV RNA remains below detectable limits

    This marks the primary evaluation point of the treatment's effectiveness

  5. Step 5

    Study completion

    The study will conclude after the week 24 evaluation

    Your participation will be complete after all required assessments are finished

Who can join the trial?

11 criteria

  • Must be between 18 and 70 years old
  • Both men and women can participate
  • Women who can become pregnant must use effective birth control methods
  • Must never have received treatment with direct-acting antiviral medications (medications that directly target the hepatitis C virus) before, whether approved or experimental
  • Must have medical records showing a history of long-term hepatitis C infection
  • Liver condition must be either:
    • Without cirrhosis (scarring of the liver), or
    • With compensated cirrhosis (early-stage liver scarring that doesn't significantly impact liver function)
    • If HIV-positive, participants must:
      • Be on HIV medications (antiretroviral therapy) for more than 8 weeks before screening
      • Have a CD4 T-cell count (type of white blood cells) above 200 cells/mm3
      • Have undetectable HIV virus levels in blood
      • Be taking HIV medications that don't interact with the study medication

Who cannot join the trial?

14 criteria

  • History of previous treatment with direct-acting antiviral agents (DAA medications) used to treat Hepatitis C
  • Co-infection with Hepatitis B virus or HIV
  • Presence of liver cirrhosis (severe scarring of the liver)
  • Current pregnancy or breastfeeding
  • Significant heart, kidney, or other organ disorders
  • Active substance abuse within the past 6 months
  • Current use of medications that could interact with study drugs
  • History of liver cancer or other types of cancer in the past 5 years
  • Abnormal blood test results showing poor liver or kidney function
  • Mental health conditions that could affect study participation
  • Unable to take oral medications
  • Participation in another clinical trial within the past 30 days
  • Known allergies to study medications or their components
  • Unstable medical conditions requiring frequent medication changes
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Bemnifosbuvir-Ruzasvir (BEM/RZR) is a combination medication used to treat chronic hepatitis C virus infection. It is an antiviral medication that works by stopping the virus from multiplying in the body. Sofosbuvir-Velpatasvir (SOF/VEL) is also a combination antiviral medication used to treat chronic hepatitis C virus infection. It works by interfering with proteins needed by the hepatitis C virus to multiply, helping to clear the virus from the body. Both medications are taken once daily and are designed to help eliminate the hepatitis C virus from the patient's system. They represent different treatment options for people with chronic hepatitis C infection.

What is already known about the treatment

  • Bemnifosbuvir-Ruzasvir (BEM/RZR)

    An oral antiviral combination medication administered once daily for the treatment of chronic Hepatitis C virus infection. This fixed-dose combination (FDC) is currently being evaluated in Phase 3 clinical trials as a potential alternative to existing HCV treatments. The medication works by targeting specific viral proteins to prevent HCV replication in infected cells, belonging to the direct-acting antiviral (DAA) class of medications.

  • Sofosbuvir-Velpatasvir (SOF/VEL)

    An established oral antiviral combination medication taken once daily for treating chronic Hepatitis C virus infection across multiple genotypes. This approved fixed-dose combination works by blocking different steps of the HCV viral replication process, with Sofosbuvir inhibiting viral RNA synthesis and Velpatasvir targeting the NS5A protein. The medication belongs to the direct-acting antiviral (DAA) class and is currently used as a standard treatment option for HCV infection.

Investigated diseases

Chronic Hepatitis C Virus (HCV) Infection - A viral infection that affects the liver, causing inflammation and damage over time. The infection begins with mild or no symptoms and develops gradually, often remaining unnoticed for years. The virus spreads through blood-to-blood contact and targets liver cells, where it multiplies and triggers an immune response. The ongoing inflammation can lead to scarring of liver tissue over time. Most people who get infected develop the chronic form of the disease, which means the infection persists for more than six months.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521096-31-00Protocol codeAT-01B-008Estimated enrolment880 patientsSponsorAtea Pharmaceuticals Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.