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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Gyncentrum Sp. z o.o.	Katowice	Poland

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Nice	Nice	France
Hopital Beaujon	Clichy	France
Fundeni Clinical Institute	Bucharest	Romania
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.	Wroclaw	Poland
Medrise Sp. z o.o.	Lublin	Poland
Hujxtzrxnlpr Hbbhhzoc	Athens	Greece
Eeugzbzmwmcy Shdi	Athens	Greece
Ltzrp Gfudfqd Hosegexh Od Azbuah	Athens	Greece
Hwmaypjh Vsno dcjgopgh	Barcelona	Spain
Coyudk Haqwkrnuqxv Ugouanouopgzz Dh Miijwokzjmd	Montpellier	France
Uiqwaosoom Gbcrnkc Havagjsb On Aqvsevubxyuopi	Alexandroupoli	Greece
Uqrwuktsuu Meajtyz Cgevrj Hfwfocclnlwjlbjth	Hamburg	Germany
Hprynosg Uzevfmdvzmvws Mhgblud Dh Voirfsbuys	Santander	Spain
Uvcakblqso Gfjzvuy Hasxgnev Oc Hgctyxyzy	Heraklion	Greece
Hialgkvy Ubmthsbfabhcn Vfimhj Dz Lq Viqozdlg	Malaga	Spain
Hfscghxy Ucuslcoybkwdrr Shbqbrpgrg &gayxlc Hrmlbix dt Hvvtzqxftfe	STRASBOURG, Alsace	France
Ij Cxslll	Myslowice	Poland
Gboui Bqqwair Kndwgpbyc Scm z owew	Klodzko	Poland
Moi Ppciqea Snr z obsm	Poznan	Poland
Stvfpvns Cuvvgd Chonnstax Bxwslepnx	Bucharest	Romania
Cvvagpy Mzgmnaje w Łiugkrus	Lancut	Poland
Ssjuyinp Jipzqqkt Ds Upaqgdw Soxpuom Iqei Cjr Nwr Sktshcq	Suceava	Romania
Clginw Hbuxkdqd Fml Ixvxwuzsnp Dhmiiynx Snj Cdjuepbi Pkhsxtjhkg Gpjfba	Galati	Romania
Gjqsenu Hgdsuxaz om Reaxfh Afluidu Pmunhfmawc	Rhodes	Greece
5 Wvinyvag Soiegbf Krecnvmme z Pjluzunhhjf Sreyd	Cracow	Poland
Sdhgtgcz Crjfco Df Bmjo Iqohffkcqpr Skk Pnjvbdxfgj Icct	Iasi	Romania
Gwtjhr Uleganbqkw Fifksrknm	Frankfurt	Germany
Sxrghckl Czrnce Jqqtxsfs Db Uhhjcms Sojgo	Sibiu	Romania
Sjkucxaz Cdvpkw Dc Bwkd Iujlpgdlsdv Ctpqnvabi	Constanta	Romania
Svkavlje Cjgoub Dw Bbsd Ivxjyqnopwt St Thcnrsxqq Dpj Vgtgpi Bqzzy	Bucharest	Romania
Eviaicbd Gaza	Leipzig	Germany
Cmulfiy Mjvasia Rvfszyvval Sqgvlo	Craiova	Romania
Stvhsnhk Cslped Df Ubpdjvk Pbzz Ds Atincdh Itilmdv	Balotesti	Romania
Hjnwaghx Pwmhye Swre	Vigo	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	31.10.2025
Germany	Not recruiting	31.10.2025
Greece	Not recruiting	31.10.2025
Poland	Not recruiting	31.10.2025
Romania	Not recruiting	31.10.2025
Spain	Not recruiting	31.10.2025

Trial locations

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.

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 ID:

2025-521096-31-00

Protocol code:

AT-01B-008

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?