Trial Outcomes & Findings for A Phase 2, Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic HCV (NCT NCT05904470)
NCT ID: NCT05904470
Last Updated: 2025-10-21
Results Overview
SVR12 defined as plasma hepatitis C virus (HCV) RNA less than the lower limit of quantitation (\<LLOQ) at 12 weeks post-treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
275 participants
Primary outcome timeframe
Day 1 through 12 weeks after end of treatment
Results posted on
2025-10-21
Participant Flow
Participant milestones
| Measure |
BEM+RZR
Bemnifosbuvir (BEM; AT-527) 550 mg in combination with Ruzasvir (RZR; AT-038) 180 mg. Administered orally as two BEM tablets and two RZR capsules once a day (QD) for 8 weeks.
|
|---|---|
|
Overall Study
STARTED
|
275
|
|
Overall Study
COMPLETED
|
255
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 2, Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic HCV
Baseline characteristics by cohort
| Measure |
BEM+RZR
n=275 Participants
Bemnifosbuvir (BEM; AT-527) 550 mg in combination with Ruzasvir (RZR; AT-038) 180 mg. Administered orally as two BEM tablets and two RZR capsules once a day (QD) for 8 weeks.
|
|---|---|
|
Age, Continuous
|
49.6 years
STANDARD_DEVIATION 13.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
192 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
|
Genotype (GT)
GT1
|
189 Participants
n=5 Participants
|
|
Genotype (GT)
GT2
|
7 Participants
n=5 Participants
|
|
Genotype (GT)
GT3
|
77 Participants
n=5 Participants
|
|
Genotype (GT)
GT4
|
2 Participants
n=5 Participants
|
|
Compensated Cirrhosis
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through 12 weeks after end of treatmentPopulation: The primary per-protocol analysis population included subjects who met all eligibility criteria, completed treatment (defined as being ≥90% compliant with the study drug regimen), had outcomes at post-treatment week 12, and had adequate study-drug exposure corroborated by pill counts and plasma drug levels adjudicated by an independent clinical pharmacologist.
SVR12 defined as plasma hepatitis C virus (HCV) RNA less than the lower limit of quantitation (\<LLOQ) at 12 weeks post-treatment
Outcome measures
| Measure |
BEM+RZR
n=215 Participants
Bemnifosbuvir (BEM; AT-527) 550 mg in combination with Ruzasvir (RZR; AT-038) 180 mg. Administered orally as two BEM tablets and two RZR capsules once a day (QD) for 8 weeks.
|
|---|---|
|
Percentage of Subjects Achieving Sustained Virologic Response at 12 Weeks Post-treatment (SVR12)
|
210 Participants
|
SECONDARY outcome
Timeframe: Day 1 through 12 weeks after end of treatmentPopulation: The primary per-protocol analysis population included subjects who met all eligibility criteria, completed treatment (defined as being ≥90% compliant with the study drug regimen), had outcomes at post-treatment week 12, and had adequate study-drug exposure corroborated by pill counts and plasma drug levels adjudicated by an independent clinical pharmacologist.
Virologic failure defined as a confirmed 1 log10 increase in HCV RNA from post-baseline nadir, or confirmed increase in HCV RNA ≥ LLOQ in any subject who achieved HCV RNA \< LLOQ.
Outcome measures
| Measure |
BEM+RZR
n=215 Participants
Bemnifosbuvir (BEM; AT-527) 550 mg in combination with Ruzasvir (RZR; AT-038) 180 mg. Administered orally as two BEM tablets and two RZR capsules once a day (QD) for 8 weeks.
|
|---|---|
|
Percentage of Subjects Experiencing Virologic Failure
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 1 through 24 weeks after end of treatmentPopulation: The primary per-protocol analysis population included subjects who met all eligibility criteria, completed treatment (defined as being ≥90% compliant with the study drug regimen), had outcomes at post-treatment week 12, and had adequate study-drug exposure corroborated by pill counts and plasma drug levels adjudicated by an independent clinical pharmacologist.
SVR24 defined as plasma HCV RNA less than the lower limit of quantitation (\<LLOQ) at 24 weeks post-treatment
Outcome measures
| Measure |
BEM+RZR
n=211 Participants
Bemnifosbuvir (BEM; AT-527) 550 mg in combination with Ruzasvir (RZR; AT-038) 180 mg. Administered orally as two BEM tablets and two RZR capsules once a day (QD) for 8 weeks.
|
|---|---|
|
Percentage of Subjects Achieving Sustained Virologic Response at 24 Weeks Post-treatment (SVR24)
|
206 Participants
|
Adverse Events
BEM+RZR
Serious events: 19 serious events
Other events: 64 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
BEM+RZR
n=275 participants at risk
Bemnifosbuvir (BEM; AT-527) 550 mg in combination with Ruzasvir (RZR; AT-038) 180 mg. Administered orally as two BEM tablets and two RZR capsules once a day (QD) for 8 weeks.
|
|---|---|
|
Cardiac disorders
Atrioventricular block complete
|
0.36%
1/275 • Number of events 1 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
General disorders
Pyrexia
|
0.36%
1/275 • Number of events 1 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Infections and infestations
Abscess limb
|
0.36%
1/275 • Number of events 1 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Infections and infestations
Dengue fever
|
0.36%
1/275 • Number of events 1 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.73%
2/275 • Number of events 2 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.36%
1/275 • Number of events 1 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Psychiatric disorders
Behaviour disorder
|
0.36%
1/275 • Number of events 1 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.36%
1/275 • Number of events 1 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.36%
1/275 • Number of events 1 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.36%
1/275 • Number of events 1 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.36%
1/275 • Number of events 1 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.36%
1/275 • Number of events 1 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Infections and infestations
Cellulitis
|
0.36%
1/275 • Number of events 1 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Injury, poisoning and procedural complications
Overdose
|
1.1%
3/275 • Number of events 3 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Infections and infestations
Pneumonia
|
0.36%
1/275 • Number of events 1 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Infections and infestations
Localised infection
|
0.36%
1/275 • Number of events 1 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
General disorders
Death
|
0.36%
1/275 • Number of events 1 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion incomplete
|
0.36%
1/275 • Number of events 1 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.36%
1/275 • Number of events 1 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
Other adverse events
| Measure |
BEM+RZR
n=275 participants at risk
Bemnifosbuvir (BEM; AT-527) 550 mg in combination with Ruzasvir (RZR; AT-038) 180 mg. Administered orally as two BEM tablets and two RZR capsules once a day (QD) for 8 weeks.
|
|---|---|
|
Nervous system disorders
Headache
|
8.7%
24/275 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Gastrointestinal disorders
Nausea
|
8.0%
22/275 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.4%
12/275 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Gastrointestinal disorders
Vomiting
|
4.4%
12/275 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
General disorders
Pyrexia
|
4.0%
11/275 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
10/275 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
General disorders
Fatigue
|
2.5%
7/275 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.2%
6/275 • Treatment-emergent adverse events were collected through 4 weeks post-treatment and serious adverse events were collected through 24 weeks post-treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator may publish or present results pertaining to the PI's activities after the first publication of the multicentre clinical trial results. Publication or presentation of data from individual study centers is subject to prior review by the Sponsor. The Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER