> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/c-beyond-efficacy-and-safety-of-bem-rzr-vs-sof-vel-in-8852864b-1999-4a8c-bfdc-0866785761e6 > Record changed: 2026-11-04 # C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV NCT06868264 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) Participants 940 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) Lead sponsor Atea Pharmaceuticals, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) Start date 2025-04-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) Number of sites 105 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) ## Title and summary **Summary** The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) **Short title** C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) **Official title** Phase 3, Randomized, Controlled, Open-label Study to Compare the Efficacy and Safety of Bemnifosbuvir-Ruzasvir Fixed-dose Combination (BEM/RZR FDC) Versus Sofosbuvir-Velpatasvir Fixed-dose Combination (SOF/VEL FDC) in Subjects With Chronic Hepatitis C Virus (HCV) Infection Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) ## Dates **Completion date** 2026-09-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) **First posted** 2025-03-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) **Registry last updated** 2026-10-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) **Primary completion date** 2026-06-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) **Start date** 2025-04-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) ## Size and sites **Actual participants** 940 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) **Participants** 940 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) **Number of sites** 105 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) **Lead sponsor** Atea Pharmaceuticals, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) ## Identifiers **Registry ID** NCT06868264 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) **ClinicalTrials.gov ID** NCT06868264 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Single masking **Masked roles** Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) ## Outcomes ### Primary outcomes 1. Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study week 24. Timeframe: Day 1 through Week 24 ### Secondary outcomes 1. Proportion of subjects achieving HCV RNA < LLOQ 12 weeks after the last dose of study drugs. Timeframe: Day 1 through 12 weeks after the end of treatment 2. Proportion of subjects experiencing virologic failure. Timeframe: Day 1 through Week 24 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06868264) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 85 Years **Healthy volunteers** No Key Inclusion Criteria: - Use of adequate contraception for females of childbearing potential - Must be direct-acting antiviral (DAA)-treatment-naïve (never exposed to an approved or experimental DAA for HCV) - Documented medical history compatible with chronic HCV - Either no liver cirrhosis or with compensated liver cirrhosis - If HIV-1-positive, must meet the following 2 criteria: 1. Antiretroviral (ARV) regimen for >8 weeks prior to screening visit, with CD4 T-cell count >200 cells/mm3 and plasma HIV-1 RNA