At the 44th Annual J.P. Morgan Healthcare Conference, Atea Pharmaceuticals outlined its strategy for hepatitis C virus (HCV), showcasing its bemnifosbuvir/ruzasvir (BEM/RZR) fixed-dose combination as a differentiated regimen designed to support expanded “test-and-treat” models of care.
The presentation highlighted that, despite the availability of highly effective direct-acting antivirals, HCV prevalence in the US continues to rise, with recent estimates indicating that more than 4 million people are living with HCV, driven by new infections outpacing treatment rates, particularly among younger populations (ages 40 and lower) affected by injection drug use. Atea argued that existing treatment paradigms have not sufficiently addressed barriers related to diagnosis, adherence, and prescribing complexity, limiting progress toward elimination targets.
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Atea positioned its bemnifosbuvir/ruzasvir regimen as a potential best-in-class profile for this approach, emphasising potency, a short treatment duration and a low risk of drug–drug interactions. In particular, the company repeatedly highlighted the relevance of proton pump inhibitor (PPI) use in HCV patients, stating that approximately 35% take PPIs and noting that patients may be co-medicated with 10-15 therapies per day, which can complicate prescribing. Atea referenced Phase II per-protocol results showing a 98% sustained virologic response 12 weeks after treatment termination and argued that the regimen’s profile is suited to real-world settings where adherence and medication history can be variable.
The presentation highlighted the company’s Phase III programme, with Atea stating that enrolment has been completed in C-BEYOND (NCT06868264T), its North American trial, with more than 900 patients enrolled and topline data expected in mid-2026, which management guided to Q3 2026. The second pivotal study, C-FORWARD (NCT07037277), is being conducted outside North America across 17 countries and 120 clinical sites, with full enrolment anticipated by the end of next quarter and results expected by the end of 2026 (Q4 2026). Atea described the programme as a head-to-head comparison versus sofosbuvir/velpatasvir, with an eight-week regimen in non-cirrhotic patients compared with 12 weeks of the active comparator, and a 12-week comparison in compensated cirrhosis, with sustained virologic response assessed at 24 weeks after treatment initiation. Management also discussed differences in FDA and EMA preferences for primary analyses and stated that the clinical trials are powered at approximately 880 patients each, supporting analyses by individual study and in combination.
Commercially, Atea pointed to market research to support potential uptake, citing a study of 153 high prescribers and payers covering more than 130 million lives, and argued that US prescribing remains concentrated, with 6,000 prescribers accounting for 80% of direct-acting antiviral (DAA) prescribing, enabling a focused speciality sales strategy. The company also outlined early commercial readiness planning, including once-daily dosing delivered as two tablets and a blister-pack format aligned to monthly reimbursement practices.
Outside of HCV, Atea reiterated plans for its asset, AT-587, in chronic hepatitis E infection in immunocompromised patients, outlining near-term clinical trial application (CTA)/Phase I plans and longer-term expectations for pivotal trial initiation in the second half of 2027, while highlighting cash and investments of more than $300m and runway through 2027 into early 2028.
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