Hepatitis C virus (HCV) treatment

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Atea Pharmaceuticals Announces Continued Advancement of Global Phase 3 HCV Program with Dosing of First Patient in C-FORWARD Outside North America
Globenewswire· 2025-06-24 11:00
Core Insights - Atea Pharmaceuticals has initiated the global Phase 3 C-FORWARD trial for the combination regimen of bemnifosbuvir and ruzasvir to treat hepatitis C virus (HCV) [1][2] - The regimen is designed to be a potential best-in-class treatment with a short duration of 8 to 12 weeks and low risk for drug-drug interactions [1][3] - HCV remains a significant global health issue, with approximately 50 million people infected worldwide, including 2.4 to 4 million in the US [2][9] Group 1: Trial Details - The C-FORWARD trial is the second Phase 3 trial, complementing the C-BEYOND trial currently enrolling patients in the US and Canada [1][5] - Each Phase 3 trial aims to enroll around 880 treatment-naïve patients, comparing the fixed-dose combination of bemnifosbuvir and ruzasvir to sofosbuvir and velpatasvir [5] - The primary endpoint for both trials is achieving HCV RNA below the lower limit of quantitation (LLOQ) at 24 weeks, indicating sustained virologic response (SVR12) [6] Group 2: Efficacy and Safety - Results from a Phase 2 study showed a robust 98% SVR12 rate in the treatment-adherent population and 95% in the efficacy evaluable population [7] - Additional Phase 1 studies indicated a low risk of drug-drug interactions and safety in patients co-infected with HIV [8] - Bemnifosbuvir has demonstrated significantly higher potency compared to sofosbuvir, with a 10-fold increase in activity against various HCV genotypes [11] Group 3: Market Context - The evolving patient population for HCV treatment includes many individuals with co-morbidities and complex medical histories, necessitating more accessible treatment options [3] - The current landscape shows a rising burden of untreated HCV, particularly in Europe, mirroring trends in North America [3] - Atea's regimen is positioned to address these challenges by combining high efficacy, short treatment duration, and minimal drug interaction risks [3]
Atea Pharmaceuticals to Host Virtual HCV KOL Panel on May 14, 2025
Globenewswire· 2025-05-01 11:00
Core Insights - Atea Pharmaceuticals is hosting a virtual panel discussion on May 14, 2025, focusing on the treatment challenges of hepatitis C virus (HCV) and the results from its Phase 2 study of bemnifosbuvir and ruzasvir [1][2] - The company will not hold a first quarter 2025 earnings conference call, resuming quarterly calls with the second quarter 2025 financial results [1] Company Overview - Atea Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to developing oral antiviral therapies for serious viral diseases, particularly focusing on HCV [15] - The company is advancing its lead program, which involves a regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, for HCV treatment [15] HCV Treatment Insights - The panel will include key opinion leaders (KOLs) from various medical fields who will discuss current patient challenges, the Phase 2 study results, and the potential benefits of optimized HCV therapies [2] - Atea is conducting two open-label Phase 3 trials, C-BEYOND and C-FORWARD, to evaluate the efficacy of the bemnifosbuvir and ruzasvir regimen compared to existing treatments [13][14] HCV Market Context - HCV remains a significant global health issue, with an estimated 50 million people chronically infected worldwide and approximately one million new infections annually [12] - In the US, between 2.4 and 4 million people are estimated to have HCV, with new infections outpacing treatment rates [12]