Ruzasvir

December 2024 FDA updates: Approved treatments include ustekinumab-kfce for inflammatory diseases, crinecerfont for CAH, nemolizumab for AD, and olezarsen for FCS. Notable actions: RMAT designation for rexlemestrocel-L, Boxed Warning for fezolinetant, and CRLs for glepaglutide and sotagliflozin. Pipeline updates: Tirzepatide outperformed semaglutide in weight loss, and novel therapies for HCV, PNH, and EoE showed promise.

December 2024 marked significant advancements in hepatology, with FDA updates on liver injury risks, breakthroughs in hepatitis treatments, and new research in MASH. Key highlights include FDA warnings for obeticholic acid and fezolinetant, positive phase 2 results for HCV treatment, and the potential of AI in MASH screening.

Mayo Clinic Arizona's removal of Clostridioides difficile from gastrointestinal pathogen panels reduced unnecessary treatments and improved diagnostic stewardship. A Salmonella outbreak linked to cucumbers sickened 68 across 19 US states, prompting a recall. The Equity in Antimicrobial Stewardship Efforts (EASE) framework aims to address disparities in antimicrobial prescribing. Atea Pharmaceuticals' hepatitis C therapy achieved a 98% sustained virologic response in a Phase 2 trial. Alba Azola discusses Long COVID's challenges, emphasizing the need for awareness and research.

Atea Pharmaceuticals' investigational HCV therapy of bemnifosbuvir and ruzasvir achieved 98% SVR12 after 8 weeks, with 99% success in non-cirrhotic genotypes 1-4 patients and 88% in cirrhotic patients. The company plans to advance to phase 3 in 2025, aiming for a fixed dose combination tablet to enhance patient convenience.

Atea Pharmaceuticals' hepatitis C treatment regimen, combining bemnifosbuvir and ruzasvir, showed 98% sustained virologic response in Phase 2 trial, with 99% success rate among non-cirrhotic patients. The company aims to simplify treatment duration and pill count in Phase 3, targeting a younger, less adherent patient population. Atea seeks to carve a niche in the hepatitis C market with a more convenient treatment option.

Atea Pharmaceuticals' Phase 2 study of bemnifosbuvir and ruzasvir for hepatitis C met primary endpoints with 98% SVR12 rate in adherent patients, demonstrating potency and safety. The Phase 3 program, expected to start in early 2025, will extend treatment duration for cirrhotic patients to 12 weeks.

Atea Pharmaceuticals' Phase 2 study of bemnifosbuvir and ruzasvir for HCV treatment achieved 98% SVR12 with an 8-week regimen, demonstrating safety and efficacy. The company plans to initiate a Phase 3 program in early 2025.

Atea Pharmaceuticals' Phase 2 study for hepatitis C treatment met primary endpoints, showing 98% SVR12 in adherent patients. The regimen, combining bemnifosbuvir and ruzasvir, was safe and well-tolerated. Atea plans to initiate a global Phase 3 program in 2025, aiming to simplify the regimen and enhance patient convenience. The company anticipates contributing to HCV eradication in the U.S. with its treatment.

Atea Pharmaceuticals' Phase 3 SUNRISE-3 study of bemnifosbuvir for Covid-19 treatment did not meet primary goal of reducing hospitalization or death. Bemnifosbuvir is also in Phase 2 for HCV treatment with ruzasvir; additional results planned for Q4.

Atea Pharmaceuticals' Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir for COVID-19 did not meet primary endpoint of reducing hospitalization or death. Bemnifosbuvir was safe and well-tolerated. Atea focuses on bemnifosbuvir and ruzasvir combination for hepatitis C treatment.