Bemnifosbuvir, Ruzasvir Regimen Shows Strong Efficacy as HCV Treatment
A phase 2 study found 95% of patients achieved a sustained virologic response at 12 weeks regardless of treatment adherence.
Positive results have been announced from a phase 2 trial evaluating a once-daily combination of bemnifosbuvir and ruzasvir for the treatment of hepatitis C virus (HCV) in adult patients, Atea Pharmaceuticals announced in a release.1 The data was presented at the European Association for the Study of the Liver (EASL) Congress 2025, held May 7 to 10 in Amsterdam, Netherlands.
Bemnifosbuvir, Ruzasvir Regimen Shows Strong Efficacy as HCV Treatment / Dzmitry - stock.adobe.com
Results from the trial (NCT05904470) showed the bemnifosbuvir and ruzasvir regimen met its primary efficacy endpoint of proportion of patients achieving sustained virologic response at 12 weeks. The therapy also met its primary safety endpoint of proportion of patients experiencing treatment related emergent adverse events.
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"The average HCV patient we are treating today is quite different than several years ago—patients are more recently infected with fewer presenting with cirrhosis, and the majority are taking concomitant medications, including some that may not be recommended with the currently available HCV therapies,” Eric Lawitz, MD, clinical professor of medicine at the University of Texas Health San Antonio, said in a release.1 “I am encouraged by the complete Phase 2 results suggesting that the regimen of bemnifosbuvir and ruzasvir may offer a potent and more convenient option for my patients. I look forward to seeing the Phase 3 results when they are available.”
The study was an open-label phase 2 trial evaluating the safety and efficacy of a once-daily combination of bemnifosbuvir and ruzasvir in adult patients with chronic HCV infection. The study cohort included 275 patients between the ages of 18 and 85 years, of which 238 had no cirrhosis and 37 had compensated cirrhosis. Patients received 550 mg bemnifosbuvir and 180 mg ruzasvir orally once a day for 8 weeks. Exclusion criteria included if patients were pregnant or breastfeeding, had a hepatitis B coinfection or HIV, and if they abused alcohol or illicit drugs.
The study found 99% of patients who adhered to treatment, were non-cirrhotic and infected with genotypes 1 to 4 achieved a sustained virologic response at 12 weeks. In patients who adhered to treatment, were non-cirrhotic, and infected with genotype 3, 100% achieved a sustained virologic response at 12 weeks. Of patients with compensated cirrhosis, 88% achieved a sustained virologic response at 12 weeks. In total, 95% of patients achieved a sustained virologic response at 12 weeks regardless of treatment adherence.
Additionally, the bemnifosbuvir and ruzasvir regimen was safe and well-tolerated, with low rates of virologic failure and no serious adverse events. Mild to moderate adverse events were reported in 43% of patients, with the most common being headache and nausea.
Atea said in the release it is currently conducting 2 phase 3 trials comparing the fixed dose combination of bemnifosbuvir and ruzasvir to a combination of sofosbuvir and velpatasvir. The trials were initiated after the company had a successful end-of-phase 2 meeting with the FDA in January 2025.
"The full results from the Phase 2 trial highlight the potential for our regimen to optimize the treatment of hepatitis C virus in all patients," Jean-Pierre Sommadossi, PhD, CEO of Atea, said in a release.1 "Our potential best-in-class regimen, which has attributes of a short treatment duration, low risk for drug-drug interactions and convenience with no food effect, creates new opportunities to treat and cure an expanded number of HCV-infected patients, and we are eager to further explore these benefits in our C-BEYOND and C-FORWARD Phase 3 trials."
READ MORE: Infectious Disease Resource Center
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