Atea Pharmaceuticals presents drug interaction profile of bemnifosbuvir

Atea Pharmaceuticals announced that data from three Phase 1 studies suggest a favorable drug-drug interaction profile. No dosage adjustment is needed for CYP3A substrates or for drugs that are sensitive substrates of efflux and hepatic uptake transporters when co-administrated with bemnifosbuvir. CYP3A is an enzyme that metabolizes many classes of prescribed medicines and medicinal supplements, and efflux/hepatic uptake transporters regulate cellular trafficking of many drugs that are commonly prescribed to patients that are at high risk for severe COVID-19. These results were presented at the Conference on Retroviruses and Opportunistic Infections, which took place February 19-22, 2023 in Seattle, Washington. Bemnifosbuvir is an investigational orally administered, direct-acting antiviral. It is being evaluated in the global SUNRISE-3 Phase 3 registrational trial for the treatment of COVID-19 in non-hospitalized patients at high risk for disease progression to hospitalization and death. Title: No Dose Adjustments for CYP3A4 Substrates When Co-Administered with Bemnifosbuvir: Results from a Phase 1, open-label, drug-drug interaction study suggest that no dose adjustments are needed when bemnifosbuvir is co-administered with drugs that are substrates of CYP3A4. In the study, bemnifosbuvir was administered with midazolam in 24 healthy participants and was well tolerated. Results showed a single dose of bemnifosbuvir only slightly increased the plasma exposure of MDZ. After repeat dosing of bemnifosbuvir simultaneously administered with MDZ, bemnifosbuvir increased plasma MDZ without affecting the exposure of the 1-hydroxymidazolam. Title: Bemnifosbuvir Has Low Potential to Inhibit P-gp, BCRP and OATP1B1 Mediated Transport Results from two Phase 1, open-label, drug-drug interaction studies suggest bemnifosbuvir has low potential to exhibit clinically meaningful inhibition of P-glycoprotein or breast cancer resistance protein/organic anion transporter polypeptide 1B1 drug transporters. Therefore, no dose adjustment is expected for drugs that are sensitive substrates of these transporters when co-administered with bemnifosbuvir. The efflux transporters P-gp and BCRP and the hepatic uptake transporter OATP1B1 regulate cellular trafficking of many drugs that are commonly prescribed to patients that are at high risk for severe COVID-19. These drugs include immunosuppressants, certain antibiotics, statins and other cardiovascular medications, certain diabetes medicines and chemotherapy. The studies assessed the effect of bemnifosbuvir on digoxin and rosuvastatin, which were used as P-gp and BCRP/OATP1B1 index drugs, respectively. Bemnifosbuvir administered with DIG or ROSU was well tolerated in the 29 healthy participants that were included in each study. A single high dose of bemnifosbuvir 1100 mg simultaneously administered with DIG slightly increased the Cmax of DIG yet had no effect on its AUC, which is consistent with the transient nature of bemnifosbuvir plasma pharmacokinetics. When dosed staggered, bemnifosbuvir did not affect the PK of DIG. A single dose of bemnifosbuvir 1100 mg administered with ROSU slightly increased the plasma exposure of ROSU.