Post by Nadica (She/Her) on Oct 23, 2024 23:13:10 GMT
beldesivir for COVID-19 Is Safe, Reduces Time to Symptom Relief in High-Risk Patients - Published Oct 22, 2024
Treatment with obeldesivir is generally well tolerated in patients at high risk for severe COVID-19 infection and associated with significant reductions in SARS-CoV-2 viral and time to symptom relief, according to study results at IDWeek 2024, held from October 16 to 19, in Los Angeles, California.
Researchers conducted a phase 3, double-blinded, placebo-controlled study to assess the efficacy and safety of early antiviral therapy with obeldesivir, an oral broad spectrum, nucleoside analog prodrug inhibitor of SARS-CoV-2 RNA-dependent RNA polymerase. Eligible study patients were adults at high risk of developing severe COVID-19. Patients were randomly assigned 1:1 to receive either obeldesivir 350 mg or placebo twice daily for 5 days. The primary endpoint was hospitalization or all-cause mortality through day 29.
The final analysis comprised 465 patients, of whom the median age was 56 years, 29% were aged 65 years and older, 56% were women, and 12% were Asian. Overall, 42% of the population had no history of COVID-19 vaccination, 92% were seropositive for SARS-CoV-2, and 76% were randomly allocated to treatment groups within 3 days of symptom onset.
At day 29, the rate of COVID-19-related hospitalization and all-cause mortality was 0% and 0.5% among obeldesivir and placebo recipients, respectively (P =.03161).
Results captured from 162 patients showed faster time to symptom alleviation among those in the obeldesivir vs placebo group (median, 7.3 vs 9.3 days; P = 0.0859).
Compared with placebo recipients, obeldesivir recipients exhibited greater reductions in SARS-CoV-2 viral load between baseline and day 5 (-0.58 log10 copies/mL; P <.0001) as well as higher rates of negative infectious titers at day 5 (100% vs 81%; P =.0001).
The safety analysis revealed comparable rates of adverse events (AE), severe AEs, and AE-related treatment discontinuations between the groups.
“In this population of participants with risk factors for severe COVID-19, ODV [obeldesivir] was generally safe and well tolerated,” the researchers concluded.
Study: Streinu-Cercel A, Castagna A, Chang S-C, et al. Obeldesivir for the treatment of COVID-19 in people with risk factors for progression to severe disease: the BIRCH study. Presented at: IDWeek 2024; October 16-19; Los Angeles, CA. Poster 2026.
Treatment with obeldesivir is generally well tolerated in patients at high risk for severe COVID-19 infection and associated with significant reductions in SARS-CoV-2 viral and time to symptom relief, according to study results at IDWeek 2024, held from October 16 to 19, in Los Angeles, California.
Researchers conducted a phase 3, double-blinded, placebo-controlled study to assess the efficacy and safety of early antiviral therapy with obeldesivir, an oral broad spectrum, nucleoside analog prodrug inhibitor of SARS-CoV-2 RNA-dependent RNA polymerase. Eligible study patients were adults at high risk of developing severe COVID-19. Patients were randomly assigned 1:1 to receive either obeldesivir 350 mg or placebo twice daily for 5 days. The primary endpoint was hospitalization or all-cause mortality through day 29.
The final analysis comprised 465 patients, of whom the median age was 56 years, 29% were aged 65 years and older, 56% were women, and 12% were Asian. Overall, 42% of the population had no history of COVID-19 vaccination, 92% were seropositive for SARS-CoV-2, and 76% were randomly allocated to treatment groups within 3 days of symptom onset.
At day 29, the rate of COVID-19-related hospitalization and all-cause mortality was 0% and 0.5% among obeldesivir and placebo recipients, respectively (P =.03161).
Results captured from 162 patients showed faster time to symptom alleviation among those in the obeldesivir vs placebo group (median, 7.3 vs 9.3 days; P = 0.0859).
Compared with placebo recipients, obeldesivir recipients exhibited greater reductions in SARS-CoV-2 viral load between baseline and day 5 (-0.58 log10 copies/mL; P <.0001) as well as higher rates of negative infectious titers at day 5 (100% vs 81%; P =.0001).
The safety analysis revealed comparable rates of adverse events (AE), severe AEs, and AE-related treatment discontinuations between the groups.
“In this population of participants with risk factors for severe COVID-19, ODV [obeldesivir] was generally safe and well tolerated,” the researchers concluded.
Study: Streinu-Cercel A, Castagna A, Chang S-C, et al. Obeldesivir for the treatment of COVID-19 in people with risk factors for progression to severe disease: the BIRCH study. Presented at: IDWeek 2024; October 16-19; Los Angeles, CA. Poster 2026.