番茄社区

Remdesivir (Veklury) hasn't been a favored therapy in hospitalists' toolbox for treating COVID-19 patients, but rumors that the drug is killing patients are unfounded, physicians say.

The allegations appear to have spawned from testimony at a organized by Sen. Ron Johnson (R-Wis.), entitled "COVID-19: A Second Opinion."

"If you look at the four independent studies, including the large study by the WHO, it shows the opposite effect ... remdesivir increases risk of death by 3%," said Paul Marik, MD, who has long touted the benefits of ivermectin and who recently resigned from his position at Eastern Virginia Medical School. "This is a toxic drug."

番茄社区 conducted a fact check of Marik's statement and could not find any evidence in the scientific literature that showed remdesivir was associated with an increased risk of death.

Overall, it appears that remdesivir is associated with a slightly lower risk of death, albeit a non-significant one, and may have some clinical benefit.

Marik's comments come on the heels of an FDA decision to expand the use of remdesivir to outpatients with mild-to-moderate COVID-19.

The of the WHO's SOLIDARITY trial referenced by Marik showed no difference in mortality for patients receiving remdesivir compared with standard care (rate ratio [RR] 0.95, 95% CI 0.81-1.11, P=0.50). And when WHO investigators pooled previous research on remdesivir -- including a study from the National Institute of Allergy and Infectious Diseases (NIAID) and two smaller trials -- they found a lower but non-significant risk of death (RR 0.91, 95% CI 0.79-1.05).

Results from the NIAID study referenced there, , were announced on April 29, 2020, and showed a quicker time to recovery for hospitalized patients who got the drug. There also appeared to be a survival advantage, but it wasn't significant (HR for death 0.70, 95% CI 0.47-1.04), according to final published findings. A also released on April 29, 2020 found no overall benefit with remdesivir for hospitalized patients, but experts said it may have been underpowered.

A fourth study in hospitalized patients, which was supported by Gilead, who manufactures remdesivir, found patients who had a shorter course of the drug had improved clinical status versus those who received standard care.

The new outpatient indication for remdesivir was supported by the phase III PINETREE study, which showed a significantly lower rate of hospitalization for those who received the drug compared with placebo (0.7% vs 5.3%, P=0.008). There were no deaths in either arm, and it was conducted before the emergence of the Delta or Omicron variants.

During the hearing, Marik raised concerns about an increased risk of renal failure with remdesivir. The FDA did warn in its expanded indication announcement that side effects could include increased levels of liver enzymes that could indicate liver injury, but made no reference to any potential renal effects. And the European Medicines Agency's Pharmacovigilance Risk Assessment Committee concluded in February 2021 that there's of kidney problems resulting from the drug.

Johnson, who is , held the hearing -- which wasn't an official Senate hearing -- in the Russell Senate Office Building on Monday. The speaker list included physicians who have been known to spread false or misleading information about COVID-19 during the pandemic.

In addition to Marik, that includes: Robert Malone, MD; Peter McCullough, MD; Aaron Kheriaty, MD; Harvey Risch, MD, PhD; and Pierre Kory, MD.

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