WHO joins Europe, Merck in recommending against ivermectin for COVID-19

ZURICH -- The World Health Organization (WHO) on Wednesday recommended against using generic anti-parasite drug ivermectin in patients with COVID-19 except for clinical trials, because of a lack of data demonstrating its benefits.

The recommendation follows the European Medicines Agency's warning last week against the drug. The U.S. Food and Drug Administration (FDA) has also recommended it not be used for COVID-19.

Officials in the Bolivian city of Trinidad launched a campaign in May last year to give out free doses of ivermectin to combat the coronavirus, although the South American country's health ministry noted the lack of evidence for it as a treatment.

Ivermectin tablets have been approved for treating some worm infestations and for veterinary use in animals for parasites. Merck, an ivermectin manufacturer, has also said its analysis did not support the drug's safety and efficacy for COVID-19.

"This applies to patients with COVID-19 of any disease severity," Janet Diaz, a top WHO official for clinical care response, told reporters of the WHO recommendation, saying it was "based on very low certainty of evidence" that ivermectin helps.

The WHO's review was based on a survey of 16 trials of ivermectin involving 2,400 people, including those comparing it with hydroxychloroquine, an older malaria medicine that has been discredited as a COVID-19 treatment. There were very few placebo-controlled studies of ivermectin.

"We certainly need more data in order to make informed decisions," said Bram Rochwerg, an associate professor at Canada's McMaster University and a co-chair of the WHO panel that reviewed ivermectin.

He said the data available was sparse and likely based on chance, though he said "high quality, trustworthy trials" were still merited.

"We did see an increase in adverse effects in patients that were randomized to ivermectin," he said, citing gastrointestinal upsets and headaches.

Worldwide, he said, there are 66 trials of ivermectin registered, with 60,000 participants, so more data on its impact on the pandemic could be coming.

"We are fighting this overuse of unproven therapies -- especially some of these repurposed drugs -- in various parts of world without evidence of efficacy," Diaz said. "There can be more harm than any good." 

-reuters

Oral COVID treatment yields promising trial data: drugmakers

SAN FRANCISCO - German pharmaceutical giant Merck and a US partner reported promising results Saturday in trials of a drug administered orally to fight COVID-19, saying it helps reduce patients' viral load. 

"At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data," said Wendy Painter, chief medical officer of the US firm, Ridgeback Biotherapeutics.

In January, Merck halted work on two COVID vaccine candidates but has pressed on with research into two products to treat the disease, including a pill-based one called molnupiravir, which it has developed with Ridgeback Biotherapeutics. 

This drug caused a significant drop in patients' viral load after five days of treatment with it, Merck said at a meeting with infectious disease experts.

This Phase 2a test -- drug trials have three stages before a product can be approved -- was carried out among 202 non-hospitalized people with symptoms of COVID-19.

There was no alert in terms of safety, and of four serious adverse events that were reported, none were considered to be related to taking this drug, Ridgeback said. 

Anti-viral oral drugs such as oseltamivir (Tamiflu) and zanamivir (Relenza) are sometimes prescribed for seasonal flu but researchers have yet to come up with something similar to fight the coronavirus.

The findings of this study -- a quicker decrease in viral load among individuals with early-stage COVID-19 who are treated with molnupiravir -- are promising, said William Fischer, lead investigator of the study and a professor of medicine at the University of North Carolina.

"If supported by additional studies, (they) could have important public health implications, particularly as the SARS-CoV-2 virus continues to spread and evolve globally," Fischer added.

Merck is also working on another oral COVID treatment called MK-711. 

Preliminary results from clinical trials with it show a more than 50 percent reduction in risk of death or respiratory trouble in patients hospitalized with moderate to severe Covid-19, the company said in January.

Agence France-Presse