Posted: 24 May 2021 08:31 AM PDT

Mosquito

Malaria, a mosquito-borne illness, affects millions of people each year across the globe and is responsible for hundreds of thousands of deaths each year. While several medications are available to treat malaria, there is worry about drug resistance developing in areas where the illness is endemic. A new drug compound under development has the potential to address that need.

Researchers from the Francis Crick Institute and the Latvian Institute of Organic Synthesis developed the new compound that blocks a step in the life cycle of the mosquito-borne parasite that causes malaria. The parasites are transmitted through a mosquito bite. The drug compound is designed to prevent the parasites from breaking out of the red blood cells where it makes its home after being transmitted into a person – halting the illness before it starts.

According to Drug Discovery Online, the compound blocks the enzyme SUB1, which is essential to the parasite. The researchers noted that existing anti-malarial drugs are aimed at killing the parasites in the blood cells. But, some of the parasites are becoming resistant to standard treatments.

"Malaria parasites invade red blood cells where they replicate many times, before bursting out into the bloodstream to repeat the process. It's this cycle and build-up of infected red blood cells which causes the symptoms and sometimes fatal effects of the disease," Mike Blackman, lead author and group leader of the Malaria Biochemistry Laboratory at the Crick Institute, said.

"If we can effectively trap malaria in the cell by blocking the parasite's exit route, we could stop the disease in its tracks and halt its devastating cycle of invading cells."

The announcement of the new compound comes at a time when researchers have been ramping up efforts to halt tropical diseases that can overwhelm healthcare resources in many countries during outbreaks. According to the World Health Organization, most malaria cases and deaths occur in sub-Saharan Africa. However, the WHO noted that parts of South-East Asia, the Eastern Mediterranean, Western Pacific, and the Americas are also at risk of the illness.

Two years ago, Novartis committed $100 million and five years of dedicated research to meet a goal of reducing malaria infections by 90% by 2030. The Swiss pharma giant said it would research new treatment options and expand access to pediatric antimalarials and implement healthcare system strengthening programs in four sub-Saharan countries, including Nigeria and the Democratic Republic of the Congo.

More recently, the University of Oxford reported an investigational malaria vaccine that uses Novavax's Matrix-M adjuvant demonstrated 77% efficacy in children over 12 months after initial dosing in a Phase IIb study. The vaccine candidate is dubbed R21/Matrix-M.

As BioSpace previously reported in the higher-dose adjuvant group, the study listed an efficacy of 77%. In the lower dose adjuvant group, they reported 71%. The study involved 12 months of follow-up, and no serious adverse events were observed.

Fact-check: Did India's COVID cases plummet after hydroxychloroquine, ivermectin use? - Austin American-Statesman

Posted: 23 May 2021 06:52 PM PDT

By Tom Kertscher, PolitiFact.com | Austin American-Statesman

Show Caption

Gateway Pundit: "COVID cases in India plummet after government promotes ivermectin and hydroxychloroquine use."

PolitiFact's ruling: Mostly False

Here's why: On May 17, the New York Times reported that the coronavirus crisis was so severe in India, with about 23 million infections confirmed, that the country was accounting for more than half of the world's daily COVID-19 cases.

The same day, The Gateway Pundit posted a story suggesting that two drugs — both of which have drawn warnings from U.S. and global public health officials not to be used for COVID-19 — were having dramatic effects in India.

The headline, widely shared on Facebook, read: "Elites Worried: COVID Cases in India Plummet After Government Promotes Ivermectin and Hydroxychloroquine Use."

More: The AMA didn't rescind statement on hydroxychloroquine

Daily COVID-19 cases in India decreased in the days before May 17 — but only after a nearly vertical rise that started in April and peaked May 8. The Indian government has recommended limited use of the two drugs for COVID-19, but there is no evidence that their use led to the drop in cases.

Neither drug is approved in the U.S. for COVID-19. And both the U.S. Food and Drug Administration and the World Health Organization recommend against using them to prevent or treat COVID-19 infection.

India's recommendations

The Gateway Pundit article links to another article that links to revised guidelines issued April 28 by India's Ministry of Health & Family Welfare. The guidelines, for "home isolation of mild/asymptomatic COVID-19 cases," recommends considering ivermectin as treatment for those patients, and says people in close contact with those patients should take hydroxychloroquine as a prevention "as per protocol and as prescribed by the treating medical officer."

Confirmed new COVID-19 cases in India declined in the days before the article was posted, based on a seven-day rolling average — but only after reaching a peak following a sharp increase that started in April.

Many experts caution that the Indian government's official tallies of confirmed cases likely vastly underestimate the actual infection figures because testing remains limited and the volume of cases has crippled the health care system in some areas. So the actual extent of the decline is not clear.

More: As COVID-19 cases and deaths spike in India, 'a sense of alarm and horror' in US

Hydroxychloroquine and ivermectin are being widely used in India for COVID-19, according to news reports. But there is no evidence they led to the recent decline in confirmed cases, given the lack of clear scientific evidence that they are effective at all in prevention or treatment.

The government's new guidelines don't give a rationale for the recommendations. They were issued several days after a research paper was published that said "results from numerous controlled prophylaxis trials," including some done in India, "report significantly reduced risks of contracting COVID-19 with the regular use of ivermectin."

Doctors in India admitted to have prescribed the drug under compulsion, peer pressure or on patient's demand, according to one news report . The health minister in Goa was quoted as saying ivermectin does not prevent a COVID-19 infection, but helps in reducing the severity of the disease.

Hydroxychloroquine has been in use much longer. In June 2020, a task force of India's health ministry recommended that frontline health care workers take it to prevent COVID-19 infection. According to the journal Nature, the task force cited three new studies conducted by government agencies, only one of which had been published, that the task force said showed it can prevent infection.

Recommendations against hydroxychloroquine

Leading U.S. and global health authorities recommend against using the two drugs for COVID-19.

In March 2020, the U.S. Food and Drug Administration authorized emergency use of hydroxychloroquine, which is FDA-approved to treat or prevent malaria, for certain hospitalized COVID-19 patients. But the FDA revoked its authorization less than three months later, after determining "it is no longer reasonable" to believe that it may be effective in treating COVID-19, "nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks."

The FDA continues to recommend against using it for COVID-19.

In guidelines issued March 2 on drugs to prevent COVID-19, the World Health Organization said: "We recommend against administering hydroxychloroquine prophylaxis to individuals who do not have COVID-19 — strong recommendation, high certainty evidence." And in guidelines issued March 31 on treating COVID-19, the organization gave a "strong recommendation against hydroxychloroquine in patients with COVID-19 of any severity."

Recommendation against ivermectin

In the treatment guidelines, the World Health Organization said: "We recommend not to use ivermectin in patients with COVID-19 except in the context of a clinical trial," citing "very low certainty evidence" about the drug.

The FDA, in an article March 5, said ivermectin should not be used to prevent or treat COVID-19. Ivermectin, which is FDA-approved to treat conditions caused by parasitic worms and parasites such as lice, in large doses "is dangerous and can cause serious harm." An FDA posting April 26 noted that a June 2020 research article described the effect of ivermectin on the coronavirus in a laboratory setting, but that more testing is needed to determine whether ivermectin might be appropriate to prevent or treat coronavirus or COVID-19.

In Austin: As COVID-19 surge devastates India, Austinites come together to send aid, prayers and hope

"It would therefore be premature to conclude absolutely that ivermectin has no place in COVID-19 treatment," Gordon Dent, a senior lecturer in pharmacology at Keele University School of Medicine in England, wrote in April. "On the basis of current evidence, however, its use cannot be recommended."

Our ruling

The Gateway Pundit claimed: "COVID cases in India plummet after government promotes ivermectin and hydroxychloroquine use."

COVID-19 cases in India dropped in mid-May only after a nearly vertical spike in cases over the previous several weeks. The Indian government has given limited recommendations for using the two drugs in connection with mild COVID-19 cases.

There is no evidence that the two drugs caused or contributed to a decline in cases in India. Neither is approved in the U.S. for COVID-19. And both the U.S. Food and Drug Administration and the World Health Organization recommend against using them to prevent or to treat COVID-19 infections, citing lack of scientific evidence of their effectiveness and the potential for serious side effects.

We rate this Mostly False.

Sources

The Gateway Pundit, "Elites Worried: COVID Cases in India Plummet After Government Promotes Ivermectin and Hydroxychloroquine Use," May 17, 2021

Our World in Data, "Daily new confirmed COVID-19 cases," accessed May 19, 2021

PolitiFact, "Fact-checking claim about the use of ivermectin to treat COVID-19," April 23, 2021

DownToEarth, "Ivermectin for COVID-19: Mismatch between global and Indian policies," May 19, 2021

World Health Organization, "WHO Living guideline: Drugs to prevent COVID-19," March 2, 2021

World Health Organization, "Therapeutics and COVID-19: living guideline," March 31, 2021

Reuters, "Fact Check-U.S. government guidance against use of hydroxychloroquine for treating COVID-19 has not changed in 2021," April 14, 2021

U.S. Food and Drug Administration, "Why You Should Not Use Ivermectin to Treat or Prevent COVID-19," March 5, 2021

U.S. Food and Drug Administration, revocation letter, June 15, 2020

U.S. Food and Drug Administration, "FAQ: COVID-19 and Ivermectin Intended for Animals," April 26, 2021

U.S. Food and Drug Administration, "Antiviral Drugs That Are Approved or Under Evaluation for the Treatment of COVID-19," Feb. 11, 2021

Quartz, "India is fighting a healthcare crisis of unimaginable proportions with woefully outdated science," April 30, 2021

India Ministry of Health & Family Welfare, "Revised guidelines for Home Isolation of mild /asymptomatic COVID-19 cases," April 28, 2021

American Journal of Therapeutics, "Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19," April 22, 2021

The Conversation, "Ivermectin: why a potential COVID treatment isn't recommended for use," April 19, 2021

Nature, "India expands use of controversial drug for coronavirus despite safety concerns," June 3, 2020

Experts Warn Against Using Ivermectin to Treat COVID-19 - Verywell Health

Posted: 26 Apr 2021 12:00 AM PDT

A medication label that reads "Ivermectin 3 mg tablet" with 3 white tablets on it.

Callista Images / Getty Images

Key Takeaways

Experts are warning that there is not enough evidence to support using a drug called ivermectin to treat COVID-19.
Ivermectin is used to treat parasitic worms. Some forms of ivermectin are intended for animals and are not safe for humans to consume.
According to the NIH, FDA, and WHO, studies on using ivermectin to treat COVID-19 have been inconclusive so far.

An unlikely drug is gaining attention as a potential treatment for COVID-19, but experts are warning against its use.

Interest in ivermectin, an inexpensive medication typically used to treat parasitic infections in both humans and animals, as a COVID-19 "miracle drug" began in June 2020 when a study found that it could reduce the viral replication of SARS-CoV-2 in vitro—or outside of a living organism.

What Is Ivermectin?

Ivermectin is a drug approved by the FDA to treat conditions caused by parasitic worms like strongyloidiasis and onchocerciasis (river blindness). It's typically an oral medication taken as a single dose, but topical formulations can be used for head lice or rosacea.

However, there is no conclusive data showing that ivermectin is effective at killing viruses inside the human body. And experts, including the Food and Drug Administration (FDA), are warning against its use for COVID-19.

Ivermectin for Animals

Ivermectin is not a new drug—Inci Yildirim, MD, PhD, a vaccinologist and pediatric infectious disease specialist at Yale Medicine and an associate professor of medicine and global health at the Yale School of Medicine, tells Verywell that it's been used in humans "since the early 1980s," and "has been on the veterinary market even longer for almost half a century."

Ivermectin was labeled as a "wonder drug" before COVID-19 because of its ability to treat parasitic infections, especially river blindness, which caused significant social and economic burdens in certain communities in Africa and South America.

People with pets are probably more familiar with the forms of ivermectin that are used to prevent heartworm disease and certain parasites. It's crucial for people to understand that the form of the drug used for their pets is not meant or safe for humans to take.

"Animal ivermectin products are usually highly concentrated and they include other ingredients that can be very dangerous for the human body," Yildirim says. "We should not self-medicate with ivermectin intended for animals such as horses or cows. Doses approved to be safe and effective in humans are different from the doses used in animals."

The FDA reports cases of people who required medical support and even hospitalization after taking ivermectin medications intended for horses.

No Evidence to Support Ivermectin for COVID

In the earlier phases of the pandemic, there were no FDA-approved COVID-19 treatments or vaccines. Many potential treatments were on researchers' radar, and ivermectin was among them.

"During that time, a group of researchers from Australia reported that ivermectin was reducing the viral replication in their experiment using cell cultures—in vitro, not in an animal or a human being—and suggested it warrants further investigation for possible treatment effect," Yildirim says.

The FDA, the National Institutes of Health (NIH), and the World Health Organization (WHO), currently state that there is insufficient data on the use of ivermectin to treat COVID-19 patients.

Merck, the company that makes ivermectin, also states that there is no evidence of the drug's therapeutic effect against COVID-19.

Lab Results Don't Always Translate to Human Use

Even though researchers found ivermectin slowed the replication of SARS-CoV-2, the virus that causes COVID-19, in a lab, that finding may not hold true within the body.

Nasia Safdar, MD, PhD, professor of infectious diseases at the University of Wisconsin School of Medicine and Public Health, tells Verywell that a dosage that works in a lab does not necessarily reflect the dose needed in humans, which might be too high to achieve safely.

Sharon Nachman, MD

Natural remedies sound nice, but there is no science or clinical trial data behind them, just personal attestations and strong feelings.

— Sharon Nachman, MD

"Think of it as a big hammer on a plate," Sharon Nachman, MD, chief of the Division of Pediatric Infectious Diseases at Stony Brook Children's Hospital in New York, tells Verywell. "Yes, you broke the plate, but you also destroyed the table and sent splinters all over the room. We don't want that kind of approach to guide us when we think a medication is ready for use in humans."

Nachman agrees with Safdar, adding that "it is but the earliest step and rarely results in efficacy in humans. Far too often these types of 'effects' are too lethal or too toxic to humans and the drug never moves past the petri dish stage."

Inconclusive Studies

While there have been, and currently are, studies evaluating the use of ivermectin to treat COVID in humans, the results are not conclusive.

A 2020 review suggested that the ivermectin doses used for inhibiting SARS-CoV-2 are not attainable in humans. A 2021 study published in JAMA Network in March showed that giving a five-day course of ivermectin to adult patients with mild COVID-19 did not reduce the duration of their symptoms.

"Many other studies after [the initial in vitro research], including the randomized clinical trials where COVID-19 patients were given ivermectin, and outcomes were compared to other treatment options, there was no benefit or worsening of disease after ivermectin use," Yildirim says. "Some studies showed patients who took ivermectin cleared the virus faster, but it didn't have any impact on the resolution of the symptoms."

What This Means For You

Ivermectin is approved by the FDA to treat conditions like strongyloidiasis and onchocerciasis. However, no data currently proves that it can treat COVID-19. To avoid harm, you should not take any unapproved COVID-19 medications or treatments.

Why Are People Turning to Ivermectin?

"Natural remedies sound nice," Nachman says. "But there is no science or clinical trial data behind them, just personal attestations and strong feelings."

Nachman points to fear and uncertainty around COVID vaccination as a possible factor driving the interest in ivermectin.

"There is a lot of vaccine hesitancy regarding COVID-19 vaccines," Nachman says. "However, as someone who has seen so many adults with COVID-19 in the hospital and too often dying from COVID-19, or suffering from symptoms that last way beyond their initial illness, I can only say that the illness is real and that prevention is the only way that we will get past this pandemic."

Safdar says that some people are choosing to self-medicate and forgo COVID-19 vaccination because of the misinformation about the pandemic and mistrust in the vaccine.

Goals of Future Research

The NIH has acknowledged published studies and randomized trials investigating the use of ivermectin in COVID-19 patients. However, it emphasizes that no conclusive verdict can be made on the drug's clinical benefit because the studies had significant limitations.

Limitations of Ivermectin Research

The research on ivermectin for treating COVID thus far has limitations, including:

Small sample sizes for most studies
Varied ivermectin dosage and schedule
Some trials were open-label (the participants and investigators knew which treatments were given)
Subjects were taking other medications at the time of the study (which can affect results)
COVID-19 severity in participants was not described well
Some studies did not have well-defined outcome measures

Safdar says that well-designed clinical trials will be needed to evaluate the use of ivermectin in relation to COVID-19—some of which are in progress already. While this is encouraging, it's important to hold these studies to a rigorous standard.

Researchers hope that the results of the current and future clinical trials will provide conclusive data on the use of ivermectin for COVID-19.

For now, avoid unconventional and unapproved treatments that can cause serious harm. Instead, focus on the safe and effective tools that we have and know work: wear a face mask, social distance, and get a COVID-19 vaccine.

"We now have more than one safe and effective vaccine against SARS-CoV-2," Yildirim says. "We know that social distancing, wearing your mask, and washing your hands frequently are very effective ways to limit the spread of COVID-19."

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.

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