The HSI Cyber Operations Officer (COO) noted the phone number “+1-718-475-90-88” on the pharmacywalmart.com website. While the location for the area code for this number is New York City, the format provided does not match that of a typical United States based phone number. Pharmacywalmart.com purports to offer for sale a number of drugs, including Stromectol (Ivermectin), Aralen (Chloroquine) and Kaletra (Lopinavir and Ritonavir), for the experimental and unapproved treatment or prevention of COVID-19.
As detailed in the affidavit filed in support of the seizure, Stromectol is the brand name of Ivermectin which is a prescription medication used to treat certain parasitic infections; Aralen is a brand name for chloroquine, most commonly used for the treatment and prevention of malaria; and Kaletra is the brand name of a combination of Lopinavir and Ritonavir which are prescription medications that are approved to treat human immunodeficiency virus 1 (HIV-1). None of those drugs are an approved preventative or treatment for COVID-19. On the page offering Kaletra for sale, the subject domain name contained the following: “In 2020, after laboratory researches, it was found out that Kaletra shows positive results in a blockage of a COVID-19 viral replication.” The affidavit alleges that this statement is not supported by trials or the FDA.
Some observational cohorts and clinical trials have evaluated the use of ivermectin for the prevention and treatment of COVID-19. Data from some of these studies can be found in Table 2c.
Recommendation
There is insufficient evidence for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the use of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.
Rationale
Ivermectin has been shown to inhibit the replication of SARS-CoV-2 in cell cultures.13 However, pharmacokinetic and pharmacodynamic studies suggest that achieving the plasma concentrations necessary for the antiviral efficacy detected in vitro would require administration of doses up to 100-fold higher than those approved for use in humans.14,15 Even though ivermectin appears to accumulate in the lung tissue, predicted systemic plasma and lung tissue concentrations are much lower than 2 µM, the half-maximal inhibitory concentration (IC50) against SARS-CoV-2 in vitro.16-19 Subcutaneous administration of ivermectin 400 µg/kg had no effect on SARS-CoV-2 viral loads in hamsters. However, there was a reduction in olfactory deficit (measured using a food-finding test) and a reduction in the interleukin (IL)-6:IL-10 ratio in lung tissues.20
Dosage and Administration
Your doctor will tell you how many tablets you need to take. The dose depends on your infection and your weight or height. The dose usually ranges from one tablet to five tablets taken as a single dose. For river blindness, you may need to take another dose in 6 to 12 months' time. Depending on whether you have typical or crusted scabies, your doctor will decide the best treatment for you. The most common course of treatment is two doses, 8-15 days apart. Stromectol can be used alone or in combination with other treatments for scabies.
Warnings and Precautions
Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis. These reactions are probably due to allergic and inflammatory responses to the death of microfilariae. Patients treated with Stromectol (ivermectin) for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself.