Plaquenil Antiviral Medication — Precision Vaccinations - PrecisionVaccinations

Plaquenil (Hydroxychloroquine) and chloroquine are used to prevent or treat malaria caused by mosquito bites. It does not work against certain types of malaria (chloroquine-resistant). 

And, Plaquenil (Hydroxychloroquine) is FDA-approved for the treatment of rheumatoid arthritis, systemic lupus erythematosus, and porphyria cutanea trade. Hydroxychloroquine is a more soluble and less toxic metabolite of chloroquine, which causes fewer side effects and is, therefore, assumed to be safer. 

Hydroxychloroquine sulfate is a colorless crystalline solid, soluble in water to at least 20 percent; chemically the drug is 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1).

Studies indicate chloroquine was first used as prophylaxis and treatment for malaria. Chloroquine (CQ) is a lysosomotropic antimalarial drug that neutralizes lysosomal acidification, thus blocking autophagosomal degradation.

Hydroxychloroquine (Plaquenil) can effectively treat disease manifestations, such as joint pain and rashes; reduce thrombotic events; and prolong survival. Chloroquine use for influenza prevention has been researched for years.

The U.S. FDA issued Authorization to permit the emergency use of hydroxychloroquine sulfate to treat adults and adolescents who are hospitalized with COVID-19 disease. Based upon limited in-vitro and anecdotal data, chloroquine or hydroxychloroquine are currently recommended for the treatment of hospitalized COVID-19 patients in several countries.

Whereas the evidence supporting the use of antimalarial medications for COVID-19 disease is equivocal, the evidence for the use of these drugs to treat immune-mediated diseases is not.

On April 7, 2020, the FDA approved an Abbreviated New Drug Application (ANDA) for Hydroxychloroquine (Plaquenil) Sulfate Tablets USP, 200 mg. for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax. Chronic discoid lupus erythematosus and systemic lupus erythematosus in adults and; Treatment of acute and chronic rheumatoid arthritis in adults.

And, on May 14, 2020, the FDA approved another ANDA for Hydroxychloroquine Sulfate Tablets USP, 200 mg for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax; Chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; Treatment of acute and chronic rheumatoid arthritis in adults.

Side effects of hydroxychloroquine include irreversible retinal damage, cardiac effects (including cardiomyopathy and QT prolongation, worsening of psoriasis and porphyria, proximal myopathy, and neuropathy, neuropsychiatric events, and hypoglycemia.

• May 28, 2020 - More than one-third of people with lupus experienced significant issues filling their hydroxychloroquine (Plaquenil) prescriptions during the COVID-19 pandemic according to results of a new survey conducted by the Lupus Research Alliance.

• May 27, 2020 - European Countries Ban Hydroxychloroquine Treatments for COVID-19 Patients.

• May 26, 2020 - The U.S. Food and Drug Administration approved artesunate for injection to treat severe malaria in adult and pediatric patients. Treatment of severe malaria with intravenous (IV) artesunate should always be followed by a complete treatment course of an appropriate oral antimalarial regimen.

• May 25, 2020 - The WHO temporarily suspended its trial of hydroxychloroquine over safety concerns. “The Executive Group has implemented a temporary pause of the hydroxychloroquine arm within the Solidarity Trial while the safety data is reviewed by the Data Safety Monitoring Board,” WHO Director-General Tedros Adhanom Ghebreyesus told reporters at a news briefing. 

• May 24, 2020 - 'We received a letter from the MHRA in which they notified us of their concerns relating to the use of hydroxychloroquine as a treatment for patients with COVID-19 in the light of the recent publication by Mehra et al in The Lancet on 22 May 2020. We have held two videoconferences with the MHRA and provided a detailed response which is summarised below. This morning we have received written confirmation from the MHRA that, “it is acceptable to allow continued randomization (of additional patients) into the hydroxychloroquine arm of the trial.'

• May 23, 2020 - Vizient, a group purchasing organization that serves about 3,000 hospitals in the U.S., said the demand for hydroxychloroquine in April was about 17 times bigger than in January 2020. Although supply expanded during the period, the volume available last month was only about half of the units ordered.

• May 22, 2020 - The Indian Council of Medical Research, India’s apex body in the field, has found that consuming the drug hydroxychloroquine reduces the chances of getting infected with Covid-19 disease.

• May 22, 2020 - A new study published in The Lancet was 'unable to confirm a benefit of hydroxychloroquine or chloroquine, when used alone or with a macrolide, on in-hospital outcomes for COVID-19. Each of these drug regimens was associated with decreased in-hospital survival and an increased frequency of ventricular arrhythmias when used for the treatment of COVID-19 disease.'

• May 20, 2020 - Brazil's Health Ministry issued new guidelines for wider use of antimalarial drug hydroxychloroquine in mild coronavirus cases. With the new guidelines, the health ministry now recommends the use of chloroquine or hydroxychloroquine by all Covid-19 patients, including children, starting in the early stages of infection. They must be prescribed by a doctor and patients will have to sign a document saying they understand the risks of taking the medication.

• May 20, 2020 - Media reports indicate that the anti-malarial drug hydroxychloroquine is being bought in bulk by the UK in case it does turn out to be an effective COVID-19 disease treatment, and or used for prevention purposes. The contract, which was uploaded to a government website on May 15, 2020, is an “open opportunity” for pharmaceutical suppliers to supply more than 33m tablets of various drugs between June and January 2021.

• May 20, 2020 - Progenabiome announced it is starting two FDA-approved clinical trials that include hydroxychloroquine. One clinical trial is for the prevention of COVID-19 disease. The second clinical trial is for the treatment of COVID-19, once infected by the coronavirus.

• May 19, 2020 - The leader of the U.S. FDA said taking the antimalarial drug hydroxychloroquine outside of a hospital is an option. “The decision to take any drug is ultimately a decision between a patient and their doctor,” FDA Commissioner Dr. Stephen Hahn said in a statement to CNBC.

• May 19, 2020 - JAMA posted an article which says 'the US FDA issued a EUA for the use of hydroxychloroquine for certain hospitalized patients diagnosed with coronavirus disease 2019 (COVID-19). Hydroxychloroquine has long been FDA-approved for the prophylaxis and treatment of malaria and used in the treatment of systemic lupus erythematosus and rheumatoid arthritis. Although this drug appears to inhibit coronavirus replication in vitro, at the time of the EUA, there was no reliable clinical evidence to support the use of these drugs to treat COVID-19 in patients.

• May 14, 2020 - The US NIH begins a phase 2b clinical trial of hydroxychloroquine and azithromycin to treat COVID-19 disease. This study is enrolling 2,000 adults with mild to moderate COVID-19 in the United States. Hydroxychloroquine is FDA-approved to prevent and treat malaria, as well as to treat the autoimmune diseases rheumatoid arthritis and lupus. Heading the study is Davey Smith, M.D., a translational research virologist, head of Infectious Diseases, and Global Public Health at the University of California San Diego School of Medicine. 

• May 14, 2020 - BMJ: Clinical efficacy of hydroxychloroquine in patients with COVID-19 pneumonia who require oxygen: an observational comparative study using routine care data.

• May 14, 2020 - Early clinical trials of an antiviral drug Hydroxychloroquine in Russia have given “promising” results in treating the new coronavirus, a joint venture announced Wednesday as Russia faced mounting Covid-19 cases.

• May 14, 2020, The U.S. FDA issued an ANDA for Hydroxychloroquine Sulfate Tablets USP, 200 mg for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax; Chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; Treatment of acute and chronic rheumatoid arthritis in adults. This Applicant Holder Full Name: HAVIX GROUP INC DBA AAVIS PHARMACEUTICALS.

• May 13, 2020 - Phase 2 Clinical Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy launched by Memorial Sloan Kettering Cancer Center.

• May 11, 2020 - The present study suggests a potential interest in the combination therapy using HCQ/azithromycin for the treatment of COVID-19 in in-hospital patients.

• May 7, 2020 - Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19, published by the NEJM. These researchers found that patients who received hydroxychloroquine had the same risk of intubation or death, as patients who did not receive the malaria drug.

• May 5, 2020 - Early treatment of COVID-19 patients with hydroxychloroquine and azithromycin: A retrospective analysis of 1061 cases in Marseille, France.

• April 29, 2020 - In the largest reported cohort to date of COVID-19 patients treated with chloroquine/hydroxychloroquine {plus minus} azithromycin, no instances of TdP or arrhythmogenic death were reported. Although the use of these medications resulted in QT prolongation, clinicians seldomly needed to discontinue therapy.

• April 27, 2020 - In a letter to Gov. Doug Ducey of Arizona, the Association of American Physicians and Surgeons, presented an updated table of studies that report results of treating COVID-19 patients with chloroquine (CQ) and hydroxychloroquine (HCQ, Plaquenil). 'Based on this evidence, we request that you rescind your Executive Orders impeding the use of CQ and HCQ and further order that administrative agencies do not impose any requirements on the prescription of CQ, HCQ, azithromycin, or other drugs intended to treat or prevent coronavirus illness that does not apply equally to all approved medications that may be used off-label for any purpose.'

• April 26, 2020 - At least 22 states and Washington, D.C., secured shipments of the drug, hydroxychloroquine, according to information compiled from state and federal officials.

• April 24, 2020 - FDA cautions against the use of hydroxychloroquine or chloroquine for COVID-19 disease treatment outside of the hospital setting or a clinical trial due to the risk of heart rhythm problems.

• April 24, 2020 - Hydroxychloroquine or Chloroquine for COVID-19: FDA Drug Safety Communication.

• April 24, 2020 - Brazil’s Federal Council of Medicine has authorized the use of hydroxychloroquine, even though there is no scientific evidence that the drug is an effective treatment for the novel coronavirus.

• April 22, 2020 - Hydroxychloroquine could be considered by healthcare professionals for pediatric patients who are diagnosed with severe COVID-19 disease and are not candidates for remdesivir or when remdesivir is not available.

• April 21, 2020 - A non-peer-reviewed study 'Outcomes of hydroxychloroquine usage in United States veterans hospitalized with COVID-19' found no evidence that the use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalized with COVID-19 disease. An association of increased overall mortality was identified in patients treated with hydroxychloroquine alone.

• April 20, 2020 - Pharmacists Help Weigh Cardiac Risks of Hydroxychloroquine. Cardiovascular side effects are more likely to occur with prolonged therapy at high doses, said Dr. White, so pharmacists should urge providers to stick with lower doses of hydroxychloroquine for no more than 10 days, and include a cardiologist in patient assessment and monitoring.

• April 20, 2020 - Novartis announced it has reached an agreement with the US Food and Drug Administration (FDA) to proceed with a Phase III clinical trial with approximately 440 patients to evaluate the use of hydroxychloroquine for the treatment of hospitalized patients with COVID-19 disease. The clinical trial drug supply will be provided by Sandoz, the generics and biosimilars division of Novartis.

• April 17, 2020 - The Russian government has authorized hospitals to treat coronavirus patients with the untested malaria drug hydroxychloroquine, which studies have linked to potentially deadly side effects. This decree instructs Russia’s national medical cardiology research center to distribute 68,600 packs of hydroxychloroquine donated by a Shanghai pharmaceutical company to hospitals across Russia for free.

• April 17, 2020 - The Indian Council of Medical Research, under the Ministry of Health and Family Welfare, has recommended chemoprophylaxis with hydroxychloroquine (400 mg twice on day 1, then 400 mg once a week thereafter) for asymptomatic health-care workers treating patients with suspected or confirmed COVID-19, and for asymptomatic household contacts of confirmed cases.

• April 16, 2020 - Hydroxychloroquine: The Drug Costa Rica Uses Successfully To Fight Covid-19.

• April 14, 2020 - The administration of HCQ did not result in a higher negative conversion rate but more alleviation of clinical symptoms than standard-of-care alone in patients hospitalized with COVID-19 without receiving antiviral treatment, possibly through anti-inflammatory effects. Adverse events were significantly increased in HCQ recipients but no apparently increase of serious adverse events. Trial registration ChiCTR2000029868.
• April 13, 2020 - The governor of South Dakota announced it is launching the first statewide trial of a possible treatment for COVID-19 in the nation. The drug hydroxychloroquine typically treats malaria, lupus, and rheumatoid arthritis.
• April 13, 2020 - The U.S. FDA announced, 'given this public health emergency, and as discussed in the Notice in the Federal Register of April 13, 2020, titled “Product-Specific Guidances; Guidance for Industry,” available at Federal Register - Guidance: Product-Specific Guidances the PSG for chloroquine phosphate, hydroxychloroquine, is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the FD&C Act and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the FDA’s good guidance practices.
• April 11, 2020 - A new study was performed by researchers at IHU Méditerranée Infection, Marseille, France, of the 1,061 coronavirus infected patients who were treated entirely with hydroxychloroquine and azithromycin, mortality is around 0.5% and that the cure rate is extremely high. It avoids worsening and clears virus persistence and contagiously in most cases.
• April 9, 2020 - The Outcomes Related to COVID-19 treated with hydroxychloroquine among In-patients with symptomatic Disease study, or ORCHID Study, is being conducted by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health.
• April 8, 2020 - The ORCHID trial (Outcomes Related to COVID-19 treated with Hydroxychloroquine among In-patients with symptomatic Disease), funded by the National Heart, Lung and Blood Institute of the National Institutes of Health, enrolled its first patient on April 2 and will include hundreds of patients to determine if hydroxychloroquine is an effective treatment against the virus projected to hospitalize thousands of U.S. residents in the coming weeks.
• April 8, 2020 - Researchers from Intermountain Healthcare and the University of Utah Health in Salt Lake City have launched two vital clinical trials to test the effectiveness and safety of two drugs—hydroxychloroquine and azithromycin—to treat patients with COVID-19 (infection with the novel coronavirus). Researchers from the two health systems plan to enroll nearly 2,300 patients who are COVID-19 positive or suspected of being positive for the virus.
• April 7, 2020 - The FDA approved an Abbreviated New Drug Application for Hydroxychloroquine Sulfate Tablets USP, 200 mg.
• April 3, 2020:  Novartis announced the donation of a substantial amount of hydroxychloroquine to treat hospitalized COVID-19 patients within Switzerland. The aim of the donation is to enable patients to access a potential treatment while also advancing clinical research in the fight against COVID-19.
• April 2, 2020 - Henry Ford Health System to lead a national study to determine the drug's effectiveness in preventing COVID-19 disease.
• March 31, 2020:  Use of Hydroxychloroquine and Chloroquine During the COVID-19 Pandemic: What Every Clinician Should Know. American College of Physicians.
• March 30, 2020:  No Evidence of Rapid Antiviral Clearance or Clinical Benefit with the Combination of Hydroxychloroquine and Azithromycin in Patients with Severe COVID-19 Infection.
• March 30, 2020:  Efficacy of hydroxychloroquine in patients with COVID-19 disease in a randomized clinical trial, found the use of HCQ could significantly shorten TTCR and promote the absorption of pneumonia.
• March 30, 2020:  About 83 percent of independent pharmacists in the USA said they should be able to dispense a limited supply of malaria drugs, as long the patient has tested positive ..... and is under a doctor's care.
• March 29, 2020: Novartis Chief Executive Vas Narasimhan said his Sandoz generics unit's malaria, lupus and arthritis drug hydroxychloroquine, plans to donate up to 130 million 200 mg doses by the end of May, including its current stock of 50 million 200 mg doses and is supporting clinical trials needed before the medicine can be approved for use against the coronavirus.
• March 28, 2020:  The FDA issued an Emergency Use Authorization for the use of oral formulations of chloroquine phosphate and hydroxychloroquine sulfate for the treatment of 2019 coronavirus disease (COVID-19) when administered by a healthcare provider pursuant to a valid prescription of a licensed practitioner as described in the Scope of Authorization (section II) of this letter.
• March 25, 2020:  The FDA added hydroxychloroquine sulfate to category 1 under the Interim Policy on Compounding Using Bulk Drug Substances, Under Section 503B of the Federal Food, Drug, and Cosmetic Act.
• March 25, 2020: The WHO urges countries to ensure the continuity of malaria services in the context of the COVID-19 pandemic.
• March 22, 2020: India's Secretary of Health issued a statement that the National Task Force for COVID-19 disease officially recommends prophylactic use of hydroxychloroquine for healthcare workers and families of laboratory-confirmed positive COVID-19 patients.
• August 22, 2005: Chloroquine is a potent inhibitor of SARS coronavirus infection and spread.

Hydroxychloroquine is currently under investigation in clinical trials for pre-exposure or post-exposure prophylaxis of SARS-CoV-2 infection, and treatment of patients with mild, moderate, and severe COVID-19. In the United States, several clinical trials of hydroxychloroquine for prophylaxis or treatment of SARS-CoV-2 infection are planned and will be enrolling soon.

One small study reported that hydroxychloroquine alone or in combination with azithromycin (Z-Pak) reduced the detection of SARS-CoV-2 RNA in upper respiratory tract specimens compared with a non-randomized control group but did not assess clinical benefit.

Clinical Trial NCT04332991: Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease (ORCHID) (Phase 3).

Clinical Trial NCT04308668: Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2 (COVID-19 PEP) (Phase 3)

Clinical Trial NCT04333654: Hydroxychloroquine in Outpatient Adults With COVID-19 (Phase1).Primary Objective: To assess the effect of hydroxychloroquine versus placebo on nasopharyngeal SARS-CoV-2 viral load in outpatient adults with COVID-19.

Clinical Trial NCT04321278: Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-CoV2 Virus (Phase 3).

Clinical Trials NCT04358068: Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19.

Note: This content is aggregated from the CDC, WHO, clinical studies, and the Precision Vax news network. This information is fact-checked by healthcare professionals, such as Dr. Robert Carlson.