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Non-oral COVID-19 Treatment Options in the Outpatient Setting
The proliferation of treatment options for SARS-CoV-2 can be seen as one of the success stories of the global COVID-19 pandemic.
Individuals who have been diagnosed with COVID-19 and are at high risk of hospitalization may be eligible for treatment with non-oral medications which have received FDA approval or emergency use authorization (EUA). These medications are administered intravenously (IV), typically in an infusion center. They can be divided into two categories: 1) monoclonal antibodies and 2) antiviral drugs.
Antibody Therapy:
Monoclonal antibodies are synthetic versions of antibodies made by the immune system against SARS-CoV-2. The body’s immune system typically takes a couple of weeks to build up antibodies against SARS-CoV-2 after an exposure (either via infection with the virus or via vaccination), therefore the administration of synthetic antibodies can effectively fast-track this targeted immune defense. Antibody treatments work by binding to certain key parts of the virus, blocking the virus from binding to and entering cells.
Antibody treatments with EUA for outpatient use include sotrovimab and bebtelovimab.
Antiviral Therapy:
Remdesivir is an antiviral drug that was previously authorized for use in hospital patients, but just recently (end of January 2022) received FDA authorization for outpatient use. Remdesivir works by incorporating into the viral RNA (ribonucleic acid), inhibiting the ability of SARS-CoV-2 to replicate.
What Are the Treatment Criteria?:
All three of the above medications are approved for use in adult or pediatric (age 12 yo and older, weighing ≥ 40 kg) patients who have mild-to-moderate symptomatic COVID-19 and who are at high risk of progression to hospitalization. In order to be efficacious, they should be started as soon as possible, no later than 7 days after symptoms began.
How Well Do The Treatments Work?
Studies have demonstrated > 80% efficacy of both remdesivir and sotrovimab for preventing hospitalization or death due to COVID-19 (if started with 7 days of symptom onset). Data are still emerging for bebtelovimab; preliminary studies have also shown a reduction in hospitalization or death in high-risk patients.
What Are the Common Side Effects?:
Monoclonal antibody treatments for COVID-19 are generally well tolerated. The most commonly reported side effects are injection site reactions and infusion-related reactions (1% of patients who received sotrovimab experienced infusion-related reactions).
The most common side effects following administration of Remdesivir were nausea, headaches, and rash. Elevated liver enzymes (a laboratory finding) are common in patients who receive Remdesivir, and caution is advised in those individuals with liver or kidney disease.
The new year found Americans mired in the peak of yet another SARS-CoV-2 wave, with the preceding holiday season scarred by overstretched health care systems and testing capacity. In response, the Biden administration has increased the accessibility of at-home COVID-19 tests on multiple fronts.
In January 2022, all US households became eligible to request four free rapid COVID-19 tests either via the website, COVIDTests.gov, or by calling 800-232-0233.
At the same time, the government also mandated that private health insurers cover up to eight at-home antigen tests per month, per covered individual, with reimbursement capped at $12 per testing kit (two tests per kit). Out of pocket costs vary between ~$10-25 per kit. Typically, the insurance provider will cover the upfront cost for in-network pharmacies and retroactively reimburse members who buy test kits from out-of-network pharmacies.
Although Medicare was not initially included in the coverage mandate, at the beginning of February the Biden administration announced that Medicare beneficiaries, including Medicare Advantage, would also become eligible for eight free at-home COVID-19 antigen tests per month, beginning in the early spring.
The expanded coverage will include over 60 million Americans, many of whom fall into the higher risk health category.
Medicaid recipients already have full coverage of at-home COVID-19 tests (8 per month).
If you haven't yet been in the situation where you've received 'the call', the one in which someone you were recently in close contact with rings you a day or two later to let you know they tested positive for COVID-19 (these days, this means positive for the highly transmissible Omicron variant), it’s highly likely that you may be in the coming weeks. Both Dr. Janet Woodcock, acting head of the FDA, and Dr. Anthony Fauci, President Biden's chief medical adviser, stated recently that they expect the majority of Americans will eventually be infected with COVID-19. Mercifully, Omicron infection appears to cause less severe disease than previous variants and a large swath of the population has a degree of protective immunity, either through vaccination and/or a previous infection.
The CDC has recently updated its recommendations for quarantine following COVID-19 exposure. To briefly summarize, if you've just found out you had an exposure and you are not experiencing any symptoms (asymptomatic):
- Stay calm. It takes time for the virus to reach detectable levels. The CDC recommends testing on Day 5 (Day 0 is the day of exposure). Testing experts have noted that Omicron tends to replicate more quickly, though, and suggest that–if possible–at-home testing can begin on day three, and continue daily through day seven.
- If you are fully vaccinated and boosted, then you do not need to quarantine (again, if asymptomatic). However, it is recommended to wear a well-fitting mask, such as an N95 or KN95, for 10 days when you are around other people.
- If you are unvaccinated or vaccinated but did not receive a booster, quarantine for 5 days. If you are asymptomatic, you can stop quarantining but should continue to wear a well-fitting mask such as an N95 or KN95 around others for 5 more days.
If you develop symptoms of COVID-19 AND/OR receive a positive test, isolate for at least 5 days if you have confirmed or suspected COVID-19, regardless of vaccination status. Day 0 is counted as either the first day of symptoms or, for those without symptoms, the date of an initial positive COVID-19 test. Isolation means you stay home, separate yourself from others in your household, and – if necessary to be around them -- wear a well-fitting mask at all times. If you had COVID-19 and had symptoms, you can end isolation after 5 full days if you are fever-free for 24 hours (without taking any fever-reducing medications), provided your other symptoms have improved. If you tested positive for COVID-19 but never developed symptoms, you can end isolation after 5 full days. In all cases, you should continue wearing a well-fitting mask around others for 10 days (days 6 - 10).
Serial Testing: If you want to take a test at the end of the 5-day isolation period, it is best to use an antigen test (the more sensitive PCR test can detect very low levels of virus and will often stay positive for weeks after infection). If the test result is negative, as above, end isolation and continue mask-wearing through day 10. If the test result is positive, you should continue isolating until day 10. If you continue to test positive on an antigen test after day 10, the safest route is to continue isolation until you have a negative test result. For many people, this may not be feasible; if this is the case, experts recommend continuing to wear a highly effective mask, such as an N95 or KN95, around others, and being mindful of your contacts (eg avoid public transportation and situations where immunocompromised persons may be present).
* Please check in with your health care provider for concerning symptoms or test results
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Researchers at the University of California, San Francisco have been evaluating hundreds of pregnant women who tested positive for coronavirus, and the impact it has had on themselves and their babies during pregnancy. The study aims to better understand the correlation between pregnancy and coronavirus. They also want to evaluate a diverse population for a more thorough grasp of the findings. The study is open for women 14 years or older who have tested positive for coronavirus or are experiencing symptoms. In addition, it will examine the impact of the virus on African American and underprivileged women who are more susceptible due to a lack of health care.
As of May 15th, 2020 The Pregnancy Coronavirus Outcomes Registry, or PRIORITY, has registered 706 women to participate in the study. The year long evaluation includes how the virus impacts maternal health, fetal development, early delivery, newborn health, transmission between mother and child, and the correlation between underprivileged women and the risk of higher mortality. Participants are asked to answer questions about their health and pregnancy, permission to review their medical records related to their coronavirus diagnosis and treatment, and contacted up to 7 times within the next year for routine checkups. The PRIORITY website states that they will continuously update their data so all of the information is available to the public eye. For more information about PRIORITY, click here to navigate to their homepage, and click here if you’re a healthcare provider who wants to refer someone, or if you are personally interested in joining the study.
Everyday Health released an article about the importance of making and keeping your appointment to see your gynecologist during the pandemic. If you are interested in learning more, click here to read the article! Make sure to book your appointment with our virtual gynecologist today.
