COVID-19 (CORONAVIRUS) TREATMENTS UNDER
CONSIDERATION
At PBIRx, our
highly experienced and educated Clinical Staff, including licensed registered pharmacists
and PharmDs, have done careful research to share the following treatments that
are being considered for use in the United States and/or being evaluated globally
in clinical trials. It is important to note that as data continues to be
collected, new treatment options will emerge.
COVID-19
(coronavirus) is a new global virus with currently no FDA
approval of medications to treat infected patients or vaccines to prevent its
rapid spread. However, since the virus began to infect and kill people in China
in December 2019, medical professionals, including pharmaceutical manufacturers
around the world, have been working to create a vaccine, while also evaluating many
different drugs and combinations of drugs to treat and prevent COVID-19.
It is important
to note that all drugs have possible adverse effects and the research focuses
on the possible risk of side effects versus potential efficacy in human
patients. Agents being used at this time are being administered in an
experimental setting under controlled conditions. No one is administered a drug
for COVID-19 without a doctor’s authorization. Data on drug effectiveness and
safety are collected by enrolling infected patients into clinical trials or through
compassionate use as they are treated.
Some of the drugs being used for COVID treatment are approved for other uses in
the United States while others have only been used in other countries until now.
Treatment options
often depend on many factors including age of patient, comorbidities, side
effect risks, severity of coronavirus symptoms, patient specific allergies, and
availability/accessibility, etc.
The first drug
approved in China, or anywhere, to treat COVID-19 is Favilavir, known
generically as favipiravir or under the brand name Avigan
in Japan. Avigan is an
anti-viral drug that is active against RNA viruses and marketed in Japan for
treatment of influenza.
According
to China National Center for Biotechnology, Favilavir demonstrated
an encouraging profile with mild adverse reactions in seventy (70) COVID-19 patients
in a clinical trial in Shenzhen
and Guangdong Provinces. The National
Medical Products Administration of China has therefore approved the use of Favilavir,
based on such clinical trials. Researchers noted that the drug has reportedly
shown efficacy in hindering the spread and treating the disease with minimal
side effects.
Favipiravir has also shown effectiveness in other reports of its treatment of
COVID-19 in China. Chinese medical authorities reported positive
responses in favipiravir clinical trials conducted in Wuhan and
Shenzhen composed of 340 people. About 91% of infected patients treated with favipiravir
showed improved lung function compared to 62% who did not receive any treatment
and did not show improvement. More significantly, those treated with favipiravir
had a median of four (4) days to test negative, compared to eleven (11) days
among those that did not receive treatment. Some health officials noted that the results
have not been as promising in people with a higher viral load and more severe
symptoms. Favipiravir is also being developed in Japan for West
Nile virus, yellow fever, and rabies.
Other drugs
showing efficacy, which also do not have FDA approval in the US for COVID -19
treatment are the anti-malaria drugs hydroxychloroquine and chloroquine
as well as Gilead’s experimental broad-spectrum antiviral drug remdesivir.
Hydroxychloroquine/chloroquine (brand name Plaquenil/Aralen, Resochin) are currently used in the United States and around the world to
treat a variety of conditions that include malaria, lupus, and rheumatoid
arthritis. Now they are being evaluated to determine if their use in COVID-19
infected patients leads to improved virological clearance and reduced mortality.
President Trump announced on March 19th that the FDA has approved testing
of hydroxychloroquine and chloroquine for the
treatment of COVID-19 through clinical trials and “compassionate use”. Below
are links to publications describing 100 patients effectively treated with chloroquine
in Wuhan, ten (10) hospitals throughout China effectively treating patients with
hydroxychloroquine, and twenty four (24) patients in France effectively treated
with chloroquine. The results in France are not officially published
yet.
The most recently
talked about and seemingly most positive of all is a new study published in the
International Journal of Antimicrobial Agents.
The study was conducted after reports from the treatment of Chinese
patients indicated that a combination of hydroxychloroquine with
a popular antibiotic shortened the duration of COVID-19infection. The new study found early evidence that the
combination of hydroxychloroquine and the antibiotic azithromycin
(Zithromax, Z-pack) could be especially effective in
treating the virus and reducing its duration in patients. The researchers
performed this study in thirty (30) confirmed COVID-19 patients comparing hydroxychloroquine
on its own or in combination with azithromycin to control
patients (received neither treatment). Hydroxychloroquine was
effective on its own and even more effective, by a significant margin, when
combined with azithromycin.
Hydroxychloroquine eliminated the COVID virus in over fifty (50)
percent of patients in 6 days while the combination eliminated the virus all
patients in five (5) days. At
enrollment, six (6) patients in the study presented with no symptoms (n=6),
twenty two (22) patients presented with upper
respiratory tract symptoms (sneezing, headaches and sore throats, n=22), and eight
(8) patients presented with lower respiratory tract symptoms (mostly coughing,
n=8).
Remdesivir a broad-spectrum nucleoside
inhibitor antiviral, also known as GS-5734, has received a lot of attention in
the media. Remdesivir is under investigation by Gilead Sciences
for treatment of Ebola virus (a filovirus) and has shown activity against other
respiratory RNA viruses like SARS-CoV and MERS-CoV. The World Health
Organization (WHO) has noted Remdesivir efficacy in treating the
coronavirus in China. There are now several studies ongoing to establish its
safety, effectiveness and dosing against COVID-19. Four (4) of these studies are located within the
United States. Of note, currently there are concerns with its safety. GI issues
and elevated liver enzymes are most notable, although this is not uncommon with
other anti-viral medications.
Kaletra
(lopinavir and ritonavir),
a drug used to treat HIV in the United States, is being evaluated beyond its
current FDA indication, for use in COVID-19. There have been reports in both
China and the US of its effectiveness in treating some COVID-19 patients. It
was effective in combination with chloroquine in an HCP in New
Jersey who said he “would be dead and gone” if not for this treatment. Kaletra,
an antiretroviral agent has formerly been shown to be effective against
severe acute respiratory syndrome (SARS) in-vitro. In clinical trials, the
medication is being studied alone and in combination with other anti-viral drug
ribavirin and with interferon.
Below are links
to guidelines from China for COVID-19 treatments, including dosing used for lopinavir/ritonavir
and other antivirals such as ribavirin.
Additionally, corticosteroids
are being investigated in multiple trials for the novel virus. Steroids have
been and continue to be used in the treatment of other severe coronavirus
infections including SARS and MERS to manage symptoms. Several alarming concerns
have arisen from those uses and interim guidance from the WHO recommends
against using corticosteroids in patients with COVID-19 unless they have
another indication.
A potential
vaccine made by Moderna in collaboration with the National Institute of Allergy
and Infectious Diseases is currently being evaluated and tested in the Seattle
area. Their aim is to illicit the immune system to develop antibodies against a
“spike protein” found on the virus.
Johnson &
Johnson, Eli Lilly and Pfizer are also actively working to develop a vaccine.
The University of
Minnesota is evaluating the hypertension drug losartan to see how
effective it can be to reduce the risk of organ failure for hospitalized
COVID-19 patients, and if it can reduce the need for hospitalization.
Specialty drugs
like Kevzara and Actemra are also being tried in
new ways to treat the lung inflammation caused by COVID-19.
The WHO
identifies baloxavir (brand name Xofluza),
a newer medication approved for influenza in the US, also as a possible COVID
treatment candidate; however, there have been supply issues since the beginning
of the flu season. It is important to note that the WHO is the only institution
identifying Xofluza as a potential therapeutic candidate at this
time. More well known in the United States is Tamiflu (oseltamivir) which has been recommended by WHO for
influenza pandemics. Tamiflu is part of a clinical trial being held in Thailand that will combine it with protease
inhibitors, favipiravir, and chloroquine for
treatment of COVID-19.
Lastly, many reports
advising against the use of the anti-inflammatory drug ibuprofen
(brand name Motrin/Advil) have come out since
Olivier Veran, the French health minister, tweeted last weekend about some
patients in France experiencing serious side effects. However, the European
Medicines Agency issued a statement on March 18th that there is
“currently no scientific evidence establishing a link between ibuprofen
and worsening of COVID-19.” The World Health Organization tweeted: “Based on
currently available information, WHO does not recommend against the use of ibuprofen.
We are also consulting with physicians treating COVID-19 patients and are not
aware of reports of any negative effects of ibuprofen, beyond the usual known
side effects that limit its use in certain populations.”
In summary, at
this time it remains to be determined how to most effectively treat (and
hopefully soon prevent) COVID-19. The global medical community continues to
work diligently to minimize the effects of COVID-19 and as new data becomes
available, treatment options will inevitably continue to be updated in this
rapidly evolving fluid pandemic. It is vital to keep in mind to follow the
guidelines of official legitimate sources like your medical professional, the
CDC and the WHO to minimize the risk and spread of this virus.
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