The National Health Surveillance Agency (Anvisa) approved the exemption from registration for the Ministry of Health to import and use in Brazil the tecovirimat antiviral drug for the treatment of monkeypox. The unanimous decision of the collegiate board was defined on Thursday (25).
According to Anvisa, the product to be imported is the same authorized in the United States for the company SIGA Technologies, manufactured by Catalent Pharma Solutions, located in Winchester, Kentucky.
Brazil should receive the drug to expand the fight against the outbreak of the disease from a partnership with the Pan American Health Organization (PAHO).
Tecovirimat, which was developed for common smallpox, was licensed by the European Medicines Agency (EMA) for monkeypox in 2022, based on data from animal and human studies. However, the drug is not yet widely available.
Antiviral drugs have properties capable of reducing the action of viruses in the human body. The fight against infection can be done by blocking the invasion of cells or by weakening viral replication, actions that contribute to preventing the evolution and worsening of diseases.
Antivirals should be used in the initial phase of infection, preferably between the first and fifth day of the onset of symptoms. The greater effectiveness of antivirals is associated with the presence of a greater amount of virus in the body, that is, a high viral load common at the beginning of the infection.
How does tecovirimat work?
Tecovirimat, also known as TPOXX, is a drug developed to treat the common smallpox virus. In the current outbreak of monkeypox, the drug has been used to fight the disease’s infection. The antiviral is available as an oral capsule (200 mg) and injection for intravenous administration.
In the United States, for example, tecovirimat was approved in 2018 by the Food and Drug Administration (FDA), a US agency similar to Anvisa, for the treatment of smallpox in adults and children, but not for Monkeypox. The US Centers for Disease Control and Prevention (CDC) maintain an expanded access protocol for the drug, which allows its use for early treatment of infection.
In animal studies, tecovirimat has been shown to decrease the chance of death from orthopoxvirus infections, such as monkeypox virus, when given early in the disease.
In people, a case series of individuals infected with the monkeypox virus, which included a patient treated with tecovirimat, suggests that the drug may shorten the duration of illness and viral spread. The results were published in scientific journal lancet.
Who can benefit from antiviral use
According to the CDC, tecovirimat may be considered for treatment in people infected with monkeypox virus with severe illness, such as bleeding cases, large lesions that are found, sepsis, inflammation of the brain (encephalitis), and other conditions that require hospitalization.
The WHO warns that newborns, children, pregnant women and people with immune deficiencies may be at risk of more severe symptoms and death from monkeypox. Worsening disease can also affect people with a history or presence of atopic dermatitis and with other active exfoliative skin conditions such as eczema, burns, severe acne, and herpes simplex virus infection.
Antiviral use may also be indicated for individuals with one or more complications, such as secondary bacterial infection, gastroenteritis with severe nausea and vomiting, diarrhea or dehydration, or other comorbidities.
WHO recommends that the use of tecovirimat be monitored in a clinical research setting with prospective data collection.
Support treatment
Monkeypox is most often a self-limiting disease, with signs and symptoms lasting two to four weeks. The incubation period, the phase in which the person has no symptoms, lasts on average from 6 to 13 days, but can reach 21 days.
In most cases, the infection does not require hospitalization and the treatment offered is supportive, with the aim of relieving symptoms, preventing and treating complications. One of the drugs used to treat the disease in the world, the antiviral tecovirimat is not yet available in Brazil.
Medications that can be used in case of pain or fever are dipyrone and paracetamol. For more severe cases, the use of opioids, under medical prescription, may be necessary.
Infectologist Estevão Portela, deputy director of the National Institute of Infectious Diseases (INI/Fiocruz), says that pain is one of the factors that can lead a patient with monkeypox to need hospitalization.
Injuries, especially genital and anal injuries, can be very painful and limit a person’s activity. The various inpatient centers create protocols for the management of this pain, which may eventually be, depending on the degree of intensity, an outpatient management with oral analgesics, but eventually the adjustment of this analgesic treatment requires hospitalization for a more intense treatment with controlled medications. ”, he explains.
Risks of complications
Skin sores caused by monkeypox and other diseases carry the risk of secondary infections caused mainly by bacteria. The cracks present in the lesions serve as a gateway for microorganisms that can be harmful to health.
“These lesions end up generating exposed areas on the skin and, eventually, places that are difficult to manage from the asepsis point of view. These lesions can end up generating a secondary bacterial infection. This may require antibiotic treatment, which sometimes needs to be performed intravenously in a hospital unit”, says Estevão.
Experts recommend that patients should seek medical attention in the face of signs of health complications, which include symptoms such as persistent pain and fever or impaired ability to swallow, for example.
According to the Ministry of Health, clinical criteria of severity are considered to be the high number of lesions (100 to 250 being a serious case and more than 250 very serious cases), respiratory failure, sepsis (generalized infection), mental confusion, increased liver (hepatomegaly), enlargement of the nodes in the neck with difficulty swallowing and dehydration.
Source: CNN Brasil
