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Related topics
* Monkeypox
* Science
* Health
* U.S. News
* Medication
* Antiviral drugs

US WARNS MONKEYPOX COULD MUTATE TO RESIST ANTIVIRAL DRUG

By MATTHEW PERRONE and MIKE STOBBESeptember 15, 2022

1 of 2
This undated image provided by Siga Technologies shows the drug TPOXX. The drug
may be effective at treating monkeypox. U.S. health officials are warning
against overuse of the lone drug currently available against monkeypox, saying
that even a small mutation to the virus could render the medication ineffective.
(Courtesy of Siga Technologies via AP)

WASHINGTON (AP) — U.S. health officials are warning against overuse of the lone
drug available to treat monkeypox, saying that even a small mutation in the
virus could render the pills ineffective.

The Food and Drug Administration updated its guidance this week for Tpoxx, which
has been prescribed to tens of thousands of patients with the virus.

In an online update, FDA officials cautioned that a single molecular change to
monkeypox “could have a large impact on the antiviral activity of Tpoxx.” Since
viruses are constantly evolving to overcome obstacles to infection, including
drugs, regulators stressed that doctors should be “judicious” in prescribing the
medication.

Meanwhile, the Centers for Disease Control and Prevention on Thursday said Tpoxx
should no longer be given to otherwise healthy adults who are not suffering
severe symptoms.

“For most patients with healthy immune systems, supportive care and pain control
may be enough,” agency officials said in a statement.

The moves to scale back Tpoxx’s use follow weeks of criticism from HIV advocates
and other patient groups who have urged the Biden administration to make the
antiviral drug more widely available. Tpoxx is approved for the related smallpox
virus, and its use against monkeypox is considered experimental and tightly
controlled by federal officials.

MONKEYPOX

'OUT OF CONTROL' STD SITUATION PROMPTS CALL FOR CHANGES

MONKEYPOX CASES DECLINING IN WA, OUTBREAK TRAJECTORY UNCLEAR

AS MONKEYPOX DROPS IN THE WEST, STILL NO VACCINES FOR AFRICA

MONKEYPOX DEATH CONFIRMED BY LA COUNTY HEALTH OFFICIALS

Doctors wishing to prescribe the drug must submit an application to the Centers
for Disease Control and Prevention, documenting their patient’s need and
agreeing to track their results and any side effects. Officials have shipped
37,000 courses of the drug to physicians.

Tpoxx works by targeting a single protein found on monkeypox, smallpox and
similar viruses. The FDA said this week that research in labs, animals and
people suggests multiple ways in which monkeypox could develop resistance to the
therapy.

The update came as federal officials on Thursday expressed cautious optimism
about the trajectory of the outbreak, noting that new cases have fallen about
50% since their peak in August.

During a White House briefing, CDC Director Dr. Rochelle Walensky attributed the
decline to vaccinations, educational outreach and individuals reducing behaviors
linked to spread. The vast majority of U.S. cases have been in men who have sex
with men, though officials emphasize that the virus can infect anyone.

Dr. Anthony Fauci, the nation’s top infectious disease official, noted that
resistance is always a risk when using antiviral drugs.

“That’s why we’re uncomfortable when you only have a single drug,” Fauci told
reporters. He added that a recently launched study of Tpoxx supported by the
National Institutes of Health will track signs of mutation that could lead to
resistance. The study is expected to enroll more than 500 patients across 60
U.S. sites.

Last month, the Biden administration invoked rare emergency powers to stretch
the nation’s limited supply of monkeypox vaccines. And last week a separate
declaration expedited the use of experimental tests for the virus.

But no changes were made to allow emergency use of Tpoxx, stoking complaints
from groups representing gay and bisexual men.

The U.S. government’s national stockpile contains has more than 1.7 million
courses of Tpoxx, originally manufactured for use during a potential
bioterrorism attack.

The FDA approved the medication in 2018 under its “animal rule,” which allows
approval based on animal data when human testing is unethical or unfeasible.
Smallpox was declared eradicated in 1980 by the World Health Organization,
ruling out the possibility for human studies.

Even though the drug was approved for smallpox, its effectiveness was measured
in monkeys infected with monkeypox, considered a reasonable predictor of
smallpox’s effect on humans. Animals receiving Tpoxx survived at higher rates
than those on a placebo. But FDA officials have cautioned that results in
animals must be confirmed in human testing.

“Without human trials, we don’t know if Tpoxx is beneficial for humans with
monkeypox,” FDA commissioner Dr. Robert Califf told Senate lawmakers at a
hearing this week.

The CDC reported last week that 3.5% of patients tracked through its Tpoxx
program reported side effects, mainly headache and nausea.

The agency has only gotten back about 200 forms from physicians documenting
patient’s initial symptoms and results, accounting for less than 1% of the doses
shipped since the start of the outbreak.

___

Stobbe reported from New York

___

The Associated Press Health and Science Department receives support from the
Howard Hughes Medical Institute’s Department of Science Education. The AP is
solely responsible for all content.

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