Monkeypox antiviral drug TPOXX promises treatment — if you can find it

Monkeypox antiviral drug TPOXX promises treatment — if you can find it

Federal regulators last week relaxed strict rules on prescribing TPOXX, the only available antiviral to treat monkeypox. But the drug remains in short supply, even in San Francisco, where the health care infrastructure is better equipped than most to deliver the drug.

The problem isn’t supply, but the bureaucracy healthcare providers must navigate to prescribe the drug, a two-week course of pills, that can keep lesions from getting worse.

This is because TPOXX, or tecovirimat, is not approved by the FDA to treat monkeypox and can only be administered under a federal designation called “expanded access investigational new drug use.” The designation requires physicians to seek federal or local institutional approval to prescribe the drug and to collect and submit much more documentation for each patient than is required for most other drugs.

Most health care providers have yet to overcome those hurdles, severely limiting access to the drug at a time when the virus is spreading rapidly and interest in treatments is growing.

There are 36 health care providers in California authorized to prescribe the monkeypox antiviral pill. By county, they are:

Mall: Kaiser Oakland, Kaiser San Leandro

Against Coast: Walnut Creek

Ash tree: Kaiser Fresno, UCSF Fresno

Long Beach: Long Beach Health and Human Services

The Angels: Cedars-Sinai Medical Center, UCLA Medical Center, Harbor-UCLA Medical Center, Olive View-UCLA Medical Center, Los Angeles LGBT Center, LA Central Health Center, Men’s Health Foundation, Kaiser South Bay (Harbor City)

Orange: STD Clinic 17th Street Testing and Treatment-Orange County Health Care Agency

sacrament: Sacramento County Public Health STD Clinic, Kaiser Sacramento

San Diego: UC San Diego, Scripps, Family Health Centers of San Diego, Kaiser San Diego, Kaiser Zion Medical Center, San Diego County STI Clinic

San Francisco: San Francisco General Hospital, UCSF, San Francisco City Clinic, Kaiser San Francisco, San Francisco Veterans Affairs Medical Center

Saint Matthew: Kaiser South of San Francisco

Saint Joaquin: Dignity Health Stockton Medical Group

Saint Clare: Santa Clara Health System, Stanford Healthcare Pharmacy, Kaiser Santa Clara, Kaiser San José

Solane: Kaiser Napa (Vacaville)

Sonoma: Kaiser Santa Rosa

Source: California Department of Public Health

There are reasons federal regulators require providers to go through additional hurdles to prescribe TPOXX. While the drug is FDA-approved to treat smallpox, a more serious cousin of monkeypox, it has not been approved to treat monkeypox. TPOXX has been through human clinical trials showing that it is safe, but has not been through randomized controlled clinical trials in humans to determine its effectiveness in treating monkeypox.

“We really don’t know if this drug works,” said Dr. Stephanie Cohen, medical director of the City of San Francisco Clinic, who helps lead the monkeypox response for the San Francisco Department of Public Health. “We don’t have good efficacy data on this drug. At the same time, we have reassuring safety data, and as a healthcare provider, every healthcare provider wants to be able to offer something to suffering patients that can help. We don’t know if this speeds up healing or not.”

Statewide, only 35 health care providers are authorized to prescribe TPOXX, according to the California Department of Public Health. While that number is up significantly from just a handful a couple of weeks ago, it leaves big gaps in coverage. The US Centers for Disease Control and Prevention late last week eased some requirements for providers to prescribe TPOXX, but even that hasn’t removed all barriers, local health officials say.

“There is still a lot of paperwork required to prescribe tecovirimat, which makes it difficult for community providers and health care providers throughout San Francisco to take on,” Cohen said.

San Francisco has more providers than most jurisdictions capable of prescribing TPOXX: UCSF, San Francisco General Hospital, City Clinic, Kaiser San Francisco, and San Francisco Veterans Affairs Medical Center. Those providers have collectively prescribed TPOXX to about 50 patients, Cohen said, including some who were referred from other parts of the Bay Area because their regular providers couldn’t give it to them.

Dr. Peter Chin-Hong, a UCSF infectious disease physician treating monkeypox patients from the current outbreak, compared the current state of TPOXX availability to the early days of COVID-19. In those early months, severe COVID patients came to UCSF from across the region to receive the antiviral remdesivir intravenously, which at the time was in short supply and reserved for the sickest patients. Remdesivir is now widely available.

Providers must obtain approval from the CDC or their own institutional review board, or both, in order to prescribe the drug. This is usually easier for large academic institutions because they have more experience than small community clinics running clinical trials and dealing with experimental drugs.

Then there is the time and resources that providers must devote to documenting each patient’s treatment. For each patient receiving TPOXX, providers must obtain informed consent, provide an intake form that describes the patient’s condition at the time treatment was sought, and conduct follow-up visits on days 7 and 21 of treatment. This information must be sent to the CDC, and it takes more staff and time to do so, something that not all medical offices have. These requirements are a stripped down version of paperwork; Before the CDC’s rollback of restrictions last week, providers also had to submit lab results and photos, and visits had to be done in person. Visits can now be done online via telehealth instead of in person.

Because monkeypox has not been considered a public health emergency in the United States, providers bear the cost of administering TPOXX, Chin-Hong said. The pills themselves are free, paid for by the federal government, but staff time to submit paperwork and track each patient is not covered by insurance.

Most people who get monkeypox probably won’t need antiviral treatment. Symptoms are mild for many people and often resolve with the help of over-the-counter pain relievers. But for the minority of patients who have more severe cases (injury to certain parts of the body or who are at risk of serious illness), medications can provide relief or reduce severity.

If the lesions are close to the eye, for example, they can affect vision and even cause blindness, Chin-Hong said. If they are in or near the mouth, it can be very painful to eat and drink. Injuries in or near the rectum or urethra can scar and cause narrowing of the anal canal or urethra. And people who are at risk of developing a severe case, such as children, pregnant women, people with moderate or severe immunosuppression and people with serious skin conditions like eczema, could also benefit, Chin-Hong said.

Catherine Ho (she/her) is a staff writer for the San Francisco Chronicle. Email: Twitter: @Cat_Ho

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