TPOXX, the anti-monkey pox virus, is the cure – if you can find it

Federal regulators last week relaxed strict rules around prescribing TPOXX, the only antiviral available to treat monkeypox. But the drug is still scarce, even in San Francisco, where the health care infrastructure is better equipped than most drugs.

The problem isn’t supplies, it’s that bureaucratic health care providers have to commute to prescribe medication, a two-week course of pills, that may prevent the lesions from getting worse.

That’s because TPOXX, or tecovirimat, is not FDA-approved for the treatment of monkeypox, and can only be given under a federal classification called “Expanded Access for Experimental New Drug Use.” The appointment requires physicians to seek federal or local institutional approval to prescribe the drug and to collect and submit far more documentation to each patient than is required for most other drugs.

Most healthcare providers have not yet eliminated these hurdles, severely limiting access to medication at a time when the virus is spreading rapidly and interest in treatments is growing.

There are 36 health care providers in California licensed to prescribe anti-monkeypox pills. By county, they are:

Alameda: Kaiser Auckland, Kaiser San Leandro

Contra Costa: Kaiser Walnut Creek

Fresno: Kaiser Fresno, University of California, San Francisco, Fresno

long beach: Long Beach Health and Human Services

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

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

Sacramento: Sacramento County Public Health Clinic, STI, 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

San Mateo: Kaiser South San Francisco

San Joaquin: Al Karama Medical Health Group Stockton

Santa Clara: Santa Clara Health System, Stanford Healthcare Pharmacy, Kaiser Santa Clara, Kaiser San Jose

Solano: Kaiser Napa (Vacaville)

Sonoma: Kaiser Santa Rosa
Source: California Department of Public Health

There are reasons for federal regulators to require providers to jump through the extra hoops of prescribing TPOXX. While the drug is approved to treat smallpox, which is a more serious cousin to monkeypox, it is not approved for the treatment of monkeypox. TPOXX has undergone human clinical trials showing it to be safe, but has not been subject to randomized controlled human clinical trials for its efficacy in treating monkeypox.

“We don’t really know if this drug is working,” said Dr. Stephanie Cohen, medical director of the San Francisco City Clinic who is helping to lead the response to monkeypox at the San Francisco Department of Public Health. We do not have good efficacy data for this drug. At the same time, we have reassuring safety data, and as a healthcare provider, all healthcare providers want to be able to offer something to patients who are struggling that may help them. We don’t know if this speeds up recovery 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 two weeks ago, it leaves significant coverage gaps. The US Centers for Disease Control and Prevention late last week reduced 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 that makes it difficult for community service providers and health care providers throughout San Francisco to do so,” 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. These providers have collectively prescribed TPOXX to about 50 patients, including some who were referred from other parts of the Bay Area because their regular providers were unable to give it to them, Cohen said.

Dr. Peter Chen Hong, an infectious disease physician at the University of California, San Francisco who treats monkeypox patients from the current outbreak, likened the current state of TPOXX availability to the early days of COVID-19. In those early months, patients with severe COVID were coming to UCSF from across the region to receive the intravenous antiviral drug Remdesivir — which was rare and reserved for the sickest patients at the time. Remdesivir is now widely available.

Providers are required to obtain approval from the CDC or their Institutional Review Board, or both, to be able to prescribe the drug. This is generally easier for large academic institutions because they have more experience than small community clinics conducting clinical trials and dealing with experimental drugs.

Then there is the time and resources that providers must spend documenting each patient’s treatment. For each patient receiving TPOXX, providers must obtain informed consent, submit an intake form describing the patient’s condition at the time they sought treatment and conduct follow-up visits on days 7 and 21 of treatment. This information needs to be sent to the Centers for Disease Control and Prevention, and it takes additional staff and time to do this—something not all medical offices have. These requirements are a miniature version of the paperwork; Before the CDC rolled back the 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 through telehealth services instead of in person.

Chen Hong said that because monkeypox is not considered a public health emergency in the United States, providers are absorbing the cost of administering TPOXX. The pills themselves are free, paid for by the federal government, but staff time to file paperwork and track every patient is not covered by insurance.

Most people who get monkeypox probably don’t need antiviral treatment. Symptoms are mild for many people and are often resolved with the help of over-the-counter pain relievers. But for the minority of patients who have more serious conditions — lesions in certain parts of the body, or are at risk for severe disease — medications can provide relief or reduce their severity.

Qin Hong said if the lesions are near the eye, for example, they can affect vision and cause blindness. If they are in or near the mouth, eating and drinking can be very painful. Lesions on or near the rectum or urethra can scar and narrow the anal canal or urethra. Chen Hong said people at risk of developing a serious condition — such as children, pregnant women, people with moderately or severely compromised immunity, and people with serious skin conditions such as eczema — could also benefit.

Catherine is (he/she) a writer for the San Francisco Chronicle. Email: [email protected] Twitter: Tweet embed

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