Posted on Tuesday - 11/15/2022 to Up Close
By Barbara Anderson
Before the first case of monkeypox had been identified in Fresno County this summer, a UCSF Fresno infectious diseases specialist had obtained “compassionate use” approval through a federal research protocol to treat patients with a drug the United States has stockpiled for smallpox.
“We got the medication in stock here. And the first patient in Fresno who was diagnosed, we got the patient in the very next day and started on treatment,” says Geetha Sivasubramanian, MD, FIDSA, director of the Infectious Disease Fellowship Program at UCSF Fresno.
Monkeypox or MPX is in the same family of orthopoxviruses as smallpox and after MPX cases began being reported in the U.S. in May, the federal Centers for Disease Control and Prevention (CDC) expanded access to tecovirimat or TPOXX, a drug that had been approved for the treatment of smallpox in 2019. Smallpox, a highly contagious and devastating disease, has been eradicated worldwide, but the U.S. has stores of TPOXX available at the U.S. Strategic National Stockpile in the event of a smallpox emergency.
A vaccine to prevent MPX for people who are at high risk of exposure to the virus is available in Fresno County at the UCSF Fresno Mobile HeaL COVID-19 Equity Project (CEP). But the vaccine is not a treatment for the infection.
TPOXX is currently the only treatment option for MPX. It is not a cure but appears to shorten the length of illness, which typically causes a painful blistering rash.MPX often is a mild illness, but some patients have required hospitalization, particularly those whose painful rash-like lesions are in sensitive areas, such as the genitals; and patients who are immunocompromised. The virus is not a sexually transmitted infection but is spread primarily through close, skin-to-skin contact. It also can be spread by contact with contaminated clothing or bedding; and droplets can be inhaled.
As of Oct. 26, Dr. Sivasubramanian, along with help from UCSF Fresno clinical research coordinators, have treated 20 patients with TPOXX. The patients were incapacitated by the painful rash or were vulnerable to complications because of a weakened immune system. Adults, children and pregnant women are eligible for the treatment.
Dr. Sivasubramanian had been preparing an educational talk on MPX in early July, when interim Fresno County Public Health Officer Rais Vohra, a UCSF Fresno emergency physician, contacted UCSF Fresno Infection Control about obtaining authorization to administer TPOXX. Dr. Sivasubramanian agreed to lead the project and staff at the UCSF Fresno Clinical Research Center, and the Community Medical Centers Institutional Review Board, which approves research projects, worked quickly to finish the paperwork necessary for CDC approval, she says.
Through the research protocol, UCSF Fresno receives a stock of TPOXX directly from the CDC. TPOXX treatment is a 14-day regimen of pills. Prior to CDC approval, the CDC had to be contacted every time a patient presented with MPX for the medication to be shipped. Now, when Dr. Sivasubramanian receives a call for a patient, she responds the same day to provide TPOXX treatment.
“The CDC wanted local champions who can take care of dispensing TPOXX for them, rather than them being involved with each patient,” Dr. Sivasubramanian says. “This is faster access for these patients who are in pain.”
“Kudos to Dr. Sivasubramanian and the UCSF Fresno Infection Control Team,” Dr. Vohra says. “They are just great partners for the Fresno County Department of Public Health and just stepped up as the investigator in the area.”
UCSF Fresno is not conducting a clinical trial of TPOXX but results of the study protocol (how quickly patients’ symptoms resolve, reports of side effects – headaches, nausea, vomiting) are sent to the CDC. This adds to a body of evidence the CDC and the U.S. Food and Drug Administration are collecting from approved providers. That data can be used to evaluate the drug for mainstream use, Dr. Vohra says. “And it is definitely helping our patients now,” he says.
Ideally, the CDC will run placebo-controlled clinical studies of TPOXX where some people get the medication and some patients do not, Dr. Sivasubramanian says. “But right now, we don’t have that data, so we have to kind of use this medication at least for the most vulnerable and for patients with the most sensitive areas that have the lesions.” If there are future clinical trials, “I am pretty certain we will take part in them,” she says.
The willingness of Dr. Sivasubramanian and the CMC Institutional Review Board to apply for approval to be a TPOXX provider is an example of UCSF Fresno’s commitment to public service, Dr. Vohra says. “It is just a great, shining example of how really impactful leadership shown by our faculty and teams are to helping the community.”