The guidance focuses on treatment with tecovirimat, pre-exposure prophylaxis and postexposure prophylaxis with the Jynneos monkeypox vaccine, and infection control among persons living with HIV (PLWH).
Amid the global monkeypox virus outbreak, which disproportionately affects men who have sex with men and people living with HIV (PLWH), the CDC has developed interim guidance for the treatment and prevention of monkeypox in PLWH.
According to a CDC Morbidity and Mortality Weekly Report, these clinical considerations focus on treatment with the antiviral drug tecovirimat, pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) with the Jynneos monkeypox vaccine, and infection control.
There are no FDA-approved treatments for monkeypox; however, there are approved drugs for smallpox and cytomegalovirus that may be effective against the virus, including tecovirimat, which is available in oral and intravenous formulations.
Although data are not available on the drug’s efficacy in treating monkeypox, a UK case report suggests tecovirimat may shorten the duration of the illness and viral shedding, and clinical trials suggest it is safe and tolerable with only minor adverse effects. Additionally, animal studies have demonstrated the drug’s efficacy in treating orthopoxvirus-induced disease.
“Randomized controlled trials in humans are underway to further assess safety as well as efficacy in treating monkeypox,” the report noted. “Tecovirimat is available from the Strategic National Stockpile (SNS) and is administered under an expanded access (ie, compassionate use) Investigational New Drug (EA-IND) protocol held by CDC.”
In severe cases, vaccinia immune globulin intravenous (VIGIV), cidofovir, and brincidofovir can be considered for treatment. According to the report, in vitro and animal studies show that cidofovir and brincidofovir have proven activity against poxviruses, but only cidofovir is available commercially or from the SNS. Meanwhile, VIGIV is available from the SNS and administered under an EA-IND protocol by the CDC for monkeypox.
Regarding PrEP, the only form that is available or authorized for monkeypox is vaccination, which is recommended for individuals at risk for occupational exposure to orthopoxviruses, including laboratory personnel performing tests for monkeypox and health care workers who are part of monkeypox response teams.
Based on the guidance, PEP can be considered after exposure to monkeypox, although vaccination after symptom onset is not expected to provide benefit.
“Although the use of smallpox vaccines for postexposure prophylaxis has not been studied in the context of monkeypox outbreaks, early administration of vaccines (≤4 days after exposure) might prevent monkeypox, and later use (5-14 days after exposure) might decrease the severity of monkeypox if infection occurs,” the report said.
Two FDA-licensed vaccines are the 2-dose Jynneos vaccine and the single-dose ACAM2000 vaccine for the prevention of orthopoxvirus infections such as smallpox. Due to the risk of severe adverse effects from the ACAM2000 vaccine, the CDC guidance recommends the Jynneos vaccine first for PLWH after consulting with their health care provider.
Finally, the guidelines say antiretroviral therapy (ART) and opportunistic infection prophylaxis should be continued in all PLWH who contract monkeypox, noting that disrupting treatment could lead to rebound HIV viremia, which may negatively impact monkeypox management or worsen illness severity.
“Persons receiving ART for HIV pre-exposure prophylaxis or postexposure prophylaxis should likewise continue taking these medications,” the guidance said. “Persons with newly diagnosed HIV infection at the time of monkeypox diagnosis should commence ART as soon as possible, in consultation with an expert in HIV care, if needed.”
Prevention and treatment considerations from the CDC will be updated as more information relating to the monkeypox outbreak becomes available.
“Until more is known, clinicians should exercise clinical judgement assessing the extent of immunosuppression from HIV and from any other sources, and the relationship of the patient’s immunosuppression to the risk for severe monkeypox illness,” the CDC guidance said.
O’Shea J, Filardo TD, Morris SB, Weiser J, Petersen B, Brooks JT. Interim Guidance for prevention and treatment of monkeypox in persons with HIV infection — United States, August 2022. MMWR Morb Mortal Wkly Rep. 2022;71(32):1023-1028. doi:10.15585/mmwr.mm7132e4