Morbidity and Mortality Weekly Report

Interim Guidance for Prevention and Treatment of Monkeypox in

Persons with HIV Infection — United States, August 2022
Jesse O’Shea, MD1,*; Thomas D. Filardo, MD1,2,*; Sapna Bamrah Morris, MD1; John Weiser, MD1; Brett Petersen, MD1; John T. Brooks, MD1

On August 5, 2022, this report was posted as an MMWR Early Patients are considered contagious until the scabs have crusted over
Release on the MMWR website (https://www.cdc.gov/mmwr). and fallen off and a fresh layer of intact skin has formed underneath.
Monkeypox virus, an orthopoxvirus sharing clinical features with Reports from the current outbreak suggest transmission
smallpox virus, is endemic in several countries in Central and patterns and clinical manifestations might not follow the clas-
West Africa. The last reported outbreak in the United States, in sic presentation of monkeypox (5–10). Although any person
2003, was linked to contact with infected prairie dogs that had can acquire monkeypox, epidemiologic data indicate that
been housed or transported with African rodents imported from transmission is currently most intense among interconnected
Ghana (1). Since May 2022, the World Health Organization networks of sexually active MSM, with transmission occurring
(WHO) has reported a multinational outbreak of monkeypox primarily through intimate skin-to-skin contact during sex
centered in Europe and North America, with approximately (6). Prodrome or systemic symptoms do not always occur or
25,000 cases reported worldwide; the current outbreak is dispro- precede the rash. Mucosal involvement occurs in approximately
portionately affecting gay, bisexual, and other men who have sex 40% of cases, including genital, perianal, and oropharyngeal
with men (MSM) (2). Monkeypox was declared a public health lesions (5). Genital and perianal lesions can be associated with
emergency in the United States on August 4, 2022.† Available severe and painful proctitis, urethritis, phimosis, and balanitis.
summary surveillance data from the European Union, England, Oropharyngeal symptoms, including symptoms resulting from
and the United States indicate that among MSM patients with tonsillitis and epiglottitis, can be associated with pain or dif-
monkeypox for whom HIV status is known, 28%–51% have ficulty swallowing.
HIV infection (3–10). Treatment of monkeypox with tecovirimat Treatment: There are no Food and Drug Administration
as a first-line agent is available through CDC for compassionate (FDA)–approved treatments for monkeypox. However, drugs
use through an investigational drug protocol. No identified drug that are approved for treatment of smallpox and cytomegalo-
interactions would preclude coadministration of tecovirimat with virus might have activity against Monkeypox virus. Tecovirimat
antiretroviral therapy (ART) for HIV infection. Pre- and postex- is an antiviral medication available in oral and intravenous
posure prophylaxis can be considered with JYNNEOS vaccine, if formulations. Animal studies have shown that tecovirimat is
indicated. Although data are limited for monkeypox in patients effective in treating orthopoxvirus-induced disease (12). Data
with HIV, prompt diagnosis, treatment, and prevention might are not available on the effectiveness of tecovirimat in treat-
reduce the risk for adverse outcomes and limit monkeypox spread. ing monkeypox in humans; however, a case report from the
Prevention and treatment considerations will be updated as more United Kingdom suggested that tecovirimat might shorten
information becomes available. the duration of illness and of viral shedding (13). Human
clinical trials indicate that the drug is safe and tolerable with
Background only minor side effects (14). Randomized controlled trials in
Signs and Symptoms: Classically, monkeypox occurs in three humans are underway to further assess safety as well as effi-
stages. After an incubation period of approximately 1–2 weeks, a cacy in treating monkeypox. Tecovirimat is available from the
prodrome, characterized by fever and lymphadenopathy occurs, Strategic National Stockpile (SNS) and is administered under
which is followed by the onset of a deep-seated vesicular or pustu- an expanded access (i.e., compassionate use) Investigational
lar rash that often begins centrally and spreads to the limbs (11). New Drug (EA-IND) protocol held by CDC.¶
Transmission of monkeypox can occur through direct contact Other treatments that can be considered in severe cases
with the infectious rash, scabs, or body fluids, through respiratory include vaccinia immune globulin intravenous (VIGIV),
secretions during prolonged face-to-face contact or intimate physi- cidofovir, and brincidofovir. Cidofovir and brincidofovir have
cal contact, or through touching items, such as clothing or linens, proven activity against poxviruses in in vitro and animal studies,
that previously touched a patient’s infectious rash or body fluids.§ but only cidofovir is currently available either commercially
or from the SNS. VIGIV is available from the SNS and is
* These authors contributed equally to this report. administered under an EA-IND protocol for monkeypox. At
† h t t p s : / / w w w . w a s h i n g t o n p o s t . c o m / h e a l t h / 2 0 2 2 / 0 8 / 0 4 /
monkeypox-public-health-emergency-united-states-becerra/ ¶ https://www.cdc.gov/poxvirus/monkeypox/clinicians/obtaining-tecovirimat.html
§ https://www.cdc.gov/poxvirus/monkeypox/transmission.html

US Department of Health and Human Services/Centers for Disease Control and Prevention MMWR / August 12, 2022 / Vol. 71 / No. 32 1023
 Morbidity and Mortality Weekly Report

this time, it is unknown whether a person with severe mon- MSM with HIV among STI cases (20); risk for monkeypox
keypox will benefit from treatment with VIGIV, cidofovir, through sexual contact is likely similarly increased. Although it
or brincidofovir because effectiveness data are not available. is possible that poorly controlled HIV would increase risk for
Pre- and Postexposure Prophylaxis: The only form of pre- monkeypox after exposure, evidence from other diseases sug-
exposure prophylaxis available or authorized for monkeypox gests that persons with HIV infection who are receiving ART
is vaccination, which currently is recommended for persons at and have robust CD4 counts are not at increased risk for most
risk for occupational exposure to orthopoxviruses, such as labo- infections, including opportunistic infections, and therefore
ratory personnel performing diagnostic testing for Monkeypox might not be at increased risk for monkeypox after exposure.¶¶
virus and members of health care worker response teams des- Available data indicate that persons with advanced and
ignated by appropriate public health and antiterror authorities uncontrolled HIV infection might be at higher risk for severe
(15). Routine immunization of all health care workers against or prolonged monkeypox disease following infection. In a
smallpox or monkeypox is not currently recommended.** 2017–2018 case series describing 122 Nigerian patients with
Postexposure prophylaxis can be considered after exposure monkeypox caused by the same strain responsible for the cur-
to monkeypox.†† Although the use of smallpox vaccines for rent outbreak, four of the seven deaths occurred among persons
postexposure prophylaxis has not been studied in the context with untreated advanced HIV infection; however, information
of monkeypox outbreaks, early administration of vaccines about the overall proportion of patients with HIV infection
(≤4 days after exposure) might prevent monkeypox, and later was not available, precluding the ability to determine whether
use (5–14 days after exposure) might decrease the severity of this mortality was disproportionately large (21). A second
monkeypox if infection occurs (16,17). Vaccination given after 2017–2018 series of 40 monkeypox cases, also from Nigeria,
the onset of signs or symptoms of monkeypox is not expected included nine persons with HIV infection for whom clinical
to provide benefit.§§ data relevant to HIV status were provided; CD4 cell counts
Two vaccines are licensed by FDA for the prevention of ranged from 20 to 357 per μL, and most patients had either
orthopoxvirus infections. JYNNEOS is a live virus vaccine that failed ART or had newly diagnosed HIV infection, suggesting
uses nonreplicating modified vaccinia Ankara (MVA) which is a lack of viral suppression. Two of nine patients with HIV in
licensed for prevention of smallpox and monkeypox in adults that case series died. Compared with other patients with mon-
aged ≥18 years (18). Because JYNNEOS contains replication- keypox, those with HIV infection had higher rates of secondary
deficient MVA, it does not present a risk for disseminated bacterial infection, more prolonged illness (and thereby also
infection, autoinoculation, or transmission to others (15). longer period of infectiousness), as well as a higher likelihood
JYNNEOS vaccine is administered as a series of two doses given of having a confluent or partially confluent rash rather than
28 days apart (18). ACAM2000 is a replication-competent discrete lesions (22). In contrast, recent reports from European
live vaccinia virus vaccine licensed for prevention of smallpox countries where most patients are receiving effective ART have
that is administered as a single dose (19). ACAM2000 was noted no deaths or evident excess in hospitalizations among
derived from Dryvax, the vaccine used in the eradication of persons with HIV infection and monkeypox to date (3,4,6).
smallpox (19). In addition, WHO has stated that a more severe disease course
has not been reported in persons with HIV infection who are
Monkeypox in Persons with HIV Infection receiving ART and have a robust immune system (23), a find-
Clinical Presentation and Outcomes: It is currently not ing supported by recent large cohort studies (5,7,8).
known whether HIV infection affects a person’s risk for Management of patients with HIV infection and mon-
acquiring monkeypox. MSM with HIV infection are at pres- keypox: ART and opportunistic infection prophylaxis should
ent disproportionately represented among monkeypox cases. be continued in all persons with HIV infection who acquire
However, ascertaining the relative roles that exposure and bio- monkeypox (Table 1). Treatment interruption might lead to
logic risks play in this disproportionality is challenging. Sexual rebound HIV viremia that could complicate the manage-
behavior that confers risk for HIV acquisition also increases ment of monkeypox, including worsening illness severity.***
risk for acquiring other sexually transmitted infections (STIs) Persons receiving ART for HIV pre-exposure prophylaxis or
leading to a similar disproportionate overrepresentation of postexposure prophylaxis should likewise continue taking these
medications. Persons with newly diagnosed HIV infection at
** https://www.cdc.gov/poxvirus/monkeypox/clinicians/smallpox-vaccine.html
†† https://www.cdc.gov/poxvirus/monkeypox/clinicians/monitoring.html
¶¶ https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-
§§ https://www.cdc.gov/poxvirus/monkeypox/considerations-for-monkeypox-
adolescent-opportunistic-infections/introduction
vaccination.html *** https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-
adolescent-arv/discontinuation-or-interruption

1024 MMWR / August 12, 2022 / Vol. 71 / No. 32 US Department of Health and Human Services/Centers for Disease Control and Prevention
 Morbidity and Mortality Weekly Report

TABLE 1. Recommendations for management of persons with HIV infection and monkeypox — United States, August 2022
Patient group and treatment Recommendations/Precautions Availability/Effectiveness in treating monkeypox
HIV management for persons with monkeypox
Known HIV infection Continue ART and opportunistic infection prophylaxis as indicated NA
Newly diagnosed HIV Begin ART as soon as possible NA
HIV pre-exposure prophylaxis Continue treatment or start, as indicated NA
HIV postexposure prophylaxis Continue treatment or start, as indicated NA
Monkeypox management for persons with HIV*
Tecovirimat (TPOXX, ST-246) Review potential interactions with ART Available from SNS
Oral and intravenous formulations available
Cidofovir (Vistide) Contraindicated if serum creatinine >1.5 mg/dL Available from SNS
Effectiveness in treating monkeypox unknown
Brincidofovir (CMX001, Tembexa) Might cause increases in serum transaminases and bilirubin Not available from SNS
Effectiveness in treating monkeypox unknown
Vaccinia immune globulin Might be considered in severe cases Available from SNS
intravenous Effectiveness in treating monkeypox unknown
Monkeypox pre-exposure prophylaxis†
JYNNEOS§ vaccine (2-dose, Safety and immunogenicity similar in persons with and without Licensed for prevention of orthopoxvirus infections,
nonreplicating live vaccinia HIV infection including monkeypox¶
virus vaccine)
Monkeypox postexposure prophylaxis†
JYNNEOS§ vaccine (2-dose, Safety and immunogenicity similar in persons with and without Limited available data. If administered ≤4 days after exposure,
nonreplicating live vaccinia HIV infection might prevent infection; administration ≥5 days after exposure
virus vaccine) might decrease severity of disease if infection occurs.
Abbreviations: ART = antiretroviral therapy; FDA = Food and Drug Administration; NA = not applicable; SNS = Strategic National Stockpile.
* https://www.cdc.gov/poxvirus/monkeypox/clinicians/treatment.html
† ACAM2000 is a replication-competent vaccina virus vaccine that is licensed for prevention of smallpox. ACAM2000 should not be used in persons with HIV infection,
regardless of immune status. https://www.fda.gov/media/75792/download
§ https://www.fda.gov/media/131078/download
¶ https://www.cdc.gov/poxvirus/monkeypox/considerations-for-monkeypox-vaccination.html

the time of monkeypox diagnosis should commence ART as persons with HIV infection. Clinical trials demonstrate that
soon as possible, in consultation with an expert in HIV care, JYNNEOS is well-tolerated with similar immunogenicity and
if needed. Monkeypox diagnosis has been reported concurrent rates of adverse events in persons with HIV infection with
with diagnosis of acute HIV infection and other STIs, high- CD4 cell counts of 200–750 per μL and persons without
lighting the importance of testing for these infections when HIV infection (25,26). In persons with HIV infection with
monkeypox is suspected or diagnosed (24). a prior diagnosis of AIDS who were virologically suppressed
Treatment of monkeypox should be considered among per- and had CD4 counts of 100–500 per μL, there were no serious
sons with HIV infection, taking into account disease severity, safety concerns and the vaccine appeared efficacious based on
degree of immunosuppression, or vulnerable sites of infection immunogenicity at standard dosing (27). However, immuno-
(e.g., the genitals or anus).††† Tecovirimat is the first-line medi- genicity among persons with HIV infection who have CD4
cation recommended for treatment of monkeypox, includ- cell counts <100 per μL or who are not virologically suppressed
ing among persons with HIV infection. Clinically relevant is not known.
interactions among tecovirimat, cidofovir, and brincidofovir Because ACAM2000 contains a replication-competent,
and certain ARTs are known and should be considered when attenuated strain of vaccinia virus, severe localized or systemic
selecting treatment (Table 2). However, none of the identified complications of ACAM2000 (e.g., progressive vaccinia) can
drug interactions should preclude coadministration of teco- occur in persons with weakened immune systems, including
virimat and antiretroviral therapy. Cidofovir is contraindicated from HIV infection (15).
in patients with serum creatinine >1.5 mg/dL because of the
associated nephrotoxicity. There are no specific contraindica- Interim Guidance
tions for use of VIGIV among persons with HIV infection. Providers should consider both viral suppression and CD4
Considerations for vaccination: The safety and immu- count in weighing the risk for severe monkeypox-associated
nogenicity of JYNNEOS have been specifically evaluated in outcomes for any patient with HIV infection. Although severe
††† https://www.cdc.gov/poxvirus/monkeypox/clinicians/treatment.html
outcomes have been observed in persons with inadequately
treated HIV infection who have CD4 counts ≤350 per μL and

US Department of Health and Human Services/Centers for Disease Control and Prevention MMWR / August 12, 2022 / Vol. 71 / No. 32 1025
 Morbidity and Mortality Weekly Report

TABLE 2. Treatments for monkeypox and clinically relevant drug interactions with antiretroviral therapies
Monkeypox
treatment ART Mechanism Clinical comments
Tecovirimat Doravirine (DOR) Induction of CYP3A4 Consultation with local pharmacists is suggested. Interaction may result in a
Rilpivirine (RPV) reduction in NNRTI and MVC levels. Per Liverpool HIV interactions database, dose
Maraviroc (MVC) increases could be considered for these antiretroviral medications during therapy
and for 2 wks after completion of tecovirimat therapy.* However, based on
evidence graded very low quality and the short treatment course of tecovirimat,
some experts believe neither dose adjustments nor additional ART are needed.†
Long-acting cabotegravir/RPV Induction of CYP3A4 Consultation with local pharmacists is suggested. Interaction might result in a
reduction in RPV levels. Per Liverpool HIV interactions database, consider addition of
oral RPV 25mg once daily (or the patient’s prior ART regimen) during treatment with
tecovirimat and for approximately 2 wks after the end of treatment could be
considered.* However, some experts believe no additional therapy is necessary
during tecovirimat treatment.† Initiation of long-acting cabotegravir/RPV should be
avoided during tecovirimat therapy and for 2 wks after conclusion of tecovirimat.§
Cidofovir Tenofovir disoproxil Nephrotoxicity; Coadministration of cidofovir and TDF is not recommended. If concomitant use of
fumarate (TDF) probenecid might inhibit TDF and nephrotoxic agents is unavoidable, renal function should be monitored
excretion of TDF closely. Probenecid might increase serum levels of TDF. Consider use of tenofovir
alafenamide (TAF) in place of TDF and monitor for renal adverse events.
Zidovudine (AZT) Probenecid increases drug Probenecid substantially increases AZT plasma levels, and if coadministered AZT
concentration of AZT should either be temporarily discontinued or decreased by 50% on the day of
cidofovir-probenecid administration to avoid AZT-induced hematological toxicity.
Brincidofovir Cobicistat (COBI) Inhibition of OATP1B1, If concomitant use with brincidofovir is necessary, increase the monitoring for
Fostemsavir (FTR) OATP1B3 adverse reactions associated with brincidofovir (i.e., elevations in transaminases
Protease Inhibitors (class) and bilirubin, diarrhea, or other gastrointestinal adverse events) and postpone the
dosing of these antiretrovirals for ≥3 hrs after brincidofovir administration.
Tenofovir disoproxil Nephrotoxicity If concomitant use of TDF and nephrotoxic agents is unavoidable, renal function
fumarate (TDF) should be monitored closely.
Zidovudine (AZT) Possible reduced renal When brincidofovir is coadministered to patients being treated with AZT, they
secretion of AZT should be closely monitored for AZT-induced hematological toxicity.
Vaccinia immune No known or anticipated — —
globulin interactions with
intravenous antiretroviral therapy
Abbreviations: ART = antiretroviral therapy; CYP = cytochrome P450; NNRTI = non-nucleoside reverse transcriptase inhibitors; OATP = organic anion transporting
polypeptide.
* https://hiv-druginteractions.org/checker
† https://cdn.hivguidelines.org/wp-content/uploads/20220715134949/NYSDOH-AI-ARVs-and-Treatments-for-Severe-Monkeypox_7-15-2022_HG.pdf
§ https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212888s005s006lbl.pdf

are likely not virologically suppressed, currently available data

Summary
are insufficient to define actionable thresholds (21,22). Until
What is already known about this topic?
more is known, clinicians should exercise clinical judgement
A multinational monkeypox outbreak disproportionately
assessing the extent of immunosuppression from HIV and
affecting men who have sex with men, including persons with
HIV infection, is ongoing worldwide. from any other sources, and the relationship of the patient’s
immunosuppression to the risk for severe monkeypox illness.
What is added by this report?
When vaccination is used for prevention of monkeypox
CDC has developed clinical considerations for prevention and
treatment of monkeypox in persons with HIV infection, including
in persons with HIV infection, JYNNEOS is preferred over
pre-exposure and postexposure prophylaxis with JYNNEOS ACAM2000. Based on current recommendations from ACIP,
vaccine, treatment with tecovirimat, and infection control. ACAM2000 is contraindicated for persons with HIV infection
What are the implications for public health practice? because of the risk for severe adverse effects resulting from the
Persons with advanced HIV might be at increased risk for severe spread of vaccinia virus (15). If high-risk exposures cannot be
monkeypox. Postexposure prophylaxis and antiviral treatments avoided, immunocompromised persons may receive JYNNEOS
are available for persons with HIV infection. Prompt diagnosis in consultation with their health care provider after careful con-
and treatment and enhanced prevention efforts might reduce sideration of the risks and benefits (15). Clinical efficacy (vaccine
the risk for severe outcomes. effectiveness) of JYNNEOS against monkeypox is unknown,
including among persons with HIV infection. Other therapies,

1026 MMWR / August 12, 2022 / Vol. 71 / No. 32 US Department of Health and Human Services/Centers for Disease Control and Prevention
 Morbidity and Mortality Weekly Report

including tecovirimat and VIGIV, can be considered for mon- 4. Iñigo Martínez J, Gil Montalbán E, Jiménez Bueno S, et al. Monkeypox
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Spain, 26 April to 16 June 2022. Euro Surveill 2022;27(22):2200424.
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logically suppressed with ART might be at increased risk for 10. European Centers for Disease Prevention and Control; World Health
severe disease related to monkeypox. Postexposure prophylaxis Organization Regional Office for Europe. Joint ECDC-WHO Reginal
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European Centers for Disease Prevention and Control; 2022. Accessed
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Corresponding Author: Jesse O’Shea, kst4@cdc.gov, 678-475-4899. the treatment of smallpox. N Engl J Med 2018;379:44–53.
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Committee of Medical Journal Editors form for disclosure of potential recommendations of the Advisory Committee on Immunization
conflicts of interest. No potential conflicts of interest were disclosed. Practices—United States, 2022. MMWR Morb Mortal Wkly Rep
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1028 MMWR / August 12, 2022 / Vol. 71 / No. 32 US Department of Health and Human Services/Centers for Disease Control and Prevention