Clinical Considerations for Treatment and Prophylaxis of Monkeypox Virus Infection in People with HIV
Updates as of October 31, 2022
- Updated monkeypox treatment information.
Who this is for: Healthcare professionals providing care for people with HIV.
What this is for: Considerations for the care of people with HIV, including prevention and treatment of monkeypox.
How to use: This information is intended as an aid for staff at healthcare facilities and for healthcare professionals developing plans for monkeypox treatment and prophylaxis.
- People with HIV-associated immunosuppression or who are not virologically suppressed can be at increased risk of severe disease with monkeypox.
- Post-exposure prophylaxis is available for people exposed to Monkeypox virus and antiviral treatment is available for people with Monkeypox virus Vaccination with JYNNEOS is considered safe for people with HIV, and antiviral treatments for monkeypox have few interactions with antiretroviral therapy.
- The use of tecovirimat should be considered in people with HIV, particularly those with immunosuppression. Addition of other therapeutics (cidofovir, brincidofovir, VIGIV) may be considered for those not improving or those progressing while on tecovirimat.
- Screening for STIs should be considered for persons evaluated for monkeypox, with appropriate care offered to those with positive test results.
These considerations are based upon evidence available to date about monkeypox in people with HIV. The approaches outlined below are intentionally cautious until additional data become available.
Available summary surveillance data from the European Union1,2,3, England4, and the United States5 indicate that among gay, bisexual, and other men who have sex with men (MSM) with monkeypox for whom HIV status is known, 28%–51% have HIV infection.
It is currently unknown whether an HIV infection increases a person’s risk of acquiring monkeypox disease after exposure.
The available data indicate that people with advanced and uncontrolled HIV can be at a higher risk of severe or prolonged monkeypox disease. In a 2017–18 case series of 122 Nigerian patients with monkeypox, 4 of the 7 deaths occurred among people with untreated advanced HIV; however, data about the overall proportion of patients who had HIV were lacking.6 A second 2017–18 case series, also from Nigeria, included 9 people with HIV for whom clinical data relevant to HIV status were provided: CD4 cell counts ranged from 20–357 cells/mm3, indicating immunosuppression. Compared with other patients, those with HIV had higher rates of secondary bacterial infection, more prolonged illness (and thereby also longer period of infectiousness), as well as a greater likelihood of a confluent or partially confluent rash, rather than discrete lesions.7 Reports from European countries, where the majority of persons with HIV are taking antiretroviral therapy and have high CD4 cell counts have not found an evident excess in hospitalizations thus far among people with HIV and monkeypox.2-4 The WHO has stated that “people with HIV…who take antiretroviral therapy and have a robust immune system have not reported a more severe course of disease.” However, in a recent report from the U.S., among persons with monkeypox, hospitalizations were more common in persons with HIV than in persons without HIV. CDC has become aware of several cases of severe monkeypox disease manifestations among people with HIV who were immunocompromised; these required hospitalization, had a prolonged disease course, developed complications and even led to death, see Severe Monkeypox in Hospitalized Patients — United States, August 10–October 10, 2022 | MMWR (cdc.gov) and HAN Archive – 00475 | Health Alert Network (HAN) (cdc.gov)
The signs and symptoms of Monkeypox virus infection are similar in immunocompetent people with or without HIV, including characteristic rash, fever, and lymphadenopathy. For immunocompromised people, Monkeypox virus infection may present with atypical manifestations or more severe illness (for example, sepsis, disseminated rash, hemorrhagic disease, large number of lesions that are confluent, necrotic lesions, severe lymphadenopathy that can be obstructing, ocular or periorbital infections, pulmonary involvement, encephalitis, myocarditis or other conditions requiring hospitalization). For more information on severe disease caused by monkeypox see Severe Monkeypox in Hospitalized Patients — United States, August 10–October 10, 2022 | MMWR (cdc.gov) and HAN Archive – 00475 | Health Alert Network (HAN) (cdc.gov).
Monkeypox disease is characterized by an incubation period, prodrome, and rash. For full details, please see Clinical Recognition | Monkeypox | Poxvirus | CDC.
Incubation and Prodrome
It is not known if people with HIV have different characteristics related to the incubation or prodromal phase of illness.
Immunocompromised people, including people with advanced HIV or untreated HIV, may present with an atypical rash, including a disseminated rash, which may make diagnosis more challenging, as mentioned earlier. In one study, people with poorly controlled HIV were more likely to have genital lesions and a confluent or partially confluent rash, as opposed to discrete lesions.6 Additionally, patients with poorly controlled HIV were more likely to have prolonged or recurrent illness. See also Severe Monkeypox in Hospitalized Patients — United States, August 10–October 10, 2022 | MMWR (cdc.gov) and HAN Archive – 00475 | Health Alert Network (HAN) (cdc.gov).
Monkeypox virus infection should also be considered when evaluating for causes of rash. Other considerations include herpes zoster (shingles), scabies, molluscum contagiosum, herpes, syphilis, chancroid, lymphogranuloma venereum, allergic skin rashes, and drug eruptions. Monkeypox can be confused with disseminated herpes zoster or herpes simplex virus infections. These herpesvirus infections, and especially disseminated herpes zoster, more commonly affect people with immunocompromising conditions. Therefore, to establish a diagnosis for immunocompromised people who present with a rash, clinicians should conduct a thorough history to assess for possible monkeypox exposures or epidemiologic risk factors, perform a complete physical examination, and order appropriate laboratory testing.
Co-infections of monkeypox with sexually transmitted infections (STI) have been reported. In a recent study, among 1,969 persons with monkeypox in eight U.S. jurisdictions, 38% had HIV infection, and 41% had an STI in the preceding year. Therefore, a broad approach to testing is recommended, including STI testing for people evaluated for monkeypox. Appropriate care should be offered to those with positive test results.9
For additional recommendations regarding case finding and clinical presentation, please see: Updated Case-finding Guidance: Monkeypox Outbreak—United States, 2022.
For additional recommendations on specimen collection for clinicians, please see: Preparation and Collection of Specimens | Monkeypox | Poxvirus | CDC.
Managing Monkeypox in People With HIV
People with HIV may be at increased risk of severe disease and prolonged infectiousness. Therefore, prophylaxis (for example, vaccination), medical treatment and close monitoring are a priority for this population. Providers should consider both viral suppression and CD4 count in weighing the risk of severe outcomes for any patient with HIV. As noted earlier, severe outcomes have been observed in people with inadequately treated HIV who have CD4 counts ≤ 350/mm3 and are likely not virologically suppressed; however, the available data are presently insufficient to define actionable thresholds. Until more is known, clinicians should exercise clinical judgement to assess the extent of immunosuppression (from HIV or any other sources) and the risk for severe monkeypox illness. The patient’s clinical team is best positioned to determine the degree of immune compromise and, with the input of public health practitioners, the need for prophylaxis (including vaccination) and treatment. The decision to treat and monitor an immunocompromised person in their home or an inpatient setting should likewise be individualized.
Managing HIV in People With Monkeypox and HIV
ART and opportunistic infection prophylaxis should be continued in all people with HIV who develop monkeypox. Antiretroviral treatment interruption may lead to rebound viremia that could complicate the management of Monkeypox virus infection (for example, worsen the severity of illness). People without HIV taking antiretrovirals for HIV pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) should likewise continue taking these medications.
For people with HIV diagnosed coincident with monkeypox or who are not taking ART, CDC recommends starting ART as soon as possible, and in consultation with an expert in HIV medicine if needed. Consultation with CDC is encouraged for severe cases. CDC offers a clinical consultation service (email email@example.com) or healthcare providers may contact the CDC Emergency Operations Center [EOC] at (770) 488-7100) and can provide additional guidance to clinicians with patient management questions.
Clinicians using antivirals for monkeypox need to be alert for drug-drug interactions with any antiretrovirals used to treat10 or prevent11, 12 HIV infection as well as with any other medications used to prevent or treat HIV-related opportunistic infections.13 Key critical interactions are discussed below for each monkeypox antiviral. Any potential drug-drug interactions not noted below can be assessed using the University of Liverpool HIV Drug Interactions database, an interactive online tool found at: https://www.hiv-druginteractions.org/checker.
Monkeypox Treatment Options
Tecovirimat (a.k.a. TPOXX, ST-246)
Tecovirimat is an antiviral medication available as a pill or as an injection for intravenous (IV) administration. It is FDA-approved for the treatment of human smallpox disease caused by variola virus in adults and children. Its use for other orthopoxvirus infections, including monkeypox, is not approved by the FDA because there are no data regarding its effectiveness in treating monkeypox in humans. Therefore, CDC holds a non-research expanded access Investigational New Drug (EA-IND) protocol (sometimes called “compassionate use”) that allows for the use of tecovirimat for primary or early empiric treatment of non-variola orthopoxvirus infections, including monkeypox, in adults and children of all ages. Tecovirimat use allowed under the EA-IND protocol [1 MB, 22 pages] is intended to be used in concert with CDC guidance for treatment of monkeypox. Tecovirimat is available from the Strategic National Stockpile and is provided at no cost.
Studies using a variety of animal species have shown that tecovirimat is effective in treating orthopoxvirus-induced disease.14 Human clinical trials indicated the drug had an acceptable safety profile.15 A case report from the UK suggested that tecovirimat may shorten the duration of monkeypox illness and monkeypox viral shedding.16
Tecovirimat should be administered early in the course of illness, along with supportive care and pain control, as needed. Courses longer than 14 days can be used if there is no improvement or if there is recurrence of symptoms after initial improvement. The decision to use oral or intravenous (IV) tecovirimat should be individualized, based on the patient’s severity of presentation, other comorbidities, or ability to eat a full, fatty meal. If clinical manifestations do not improve, if the disease progresses despite the use of oral tecovirimat, or if there are concerns about absorption, IV tecovirimat can be used. If there is no improvement, IV tecovirimat should continue to be administered and the addition of the other therapeutics below may be considered. Consultation with CDC is encouraged for severe cases of monkeypox.
Cidofovir and Brincidofovir
Healthcare providers may consider the use of cidofovir or brincidofovir in severe cases of monkeypox. Cidofovir is approved by the FDA for treatment of cytomegalovirus (CMV) retinitis in patients with advanced HIV. It is administered as an intravenous infusion and is commercially available. Brincidofovir is approved by the FDA for the treatment of human smallpox disease in adult and pediatric patients, including neonates. It is administered orally as a tablet or oral suspension. Brincidofovir is made available from the Strategic National Stockpile for treatment of monkeypox to clinicians who request and obtain an FDA-authorized single-patient emergency use IND (e-IND). Brincidofovir and cidofovir should not be used simultaneously.
Data are not available on the effectiveness of cidofovir and brincidofovir in treating human cases of monkeypox. However, both have proven activity against poxviruses in in vitro and animal studies. At this time, it is unknown if a person with severe Monkeypox virus infection will benefit from treatment with either antiviral, although their use should be considered in such instances.
Vaccinia Immune Globulin Intravenous (VIGIV)
Healthcare providers may consider the use of VIGIV in severe cases of monkeypox. Data are not available on the effectiveness of VIGIV in treatment of Monkeypox virus infection. VIGIV for the treatment of monkeypox is administered under an EA-IND [PDF – 418 KB], and it is unknown whether a person with severe Monkeypox virus infection will benefit from treatment with VIGIV.
Special Considerations for Use of these Therapeutics in People With HIV
Tecovirimat (a.k.a. TPOXX, ST-246)
Few interactions are expected with antiretroviral therapy for HIV. However, none of the identified drug interactions should preclude coadministration of tecovirimat and antiretroviral therapy. According to the Liverpool HIV drug interactions database, tecovirimat may result in a reduction in levels of the non-nucleoside reverse transcriptase inhibitors (NNRTIs) doravirine and rilpivirine, and the CCR5 antagonist maraviroc. Dose increases for doravirine, rilpivirine, and maraviroc could be considered when co-administered with tecovirimat and for two weeks after completion of tecovirimat therapy (see Liverpool website for details). 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. Consultation with local pharmacists and HIV experts is suggested.
When co-administering tecovirimat with long-acting cabotegravir/rilpivirine, tecovirimat might result in a reduction in rilpivirine levels. Per the Liverpool HIV interactions database, the addition of oral rilpivirine 25mg once daily (or the patient’s prior ART regimen) during treatment with tecovirimat and for approximately 2 weeks 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/rilpivirine should be avoided during tecovirimat therapy and for 2 weeks after the conclusion of tecovirimat.
Cidofovir and Brincidofovir
Cidofovir is contraindicated in patients with serum creatinine >1.5 mg/dL because of associated nephrotoxicity. Co-administration of cidofovir with tenofovir disoproxil fumarate (TDF) is not recommended. If concomitant use of TDF and nephrotoxic agents is unavoidable, renal function should be monitored closely. Cidofovir is typically co-administered with probenecid both to reduce nephrotoxicity and boost its effectiveness. Probenecid substantially increases zidovudine plasma levels; if co-administered, zidovudine should either be temporarily discontinued or decreased by 50% on the day of cidofovir-probenecid administration to avoid zidovudine-induced hematological toxicity.
Brincidofovir has clinically relevant drug interaction with protease inhibitors (PIs), cobicistat, and fostemsavir, that may require modification of therapy. If PIs or fostemsavir are co-administered with brincidofovir, clinicians should monitor closely for adverse reactions (for example, elevations in transaminase levels), and dosing of antiretroviral therapy should be delayed for at least 3 hours after brincidofovir administration.
Both cidofovir and brincidofovir have interactions (including contraindications for use) with other medications that should be assessed by the clinical team. Cidofovir is available commercially and brincidofovir is available from the SNS.
Vaccinia Immune Globulin Intravenous (VIGIV)
There are no specific contraindications for use of VIGIV among people with HIV, and no known or anticipated interactions with antiretroviral therapy.
Monkeypox can cause keratitis. Caution should be exercised when using VIGIV in the treatment of people with active keratitis, as increased corneal scarring was observed in an animal model of vaccinia keratitis. This finding, however, has not been found in other studies. Therapeutic considerations for ocular monkeypox are included in the guidance on Management of Ocular Monkeypox.
VIGIV is contraindicated in individuals with a history of anaphylaxis or prior severe systemic reaction associated with the parenteral administration of this or other human immune globulin preparations. VIGIV is contraindicated in IgA-deficient patients with antibodies against IgA and a history of IgA hypersensitivity.
Vaccination with live virus vaccines (for example, varicella, measles, mumps, and rubella) should be deferred for 3 months after use of VIGIV.
For additional details regarding therapeutic recommendations, see Treatment.
Monkeypox Pre-Exposure Prophylaxis
Pre-exposure prophylaxis for monkeypox by vaccination should be offered to people with HIV if indicated. The risks and benefits of pre-exposure prophylaxis by vaccination should be discussed with the patient using shared decision-making.
When pre-exposure prophylaxis by vaccination is chosen, JYNNEOS should be used for people with HIV. Based on available guidance from ACIP, ACAM2000 should not be used for people with HIV due to the risk of adverse effects from the spread of vaccinia virus.
Tecovirimat or VIGIV can also be considered for prophylactic use in an exposed person with severe immunodeficiency in T-cell function for which vaccination following exposure to monkeypox virus is contraindicated, on a case-by-case basis, depending on the conditions that necessitate an alternative option to vaccination.
Monkeypox Postexposure Prophylaxis
Postexposure prophylaxis for monkeypox by vaccination should be offered to people with HIV as indicated. The benefits and potential adverse effects of postexposure prophylaxis by vaccination should be discussed with the patient using shared decision-making. Other therapies, including the antiviral medication tecovirimat and vaccinia immune globulin, may be considered for monkeypox PEP on an individual case-by-case basis depending on the known high-risk exposure to a confirmed or probable case of infection and clinical conditions that necessitate an alternative option to PEP vaccination. The efficacy of these therapies as monkeypox PEP is unknown.
While the use of vaccines for post-exposure prophylaxis has not been studied, early use of vaccination (within 4 days from exposure) could prevent Monkeypox virus infection, and later use (5 days or more after exposure) may decrease the severity of monkeypox disease if infection occurs.
When postexposure prophylaxis for monkeypox by vaccination is chosen, JYNNEOS should be used for people with HIV due to the risk of adverse effects from the spread of vaccinia virus with ACAM2000.
JYNNEOS is a two-dose live virus vaccine that uses non-replicating modified vaccinia Ankara (MVA). It is licensed by FDA for prevention of both smallpox and monkeypox disease in adults 18 years of age and older. The safety and immunogenicity of JYNNEOS has been specifically evaluated in people with HIV. In one study, which enrolled people with HIV with CD4 counts between 200 and 750 cells/mm3, the rates of adverse events did not differ between people with and without HIV. In another study, which enrolled people with HIV and CD4 counts >350 cells/mm3 and people without HIV, vaccination was well tolerated and comparably immunogenic in terms of neutralizing antibody responses in both groups. In another trial specifically enrolling people with a prior diagnosis of AIDS who were virologically suppressed and had CD4 counts between 100 and 500, there were no serious safety concerns, and the vaccine appeared efficacious based on immunogenicity at standard dosing. Immunogenicity among people with HIV who have CD4 counts below 100 cells/mm3 or who are not virologically suppressed remains unknown.
For more information, please see: Considerations for Monkeypox Vaccination.
ACAM2000 is a single-dose live virus vaccine that uses replication competentvaccinia. It is licensed by FDA for prevention of smallpox. ACAM2000 should not be given to people with HIV (regardless of immune status). Severe localized or systemic infection with vaccinia (progressive vaccinia) may occur in people with weakened immune systems, including from HIV.
ACAM2000 vaccination should also be avoided if the vaccine recipient cannot sufficiently isolate from household contacts who have a history of atopic dermatitis or other active exfoliative skin conditions, an immunocompromising condition, or who are pregnant or aged <1 year. Household contacts include people with prolonged intimate contact with the potential vaccinee (for example, sexual contacts) and others who might have direct contact with the vaccination site or with potentially contaminated materials (for example, clothing or vaccination site dressings).
For more information, please see: Considerations for Monkeypox Vaccination.
Vaccine Adverse Events
All adverse reactions should be reported to the Vaccine Adverse Event Reporting System (VAERS). Reports can be filed by healthcare providers or by vaccine recipients. To file an adverse reaction report, please visit www.vaers.hhs.gov or call 1-800-822-7967. VAERS is only for reporting reactions, and VAERS staff members do not give medical advice.
U.S. healthcare providers and health department staff with a complex monkeypox vaccine safety question about a specific patient residing in the U.S. or vaccine safety issue can contact the Clinical Immunization Safety Assessment (CISA) Project at CISAeval@cdc.gov to request a case consultation. In case of an emergent clinical vaccine safety inquiry, healthcare providers and health department staff can call the CDC Emergency Operations Center (EOC) Watch Desk at (770)-488-7100.
People with HIV should follow the same guidance as anyone else to protect themselves from monkeypox:
- Avoid direct contact with rashes, sores, or scabs of a person with monkeypox, including during intimate contact such as sex. We believe this is currently the most common way that monkeypox is spreading in the U.S.
- Avoid contact with objects, fabrics (for example, clothing, bedding, or towels), and surfaces that have been used by someone with monkeypox.
- Avoid contact with respiratory secretions, through kissing and other face-to-face contact from a person with monkeypox.
For more information, including guidance around sex visit Monkeypox Facts for People Who are Sexually Active | Monkeypox | Poxvirus | CDC
Isolation and Infection Control
Infection control practices for the care of people with monkeypox are the same regardless of HIV status. People with monkeypox isolating at home should also follow precautions to protect others in the household.
A person is contagious until after all the scabs on the skin have fallen off and a fresh layer of intact skin has formed underneath. Based on limited evidence from Ogoina et al., this period of contagiousness may be prolonged due to a longer period of illness in people with HIV who are not virologically suppressed. Decisions regarding discontinuation of isolation precautions at a healthcare facility and at home should be made in consultation with the local or state health department.
For information about skin care for individuals with monkeypox lesions, please see Monkeypox: Caring for the Skin [166KB, 2 Pages].
- European Centers for Disease Prevention and Control; World Health Organization Regional Office for Europe. Joint ECDC-WHO Reginal Office for Europe monkeypox surveillance bulletin. Stockholm, Sweden: European Centers for Disease Prevention and Control; 2022. Accessed August 3, 2022. https://monkeypoxreport.ecdc.europa.eu.
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- Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services. Available at: https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf
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