Guidance for COVID-19 and people with HIV

This guide reviews special considerations regarding COVID-19 for people living with HIV and their healthcare providers in the United States. Information and data about COVID-19 are evolving rapidly. Clinicians should consult up-to-date sources for more specific recommendations regarding the prevention, diagnosis, and treatment of COVID-19, including the NIH COVID-19 Treatment Guidelines , which have a section on Special Considerations in People Living with HIV .

Actualmente se desconoce si las personas con VIH corren un mayor riesgo de contraer la infección por SARS-CoV-2. Están surgiendo datos sobre el curso clínico de COVID-19 en personas con VIH. En la serie de casos inicial de Europa y Estados Unidos, no se encontraron diferencias significativas en los resultados clínicos entre las personas con VIH que desarrollaron COVID-19 y las personas sin VIH. Por ejemplo, los datos del Veterans Aging Cohort Study compararon los resultados en 253 participantes, en su mayoría hombres, con VIH y COVID-19 que fueron emparejados con 504 participantes con solo COVID-19. En esta comparación, no surgieron diferencias en la hospitalización relacionada con COVID 19, la admisión en la unidad de cuidados intensivos (UCI), la intubación o la muerte entre pacientes con o sin VIH. Por el contrario, en otros estudios de cohortes de los Estados Unidos, el Reino Unido y Sudáfrica se han informado peores resultados, incluido un aumento de las tasas de mortalidad por COVID 19, en personas con VIH. En un estudio de cohorte multicéntrico de 286 pacientes con VIH y COVID-19 en los Estados Unidos, un recuento más bajo de CD4 (es decir, <200 células / mm ³ ), a pesar de la supresión virológica, se asoció con un mayor riesgo para el criterio de valoración combinado de ingreso en UCI, ventilación mecánica o muerte. ¹⁴ En otro estudio de 175 pacientes con VIH y COVID-19, un recuento bajo de CD4 o un nadir de CD4 se asoció con malos resultados. En un estudio de cohorte en Nueva York, las personas con VIH tuvieron tasas más altas de hospitalización y mortalidad con COVID-19 en comparación con las personas sin VIH. ^d

In the general population, people at higher risk for severe COVID-19 include those over 60 years of age; pregnant women; and those with comorbidities, such as obesity, diabetes mellitus, cardiovascular disease, lung disease, a history of smoking, sickle cell disease, and solid organ transplant recipients. ^¹ Many people living with HIV have one or more comorbidities that may put them at higher risk for a more severe course of COVID-19. Both COVID-19 and HIV disproportionately affect communities of color. Based on the available literature, close monitoring of all people with HIV and SARS-CoV-2 infection is warranted, especially those with advanced HIV or comorbidities.

Guidance for all people with HIV

People with HIV should follow all applicable recommendations from the U.S. Centers for Disease Control and Prevention (CDC) to prevent SARS-CoV-2 infection , such as practicing social or physical distancing, consistently wearing masks, avoiding crowded areas, and using proper hand hygiene (AIII) .
People with HIV should receive SARS-CoV-2 vaccines, regardless of viral load or CD4 count, because the potential benefits outweigh the potential risks. (AIII) .
- According to recent literature to date, people with HIV appear to be at higher risk of severe outcomes with COVID-19 compared to people without HIV and should be included in the high-risk medical conditions category when developing vaccine priority (AIII).
- People with HIV were included in clinical trials of both mRNA vaccines; at this time, safety and efficacy in this specific subgroup have not been fully reported. People with HIV who are well controlled on antiretroviral therapy (ART) generally respond well to licensed vaccines. Guidance for these vaccines, including for people with HIV, is available through the Advisory Committee on Immunization Practices (ACIP) and the Infectious Diseases Society of America . Confidentiality regarding their underlying condition should be maintained when administering vaccines to people with HIV.
Current recommendations from the American College of Pediatric Infectious Diseases (ACIP), the American College of Obstetricians and Gynecologists (ACOG), and the Society for Maternal-Fetal Medicine (SMFM) state that pregnant and breastfeeding individuals who otherwise meet the criteria for vaccination should not have restricted access to the vaccine. The CDC also provides information on vaccine considerations for people who are pregnant or breastfeeding .
Influenza and pneumococcal vaccines should be kept up to date, paying attention to the timing because receiving other vaccines within 2 weeks of COVID-19 vaccination is not recommended (AIII) .
People with HIV who have COVID-19 should be treated clinically in the same way as people in the general population with COVID-19, including when making healthcare triage (AIII) determinations.

Antiretroviral therapy

Healthcare providers must do everything possible to ensure that people with HIV maintain an adequate supply of ART and all other concomitant medications (AIII) .
People with HIV should talk to their pharmacists and/or healthcare providers about exploring alternative delivery options, such as switching to mail-order medication delivery, where possible.
People with HIV for whom a regimen change is planned for reasons other than toxicities or virological failure should consider delaying the change until close follow-up and monitoring is possible (AIII) .
Many medications, including some antiretroviral agents (ARVs) (e.g., lopinavir/ritonavir, boosted darunavir, tenofovir disoproxil fumarate/emtricitabine), have been or are being evaluated in clinical trials or are prescribed off-label for the treatment or prevention of COVID-19. Currently, no ARV has been shown to be effective in these settings. People with HIV should not change their ARV regimens or add ARV medications to their regimens for the purpose of preventing or treating SARS-CoV-2 infection (AIII) .

Follow-up visits to the clinic or laboratory related to HIV care

Together with their healthcare providers, people living with HIV should weigh the risks and benefits of attending HIV-related clinical appointments at this time versus not attending in person. Factors to consider include the extent of local COVID-19 transmission, the health needs that will be addressed during the appointment, their HIV status (e.g., CD4 cell count, HIV viral load), the interval since their last lab test, their need for vaccinations, and their overall health.
Telephone or virtual visits for routine or non-urgent care and adherence counseling can replace face-to-face meetings.
For people who have a suppressed HIV viral load and are in stable health, routine medical and laboratory visits should be postponed as much as possible.

People with HIV and in opioid treatment programs

Physicians treating people with HIV who are enrolled in opioid treatment programs (OTPs) should consult the Substance Abuse and Mental Health Services Administration (SAMHSA) website for updated guidance on how to avoid treatment interruptions during the COVID-19 pandemic. State methadone agencies are also responsible for regulating OTPs in their jurisdictions and can provide additional guidance.

Guidance for people with HIV in self-isolation or quarantine due to exposure to SARS-CoV-2

Healthcare workers should:

Verify that patients have adequate supplies of all medications and expedite renewals of additional medications as needed.
Design a plan to assess patients if they develop COVID-19-related symptoms, including possible transfer to a healthcare facility for COVID-19-related care.

People with HIV should:

Contact your healthcare providers to inform them that you are isolating or quarantining.
Inform your healthcare providers about the specific quantity of ARV medications and other essential medicines you have on hand and coordinate the delivery of refills, if necessary.

Guidance for people with HIV who have fever and/or respiratory or other symptoms and are seeking assessment and care

Guidance for healthcare workers

Follow CDC recommendations , as well as guidance from your local and state health departments on infection control, triage, diagnosis, and management.

Guidance for people with HIV

Follow CDC recommendations regarding symptoms .
Call your healthcare provider for medical advice if you develop a fever and other symptoms (e.g., cough, shortness of breath). New or worsening shortness of breath warrants an in-person evaluation.
Call the clinic in advance before showing up to the care providers.
Always practice respiratory and hand hygiene and cough etiquette when visiting a healthcare facility, and wear a mask.
Notify the registration staff immediately upon arrival if you experience symptoms while at a clinic or emergency center without prior notice, so that steps can be taken to prevent the transmission of COVID-19 in the healthcare setting. Specific clinical actions include placing a mask on the patient and promptly moving them to a room (if available, with negative pressure) or other space separate from other people.

Guidelines for the management of people with HIV who develop COVID-19

Guidance when hospitalization is not necessary

A person with HIV should do the following:

Manage symptoms at home with supportive care for symptom relief.
Maintain close communication with your healthcare provider and report any progression of symptoms (e.g., fever lasting >2 days, new shortness of breath). Patients and/or caregivers should be aware of warning signs and symptoms that warrant an in-person evaluation, such as new dyspnea, chest pain/tightness, confusion, or other changes in mental status.
Continue your ARV therapy and other medications as prescribed.
Note that people with HIV with additional comorbidities may be eligible for one of the anti-SARS-CoV-2 monoclonal antibodies available through the FDA Emergency Use Authorization. ^20-22

Guidance when a person with HIV is hospitalized

ART should be continued. If ARV medications are not on the hospital formulary, administer medications from the patient's home supplies.
Substitutions of ARV medications should be avoided . If necessary, clinicians may consult recommendations on ARV medications that can be changed in the U.S. Department of Health and Human Services (HHS) guidelines for the care of people living with HIV in disaster areas.
If patients receive an intravenous (IV) infusion of ibalizumab (IBA) every 2 weeks as part of their ARV regimen, physicians should make arrangements with the patient's hospital provider to continue administering this drug without interruption.
If patients are taking an investigational ARV drug as part of their regimen, arrangements should be made with the research study team to continue the drug if possible.
For critically ill patients requiring tube feeding, some antiretroviral (ARV) medications are available in liquid formulations, and some, but not all, pills can be crushed. Clinicians should consult an HIV specialist and/or pharmacist to assess the best way for a tube-fed patient to continue an effective ARV regimen. This information may be available on the drug label or in this document from the Toronto General Hospital Immunodeficiency Clinic .

Guidance on approved, investigational, or off-label treatments for COVID-19

Remdesivir is currently the only FDA-approved antiviral treatment for COVID-19. Dexamethasone is commonly used to treat COVID-19 patients who require supplemental oxygen. People with HIV who are hospitalized with COVID-19 should generally receive these medications for the same indications as people with COVID-19 who do not have HIV coinfection.
Several other medications are available through FDA Emergency Use Authorizations, including baricitinib, convalescent plasma, bamlanivimab, bamlanivimab plus etesvimab, and casirivimab plus imdevimab. Clinicians should consult the latest COVID-19 Treatment Guidelines for methods of managing COVID-19 based on disease severity.
For HIV patients receiving treatment for COVID-19, clinicians should assess for potential drug interactions between the COVID-19 treatment and the patient's antiretroviral therapy (ART) and other medications. Information on potential drug interactions can be found on product labels, in drug interaction resources , clinical trial protocols, or in investigator handouts.
When available and indicated, clinicians may consider enrolling patients with HIV in a clinical trial evaluating the safety and efficacy of an experimental treatment for COVID-19. People with HIV should not be excluded from consideration for these trials. Clinicaltrials.gov is a helpful resource for finding studies investigating potential treatments for COVID-19.

Additional guidance for physicians specializing in HIV

Some Medicaid and Medicare programs, commercial health insurers, and AIDS Drug Assistance Programs (ADAPs) have restrictions that prevent patients from obtaining a 90-day supply of antiretroviral drugs (ARVs) and other medications. During the COVID-19 pandemic, physicians should request that insurers/programs remove these medication supply quantity restrictions. ADAPs should also provide patients with a 90-day supply of medications.
People living with HIV may need additional support with food, housing, transportation, and childcare during times of crisis and economic hardship. To improve engagement with care and continuity of antiretroviral therapy, clinicians should make every effort to assess their patients' need for additional social support and connect them with resources, including navigation services when possible.
During this pandemic, social distancing and isolation can exacerbate mental health and substance use problems for some people living with HIV. Clinicians should assess and address these patient concerns and arrange additional consultations, preferably virtually, as needed.
Telehealth options, including phone calls or video calls, should be considered for routine visits and triage visits for patients who are ill.
Reports indicate that some measures designed to control the spread of COVID-19 may increase the risk of intimate partner violence and/or child abuse, as well as limit people's ability to distance themselves from abusers or access outside support. Providers should assess patient safety at every clinical encounter, whether in person or via telemedicine, being mindful of the patient's ability to speak privately.
During the COVID-19 pandemic, reproductive desires and pregnancy planning should be discussed with all individuals of childbearing age. This discussion should include information about what is known and unknown about COVID-19 during pregnancy. Pre-pregnancy conversations should be patient-centered and include the option of postponing efforts to conceive until after the peak of the pandemic and/or further information about the effects of COVID-19 during pregnancy. Individuals may be at increased risk of unintended pregnancies when stay-at-home measures are in place, and the continuation or initiation of appropriate contraception, including emergency contraception, should be addressed. Based on clinical trial data, the use of intrauterine devices and contraceptive implants may be considered after the expiration date specified in the package insert. ^²³ ^Depot medroxyprogesterone acetate may also be considered for subcutaneous self-injection.

Special considerations for pregnancy, HIV and COVID-19

COVID-19 and pregnancy

Although data is limited, to date there is no evidence to suggest that pregnant people are more susceptible to SARS-CoV-2 infection than non-pregnant people.
Overall, the risk of severe illness or death from COVID-19 remains relatively low in pregnant people compared to non-pregnant women of reproductive age. However, studies from the United States, the United Kingdom, and Sweden, as well as a meta-analysis of 77 studies, show that pregnant women with COVID-19 have a higher risk of hospitalization, intensive care unit admission, and mechanical ventilation compared to age-matched non-pregnant women with COVID-19. Some, but not all, of these studies found a higher risk of death among pregnant women with COVID-19.
As in the general population, there is a disproportionately high rate of COVID-19 among pregnant women of color compared to white women and possibly a higher rate of COVID-19 severity among pregnant women of color compared to white women.
Cohort studies have not shown an increase in fetal loss in pregnant women with COVID-19 compared to those without COVID-19.
Emergency cesarean delivery and preterm birth (28 to 36 weeks of gestation) appear to be more frequent in pregnant women with COVID-19 compared to those without. Although there has been some increase in admission to the neonatal intensive care unit in newborns exposed to SARS-CoV-2, this trend is mainly due to complications of prematurity or known exposure, and most newborns recover well.
Vertical transmission of SARS-CoV-2 from mother to child appears to be very rare; neonatal infection seems to occur in most cases after birth.

COVID-19, pregnancy and HIV

Currently, there is limited data available on pregnancy and maternal outcomes in people who have COVID-19 and none specifically for pregnancy outcomes in people with COVID-19 and HIV.
Pregnant women with HIV who have COVID-19 should be treated clinically the same as pregnant women without HIV who have COVID-19, including when making care triage determinations and decisions about vaccination and treatment. COVID-19 treatment and vaccination should not be withheld in pregnant women with HIV; see the joint statement from the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine .
Pregnant people with HIV admitted for COVID-19 should continue their antiretroviral (ARV) regimen. Clinicians should consult with an HIV expert if regimen changes are needed for people who are not virally suppressed.

Children with HIV

Current knowledge about COVID-19 in children and children with HIV can be summarized as follows:

There is minimal data on COVID-19 among children with HIV infection. One report from South Africa of 159 children with COVID-19 included two children with HIV.^³⁴ Although both children with HIV were hospitalized, only one was symptomatic and neither died. HIV infection did not appear to contribute to more severe COVID-19 illness. ^³⁵ Like the adult population, children and adolescents of color have disproportionately higher rates of COVID-19 illness and hospitalization. ^³⁶
Children appear less likely to become seriously ill with COVID-19 than older adults. ^37-39
There may be some subpopulations of children at higher risk of more severe COVID-19 disease: younger age (under 1 year), obesity, underlying lung or heart disease, and immunodeficiency are associated with more severe outcomes. ⁴⁰
A multisystem inflammatory syndrome in children (MIS-C) presenting with hyperinflammatory shock resembling Kawasaki disease and toxic shock syndrome has been described as temporally associated with SARS-CoV-2 infection in the United States, the United Kingdom, Europe, and southern Africa, with the syndrome occurring 2 to 4 weeks or more after infection. Children have serologic evidence of infection but may not have a positive nasopharyngeal RT-PCR test.^{^41-43} Children may present with a variety of signs and symptoms, including fever and gastrointestinal symptoms; significantly elevated inflammatory markers; and, in severe cases, myocarditis and cardiogenic shock. Children with MIS-C tend to be older (mean age 8 years) than those with classic Kawasaki disease (peak incidence at 10 months). ^{^44,45}
Infants and children with HIV should be up to date on all vaccinations, including influenza and pneumococcal vaccines. Refer to the Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children for information on immunizations , including a vaccination schedule for children with HIV .
Guidelines for ART management and clinical or laboratory monitoring visits related to HIV care in children with HIV during the pandemic should follow the guidelines described above (see sections “Antiretroviral Therapy” and “Clinical or Laboratory Monitoring Visits Related to HIV Care”).

At: https://clinicalinfo.hiv.gov/en/guidelines/covid-19-and-persons-hiv-interim-guidance/interim-guidance-covid-19-and-persons-hiv