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Special Considerations in People With HIV

Last Updated: April 21, 2021

Summary Recommendations
Summary Recommendations

Prevention of COVID-19

  • The COVID-19 Treatment Guidelines Panel (the Panel) recommends that people with HIV receive SARS-CoV-2 vaccines regardless of their CD4 T lymphocyte cell count or HIV viral load, because the potential benefits outweigh the potential risks (AIII).

Diagnosis of COVID-19

  • The Panel recommends using the same approach for diagnosing SARS-CoV-2 infection in people with HIV as in people without HIV (AIII).

Management of COVID-19

  • Recommendations for the triage, management, and treatment of COVID-19 in people with HIV are the same as those for the general population (AIII).
  • In people with advanced HIV and suspected or documented COVID-19, HIV-associated opportunistic infections (OIs) should also be considered in the differential diagnosis of febrile illness (AIII).
  • When starting treatment for COVID-19 in patients with HIV, clinicians should pay careful attention to potential drug-drug interactions and overlapping toxicities among COVID-19 treatments, antiretroviral (ARV) medications, antimicrobial therapies, and other medications (AIII).
  • People with HIV should be offered the opportunity to participate in clinical trials of vaccines and potential treatments for SARS-CoV-2 infection.

Management of HIV

  • People with HIV who develop COVID-19, including those who require hospitalization, should continue their antiretroviral therapy (ART) and OI prophylaxis whenever possible (AIII).
  • Clinicians who are treating COVID-19 in people with HIV should consult an HIV specialist before adjusting or switching ARV medications (AIII).
  • An ARV regimen should not be switched or adjusted (i.e., by adding ARV drugs to the regimen) for the purpose of preventing or treating SARS-CoV-2 infection (AIII).
  • For people who present with COVID-19 and a new diagnosis of HIV, clinicians should consult an HIV specialist to determine the optimal time to initiate ART.
Rating of Recommendations: A = Strong; B = Moderate; C = Optional
Rating of Evidence: I = One or more randomized trials without major limitations; IIa = Other randomized trials or subgroup analyses of randomized trials; IIb = Nonrandomized trials or observational cohort studies; III = Expert opinion

Introduction

Approximately 1.2 million persons in the United States are living with HIV. Most of these individuals are in care, and many are on antiretroviral therapy (ART) and have well-controlled disease.1 Similar to COVID-19, HIV disproportionately affects racial and ethnic minorities and persons of lower socioeconomic status in the United States;2 these demographic groups also appear to have a higher risk for severe outcomes with COVID-19. Information on SARS-CoV-2/HIV coinfection is evolving rapidly. The sections below outline the current state of knowledge regarding the prevention and diagnosis of SARS-CoV-2 infection in people with HIV, treatment and clinical outcomes in people with HIV who develop COVID-19, and management of HIV during the COVID-19 pandemic. In addition to these Guidelines, the Department of Health and Human Services (HHS) Panel on Antiretroviral Guidelines for Adults and Adolescents has developed the Interim Guidance for COVID-19 and Persons with HIV.

Clinical Outcomes of COVID-19 in People With HIV

Data are emerging on the clinical outcomes of COVID-19 in people with HIV. In a case series of people with COVID-19 in Europe and the United States, no significant differences were observed in the clinical outcomes for COVID-19 between people with HIV and people who did not have HIV.3-10 For example, the Veterans Aging Cohort Study compared the clinical outcomes for 253 veterans with HIV and COVID-19 and the outcomes for a matched comparator arm of 504 veterans without HIV who developed COVID-19. More than 95% of the participants in this study were male. In this comparison, no differences were found between the outcomes for patients with HIV and those who did not have HIV.11

In contrast, worse outcomes for patients with HIV and COVID-19, including increased COVID-19 mortality rates, have been reported by subsequent cohort studies in the United States, the United Kingdom, and South Africa.12-17 In a multicenter cohort study of 286 patients with HIV and COVID-19 in the United States, lower CD4 T lymphocyte (CD4) cell counts (i.e., <200 cells/mm3) were associated with a higher risk for the composite endpoint of intensive care unit admission, mechanical ventilation, or death. This increased risk was observed even in patients who had achieved virologic suppression of HIV.15 In another study of 175 patients with HIV and COVID-19, a low CD4 count or a low CD4 nadir was associated with poor outcomes.16 In a cohort study conducted in New York, people with HIV and COVID-19 had higher rates of hospitalization and mortality than people with COVID-19 who did not have HIV.17

Prevention of COVID-19 in People With HIV

The COVID-19 Treatment Guidelines Panel (the Panel) recommends using the same approach for advising persons with HIV on the strategies to prevent acquisition of SARS-CoV-2 infection that is used for people without HIV (AIII). There is currently no clear evidence that any antiretroviral (ARV) medications can prevent the acquisition of SARS-CoV-2 infection.

People with HIV should receive SARS-CoV-2 vaccines, regardless of their CD4 count or HIV viral load, because the potential benefits outweigh the potential risks (AIII). People with HIV were included in the clinical trials of the two mRNA vaccines and the adenovirus vector vaccine that are currently available through Emergency Use Authorizations (EUAs) from the Food and Drug Administration;18-20 however, the safety and efficacy of these vaccines in people with HIV have not been reported. Typically, people with HIV who are on antiretroviral therapy (ART) and who have achieved virologic suppression respond well to licensed vaccines. Guidance for using these vaccines, including guidance for people with HIV, is available through the Advisory Committee on Immunization Practices (ACIP). A patient’s HIV status should be kept confidential when administering a vaccine.

Diagnostic and Laboratory Testing for COVID-19 in People With HIV

Diagnosis of COVID-19 in People With HIV

The Panel recommends using the same approach for diagnosing SARS-CoV-2 infection in people with HIV as in those without HIV (see Testing for SARS-CoV-2 Infection) (AIII). There is currently no evidence that the performance characteristics of nucleic acid amplification testing differ in people with and without HIV when diagnosing acute SARS-CoV-2 infection. The Panel recommends against the use of serologic testing as the sole basis for diagnosis of acute SARS-CoV-2 infection (AIII). However, if diagnostic serologic testing is performed in a patient with HIV, the results should be interpreted with caution because cross-reactivity between antibodies to SARS-CoV-2 and HIV has been reported.21

Correlation of CD4 Count in People With HIV and COVID-19

The normal range for CD4 counts in healthy adults is about 500 to 1,600 cells/mm3. Persons with HIV who have a CD4 count of ≥500 cells/mm3 have similar cellular immune function to persons without HIV. In people with HIV, a CD4 count <200 cells/mm3 meets the definition for AIDS. For patients on ART, the hallmark of treatment success is plasma HIV RNA below the level of detection by a polymerase chain reaction assay. Lymphopenia is a common laboratory finding in patients with COVID-19; in patients with HIV, clinicians should note that CD4 counts obtained during acute COVID-19 may not accurately reflect the patient’s HIV disease stage.

There have been some reports of persons with advanced HIV who have presented with COVID-19 and another coinfection, including Pneumocystis jirovecii pneumonia.22,23 In patients with advanced HIV who have suspected or laboratory-confirmed SARS-CoV-2 infection, clinicians should consider a broader differential diagnosis for clinical symptoms and consider consulting an HIV specialist (AIII).

Clinical Presentation of COVID-19 in People With HIV

It is currently unknown whether people with HIV have a higher incidence of SARS-CoV-2 infection or a higher rate of progression to symptomatic disease than the general population. Approximately 50% of persons with HIV in the United States are aged >50 years, and many have comorbidities that are associated with more severe illness with COVID-19, including hypertension, diabetes mellitus, cardiovascular disease, tobacco use disorder, chronic lung disease, chronic liver disease, and cancer.24

There are a number of case reports and case series that describe the clinical presentation of COVID-19 in persons with HIV.3-10,25,26 These studies indicate that the clinical presentation of COVID-19 is similar in persons with and without HIV. Most of the published reports describe populations in which most of the individuals with HIV are on ART and have achieved virologic suppression. Consequently, the current understanding of the impact of COVID-19 in persons with advanced HIV who have low CD4 counts or persistent HIV viremia is limited.

Management of COVID-19 in People With HIV

Recommendations for the triage and management of COVID-19 in people with HIV are the same as those for the general population (AIII).

The treatment of COVID-19 in persons with HIV is the same as that for persons without HIV (AIII). In outpatients, people with HIV who are immunosuppressed or who have certain underlying comorbidities are candidates for the monoclonal antibodies that are available through EUAs.27-29 In hospitalized patients, the appropriate treatment strategy depends on disease severity (see Therapeutic Management of Adults With COVID-19).

When starting treatment for COVID-19 in patients with HIV, clinicians should pay careful attention to potential drug-drug interactions and overlapping toxicities among COVID-19 treatments, ARV medications, antimicrobial therapies, and other medications (AIII). Both tocilizumab and dexamethasone, which are recommended for some patients with severe or critical COVID-19, are immunosuppressive agents. The safety of using these drugs in immunocompromised patients, including those with advanced HIV, has not been studied. Therefore, patients with advanced HIV who are receiving these drugs should be closely monitored for secondary infections. Dexamethasone is a dose-dependent inducer of cytochrome P450 3A4 and could potentially lower the levels of certain coadministered ARV drugs. More than a single dose of dexamethasone is not recommended for patients who are receiving rilpivirine as part of their ARV regimen. Clinicians should consult an HIV specialist before administering dexamethasone to these patients. Whether administering up to 10 days of dexamethasone impacts the clinical efficacy of other ARV drugs is unknown. Patients with HIV who are receiving dexamethasone for COVID-19 should follow up with their HIV providers to assess virologic response.

Although some ARV drugs are being studied for the prevention and treatment of COVID-19, no agents have been shown to be effective.

People with HIV should be offered the opportunity to participate in clinical trials of vaccines and potential treatments for COVID-19. A variety of immunomodulatory therapies are prescribed empirically or administered as part of a clinical trial to treat severe COVID-19. Data about whether these medications are safe to use in patients with HIV are lacking. If a medication has been shown to reduce the mortality of patients with COVID-19 in the general population, it should also be used to treat COVID-19 in patients with HIV, unless data indicate that the medication is not safe or effective in this population.

Management of HIV in People With SARS-CoV-2/HIV Coinfection

Below are some general considerations regarding the management of HIV in people with SARS-CoV-2/HIV coinfection.

  • Whenever possible, ART and opportunistic infection prophylaxis should be continued in a patient with HIV who develops COVID-19, including in those who require hospitalization (AIII). ARV treatment interruption may lead to rebound viremia, and, in some cases, the emergence of drug resistance. If the appropriate ARV drugs are not on the hospital’s formulary, administer medications from the patient’s home supplies (if available).
  • Clinicians who are treating COVID-19 in people with HIV should consult an HIV specialist before adjusting or switching a patient’s ARV medications. An ARV regimen should not be switched or adjusted (i.e., by adding ARV drugs to the regimen) for the purpose of preventing or treating SARS-CoV-2 infection (AIII). Many drugs, including some ARV agents (e.g., lopinavir/ritonavir, boosted darunavir, tenofovir disoproxil fumarate/emtricitabine), have been or are being evaluated in clinical trials or are prescribed for off-label use for the treatment or prevention of SARS-CoV-2 infection. To date, lopinavir/ritonavir and darunavir/ritonavir have not been found to be effective (see Lopinavir/Ritonavir and Other HIV Protease Inhibitors).30,31 Two retrospective studies have suggested that tenofovir disoproxil fumarate/emtricitabine may play a role in preventing SARS-CoV-2 acquisition or hospitalization or death associated with COVID-19; however, the significance of these findings is unclear, as neither study adequately controlled for confounding variables such as age and comorbidities.12,26
  • For patients who are taking an investigational ARV medication as part of their ARV regimen, arrangements should be made with the investigational study team to continue the medication, if possible.
  • For critically ill patients who require tube feeding, some ARV medications are available in liquid formulations, and some ARV pills may be crushed. Clinicians should consult an HIV specialist and/or pharmacist to assess the best way for a patient with a feeding tube to continue an effective ARV regimen. Information may be available in the drug product label or in this document.
  • For people who present with COVID-19 and have either a new diagnosis of HIV or a history of HIV but are not taking ART, the optimal time to start or restart ART is currently unknown. For people with HIV who have not initiated ART or who have been off therapy for >2 weeks before presenting with COVID-19, the Panel recommends consulting an HIV specialist regarding initiation or re-initiation of ART as soon as clinically feasible. If ART is started, maintaining treatment and linking patients to HIV care upon hospital discharge is critical. If an HIV specialist is not available, clinical consultation is available by phone through the National Clinical Consultation Center, Monday through Friday, 9 am to 8 pm EST.

Special Considerations in Children and Pregnant Women With HIV Who Develop COVID-19

Currently, there is limited information about pregnancy and maternal outcomes in women with HIV who have COVID-19 and in children with HIV and COVID-19. Please see the sections in these Guidelines that discuss the management of COVID-19 during pregnancy and in children, and to the HHS Interim Guidance for COVID-19 and Persons With HIV.

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