US DHHS Guidelines with Australian commentary
The ASHM Sub-Committee for Guidance on HIV Management in Australia notes that COVID-19 and its implications for people with HIV is a rapidly changing field. Guidelines making recommendations in this field have the potential to become outdated quickly, therefore guidance should always be considered in the context of Australian-based resources that are rapidly updated. These include:
AU comment: National COVID-19 Clinical Evidence Taskforce
AU comment: COVID-19 Drug Interactions
AU comment: Community information
Interim Guidance for COVID-19 and Persons with HIV
Last Updated: June 19, 2020
Guidance for all Persons with HIV
- In current reports, individuals aged >60 years and those with diabetes, hypertension, cardiovascular disease, pulmonary disease, or obesity are at highest risk of life-threatening COVID-19, the illness caused by the virus known as SARS-CoV-2.
- The limited data currently available do not indicate that the disease course of COVID-19 in persons with HIV differs from that in persons without HIV. Before the advent of effective combination antiretroviral therapy (ART), advanced HIV infection (i.e., CD4 cell count <200/mm3) was a risk factor for complications of other respiratory infections. Whether this is also true for COVID-19 is yet unknown.
- Some people with HIV have other comorbidities (e.g., cardiovascular disease, lung disease) that increase the risk for a more severe course of COVID-19 illness. Chronic smokers are also at risk of more severe disease.
- Thus, until more is known, additional caution for all persons with HIV, especially those with advanced HIV or poorly controlled HIV, is warranted.
- Every effort should be made to help persons with HIV maintain an adequate supply of ART and all other concomitant medications.
- Influenza and pneumococcal vaccinations should be kept up to date.
- Persons with HIV should follow all applicable recommendations of the U.S. Centers for Disease Control and Prevention (CDC) to prevent COVID-19, such as social distancing and proper hand hygiene. These recommendations are regularly updated.
- Information on COVID-19 prevention in children with HIV for pediatric health care providers and the general public is available from CDC.
- CDC also provides information about COVID-19 prevention during pregnancy.
Persons with HIV Should:
- Maintain on-hand at least a 30-day supply—and ideally a 90-day supply—of antiretroviral (ARV) drugs and other medications.
- Talk to their pharmacists and/or health care providers about changing to mail order delivery of medications when possible.
- Persons for whom a regimen switch is planned should consider delaying the switch until close follow-up and monitoring are possible.
- To date, no drug has been proven to be safe and effective for treating COVID-19. Many drugs, including some ARV agents (e.g., lopinavir/ritonavir, boosted darunavir, tenofovir disoproxil fumarate/emtricitabine), are being evaluated in clinical trials or are prescribed for off label use for the treatment or prevention of COVID-19. Persons with HIV should not switch their ARV regimens or add ARV drugs to their regimens for the purpose of preventing or treating SARS-CoV-2 infection.
Clinic or Laboratory Monitoring Visits Related to HIV Care:
- Together with their health care providers, persons with HIV and their providers should weigh the risks and benefits of attending, versus not attending in-person, HIV-related clinic appointments at this time. Factors to consider include the extent of local COVID-19 transmission, the health needs that will be addressed during the appointment, and the person’s HIV status (e.g., CD4 cell count, HIV viral load) and overall health.
- Telephone or virtual visits for routine or non-urgent care and adherence counseling may replace face-to-face encounters.
- For persons who have a suppressed HIV viral load and are in stable health, routine medical and laboratory visits should be postponed to the extent possible.
Persons with HIV and in Opioid Treatment Programs:
- Clinicians caring for persons with HIV who are enrolled in opioid treatment programs (OTPs) should refer to the Substance Abuse and Mental Health Service Administration (SAMHSA) website for updated guidance on avoiding treatment interruptions. State methadone agencies are also responsible for regulating OTPs in their jurisdictions and may provide additional guidance.
Guidance for Specific Populations
Pregnant Individuals with HIV:
- Currently, there is limited information about pregnancy and maternal outcomes in individuals who have COVID-19.
- Immunologic and physiologic changes during pregnancy generally increase a pregnant individual’s susceptibility to viral respiratory infections, possibly including COVID-19. As observed with other coronavirus infections, the risk for severe illness, morbidity, or mortality with COVID-19 may be greater among pregnant individuals than among the general population.1
- Although limited, currently available data do not indicate that pregnant individuals are more susceptible to COVID-19 infection or that pregnant individuals with COVID-19 have more severe illness.2,3 Adverse pregnancy outcomes, such as fetal distress and preterm delivery, were noted in a small series of pregnant women with COVID-19 infection and have been reported with SARS and MERS infections during pregnancy.4-6
- Findings from a small group of pregnant women with COVID-19 did not find evidence for vertical transmission of COVID-19, although at least one case of neonatal COVID-19 has been described.3,7,8
- Information on pregnancy and COVID-19 is available from CDC, the Society for Maternal-Fetal Medicine, and the American College of Obstetricians and Gynecologists.
Children with HIV:
- From the limited available data, children appear less likely to become severely ill with COVID-19 than older adults.9-11 However, there may be subpopulations of children at increased risk of more severe COVID-19 illness; in studies of infection with non-SARS-CoV-2 coronaviruses in children, younger age, underlying pulmonary pathology, and immunocompromising conditions were associated with more severe outcomes.12
- Infants and children with HIV should be up to date on all immunizations, including influenza and pneumococcal vaccines. Refer to the Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Exposed and HIV-Infected Children information on immunizations, including a vaccine schedule for children with HIV.
Guidance for Persons with HIV in Self-Isolation or Quarantine Due to SARS-CoV-2 Exposure
Health Care Workers Should:
- Verify that patients have adequate supplies of all medications and expedite additional drug refills as needed.
- Devise a plan to evaluate patients if they develop COVID-19-related symptoms, including for possible transfer to a health care facility for COVID-19-related care.
Persons with HIV Should:
- Contact their health care provider to report that they are self-isolating or in quarantine.
- Specifically, inform their health care provider how much ARV medications and other essential medications they have on hand.
Guidance for Persons with HIV who have Fever or Respiratory Symptoms and are Seeking Evaluation and Care
Health Care Workers Should:
- Follow CDC recommendations, as well as state and local health department guidance on infection control, triage, diagnosis, and management.
Persons with HIV Should:
- Follow CDC recommendations regarding symptoms.
- If they develop a fever and symptoms (e.g., cough, difficulty breathing), they should call their health care provider for medical advice.
- Call the clinic in advance before presenting to the care providers.
- Use respiratory and hand hygiene and cough etiquette when presenting to the health care facility and request a face mask as soon as they arrive.
- If they present to a clinic or an emergency facility without calling in advance, they should alert registration staff immediately upon arrival of their symptoms so that measures can be taken to prevent COVID-19 transmission in the health care setting. Specific actions include placing a mask on the patient and rapidly putting the patient in a room or other space separated from other people.
Guidance for Managing Persons with HIV who Develop COVID-19
When Hospitalization is Not Necessary, the Person with HIV Should:
- Manage symptoms at home with supportive care for symptomatic relief.
- Maintain close communication with their health care provider and report if symptoms progress (e.g., sustained fever for >2 days, new shortness of breath).
- Continue their ARV therapy and other medications, as prescribed.
When the Person with HIV is Hospitalized:
- ART should be continued. If the ARV drugs are not on the hospital’s formulary, administer medications from the patients’ home supplies.
- ARV drug substitutions should be avoided. If necessary, clinicians may refer to recommendations on ARV drugs that can be switched in the U.S. Department of Health and Human Services (HHS) guidelines for caring for persons with HIV in disaster areas.
- For patients who receive ibalizumab (IBA) intravenous (IV) infusion every 2 weeks as part of their ARV regimen, clinicians should arrange with the patient’s hospital provider to continue administer of this medication without interruption.
- For patients who are taking an investigational ARV medication as part of their 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, but not all, 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 from this document from the Toronto General Hospital Immunodeficiency Clinic.
When Receiving Investigational or Off-Label Treatment for COVID-19:
- There is currently no approved treatment for COVID-19. Several investigational and marketed drugs are being evaluated in clinical trials to treat COVID-19 or may also be available via compassionate use or off-label use.
- For patients receiving COVID-19 treatment, clinicians must assess the potential for drug interactions between the COVID-19 treatment and the patient’s ARV therapy and other medications. Information on potential drug interactions may be found in product labels, drug interaction resources, clinical trial protocols, or investigator brochures.
- When available, clinicians may consider enrolling patients in a clinical trial evaluating the safety and efficacy of experimental treatment for COVID-19. Persons with HIV should not be excluded from these trials. ClinicalTrials.gov is a useful resource to find studies investigating potential treatments for COVID-19.
Additional Guidance for HIV Clinicians
- 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 ARV drugs and other medications. During the COVID-19 outbreak, clinicians should ask providers to waive drug-supply quantity restrictions. ADAPs should also provide patients with a 90-day supply of medications.
- Persons with HIV may need additional assistance with food, housing, transportation, and childcare during times of crisis and economic fragility. To enhance care engagement and continuity of ARV therapy, clinicians should make every attempt to assess their patients’ need for additional social assistance and connect them with resources, including navigator services when possible.
- During this crisis, social distancing and isolation may exacerbate mental health and substance use issues for some persons with HIV. Clinicians should assess and address these patient concerns and arrange for additional consultations, preferably virtual, as needed.
- Telehealth options, including phone calls, should be considered for routine visits and to triage visits for patients who are ill.
- There are reports that measures designed to control the spread of COVID-19 may increase the risk of gender-based violence against women and girls, as well as limit their ability to distance themselves from abusers or to access external support. Providers should assess patient safety at each clinical encounter, both in-person or via telemedicine, being cognizant of the patient’s ability to speak privately.
- During the COVD-19 outbreak, reproductive desires and pregnancy planning should be discussed with all women of childbearing potential. This discussion should include information on what is known and not known about COVID-19 during pregnancy. Preconception discussions should be patient-centered and should include the option to defer efforts to conceive until after the peak of the pandemic and/or more is known about the effect of COVID-19 during pregnancy. Women may be at increased risk of unintended pregnancy when stay-at-home measures are in effect and continuation or initiation of appropriate contraception should be addressed, including emergency contraception. Based on clinical trial data, use of intrauterine devices and contraceptive implants beyond the expiration date specified on a package insert may be considered. Depot-medroxyprogesterone acetate may also be considered for subcutaneous self-injection.
More information regarding ARV management in adult, pregnant, and pediatric patients, as well as recommendations for prophylaxis and treatment of specific opportunistic infections, can be found in the medical practice guidelines for HIV/AIDS.
The CDC website provides information about COVID-19 for people with HIV.
This interim guidance was prepared by the following working groups of the Office of AIDS Research Advisory Council:
- HHS Panel on Antiretroviral Guidelines for Adults and Adolescents
- HHS Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV
- HHS Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission
- HHS Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV
- HHS Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children
- Society for Maternal-Fetal Medicine, Dotters-Katz S, Hughes BL. Coronavirus (COVID-19) and Pregnancy: What Maternal-Fetal Medicine Subspecialists Need to Know. 2020. Available at: https://s3.amazonaws.com/cdn.smfm.org/media/2267/COVID19-_updated_3-17-20_PDF.pdf.
- Liu Y, Chen H, Tang K, Guo Y. Clinical manifestations and outcome of SARS-CoV-2 infection during pregnancy. J Infect. 2020. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32145216.
- Chen H, Guo J, Wang C, et al. Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records. Lancet. 2020;395(10226):809-815. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32151335.
- Siston AM, Rasmussen SA, Honein MA, et al. Pandemic 2009 influenza A(H1N1) virus illness among pregnant women in the United States. JAMA. 2010;303(15):1517-1525. Available at: https://www.ncbi.nlm.nih.gov/pubmed/20407061.
- Alfaraj SH, Al-Tawfiq JA, Memish ZA. Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection during pregnancy: Report of two cases & review of the literature. J Microbiol Immunol Infect. 2019;52(3):501-503. Available at: https://www.ncbi.nlm.nih.gov/pubmed/29907538.
- Wong SF, Chow KM, Leung TN, et al. Pregnancy and perinatal outcomes of women with severe acute respiratory syndrome. Am J Obstet Gynecol. 2004;191(1):292-297. Available at: https://www.ncbi.nlm.nih.gov/pubmed/15295381.
- Wang D, Hu B, Hu C, et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China. JAMA. 2020. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32031570.
- Wang S, Guo L, Chen L, et al. A case report of neonatal COVID-19 infection in China. Clin Infect Dis. 2020. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32161941.
- Dong Y, Mo X, Hu Y, et al. Epidemiological characteristics of 2,143 pediatric patients with 2019 coronavirus disease in China. Pediatrics. 2020. Available at: https://pubmed.ncbi.nlm.nih.gov/32179660/.
- Cruz A, Zeichner S. COVID-19 in children: initial characterization of pediatric disease. Pediatrics. 2020. Available at: https://pediatrics.aappublications.org/content/pediatrics/early/2020/03/16/peds.2020-0834.full.pdf.
- Shen K, Yang Y, Wang T, et al. Diagnosis, treatment, and prevention of 2019 novel coronavirus infection in children: experts' consensus statement. World J Pediatr. 2020. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32034659.
- Ogimi C, Englund JA, Bradford MC, Qin X, Boeckh M, Waghmare A. Characteristics and outcomes of coronavirus infection in children: The role of viral factors and an immunocompromised state. J Pediatric Infect Dis Soc. 2019;8(1):21-28. Available at: https://www.ncbi.nlm.nih.gov/pubmed/29447395.