| What's New in the COVID-19 and HIV Guidance  Since the last publication of this guidance in February 2021, several new advances in COVID-19 therapeutics have provided more guidance on the prevention and treatment of COVID-19, including for people with HIV. Below are the key updates to this guidance: - This guidance continues to recommend that all people with HIV receive COVID-19 vaccines and the recommended booster doses, according to the Centers for Disease Control and Prevention (CDC) guidance.
- The Guidelines Working Groups of the NIH Office of AIDS Research Advisory Council (the Panels) note that the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the combination of tixagevimab with cilgavimab—anti-SARS-CoV-2 monoclonal antibodies (mAbs)—for pre-exposure prophylaxis for persons aged 12 years or older and at high risk for severe COVID-19. People with advanced or untreated HIV are eligible for receiving these anti-SARS-CoV-2 mAbs.
- The Panels note that five treatment options are now available for non-hospitalized patients with mild-to-moderate COVID-19 and who are at high risk of progression to severe disease. Among these options is a new oral antiviral agent—ritonavir-boosted nirmatrelvir—given for 5 days. It is recommended that people with HIV who are on ritonavir- or cobicistat-based antiretroviral (ARV) regimens be maintained on their ARV drugs without any dosage modification.
- The guidance provides an update on what to do with ARV regimens when a person with HIV requires hospitalization for the treatment of COVID-19, with specific recommendations for patients who receive long-acting injectable cabotegravir and rilpivirine as part of their regimens.
For pregnant individuals with HIV: - The Panels revised language and added new data and citations regarding increased risks of severe illness and death in pregnant versus non-pregnant individuals with COVID-19, as well as higher risks of complications, adverse pregnancy outcomes, and mortality in pregnant people with COVID-19 illness.
- The Panels also note emerging data about an increased risk for stillbirth in pregnant people with COVID-19, with a stronger association during the period the Delta variant was predominant than during the pre-Delta variant period.
- Unfortunately, there are no updates about pregnancy or maternal outcomes for people with HIV and COVID-19 as data remain limited.
- COVID-19 vaccination is strongly recommended for all pregnant and lactating individuals, as well those planning pregnancy.
For children with HIV: - The Panels updated the epidemiology of COVID-19 severity in children, including multisystem inflammatory syndrome in children (MIS-C), and added new references and links to relevant resources.
- The guidance now includes COVID-19 vaccine recommendations for children with HIV, with links to relevant CDC resources. Approvals, authorizations, and vaccine dosing differ by age group and vaccine manufacturer.
- The Panels note that some anti-SARS-CoV-2 mAbs are available under EUA for treatment, and for PrEP and post-exposure prophylaxis against COVID-19 in infants and children with HIV. Eligibility and indications for anti-SARS-CoV-2 mAbs are evolving; the CDC and FDA websites, and the National Institutes of Health COVID-19 Treatment Guidelines should be reviewed for updates.
- The guidance notes that remdesivir is now FDA approved for treatment of COVID-19 in children aged ≥12 years and weighing at least 40 kg, and it is available under EUA for treatment of COVID-19 in children aged <12 years and weighing ≥3.5 kg.
Read the full Guidance for COVID-19 and People with HIV. To view or download the guidelines, please see the Guidance for COVID-19 and People with HIV section of Clinical Info's website. Clinical Info Welcomes Your Feedback on the latest revisions to the Guidance for COVID-19 and People with HIV. Please send your comments with the subject line "Guidance for COVID-19 and People with HIV" to ContactUs@hivinfo.nih.gov by March 16, 2022. | | | | |
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