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COVID-19 and ART Access

CME

Ensuring Uninterrupted ART for Patients With HIV During the COVID-19 Pandemic

Physicians: Maximum of 0.50 AMA PRA Category 1 Credit™

Released: April 21, 2020

Expiration: April 20, 2021

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The COVID-19 pandemic has upended all our lives by changing almost every facet of how we live day to day. Therefore, providing persons with HIV (PWH) and their loved ones sound messaging, consistent with public health guidance, on flattening the curve by maintaining social distancing, hand hygiene, and cough etiquette is critical. However, we must recognize that some of these measures may be more difficult for PWH because of systemic healthcare and social disparities.

Yet, within our reach, is the ability to provide clear messaging to PWH regarding the need for ART adherence as well as practical advice on how this can be accomplished during such a turbulent time. The DHHS has released interim guidance on COVID-19 for PWH that includes considerations for ensuring patients with HIV maintain interrupted ART.

Basic Considerations for Maintaining ART
First, patients should talk to their pharmacists or healthcare providers about changing to a mail order delivery of medications. Patients should receive at least a 30-day supply of ART or, when possible, a 90-day supply of ART. This may be challenging to implement in practice due to insurance restrictions. However, all efforts should be made in requesting waivers from insurance companies that restrict patients from obtaining a 90-day supply of ART and other medications. In addition, arrangements should be made for patients to continue biweekly ibalizumab infusions, without interruption, if this is currently part of their ART regimen.

Switching ART
The DHHS provides clear guidance that clinicians should consider delaying any ART switch until closer follow-up and monitoring is possible. At this time, I would recommend waiting to make regimen changes for simplification purposes only, such as switching to a single tablet regimen. I would also proceed with caution when considering switching ART in patients without stable viral suppression. My concern regarding switching ART regimens in these patients is that they require close monitoring following an ART switch. They need the involvement of a treatment adherence specialist and good case management support. If these services can be provided by telephone, then I think the regimen can be switched to try to achieve viral suppression. However, without this careful monitoring and follow-up, they may fail any new regimen, which would decrease the available options in the future.

Of importance, the guidance is very clear that a patient who is not currently receiving a PI should not be switched to a regimen to include a PI in order to prevent or treat COVID-19. It is important to note that although lopinavir/ritonavir has been used off label to treat COVID-19, lopinavir/ritonavir did not demonstrate a statistically significant difference in clinical improvement or mortality compared with standard of care in a small, randomized, controlled, open-label trial in hospitalized patients with confirmed SARS-CoV-2 infection (the etiologic agent for COVID-19).

Considerations for PWH Hospitalized for COVID-19
Additional considerations for maintaining stable ART for hospitalized patients are also outlined in the DHHS guidance, as we must anticipate that some of our patients may be hospitalized with severe COVID-19 disease. Of utmost importance is the clear recommendation that ART should be continued and ARV substitutions should be avoided. Although the guidance states that medications can be administered from the patients’ home supply if not available at the hospital, I think that it is best for PWH to bring their medications from home to avoid drug substitutions and to ensure continuation of the same ARVs. These considerations also apply to investigational ARV medications, so arrangements should be made with the study team to maintain the ARV supply to patients in the case of hospitalization. Patients receiving ibalizumab should continue to receive biweekly infusions while hospitalized, without interruption. Finally, for PWH who may need a feeding tube, it will be vital to consult with a pharmacist, as not all ART regimens are available in liquid formulation and not all pills can be crushed. Although these may seem like logical and practical recommendations, they can easily be overlooked during a crisis such as an urgent hospitalization for respiratory distress. Therefore, it is important to consider these scenarios ahead of time and have a plan in place for the needs of individual patients to continue their current ART regimen if hospitalized.

Treatment of COVID-19 in PWH
As new treatments are continually being proposed for off-label or compassionate use, it will be important to consider these treatments in combination with the patient’s ART regimen. For example, some clinicians are using a combination of hydroxychloroquine and azithromycin based on very limited data. There is no obvious contraindication for using this combination treatment with currently available ARVs, including boosted PIs. However, it is important to check drug–drug interactions, especially given the potential for hydroxychloroquine and azithromycin to cause QT prolongation. Finally, PWH should be encouraged to participate in any COVID-19 investigational trials and should not be automatically excluded because of their HIV status.

Your Thoughts
How are you ensuring that your patients maintain stable, uninterrupted ART during the COVID-19 pandemic? Answer the polling question and please share your thoughts in the discussion section.

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