HIV Care and Coronavirus (COVID-19): Info and HHS/CDC Recommendations for HIV/AIDS Clinicians

The current outbreak of novel coronavirus has prompted an upsurge of fear, stigma and virus-shaming that is all too familiar to people living with HIV. For health care providers and other front-line professionals serving people with HIV, this means not only the added burden of managing the outbreak among their patients and clients, but also the opportunity to alleviate panic and keep those they serve well-informed.

This article consolidates the most recent provider-focused information available regarding the intersection between HIV and SARS-CoV-2, the novel coronavirus behind the COVID-19 pandemic. We'll share recently released information from U.S. health officials and other reputable sources, as well as newly published research of potential relevance to the care of people living with HIV who are affected by or concerned about novel coronavirus infection.

An extensive listing of sources and reference links are provided at the bottom of the article.

HIV and Novel Coronavirus: The Latest

Here is a ticker of our updates on the intersection of HIV and COVID-19:

• July 9: Two of the largest studies to date involving COVID-19 hospitalization among people living with HIV were presented at the 23rd International AIDS Conference—but they ultimately offer little clarity on the interplay between the two viruses.
• June 26: A Spanish study published in Annals of Internal Medicine suggests a relationship between HIV antiretroviral use (particularly emtricitabine/tenofovir disoproxil fumarate, a.k.a. Truvada) and a lower risk for SARS-CoV-2 infection or COVID-19 diagnosis. But the signal is far from clear.
• May 30: Clinical Infectious Diseases published a case report of 31 people living with HIV who were hospitalized for COVID-19 in New York City, the largest U.S.-based case report to date. It found no evidence of increased risk for COVID-19 hospitalization or severity of disease course among HIV-positive people.
• May 15: The Centers for Disease Control and Prevention published a "dear colleague" letter outlining revised guidance regarding the provision of pre-exposure prophylaxis (PrEP) services during the COVID-19 pandemic. The guidance includes a loosening of quarterly HIV testing recommendations to allow for home-based and self-administered HIV tests, and also suggests 90-day PrEP prescritions instead of 30-day prescriptions.
• April 21: A National Institutes of Health expert panel featuring several prominent HIV clinician-researchers published guidelines on the treatment of COVID-19.
• April 15: The Lancet HIV published a set of five case studies involving people living with HIV in Spain who were admitted to a hospital and treated for COVID-19. Four of the five had been discharged at the time the study went to publication.
• April 3: In a webinar hosted by the International AIDS Society, Meg Doherty of the World Health Organization stated her agency believed that, based on available data, people with well-controlled HIV were not at increased risk from the novel coronavirus.
• April 1: The HIV Vaccine Trials Network announced suspensions or other coronavirus mitigation steps for its enrolling and active studies.
• March 20: The U.S. Department of Health and Human Services posted interim COVID-19 guidance for people living with HIV.
• March 18: The Centers for Disease Control and Prevention added an HIV-specific FAQ to its collection of novel coronavirus resources.
• March 18: The New England Journal of Medicine published a study finding that the antiretroviral lopinavir/ritonavir was not an effective treatment for COVID-19.
• March 17: The U.S. Health Resources & Service Administration posted an FAQ addressing numerous queries from individuals and organizations that provide services under the Ryan White HIV/AIDS Program. The FAQ has been updated several times since its initial launch.
• March 16: Drugmaker Johnson & Johnson announces there are no data to suggest the antiretroviral darunavir has efficacy against SARS-CoV-2.
• March 11: The Journal of Medical Virology published a case study on a person living with HIV in Wuhan, China, who developed and recovered from COVID-19.
• March 10: CDC health officials and researchers presented the latest data and available information regarding the novel coronavirus at CROI 2020, a major annual medical meeting that primarily features new research on HIV and other infectious diseases.

Case Reports: HIV and Novel Coronavirus (SARS-CoV-2) Coinfection

[This section was last updated June 26, 2020.]

Until mid-April, there was a dearth of scientific literature exploring the intersection between HIV infection and the novel coronavirus (or COVID-19, the disease it causes). Since then, a few dozen case reports and other relevant studies, most of them small, have trickled into medical journals.

Nonetheless, SARS-CoV-2 testing and in-depth data reporting among people living with HIV remains spotty, particularly in the U.S. This has restricted not only an accurate count of the number of people infected, but also the accumulation of reliable epidemiological data including COVID-19 geographical trends, hospitalization rates, and risk factors—as well as research regarding novel coronavirus transmission risks and outcomes among people living with HIV.

Case Reports Indicate No Major Differences in COVID-19 Among HIV-Positive People

As of June 25, at least 35 case reports have appeared in scientific literature involving a total of approximately 310 people living with HIV who developed COVID-19. The largest of these case reports come from Madrid, Spain (51 patients, reported in The Lancet HIV on May 28); Milan, Italy (47 patients, reported in Clinical Infectious Diseases on May 14); Germany (33 patients, reported in Infection on May 11); and New York City (31 patients, reported in Clinical Infectious Diseases on May 30).

The total amount of data published thus far on COVID-19 in the setting of HIV remains small. But the vast preponderance of the data availabile suggest that people living with HIV are not inherently more at risk for coronavirus infection than the general population, nor are they inherently more at risk for death or for experiencing a more severe course of COVID-19 relative to HIV-negative individuals. (One notable exception to this trend was a report issued by the South Africa’s Western Cape province public health department in June, which suggested that HIV infection increased COVID-19 mortality risk—but did not control for all other known risk factors for COVID-19 that may simply be more prevalent among people living with HIV.)

There is no evidence to support any protective benefit to antiretroviral therapy. There is insufficient evidence to support hypotheses that severe immune suppression as a result of advanced HIV disease may be protective against COVID-19 severity, since much of the available research to date has involved individuals with a suppressed viral load.

A list of all published case reports of which we're aware (ordered from most to least recent) can be found in the resources section at the end of this article.

Initial Published HIV/COVID-19 Case Reports

Prior to mid-April 2020, only a few case reports regarding COVID-19 in people living with HIV had appeared in medical literature.

The Lancet HIV published a clinical case series on April 15, in which Spanish researchers describe five COVID-19 cases among HIV-positive people in a Barcelona hospital. Four of the five had been discharged from the hospital at the time of publication.

Three of the patients were cisgender men; the other two were transgender, though the case report does not make clear how the patients specifically gender-identified. All reported sex with men as their HIV risk factor; two were sex workers. They ranged in age from 29 to 49; one was diagnosed with HIV this year, but most had been diagnosed at least seven years ago.

Four of the five patients had their antiretroviral regimens altered, since at the time researchers still had no solid data exploring the potential viability of lopinavir/ritonavir and boosted darunavir as COVID-19 treatment options. (Remdesivir was not used.) All patients also received hydrochloroquine along with one or more additional experimental treatments. Two patients received intensive care unit treatment; one was placed on invasive ventilation, and remained in the hospital at time of publication, three weeks after his admission.

In their case report, the researchers noted that roughly 1% of Barcelona hospital admissions for COVID-19 involved people living with HIV.

The first published case of COVID-19 development in a person living with HIV was published as a letter to the editor on March 11 in the Journal of Medical Virology. The brief case report describes a 61-year-old man with comorbid type-2 diabetes who was a heavy cigarette smoker.

Though it's not made clear within the case report, the individual appears to have been diagnosed with HIV in the course of his hospitalization and treatment for COVID-19; at diagnosis, his CD4 percentage was reportedly just 4.75%.

He was administered twice-daily lopinavir/ritonavir orally for 12 days -- in an effort to treat the COVID-19, not the HIV infection. The man recovered and was released from the hospital 13 days after his initial admission. No other information was published regarding his HIV status, relevant labs, or antiretroviral treatment situation.

A second case report involving an HIV-positive COVID-19 patient from Wuhan was published in the same journal on April 14. This patient was a 24-year-old man who had been diagnosed with HIV two years prior and was on antiretroviral therapy.

A CT scan of the patient, who developed non-severe pneumonia despite normal cardiovascular labs, revealed "patchy shadows in the peripheral lung, involving the interlobar fissure," an atypical finding in a COVID-19 patient, the researchers reported. The patient's pulmonary lesions resolved quickly, improving within a week of his initial symptoms and largely vanishing by day 15.

The researchers hypothesized that perhaps the patient's antiretroviral ther contributed to his rapid recovery. The researchers treated him with lopinavir/ritonavir while continuing his existing regimen, which consisted of efavirenz, lamivudine, and tenofovir (coformulated in the U.S. as Atripla, a fixed-dose combination pill approved in 2006). Although lopinavir/ritonavir has not shown any benefit as COVID-19 treatment, the authors suggested further research into whether it may interact favorably with other antiretrovirals in reducing COVID-19 severity.

HIV Antiretrovirals and Other Drugs for COVID-19 Treatment

[This section was last updated July 17, 2020.]

Although there's been plenty of speculation, there has been no reliable research to identify any HIV medication as an effective treatment for COVID-19, at least not by itself.

Specifically:

• Darunavir (Prezista): There are no data to suggest that darunavir-based antiretroviral therapy can effectively treat COVID-19, according to a release by the drug's U.S. manufacturer, Johnson & Johnson, on March 16. A 30-person Chinese trial found no benefit to the use of cobicistat/darunavir [Prezcobix] in COVID-19 patients.
• Lopinavir/Ritonavir (Kaletra): Lopinavir/ritonavir offered no benefit over current standard of care in the treatment of severe SARS-CoV-2 infection, according to a 199-patient study published in the New England Journal of Medicine on March 18. However, a combination regimen consisting of lopinavir/ritonavir, interferon beta-1b, and ribavirin did appear to both reduce coronavirus shedding and shorten hospital stays, according to results from a 127-patient Phase 2 study published in The Lancet on May 8.
• Remdesivir: This former investigational HIV drug received conditional FDA approval for emergency use as novel coronavirus treatment on May 1. It has shown tentative signs of promise in potentially reducing the length and severity of COVID-19 illness, although peer-reviewed results from fully powered studies are still lacking. Caution should be used when interpreting news reports on this drug.
• Tenofovir/Emtricitabine: The fixed-dose HIV treatment and prevention drug best known by the brand name Truvada has been associated with reduced SARS-CoV-2 infection risk and COVID-19 severity in some research. But the findings remain far from conclusive at this point.
• Tocilizumab: This investigational monoclonal antibody binds to interleukin-6, which has long been explored as a potential marker for—or even a contributor to—long-term health complications in people living with HIV. A small, non-randomized, retrospective study published on April 29 found evidence of rapid improvement among people with severe COVID-19 who received the drug.

In addition, nelfinavir (Viracept) has received scientific interest as potential COVID-19 interventions, but no trial data have yet been released or published regarding these drugs.

NIH Guidelines Avoid Recommending Any Specific Drug for COVID-19

COVID-19 treatment guidelines published on April 21 by the National Institutes of Health include discussions of a number of drugs that have been investigated as potential COVID-19 therapies, but declines to recommend any.

The guidelines, produced by a panel of 50 clinicians (including several highly experienced HIV physician-researchers) and government officials, are co-chaired by three physicians with an extensive background in HIV: Roy Gulick, M.D., H. Clifford Lane, M.D., and Henry Masur, M.D.

Most notably, the guidelines include an in-depth analysis of chloroquine and hydroxycholoroquine (with or without azithromycin), which has shown little promise—and a fair amount of toxicity risk—in more recent data from increasingly well-constructed studies.

As NIAID director Anthony S. Fauci, M.D., has publicly stated, there are no trials to support the claim that hydroxychloroquine with or without azithromycin can effectively and safely prevent or treat SARS-CoV-2 infection, or lessen the symptoms assoicated with COVID-19. The evidence regarding anti-SARS-CoV-2 activity to date has been almost entirely anecdotal, leaving open the possibility that other causes were at play in the clinical improvement of those patients.

Neither of these drugs is an antiviral, which is why there is so much skepticism around the limited reports of their success:

• Hydroxychloroquine is an anti-malarial medication—and malaria is a parasitic disease.
• Azithromycin is an antibiotic used commonly in the prophylaxis and treatment of bacterial pneumonia, as well as the treatment of ear infections, sinus infections, and a number of sexually transmitted infections, including chlamydia, gonorrhea, and early syphilis.

Azithromycin also has a long history of usage in the context of the HIV epidemic: It is one of the drugs prescribed prophylactically against mycobacterium avium complex (MAC) in people living with HIV. Opportunistic infection guidelines recommend the use of azithromycin to prevent disseminated MAC in people with a CD4 count below 50 unless they are virologically suppresed on antiretroviral therapy or are about to begin HIV treatment.

HIV-Related Conferences Delayed or Cancelled Due to the Coronavirus Pandemic

This evolving list focuses primarily on major domestic U.S. conferences and meetings of the HIV workforce, but includes several of the more significant international meetings as well.

• 23rd International AIDS Conference (AIDS 2020): ONLINE-ONLY. The in-person conference in San Francisco and Oakland, California, slated for July 6-10, was cancelled. The meeting took place virtually from July 6-9; here's a glimpse of some of the clinical research highlights.
• ACTHIV 2020: POSTPONED. The new meeting dates are Aug. 20-22, 2020 (formerly April 16-18). Organizers still plan to hold an in-person meeting in Chicago, Illinois.
• Adherence 2020: POSTPONED. The new meeting dates are Nov. 1-4, 2020 (formerly June 7-10). Organizers still plan to hold an in-person meeting in Orlando, Florida.
• AIDSWatch 2020: ONLINE-ONLY. The in-person event, slated for March 30-31 in Washington, D.C., was replaced by a one-day virtual event on March 30.
• ANAC 2020: ONLINE-ONLY. The annual meeting of the Association of Nurses in AIDS Care, which had been scheduled for Nov. 12-14 in Tampa, Florida, has been canelled. ANAC has stated it intends to hold a virtual meeting featuring the same speakers and topics, but has not yet announced dates or a program.
• CROI 2020: ONLINE-ONLY. The in-person event, slated for March 8-12 in Boston, Massachussetts, was held on schedule, but all sessions were livestreamed.
• HIV2020: RESCHEDULED. The in-person conference in Mexico City, slated for July 6-9, has been cancelled; organizers will instead roll out a series of online events from June through October 2020.
• HIV Research for Prevention (HIVR4P): POSTPONED. The new meeting dates are Jan. 17-21, 2021 (formerly Oct. 11-15, 2020). Logistics TBA: The location will either be in Cape Town, South Africa, or virtual.
• National Latinx Conference on HIV/HCV/SUD: CANCELLED. The meeting had been scheduled for April 3-5 in Albuquerque, New Mexico.
• Ryan White Conference on HIV Care & Treatment: ONLINE-ONLY. The meeting will take place as previously scheduled from Aug. 11-14, but will be entirely virtual. In a post announcing the decision on HIV.gov, Laura Cheever, M.D., also noted that "the times will be adjusted to accommodate different time zones."
• SYNChronicity 2020: POSTPONED. The new meeting dates are Dec. 15-17, 2020 (formerly May 11-12). Organizers still plan to hold an in-person meeting in Washington, D.C.
• U.S. Conference on HIV/AIDS: ONLINE-ONLY. The in-person event, originally scheduled for Oct. 10-13 in San Juan, Puerto Rico, will be re-imagined as a virtual event taking place from Oct. 19-21.

HRSA Launches Ryan White HIV/AIDS Program FAQ

UPDATE March 25: To address coronavirus-related queries from providers of Ryan White HIV/AIDS Program services, the U.S. Health Resources & Service Administration (HRSA) added a frequently asked questions page to its website on March 17.

As of March 25, the page contained answers to 33 specific questions; it has been updated at least three times since its initial launch.

The FAQ is organized into seven categories:

• Provision of HIV Care and Client Services, which includes questions regarding care center protocols and policies, "essential services" definitions, and the use of funding to support patients' basic life needs.
• AIDS Drug Assistance Programs, which addresses questions about remotely refilling prescriptions, 90-day prescription refills, recertification requirements, and issues with patients' abilities to access their regular pharmacies.
• Utilizing Telehealth, which tackles questions about whether telehealth can be performed outside the clinic and whether telephone calls can be considered telehealth.
• Resources and Oversight, which covers questions regarding scheduled on-site HIV/AIDS Bureau visits, availability of equipment to treat COVID-19 in HIV clinics, and the legalities of Ryan White staff being assigned to COVID-19 duties.
• Funding Opportunities, Reporting Requirements, and Upcoming Events, which tackles questions about previously scheduled grant submission and reporting deadlines, as well as future conference and webinar dates.
• Travel Guidance, which briefly addresses the realities of travel during a public health emergency.
• Grants Management, which focuses on a diverse set of questions ranging from billing/invoice logistics to a recommended course of action when an irreplaceable staff member falls ill with COVID-19.

U.S. Health Department Posts "Interim Guidance" on Coronavirus for People Living With HIV

UPDATE March 20: A detailed set of recommendations regarding coronavirus pandemic preparation and coinfection management for people living with HIV was posted to AIDSinfo, the U.S. Department of Health and Human Services (HHS) portal for HIV-related information.

The HHS guidance offers specific suggestions on these key issues:

• Switching antiretroviral therapy: The guidance recommends delaying regimen changes due to challenges in ensuring proper monitoring and follow-up.
• Appointment postponement: The guidance urges careful consideration to the importance of any in-person meetings between HIV care/service providers and people with HIV. For people who are virally suppressed and whose health is stable, the guidance recommends postponing routine care provider visits and lab tests.
• Planning for isolation: The guidance offers a number of recommendations on how PLWHV can hedge against the possibility of interrupted access to antiretroviral treatment and care, including ensuring they have a 30- to 90-day supply on hand, considering delivery of medications by mail, and formulating a plan in advance between themselves and their care providers regarding what to do if they develop COVID-19 symptoms.
• HIV and SARS-CoV-2 coinfection management: The guidance discusses the importance of continuing a person's antiretroviral therapy as prescribed (with no substitutions), even if they are hospitalized and intubated. It also warns against the risk of interactions between a person's current treatment regimen and any treatment received for COVID-19.

In addition, the guidance includes information for providers regarding:

• Coronavirus risk factors among people with HIV, such as older age, cardiovascular disease, cigarette smoking, diabetes, hypertension, and pulmonary disease.
• Currently available knowledge for HIV-positive pregnant women and HIV-positive children.
• The possibility of obtaining waivers from drug providers that would allow them to prescribe a 90-day supply of medications.
• The potential value of tele-health in ensuring continuation of care and triage in case of emerging illness.
• The importance of holistic care, including paying attention to an HIV-positive patient's mental health and logistical challenges (e.g., access to food, transportation, and child care), and of assisting wherever possible.

CDC Publishes "What People With HIV Should Know" Coronavirus FAQ Page

UPDATE March 19: The Centers for Disease Control and Prevention (CDC) added an HIV-specific FAQ page to its collection of novel coronavirus resources on March 18. As of its initial publication, the page—which is explicitly written for an audience of people living with HIV (PLWHIV)—addresses eight key issues:

• COVID-19 risk among PLWHIV. (In short: We aren't sure.)
• COVID-19 prevention guidance. (In short: The same as everyone else, plus adhere to antiretroviral therapy.)
• Extra precautions for people over 50 and those with underlying conditions. (In short: Maintain a 30-day medication supply; keep vaccinations up to date; plan for a potential two-week home isolation; establish remote social connections.)
• What to do if a PLWHIV believes they may have COVID-19. (In short: Let their care provider know.)
• Whether antiretrovirals can treat COVID-19. (In short: We're not sure, but don't switch regimens on a hunch.)
• Potential HIV medication and PrEP shortages. (In short: There's no sign of any problems.)
• Travel concerns. (In short: Follow the same guidance everyone else is following.)
• Stigma concerns. (In short: Yep, that's definitely a concern.)

CDC Shares Latest HIV-Related Coronavirus Information and Guidance at CROI 2020

[Below is our original reporting for this article, which was posted on March 11.]

At the annual Conference on Retroviruses and Opportunistic Infections (CROI 2020)—which was transformed at the last moment from an in-person meeting into an online event, to curtail the ongoing outbreak—John T. Brooks, M.D., a medical epidemiologist with the Division of HIV/AIDS Prevention at the U.S. Centers for Disease Control and Prevention (CDC), took the opportunity to remind those tuning in that stigma is one of the greatest public health dangers during an infectious disease epidemic.

“I encourage all of us to use our rich collective experience with HIV to help fight anti-COVID-19 stigma,” Brooks said.

In addition to processing the relived trauma of the early panic of HIV/AIDS, people living with HIV may need to start preparing for what will happen if this new epidemic shows up in their community, Brooks noted.

This new coronavirus is a close cousin of SARS (severe acute respiratory syndrome, of which there was a global outbreak in 2003). It produces a short-lived illness known as COVID-19 (short for “coronavirus disease 2019”) that manifests like the flu and typically abates after a few weeks—although it can lead to more severe symptoms and even death in some people. It first appeared in China and quickly spread to more than 100 other countries, including the United States. (Brooks pointed out that people of Chinese descent have been inappropriately targeted and stigmatized due to the novel virus’ origins in China.)

At the time this article was filed, more than half of U.S. states had reported cases of COVID-19. Large cities such as New York, San Francisco, Seattle and surrounding areas are already seeing major outbreaks, with experts predicting that the virus is almost certain to spread to the rest of the country.

During a special session at CROI 2020, Brooks gave attendees an overview of what we know about COVID-19 so far and offered specific recommendations for clinicians to convey to people living with HIV—many of whom may be considered high risk for COVID-19 acquisition due to demographic and other health factors.

“COVID-19 has spread worldwide with remarkable speed,” Brooks said. The virus appears to be highly contagious, and its symptoms are difficult to distinguish from the common flu. For that reason, many people who develop symptoms of COVID-19 may be asked to ride it out at home, he explained.

Though estimates vary, “the case fatality rate is likely somewhere between 0.5 and 3.5%,” Brooks said. “[That means] COVID-19 could be five to 35 times more deadly than seasonal influenza.”

Data so far indicate the virus is more dangerous among people with underlying health conditions, as well as those over the age of 60. Brooks pointed out that “CDC estimates that equal to or more than 50% of people with HIV are over 50 years old.”

This, paired with underlying persistent viral infection, means “all people with HIV should take precautions against this new virus,” Brooks said.

According to Brooks, all Americans should be prepared to obey “social distancing” orders from their local public health officials, which will likely include measures such as keeping children home from school, avoiding public transportation, and possibly self-isolation for days or weeks.

For people living with HIV and their providers, this means:

• Ensuring at least a 30-day supply of medication at all times.
• Keeping vaccinations up to date—especially pneumonia and flu vaccines.
• Establishing a plan for providers and their patients to stay in touch, including telemedicine options, if either is isolated or quarantined.
• Figuring out how people living with HIV can stay in touch with friends and family members using remote technology, which will help keep spirits up while isolated or quarantined.

HIV care providers are uniquely prepared for this moment. In particular, those who lived and worked through the early years of the HIV epidemic can help remind others—both patients and the public at large—that stigma is one of the greatest enemies of public health.

Providers are also in a position to reinforce the ways in which people living with HIV can take steps now to protect themselves and their loved ones from potential harm—and can do so without demonizing the people already living with, and recovering from, this novel coronavirus.

Additional resources for the general HIV community on the novel coronavirus are available at TheBody.