Liz Highleyman

Compared with the general population, people with compromised immunity are at higher risk of contracting the new coronavirus and developing more serious COVID-19 illness. The HIV population is aging, and nearly half are over 50. Those with low CD4 T-cell counts, indicating advanced immune suppression, are at greatest risk. People with HIV are more likely to develop cardiovascular disease and may do so at a younger age. Certain HIV medications, especially older drugs, can cause neutropenia, or depletion of immune system white blood cells that fight infection.

“When you look at who’s been most profoundly ill, it tends to be people who are older, in their 60s, 70s and 80s. As you get older, your immune system doesn’t function as well,” says Steve Pergam, MD, MPH, of the Vaccine and Infectious Disease Division at Fred Hutchinson Cancer Research Center.

Among people living with HIV, “it’s all based on level of immune suppression,” Pergam told POZ. “For an HIV patient who is on stable antiretroviral therapy and has a normal CD4 count, their risk may be slightly increased. People often lump HIV patients with other immunosuppressed patients, but HIV is a different disease than it was years ago. For people who have a reconstituted immune system because of treatment, I think the risk is not going to be tremendously different.”

“For cancer patients on chemotherapy, people with solid organ transplants or bone marrow transplants and those who use high-dose steroids for autoimmune diseases, the risk will likely be more severe,” he continues. “They may shed the virus for longer. They may be more likely to develop pneumonia and more likely to die. We don’t know until we have more information, but many of us have concerns about that.”

People with a weakened immune system may be unable to fight off the virus, or they may develop an excessive inflammatory immune response known as a cytokine storm. Paradoxically, immune suppression can sometimes mean fewer or milder early symptoms, such as fever, even as the virus and the body’s response to it ravage the lungs and other organs.

“The symptoms may be more subtle, so we have to have more awareness,” Pergam says. “Oftentimes their initial symptoms may be less prominent, but the level of complex disease may be more severe.”

Taking Precautions 

Experts recommend that everyone take common-sense precautions to prevent transmission of the new coronavirus—the same ones recommended to prevent seasonal flu: 

• Avoid close contact—meaning within about six feet—with people who have a cough or other respiratory symptoms.
• Wash your hands with soap and water thoroughly and often for at least 20 seconds.
• Use alcohol-based hand sanitizer when soap and water are unavailable.
• Avoid touching your eyes, nose and mouth.
• Healthy people do not need to routinely wear face masks to prevent infection, but use a mask if you are caring for someone who is ill.
• Get the flu vaccine. Older people should also consider getting vaccinated against pneumonia.

If you are ill: 

• Cough or sneeze into a tissue or your bent elbow, and immediately dispose of tissues in the trash.
• Avoid close contact with others.
• Stay home if you are sick.
• If you think you may have been exposed to the coronavirus, contact a health care provider promptly if you develop a fever, cough or difficulty breathing.
• Before you go to a clinic or hospital, call ahead so the staff can take appropriate precautions.
• Wearing a face mask can stop the spread of droplets that can transmit the virus to others.

Older individuals, people living with HIV and those with cardiovascular disease or other conditions may benefit from extra precautions.

“I advise people to have hand sanitizer wherever they go and use it frequently in public places—I have it in my pocket all the time. Wash your hands with soap and water long enough to sing the ’Happy Birthday’ song,” Pergam advises.

“I always talk with patients about the idea of social distancing. I’m not saying you can’t live your life as a normal person. But you don’t have to go out to dinner when a restaurant is super crowded—you might eat a little earlier or you might order in,” he adds. “If you’re having friends or family over, ask them if they have any symptoms. Have a hand gel dispenser at your front door and make sure everybody uses it. Make sure to tell friends and family that they should be up to date on their vaccines for other things.”

People who need prescription medications should try to have a supply to last at least a couple weeks and preferably a few months. Shortages could happen because the ingredients for many drugs—especially generics—are produced in China. Pergam acknowledges that this can be difficult because of high drug costs and insurance restrictions. You may be able to order medications for three months at a time. Or renew your prescriptions as soon as you are able to—even if they haven’t run out yet—so you have a buffer of several days.

The Food and Drug Administration is keeping track of medication shortages that may result from the coronavirus epidemic. According to a recent statement, only one unspecified drug is now in short supply. HIV expert Tim Horn of NASTAD (formerly the National Alliance of State & Territorial AIDS Directors) checked on the status of brand name and generic antiretroviral drugs and found no current shortages.

It’s also a good idea to have at least a two-week supply of food, water, cleaning supplies and other household necessities on hand. And don’t forget to stock up on pet food. You may be able to have goods delivered to avoid going to stores. Or ask a friend or family member without compromised immunity for help.

As the COVID-19 outbreak becomes more widespread, “disruption to everyday life might be severe,” according to Nancy Messonnier, director of CDC’s National Center for Immunization and Respiratory Diseases, who advises businesses to explore remote work options and families to consider plans in case schools close.

“Talk to your employer about opportunities to work from home,” Pergam advises. “And have them remind everyone you work with not to come to work sick.”

Stay in communication with your health care providers, and keep up to date on new developments. Let them know if you have questions or concerns, especially if you have new symptoms or were recently exposed to someone who is ill.

“The biggest thing to get across is, don’t panic,” Pergam says. “We’re all expecting this to be a prolonged and complicated process. The best thing people can do is focus on ways that they can protect themselves because those small things can be enough to provide an extra layer of protection for everyone.

For more details, visit the U.S. and global coronavirus tracker from Johns Hopkins University and the CDC COVID-19 website.

As pre-exposure prophylaxis (PrEP) gains acceptance, medical experts and policymakers are finding new ways to make this effective HIV prevention tool accessible to more people who could benefit.

Last month the California Senate passed a bill that will allow pharmacists to provide PrEP and post-exposure prophylaxis (PEP) without a prescription. And in June, the U.S. Preventive Services Task Force (USPSTF) recommended that health care providers offer PrEP to people at risk of acquiring HIV, paving the way for broader insurance coverage.

PrEP at the Pharmacy

SB 159, co-authored by Senator Scott Wiener (D-San Francisco) and Assemblymember Todd Gloria (D-San Diego), authorizes pharmacists to offer a month’s worth of PrEP or a course of PEP without prescription from a physician. It also prohibits insurance companies from requiring prior authorization for PrEP coverage.

On May 21, the Senate approved the bill by a wide 34-to-1 margin, sending it on to the Assembly.

“By allowing pharmacists to furnish these revolutionary medications, we will help reduce HIV infection rates and create a stronger path toward ending new HIV infections entirely,” Wiener said. “We have the tools to end new HIV infections, and we can get there in our lifetime.”

San Francisco AIDS Foundation (SFAF) co-sponsored the bill and was involved in the process of moving it forward, said Courtney Mulhern-Pearson, senior director of policy and strategy.

“The goal of the bill is to make PrEP accessible at a point when people are willing and able to start,” she said. “We’re looking at PrEP uptake and realizing we need to do more to increase access across the state. This is an innovative way to increase access to and awareness of PrEP and to make sure it’s available to all who need it.”

The bill’s current language allows pharmacists to provide a 30-day supply of Truvada (tenofovir disoproxil fumarate/emtricitabine) PrEP to individuals who have had a negative HIV test within the previous seven days. The client would then be referred to a medical provider for the recommended monitoring, including screening for sexually transmitted infections (STIs) and kidney function tests. Pharmacists would also be able to offer a month-long course of PEP, which can prevent HIV infection if started within 72 hours after exposure to HIV.

Some have raised concerns about providing PrEP without testing kidney function in advance, because the tenofovir in Truvada could potentially cause kidney impairment in susceptible individuals. But studies have shown that kidney problems are uncommon among people using Truvada for HIV prevention.

“One month is not going to be a problem,” according to Robert Grant, MD, of the University of California at San Francisco, who led a major study showing that PrEP is highly effective for gay and bisexual men. “We’re not seeing kidney problems very much at all in people seeking PrEP. These typically occur four to five months after starting and they’re rare.”

“We’re only providing PrEP to a small proportion of people who could benefit, and making it more accessible and more convenient at pharmacies will be a step toward stopping HIV transmission,” Grant added.

The Centers for Disease Control and Prevention estimated that less than 10% of the more than 1.1 million people at high risk for acquiring HIV were using PrEP as of 2015. The numbers were even lower for African Americans (1%) and Latinx people (3%), who have high rates of new HIV infections. In California, the state Office of AIDS estimates that as many as 240,000 Californians could be eligible for PrEP, but only around 9,000 people were using it as of late 2016.

“The low rates of PrEP and PEP use across California signal the need to offer these effective prevention tools in additional ways,” said SFAF CEO Joe Hollendoner. “This bill removes unnecessary barriers and streamlines access to PrEP and PEP, so anyone who needs preventative measures can get them.”

USPSTF Recommendation

The new USPSTF recommendation for PrEP carries an “A” grade, meaning it is well-supported by scientific evidence. The Affordable Care Act requires insurers to cover preventive recommended services with an “A” or “B” rating.

“The new recommendation for PrEP is enormously important news for the struggle against HIV,” said Grant. “This grade A recommendation reflects the available evidence, which strongly supports the use of PrEP as a safe, effective method of HIV prevention.”

As described in a June 11 statement in the Journal of the American Medical Association, the recommendation says that clinicians should offer PrEP to sexually active men who have sex with men (MSM) and heterosexual women and men who have an HIV-positive sex partner, do not use condoms consistently, or have had an STI within the past six months. PrEP is also recommended for people who injection drugs who share needles or other injection equipment.

Although few transgender people have been included in trials, PrEP has been shown to reduce the risk of acquiring HIV through receptive or insertive anal or vaginal sex, so it can be considered for cisgender and transgender people alike, according to the authors.

The task force experts recommend once-daily Truvada—currently the only PrEP regimen approved by the Food and Drug Administration—for all at-risk groups. But it also says that tenofovir disiproxil fumarate alone, which is available as an inexpensive generic, is an option for heterosexual men and women and people who inject drugs, based on studies showing that it lowers HIV risk in these groups. No equivalent studies with MSM have been done.

The new recommendation has the potential to substantially expand access to PrEP. Many private insurers already cover Truvada for HIV prevention—which is priced at around $1,600 per month—but cost sharing is common. Gilead Sciences offers a co-pay card that people with private insurance can use to cover out-of-pocket costs, but some claim this benefit is inadequate. Many state Medicaid programs, including California’s, cover PrEP, but this represents a substantial public financial burden given competing funding needs.

Expanding PrEP use among people who need it most will also require raising awareness and combatting stigma.

“PrEP has been proven to be a highly effective intervention in preventing new cases of HIV, and receiving an A grade is an important step towards increased access,” Hollendoner said. “We know, however, that access alone does not result in utilization, so we call on healthcare providers to educate their patients who are at risk for HIV acquisition—especially those who are people of color—about PrEP and how it can protect their sexual health.”

As use of PrEP continues to grow, epidemiological evidence is starting to show a link between increased use and declines in new HIV infections. A study presented at the International AIDS Conference in Amsterdam shows an association between higher PrEP use and lower HIV incidence in the U.S. These figures highlight ongoing disparities in PrEP use, with some of the groups who need effective HIV prevention being the least likely to use it.

The Food and Drug Administration approved Truvada (tenofovir/emtricitabine) for HIV prevention in July 2012. For the past several years Gilead Sciences has been reporting PrEP use estimates from an ongoing survey of Truvada prescriptions at retail pharmacies.

Data from January 2012 through December 2017 show that the total number of people who have ever started PrEP exceeded 177,000. But PrEP still is only reaching a small proportion of those who might benefit. The Centers for Disease Control and Prevention (CDC) estimates that less than 10% of the nearly 1.5 million people at substantial risk for HIV infection are using it.

PrEP and new HIV diagnoses

Is increasing use of PrEP leading to a decline in new HIV infections? Trends in cities with high PrEP use suggest this may be the case.

In San Francisco, HIV incidence has declined steeply since the widespread adoption of PrEP in 2013, reaching its lowest-ever level in 2016. Dramatic declines in new infections among gay men have also been reported in London and Sydney. But stepped up HIV testing and the “treatment as prevention” effect of starting antiretroviral therapy immediately after diagnosis makes it hard to tease out the contribution of PrEP.

Patrick Sullivan from Emory University’s Rollins School of Public Health in Atlanta and colleagues from Gilead and the Centers of Disease Control and Prevention (CDC) looked at the correlation between PrEP use and new HIV diagnoses, using data from people age 13 and older in all 50 states and Washington, D.C., between 2012 and 2016.

A pharmacy survey examined a representative sample of anonymous prescription data from more than 80% of retail pharmacies in the United States, including independent pharmacies, chain stores, mail-order pharmacies and clinics. It did not include military or university health services or independent closed health systems like Kaiser Permanente.

Nationwide, the overall HIV diagnosis rate decreased significantly, from 15.7 per 100,000 persons in 2012 to 14.5 per 100,000 in 2016, an estimated annual decline of -1.6% per year. During the same period, PrEP use increased from 7.0 per 1,000 eligible individuals to 68.5 per 1,000, an estimated annual increase of +78.0%.

But there were some notable differences between states. The quintile or fifth of states with the highest PrEP use (11.0% of eligible individuals) saw a -4.7% decline in new HIV diagnoses. In contrast, new diagnoses actually increased by +0.9% in the quintile with the lowest PrEP use (3.5% of eligible individuals).

In an attempt to tease out the effect of PrEP versus treatment as prevention, the researchers also looked at viral load data from a subset of states, finding that PrEP use remained significantly associated with declines in new HIV diagnoses after controlling for levels of viral suppression.

“By documenting significant declines in average new cases of HIV in states where Truvada for PrEP has been most widely adopted, our analysis emphasizes the importance of improving access to HIV screening and a full range of prevention tools, including PrEP, in U.S. states,” Sullivan said in a Gilead press release about the study.

PrEP use among teens

Gilead researchers also did an analysis of PrEP use among young people, a group with a high unmet need for HIV prevention. In 2016, youth ages 13 to 24 accounted for 21% of new HIV diagnoses, according to the CDC. More than 80% of these were among young gay and bisexual men, with more than half among young black gay men.

The FDA extended its approval of Truvada for PrEP to adolescents in May. Studies have shown that teens (age 15 to 17) and young adults (age 18 to 22) can do well on PrEP, but they may need more ongoing support than older adults to maintain good adherence.

The latest pharmacy survey numbers indicate that 15.4% of PrEP users are under age 25, with only 1.5% of them being 17 or younger.

People ages 12 to 24 accounted for 17.0% of all PrEP users in 2012. The proportion declined a bit during 2014-2016, as PrEP use skyrocketed among older gay and bi men, but then rose back to about the same level in 2017.

Breaking down the age distribution further, adolescents age 12 to 17 accounted for around 20% of PrEP prescriptions among people under 25 in 2012 and 2013. But, for unexplained reasons, both the proportion and the absolute number then started to fall, plummeting to 3.9% in 2016 and 2017.

In the early years of the survey, before gay men started promoting PrEP within their communities, a large proportion of PrEP users were women. In part, this reflected the use of PrEP to prevent HIV transmission within serodiscordant couples who were trying to conceive.

Today, the youngest PrEP users are still predominately girls and young women. Although women account for about 18% of PrEP users overall, they make up more than 80% of those age 17 and under. This disparity suggests that awareness of the need for HIV prevention, or willingness of providers to prescribe it, is greater for young women than for young men.

Adolescents ages 12 to 17 received Truvada for PrEP mostly from pediatricians, while family practice and internal medicine doctors provided most prescriptions for those 18 and older. A majority (59%) of PrEP users in the 17 and under age group received coverage through Medicaid, compared with 22% of those ages 18 to 24 and 13% of older adults. Nearly a third of those ages 18 to 24 and 38% of older adults obtained PrEP through commercial insurance.

Based on these findings, the researchers concluded, “there remains an important unmet need to improve awareness and engagement in HIV prevention for adolescents and young adults at risk for HIV.”

Sources:

Magnuson, D. and colleagues. Adolescent use of Truvada (FTC/TDF) for HIV pre-exposure prophylaxis (PrEP) in the United States (2012-2017). AIDS 2018, Abstract 2621.

Sullivan, P. and colleagues. The impact of pre-exposure prophylaxis with TDF/FTC on HIV diagnoses, 2012-2016, United States. AIDS 2018, Abstract 13004.

Liz Highleyman is a freelance medical writer and editor of HIVandHepatitis.com.