COVID-19 Vaccines and Patients With HIV

In this podcast, Rajesh Gandhi, MD, talks about what you should know about COVID-19 vaccines for your patients with HIV, including whether COVID-19 vaccines are safe for people with HIV, how managing patients with HIV has changed during the COVID-19 pandemic, and what research still needs to be done on COVID-19 vaccines and patients with HIV. He also presented on this topic at the annual ACT HIV 2021 meeting. 

Additional Resources:

• Gandhi, R. COVID vaccines: what you should know for your patient with HIV. Presented at: American Conference for the Treatment of HIV 2021; May 20-22, 2021; Virtual. https://www.acthiv.org/acthiv-2021-program/
• Triant VA, Gandhi RT. When epidemics collide: why people with HIV may have worse COVID-19 outcomes and implications for vaccination. Clin Infect Dis. Published online January 4, 2021. https://doi.org/10.1093/cid/ciaa1946 

Rajesh Gandhi, MD, is an infectious disease physician at Massachusetts General Hospital in Boston, Massachusetts, a codirector of the Harvard University Center for AIDS Research, and the chair of the HIV Medicine Association. 

TRANSCRIPTION:

Jessica Bard: Hello, everyone and welcome to another installment of "Podcast 360," your go‑to resource for medical news and clinical updates. I'm your moderator Jessica Bard, with Consultant360 Specialty Network.

According to the most recent surveillance data from the CDC, an estimated 1.2 million people in the United States had HIV at the end of 2018. Dr Raj Gandhi is here to speak with us today, about COVID‑19 vaccines and HIV.

Dr Gandhi is an infectious disease doctor at Massachusetts General Hospital, a co‑director of the Harvard University Center for AIDS research and the Chair of the HIV Medicine Association. He's based in Boston, Massachusetts.

Thank you for joining us today, Dr Gandhi. You presented a session COVID vaccines what you should know for your patient with HIV at the ACTHIV 2021 annual meeting. Can you please give us an overview of your session?

Dr Rajesh Gandhi: Sure, I started out by talking about how well did the authorized vaccines work in general, not just for people with HIV. We talked about the three main vaccines in the US.

We talked about Pfizer, which has about a 95‑percent efficacy rate. We talked about Moderna, which also has about a 95‑percent efficacy rate. We talked about the J&J or Johnson vaccine, which has a high effectiveness rate, especially against hospitalization and against severe COVID‑19.

The last of those vaccines was studied in the US, but also in South Africa and in South America. Therefore, the efficacy varied a little bit because it was studied in different parts of the world, as well as with different amounts of infection.

We started off with the efficacy. We touched on the fact that we don't yet know precisely how long the vaccines will last, but there are good data going out to at least six months showing that the efficacy persists for at least six months, and that the antibody levels persist for at least six months.

As to whether we'll need boosters, time will tell we don't know yet. The next thing we talked about is do these vaccines prevent asymptomatic infection and transmission?

There are accumulating data that vaccines not only protect against symptomatic infection, but also protect against asymptomatic infection.

There was also a very interesting study, which we talked about showing that the viral loads in people who get COVID‑19, a week or two after getting the vaccine, the viral loads tend to be lower and so that supports the idea that the vaccines may prevent transmission, although more to come on that.

The next area that we talked quite a bit about, because it's in the news and we all want to know the answer to this, is what are the variants going to do to the vaccines. Thus far when you look at what's called neutralization activity, the B117 variant which was first found in the UK, looks like it's neutralized quite well by the main vaccines, the ones authorized in the US.

One of the variants is a little harder for the vaccines to neutralize, at least, in laboratory studies. That's the B1351 variant that was first detected in South Africa.

But despite that difference and the neutralization in the laboratory, all the vaccines seems to be protecting against severe COVID‑19 and hospitalization even in people who are infected with the variants. Thus far, we've gotten reassuring data on that front.

The one exception to that is the AstraZeneca vaccine, which is not yet authorized in the US. In a smallish study, it did not protect against mild to moderate COVID‑19 in South Africa. We'll just have to wait and see if all the vaccines are going to be protective if there's going to be some nuanced differences between the different vaccines.

In general, the take‑home message today, at least, is that the FDA‑authorized vaccines are doing well against the variants, especially when it comes to severe disease and hospitalization.

We talked a little bit about these rare side effects that are in the news of the vaccines starting with anaphylaxis. Anaphylaxis is very rare with the COVID vaccines. Probably about four to five cases of anaphylaxis per million vaccines delivered. That's pretty similar to other vaccines when it comes to anaphylaxis.

That rate of anaphylaxis is way less than something like penicillin. Penicillin has a much higher rate of anaphylaxis than these vaccines.

Then lastly, we talked about what's called thrombosis with thrombocytopenia syndrome, TTS. These are rare instances of clots that have been reported sometimes in the cerebral veins, sometimes in the abdominal veins. The rate of this seems to be about two per million.

When you look at everybody a little bit higher in young women, women under the age of 50, but when you do an analysis as to the benefits of the vaccine versus the risks, the benefits way outweigh the risks of the vaccine.

That being said, we do tell people, especially young women about this rare syndrome just so that they can report any symptoms that might be an early indicator for this TTS syndrome.

Then the last section of the talk with just the couple of frequently asked questions, do the vaccines work in immunosuppressed patients? That is the question we get asked the most. Thus far, I think we can say that the vaccines are safe in immunosuppressed patients, but what we don't yet know is if how effective they are.

There are some data that antibody responses to the vaccines are less strong in people who are immunosuppressed.

I think that's why the CDC has sent the message that people who are immunosuppressed should continue to take all these social distancing and masking mitigation measures that all of us have been asked to take for the last year or more because we don't yet know how effective these vaccines will be in people who are immunosuppressed.

I will say at our institution, we have seen some vaccine breakthroughs in our immunosuppressed patients, particularly those who are B‑cell‑depleted. There's a lot of active work trying to figure out, do those people need boosters, is there another way to get those antibody responses up. That's a brief overview of the session.

Jessica: I want to dig a little bit deeper on that last bullet point there, COVID‑19 vaccines for people with HIV. Can you dig a little bit deeper and tell us more about the safety for people with HIV?

Dr Gandhi: Sure. I'm going to stick with the three authorized vaccines in the US. All three of those vaccines that are authorized in the US, Pfizer, Moderna, and J&J, all of them included in the clinical trials, the pivotal clinical trials that lead to their authorization, people with stable HIV.

What do I mean by stable HIV? That means people with HIV or on antiretroviral therapy with a reasonable CD4 count. What they can say is...what I would say is the vaccines are...There's every reason to think that they'll be safe in people with HIV.

Really important point to make sure we all attend to and when we counsel our patients, we remember this, these vaccines are not replicating vaccines. There's no reason to think that someone with HIV would be at somewhat increased risk. The two mRNA vaccines, Pfizer and Moderna, they don't replicate. The mRNA makes the spike protein and then that's what elicits the immune response, but also the J&J vaccine which is an adenovirus vaccine.

That's not a replicating adenovirus vaccine so there's no reason to think that people with HIV would have any safety concerns, even if they're immunosuppressed.

What we don't yet know is how effective they are in people with HIV because even those three big trials included people with HIV, they didn't include tens of thousands of people.

In the Moderna and Pfizer, they included a little over 200 people with HIV, and then the J&J vaccine trial, they included about 1,200. We don't yet have enough information on that, to say how effective they are and they haven't released the information on people with HIV.

One better good news is, two preprints that came out in the week or two prior to the meeting looked at immunogenicity, how well the vaccines induce immune responses with people with HIV, and people without HIV. These studies were done in the UK and in South Africa, with the AstraZeneca vaccine, not yet authorized in the US, but authorized by the WHO.

What those two studies showed is that people with HIV and people without HIV had similar immune responses to the AstraZeneca vaccine.

That's reassuring that despite the fact that people with HIV have differences in their immune system, that these vaccines are eliciting a good immune response, antibody responses, and T cell responses. We need that kind of same data with the US authorized vaccines but I'm optimistic that the vaccines will elicit a good immune response for people with HIV.

The one last thing I'll say about people with HIV is, we were talking earlier about immunosuppressed patients. I'm firmly convinced that many people with HIV have a very good immune system if they're on antiretroviral therapy, they're likely to have good immune responses like the AstraZeneca vaccine studies showed us.

We do need more information on people with low CD4 counts, people with CD4 counts less than 200 as to how protected they are because those people haven't been traditionally part of those clinical trials.

If I have a patient with a low CD4 count, I do tell them, A, to get on antiretroviral therapies to try to get CD4 count up and B, to continue to take precautions because we don't yet know how effective the vaccine would be if your CD4 count is less than 200.

Jessica: How can healthcare providers help protect their patients with HIV against COVID‑19?

Dr Gandhi: First and foremost, encourage them and make it easy as possible to get them vaccinated. There's no doubt that vaccination is by far the most effective way to prevent COVID‑19 and there's every reason to think that that will be the case for people with HIV as it is for people without HIV.

In someone with low CD4 count less than 200, I would tell people to get on antiretroviral therapy and try to get their CD4 count up. As I was mentioning before, for those people who have a very low CD4 count, until the CD4 count comes up, it's reasonable to caution them to wear masks and to social distance to take those precautions, extra precautions, because their CD4 count is low.

Then we'll have to wait and see, is there a way to boost people or to get people whose CD4 count is low to have a stronger immune response. Those are the kinds of active investigations that people are doing right now.

Jessica: I wasn't sure if this was too much of a softball question for you, but you said this was worth talking about. Are people with HIV at a higher risk for COVID‑19 than other people?

Dr Gandhi: Yeah, that's a good question. Let's take ourselves back to about a year ago, when COVID‑19 burst on the scene and everyone who care people with HIV wanted to know the answer to the question, "Are our patients with HIV more likely to get severe COVID‑19 or just the same as everyone else?"

Some of the early studies out of New York City and other places suggest that people with HIV weren't protected from getting COVID, but they didn't see any signal that there was worse outcomes.

What we have learned subsequently though is, if you take larger studies, studies from South Africa, which included, many, many people with HIV, studies from the UK, and then more studies from the United States, the recent studies have shown that there is a signal that people with HIV do have worse outcomes for COVID than people without HIV.

What's not clear though, is that because of the HIV, or is it because people with HIV often have comorbidities, things like heart disease, things like lung disease? Finally, is it because of social determinants of health? We know that people with HIV often are people of color or have economic disadvantages. How those three relate to those more severe outcomes is still debated.

What I like to tell people though is because there are reasons to think that people with HIV may have severe outcomes, we should be prioritizing them for getting the vaccine. Now that we have adequate supplies of vaccine in the US, that's less of a push. Everyone can get the COVID vaccine.

A few months ago, when there were limited supplies, I and others were arguing that people with HIV should be prioritized because there is some evidence that they have worse outcomes. Complicated message, but the bottom line is everyone with HIV should get vaccinated.

We should continue to work on reversing anything we can on social determinants of health that might be contributing to worse outcomes.

Jessica: How has caring for patients with HIV changed during the COVID‑19 pandemic compared with before the pandemic?

Dr Gandhi: That's an excellent question. In the worst of the pandemic, back last year in April, May, many of our patients with HIV were concerned about coming to the hospital. Because hospitals like mine were very much focused on the COVID response, what we did back last year is we had to ensure our patients with HIV had adequate supplies of medications.

In the past, sometimes we would only give 30‑day supplies. We tried to expand that to 90‑day supplies. We didn't want people running out. We didn't want people to have to go to their pharmacy every 30 days if we could get them 90‑day supplies.

People who have been stable for many, many years, we spaced out the frequency of blood testing. If someone had done well for years and years, we didn't necessarily need them to come in every three months or even every six months. We could space that out.

That was also a reflection of the fact that just our viral load testing was under a lot of stress because COVID testing uses some of the same kind of reagents, and so we had to prioritize and we did prioritize COVID testing.

We, like all of medicine, switched from in‑person care to a lot of virtual care. Telemedicine became our way of staying connected with patients and making sure that we continue to care for them, even though we weren't doing as many in‑person visits.

Fast forward to May 2021, now, things are better in the United States. We are seeing many more of our patients with HIV in person rather than through telemedicine. We keep the telemedicine option for people who, for whatever reason, can't come in and see us in person.

We still continue to see people through telemedicine. I do think that makes it a little easier for people who are working or for people who are having transportation difficulties to connect with their clinician.

We are doing more routine viral load testing. The reagent supply has improved. We're back to testing people every 6 to 12 months, like what we were doing prior to COVID.

We're just reconnecting with people who, in the worst of COVID, we have less of a connection with and trying to resume the preventive care that they all need, resuming the medical care that were given for decades. We're in a better place than we were a year ago. Things changed profoundly, but things are getting back to normal.

Jessica: What research still needs to be done on COVID‑19 vaccines in patients with HIV?

Dr Gandhi: One bit of research that we definitely need to know the answer to is how long do these vaccines last, both for people without HIV but also for people with HIV? Are boosters going to be necessary?

What's particular for HIV is, for people with HIV with low CD4 counts, are the current vaccines strong enough? Do they need a stronger vaccine or booster vaccines for that somewhat more immunosuppressed category of people with HIV? I would say those are the two highest priorities.

Jessica: What are the overall take‑home messages for our audience from your session?

Dr Gandhi: I'd say a couple. One is, COVID vaccines work. They have made it possible for us to return closer to normal in a relatively short period of time.

The other lesson is that evidence for COVID vaccines look like they're going to support the idea that they prevent asymptomatic infection as well as transmission, although, more information is coming down the pike on that.

Third, although the variants have to be watched carefully, thus far, the vaccines look like they're working against the variants, at least prevent severe disease. The real take‑home lesson there is we need to continue to drive down numbers globally, because these variants arise when there's a lot of cases of COVID‑19.

One thing we haven't talked about, but I'll mention here, is globally, COVID‑19 is not under control. Globally, COVID‑19 is surging in places like India, like Brazil, like parts of South America. So long as there's COVID‑19 circulating around the world, we need to be engaged as citizens of the world.

To have vaccines not just in the US, but worldwide, both for humanitarian reasons, but also to forestall the development of variants that will abate the vaccines. Last, although there are rare side effects from the vaccines, the benefits clearly outweigh those small risks.

What we need to know now is how to protect our patients who are the most vulnerable, people who are immunosuppressed, people who had B‑cell depleting therapies, people with HIV with low CD4 counts. That's the last take‑home lesson. There's more research to come on the most immunosuppressed.

Jessica: Is there anything else you'd like to add today that you think that we missed?

Dr Gandhi: This has been an incredibly difficult period, but I think it has brought us all together and especially around making sure that we achieve equity. HIV has pointed out for decades that medical care is inequitable. COVID‑19 has pointed that out yet again.

This pandemic, if there's any silver lining, is to try to focus on a more equitable treatment and vaccination and healthcare access for people with HIV, as well as for all people so that we can correct some of the inequities that both HIV and COVID‑19 have demonstrated.

Jessica: I want to thank you so much for your time today. Thank you for all of your hard work and research on this very important topic.

Dr Gandhi: Thanks. Thanks for having me.