From Zero to Protected Podcast: Accelerating HIV Prevention With Rapid-Start PrEP

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From Zero to Protected: Accelerating HIV Prevention with Rapid‑Start PrEP

Dr. Kenneth Mayer (Harvard Medical School): Well, thank you very much, Karen. Hello, everyone. Good to be with you today.

Pre‑Exposure Prophylaxis Works!

So, why are we talking about these issues? Well, PrEP works. That's the most important thing to keep in mind. So, whether it's same‑day or whether it's not same‑day, the important thing is we really want to ensure that all individuals who might benefit from PrEP get access to it because, you know, PrEP, which is the use of antiretroviral medication by people without HIV to protect themselves, there's strong evidence that this is beneficial. When taken consistently, it can decrease HIV risk substantially, almost 100% for people who are acquiring HIV by sex.

PrEP Discussions Should Be Part of Routine Medical Care

PrEP discussions are recommended to be part of routine clinical care now. The U.S. Preventive Services Task Force says this. So, it's not that everybody who's sexually active should be on PrEP, it's that we as providers should be talking to our patients about PrEP as an option. It's a tragedy that there's a large number of people who would benefit from PrEP who are not receiving it. And certainly, this also includes people who inject drugs, as well as people who are sexually active.

Standard and Same‑Day PrEP Defined

And then, when we think about PrEP, how do we deliver PrEP, there's what we would call standard PrEP, which is how we were doing it several years ago, which is that the person gets evaluated, a bunch of laboratory tests get sent off. Usually, they take several days. So, the PrEP is prescribed when all the tests come back after seven days.

The same‑day PrEP, though, can be same‑day in different senses as well. There's same‑day PrEP prescription, which means that the clinician takes a medical history. The person doesn't appear to be having acute HIV symptoms. They're given a script, but they're told not to start until they get all the test results.

That's really not what we're talking about today. Ultimately, what we really are emphasizing with same‑day PrEP start is when PrEP is prescribed and started the same day. And this begins after a person gets a rapid point‑of‑care HIV test. And part of what we'll talk about first is, what data says that this is a safe thing to do to send off the labs and then get the results a little bit later.

IAS‑USA Guidelines: Don’t Delay PrEP!

And basically, one of the normative bodies, the International AIDS Society‑USA, their guidelines say, don't delay PrEP because the risk of having a problem, for example, nephrotoxicity from tenofovir with a couple day exposure is a lot less in terms of long‑term health consequences than somebody leaving the clinic without a script and becoming infected with HIV. But the important thing, we certainly want to know that the person is not living with HIV. So, we want to make sure that they are HIV uninfected with at least the best rapid evidence we have. So, we definitely want to have a rapid point‑of‑care test, test for antibody and antigen that will allow us to determine whether the person was recently infected. And the PrEP can then be started. The individual can begin the medication while waiting for the test results.

Rationale for Same‑Day PrEP

You know, and the rationale is this. That somebody who leaves a clinic and is told, "Well, you'll have to come back another ‑ another clinic," take time off from work, have to find parking. At my clinic in urban downtown Boston, parking is not a small matter. So, if you can do things in one visit versus two visits, that's a big deal. People are ready if they're mentally ready to get the script. Best to reinforce that people are protected sooner, and it's a better overall patient experience.

Same‑Day PrEP Initiation: A Strategy to Improve Access

It's really important to think about it's not one‑size‑fits‑all. It may not be perfect for everyone. So, there are a number of things that we have to consider. Certainly, we have to think about the barriers for PrEP that people have. And certainly, we think that it's decreasing barriers by reducing office visits and travel time. It may increase engagement in care, and it may be similar to what people have for other medications. Like, why are you taking so long to give me this medication when I got my initial script for my statin so quickly, for example. But there certainly are reasons that same‑day PrEP may not be the right thing either.

They're cost issues. Some of the PEP medications or PrEP medications require prior authorizations, and that can be problematic and take time. So, it may not be feasible to get the same day if the person thinks they may have a huge out‑of‑pocket expense. So, there are cost issues. And certainly, some people's insurance will require different kinds of documentation that a clinic may not be able to provide very quickly.

It may be more complicated getting the labs turned around quickly as well, or getting contact with a pharmacy to get the medication same‑day.

There may be other individuals who may have clinical reasons why you may not want to consider same‑day PrEP. If somebody has known renal disease, you may obviously want to know the creatinine before starting a tenofovir regimen. Certainly, if somebody has symptoms of acute HIV infection, that's not a candidate for PrEP. So, certainly if there's any suspicion of that, one would wait about same‑day PrEP.

And certainly, if somebody is in the middle of travelling or has an unstable housing situation, certainly you would prefer to have all the information because you wouldn't want to start the medication and then find that there's a lab that needs to be acted on and you're not able to reach the patient.

Same‑Day PrEP: Testing and Monitoring

Dr. Sarah Rowan (University of Colorado School of Medicine): Thank you. Hi everyone. I'm going to talk about some of the logistical issues around same‑day PrEP.

Same‑Day PrEP Requirements

So, first off, same‑day PrEP requirements. PrEP is prescribed and started the same day as the initial visit.

So, clinicians should conduct a point‑of‑care HIV test and a pregnancy test if relevant. And ideally, the pregnancy test will come back with the same‑day result. And then we'll be sending a lab‑based fourth‑generation HIV antigen/antibody test and/or an HIV RNA test, depending on your protocols. And then sending lab‑based HIV tests as well, which we won't have the results for right away.

And another point to make here is that the point‑of‑care HIV test, it should be a fourth‑generation HIV point‑of‑care test if possible. And we know that with point‑of‑care, the fourth‑generation antigen component may be less sensitive, but that is what's recommended. The oral rapid test is not recommended.

And then we'll be drawing blood for laboratory‑based creatinine. We'll review lab results in ‑ within, you know, 72 hours or less and then rapidly follow up about any reactive HIV tests, obviously, if renal dysfunction is identified, if someone is surface antigen positive for hepatitis B, indicating that they have hepatitis B infection. And then if they are negative for surface antigen and surface antibody, then we'll be following up to advise vaccination for hepatitis B.

Dispense, prescribe oral PrEP, or administer the PrEP injections. Collect specimens for other STI testing. Schedule follow‑up tests and appointments, and then assist with enrolment in cost assistance programs or health insurance as relevant. So, these are kind of the main ‑ tenets of starting same‑day PrEP.

Monitoring: At PrEP Initiation

So, in terms of monitoring for PrEP, the monitoring isn't any different than it is with standard non‑same‑day PrEP.

But at initiation, the current guidelines are to get both an HIV test with an antigen/antibody assay plus/minus an HIV RNA when starting oral and injectable PrEP, STI testing, hepatitis B serology. If you'll be starting F/TAF formulation of oral PrEP, it's recommended to get a cholesterol and triglycerides to get a lipid panel because of the possible effect on lipids of F/TAF. And then to check kidney function if you'll be starting oral PrEP.

Injectable PrEP lipids and kidney function are not affected, so you don't need to start that prior to ‑ to order those prior to starting injectable PrEP.

Similarly, injectable PrEP doesn't affect hepatitis B, so understanding the person's Hep B status is less critical. It's still reasonable to get it, but it's not required prior to starting injectable PrEP.

Then, PrEP can be prescribed based on that negative HIV antigen/antibody rapid test while awaiting all of the other test results. So, including the Hep B result, including the lipids and the kidney function.

Same‑Day PrEP: Choosing Among PrEP Options

So, choosing among PrEP options. There's a wide array of PrEP options now, and so what is best for a particular scenario is influenced by available data based on exposure type.

Comorbidities, especially renal disease. Drug‑drug interactions. And then, most importantly, is patient preference.

What Is the Ideal PrEP Regimen?

So, we know that the ideal regimen is the one that the person decides to take because that's the thing about PrEP is, you know, it works if you take it. So, the ideal can change depending on each person's journey.

Current PrEP Options

And so, the current PrEP options. For the once daily oral pills, we do have FTC/TDF, and we have FTC/TAF. FTC/TDF can be used as an on‑demand approach instead of daily for cisgender men, and that is supported by international guidelines, not the CDC guidelines. And PK data may support on‑demand for all populations, but right now it's only been studied for cisgender men who have sex with men to use on‑demand.

And then FTC/TAF is not approved for protection against HIV acquisition through receptive vaginal sex or for people who inject drugs. So, for cis women who have receptive vaginal sex, TDF/FTC is preferred. Same with people whose HIV risk is shared injection equipment.

And then the long‑acting injections. Cabotegravir, it's an IM injection every two months, and there's a seven‑day window on either side for when that injection is received.

And then lenacapavir, our newest tool in the toolbox, is given subcutaneously every six months, and there's a two‑week window for that one.

Why Some Might Need a Long‑Acting HIV Prevention Option

So, why might some need a long‑acting HIV prevention option. Daily oral PrEP is effective, but it's not ideal for everyone. As anyone who is currently offering an injectable PrEP regimen knows, there's a lot of interest in injectable PrEP. So, long‑acting options may be helpful for folks with daily adherence challenges. And it's mentioned for people who have drug or alcohol use, but I think that's kind of the biggest draw for a lot of people who want to be on PrEP but are afraid that they can't remember a daily pill or even an as‑needed pill.

And then stigma. So, some people feel that they don't want to have a medication in their bathroom or in their medical closet. So, they would prefer an injection because they feel stigmatized.

And then people with travel, with frequent time zone changes, may have trouble remembering their daily PrEP. And really just offering the choice is so powerful to people as they can have a choice in which PrEP formulation they take, and that really drives adherence.

Preference Influences PrEP Choice

So, the PURPOSE 2 trial evaluated twice‑yearly lenacapavir versus daily FTC/TDF as HIV PrEP in cisgender men and trans women and men and gender non‑binary people aged 16 years and older, and they found that factors influencing preferences for specific PrEP modalities were multifaceted. Those favoring twice‑yearly injections cited perceived efficacy, adherence, feasibility, and convenience, which is probably what we would all have guessed as terms of why these injections are preferred. And those favoring daily pills reported that the pain and discomfort of an injection was a primary motivator to opt for pills.

So, the investigators concluded that recognizing people's preferences may improve discussions, uptake, and adherence to PrEP among diverse populations. Again, just really underscoring that preference drives adherence. So, it's cool that we have options now, which wasn't the case 10 years ago.

Choosing Between PrEP Options

So, choosing between PrEP options. The pros: again, the oral options, widely available. They don't require an injection, and the visits are quarterly, so every three months.

Cons are the pill burden. Efficacy is affected by nonadherence. And on‑demand dosing for FTC/TDF. Some people may find this complex.

And then the injectable. The pros: it's long‑acting, every two months or every six months, depending which option people take. Does not require daily adherence. May provide more confidentiality.

But the cons is that a healthcare provider is required to administer the injection, so it can't be done in someone's home on their own time for the most part. And it must ‑ they must present for injection visits and can lead to resistance development before or during treatment or following discontinuation if HIV is acquired. So, just to say, there's this very long tail with the injectables. And if someone doesn't get coverage with an oral medication and then gets HIV, there is a very high risk for resistance to the components of the injectable prevention medicine.

So, just a reminder that if someone is not going to be able to come back in two months, something came up, they need to be gone for three months, we need to be able to get them oral PrEP to take until they can come back for their next injectable treatment so that they don't have some time where they're uncovered, and particularly with that tail, as I mentioned, because of the risk for resistance if someone gets HIV.

On‑Demand Oral FTC/TDF PrEP

So, the way it works is people take two pills, 2 to 24 hours before sex. So, it does require some predictability with someone's sex life. And then one pill 24 hours after the first two pills, and after sex, and another pill 48 hours after those first two pills. So, you wind up taking four pills for each ‑ for each time someone has condomless sex to prevent HIV.

Not recommended for Hep B coinfection. Very important point here that if someone has hepatitis B, they can be on oral PrEP, but they need to stay on oral PrEP. And then when they decide to go off of oral PrEP, they need to discuss it with their medical provider and be closely monitored to avoid a Hep B flare. But on‑demand, the way someone's taking it and then not taking it, the intermittent ‑ the intermittent medication exposure can be risky for hepatitis B flare. So, if someone has Hep B, on‑demand is not an option for them.

Similarly, those who may just find the whole thing too confusing, it's better to just do oral or injectable.

And then people at risk of HIV from vaginal exposure, 2‑1‑1 is not recommended at this time, although, you know, that may change in the future.

Expanding PrEP Uptake

So, expanding PrEP uptake. We'll talk a little bit about how to put some of these ideas into practice.

Expanding PrEP Uptake

So, reminder to people: it doesn't require HIV expertise. PrEP is much simpler than HIV treatment, and HIV treatment has gotten very simple recently. So, if you have a patient who's interested in PrEP, don't worry if you don't know that much about HIV treatment.

And we can learn from contraceptive care in the United States. The expansion of contraceptive care services beyond OB/GYN and midwives, vastly increased access to and prescription of contraception. So, really encouraging not just primary care, but also OB/GYN to think about PrEP and potentially several other providers.

Everyone Has a Role

So, any HCP can inform patients about PrEP. So, if you're a surgeon, you can inform patients about PrEP, if you're a medical assistant, any healthcare provider licensed to prescribe medications can prescribe PrEP. So, you certainly don't ‑ don't need to have specialized expertise to prescribe PrEP.

And primary care providers, family medicine, internal medicine, APPs, and clinical pharmacy practitioners can prescribe PrEP. And that, you know, varies depending on jurisdiction, but in many places, clinical pharmacists are prescribing through clinical practice agreements and other arrangements.

Healthcare providers who do STI management, substance use disorder treatment. This is a great potential place to talk about PrEP and prescribe it. And then sexual health and reproductive health care as well.

When and Where to Consider Same‑Day PrEP

So, when and where to consider it?

Sexual health clinics; that's where I work in a sexual health clinic, and we find that this is an ideal venue to discuss PrEP because you're talking about someone's sexual health. And primary care clinics.

Emergency departments are an emerging venue for PrEP prescriptions. And we think this is probably very safe and potentially highly effective to reach folks who aren't getting much health care otherwise.

Harm reduction centers can be a place to discuss. And if you have prescribers available, this could also be a really important way to reach people who aren't getting health care at other places, and maybe at risk for HIV. Similarly, substance use treatment centers.

And the populations: really anyone seeking HIV or STI testing, it's important to discuss PrEP and consider prescribing if indicated. Individuals who inject drugs. Pregnant persons at increased risk for HIV. Individuals whose sexual partners are living with HIV and not on antiretroviral therapy. So, if someone discloses to you that they have a partner who is HIV positive and they're not sure about their medication adherence, this is a high priority for PrEP.

And then don't forget people completing nPEP. Very high priority to discuss PrEP.

nPEP as an Option for Same‑Day PrEP

nPEP is nonoccupational postexposure prophylaxis that is giving a full HIV regimen. nPEP is certainly a great opportunity to discuss PrEP and to transition directly to PrEP.

Same‑Day PrEP: Special Situations

Situations for Shared Decision‑making: Rapid HIV Test Result Not Available

Sometimes we don't have all the perfect conditions in place, but a same‑day PrEP is not necessarily off the table. So, what if a rapid HIV test result is not available? You can review the timing of the last HIV test and the timing of the person's last sexual activity or injection drug use and confirm contact info for abnormal results. And then, really, it's going to be shared decision‑making.

If you want to start same‑day PrEP, you really need to have contact information so that if the HIV test is positive, you can convert to HIV treatment immediately. The patients need to know that if they have undiagnosed HIV that there ‑ and they take oral PrEP, then there is a risk for an M184V mutation. Or if they're starting long‑acting CAB, then there's a risk for developing integrase inhibitor mutations if they have HIV unrecognized. And there's also a possibility for long‑acting early viral inhibition. So, it may delay HIV diagnosis.

So, just really, I think case to case. If you don't have a rapid HIV test available but you have a patient for whom PrEP could be beneficial, I think starting is not unreasonable as long as they're aware of the risks of starting PrEP with unrecognized HIV.

Situations for Shared Decision‑making: Unclear History of Renal Disease or HBV

Another situation for shared decision‑making would be an unclear history of renal disease or Hep B. So, we mentioned that you don't have to have the lab results available before you start PrEP. But if someone reports a history of renal disease or hepatitis B, typically we wouldn't be starting same‑day oral PrEP. Injectable PrEP is fine. However, if the risk for HIV is high, you could consider it if there's an unclear history while you're waiting for the labs. Fortunately, the short‑term use of oral PrEP, even TDF, is unlikely to worsen renal function in the short term. So, again, you'd want to confirm contact info. And then if they say, "I think I had a kidney problem, I don't know what it was," and it turns out their creatinine clearance is low, you could reach them and switch their PrEP, in short order.

Similarly, if they say, "I don't know if I had Hep B. I'm not real clear about that." You wouldn't start 2‑1‑1, but you could start oral PrEP and if it turns out that they are surface antigen‑positive, you just reach the person and tell them "Hey, you do have hepatitis B, so you need to stay on treatment because it's also treating your Hep B, and when you stop, your Hep B could flare, so we need to be closely monitoring you."

And then individuals living with Hep B should consult an ID specialist and hepatologist prior to stopping daily oral PrEP.

So, those are the caveats for people with kind of an unclear history while you're waiting for lab results.

Considerations for Paying for PrEP

Considerations for paying for PrEP. It's covered by most insurance programs and Medicaid. It's required by the ACA. So, if someone has coverage, PrEP should be covered. Sometimes prior authorizations are required.

Low‑cost options are available through GoodRx, mostly for FTC/TDF.

340b pricing may be available for patients without insurance in some clinics, so check with your local 340b providers to see if they have low‑cost FTC/TDF.

And then there are manufacturer assistance programs for all of the different options. You can check with your state health department as well. I know in Colorado, our state health department has a robust PrEP assistance program. And then some states have assistance programs.

And then we think that framing PrEP as a positive health choice is incredibly powerful. So, emphasize that taking PrEP is about empowerment and self‑care. It's not about risk behaviors, or it's really about taking control of your health so that you can live the life that you want to live.

You can present PrEP as a routine prevention option for all sexually active persons, similar to contraception and HPV vaccines. This doesn't need to be just for specific groups or folks who are considered high risk. This is really routine HIV prevention.

So, with that, I think we're kind of winding down with the key points.

Prescribing PrEP: Key Points for Implementation

So, prescribing PrEP implementation. We talked a little bit about the need for more PrEP. We talked about the data behind the safety and efficacy of same‑day PrEP.

And then the key points for implementation is that same‑day PrEP decreases barriers to PrEP uptake. It minimizes the number of people lost at the early points in the PrEP care continuum, and it increases timely uptake and accelerates the onset of protection against HIV.

PrEP should be started as soon as possible following a negative rapid HIV antigen/antibody test.

The choice of PrEP regimen should be based on the needs and preferences of each patient. So, modality frequency, adherence, and comorbidities. So, really tailor the PrEP options to the patient.

And settings with access to point‑of‑care testing, the ability to provide prescriptions, and provide appropriate follow‑up can implement same‑day PrEP.

Audience Q&A

Cool. And now we are at the audience Q&A, so I'll turn it over to Dr. Mayer.

Dr. Mayer: Thank you. Thank you, Dr. Rowan. So, hopefully we've covered this topic fairly thoroughly, but there are a few questions that I think always come up that are very relevant.

One is: What happens if the point‑of‑care test is ambiguous? How would you handle that, Sarah? Dr. Rowan: We don't get too many ambiguous point‑of‑care tests. You can definitely get false positive point‑of‑care test. That is something that we see regularly. And so, if you had a positive point‑of‑care test, I would defer until I had a confirmatory test result, and then I would start HIV treatment. If it's ambiguous, I think I would be repeating the test. And if it's gain ambiguous, I would hold off and do a lab‑based test to get a more definitive answer.

Dr. Mayer: Yeah, I agree with you. I mean, the other thing, which I don't think is common is that you could use a different point‑of‑care test, but a lot of clinics don't have that availability. But there are more than one fourth‑gen point‑of‑care tests available.

One of the questions that I have is, in your practice right now, of the people who are same‑day PrEP, what percentage are getting long‑acting medication versus oral medication?

Dr. Rowan: For us, our standard of care is same‑day PrEP. We also will do telehealth visits for PrEP. So, in that case, if someone has a recent HIV test, we'll prescribe it same day as a telehealth visit.

And the majority of the same‑day starts are oral because we have to get approval for cabotegravir. And we're hoping to implement lenacapavir in the next month. But it's just a little bit of paperwork. So, in our practice, we're not starting same‑day injectable. We're getting the labs and having folks come back within a week to start injectable.

Dr. Mayer: Yeah, I think we're very similar. I don't think we're at the point yet where I would say that same‑day is the default mode, but I'd say definitely the majority of people who are starting PrEP these days are same‑day. But in terms of the injectable, I think the biggest issue is, as you say, the insurance that, you know, we have, you know, we have a lot of access to the medications, but there's still some prior approvals and some paperwork. We actually have legislation going through our state government to try to sort of simplify the process, make it more accessible, but it's still a work in progress.

Have you encountered any other sticking points for people to think about as they migrate their practice towards doing more same‑day PrEP? I mean, any growing pains that you felt that you encountered in Denver?

Dr. Rowan: I think the biggest sticking point is just coverage. I think medically, we're not running into problems.

We've seen when people do same‑day starts, they have pretty much the same kind of long‑term PrEP retention as people who do, you know, not same‑day starts. So, that hasn't really been a problem. So, I think the main thing is just getting folks enrolled in pharmaceutical assistance programs if that's the path that we're going through. We also have a program called the Public Health Assistance Program, and we get people enrolled in that if they're insured. And then sometimes we have people who have insurance, so they are not eligible for pharmaceutical assistance programs, but their insurance, you know, there's issues. So, occasionally we have a prior authorization problem. Or if someone has Medicaid in another state and there's like little caveats. But I think medically, we feel very comfortable with this approach.

Dr. Mayer: Yeah. No, I think what you said very ‑ I would endorse everything you said, which is that the medical part is the easy part. It's the insurance. But I think that's a cautionary tale for everybody listening today, is just, as you initiate these programs, to be talking with the companies that make the medications because there are access programs. Talking with your state health department or city health department because there are ways to figure this out. And then it's having dedicated staff.

There was one question, the chat before we wind down. What is the first‑line medication, and what if it didn't seem useful for the patient? In terms of first line, I think our message today is that there are multiple options and that, you know, different meds will be better for different patients. Some people don't want to take pills, and some people don't want to have shots. And all of these modalities work as PrEP, and we now have data that says that they can work as same‑day PrEP. So, I don't think there's one first line.

But really everything that we use for PrEP can be used for same‑day PrEP, but it has to be for the right population. And if it didn't seem useful, we monitor people. But again, fortunately, there are very few PrEP failures. I think that's really the take‑home today as well. But certainly, it may not be useful for a patient because some patients get nausea, for example, on tenofovir‑based regimens. And so, that may not be a useful medication for them because of that side effect. But then they can get injectable medications. So, a lot of this gets back to, sort of, you know, having some understanding of the different PrEP medications and then trying to fit the right medicine for the right patient, the right situation.