Transcript for CDC Telebriefing: Daily Pill Prevents HIV – New CDC estimates underscore the need to increase awareness of a daily pill that can prevent HIV infection

OPERATOR: Welcome and thank you for standing by. All participants are in listen-only mode until the question and answer session of today’s conference call. At that time, you may press star 1 to ask a question. Today’s call is being recorded. If you have any objections, you may disconnect. I will turn the meeting over to Mrs. Kathy Harben.

KATHY HARBEN: Thank you all for joining us today for the release of a new CDC “Vital signs,” this one on the use of pre-exposure prophylaxis, or P.r.E.P., for HIV prevention. We’re joined today by CDC’s Principal Deputy Director, Dr. Anne Schuchat, as well as Dr. Jonathan Mermin, and he is Director of CDC’s National Center for HIV, Hepatitis, STDs, and TB prevention. We’re also joined by Dr. Eugene McCray. He is Director of CDC’s Division of HIV Prevention. I’ll now turn the call over to Dr. Schuchat.

DR. ANNE SCHUCHAT: Thanks so much, Kathy. Thanks, everyone, for joining us today to discuss CDC’s new “Vital signs” Report. Each month we focus on the latest data about a critical health Issue facing our nation and what can be done to better protect the public’s health. This month, in advance of world AIDS Day on December 1st, our “vital sign” report is on HIV prevention. HIV continues to threaten the health of too many Americans. More than a million people live with the disease in the United States, and about 40,000 new infections are diagnosed each year. CDC has recommended pre-exposure prophylaxis, or PrEP as one of several effective actions for reducing the risk of HIV infection. PrEP is a daily pill for people at substantial risk of acquiring HIV that prevents the virus from establishing a permanent infection when an individual is exposed to the virus sexually or through Injection drug use. When taken daily, PrEP can reduce the risk of sexually acquired HIV infection by more than 90 percent and by more than 70 percent among people who inject drugs. While using PrEP inconsistently results in much lower levels of protection, a growing body of research indicates that PrEP is highly effective in preventing HIV infection when taken consistently. In today’s “vital signs,” we explore new data that suggests many Americans who are at substantial risk for HIV infection may benefit from PrEP according to our research, there are one in four sexually active adult men, one in five who inject drugs, and one in 200 heterosexual active adults. Today’s “vital signs” drug on data, the national on survey drug use and health, and the national survey of family growth. We’ll expand upon the findings in just a few minutes, but first I want to stress that we need to do more work to make sure clinicians are aware of PrEP Although PrEP for HIV prevention was approved by the Food and Drug Administration in 2012 and CDC has published clinical guidelines on PrEP. One recent study found one-third or 34 percent of primary health care providers still had never heard of PrEP so we need to increase awareness among clinicians. We also need to provide them with the tools to help identify patients at substantial risk for HIV infection, determine which prevention options are best for those patients, and counsel those patients about all of their prevention options. Here’s the bottom line. Doctors need more prep about PrEP we recognize that clinicians are working in a highly complex prevention landscape. That’s why along with PrEP all available prevention actions should be considered, including HIV testing so people actually know if they’re infected, treatment to suppress the virus among people living with HIV, correct and consistent use of condoms, reducing risk behaviors, and drug treatment and use of sterile injection equipment for people who Inject drugs. For a closer look at findings and more specifics about who can benefit most from PrEP, I’d like to turn it over to Dr. Jonathan Mermin, Director of CDC’s National Center for HIV/AIDS., Viral Hepatitis, STD, and TB Prevention.

DR. JONATHAN MERMIN: Thank you, Dr. Schuchat. Before we discuss these findings, it would be helpful to discuss findings. PrEP be considered for those people who do not have HIV but are substantial risk for infection. Including any sexually active adult in an ongoing sexual relationship with an HIV-infected partner, gay and bisexual men who aren’t In a monogamous relationship with a recently tested HIV-negative partner and don’t always use condoms or have recently been diagnosed with a sexually transmitted Infection. People who inject drugs that aren’t prescribed by a clinician and don’t always use sterile injection equipment and those who are at risk for acquiring HIV sexually. And heterosexual men and women who don’t always use condoms with sexual partners who are at substantial risk for HIV infection, including bisexual men and people who inject drugs. As part of our high-impact approach to prevention, we wanted to gain a clear perspective of where PrEP could potentially achieve the greatest result in combatting HIV. PrEP is a powerful prevention tool, but it is still not reaching all those who need it. To help guide education efforts, we wanted to determine how many Americans need to be counseled that PrEP could be an option for them. We therefore analyze national data to estimate the total numbers, percentages and proportions of people with indications for PrEP in three transmission risk populations: Men who have sex with men; people who inject drugs and heterosexually active adults. So these are subgroups that do not consistently adhere to the variety of prevention methods that Dr. Schuchat outlined. Our analyses find 25percent or about 492,000 gay and bisexual men have indications for PrEP 19 percent or about 115,000 people who inject drugs have indications for PrEP less than 1 percent of heterosexually active adults have indications for PrEP; regardless of whether its men who have sex with men, people who inject drug, or heterosexually active adults, it’s important that clinicians discuss behavioral risks with all patients to identify those individuals who are at substantial risk and could benefit from more information about PrEP as a potential prevention option for them. As Dr. Schuchat also mentioned, clinicians are operating within a highly complex HIV prevention landscape, and though PrEP is promising and can help fill gaps, no single tool will be sufficient to end the HIV epidemic in the United States. To maximize the success of our national HIV prevention efforts, we must use all the tools we have to achieve meaningful results. For example, keeping HIV under control through treatment helps people with HIV live longer, healthier lives and can dramatically reduce the risk of transmitting the virus to others. But currently, just about 30 percent of Americans with HIV have their virus suppressed. As today’s report indicates, other effective HIV prevention tools are not consistently used by all who need them. Many of those with sexual and drug related risk are not consistently protected by condoms or sterile equipment. This is where PrEP can fill an important gap. To fill that gap, we must achieve greater awareness among clinicians and help them connect PrEP with the people who could most benefit from it. So now I want to turn things over to Dr. Eugene McCray, Director of CDC’s Division of HIV/AIDS Prevention who can tell us a bit about what CDC is doing to ensure more Americans can take advantage of PrEP

DR. EUGENE MCCRAY: Thank you, Dr. Mermin. PrEP is one piece of CDC’s overall high-impact HIV prevention strategy that you mentioned, a strategy that matches the right tools to the right people. CDC continues to work to scale up other highly effective prevention strategies, such as ensuring people living with HIV are receiving care and treatment to prevent transmission to others and to help them live longer, healthier lives, encouraging consistent and correct condom use and educating those at high risk of transmitting or acquiring HIV about all available prevention strategies, including PrEP. PrEP will be one of the right tools for some people at high risk of HIV infection. Our experience shows when we focus our effort, we can succeed in increasing use of PrEP For example, in a separate analysis also reported in “vital signs” today, researchers from New York State Department of Health found that PrEP used among New Yorkers covered by Medicaid increased substantially just a year after statewide efforts were launched to increase PrEP knowledge among potential prescribers. San Francisco started focusing on making PrEP available to people at risk, including providing it at no charge to the uninsured in 2013. Today, by some estimates, 15 percent of gay men in San Francisco are taking PrEP While we can’t credit this to PrEP alone, last year San Francisco reported a record low of only 302 new HIV diagnoses to more than 2,000 annually reported at the epidemic’s peak. This type of effort needs to be replicated nationally. Strategically scaling efforts and targeting the rights people who stand to benefit from it the most. So CDC is working on many fronts to ensure that people know about PrEP and can access the drug if they choose to. For example, early this year, we announced a $216 million investment nationally, in part to help community-based organizations ensure high-risk negative, HIV-negative individuals have access to prevention and support services such as PrEP We also announced an additional $125 million investment to help health departments expand use of PrEP and other high-impact prevention strategies. We’re supporting research to better understand the practical requirements, cost, and impact of providing PrEP at federally qualified health centers. CDC has published a range of resources to educate and provide PrEP– I’m sorry, resources to educate and provide advice to providers about PrEP. In addition to our 2014 clinical guidelines, we’ve also discussed and developed step-by-step checklists and interview guides and we support a hotline to answer questions for providers about when and how to offer PrEP. PrEP isn’t right for everyone. No single method is, but its rights for some people. When the men and women at high risk for HIV adhere well to PrEP or whatever prevention methods work best for them, we can make gains in national efforts to slow the HIV epidemic. Now I’ll turn it back to Dr. Schuchat for closing remarks and to sum up today’s findings.

DR. ANNE SCHUCHAT: Thank you, Dr. McCray. In summary, I want to reiterate, PrEP works, but doctors need more prep about PrEP And PrEP can only make a difference if all health care providers, not just infectious disease specialists, are aware of it and know who can most benefit from it. And if the people at greatest risk for HIV infections know PrEP may be a viable prevention option. To truly affect change in the nation’s HIV epidemic, we need continued and collaborative action from clinicians, medical and professional associations, advocates, and groups that implement HIV prevention efforts. And we also need the media. Now I’ll turn things back to Kathy to moderate the question session.

KATHY HARBEN: Okay. Thank you, Dr. Schuchat. Jenny, we are ready for questions now.

JENNY: Thank you. We will now begin the question and answer session. If you would like to ask a question over the phone, please press star 1. Please unmute your phone and record your name and company clearly when prompted. To withdraw your request, you may press star 2. Our first question over the phone comes from Maggie Fox, NBC News. Your line is open.

MAGGIE FOX: Hi, thanks very much. I’m wondering if we can elaborate a bit more on what does work. New York reported on some of their success rates. Dr. Mermin mentioned what’s happening In San Francisco. Can we have a bit more detail on how, especially in this age where everybody doesn’t watch the news every night, you get the word out to the doctors and to the people at high risk of HIV who need to know about this. Thanks.

DR. ANNE SCHUCHAT: Yeah, thank you, Maggie. The question is about what the secrets of success in New York were or San Francisco. I think a key factor in both communities is that they brought the relevant groups together. The New York state report describes a statewide stake holder effort where they had Insurers and clinician groups and Medicaid groups and so forthcoming together to figure out how are we going to make this work in our community. I think in San Francisco similarly, the health department, the clinician organizations, the stakeholder groups, you know, often when a new drug is licensed or approved by the FDA, docs just take it up, but this is a little different and a little more complicated. We think there was a collaborative effort to pull the stakeholders together to plan how to make this happen. You needed to raise awareness among clinicians. You needed to make sure the Insurers were ready to go and that co-payments or medical assistance might be offered. You needed to make sure that the frequent questions were answered about how to monitor patients and that consumers had the kind of Information they needed. So I think that in those two episodes, they really brought groups that were knowledgeable together to try to make a plan of action locally. So I think — did you have a follow-up question?

MAGGIE FOX: Well, I would just like to be able to paint a picture of what that looks like. I mean, it’s all kind of theoretical, isn’t it? What do they actually do? What did work and what didn’t? Also, I wasn’t real clear on the statistics out of San Francisco. I was hoping we could get a repeat of that. Thanks.

DR. ANNE SCHUCHAT: Okay, sure. Dr. McCray is going to go into a little bit more detail.

DR. MCCRAY: Sure. Just to add, specifically, providers play a central role in increasing awareness and that was very much a part of the process in New York City. The advocates also play an important role. Specifically, they can raise PrEP awareness and understanding in the at-risk population so that consumers of PrEP know that it’s available to them. And then of course the medical and professional associations play an important role in educating providers and sharing lessons learned. That was clearly a big part of the New York City and San Francisco effort. And fourthly, there are important groups that are relevant in terms of implementing PrEP in the communities, state and local health departments, community based organizations.  It’s really important they be a part of the process, and they can really integrate PrEP education into existing programs and to those that are working in clinical studies. They can provide PrEP to patients with Indications for use. Finally, the individuals that are at substantial risk for HIV need to be educated and involved in the process. They can really, in many instances, put pressure on their providers and ask their providers specifically about providing PrEP to them. All of those things happened in New York City or are happening in New York City and San Francisco, which I think has been responsible for the uptick we’ve seen there.

DR. ANNE SCHUCHAT: Next question, operator?

OPERATOR: Next we have Mike Stobbe, the Associated Press. Your line is open.

MIKE STOBBE: Hi. Thank you for taking my call. Just a couple questions. So these are estimates of how many people could be or should be counseled about PrEP I want to make sure I don’t make a bad assumption. What do you mean by counseling? Does it mean that a doctor or health care provider recommend that they get PrEP or does it mean merely inform them about the existence of PrEP as an option ? and I was wondering, do you all have statistics about what proportion of people who are counseled about PrEP choose to go on to it? And I had a third question, which is, of the roughly 1.2 million who I guess are eligible for counseling, do you know how many have been counseled about it?

DR. ANNE SCHUCHAT: Thanks so much, Mike. We don’t have the statistics on how many people have been counseled or on what proportion of those who are counseled decide to opt for PrEP. What we mean by that discussion is going through risk behaviors with a person and going through lifestyle and adherence issues with a person, sorting out whether a person will be able to regularly take medication, come back for follow-up appointments. We recommend every three months a person continues to see a provider for lab tests and checks to make sure that they’re not having side effects from the drugs and that they’re taking them the right way. The conversation also involved really reviewing the behaviors and continuing to promote risk reduction, even if you go on PrEP We want to make sure people are protecting themselves from other sexually transmitted infections, which won’t be blocked by the PrEP medicine. Did you have a follow-up?

MIKE STOBBE: No. That’s it. Thank you.

OPERATOR: Our next question comes from Duncan Osborne, Gay City news. Your line is open.

DUNCAN OSBORNE: So I was in a town hall meeting this past Thursday with a group of advocates and some PrEP users. they’re saying what they’re finding is doctors don’t know about PrEP and in some instances when doctors eithers do know about PrEP or are told about PrEP by a patient who wants it that the doctors are resistant to prescribing PrEP I thought I heard a statistic about how many doctors know about PrEP from you. Do you have that information? How many doctors are trained about PrEP and can prescribe it? Do you have any data about doctors being resistant to prescribing P.r.E.P.?

DR. ANNE SCHUCHAT: Thanks so much for those questions. The survey of docs from 2015 estimated that 34 percent were not aware of PrEP Now, the idea that two-thirds are aware of it doesn’t mean two-thirds are comfortable with prescribing it. So we do think that this is a fairly new intervention for many clinicians. So we don’t have statistics about resistance or reluctance. But one of the key things about today’s “vital signs” is that the program is issuing tools to make it much easier for clinicians to learn how to prescribe P.r.E.P., to learn how to counsel, to learn how to have these discussions. This issue is shown in our “vital signs” with a five-step process that is really not that complicated. So I think your information from the town hall is probably quite accurate, that many people don’t know about this and aren’t using this in a routine way, but that’s what today’s release is about. Really helping the word get out, that we think PrEP is highly effective. It’s a good tool for the right people, and it’s not that complicated to deliver. So we think any prescribing health care provider can deliver PrEP care.

DUNCAN OSBORNE: Can I ask a quick follow-up here?

DR. ANNE SCHUCHAT: Sure.

DUNCAN OSBORNE: How many doctors were surveyed in this 2015 survey, and did you see any differences by region or by City?

DR. ANNE SCHUCHAT: I don’t have the Information on the survey details. It was a national doc-style survey in 2015 carried out by the Porter Novelli services. I don’t have the numbers. Those types of services don’t usually use City-specific data. They’re really a snapshot we can use over time. Thanks for that question.

DUNCAN OSBORNE Thank you.

DR. ANNE SCHUCHAT: Next question, operator.

OPERATOR: Next we have Adam Smelts, “Pittsburgh Post-gazette.” Your line is open.

ADAM SMELTS: Thanks, doctors, for taking some time to talk today. Wanted to get a little bit into the cost question. I’m curious if any of you can speak to how much this treatment costs and if generally it’s covered by common insurance plans.

DR. ANNE SCHUCHAT: Yeah, thanks. The cost may be misleading. We they it’s estimated to be about $10,000 a year, but there are many negotiating tools and also medical assistance that’s available for people who are low income. We know that Medicaid, the public insurance, covered PrEP, and most private insurance will cover PrEP, but they may need some preapproval to be made. One of the tools that we’re providing is information about how to help make sure your patients are, you know, applying for insurance and have access to the medicines. We know that the company has drug assistance programs to help patients without insurance pay for PrEP but to help get assistance with the co-pays and such, there are tools. That’s one of the things that the New York State Health Department worked out in really planning their rollout. Both working out, you know, directories of PrEP providers to make that accessible to consumers, and then also convening the insurer groups to make sure that they could make this simple. This is a recommended intervention that we think is quite effective, and it’s a lot more cost effective to prevent HIV than to have a lifetime of health care costs.

ADAM SMELTS: Thank you.

DR. JONATHAN MERMIN: And this is Jonathan Mermin. I wanted to add to Dr. Schuchat’s comments that there’s some examples of PrEP Programs that have had high access for the people who need the medication. So for example, in Seattle, where it’s one of the priority HIV prevention tools, a program that is providing PrEP found that less than 1 percent of the patients needed to use co-pay — or to pay for co-pays for the medication itself. So the science clearly calls out that PrEP works. In addition, the lives of Americans are too important for us not to get PrEP to those people who really need it.

ADAM SMELTS: Thank you.

OPERATOR: Our next question comes from Josh Steinberg, ABC News. Your line is open.

JOSH STEINBERG: Hi. Thanks so much for giving this talk. I have a two-part question. Can you comment on some of the side effects or negative consequences of P.r.E.P.? And if people use PrEP inconsistently, does this lead to viral drug resistance should they become infected at a later time?

DR. ANNE SCHUCHAT: The principle side effect that needs to be monitored is kidney function. We recommend people return to the clinic every three months and have a blood test to check on how their kidneys are doing. The issue of resistance was a big question, but the data so far are reassuring. So we think that, you know, the regiment for PrEP is not the same as the regiment for treatment of HIV, but we do have good results right now that PrEP is safe and effective for the right people as long as you’re coming back for care and get monitored — get your kidney function monitored.

JOSH STEINBERG: Thanks so much.

DR. ANNE SCHUCHAT: Next question.

OPERATOR: Our next question comes from Matt Henney, project Q Atlanta.

MATT HENNEY: Hi. I have two different questions. That is, one of the largest HIV care providers, AIDS health care foundation, has been pretty strident in their criticism of PrEP… Any response to that criticism? Also, the second part of that is just this week the CDC came out with a new study that shows gay men are helping fuel a rise in chlamydia, gonorrhea, and syphilis infections. Some critics of PrEP are linking that to PrEP’s increased use. Can someone address that as well? Thank you.

DR. ANNE SCHUCHAT: Let me begin, and then I think Dr. Mermin will follow up. First thing to say is there was concern early on that people might increase their risk taking following prescriptions for P.r.E.P., but recent studies are reassuring about that. You know, of course this is not the only Intervention. We think it’s very important to use condoms or clean needles. But we do think that PrEP has an important role to play in prevention. so we’re not saying that this is the only tool and we think it needs to be a full tool box for intervening against HIV, but that the more recent studies from Kaiser Permanente and the adapt study are reassuring about increasing risk behavior in light of taking PrEP

JONATHAN MERMIN: And this is Jonathan Mermin. So first, there has been an alarming increase in the number of syphilis diagnoses in the United States over the past few years. And we are also seeing increases in the number of gonorrhea infections among gay and bisexual men. For syphilis, over 80 percent of those infections are also in gay and bisexual men. 50 percent of those are among gay and bisexual men with HIV infections. All of those increases started before PrEP became available or before CDC issued guidelines. So there are factors that are increasing STDs among gay and bisexual men that started to occur before the onset of PrEP However, as Dr. Schuchat mentioned, we want to make sure that people who do access PrEP also have access to other STD prevention tools like condoms and like diagnosis and treatment of their STDs and of STDs among their partners. There’s several reasons. One, in itself it prevents STD Infections, which can have negative health outcomes. The other is that having an STD can increase the chance that you would acquire or transmit HIV infection. We want to make sure that isn’t happening. At the current time, we have not seen a negative consequences, as Dr. Schuchat mentioned. So for example, in the Kaiser Permanente study, there were no HIV infections among several hundred men who were taking P.r.E.P., but there was a fairly high rate of STD acquisition.

OPERATOR: There are no further questions over phone at this time. As a reminder, if you’d like to ask a question, please press star followed by the number 1.

KATHY HARBEN: Just checking to see if there are any questions. Okay. Thank you to reporters for joining us today. Thank you, also, Dr. Schuchat, Dr. Mermin, and Dr. McCray. For follow-up questions, you can call the press office at 404-639-3286 or send an e-mail to medIa@cdc.gov. All of the materials that were mentioned today that will help health care providers are available on the CDC “vital signs” website. That’s at cdc.gov/vital signs. Later today, a transcript of this telebriefing will be posted on the newsroom page at cdc.gov. Thank you, all.

OPERATOR: That concludes today’s conference call. Thank you for participating. You may disconnect at this time. 

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES