UC San Diego researchers working on preventing HIV in high risk individuals.
April 18, 2012 1:11 p.m.
Dr. Richard Haubrich, UC San Diego, Professor of Medicine, Infectious Diesease.
Related Story: HIV Prevention Pill To Be Tested In San Diego
CAVANAUGH: Our top story on KPBS Midday Edition, UC San Diego researchers are starting an HIV prevention study that involves the use of a new pill. Doctors say taking the pill may have people at high risk of infection to stay HIV free. I'd like to welcome my guest, doctor Richard Haubrich is professor of medicine, are the division of infectious disease.
HAUBRICH: Thank you so much.
CAVANAUGH: You'll be working with people who are healthy, right? Not infected with HIV and
HAUBRICH: That's correct. So this trial that we are talking about is part of a package at studies all aimed at reducing HIV transmission, and keeping people who are infected on therapy and safe. So this particular component, are the prep study will work with people who are at high risk for HIV based on their sexual behavior, and they'll be MSN, men have sex with men, and they will -- because of their high-risk behavior, be offered an option to reduce their risk of HIV, to take this combination medicine called Truvada. The whole package, really, includes a lot of other things to help prevent HIV, such as risk reduction, use of condoms, and other things that can help reduce their transmission, as well as repeated testing for HIV and safety testing.
CAVANAUGH: Now, tell me what is the criteria for high risk?
HAUBRICH: So the criteria for entry into the study are still being negotiated, but it will include people who have multiple sexual partner, who have sex with people they know are HIV infected, and so we'll include a lot of high-risk behaviors.
CAVANAUGH: How difficult is it to get healthy people involved in a study like this?
HAUBRICH: I think it's -- something that we're offering to people. Right now, the CDC has interim guidance for the use of this medication, Truvada, for prep. The problem is right now it's not available routinely. Let's hard to get it paid for. Maybe some insurances might pay for it. The study provides an opportunity for those who are interested to receive the medicine from the study, free of charge, and all the laboratory and safety monitoring recommended will also be done as well. Having it available will help, and in our discussions with the county health folks who do HIV testing, they noticed that there was a lot of those who tested HIV negative in getting prep. But right now, there's no way for them to get it. So we're hoping this will represent an opportunity for people who are interested. Another category of people might be those who have an HIV infected partner. Obviously treating the partner will help reduce the risk, but also treating the uninfected person can further reduce their risk.
CAVANAUGH: Will the subjects in this study be asked to practice safe sex or not? Will the pill be it, or will there be a whole criteria of things that people in this study should be doing?
HAUBRICH: So the prevention is really a group of things that will help reduce their risk behavior, as well as using the pill. There's some concern about prep that it might increase people's risk behavior. So far in studies that have been done including the study published a couple years back, when they looked at risk behavior during the course of the study, it was reduced in the participants. So we'll carefully be asking people using a way that is confidential, and we will be advising them to reduce their risky behavior in addition to taking the medication.
CAVANAUGH: Tell us a little bit more about this drug, Truvada. What do we know about its effectiveness?
HAUBRICH: It's one of the most-used medications to treat people with HIV. We know a lot about it. It's recommended for virtually everyone in HIV naive people. The drug lasts a long time in the body, so you only have to take it once a day. And presumably may even last longer than that, even though the current recommendations are to take it once a day. Two, it's very safe. Lots of experience suggests that there are minor side effects, but those can be easily managed, and we monitor people carefully for longer term side effects. It's been shown to be effective. There have been now a number of randomized clinical studies that show that giving Truvada to people reduces their risk of HIV. So it's a list of those things in a well-tolerated safe medication that prompts us to look at it in giving it to people who are otherwise healthy. So whenever you give a medicine for prevention to a person, you have to weigh the risks and the benefits.
CAVANAUGH: Right. I was going to ask you, you say there are well-tolerated side effects of these drugs. What are they?
HAUBRICH: One of the more common ones that occurs in a small percentage of people is nausea. That can go away after a few days' time. Then there are effects on the kidney that can be watched for using blood tests. So we'll be monitoring those every three months. Finally there's events of bone effects of the medication, and those have been studied in a lot of different studies as well.
CAVANAUGH: Now else will you be monitoring the people who participate in this study? I read that you're actually going to be sending text messages to remind them to take the pill; is that right?
HAUBRICH: Yeah. So one of the key predictors of whether or not Truvada works for prep is whether people take it. It's not too surprising to find out that if you don't take a medicine, it's not going to work. But the randomized studies to date have then that in those people that take the medicine much more regularly, their risk of HIV is lower. And if you look at people who take it only intermittently, then their risk of HIV is no different from not being on the medicine. So we think that the key to using a medicine like Truvada for prep is helping people being adherent to the medication. So we've designed actually a randomized intervention, where we give everybody the full prevention package. Then half of the folks will also on top of that get text messages that they design, they say I'm going to receive this message, and they decide what it says. This has been piloted by one of our researchers named David Moore at UCSD, and he's working in high risk people with HIV and thinks this intervention will help also those without HIV. So half the group will get the text messages. And what we want to see at the end of a year follow up of all the folks is do the people who get text messages and extra help from what we call an alert worker have better adherence and stay on the medicine than those that don't?
CAVANAUGH: If these measures are found to be successful, how do you imagine they're going to be used in the community outside of a clinical setting?
HAUBRICH: So the use of cellular technology is a very exciting area. There's a lot of different studies going on both at UCSD and many other places, looking at text messaging, video messaging, to show adherence to medications for TB, a lot of different studies going on for that. The technology is here, even here at UCSD, we have the cal IT 2 folks that have a setup to be able to do this. The cost of buying these bulk text messages are relatively inexpensive. So it's something that conceivably could be set up in a big clinic that was doing adherence and prep for uninfected people that could help people be successful.
CAVANAUGH: Speaking of cost, the cost of this pill has been estimated to be about $10,000 a year for daily use. Could the study that you're embarking on be used to maker the case for insurance coverage?
HAUBRICH: Yeah, the criteria for insurance coverage are first of all approval by the FDA, usually, and this Truvada has been submitted by the company that manufactures it to look for FDA approval. They have to demonstrate safety and efficacy in that regard. The efficacy has been demonstrated. Our study takes that to the next step and says how is it going to be implemented in a more clinical setting where the monitoring is less frequent than was done on the randomized studies, that is every three months as recommended by CDC, and how well will people do at staying on the medication
? That's what we'll help to show. I think the FDA is deliberating on whether they should approve the medicine for prevention, and that will be the first step at getting it improved by insurance.
CAVANAUGH: The people involved in this study receiving not only the pill but a preventive package of counseling and so forth, how will you determine if it's the pill working or the higher awareness of risk that's actually keeping people from contracting HIV?
HAUBRICH: That's a really good question. And I do want to emphasize, our study is not large enough to show that we actually are reducing HIV transmission. Everybody of course is getting the medication. What we'll be able to show is how successful in general people are, and whether this additional text messaging intervention helps people be adherent. The several studies that have been done, some have not shown as good a benefit as others. The studies that have shown less of a benefit have been ones where they look carefully and see people are not adherent to the medicine. So particularly in one large study that didn't show a very big benefit, that study showed clearly the relationship between taking the medicine and the benefit of it. So if we can show that in a more clinical setting, people are successful at taking the medication, that'll be a big plus in terms of its utility.
CAVANAUGH: Now, the use of this drug, and other drugs over the years, have really increased the quality of life and life span for those diagnosed with HIV. How far would you say we have come here in San Diego County?
HAUBRICH: I think that the success of antiretroviral therapy has been one of the things that I've been very privileged to take part in. Aye done many studies since one of the first studies of antiretrovirals. We have gone through single drug regiment, dual drug regiments to finally finding out that we need to give triple combinations, and in so doing can suppress the virus in the vast majority of people, and recently we've seen the advent of newer drugs that have activity against drug resistant viruses. The key is keeping the virus suppressed. That does several things. For the individual, it helps their immune system stay restored. And if they can get their T-cells up, we knowing that the lifespan of an HIV infected person should not be different than if they didn't have HIV.
CAVANAUGH: Wow, that's a change.
HAUBRICH: If you look at our clinic in San Diego, at the Owen clinic run by doctor Chris Matthews, the vast majority of people on therapy have suppressed virus. So that's really been a key advantage. The thing it does is the public health advantage. If people are on therapy and have suppressed virus, they are much less likely to transmit HIV to somebody else. And so there's a public health benefit as well as the individual benefit. So now that's part of the prevention package. The second part is helping people stay in care. Obviously if someone is HIV infected, they might come to clinic but then they drop out.
CAVANAUGH: My last quick question to you, if someone is hearing this and is interested in being part of your study, how might they contact you?
HAUBRICH: So the AVRC is where the study will be done in San Diego, and the number is 543-8080 in the 619 area code or our website, AVRCtrials.org.
CAVANAUGH: With thank you so much.
HAUBRICH: Thank you.