The truth about Truvada

The use of Truvada as a pre-exposure prophylaxis (PrEP) has become the topic of conversation for sexually active people in the LGBT community and beyond. The drug when taken appropriately can prevent the contraction of HIV even when a person may have been exposed to the virus. San Diego LGBT Weekly wanted to get accurate answers to the questions being asked about Truvada in the bedrooms, barrooms and ballrooms in San Diego. We interviewed the medical director of the AIDS Healthcare Foundation, Dr. Adam Zweig, to get the truth about Truvada. This is a must-read for anyone who is sexually active.

Stampp Corbin: Dr. Zweig, what is your educational background?

Dr. Adam Zweig: I’m a Harvard University undergraduate, and then I attended USCD for medical school. I did my residency in Phoenix at the VA hospital and worked for the past 22 years at Scripps Clinic where I performed HIV medicine for the group. I opened this new medical center in September, mainly because I wanted to move into the community.

Can you give me an overview about Truvada?

Truvada is a medication that’s one pill that actually has two medications in it. One is called tenofovir, and the other is called emtricitabine. It’s a medication that has actually been around for years as a treatment for patients with HIV infections. A study came out a few years ago which looked at using this one pill – Truvada, as a way to prevent contracting HIV in patients who were at risk.

In the study, the medication was relatively successful at preventing HIV acquisition. In 2012,the FDA approved the use of this medication for pre-exposure prophylaxis (PrEP)… allowing us to prescribe it to an individual who we feel is at high risk for contracting HIV. The CDC (The Centers for Disease Control) defines five groups of patients that we as providers should consider using pre-exposure prophylaxis.

So that would include gay men and intravenous drug users?

This can be varied obviously depending on each individual’s interpretation but it is usually gay men who had unprotected anal intercourse in the past six months or an STD in the past six months.

Both tops and bottoms?

Yes. No. 2 is injection recreational drug users as you mentioned. No. 3 is sex trade workers. No. 4 is the discordant couple … meaning an HIV negative individual who has a positive partner. No. 5 is a heterosexual person who is sexually active with somebody that he or she thinks may be bisexual or an injection drug user. Those are the five groups who should consider using PrEP.

Let’s talk about the efficacy of the drug. I’ve read everything from 92-95 percent effectiveness. Is Truvada as effective as a condom? Is it better than a condom? Should it be used in conjunction with a condom?

In the trial which was named iPrex, the efficacy was actually 42 percent in the treatment arm. That means in the patients who were receiving Truvada there was a 42 percent reduction in HIV acquisition compared to the people receiving a placebo. The issue is that not all patients in the treatment arm were actually taking the pill. When blood tests were done to see if there was actually any medication in the blood stream of those patents who were supposed to be taking (Truvada), then in the people who had medication in their system the efficacy rate increased to 72 percent. By extrapolation, it was determined that with the people who took the drug properly that the efficacy rate was actually 92-95 percent.

So what you’re saying is people were not completely adhering to the drug regimen?

That’s correct.

So through extrapolation we get to the 92 to 95 percent efficacy as the best estimate of the drug’s effectiveness?

That’s right. So the estimate was that if an individual at risk for HIV acquisition took this medicine every day and did not miss a dose then it would be about 92 to 95 percent.

If (Truvada) is 92-95 percent effective that’s not as good as a condom, right? A condom is 99 percent effective, right?

Current estimates are 90 to 95 percent in reducing HIV transmission, if used consistently.

Can I go and have unprotected sex or is Truvada a treatment that is to protect me from the 1 percent chance that the condom fails?

Here is the way I present it to my patients and I think the way the FDA (Federal Drug Administration), the CDC and the medical community want it to be used. We don’t want Truvada to be used in place of condoms. Truvada or pre-exposure prophylaxis is one tool that we use to reduce the risk of HIV acquisition in somebody who is at risk. It doesn’t mean either or. I want an individual who is sexually active to enjoy their sexual activity and yet not place themselves or others at risk. So what I tell people is that if they are not in a monogamous relationship to use condoms as much as possible. We all know that using condoms every time is not likely to happen. Things happen, condoms break, you might get tipsy and forget to use it if you are out at a club or you may find yourself in a situation when a condom just isn’t available. If somebody is taking Truvada then they have back up. It’s not going to be that much of an issue.

So based on that scenario, why wouldn’t I do PEP instead? Meaning post-exposure prophylaxis – taking a regimen of drugs immediately after exposure?

It’s certainly a possibility but post-exposure prophylaxis is a little difficult because in order to be effective you have to see your doctor or go to the emergency room and be placed on anti-retroviral therapy of three medications within 72 hours of exposure.

So with the post exposure prophylaxis (PEP) regimen, how long does that have to go?

Usually you use it for 30 days. So if somebody has a high risk exposure we do an HIV test at the time of the exposure, place the patient on medications for 30 days; then, if the next HIV antibody test is negative, we can usually stop the medication.

OK, so the post exposure scenario is 30 days, three pills a day.

Not three pills … three medications a day.

Three medications a day for 30 days and then you make a determination of whether you are or, hopefully, you’re not HIV positive at the end of that result. I want the reader to understand the difference. What I’ve read is that PrEP is something that I’m going to be taking as a daily regimen for as long as I’m sexually active.

For as long as you’re sexually active, it would be a daily regimen for as long as you are at risk. For instance if somebody is in a confirmed monogamous relationship there would be no need for somebody to take a … you’re smiling.

I don’t know of any confirmed monogamous relationships … and I’m not talking just about in the LGBT community. No one knows what their partner is doing.

That’s a decision you have to make yourself. There are a lot of gay couples that are monogamous. They feel that they are monogamous with each other. If you feel you are not at risk, then you would not need to take an expensive medication that has potential side effects. Of course nobody is going to know for sure.

And that’s an issue …

Absolutely, and that’s for an individual to decide; how much they feel they can trust their partner.

Let’s say that I do decide to take Truvada. If I take it right now, walk out of here, have safe sex and the condom breaks, am I protected?

No. The way this medication works is it needs time to be absorbed and get to adequate serum levels, and then get into the cells where it works. In order for (Truvada) to be effective, it would take at least four days or so for the medication to provide protection.

OK, three to four days?

Most likely, yes. I would tell a patient they are probably not going to be protected until they have taken the drug for at least a week. Once again, I would still like them to employ safe sexual practices as much as possible. I wouldn’t want them to say, “OK, I’ve been on Truvada a week now I can bareback as much as I want.”

We are getting to the ultimate question, if I am using condoms should I go on a Truvada regimen to protect me against the 1 percent likelihood that the condom is not going to be effective?

The way I would look at it, and some people may disagree, is that if you are an individual who is sexually active and you use condoms every time you are sexually active – we are talking about anal sex here; I don’t think anybody expects oral sex to be performed with a condom. If you use a condom and your partner uses a condom every single time I don’t think that individual needs to use PrEP. If the condom breaks then we can use post-exposure prophylaxis (PEP) with that individual. I am more worried about a person who is not using a condom every time. That’s the person that I would consider a candidate for pre- exposure prophylaxis (PrEP).

You know the World Health Organization and the Centers for Disease Control have been suggesting PrEP for sexually active gay men. Why so much controversy? Do you think the treatment will lead to more risky behavior, as some AIDS organizations suggest?

There are probably two potential issues with PrEP. No. 1 is what you just mentioned; will prescribing this medication increase the frequency of risky sexual behavior in patients who take it? That is the first controversy. The second issue is with compliance. If I prescribe this medication and somebody takes it irregularly, then ends up getting HIV and continues to take the medication irregularly, then I am worried about the possibility of resistant HIV developing. The person may be able to spread this resistant virus to other people. So those are the two issues. Will prescribing PrEP increase the frequency of risky sexual behavior and thereby the frequency of STDs such as gonorrhea, chlamydia, herpes, hepatitis B and hepatitis C? Will non-compliant patients increase the possibility of developing a (Truvada) resistant virus?

In terms of an increase in risky behavior, those exact same things were said about the birth control pill, that women were going to become more promiscuous, that the birth control pill doesn’t protect against STDs. So why is it that PrEP is getting all of this controversy around the issue when it’s the same issue when you tell a woman to go on a birth control pill?

I think that is a valid point, but I also do think that there is a difference in the population that we are talking about in terms of heterosexual women and gay men.

In terms of contraction of STDs?

Well, I would probably think there is a difference, and I don’t want to be inflammatory about this; the number of sexual partners would be different between those two groups. That being said, you are exactly right, it did not happen in women, it may not happen in men. In gay men I think there is a concern which certainly hasn’t been proven yet. There are a couple of studies that seem to show that the rate of risky sexual behavior did not go up when people thought that they were on Truvada. However, there was also a study that came out from Kaiser Permanente in Northern California a few months ago that showed the rate of condom-less sex increased by 45 percent in men that were on Truvada. So we have some conflicting data.

OK.

I think there will probably be two groups of gay men. One group who are really worried about contracting HIV and other STDs, who will not increase their risky sexual behavior. And then a group of gay men who will probably look to the medicine to give them a way out from having to use condoms; in that group it may increase the rate of risky sexual behavior. I don’t have any numbers to back me up. I’m in no way trying to be judgmental. Certainly, someone practicing condom-less sex should get regular STD screening.

What’s more concerning is what you said about potentially producing an HIV strain resistant to Truvada. Can you be a little bit more specific about what you are saying?

We know in people who have chronic HIV infection that the more non-compliant the patient is, the more likely they will develop a resistant viral strain.

But Truvada is really is for people who are HIV negative?

Truvada if used alone. We use Truvada all the time in people who are HIV positive but we use it along with another medication.

Right. So I’m HIV negative, I go on Truvada, I use condoms sometimes, I don’t use condoms other times. How does that affect this resistant strain?

If you are HIV negative taking Truvada incorrectly, it is not going to do anything with the HIV strains out there because you don’t have HIV. What we are worried about is the person who is not taking the medication correctly, who might take it for two days then not take it for five days who is HIV negative and then acquires HIV.

Because they have don’t have enough Truvada in their system, it creates a strain that’s resistant?

It may. If the patient does not know they have become HIV positive and they continue to take the medicine inconsistently, we worry about that HIV strain becoming resistant. In the clinical trials resistance was rare, but as this drug is rolled out to more and more people, there are concerns about the development of a resistant virus.

So Truvada is not a planned activity? I’m going to a circuit party for four days and I know I’m going to be in a hyper-charged sexual environment. I shouldn’t say, “Oh I’m going to take Truvada for five days before I go; I’m going to take it the whole time I’m there and then when I come home I am going to go off of it.”

Right. So, once again, as a member of the medical community, that is worrisome. Most of the time sexual activity is notoriously unpredictable – it can happen at any time therefore if you not taking this medication every day you may not be protected

What I am asking about is planned sexual activity. I know I’m going to a hyper-charged sexual environment; I start (Truvada) the week before I go, come back and stop, because I don’t live in a hyper-charged sexual environment.

I don’t know if there are any studies that have looked at it like that. I imagine that strategy would work, I can’t imagine why it wouldn’t work if you take it far enough in advance and you stop it at least after your risky exposure is over. It probably would work. But once again, what I am worried about is exposures during unplanned sexual activity, so that would be the issue.

OK. I have decided that I’m going to go on Truvada (PrEP). What are the side effects?

The good thing about this medicine is that the short-term side effects are pretty minimal. A small percentage of people get some gastro-intestinal disturbance… nausea or vomiting. It usually gets better after a week or two, but other than that it’s extremely well tolerated. The problems are long-term toxicity, which once again are relatively rare, but there are definitely some people who can get kidney dysfunction or bone loss due to long-term use of Truvada.

Which is true of diabetic drugs.

Correct. But there is no drug to treat anything that does not have potential side effects. When somebody comes in to see me I have to weigh the benefits versus the risk. And the side effects are part of the risks.

This is the first drug that is a true prophylactic. I’m going to go on this drug regimen to prevent something I do not have.

That’s right. It’s a preventative medicine; you are not treating a disease. A patient may be on it long-term, especially if their risk for acquisition is present for a while. The two major risks are, as I mentioned, kidney dysfunction and No. 2 is bone loss leading to osteoporosis. The good thing is in most young men the risk for kidney dysfunction and the risk for osteoporosis is very low.

This is a major decision. We were just talking about long-term toxicity but we don’t have studies that have looked at it for that long.

Well we do. We’ve used the components of Truvada for HIV infection for years. These drugs have been available for at least 13 years.

So you’re saying the maximum would be the toxicity you would experience with an HIV cocktail that has been in use for many years?

Correct.

So it could be less toxicity because you are only taking the one drug?

Correct. We are talking about healthy people. A lot of patients that are HIV positive have other health issues.

Do you consider Truvada the best way to prevent contracting HIV in today’s environment?

I consider it one way of preventing that. One of the tools we should be using together to prevent HIV infection. If I was at risk for HIV, in one of those five risk categories that we talked about, would I take Truvada? The answer is yes. I would also, once again, try to use condoms as much as I could. Second, I would try to do my best at choosing my partners … I want to say responsibly … but that is kind of a charged word.

That is a charged word. So let’s try this; I’m going to be your 20-year-old son. “Dad, I just heard about this drug Truvada and you know I’m gay. You’re a doctor Dad, what do you think I should do?”

I would say, son, I do think that you should use Truvada. Do you have multiple sexual partners? Even one sexual partner who you aren’t completely sure is monogamous with you, then I think you will have great benefit from taking Truvada. I want you to take it every day. And I want you, as much as you can, to use a condom when you are sexually active.

OK.

And if that doesn’t happen all the time you are still a good person. I’m not going to judge you and you have to do what’s right for you. You are a smart person. I think those are the best ways that you can protect not only yourself but your partner or partners.

I think that really sums it up. Thank you very much Dr. Zweig for the interview and your services to the LGBT community.

Truvada: How to get a prescription?

If you are a sexually active gay male, or a member of one of the five groups recommended to take Truvada or PrEP, and want to take the drug as an additional level of protection against contracting HIV, here is the process:

Contact your primary care physician

Your primary care physician has the ability to prescribe you Truvada. Unfortunately, many physicians are not educated about the drug and its benefits to HIV- patients. If your doctor is not familiar with Truvada or refuses to prescribe the drug, ask for a referral to an HIV specialist within your provider network, or seek out an HIV specialist on your own within your provider network. The HIV specialist should provide you with the requested prescription.

How can I drive my physician to make a referral to an HIV specialist if he does not want to prescribe Truvada or PrEP?

If your doctor is giving you trouble about making a referral, you are probably with the wrong doctor. Your doctor should be cognizant of the fact that you believe you are at risk for contracting HIV and should honor your request for a referral to an HIV specialist. If not, it may be time to change doctors.

I don’t feel comfortable discussing my desire to take Truvada with my primary care doctor, is there another option?

Yes. You can make an appointment with another doctor that specializes in HIV medicine or at the AIDS Healthcare Foundation. However, if the appointment is not in your provider network or requires a referral from your primary care physician, you may need to cover the cost of the doctor visit out of pocket. Dependent upon your insurance plan you may not be able to see a physician out of network at all. Before making an appointment, verify that your insurance company will pay for the visit, or if not, what that potential out of pocket expense will be.

Call the AIDS Healthcare Foundation to make an appointment to get a prescription or contact The San Diego LGBT Center or Family Health Centers of San Diego for additional HIV prevention resources.

Once I get a prescription for Truvada, does every pharmacy carry the drug?

Yes. However, pharmacies that specialize in HIV care will most likely have the staff available to help you navigate the special programs available to cover co-pays and minimize the cost to you. For example, the AIDS Healthcare Foundation in Hillcrest helps people understand their insurance options. There are also other pharmacies specializing in HIV healthcare and prescriptions in the city.

Truvada: How to pay for your prescription?

Once a person decides to take a regimen of Truvada, the next questions are often how much does it cost and how will I pay for it? San Diego LGBT Weekly interviewed Brandon Patchett, pharmacist at AIDS Healthcare Foundation in Hillcrest to get answers to these common questions. Please read all of the answers; the net message is the drug can be very affordable for the average person with insurance and for those who take advantage of the programs offered to help pay for the drug.

San Diego LGBT Weekly: I‘ve read that most insurance companies cover the drug including Medicaid, is that true?

Brandon Patchett: Since Truvada is a widely used medication used to treat HIV, all insurance companies have it included in their medication formulary and it is covered. In some cases, special paperwork or authorization may be needed for the drug to be used as pre-exposure prophylaxis (PrEP).

Brandon, how much is the net cost for Truvada? Meaning what will the average person pay per month?

The universally recognized price for Truvada is $1,539.90 for 30 tablets. A client with insurance would pay a fraction of this cost, some who qualify for manufacturer programs may pay next to nothing. A cash paying client without insurance coverage would pay a price for Truvada somewhere close to this figure. The final out of pocket cost is variable from pharmacy to pharmacy depending on the actual acquisition cost the pharmacy has negotiated with its individual drug wholesaler.

What about the copay for those with insurance, is it really expensive?

With insurance coverage, the majority of the cost of Truvada is covered by the insurance plan. The client is responsible for a copayment that is different from plan to plan. Truvada is often in a higher copay tier since it is classified as a

specialty medication so check with your insurance plan before filling your prescription.

What is required to qualify for the manufacturer of Truvada, Gilead Sciences, Copay Coupon Program that covers a person’s co-pay? Are you saying that under the program a person taking Truvada can pay nothing?

Gilead Sciences, the manufacturer of Truvada, offers a Copay Coupon Card that will provide up to $300 of coverage for insurance copayments. Any routine copayment that is $300 or less, will be covered in full by the Copay Coupon Card, leaving $0.00 out of pocket cost. To qualify for the Copay Coupon Program, you must have insurance coverage to help with your prescription costs and it cannot be a government provided insurance plan. Individuals with Medicare, Medi-Cal, or Tricare prescription coverage (among others) are not eligible for the Copay Coupon.

What about those who do not have insurance, how do they pay for Truvada? Gilead Sciences provides a Truvada for PrEP Medication Assistance program that may provide medication to an uninsured client at no cost. There are specific qualifications for this program that can be found at http://www.gilead.com/responsibility/us-patient-access

If a client does not have insurance and does not qualify for PrEP Medication Assistance, the client must pay the full cash price for Truvada.

AIDS Healthcare Foundation offers a free service to help people figure out how to pay for Truvada, correct?

The pharmacists at AHF help with any insurance authorizations that may be required for Truvada coverage, and help to identify and enroll clients into the proper copay assistance programs to minimize out of pocket costs.

So anyone can get their prescription filled at AIDS Healthcare Foundation?

AIDS Healthcare Foundation is a not for profit entity and 96 cents of every dollar earned goes back to support HIV treatment and programs throughout the world. Anyone may get their prescriptions filled at AHF and by doing so you are helping to support the HIV community and treatment programs all over the world.

Resources

AIDS Healthcare Foundation

3940 4th Ave., Ste.140

619-516-8920

freeSTDcheck.org

The San Diego LGBT Community Center

3909 Centre St.

619-692-2077

thecentersd.org/programs/hiv-services

Family Health Centers of San Diego

3544 30th St.

619-876-4462

fhcsd.org