HIV prevention drug brings opportunities and challenges

Truvada pills. Photo: Jeffrey Beall.

 

For the first time, AIDS researchers, service providers and willing primary care physicians have an FDA-approved drug to reduce the risk of contracting HIV.

Last Monday the U.S. Food and Drug Administration approved Truvada, a combination tablet of antiretroviral drugs, as a preventative therapy for adults at high risk of becoming HIV-positive.

And so in Chicago and across the country, those at the forefront of prevention and education are developing plans to administer the drug to those who need it most, bringing forward recurring challenges in the fight against HIV like knowing one’s status, equal access to healthcare and condom use.

The Drug

Truvada, a combination of tenofovir and emtricitabine, prevents HIV from altering the genetic material of proteins on the surface of healthy T helper cells, which in turn keeps the cells from producing or replicating the virus. It was previously approved in combination with other antiretrovirals for HIV-positive adults and children over 12.

The drug, to be effective as a preventative measure or pre-exposure prophylaxis (PrEP), must be taken daily. It is indicated by the FDA to be used as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing.

It must only be used by HIV-negative individuals and the FDA says those taking Truvada as PrEP must be tested every three months for as long as they take the drug.

Truvada alone is not sufficient to keep an infected individual’s viral load under control and the FDA wants to mitigate risks of a Truvada-resistant strain of HIV from developing.

Getting Tested

Thus HIV tests will remain the first line of defense in preventing HIV. Jim Pickett, director of prevention advocacy and gay men’s health at the AIDS Foundation of Chicago, said the testing room will be the first stop in the system to identify, support and treat those at high risk of contracting HIV.

“You must know you are HIV-negative to start on Truvada as PrEP,” Pickett said. “Testing will be the first entry point.”

For service providers that offer HIV tests like the Test Positive Aware Network, which provides 3,000 free HIV tests a year, risk reduction counseling sessions will change.

“The counseling session always starts with, ‘Why do you think you might be positive?’ Bill Farrand, CEO of the Test Positive Aware Network, said.

He said in the past when people have reoccurring trouble with condom usage or sharing needles, there wasn’t much test counselors could do. Now there’s another option: a medical referral.

Pickett said the discussion of a pharmaceutical option will be a big shift for people who test negative.

“When people test positive out in a club or in a clinic, they’re not just sent to the wind,” Pickett said. “They’re provided a route, a map, a referral into care so they can get the treatment they need. With negative people, up until now, we have basically said, ‘Great, you’re HIV negative. Good luck. See ya later.’ If you’re positive, the goal is to loop you in for treatment services but if you’re negative, that piece hasn’t happened. HIV-negative people will need to be provided that opportunity to think through PrEP.”

The Doctor Visits

Pickett said the counseling sessions with HIV tests will be the gateway to a system that is still being developed that will administer Truvada. He said that those who want PrEP will need to be provided with care and treatment services that is very similar to what HIV-positive people receive, starting with the basics like regular visits to the doctor.

Kristin Baker, director of clinical operations at Howard Brown Health Center, said Truvada will be incorporated into the official protocol at Howard Brown.

“It’s another tool in our toolbox to engage patients in talking about prevention and safe sex practices,” Baker said. “We’re working to make sure there’s a lot of support with pre- and post-counseling when a patient presents as a candidate for PrEP. It needs to be a multidisciplinary approach.”

Baker said patients will need a baseline HIV test, another test one month out and then continuous test every three months. So interested parties should be ready for regular visits to the clinic.

Prescriptions will not be given past three months.

“The important piece of PrEP will be engaging the patient in not just medical care but also education, the importance of condom use,” Baker said. “This will lead to a successful PrEP program as opposed to just writing a prescription for it.”

Clinical Trials

The best examples of how to administer Truvada can probably be found in a trial under way in Chicago that under the supervision of Dr. Sybil Hosek, a clinical psychologist and HIV researcher at John Stroger Hospital of Cook County. Hosek began to recruit young gay black and Latino men for her study in the fall of 2009 because the early Truvada studies in the United States did not include many young men.

In December of 2010, the first large, global studies on Truvada as PrEP came out showing that the drug worked. At this point her study participants formerly taking the placebo were all offered the drug. Last August, the participants were enrolled in a larger open-label extension to study safety and behavior in the long term.

“Clearly being in a study you’re getting a lot more attention than you would normally get, you’re getting access to more services than you normally would,” Hosek said. “Can this be brought to the real world? We need to figure out the best way to keep people engaged in their health.”

Demonstration studies are now beginning that will study the best way to couple PrEP with other prevention and education measures.

Is It For Me?

While men who have sex with men are generally considered at high risk for HIV, it will only make sense for some. Hosek said Truvada as PrEP is definitely not for everyone. She said it’s an option that must be weighed on an individual basis.

“If you’re a person who is consistently using condoms in your relationship and consistently practicing safe sex all the time and you don’t feel you need an additional method, PrEP is not for you. If you’re somebody that struggles with that and would like an alternative, PrEP might be for you,” Hosek said.

Hosek said taking Truvada as PrEP is a good option for individuals with known HIV-positive partners and those who don’t want to or cannot guarantee their partner will use a condom.

Hosek also stressed that you don’t have to stay on it indefinitely.

“People have to evaluate what their risk is at any given time in their lives,” Hosek said. “We are all in and out of relationships and or in and out of the bar scene or club scene. It all depends on the experiences that you’re having at that particular time. It doesn’t have to be forever. It can be for a risky or experimental point in your life and not later on when you get into a relationship for example.”

The other concern, particularly for young people, is that the pill must be taken daily. Studies show that when people know what they’re taking, adherence has improved.

Cost

Pickett of the AIDS Foundation of Chicago stressed that the key issue is getting Truvada as PrEP to those who need it.

“How do we make sure that those truly at risk, how do we make sure — for instance young, gay black men who are 20 have access to this with the same degree as someone who is established, has full healthcare and insurance?” Pickett said.

How those who need Truvada most will pay for it is still unclear although the Healthcare Reform Act should require insurance companies to pay for it — and some already have been, he said. The FDA approval should also pave the way for public payers to cover it too.

Gilead Sciences, the pharmaceutical company that makes Truvada, has also made promises that the $13,000 per year price tag will not be an impediment for those who cannot afford it, Pickett added.

Condom Use and Safe Sex

“Safe sex” — or sex with a condom — has been the preventative tool against HIV infection since the virus was first isolated in 1983.

And some are worried that Truvada could decrease condom use. The AIDS Healthcare Foundation’s founder and president Michael Weinstein has been a vocal opponent of the approval.

These criticisms are unfounded, Pickett and Hosek said.

“If people are using condoms consistently and correctly now, I’d encourage them to continue doing that. If they work for you, they are great. They are a fantastic tool,” Pickett said. “But If someone is taking Truvada consistently and correctly, then that is safe sex — when we’re talking about HIV. And let’s be very, very clear: Lots of people have made the choice not to use condoms.”

Pickett said many people, both gay and straight, have “left condoms at the door for decades” and studies show Truvada to have a similar rate of efficacy as condoms that are used correctly and consistently.

Many recent headlines have said the drug reduced the risk of HIV infection by 42 percent among HIV-negative men or transgender women who had unprotected sex with multiple partners but for those who had measurable levels of Truvada in their blood, in essence those who took it regularly, the efficacy rate was around 90 percent.

Hosek said that the Truvada PrEP studies have actually shown a decrease in risky behaviors, probably because participants are being regularly tested for HIV and counseled on how to decrease their risk.

The Final Word

“In Chicago we have some very intense hotspots of infection,” said Farrand of TPAN. “It needs to be cautiously provided along with the other prevention things we’re doing, not just as a magic bullet. But for those most at risk or those having the most trouble reducing their risk, it’s a potentially life-saving opportunity. It’s one more weapon in the arsenal. We need to use everything we’ve already been using.”