Truvada has been approved for 18 months, but few gays are taking it or talking about it. The president of the nation’s largest HIV care provider says that’s because we aren’t interested.

By: David Heitz –

A pill a day to keep HIV away?

It’s true. And it’s unfathomable for some gay men who came of age in era when HIV meant death. For decades, the only way to protect yourself was abstinence or to wrap it up.

That has all changed. Truvada, manufactured by Gilead Sciences, is known as a pre-exposure prophylaxis, or PrEP. Taken once daily, it is highly effective at preventing HIV infection.

According to the U.S. Centers for Disease Control, studies show that people who take the drug once a day, as directed, can significantly reduce their risk of HIV infection. It doesn’t work if it’s not taken every day. Studies show that among men who have sex with men who have detectable levels of medication in their blood, risk of transmission is reduced by more than 90 percent, according to the CDC.

Truvada is a combination of tenofovir disoproxil fumarate plus emtricitabine. Those drugs individually are used to treat people living with HIV, but PrEP is only for people who do not have HIV.

The U.S. Food and Drug Administration approved Truvada about 18 months ago. Still, many gay and bisexual men, and the transgendered, particularly outside urban cities, express surprise when they hear about Truvada.

Paul Lappin, a spokesman for The Project Quad-Cities, said nobody at his organization knows of a single person on it. The Project is located in a metropolitan area of about 500,000 people straddling the Mississippi River running through Iowa and Illinois.

A once daily pill to prevent HIV? And not many people know about it?

 

A powerful PrEP foe

The U.S. Food and Drug Administration approved Truvada after two large clinical trials demonstrated it works.

The National Institute of Health sponsored the first trial, known as iPrEx, in July 2007. It looked at 2,500 gay men and transgender women. It included participants from around the world, including the U.S., Brazil, Peru, Ecuador, Thailand South Africa.

The study showed Truvada worked in reducing infections by 43 percent, overall, when compared to those who received a placebo. Among those at extremely high risk, who reported having unprotected anal sex, Truvada reduced HIV transmission by 58 percent.

It is important to remember that these overall numbers include data from study participants who did not take the medication as directed. Repeated studies have shown that the higher the level of Truvada in the blood, the greater the effectiveness.

Some have argued against the use of PrEP, saying the drug could spawn dangerous, resistant strains of HIV. In the iPrEx study, two people developed drug resistance. However, they already had been infected with the virus and traditional testing before the study did not reveal antibodies. Still, this has raised an alarm. Little is known about the long-term use of the drug, but more studies are under way.

AIDS Healthcare Foundation (AHF), the largest provider of HIV care in the U.S., led the fight against FDA approval of Truvada. The concern was that it would result in people having riskier sex, but so far no studies have demonstrated that.

The FDA requires an HIV test before someone can be given Truvada. Doctors also have been advised to look for flu-like symptoms or anything that could reveal an early, undetectable infection.

But Michael Weinstein, president of AHF, said there is no way to know if doctors really are performing an HIV test before writing a Truvada script, or if they are requiring regular tests during treatment.

The FDA recommends quarterly HIV tests for someone on Truvada in case infection does occur.

Weinstein said he could get behind “any prevention strategy” that showed an effectiveness of 70 to 80 percent. He’d like to see PrEP come in the form of a patch under the skin or a monthly injection so it would have a longer half life for those who forget to take it.

“There are people saying this is an old fogy trying to push this outdated strategy on young gay men,” Weinstein said. “First of all, some things don’t go out of fashion, such as washing your hands to avoid infections in hospitals. Nothing has come out that’s better than that and it’s unlikely there ever will.”

Although studies have shown the drug to be well tolerated, it can lead to kidney problems. Those already suspected of having kidney problems must be closely monitored.

 

Meet Jeremy Dykes

From January 2011 to March 2013, about 1,800 prescriptions were written for PrEP, half of them for women. That number does not include thousands of other people across the U.S. who have taken PrEP in clinical trials. Even before FDA approval, Truvada could be prescribed off-label as PrEP.

That more gay men are not taking PrEP raises many questions. Is it too expensive? Not worthwhile?

HIV Prevention Drug Truvada as PrEP

Source: Dr. Joel Gallant

Dr. Joel Gallant, chairman of the HIV Medicine Association, believes that a lot of gay men just don’t know about the drug.

Jeremy Dykes, 39, lives in Nashville, Tenn. He began taking Truvada about a month ago. So far, he has not experienced any side effects, he said.

Dykes is not a fan of condoms. At the same time, he never thought the day of gay sex without a condom ever would be remotely sensible.

To that end, he enrolled in the HIV vaccine trial at Vanderbilt University. That’s how he learned of Truvada. Initially, when he checked with his insurance company, he learned the drug required “prior approval,” and he didn’t want to jump through hoops. In November, that policy changed, however.

Dykes immediately went to a doctor in Nashville who is well-known for being gay-friendly. Like many gay men, he otherwise was healthy and did not have primary care physician.

The doctor explained the potential side effects of the drug, performed tests for HIV and other STDs, and wrote a 90-day script for Truvada. “He put a ‘diagnosis’ of ‘high risk sexual behavior’ on my chart,” Dykes said.

Dykes gets tested for HIV eight times per year and is screened quarterly for kidney and bone-density issues, which can be side effects of Truvada.

 

Paying for Truvada

Truvada costs about $1,000 per month without insurance, Gallant said. While he mostly sees patients who already have HIV, he has prescribed it to some people as PrEP. None of them have had problems getting their private insurance companies to pay for the medicine, he said. “I’ve never even had to fill out a prior authorization form.”

Even some state Medicaid programs, such as New York, pay for PrEP with prior authorization. Gilead also offers assistance to people who need help paying for PrEP.

“This is a tempest in a teapot,” Weinstein said. “People are saying AHF killed PrEP and that’s why people don’t know about it. Doctors who provide care for gay men are not prescribing it and the gay men are not asking for it.”

If this were a hot new pill on the party circuit, surely many gay men would have heard of it 18 months after its rollout, he argued. “If this were a new recreational drug it would have spread through the grapevine instantly.”

 

Information

Although, not directly related to PrEP, Dr. Gallant disclosed he has previously performed research for Gilead.  Although imstilljosh.com doesn't believe there is a conflict of interest, we wanted readers to be informed.  For more detailed disclosures, click here.

COMPLERA, EMTRIVA, GILEAD, the GILEAD Logo, GSI, HEPSERA, TRUVADA, the TRUVADA Logo, and VIREAD are trademarks of Gilead Sciences, Inc., or its related companies. ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. WALGREENS is the trademark of Walgreen Co. or its subsidiaries. iTUNES and iTUNES logo are trademarks of Apple, Inc. All other marks are the property of their respective owners. Any information found on their websites are not necessarily the view or opinion of imstilljosh.com.

imstilljosh.com's Special Health Section - The LGBT PrEP Guide for HIV Prevention is for informational purposes and should not be considered medical advice, diagnosis or treatment recommendations. more details

HIV BLOG, http://imstilljosh.com, reserves the right to alter, delete, update, or not this section. This information could be out-of-date, so please perform due diligence when linking to this section.  If you choose to link to this section, please use- http://prep.imstilljosh.com. Thank you.