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Drug combo, with condoms, prevents HIV

Knoxville News-Sentinel (TN) - 11/13/2015

Nov. 13--It's been more than three years since the FDA approved a daily pill for HIV prevention that, when taken correctly and used with condoms, is close to 100 percent effective at stopping HIV transmission.

A year and a half ago, the national Centers for Disease Control and Prevention amended its recommendations to say people at high risk of getting HIV should take the medication.

So what's preventing its widespread use in East Tennessee?

To start with, many patients and providers don't know it's available, said Dr. Carolyn Wester, medical director for the HIV/STDs section of the Tennessee Department of Health.

"The CDC has done a wonderful job of making the protocol very simple," Webster said. "It's a matter of getting the word out there."

The use of drugs for Pre-Exposure Prophylaxis -- more commonly called "PrEP" -- isn't new. Right now, several clinical trials are looking at drugs that might be used to prevent HIV transmission, but so far the only one approved for PrEP is Gilead Sciences' Truvada, a combination of the drugs tenofovir and emtricitabine that studies show prevents the HIV-1 virus, the most common strain here, from replicating and "taking hold" in the body.

Already used to treat HIV patients, the drug combination has few side effects. Nausea and diarrhea typically go away after the first few weeks; in rare instances, patients can have neuropathy or kidney problems.

In tightly controlled studies with subjects who took the drug at the same time every day, Truvada was more than 92 percent effective at preventing HIV transmission. Condoms alone are about 86 percent effective against HIV transmission. PrEP and condoms used together reduce the risk to virtually nil, and condoms protect against other sexually transmitted diseases -- gonorrhea, syphilis and chlamydia -- that PrEP doesn't touch, as well as preventing pregnancy.

The CDC recommends PrEP for people in a relationship where one partner is HIV-positive and the other is negative; men who have sex with men who are not in monogamous relationships; and IV drug users. That last group poses problems because, in order for PrEP to work, it must be taken daily, long term, which some people with drug addictions may not be able to manage. People who don't take the drug correctly don't seem to build up a resistance, but efficacy drops to about 42 percent or lower.

Ernie Hoskins, director of Positively Living's ACT HIV education program, said access to care is an issue. Though the drug is expensive -- $1,500 a month -- most insurers will cover it, and Gilead has a patient assistance program for the uninsured. But those who take it require labwork every three months, to check HIV status and kidney function, and some candidates can't afford the doctor bills, Hoskins said.

"It's quite a bit of money for someone who doesn't have a lot of money," he said.

Hoskins himself began taking PrEP last month, so he could experience firsthand any side effects (so far, he's had none) or issues getting the drug (the chain pharmacy where he filled his first 90-day prescription hadn't heard of PrEP but filled his after calling the parent company).

Hoskins and Dr. John Law, who practices with Summit Medical Group's Farragut Family Practice, are among those looking for a solution for labwork for uninsured patients who want PrEP.

Law, who began prescribing PrEP earlier this year, said it costs much more to treat patients who do get infected with HIV -- not to mention the devastating effects of the virus. New infections are most common among men in their 20s and 30s "who didn't live though the 'horror years' of AIDS and consequently see their friends that are positive living normal lives," he said. "They're thinking of it as a chronic illness, much like diabetes or high blood pressure, and they don't see the end phase."

Law said he sees some patients who plan to take PrEP "indefinitely," others who want to take it while dating, until they enter a permanent, monogamous relationship. He makes it clear PrEP is a commitment, "not something you use just before you go out on a date."

Lori Gibbs, resource specialist for the Hope Center, said compliance is the biggest issue for people using PrEP. Second is that the drug might give them a "false sense of security" they take as license to engage in risky behavior, or forgo condoms. The United States sees 50,000 new HIV infections annually, and many people infect others before learning they have HIV.

"We don't yet have the counseling (in this area) that's needed for clients before they go on PrEP," said Gibbs, who's planning training sessions for local providers and PrEP candidates. "Nobody needs to hail (PrEP) as a miracle. It's not. It's another way to prevent HIV. But you need to use all the tools in your toolbox to protect you."


What is PrEP? A combination pill of two drugs, taken daily, long-term to prevent HIV transmission

Who should take PrEP? People able to commit to taking the drug daily, who are HIV-negative and in a relationship with someone who is HIV-positive; men who have sex with men; and IV drug users.

What is involved? An initial visit and bloodwork, then bloodwork every three months.

How do you get PrEP? Talk to your primary-care physician, or to your HIV-positive partner's physician. Locally, Dr. John Law at Farragut Primary Practice (865-675-1953; and Planned Parenthood (865-694-7155; see PrEP patients.


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