Gilead's Pill Can Stop HIV. So Why Does Almost Nobody Take It?

[Earthnut]

https://finance.yahoo.com/news/gileads-pill-stop-hiv-why-050117837.html

Gilead's Pill Can Stop HIV. So Why Does Almost Nobody Take It?

Bloomberg By Caroline Chen

(Bloomberg) -- Gilead Sciences Inc. may be one of the first drugmakers in history to have people asking why it’s not doing more to pitch its medicine.

Truvada, Gilead’s HIV drug, has been approved since 2004 for people with the virus. In 2012, use was expanded to people without HIV as a way of preventing transmission -- a practice called PrEP, or pre-exposure prophylaxis. Taken daily, it can prevent infections 92 percent of the time, meaning it could drastically reduce new infections in sexually active gay men, among the U.S.’s highest-risk communities.

Thanks to its use in HIV patients, Truvada’s been a financial success, bringing Gilead $1.79 billion in the U.S last year. Yet out of 3.3 U.S. million prescriptions from January 2012 to March 2014, only 3,200 were for prevention.

There are many reasons: Gilead says PrEP isn’t a moneymaker, so the drugmaker doesn’t pitch the medicine to many of the primary care doctors who see healthy, HIV-negative gay men most likely to benefit from Truvada. Patients and advocates say doctors often don’t know about the medicine, and some insurance plans leave patients with copays as high as $1,300, making use by the healthy less affordable.

The result is thousands of people who could significantly lower their HIV risk, yet don’t. Some 50,000 Americans are diagnosed with HIV each year, with the highest rates among young gay males, according to the U.S. Centers for Disease Control and Prevention.

Yet in November, Gilead said that 42 percent of PrEP prescriptions written through March 2014 were for women, and only 7.4 percent were for men younger than 25.

‘Pointing Fingers’

Peter Jirak, a gay, 42-year-old software engineer in Minneapolis, first heard about Truvada on the radio. When he went to his doctor, she told him she’d never prescribed it. He had to go to a specialist to get the medicine.

“There’s a circle of pointing fingers,” said Jim Pickett, director of prevention advocacy and gay men’s health at the AIDS Foundation of Chicago. “HIV specialists are like, ‘I don’t see HIV-negative people,’ and you see a primary care physician, and they say, ‘You need to see a specialist.’”

The drugmaker’s sales force is focused on HIV specialists, not primary care doctors who see healthy people. Gilead “does not view PrEP as a commercial opportunity and is not conducting marketing activities around Truvada as PrEP,” said Cara Miller, a spokeswoman. Instead, the Foster City, California, company supports more than 50 community organizations around the U.S., paying for educational efforts.

Outside the Bubble

Gilead’s funding “is great, and necessary work,” said Pickett. Yet Gilead “reps have access to doctors and nurses who are not in the HIV bubble -- and if they would engage with them around Truvada as PrEP, we’d have a lot more providers aware and educated.”

Truvada interferes with a protein called reverse transcriptase, which is used by HIV-infected cells to make copies of the virus. The high number of female users are possibly married to HIV-positive partners and trying to get pregnant, according to Susan Buchbinder, an epidemiologist at UCSF who works with the San Francisco Department of Public Health. Gilead said prescriptions for men started rising in 2013.

Buchbinder said she’s hopeful that, over time, uptake will increase among men, and that she’s already seeing a substantial rise in prescriptions in San Francisco. Reaching even a fraction of high-risk patients could make a difference. A paper published in the Annals of Internal Medicine predicted that initiating PrEP in 20 percent of men who have sex with men could reduce new U.S. HIV infections by 13 percent.

Affordable?

While Truvada is covered by insurers, it can come with copayments that make it unaffordable compared to condoms. Depending on insurance plan, PrEP can cost as little as $20 a month, or hundreds.

Gilead’s assistance program covers as much as $300 a month, helping 93 percent of participants lower their monthly out of pocket expenses to under $25, according to Miller. The program helped Jirak bring his $140-a-month copay to $0.

“$140 is enough that it would cause me to pause and say, ‘Do I benefit enough from the medicine?’” he said.

Others pay more, especially in the lowest-level plans under the Affordable Care Act, which can feature high up-front costs. David Evans, director of research advocacy at San Francisco-based Project Inform, an advocacy group for people with HIV/AIDS, said that he’s worked with patients who have seen initial bills of $1,300 a month before full coverage kicks in.

Make or Break

Carlos Coronado, a 32-year-old nursing assistant in New York City, said his privately run Medicaid plan wouldn’t cover PrEP. To get the drug, he enrolled in two clinical trials that will give him 18 months’ worth.

After that, his access to the drug will depend on his new insurance. “Copay affordability will make or break my ability to stay on PrEP,” he said in an online message.

Some people seeking Truvada are also facing judgment from doctors.

“The assumption is, if you’re using Truvada to prevent HIV, you’re engaging in fabulous orgies while high on meth,” Jirak said.

He says he’s responsible yet lives in the real world. “Most of us will have some amount of sex without condoms under some circumstances,” he said. “Compliance with condom use requires one think logically and rationally when one is right about to have sex -- when one’s mind is least likely to think logically and rationally.”

Safe Sex

He’s had multiple past partners who are HIV positive. “I am in a relationship. The advantage to Truvada as PrEP is that it allows us to be unconcerned about HIV.”

In a vacuum without a large group of knowledgeable doctors or Gilead’s efforts to do wider education, much of the work has been left to patients and advocates. PrEP Facts, a Facebook group with more than 5,400 members, keeps lists of doctors in major cities known to prescribe the drug.

In the meantime, patients have to teach the rest. Bruce Kleinschmidt, a 62-year-old attorney in Louisville, Kentucky, said his physician had never heard of Truvada. His doctor agreed to prescribe the drug, though he questioned the need for regular lab tests for STDs and to monitor liver function until Kleinschmidt returned with information from the CDC.

Despite all the barriers, many PrEP users say that working through the obstacles is worth it, and having peace of mind is invaluable.

“It’s taken away the worry, when I get an HIV test I don’t have that knot in my stomach or cold sweat waiting for the results to come back,” said John Lee, a 37-year-old retail manager in Nashville, Tennessee.

For Kleinschmidt, the pill brings back memories of now-dead friends he met through decades of pro-bono work with AIDS patients. “I buried so many friends, it’s unbelievable,” he said. “I quit counting at 25.”

In the first weeks after he received his prescription, he had a daily ritual. “I would hold up the pill and think of a dead friend, and say, ‘I’m taking this for you. God, I wish it was around to have helped you.’”

To contact the reporter on this story: Caroline Chen in San Francisco at cchen509@bloomberg.net

To contact the editors responsible for this story: Crayton Harrison at tharrison5@bloomberg.net Drew Armstrong, John Lear

[Walkabout]

since I am in the lowest risk group and must take other meds probably for life , I would not take this and spend my money on supplements I know are keeping my immune system strong. I would not a malaria preventative either unless I lived in a area highly prone to the infection.