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Turn on course, Gilead markets, HIV drug for prevention

In this Thursday, May 10, 2012 file photo, a doctor holds Truvada pills at her office in San Francisco. (AP Photo/Jeff Chiu)

NEW YORK – Gilead Sciences Inc has started with the commercialization of the HIV treatment with Truvada in a way thousands of consumers already use it – to prevent being infected with the virus that causes AIDS.

The company launched Truvada in the US market in 2004 for the treatment of HIV. In 2012 Gilead won approval to market for prevention after two large, peer-reviewed studies showed that it also was effective in preventing infections in healthy people.

But the company decided against promoting the drug as a preventive treatment, delaying the patient’s lawyers who feared that it might encourage promiscuity and unsafe practices, such as having sex without a condom.

Even without Gilead’s help, many consumers learned Truvada was more than 90 percent effective in the test on the prevention of an HIV infection. In 2014, the U.S. Centers for Disease Control and Prevention recommended as an option for people with a high risk of HIV infection.

As many as 90,000 people in the United States used the drug for prevention or pre-exposure prophylaxis (PrEP), last quarter. That is from 60,000 to 70,000 earlier this year, the company said. Also, use is growing in France, where about 2,000 people have been prescribed Truvada for prevention since January.

In July, the drugmaker began marketing Truvada for PrEP to doctors through professional publications, digital advertising and other channels, including the website PreventHIV.com.

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And this fall, the drugmaker began direct marketing to the consumers, with print ads in publications aimed at the lesbian, gay, bisexual, and transgender community, including Lawyer and SWERV. The plan to rapidly expand to social media and digital.

Gilead said it wants to reach people whose doctors are either unaware or reluctant to prescribe Truvada for prevention.

The marketing is mainly driven by the demand of patients,” said David Piontkowsky, Gilead, vice-president of the HIV Medical Affairs, in an interview.

The attitudes towards Truvada started to change a few years ago as doctors, AIDS activists and potential users saw its effectiveness, he said. The “criticism is now, we don’t say enough.”

Truvada is helping strengthen Gilead, the profit as the sales of the biggest moneymakers treatments for hepatitis C – decline.

The U.S. net product sales of Truvada for the first nine months of 2016 is $1.8 billion, compared with $1.5 billion for the same period in 2015. The company said in the earnings report that profit was the result of price increases and “increase of the use of Truvada for prep.”

“We expect PrEP to continue to be a significant part of Gilead, the growth of HIV going forward, particularly in the united states,” Gilead Chief Operating Officer Kevin Young recently told investors.

The new Truvada campaign is well received, even by those who once against promoting the drug for prevention. They include David Duran, a writer and HIV advocate, who has helped in popularizing the term “Truvada Whore” in a 2012 article about his fear that it would encourage people to have sex without a condom.

Duran began to rethink that related about a year later, in the light of recent research showing that PrEP has helped prevent more cases of HIV, without an increase in other sexually transmitted disease, that suggested people were using condoms.

“I am glad that they are starting to pump money into marketing and awareness,” Duran said. “There is a solid base of people who know about PrEP, but it is still not a subject in the whole country knows.”

GROWTH POTENTIAL

As a preventive measure, the blue Truvada pill is taken once daily. Some persons experience nausea, vomiting and headaches during the first few weeks on the drug.

Users should be tested every three months to ensure that they have no HIV or other sexually transmitted diseases and for the monitoring of the functioning of the kidneys and the bone density.

Some Medicaid programs and most private insurance cover the treatment, which lists for $1,500 per month for a negotiated discounts. With a greater awareness and a favorable coverage for preventive treatments, the number of Americans with Truvada may rise, said the company and in the health care system.

An estimated 50,000 new U.S. HIV infections diagnosed per year.

The CDC estimated in 2015, which is approximately 1.2 million Americans were at substantial risk of HIV infection and can benefit from the PrEP.

That includes men who have sex with men, transgenders and women who have sex with men, partners of people who are HIV positive and intravenous drug users who share needles.

The number of high-risk groups “is much broader than one might think,” said Dr. Jennifer Childs-Roshak, president and CEO of Planned Parenthood League of Massachusetts. “It is not only men with multiple partners. There are a whole range of people who could benefit from it.”

At least 15 patients have gone Truvada for prevention because Planned Parenthood six Massachusetts clinics started offering it this fall. Planned Parenthood of New York City plans to offer for the treatment of 50,000 patients, said Julia Sullivan, an associate director of the quality of the management.

A wider use could also buffer Gilead when Truvada, the only drug currently approved in the United States for the Preparation, will lose patent protection in 2021. Gilead has a successor treatment at work. The once-daily F/TAF (emtricitabine/tenofovir alafenamide) is approved for the treatment of HIV and is under study as a preventive.

“PrEP is indeed an important part of Truvada,” said Leerink ners analyst Geoffrey Porges. “It can certainly keep Truvada relatively flat, but the main question is, when will they show that TAF works for PrEP?”

In the meantime, the concept of taking an HIV medicine to prevent infection, is making a stop in the popular AMERICAN culture. It came in an episode of “Transparent” from Emmy award-winning Amazon series about a family with a transgender parent, if a character was contemplating sex with an HIV-positive partner.

“We were trying to move the conversation to indicate what happens in real life,” said a writer on the show who works under the name Our Lady J. “PrEP is a big part of that conversation. If an HIV positive person, I am struck with the level of ignorance around PrEP.”

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