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 The company introduced Truvada to the U.S. market in 2004 for HIV
treatment. In 2012, Gilead won approval to market it for prevention
after two large, peer-reviewed studies showed it also was effective
at preventing infections in healthy people.
But the company decided against promoting the drug as a preventative
treatment, deferring to patient advocates who feared it could
encourage promiscuity and unsafe practices, such as having sex
without condoms.
Even without Gilead's help, many consumers learned Truvada was more
than 90 percent effective in tests at preventing HIV infection. In
2014, the U.S. Centers for Disease Control and Prevention
recommended it as an option for people at high risk for 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's
up from 60,000 to 70,000 earlier this year, the company said. Usage
also 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.
And this fall, the drugmaker began marketing directly to consumers
with print advertisements in publications geared toward the lesbian,
gay, bisexual and transgender community, including OUT, Advocate and
SWERV. It plans soon to 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 primarily driven by demand by patients," said
David Piontkowsky, Gilead's vice president of HIV Medical Affairs,
in an interview.
Attitudes toward Truvada started to change a couple years ago as
doctors, AIDS activists and potential users saw its effectiveness,
he said. The "criticism now is we're not saying enough."
Truvada is helping bolster Gilead's profits as sales of its biggest
moneymakers – treatments for hepatitis C – decline.
U.S. net product sales of Truvada for the first nine months of 2016
were $1.8 billion compared with $1.5 billion for the same period in
2015. The company said in its earnings report that the gain was
driven by price increases as well as "increased usage of Truvada for
PrEP."
"We expect PrEP to continue to be a significant part of Gilead's
growth in HIV going forward, particularly in the U.S.," Gilead Chief
Operating Officer Kevin Young recently told investors.
The new Truvada campaign has been well received, even by those who
once opposed promoting the drug for prevention. They include David
Duran, a writer and HIV advocate, who helped popularize the term "Truvada
Whore" in a 2012 article describing his fear that it would encourage
people to have sex without condoms.
Duran began rethinking that concern about a year later in light of
newer research showing that PrEP helped prevent more cases of HIV,
without a rise in other sexually transmitted disease, which
suggested people were using condoms.
"I'm thrilled they are starting to pump some money into marketing
and awareness," Duran said. "There is a solid base of folks who know
about PrEP, but it's still not a topic the country as a whole knows
about."
GROWTH POTENTIAL
As a preventive measure, the blue Truvada pill is taken once daily.
Some people experience nausea, vomiting or headaches during the
first few weeks on the drug.
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Users must be tested every three months to ensure they don't have
HIV or other sexually transmitted diseases and to monitor kidney
function and bone density.
Some Medicaid programs and most private insurance cover the
treatment, which lists for $1,500 a month before any negotiated
discounts. With greater awareness and favorable coverage for
preventative treatments, the number of Americans using Truvada could
rise, said the company and healthcare providers.
An estimated 50,000 new U.S. HIV infections are diagnosed each year.
The CDC estimated in 2015 that about 1.2 million Americans were at
substantial risk of HIV infection and could benefit from PrEP.
That includes men who have sex with men, transgender 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 just men with
multiple partners. There are a whole host of folks who could
benefit."
At least 15 patients have gone on Truvada for prevention since
Planned Parenthood's six Massachusetts clinics began offering it
this fall. Planned Parenthood of New York City plans to offer the
treatment to all of its 50,000 patients, said Julia Sullivan,
associate director of quality management.
Wider use also could buffer Gilead when Truvada, the only drug
currently approved in the United States for PrEP, loses patent
protection in 2021. Gilead has a successor treatment in the works.
The once-daily F/TAF (emtricitabine/tenofovir alafenamide) has been
approved for HIV treatment and is under study as a preventative.
"PrEP is indeed a significant part of Truvada," said Leerink
Partners analyst Geoffrey Porges. "It can certainly keep Truvada
relatively flat but the key question is, when will they show that
TAF works for PrEP?"
In the meantime, the concept of taking an HIV drug to prevent
infection is making inroads in popular U.S. culture. It came up in
an episode of "Transparent," the Emmy award-winning Amazon series
about a family with a transgender parent, when a character was
contemplating sex with an HIV-positive partner.
"We were trying to make the conversation reflect 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. As an HIV positive
person, I'm struck with the level of ignorance around PrEP."
(Reporting By Jilian Mincer; Editing by Michele Gershberg and Lisa
Girion)
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