[Ip-health] Don McNeil in the New York Times: Advocating Pill, U.S. Signals Shift to Prevent AIDS

Thiru Balasubramaniam thiru at keionline.org
Wed May 14 21:36:52 PDT 2014


HEALTH <http://www.nytimes.com/pages/health/index.html>Advocating Pill,
U.S. Signals Shift to Prevent AIDS

14, 2014

Federal health officials recommended Wednesday that hundreds of thousands
of Americans at risk for AIDS take a daily pill that has been shown to
prevent infection with the virus that causes it.

If broadly followed, the advice could transform AIDS prevention in the
United States — from reliance on condoms, which are effective but unpopular
with many men, to a regimen that relies on an antiretroviral drug.

It would mean a 50-fold increase in the number of prescriptions for the
drug,Truvada <http://www.truvada.com/> — to 500,000 a year from fewer than
10,000. The drug costs $13,000 a year, and most insurers already cover it.

The guidelines tell doctors to consider the drug regimen, called PrEP, for
pre-exposure prophylaxis, for gay men who have sex without condoms;
heterosexuals with high-risk partners such as drug injectors or male
bisexuals who have unprotected sex; patients who regularly have sex with
anyone they know is infected; and anyone who shares needles or injects

Officials at the Centers for Disease Control and Prevention have long been
frustrated that the number of H.I.V. infections in the United States has
barely changed in a decade, stubbornly holding at 50,000 a year, despite 30
years of official advice to rely on condoms to block transmission.

Although there is no guarantee that gay men will adopt the drug regimen,
federal officials say something must be done because condom use is going
down. In a C.D.C.
November, the number of gay men reporting recent unprotected sex rose
nearly 20 percent<http://www.nytimes.com/2013/11/28/health/unprotected-sex-among-gay-men-on-the-rise-health-officials-say.html>
2005 to 2011.

Nevertheless, advocates for the drug regimen were elated at Wednesday’s

“This is wonderful,” said Damon L. Jacobs, a therapist in Manhattan who is
HIV negative, has been on the regimen since 2011 and runs a Facebook page
promoting it. “When an institution like the C.D.C. makes a statement, it
makes a profound difference to the doctors who are ambivalent.”

Dr. Jonathan Mermin, director of the C.D.C.’s national center for AIDS and
other sexually transmitted diseases, said the new guidelines should save
many lives.

“On average, it takes a decade for a scientific breakthrough to be
adopted,” he said. “We hope we can shorten that time frame and increase
people’s survival.”

While many antiretroviral drugs could in theory be used for the drug
regimen, the only pill approved for that purpose by the Food and Drug
Administration is Truvada, made by Gilead Sciences.

Truvada, a mix of tenofovir and emtricitabine, is considered relatively
safe with few side effects. Generic versions are made in India, and it has
become the backbone of AIDS treatment in poor countries.

Common side effects include headache, stomach pain and weight loss. Rare
but serious ones include liver and kidney damage.

Officially, the C.D.C. is endorsing the drug regimen only in conjunction
with condoms. But health officials say they know that some people will stop
using them. Many gay men, including Mr. Jacobs, report doing just that.

That raises their risk of contracting other diseases, like syphilis and
gonorrhea. But health officials argue that the benefits of taking the drug
regimen outweigh the risks.

“Making the perfect the enemy of the good is something we’ve got to get
over,” said Dr. Anthony S. Fauci, director of the National Institute of
Allergy and Infectious Diseases and the country’s best-known AIDS doctor.
“I strongly support the C.D.C. doing this.”

Syphilis and gonorrhea can usually be cured with antibiotics, but H.I.V.
lasts for life and is fatal if left untreated. Even those treated properly
often develop early heart disease and other problems.

Since 2010, three separate studies using Truvada have shown that when taken
daily it can vastly reduce the chances of infection. That held true forgay
men <http://www.nejm.org/doi/full/10.1056/NEJMoa1011205>, heterosexual
couples <http://www.nejm.org/doi/pdf/10.1056/NEJMoa1108524> and drug
In the study of gay men, known as iPrEx, men whose blood tests showed they
had taken their pill every day were 99 percent protected.

The new guidelines say patients should have an H.I.V. test before starting
the regimen, to make sure they are not already infected. (Prophylaxis
involves doses of two drugs, but anyone with the disease should be on
triple therapy.)

Patients should be retested every three months to be sure that they are
still H.I.V. negative, that they are not developing side effects from the
drug and that they have not caught any other sexually transmitted diseases.

While many AIDS specialists endorse the drug regimen, it has not caught on
among doctors as a whole.

A survey<http://www.aidsmap.com/Widespread-support-for-HIV-PrEP-among-infectious-disease-doctors-in-the-US-and-Canada/page/2810626/>
1,175 infectious disease specialists in the United States and Canada
published in December showed that 74 percent supported it, but only 9
percent had actually prescribed it.

“There’s a lot of inertia among doctors, and a strong statement from the
C.D.C. will be pretty valuable for overcoming that,” said Dr. Demetre C.
Daskalakis, an AIDS specialist at Mount Sinai Hospital in New York who has
many patients on the regimen.

Also, the drug regimen has not caught on among gay men, who are by far the
largest risk group.

By analyzing pharmacy databases, Gilead has tried to track how many Truvada
prescriptions are for the drug regimen, rather than AIDS treatment. As of
last September, the company said, it knew of only 2,319 — of which 49
percent were for women.

Advocates said there were several reasons there had been little clamor for
the drug regimen. First, while many doctors prescribe statins as
prophylaxis against heart attacks, for example, only AIDS specialists are
likely to prescribe AIDS drugs as prophylaxis. But uninfected gay men have
no reason to see AIDS specialists, and usually see general practitioners if
they see doctors at all.

Also, Truvada is expensive. However, private insurers and state Medicaid
programs have thus far generally covered such prescriptions, and Gilead has
a program covering co-pays and giving Truvada to the uninsured.

“In my experience, it’s a simple process to get the meds approved,” Dr.
Daskalakis said.

Another reason is that Gilead does not advertise Truvada for prophylaxis,
even though the F.D.A. approved it for that use in 2012 and Gilead does
advertise it for treatment, for which it was approved in 2004.

A company spokeswoman said it had no plans to do so, but it does make
grants to gay organizations that espouse the drug regimen.

Not advertising helps Gilead avoid controversy.

Michael Weinstein, president of the AIDS Healthcare Foundation, has called
Truvada a “party drug” and argued that the drug regimen would encourage men
to avoid condoms and thus increase the infection rate. He called the
release of the guidelines “a shameful chapter in the history of the C.D.C.”

That debate has played out on gay websites, where men favoring the drug
regimen are often stigmatized as “Truvada whores.” (The term was coined in
a 2012 Huffington Post
author has since publicly

“People are reacting out of fear,” Mr. Jacobs said. “Gay men who embraced
the condom message and survived the trauma of 30 years ago have PTSD. This
is a paradigm shift, and people don’t like change.”

Recently, a lash against the backlash has emerged, with a few men
“Truvada Whore”
just as others proudly wear “Queer” or “H.I.V. Positive” ones.

Adam Zeboski, a test counselor for the San Francisco AIDS Foundation, makes
and sells “Truvada Whore” T-shirts to raise money for the foundation.

“People are both very supportive and very offended,” he said. “By
reclaiming the ‘Truvada Whore’ term, we’re taking the power away from those
who use it against us.”

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