Truvada (emtricitabine and tenofovir disoproxil fumarate),
manufactured by Gilead Sciences, is the first drug approved to reduce
the risk of HIV infection. In a pre-exposure prophylaxis, or PrEP,
regimen, HIV-negative people who are at high risk may take a daily dose
of Truvada, which has been proven to lower their infection risk if they
are exposed to the virus.
PrEP treatment is meant to be employed
alongside other prevention methods, such as safer sex practices,
risk-reduction counseling, and regular HIV testing.
In giving the
green light to Truvada on July 16, 2012, FDA Commissioner Dr. Margaret
A. Hamburg said, "Every year, about 50,000 U.S. adults and adolescents
are diagnosed with HIV infection, despite the availability of prevention
methods and strategies to educate, test, and care for people living
with the disease. New treatments as well as prevention methods are
needed to fight the HIV epidemic in this country."
See the Infographic: Truvada PrEP for Men Who Sleep with Men
A Work in Progress
Dr.
Kenneth Mayer, a visiting professor at Harvard Medical School and the
medical research director at Boston’s Fenway Institute (a research
center dedicated to providing medical services to LGBT communities),
expressed a favorable opinion about Truvada for HIV prevention—while
emphasizing that the drug’s use for this purpose is in its infancy.
“It
has potential to help people,” he told Healthline. “Several randomized
control trials show that it decreases HIV incidence, but it’s not a
simple matter. It’s in its early days, and it’s very analogous to the
early days of hormonal contraception. The initial hormonal contraception
was only progestin. It was a very high dose, and that had more side
effects … people got smarter about how to give it less frequently and to
modulate the chemicals.”
In trials, Truvada has proved, overall,
to be safe and well tolerated, though a small minority of people did
show some side effects. And many medical experts and HIV experts have
raised serious concerns about the ability of high-risk patients to
consistently take a pill every day—if it’s not taken daily, it loses
efficacy, and there are fears that poor adherence to a daily schedule
could lead to HIV infections and Truvada-resistant strains of HIV.
Dr.
Mayer said that it is important for healthcare providers to determine
patients’ motivations and their willingness to be monitored: “It’s not a
vaccine," he explained. "It’s a commitment to taking pills on a regular
basis."
Thomas D. Chiampas, Pharm.D., BCPS, AAHIVP, a clinical
assistant professor and clinical pharmacist at the University of
Illinois College of Pharmacy, was initially skeptical about the use of
Truvada for PrEP. But after reading the results of studies and talking
to preceptors and students, he echoed Dr. Mayer’s sentiments.
“I
do think Truvada for PrEP, when safe for the patient and taken
appropriately with 100 percent medication adherence, does have the
potential to diminish HIV transmission and thus AIDS infections. At our
clinics we only see HIV-positive individuals; therefore, we do not
prescribe Truvada for PrEP," he said. "I do believe more education is
needed about Truvada for PrEP—in particular, appropriate prescribing
duration, assessment of risk factors, assessment of adherence, and lab
monitoring,” he said.
A Numbers Game
According to several
accounts, 1,774 people filled prescriptions for Truvada for PrEP between
January 2011 and March 2013. But while those numbers may seem low, many
others are receiving the medication through ongoing clinical trials.
Get the Inside Story: Q&A with PrEP Patient Michael Rubio
And
at about $13,000 a year, Truvada for PrEP does not come cheap. While
most insurance companies in the U.S. cover Truvada, affordability can be
an issue if a person has a high-copay insurance plan. “For many people,
it’s not necessarily expensive, but it does involve people being
motivated consumers, since a physician might have to get prior approval
with some insurance companies,” said Dr. Mayer.
Education Is Key
There
is some agreement among the medical community that riskier sexual
behavior is on the rise, and that more education about HIV and AIDS
prevention is crucial.
Fenway Health is one of several groups that
have received non-restricted educational and research grants from
Gilead Sciences, according to Dr. Mayer. “We’ve used some of the funding
to convene a conference about best practices in HIV prevention and have
developed some educational materials for people in the community, so
they can be informed consumers. Their goal is not to push people to use
PrEP, but [to let them] know about it. Obviously, it’s not the answer
for some people,” he said.
Fenway has also conducted research on
whether people are starting to use the medication, what people know
about it, and what concerns they have.
One eye-opening finding of
the focus group is that some people are not comfortable talking about
their sexual behavior with their doctors, according to Dr. Mayer.
“This
medication is not something that you would give to everybody,” said Dr.
Mayer. “It is individuals who are having unprotected sexual behavior
with any regularity, particularly if they have a known HIV-infected
partner, who are the key targets for using PrEP. There are a number of
people who said, ‘Well, I wouldn’t be comfortable divulging my behavior
to my doctor, so I don’t know how I would ask for it.’ That was one
concern.”
“The focus group findings also revealed that even though
the drugs’ side effect profile is quite low, some individuals felt that
any risk of any side effect was unacceptable if they were otherwise
healthy,” he added.
What Are the Side Effects?
Acknowledging
that tenofovir has been associated with kidney problems in HIV-infected
people, Dr. Mayer believes that this side effect is not a major
drawback if patients are monitored.
“The kidney problems that
people are monitored for tend to be self-limited. You stop the
medication, and the creatinine [which is evidence of kidney dysfunction]
goes back to normal, so it’s not as if people automatically go into
irreversible kidney failure," Dr. Mayer explained. "But what it means
is, particularly if they have preexisting kidney disease, or, for
example, untreated hypertension for a long time, if they go on the
medication, they need to be carefully monitored. We do kidney function
within a month after people start the medication, and then if it looks
good, we do quarterly monitoring of kidney function. So that’s an
important side effect. It’s uncommon though; it was in the 1 percent to 2
percent range that people had to stop the medication because of kidney
problems in the course of the trials.”
Other side effects reported
in trials include weight loss (2 percent), nausea (2 percent), and
headache (4 percent), according to Fenway Medical.
Complacent Attitudes and Risky Behaviors?
Many
medical professionals agree that the current generation of sexually
active young adults is more complacent about HIV and AIDS than the
generation before it.
For much of the 1980s and early 1990s, the
lack of effective treatments for AIDS made the disease more frightening.
But current therapies are so effective that HIV/AIDS is widely seen as a
manageable health condition, not the death sentence it once was. And
this may lead to young people being lax when it comes to safe sex
practices.
Dr. Mayer explains, “Young people may feel invulnerable
and the epidemic may be quieter for them, because they don’t know
people with AIDS. Years ago, the drugs had more side effects and people
were sicker. In many cities, you could spot people that you had the
sense might have AIDS … and that’s not the case anymore.”
As such,
one major concern for medical professionals is whether using Truvada
will lead to riskier sexual practices—and thereby increase people’s risk
for other STDs.
Maurizio Bonacini, M.D., is an associate clinical
professor at the University of California, San Francisco, and the
director of the HIV-Liver program at California Pacific Medical Center.
He is adamantly opposed to Truvada for AIDS prevention: “I found it
appalling that Truvada was approved to prevent HIV. So now we will have
people that have high risk sex taking a tablet with questionable
adherence, and placing themselves at risk for HBV [hepatitis B], HCV
[hepatitis C], HAV [hepatitis A], HSV [herpes simplex virus], HPV [human
papillomavirus], and whatever other acronym that will spell health
trouble,” he said
Fred Mayer, R.Ph., the president of Pharmacists
Planning Service Inc. (PPSI), a California non-profit corporation that
offers a large number of health-awareness programs to promote public
health and education, gave a thumbs-up to Truvada for prevention, but
feels that there is not enough of a promotional push for using the drug
in conjunction with condoms and other safer sex practices.
“I
think any new development in prescription drugs, especially for AIDS, is
great as a consumer advocate," Mayer said. "The only downside I see as a
consumer advocate with a public health pharmacy organization is they
are promoting this drug as an AIDS preventative and should be promoting
this drug with the use of condoms, for prevention of STDs, STIs,
chlamydia, et cetera,” he said.
Chiampas agrees: “People think,
‘OK, it’s a pill I can take.’ But adherence counseling, follow-up for
labs and assessments, pregnancy tests, hepatitis tests, sexually
transmitted diseases, HIV—all of those tests need to be drawn every two
to three months to six months out for safety concerns.”
New Avenues for Education and Counseling
In
terms of public health initiatives, social media presents new
opportunities and new challenges. In the recent past, materials for
people who are at high risk for AIDS were provided at places where they
congregated. “For example, [if] gay men meet in a bar or club, you can
do lot of education, you can have materials in the club—people would
know where to go to recruit people for trials and studies,” said Dr.
Mayer.
But as more and more people are socializing and finding
sexual partners on their handheld devices, outreach can be more
difficult.
“We’ve learned to be creative,” said Dr. Mayer. “The
challenge is that organizations that in the past helped instill a sense
of community… are not as strong anymore, because people are meeting
partners online. On the other hand, with the Internet you can also offer
a lot of education materials and you can educate people in the privacy
of their home. It’s a matter of figuring out creative ways.”
Josh
Robbins, an HIV activist and patient advocate and blogger, has recently
launched a digital LGBT PrEP Guide for HIV Prevention at
I'm Still Josh.
“I fall short of endorsing PrEP because I don’t believe that’s the best
place for our voice,” said Robbins. "What I believe in is giving people
the power to be informed and then to make an educated decision with
their physician or healthcare provider."
Robbins explained, "I’m
not saying PrEP is right for everybody, but I’m not saying you should
ignore PrEP. It is important, maybe, for me to say that, because the FDA
has neither tested nor approved a condom for anal sex. PrEP is the only
FDA-approved prevention method. It is the only one in the arsenal when
we talk about what do we have for the prevention of HIV… as long as you
have an educated discussion with a physician or whoever is the
stakeholder in helping you make a decision, then, whether I agree with
your decision or not, at the end of the day I’m glad that you had that
discussion.”
Chiampas and one of his colleagues are planning to
conduct a survey for general practitioners to see how comfortable they
feel about Truvada. “Our concerns are the appropriate monitoring and
follow-up, as well as counseling," he said.
He added that people
on a PrEP regimen should be seen by a healthcare provider every two to
three months, to be tested for HIV, kidney function, pregnancy, and
other things. “The adherence issue cannot be stressed enough,” he said.
“But when taken with 100 percent adherence, Truvada for PrEP was very
effective in preventing HIV transmission between homosexual,
heterosexual, and injection drug-use populations.”
And all the
experts stress that although PrEP is an effective option, there is no
100 percent guaranteed way to prevent sexually transmitted HIV
infection.
The Future of HIV/AIDS Prevention
Now that the darkest days of the AIDS crisis have passed, what does the future of treatment and prevention of HIV look like?
Dr.
Mayer sees the glass as half full. “We are at an interesting point, a
watershed moment where we have proof-of-concept that treating people
earlier will make them less infectious, and we have proof-of-concept
that for high-risk people, taking medication on a daily basis before and
after high-risk behavior will make them less likely to become infected.
We have new tools in the last few years, but they are not being
implemented as quickly as many of us would like. It is going to take
time. A lot of it is professional education in the media, a lot of it is
public education, continuing the discussion.”
He adds, “None of
us who work in this area think that we are going to necessarily give the
same medication the same way over the next decade. There are a number
of different studies looking at: Can you give less drug? Should you give
different drugs that have different side effect profiles? Can you give
the medication in different ways ... such as gels, vaginal rings, and
injectables? It’s a very interesting time.”
Chiampas sums up the
future in these words: “We think a lot of patients … will be going to
their general family medicine provider and they might say, ‘I’m not
positive, but I’m not in a monogamous relationship, so can I get this
drug?’ or ‘My partner is HIV positive and his provider only deals with
HIV patients, so can I get it through you?’ That’s where a lot of the
education might be targeted.”
Finally, Dr. Mayer points out that
the Centers for Disease Control and Prevention’s (CDC) guidance on the
use of PrEP addresses heterosexual couples as well as women who want to
conceive a child.
“One study in Africa enrolled [HIV-status]
discordant heterosexual couples," he said. "It was quite a large study
with almost 5,000 participants. Part of the package insert and CDC
guidance is for heterosexual couples using this medication. It’s part of
a larger piece. There are also studies that show that people who are
infected who go on treatment become less infectious. The whole idea now
is using antiretrovirals for prevention. Part of this is treating
infected people earlier and working with them to maintain adherence so
they are less likely to transmit."
"The other part of the equation
is to identify the riskiest uninfected people and to offer them PrEP so
they don’t become infected in the first place.”