HIV drugs:

HIV infection is a disease caused by
the human immunodeficiency virus
(HIV). The condition gradually destroys
the immune system, which makes it
harder for the body to fight infections.
AIDS (acquired immune deficiency
syndrome) is the final and most
serious stage of HIV disease, which
causes severe damage to the immune
system.
At the time of diagnosis with HIV, many
people have not experienced any
symptoms.
Acute HIV infection can appear like
infectious mononucleosis, flu, or other
viral illnesses.


GILEAD'S QUAD AND EVIPLERA
In September 2011  Gilead reported
strong phase-three trial results for the
pill popularly known as the "quad"
because it includes four different
components.

Four days later a European regulatory
panel endorsed the use of the
company's Eviplera, a less-
complicated combo drug that the FDA
approved under the name Complera in
August 2011.

Both products lack the strange effects
on the brain that Atripla sometimes
has. But analysts say the quad pill is
more important, because if approved,
it would probably displace Complera.
Trials show Complera works best on
patients with a low viral load, but for
the 40% with a higher viral load it isn't
as effective as Atripla. The quad
seems to work at all load levels.







FDA APPROVES COMPLERA, A
ONCE DAILY, 3 DRUG COMBINATION
FOR HIV
In August 2011 the FDA  granted
approval of Complera, a once-daily, 3-
drug combination for  HIV-infected
patients.

Complera is a single tablet that
contains rilpivirine (Edurant, Janssen
Pharmaceuticals), a nonnucleoside
reverse transcriptase inhibitor (NNRTI),
and tenofovir (Viread, Gilead
Sciences), and emtricitabine (Emtriva,
Gilead Sciences), both nucleoside
reverse transcriptase inhibitors
(NRTIs).

Approval of the combination drug was
based on previously conducted phase
3 randomized studies (ECHO and
THRIVE) of rilpivirine, on which
approval of that drug was based. No
new studies were conducted for
approval of Complera.

A bioequivalence study demonstrated
that the triple-drug tablet achieved the
same blood levels as each of the
drugs administered individually.

The recommended dose of Complera
is 1 tablet, containing emtricitabine 200
mg, rilpivirine 25 mg, and tenofovir 300
mg, once daily, to be taken with food.





TRUVADA: TAKING DAILY PILL
GREATLY REDUCES THE RISK OF
ACQUIRING HIV
Two studies released in July 2011
show AIDS drugs can sharply reduce
the risk of heterosexuals acquiring HIV.

A study examined 4,758 heterosexual
couples in Kenya and Uganda in which
one partner had HIV and the other
didn't. Researchers found those who
received a daily dose of a drug called
tenofovir (viread) had an average of
62% fewer infections than those taking
a placebo, while those who received a
drug combining viread and another
medication, emtricitabine (truvada),
had an average of 73% fewer
infections. The drugs, marketed by
Gilead Sciences Inc. are thought to
work by preventing the virus from
replicating and establishing an
infection.

The study, funded by the Bill and
Melinda Gates Foundation, wasn't
supposed to end until late 2012. But
after reviewing partial results, an
independent data and safety
monitoring board decided  to halt the
trial early because the findings were so
strong.

A separate study led by the U.S.
Centers for Disease Control and
Prevention of 1,200 uninfected
heterosexual men and women in
Botswana found those taking a daily
dose of Truvada reduced their risk of
acquiring HIV by about 63%, compared
with those taking a placebo.

In a move aimed at increasing access
to AIDS drugs world-wide, Gilead said
in July 2011 that it had licensed the
rights to several of its therapies to four
drug makers in India, as well as to an
international organization called the
Medicines Patent Pool, which plans to
license the rights to other companies.
In the U.S., 30-pill bottles of Viread
cost $693.74 and of Truvada cost
$1,074.64. Gilead's deals with Indian
drug makers have cut the cost of its
antiretrovirals to as little as $6.15 a
month, or 21 cents a day in some
countries.

An estimated 56,000 persons acquire
HIV each year in the US, and more
than half of them are gay and bisexual
men.

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HIV DRUGS OVERVIEW

As of early 2011 Gilead Sciences is
still leading the competition for
developing AIDS drugs.

The biotech's Truvada had sales of
$2.5 billion in 2009 and its three-drug
combination pill Atripla that it
developed with Bristol-Myers Squibb  
brought in sales of $2.4 billion.

During the Vienna HIV 2010
conference, Gilead  released results
on different advances including the
success of a vaginal gel that includes
its drug Viread, which is a component
in its three best-selling drugs. The
results of the study, which followed 900
women in South Africa over the last
three years, show that the gel cuts the
chances of acquiring the virus by 39%
when applied before and after sex.

In presentations  made at the
conference, data released showed
Merck's drug Isentress combined with
Abbott Laboratories' Kaletra
suppressed the virus as successfully
as older drugs by Gilead.

The study compared Isentress and
Truvada, when combined with Kaletra,
in the treatment of 206 patients who
hadn’t taken any other drugs for the
virus. Among patients taking Isentress,
83% had undetectable virus levels at
48 weeks, compared with 85% of those
on Truvada.

GlaxoSmithKline and its partner
Shionogi are progressing a new drug
against HIV into final-stage clinical
testing, ramping up competition in a
class of AIDS drugs known as
integrase inhibitors.

The two drug makers said they would
be progressing the experimental
medicine, S/GSK1349572, into Phase
III clinical trials later in 2010, following
promising results from two Phase IIb
studies.

Integrase inhibitors are designed to
block genetic information needed for
the human immunodeficiency virus
(HIV) to reproduce and are seen as an
important new weapon in the fight
against AIDS.

Merck & Co already has an
established integrase inhibitor drug
called Insentress, which sold $752
million in 2010, and Gilead has a rival
product in Phase III testing called
elvitegravir.

But industry analysts believe Glaxo's
next-generation once-daily compound,
which does not require a booster, may
have an edge over rivals, with initial
data suggesting it is highly potent and
has a superior resistance profile.

Success with '572 could signal the re-
emergence of Glaxo as a significant
player to rival Gilead in the HIV
marketplace.






LUBRICANTS USED IN ANAL SEX MAY
MAKE IT EASIER FOR HIV TO BE
TRANSMITTED
The risk of acquiring HIV through
unprotected anal sex is at least 20
times greater than with unprotected
vaginal sex.  
Could the use of lubricants - at least
certain kinds - be another risk factor
among men and women who engage
in  anal intercourse?
Two studies presented at the
International Microbicides Conference
in Pittsburgh, suggest the answer is
yes.

In one study involving nearly 900 men
and women in Baltimore and Los
Angeles, the researchers found that
those who used lubricants were three
times more likely to have rectal
sexually transmitted infections (STIs).
Another study that subjected popular
over-the-counter and mail-order
lubricants to rigorous laboratory tests
discovered that many of the products
were toxic to cells and rectal tissue.

In the United States alone, receptive
anal intercourse is practiced in up to
90 percent of gay and other men who
have sex with men, according to
International Rectal Microbicides
Advocates.  U.S. estimates and
surveys in the United Kingdom indicate
between 10 to 35 percent of
heterosexual women have engaged in
anal sex at least once. Globally,
estimates suggest 5 to 10 percent of
sexually active women are having anal
sex. While condoms are generally
effective for protecting against HIV and
other STIs, most acts of anal sex go
unprotected.

Microbicides - substances applied
topically on the inside of the rectum or
vagina - could potentially help prevent
the rectal transmission of HIV, and
some are being tested in early Phase I
safety studies. Another approach
called oral pre-exposure prophylaxis
(PrEP) involves the use of
antiretroviral drugs to reduce the risk
of HIV in HIV-negative people. A large
Phase III trial of PrEP involving men
who have sex with men in South
America, Africa and the United States
is expected to report results by early
next year. Yet, if either of these
approaches is found effective in
clinical trials, they will do no good if
those most at risk don't use them.



HANDHELD CD4 CELL COUNTER
CD4 cells, one of the white blood cell
types that HIV attacks, serve as a sort
of bellwether for the progression of an
HIV infection. A patient's CD4 cell
values help a physician evaluate if the
patient should be placed on anti-
retrovirals, and help indiciate if the
treatment provided is effective. In other
words, knowing an HIV positive
patient's CD4 cell values is more or
less critical.

The current method of counting CD4
involves flow cytometry, a process
where a big expensive ($50 - 100K+)
machine shoots a laser at a thin
stream of fluid containing cells and
counts them. It works, it's accurate, but
it's expensive and most people in the
developing world don't have access to
such machines.

A new technology, pioneered by
Daktari Diagnostics, a company out of
Arlington, MA, is set to enter clinical
trials in the summer of 2010 and has
promise to provide an inexpensive,
point of care, CD4 cell counting
machine for the developing world. It
works via principles of microfluidics
and has tiny channels that shuttle
small blood samples over detectors.
The detectors at the end of these
channels  make use of an electrical
contact that detects the impedance of
the cell. Impedance is, roughly, a
measurement of the resistance of an
object to the flow of electricity through
it, and cells have unique impedance
fingerprints. CD4 cells, for example,
have a different impedance than red
blood cells. This allows the detector to
determine how many CD4 cells are in
the sample.


ALTERNATIVE: VITAMIN D IMPROVES
T-CELL COUNTS
Some of the most interesting research
involves vitamin D.  Investigators from
Switzerland analyzed 211 HIV-positive
patients to determine their vitamin D
levels in the spring and the fall,
resulting in the highest and lowest
vitamin D levels in their bodies. In HIV-
infected patients, vitamin D
supplementation was shown to improve
T-cell counts and lower death rates
from HIV.

Vitamin D is involved in hundreds of
body processes. Its absence can result
disrupt many vital process leading to a
wide variety of conditions and
diseases, ranging from depression to
breast cancer to diabetes and high
blood pressure.

The study investigators recommend
that all HIV-positive patients routinely
be screened for vitamin-D deficiency
and receive an adequate supply to
reduce their risk for adverse outcomes.