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May 9, 2010)
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2010-05-07
The new subtype was
detected after the Bureau and the medical experts at the
The Bureau said that
unprotected sex was the major way through which the HIV was transmitted in
The HIV can be divided
into two strains, the HIV-1 and HIV-2, and CRF12_BF is a recombinant subtype of
the virus, which has been found in South America and parts of
Being an international
city, a large number of visitors flock into the city every day, which makes it
unavoidable for foreign virus to be brought into
The Bureau added that it
has closely followed the situations of the patients who contracted the new HIV
subtype, and they have reacted well to the medical treatment like other AIDS
patients.
A total of six AIDS cases
were recorded in the first quarter of this year, two of which were locals,
bringing the total number of such cases to 433 since 1986 when the record was
started.
To curb the spread of the
deadly virus, the government of Macao Special Administrative Region (SAR) has
formed a joint-department committee in 2005 to fight AIDS, and the SAR's
anti-drug law was promulgated in 2009.
Genetic Mutation Allows
Some People to Never Get AIDS
By Daniel J. DeNoon
WebMD Health News
Reviewed by Laura J.
Martin, MD
May 7, 2010 - Harvard/MIT
researchers appear to have solved one of the great mysteries of HIV -- and may
at last be on track to develop an effective AIDS vaccine.
The mystery is why about
one in 200 people infected with HIV -- dubbed "elite controllers" --
never get AIDS. It's long been thought that solving this secret would lead to
the Holy Grail of AIDS research: an effective vaccine.
Now researchers led by
MIT's Arup Chakraborty, PhD, and Harvard's Bruce D. Walker, MD, report that
elite controllers have a rare set of genes that allow their immune systems to
unleash killer T cells with unusual powers. The findings come from an elegant
series of experiments, including study of 1,100 elite controllers and 800 people
with AIDS.
Normal killer T cells work
as a team. It usually takes a swarm of these cells, which recognize different
bits of a virus, to kill virus-infected cells. But this process is too slow to
stop fast-mutating viruses such as HIV. The astonishing ability of HIV to change
its spots via mutation is one reason the normal immune system can't control the
virus.
The killer T cells in
elite controllers don't need help. They knock off virus-infected cells all by
themselves. Moreover, they are "broadly reactive" and can kill off
mutant HIV variants as they arise.
There's a downside to
having broadly reactive killer T cells: They don't always leave normal cells
alone. This makes elite controllers more susceptible to autoimmune diseases.
But there's an upside,
too. Elite controllers aren't just impervious to HIV. They're also protected
against other fast-growing viruses such as hepatitis C virus.
As it turns out, normal
people have a few of these "broadly reactive" killer T cells. A few
may be all that are needed.
"We think they might
be coaxed into action with the right vaccine," Chakraborty says in a news
release.
Once activated and
directed against HIV, these super killers would naturally expand by cloning
themselves in large numbers.
The study drew praise from
Nobel laureate and CalTech researcher David Baltimore, PhD.
"Rarely does one read
a paper that stretches the mind so surprisingly far,"
Chakraborty, Walker, and
colleagues report their findings in the May 5 online issue of the journal
Nature.
The Swiss drug maker has
the option of filing an appeal against the patent office’s decision on Valcyte
with IPAB
Radhieka Pandeya
On Wednesday, the Indian
Patent Office annulled the patent on Valcyte, granted to Swiss drug maker F.
Hoffmann-La Roche Ltd, following opposition by domestic drug makers and patient
groups.
Cipla Ltd, Ranbaxy
Laboratories Ltd, Matrix Laboratories Ltd and Bakul Pharma Ltd, along with
patient groups Indian Network for People Living with HIV/AIDS and Tamil Nadu
Networking People with HIV/AIDS, had challenged the Valcyte patent on technical
grounds.
“Since the object of the
invention is to provide a prodrug of ganciclovir with improved oral
bioavailability, the comparison provided in the specification to show such an
improvement is not scientific,” said S.P. Subramaniyan, patent controller.
A prodrug is biologically
inactive itself, but gets converted into an active drug inside the body.
Bioavailability is the amount of a drug that reaches the systemic circulation in
its original form after administration.
Amar Lulla, chief
executive of Cipla, said the patent office’s decision was fair.
“We are exploring the
legal options,” said a spokesperson for Roche.
In August, Roche reduced
the price of Valcyte by nearly one-third after the government slashed import
duty on it. The medicine became available for Rs475 per tablet, down from Rs700.
But the generic version of Valcyte, launched by Cipla in 2008 under the brand
name Valcept, costs Rs245 a tablet, or Rs64,680 for the entire
treatment—almost half the cost of treatment with Valcyte.
Roche filed patent and
trademark infringement lawsuits in the
“If there is no patent,
they (Roche) cannot fight anything,” said Anand Grover, director of the
Lawyers Collective on HIV/AIDS in
However, Roche has the
option of filing an appeal against the patent office’s decision at the
Intellectual Property Appellate Board (IPAB).
“Since this appears a
well- reasoned and logically coherent decision, the chances of it being
overruled by IPAB are slim,” said Shamnad Basheer, professor in intellectual
property law at National University of Juridical Sciences.
“This decision sends a
strong signal to the world that
radhieka.p@livemint.com
Tue, May 4 2010
WASHINGTON (Reuters) -
The Food and Drug
Administration said on Monday it was probing reports of liver toxicity with
patients who used Kaletra to prevent HIV infection after exposure to the AIDS
virus.
The agency also said it
was investigating cases of male breast cancer in patients treated with Avodart
as well as Merck & Co's prostate drug Proscar and baldness treatment
Propecia.
The FDA releases a
quarterly list of safety probes to inform the public about early investigations
of potential side effects that have been reported. The list released on Monday
covered issues identified between October and December 2009.
Being on the list does not
mean the FDA has concluded the drug causes the specific risk, the agency said.
Abbott spokeswoman
Elizabeth Hoff said the company added information to Kaletra's label last week
noting that patients who took the drug to prevent HIV infection were among those
who should undergo liver monitoring tests.
The label says some
reported cases of liver dysfunction were serious. "However, a definitive
causal relationship with Kaletra therapy has not been established," the
drug label says.
Merck spokeswoman Pam
Eisele said the prescribing instructions for Proscar and Propecia already
mention cases of male breast cancer seen in clinical trials. Both drugs contain
the same active ingredient.
"A causal
relationship has not been established," she said.
Glaxo spokeswoman Sarah
Alspach said the company evaluates all reported cases of breast cancer in men
taking Avodart.
"Based on reports
evaluated to date, there is not conclusive evidence of a causal association
between Avodart and male breast cancer," she said.
The FDA posted the list.
(Reporting by Lisa
Richwine; Editing by Tim Dobbyn; Carol Bishopric)
08 May 2010
Research from the
Kaposi's Sarcoma is a cancer caused by a human herpes virus and is widespread in
sub-Saharan
Researchers from
"This is the first time that the cellular protein, PYM, has been shown to
play a role in virus replication and Kaposi's Sarcoma," explains Dr Adrian
Whitehouse, who led the research. "Our work is still at a very early stage,
but it should in time be possible to design drugs which block the interaction
between PYM and the virus protein, thereby stopping the virus replicating and
hopefully stopping the cancer from developing."
Kaposi's Sarcoma-associated herpesvirus is an opportunistic infection which is
most prevalent amongst people with a weakened immune system, such as those
infected with HIV. Treatment for KS does exist but currently involves
chemotherapy and highly active antiretroviral therapy which is both toxic and
not always effective. Moreover, such combined therapies are only available to a
small percentage of those affected in sub-Saharan
The researchers - funded by the Wellcome Trust and BBSRC - are now looking to
obtain the structure of these two interacting proteins, as the next step towards
designing an anti-viral drug to combat the disease.
Source:
Dr. Adrian Whitehouse
University of
07 May 2010
Dynavax Technologies Corporation (NASDAQ: DVAX) reported completing the first
immunizations of over 2,000 subjects enrolled in its large-scale Phase 3 study
of HEPLISAV™. This starts a 12-month follow-up on these subjects and sets the
study's completion for May 2011. Dynavax said this event supports its goal of a
BLA submission for HEPLISAV in the second half of 2011.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate
is being evaluated in two Phase 3 studies that are directed toward fulfilling
licensure requirements in
About Hepatitis B Vaccines
Currently available hepatitis B vaccines require three doses over six months to
achieve full immunogenicity in healthy patient populations. Because compliance
with this vaccine regimen is low, new vaccines are needed to provide increased
protection with fewer doses in a shorter timeframe. Furthermore, currently
available vaccines do not fully address the needs of several patient
populations, including those with chronic kidney disease, HIV or chronic liver
disease. In particular, patients with compromised immune systems require both
rapid and enhanced protection, either because they are less responsive to
conventional vaccine regimens or because they are at high risk of infection.
Source
Dynavax Technologies Corporation
07 May 2010
URL Pharma, Inc., announced that the U.S. Food and Drug Administration (FDA) has
issued new label information affecting all approved protease inhibitors for
treatment of HIV when co-administered with Colcrys® (colchicine, USP). These
dosing guidelines are intended to avoid potentially fatal drug-drug
interactions.
These new dosing recommendations were issued as a result of several clinical
studies designed and conducted by URL Pharma that uncovered the risk of serious
interactions when colchicine is taken along with certain other prescription
medications. In addition to protease inhibitors, the URL Pharma studies
discovered potentially dangerous interactions between colchicine and certain
hypertension medications and antibiotics. URL Pharma conducted 17 clinical
trials as part of its submissions to the FDA in the 3 New Drug Applications (NDAs)
filed for Colcrys.
"The drug-drug interaction studies we conducted for Colcrys have yielded
new and critically important guidance for physicians on the safe and appropriate
use of colchicine, particularly among special populations, and represent a
significant public health milestone in the treatment of gout," said Matthew
W. Davis, M.D., R.Ph., Chief Medical Officer. "Prior to our work,
scientifically rigorous guidance on dosing colchicine to avoid drug interactions
was virtually non-existent. We urge all healthcare providers to consult the new
labeling for protease inhibitors prior to concomitant use with Colcrys."
New Colcrys Dosing Guidance
The new dosing adjustment covers all approved protease inhibitors for the
treatment of HIV-1 infection, including Lexiva® (fosamprenavir calcium) and
ritonavir.
-- Patients with hepatic or renal impairment: For the prevention or treatment of
gout flares, or for FMF, FDA has recommended against the co-administration of
Colcrys with protease inhibitors.
-- Acute gout flares: The new recommended dosing for the treatment of gout
flares is 0.6 mg (1 tablet) x 1 dose, followed by 0.3 mg (half tablet) 1 hour
later; this dose to be repeated no earlier than 3 days.
For patients taking Lexiva without ritonavir, the suggested dose is 1.2 mg (2
tablets) x 1 dose; this dose is to be repeated no earlier than 3 days.
-- Prophylaxis of Gout Flares: In patients taking Colcrys for the prophylaxis of
gout flares, FDA recommends that if the original colchicine regimen was 0.6 mg
twice a day, the regimen should be adjusted to 0.3 mg once a day. If the
original colchicine regimen was 0.6 mg once a day, the regimen should be
adjusted to 0.3 mg once every other day.
In patients taking Lexiva without ritonavir, FDA recommends that if the original
Colcrys regimen was 0.6 mg twice a day, the regimen should be adjusted to 0.3 mg
twice a day or 0.6 mg once a day. However, if the original Colcrys regimen was
0.6 mg once a day, FDA recommends it be adjusted to 0.3 mg once a day.
-- Familial Mediterranean fever (FMF): In patients with FMF, FDA recommends a
maximum daily dose of Colcrys of 0.6 mg (may be given as 0.3 mg twice a day)
when co-administered with protease inhibitors.
However, in FMF patients taking Lexiva without ritonavir, the maximum daily dose
of Colcrys is recommended to be no more than 1.2 mg (may be given as 0.6 mg
twice a day).
"At URL Pharma, patient safety is our primary concern," said Richard
H. Roberts, M.D., Ph.D., President, Chief Executive Officer and Chairman of URL
Pharma. "This is evidenced by the fact that our rigorous clinical program
for Colcrys discovered these previously unknown drug-drug interactions. Patients
and physicians should feel confident that they are prescribing and using a
thoroughly tested, FDA-approved medication that meets all modern standards of
safety, efficacy, purity, consistency and labeling."
Colcrys received approval from the U.S. Food and Drug Administration (FDA) on
July 30, 2009 for use in treating acute gout flares at the first sign of a
flare, and for the treatment of FMF. Colcrys received FDA approval for the
prophylaxis of gout flares on October 19, 2009. It is the first and only
single-agent colchicine treatment to receive FDA approval.
About Gout and Painful Gout Flares
Gout is a painful form of arthritis that affects an estimated 3 to 5 million
Americans, most commonly adult men. It occurs when excess uric acid in the body
is deposited as needle-like crystals, or tophi, in the joints or soft tissues,
which cause inflammatory arthritis and can lead to gout flares typically lasting
three to 10 days.
Gout flares are characterized by intermittent swelling, redness, heat, joint
stiffness and pain, which are often excruciating and can be debilitating enough
to significantly interfere with work, social activities and daily living. For
many people, gout initially affects the joint of the big toe, though it can also
affect other joint areas such as the ankles, heels, knees, wrists, fingers and
elbows.
Important Safety Information
COLCRYS (colchicine, USP) tablets are indicated for the treatment of acute gout
flares.
COLCRYS is contraindicated in patients with renal or hepatic impairment who are
concurrently prescribed P-gp inhibitors or strong inhibitors of CYP3A4 as
life-threatening or fatal toxicity has been reported. Dose adjustments of
COLCRYS may be required when co-administered with P-gp or CYP3A4 inhibitors. The
most common adverse events in clinical trials for the prophylaxis and treatment
of gout were diarrhea and pharyngolaryngeal pain. Rarely, myelosuppression,
thrombocytopenia, and leukopenia have been reported in patients taking
colchicine. Rhabdomyolysis has been occasionally observed, especially when
colchicine is prescribed in combination with other drugs known to cause this
effect. Monitoring is recommended for patients with a history of blood
dyscrasias or rhabdomyolysis.