News (Updated August
14, 2011)
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Wed, Aug 10 2011
WASHINGTON (Reuters) -
Regulators approved a once-daily HIV pill by Gilead Sciences Inc, giving a new
source of revenue to the leading maker of HIV medicines as it faces expiring
patents.
The Food and Drug
Administration on Wednesday gave a nod to the pill Complera for patients who
have not received prior treatment for the virus that causes AIDS. The
$1,705-a-month drug combines
Gilead currently sells
another once-daily pill, Atripla, that combines Truvada with Bristol-Myers
Squibb Co's Sustiva, but the
Under the deal with
J&J,
The company's sales of
AIDS drugs have benefited from new
Shares of
Also on Wednesday, the
company said it has resolved all issues raised in an FDA warning letter from
September. The FDA at the time raised concerns about manufacturing problems and
product quality at a
Now, the company's
response and actions have "sufficiently addressed" FDA's concerns,
Gilead last month became
the first drugmaker to sign up for a new patent pool, where it plans to share
intellectual property rights on its medicines with a goal of making treatments
more widely available to the poor.
Around 33 million people
worldwide have the human immunodeficiency virus, HIV, that causes AIDS, most
living in Africa and
(Reporting by Alina
Selyukh and Anna Yukhananov; editing by Andre Grenon and Carol Bishopric)
13 Aug 2011
The start of a Phase IIb proof- of-concept efficacy trial of a new
investigational tuberculosis (TB) vaccine that involves people living with the
human immunodeficiency virus (HIV) was announced by Aeras and the
Oxford-Emergent Tuberculosis Consortium (OETC).
The trial, funded and supported primarily from the European and Developing
Countries Clinical Trials Partnership (EDCTP) will be carried out at research
sites in Senegal and South Africa and is the first proof-of-concept efficacy
trial in people infected with HIV using MVA85A, which is being developed by OETC
(a joint venture between the University of Oxford and Emergent BioSolutions) and
Aeras.
TB is the second highest infectious disease killer worldwide and the main cause
of death for people infected with HIV. Researchers anticipate that the trial
will provide important safety, immunogenicity and efficacy data about this
vaccine.
The study will be directed by the UK Medical Research Council in The Gambia,
Aeras, and the University of Oxford and carried out at two sites by the
University of Cape Town (UCT) Institute of Infectious Disease and Molecular
Medicine in Khayelitsha, South Africa and Laboratoire de Bacteriologie-Virologie
du Centre Hospitalier Universitaire Aristide Le Dantec in Dakar, Senegal in
which approximately 1,400 HIV positive adults aged 18-50 will be tested with the
vaccine.
The trial is the second phase of the first proof-of-concept clinical trial of
the same candidate TB vaccine, which recently reached full enrollment with
almost 3,000 infant participants in
Following a recent visit to a clinical trial site of this vaccine candidate in
infants in
"Clinical trials of
new vaccines against tuberculosis must be an urgent priority on our agenda, as
too many lives are lost to TB, especially among people living with HIV. I am
anxious to see a new TB vaccine licensed, and I am proud that European Union
Member States are investing in this critically-important work."
Professor Charles Mgone, Executive Director of EDCTP, added:
"The TB and HIV
co-epidemic is devastating, requiring a concerted global response. EDCTP in
partnership with Aeras, Oxford-Emergent Tuberculosis Consortium and others is
committed to accelerate research and development of this promising vaccine
against tuberculosis by co-financing the clinical trial as an essential part in
its evaluation."
Tuberculosis claims 1.7 million lives per year with over two billion people
infected worldwide, which relates to approximately one in three people on the
planet.
HIV-positive people who live in countries with a high occurrence of TB are 20
times more likely to contract TB than those who are HIV-negative. According to
the World Health Organization (WHO), 2008 registered an estimated 1.4 million
new cases of TB among HIV-positive people, with TB being responsible for 23
percent of AIDS-related deaths.
The only vaccine currently-licensed against TB, the Bacille Calmette-Guérin (BCG)
vaccine is ineffective in preventing adult pulmonary TB, which is the most
common form of the disease.
Jim Connolly, President and Chief Executive Officer of Aeras, the trial sponsor,
said:
"A new, more
effective TB vaccine would be game-changing in international efforts to
eliminate TB globally by 2050. Studies have already shown that this promising
vaccine has an acceptable safety profile and stimulates strong immune responses
in HIV-infected individuals."
Medicines Control Council of South Africa, the South African Department of
Health, and the Comité National d'Ethique pour la Recherche en Santé (CNERS)
in
Fuad El-Hibri, Chairman and Chief Executive Officer of Emergent BioSolutions
said:
"Together with our
partners, Emergent BioSolutions is proud to be leading the development of a new
vaccine to defeat TB, one of the world's deadliest infectious diseases. This
trial is particularly critical because of its focus on adults living with HIV.
If we are successful, MVA85A will help make the dream of a world free from TB a
reality."
Dr. Helen McShane, a Wellcome Trust Senior Clinical Research Fellow at the
"It is great to see
the vaccine candidate we initially developed at
Written by
Copyright: Medical News Today
12 Aug 2011
The review of a major national population HIV study has found that the HIV
infection rate among low-income heterosexuals in 24 American cities with a high
prevalence of AIDS is 10 to 20 times greater than in the general
The link between high HIV rates and low socioeconomic status couldn't be
attributed to factors typically associated with HIV infection risk in
heterosexuals such as crack cocaine use, being diagnosed with a sexually
transmitted disease, or having an exchange sex partner.
While major racial disparities are a feature of the HIV/AIDS epidemic in the
The U.S. Centers for Disease Control and Prevention surveys persons in selected
metropolitan statistical areas (MSAs), using the National HIV Behavioral
Surveillance System (NHBS). This report summarizes data collected from
heterosexuals in 24 MSAs with a high prevalence of acquired immunodeficiency
syndrome (AIDS) that participated in NHBS during 2006 and 2007.
NHBS is an annual cross-sectional survey of three populations at high risk for
HIV infection: men who have sex with men (MSM), injection-drug users (IDUs), and
heterosexuals at increased risk for HIV infection. Data are collected in annual
cycles from one risk group per year, with each population surveyed once every 3
years.
Twenty-five MSAs with high AIDS prevalence were selected for the survey. In each
MSA, NHBS project staff members recruited participants using either
respondent-driven sampling (15 MSAs) or venue-based sampling (10 MSAs).
Recruitment efforts targeted residents of census tracts with high rates of
poverty and HIV diagnoses, referred to as high-risk areas. For respondent-driven
sampling, a small number of initial participants were recruited by project staff
members or referred by community-based organizations. Initial and subsequent
participants who lived in high-risk areas were then asked to recruit up to five
other persons using a coded coupon to track their referrals. Recruitment
continued for multiple waves of peer referral.
In summary, of 14,837 heterosexuals aged 18 to 50 years who were interviewed and
tested, 2% were HIV infected. HIV prevalence was higher among those with lower
socioeconomic status (SES). For example, HIV prevalence was 2.8% among
participants with less than a high school education compared with 1.2% among
those with more than a high school education, 2.6% among participants who were
unemployed compared with 1.0% among those who were employed, and 2.3% among
participants with annual household incomes at or below the poverty level
compared with 1% among those with incomes above the poverty level.
As mentioned above, this association between HIV prevalence and SES could not be
attributed to factors commonly associated with HIV infection risk in
heterosexuals, such as using crack cocaine, exchanging sex for things such as
money or drugs, or being diagnosed with a sexually transmitted disease (STD).
Based on the association observed between HIV prevalence and SES, HIV prevention
activities targeted at heterosexuals in urban areas with high AIDS prevalence
should be focused on those with lower SES.
Based on their findings, the CDC authors recommended that HIV prevention
programs aimed at heterosexuals should focus on those in low-income areas.
Written by Sy Kraft
Copyright: Medical News Today