News (Updated
August 3, 2008)
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Published online 30
July 2008 | Nature 454,
564 (2008) | doi:10.1038/454564a
Controversy is surrounding a phase II clinical trial of an HIV vaccine that
began in Italy this month.
Led by Barbara Ensoli of the ISS in Rome, Italy's major health research
laboratory, the trial is testing a vaccine based on a protein called Tat,
which is involved in the replication of HIV.
But critics, including HIV co-discoverer Robert Gallo of the University of
Maryland School of Medicine in Baltimore, argue that the scientific basis for
Ensoli's vaccine is weak. They note that Tat has proved ineffective in animal
models in other labs.
Critics in Italy are also complaining that Ensoli's phase I trial was
insubstantial, and that the government has allocated a disproportionate amount
of money — €21 million (US$33 million) over three years — to the work.
Ensoli says that she expects the phase II trial to be looked on favourably
by an ISS external committee of experts that will meet this winter.
July 28, 2008
Holleypharm has signed an agreement for artemisinin with the William J.
Clinton Foundation, agreeing to lower the price of a leading artemisinin-based
combination therapy for malaria by 30% and reduce the price volatility of
artemisinin, the key raw material for this and other ACTs, by 70%.
According to the agreement, Holleypharm will regularly supply artemisinin
as raw material for other enterprises that have also signed long term
agreements, to ensure that the market price of artemisinin and compound
preparations is in a reasonable range.
The reduced prices will be available to the 69 countries in Africa, Asia,
Latin America and the Caribbean that make up the Clinton HIV/AIDS Initiative
purchasing consortium.
Friday August 1, 9:21 am ET
NEW YORK (AP) -- Biotechnology company Gilead Sciences Inc. said Friday it
plans to begin selling its HIV drug Atripla in 12 countries including Russia,
Mexico and Australia.
Atripla is a daily HIV treatment that combines two Gilead drugs, Viread and
Emtriva, with Bristol-Myers Squibb Co.'s Sustiva.
Merck & Co. distributes the drug in 94 developing countries and
Bristol-Myers sells it in Europe, but under the new agreement, Gilead will
take the primary role in registering and selling the drug in Argentina,
Australia, Chile, Hong Kong, Israel, Mexico, New Zealand, Russia, Taiwan,
Thailand, Turkey and Uruguay.
Gilead and Merck plan to make the drug available as soon as possible in
those countries, and may add other nations to the agreement. They said the new
agreement will make the drug available in a total of 138 countries.
Friday August 1, 9:00 am ET
By Erika Kinetz, AP Business Writer
NEW DELHI (AP) -- Ranbaxy Laboratories Ltd., India's largest pharmaceutical
company, said Friday that the World Health Organization had included another
of its HIV-fighting drugs on its prequalification list.
That brought to 18 the number of Ranbaxy antiretrovirals the WHO has
approved as safe, effective and high quality.
The drug, Abacavir, will be manufactured at the company's WHO-approved
factory in Paonta Sahib, India, the company said in a statement.
The company says its antiretrovirals, or ARVs, have been used by over
500,000 patients in more than 60 countries.
"We are pleased to have one more product on the WHO pre-qualification
list," Ranbaxy CEO Malvinder Mohan Singh said in the statement.
"This is yet another significant step in our effort to offer high
quality, affordable ARV medicines, for the benefit of the needy HIV patients
in the developing and developed parts of the world. We remain committed to
supporting the global fight against HIV/AIDS."
The WHO list of prequalified drugs for HIV/AIDS, malaria, tuberculosis and
reproductive health guides procurement decisions by agencies like UNAIDS and
UNICEF.
The U.S government has been investigating Ranbaxy since 2006, when the Food
and Drug Administration issued a warning letter over manufacturing violations
found at a company plant in India.
Ranbaxy has promised to cooperate fully with the investigation.
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25/07/2008 (GMT+7) |
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An HIV patient at HCM City-based Nhan Ai Hospital
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VietNamNet Bridge – After several newspapers reported that an HIV/AIDS
patient in China had recently recovered, many patients began seeking ways
to get to China for treatment.
Xinhua
News recently quoted the Centre of Disease Control of Jilin Province,
China as saying that a farmer named Wen Congcheng had tested HIV-negative
six years after being diagnosed HIV-positive.
Wen Congcheng
first tested HIV-positive in 2001 at a local disease prevention and
control centre when it was screening blood-plasma donors. Late in 2003, he
was re-confirmed as having HIV/AIDS as a result of another test, this one
at the Centre of Disease Control of
Jilin Province. However, in July this
year, Wen received a negative test result at the No. 1 Clinical Hospital
of Beihua University in Jilin.
Wen decided
to seek another opinion and went to the First Hospital of the China
Medical University and another three hospitals for HIV tests, all of which
turned out to be negative. The Jilin municipal CDC carried out a follow-up
test which confirmed the negative result, and later the provincial CDC
also confirmed the result. If all the positive and subsequent negative
test results are verified, Wen would be the first person in China to
become free of HIV after having contracted it.
In Vietnam,
after newspapers released this news, telephone lines at HIV/AIDS
consulting rooms were jammed because of patients’ requests for further
information. Many said that they heard that some Vietnamese HIV carriers
had been successfully treated in China.
However,
Deputy Minister of Health Trinh Quan Huan confirmed that to date there is
no medicine that completely cures HIV/AIDS and no patients in Vietnam have
survived this disease.
A doctor
specialising in HIV/AIDS at HCM City-based Nhan Ai Hospital said ten years
ago an HIV carrier was found to be free of HIV after several years of
treatment. However, the ratio of lucky patients is 1/100 million.
He said the
Chinese patient didn’t take any medicine but he still recovered from the
disease so perhaps he has a special immune system or there were errors on
the test in 2001.
An expert at
the National Institute for Communicable and Tropical Diseases said of 33
million HIV/AIDS patients around the world, only 1-2 have recovered from
this disease so the possibility of completely curing HIV patients is tiny.
Experts say
that the current HIV treatment methods and drugs can’t completely expel
the HIV virus from the human body.
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Wednesday July 30, 6:47 pm ET
By Paul Elias, Associated Press Writer
SAN FRANCISCO (AP) -- Drug company Abbott Laboratories Inc. agreed Wednesday
to pay between $10 million and $27.5 million to settle an antitrust lawsuit
filed by AIDS patients over the company's 400 percent price hike of a popular
HIV drug.
The ultimate payout depends on the resolution in an appeals court of three
technical legal questions, Abbott spokeswoman Melissa Brotz said.
The settlement also needs to be approved by a federal judge in Oakland,
where the lawsuit was set to go to trial next month.
The Chicago-based company had faced as much as $1 billion in damages if the
judge agreed with the patients' economic experts and found Abbott hiked the
price of the drug to stifle competition.
Lawyers for the patients didn't immediately return telephone calls.
The drug, Norvir, is a key component in several important
"cocktails" containing drugs made by rivals to treat the disease.
On Dec. 3, 2003, Abbott increased the price of Norvir's average daily cost
per patient from $1.71 to $8.57, prompting cries of price gouging from the
AIDS community.
The Food and Drug Administration originally approved the pioneering AIDS
drug in 1999 as a standalone treatment. But by 2003, doctors were prescribing
Norvir as a "booster" drug to be used along with other drug
combinations. The Norvir price hike effectively increased the cost of those
combinations.
Abbott said it increased the drug's price because patients required much
smaller doses of Norvir when used as a booster rather than as a standalone
drug.
The patients and others, including several rival drug makers, accused the
company of raising Norvir's price to drive up the cost of competitors' AIDS
cocktails and drive traffic to Abbott's newly introduced multi-drug cocktail
called Kaletra.
Abbott still faces six other antitrust lawsuits filed by 16 companies,
including rival SmithKline Beacham Corp. Two other lawsuits filed in Illinois
have been dismissed.
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